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Who doesn’t text in 2022? Most state Medicaid programs

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Mon, 04/18/2022 - 11:07

West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Direct-to-Consumer Teledermatology Growth: A Review and Outlook for the Future

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Fri, 04/08/2022 - 10:48
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Direct-to-Consumer Teledermatology Growth: A Review and Outlook for the Future

In recent years, direct-to-consumer (DTC) teledermatology platforms have gained popularity as telehealth business models, allowing patients to directly initiate visits with physicians and purchase medications from single platforms. A shortage of dermatologists, improved technology, drug patent expirations, and rising health care costs accelerated the growth of DTC dermatology.1 During the COVID-19 pandemic, teledermatology adoption surged due to the need to provide care while social distancing and minimizing viral exposure. These needs prompted additional federal funding and loosened regulatory provisions.2 As the userbase of these companies has grown, so have their valuations.3 Although the DTC model has attracted the attention of patients and investors, its rise provokes many questions about patients acting as consumers in health care. Indeed, DTC telemedicine offers greater autonomy and convenience for patients, but it may impact the quality of care and the nature of physician-patient relationships, perhaps making them more transactional.

Evolution of DTC in Health Care

The DTC model emphasizes individual choice and accessible health care. Although the definition has evolved, the core idea is not new.4 Over decades, pharmaceutical companies have spent billions of dollars on DTC advertising, circumventing physicians by directly reaching patients with campaigns on prescription drugs and laboratory tests and shaping public definitions of diseases.5

The DTC model of care is fundamentally different from traditional care models in that it changes the roles of the patient and physician. Whereas early telehealth models required a health care provider to initiate teleconsultations with specialists, DTC telemedicine bypasses this step (eg, the patient can consult a dermatologist without needing a primary care provider’s input first). This care can then be provided by dermatologists with whom patients may or may not have pre-established relationships.4,6

Dermatology was an early adopter of DTC telemedicine. The shortage of dermatologists in the United States created demand for increasing accessibility to dermatologic care. Additionally, the visual nature of diagnosing dermatologic disease was ideal for platforms supporting image sharing.7 Early DTC providers were primarily individual companies offering teledermatology. However, many dermatologists can now offer DTC capabilities via companies such as Amwell and Teladoc Health.8

Over the last 2 decades, start-ups such as Warby Parker (eyeglasses) and Casper (mattresses) defined the DTC industry using borrowed supply chains, cohesive branding, heavy social media marketing, and web-only retail. Scalability, lack of competition, and abundant venture capital created competition across numerous markets.9 Health care capitalized on this DTC model, creating a $700 billion market for products ranging from hearing aids to over-the-counter medications.10

Borrowing from this DTC playbook, platforms were created to offer delivery of generic prescription drugs to patients’ doorsteps. However, unlike with other products bought online, a consumer cannot simply add prescription drugs to their shopping cart and check out. In all models of American medical practice, physicians still serve as gatekeepers, providing a safeguard for patients to ensure appropriate prescription and avoid negative consequences of unnecessary drug use. This new model effectively streamlines diagnosis, prescription, and drug delivery without the patient ever having to leave home. Combining the prescribing and selling of medications (2 tasks that traditionally have been separated) potentially creates financial conflicts of interest (COIs). Additionally, high utilization of health care, including more prescriptions and visits, does not necessarily equal high quality of care. The companies stand to benefit from extra care regardless of need, and thus these models must be scrutinized for any incentives driving unnecessary care and prescriptions.

Ultimately, DTC has evolved to encompass multiple definitions in health care (Table 1). Although all models provide health care, each offers a different modality of delivery. The primary service may be the sale of prescription drugs or simply telemedicine visits. This review primarily discusses DTC pharmaceutical telemedicine platforms that sell private-label drugs and also offer telemedicine services to streamline care. However, the history, risks, and benefits discussed may apply to all models.

Definitions of DTC Business Models in Health Care

 

 

The DTC Landscape

Most DTC companies employ variations on a model with the same 3 main components: a triage questionnaire, telehealth services, and prescription/drug delivery (Figure). The triage questionnaire elicits a history of the patient’s presentation and medical history. Some companies may use artificial intelligence (AI) algorithms to tailor questions to patient needs. There are 2 modalities for patient-provider communication: synchronous and asynchronous. Synchronous communication entails real-time patient-physician conversations via audio only or video call. Asynchronous (or store-and-forward) communication refers to consultations provided via messaging or text-based modality, where a provider may respond to a patient within 24 hours.6 Direct-to-consumer platforms primarily use asynchronous visits (Table 2). However, some also use synchronous modalities if the provider deems it necessary or if state laws require it.

Typical direct-to-consumer (DTC) dermatology model interaction.
Typical direct-to-consumer (DTC) dermatology model interaction.

Once a provider has consulted with the patient, they can prescribe medication as needed. In certain cases, with adequate history, a prescription may be issued without a full physician visit. Furthermore, DTC companies require purchase of their custom-branded generic drugs. Prescriptions are fulfilled by the company’s pharmacy network and directly shipped to patients; few will allow patients to transfer a prescription to a pharmacy of their choice. Some platforms also sell supplements and over-the-counter medications.

List of DTC Companies Offering Dermatology Care and Medication Sales

Payment models vary among these companies, and most do not accept insurance (Table 2). Select models may provide free consultations and only require payment for pharmaceuticals. Others charge for consultations but reallocate payment to the cost of medication if prescribed. Another model involves flat rates for consultations and additional charges for drugs but unlimited messaging with providers for the duration of the prescription. Moreover, patients can subscribe to monthly deliveries of their medications.

Foundation of DTC

Technological advances have enabled patients to receive remote treatment from a single platform offering video calls, AI, electronic medical record interoperability, and integration of drug supply chains. Even in its simplest form, AI is increasingly used, as it allows for programs and chatbots to screen and triage patients.11 Technology also has improved at targeted mass marketing through social media platforms and search engines (eg, companies can use age, interests, location, and other parameters to target individuals likely needing acne treatment).

Drug patent expirations are a key catalyst for the rise of DTC companies, creating an attractive business model with generic drugs as the core product. Since 2008, patents for medications treating chronic conditions, such as erectile dysfunction, have expired. These patent expirations are responsible for $198 billion in projected prescription sales between 2019 and 2024.1 Thus, it follows that DTC companies have seized this opportunity to act as middlemen, taking advantage of these generic medications’ lower costs to create platforms focused on personalization and accessibility.

Rising deductibles have led patients to consider cheaper out-of-pocket alternatives that are not covered by insurance.1 For example, insurers typically do not cover finasteride treatment for conditions deemed cosmetic, such as androgenetic alopecia.12 The low cost of generic drugs creates an attractive business model for patients and investors. According to GoodRx, the average retail price for a 30-day supply of brand-name finasteride (Propecia [Merck]) is $135.92, whereas generic finasteride is $75.24.13 Direct-to-consumer pharmaceutical companies offer a 30-day supply of generic finasteride ranging from $8.33 to $30.14 The average wholesale cost for retailers is an estimated $2.31 for 30 days.15 Although profit margins on generic medications may be lower, more affordable drugs increase the size of the total market. These prescriptions are available as subscription plans, resulting in recurring revenue.

Lax US pharmaceutical marketing regulations allow direct advertising to the general public.16 In 1997, the US Food and Drug Administration allowed DTC advertisements to replace summaries of serious and common adverse effects with short statements covering important risks or referrals to other sources for complete information. In 2015, the US Food and Drug Administration guidelines preventing encouragement of self-diagnosis and self-treatment were withdrawn.5 These changes enable DTC companies to launch large advertising campaigns and to accelerate customer acquisition, as the industry often describes it, with ease.

 

 

Rapid Growth and Implications

Increasing generic drug availability and improving telemedicine capabilities have the potential to reduce costs and barriers but also have the potential for financial gain. Venture capital funds have recognized this opportunity, reflected by millions of dollars of investments, and accelerated the growth of DTC health care start-ups. For example, Ro has raised $376 million from venture capital, valuing the company at $1.5 billion.3

Direct-to-consumer companies require a heavy focus on marketing campaigns for customer acquisition. Their aesthetically pleasing websites and aggressive campaigns target specific audiences based on demographics, digital use habits, and purchasing behavior.4 Some campaigns celebrate the ease of obtaining prescriptions.17 Companies have been effective in recruiting so-called millennial and Generation Z patients, known to search the internet for remedies prior to seeking physician consultations.18 Recognizing these needs, some platforms offer guides on diseases they treat, creating effective customer-acquisition funnels. Recruitment of these technology-friendly patients has proven effective, especially given the largely positive media coverage of DTC platforms––potentially serving as a surrogate for medical credibility for patients.18

Some DTC companies also market physically; skin care ads may be strategically placed in social media feeds, or even found near mirrors in public bathrooms.19 Marketing campaigns also involve disease awareness; such efforts serve to increase diagnoses and prescribed treatments while destigmatizing diseases. Although DTC companies argue this strategy empowers patients, these marketing habits have the potential to take advantage of uninformed patients. Campaigns could potentially medicalize normal experiences and expand disease definitions resulting in overdiagnosis, overtreatment, and wasted resources.5 For example, off-label propranolol use has been advertised to attract patients who might have “nerves that come creeping before an important presentation.”17 Disease awareness campaigns also may lead people to falsely believe unproven drug benefits.5 According to studies, DTC pharmaceutical advertisements are low in informational quality and result in increased patient visits and prescriptions despite cost-effective alternatives.5,20-22

Fragmentation of the health care system is another possible complication of DTC teledermatology. These companies operate as for-profit organizations separated from the rest of the health care system, raising concerns about care coordination.8 Vital health data may not be conveyed as patients move among different providers and pharmacies. One study found DTC teledermatology rarely offered to provide medical records or facilitate a referral to a local physician.23 Such a lack of communication is concerning, as medication errors are the leading cause of avoidable harm in health care.24

Direct-to-consumer care models also seemingly redefine the physician-patient relationship by turning patients into consumers. Patient interactions may seem transactional and streamlined toward sales. For these platforms, a visit often is set up as an evaluation of a patient’s suitability for a prescription, not necessarily for the best treatment modality for the problem. These companies primarily make money through the sale of prescription drugs, creating a potential COI that may undermine the patient-physician relationship. Although some companies have made it clear that medical care and pharmaceutical sales are provided by legally separate business entities and that they do not pay physicians on commission, a conflict may still exist given the financial importance of physicians prescribing medication to the success of the business.16

Even as DTC models advertise upon expanded access and choice, the companies largely prohibit patients from choosing their own pharmacy. Instead, they encourage patients to fill prescriptions with the company’s pharmacy network by claiming lower costs compared with competitors. One DTC company, Hims, is launching a prescription-fulfillment center to further consolidate their business.17,19,25 The inherent COI of issuing and fulfilling prescriptions raises concerns of patient harm.26 For example, when Dermatology.com launched as a DTC prescription skin medication shop backed by Bausch Health Companies Inc, its model included telemedicine consultation. Although consultations were provided by RxDefine, a third party, only Dermatology.com drugs were prescribed. Given the poor quality of care and obvious financial COI, an uproar in the dermatology community and advocacy by the American Academy of Dermatology led to the shutdown of Dermatology.com’s online prescription services.26

The quality of care among DTC telemedicine platforms has been equivocal. Some studies have reported equivalent care in person and online, while others have reported poor adherence to guidelines, overuse of antibiotics, and misdiagnosis.8,23 A vital portion of the DTC experience is the history questionnaire, which is geared to diagnosis and risk assessment.25 Resneck et al23 found diagnostic quality to be adequate for simple dermatologic clinical scenarios but poor for scenarios requiring more than basic histories. Although Ro has reported leveraging data from millions of interactions to ask the right questions and streamline visits, it is still unclear whether history questionnaires are adequate.17,27 Additionally, consultations may lack sufficient counseling on adverse effects, risks, or pregnancy warnings, as well as discussions on alternative treatments and preventative care.17,23 Finally, patients often are limited in their choice of dermatologist; the lack of a fully developed relationship increases concerns of follow-up and monitoring practices. Although some DTC platforms offer unlimited interactions with physicians for the duration of a prescription, it is unknown how often these services are utilized or how adequate the quality of these interactions is. This potential for lax follow-up is especially concerning for prescriptions that autorenew on a monthly basis and could result in unnecessary overtreatment.

 

 

Postpandemic and Future Outlook

The COVID-19 pandemic dramatically impacted the use of telemedicine. To minimize COVID-19 transmission, the Centers for Medicare & Medicaid Services and private payers expanded telehealth coverage and eliminated reimbursement and licensing barriers.28 A decade’s worth of regulatory changes and consumer adoption was accelerated to weeks, resulting in telemedicine companies reaching record-high visit numbers.29 McKinsey & Company estimated that telehealth visit numbers surged 50- to 175-fold compared with pre–COVID-19 numbers. Additionally, 76% of patients were interested in future telehealth use, and 64% of providers were more comfortable using telehealth than before the pandemic.30 For their part, US dermatologists reported an increase in telemedicine use from 14.1% to 96.9% since COVID-19.31

Exactly how much DTC pharmaceutical telemedicine companies are growing is unclear, but private investments may be an indication. A record $14.7 billion was invested in the digital health sector in the first half of 2021; the majority went to telehealth companies.30 Ro, which reported $230 million in revenue in 2020 and has served 6 million visits, raised $200 milllion in July 2020 and $500 million in March 2021.32 Although post–COVID-19 health care will certainly involve increased telemedicine, the extent remains unclear, as telehealth vendors saw decreased usage upon reopening of state economies. Ultimately, the postpandemic regulatory landscape is hard to predict.30

Although COVID-19 appears to have caused rapid growth for DTC platforms, it also may have spurred competition. Telemedicine providers have given independent dermatologists and health care systems the infrastructure to implement custom DTC services.33 Although systems do not directly sell prescription drugs, the target market is essentially the same: patients looking for instant virtual dermatologic care. Therefore, sustained telemedicine services offered by traditional practices and systems may prove detrimental to DTC companies. However, unlike most telemedicine services, DTC models are less affected by certain changes in regulation since they do not rely on insurance. If regulations are tightened and reimbursements for telehealth are not attractive for dermatologists, teledermatology services may see an overall decrease. If so, patients who appreciate teledermatology may shift to using DTC platforms, even if their insurance does not cover them. Still, a nationwide survey found 56% of respondents felt an established relationship with a physician prior to a telemedicine visit is important, which may create a barrier for DTC adoption.34

Conclusion

Direct-to-consumer teledermatology represents a growing for-profit model of health care that provides patients with seemingly affordable and convenient care. However, there is potential for overtreatment, misdiagnosis, and fragmentation of health care. It will be important to monitor and evaluate the quality of care that DTC teledermatology offers and advocate for appropriate regulations and oversight. Eventually, more patients will have medications prescribed and dermatologic care administered through DTC companies. Dermatologists will benefit from this knowledge of DTC models to properly counsel patients on the risks and benefits of their use.

References
  1. Vennare J. The DTC healthcare report. Fitt Insider. September 15, 2019. Accessed February 23, 2022. https://insider.fitt.co/direct-to-consumer-healthcare-startups/
  2. Kannampallil T, Ma J. Digital translucence: adapting telemedicine delivery post-COVID-19. Telemed J E Health. 2020;26:1120-1122.
  3. Farr C. Ro, a 3-year-old online health provider, just raised a new round that values it at $1.5 billion. CNBC. July 27, 2020. Accessed February 23, 2022. https://www.cnbc.com/2020/07/27/ro-raises-200-million-at-1point5-billion-valuation-250-million-sales.html
  4. Elliott T, Shih J. Direct to consumer telemedicine. Curr Allergy Asthma Rep. 2019;19:1.
  5. Schwartz LM, Woloshin S. Medical marketing in the United States, 1997-2016. JAMA. 2019;321:80-96.
  6. Peart JM, Kovarik C. Direct-to-patient teledermatology practices. J Am Acad Dermatol. 2015;72:907-909.
  7. Coates SJ, Kvedar J, Granstein RD. Teledermatology: from historical perspective to emerging techniques of the modern era. J Am Acad Dermatol. 2015;72:563-574.
  8. Rheuban KS, Krupinski EA, eds. Understanding Telehealth. McGraw-Hill Education; 2017.
  9. Schlesinger LA, Higgins M, Roseman S. Reinventing the direct-to-consumer business model. Harvard Business Review. March 31, 2020. Accessed February 23, 2022. https://hbr.org/2020/03/reinventing-the-direct-to-consumer-business-model
  10. Cohen AB, Mathews SC, Dorsey ER, et al. Direct-to-consumer digital health. Lancet Digit Health. 2020;2:E163-E165.
  11. 6 telehealth trends for 2020. Wolters Kluwer. Published January 27, 2021. Accessed February 23, 2022. https://www.wolterskluwer.com/en/expert-insights/6-telehealth-trends-for-2020
  12. Jadoo SA, Lipoff JB. Prescribing to save patients money: ethical considerations. J Am Acad Dermatol. 2018;78:826-828.
  13. Propecia. GoodRx. Accessed February 23, 2022. https://www.goodrx.com/propecia
  14. Lauer A. The truth about online hair-loss treatments like Roman and Hims, according to a dermatologist. InsideHook. January 13, 2020. Accessed February 23, 2022. https://www.insidehook.com/article/grooming/men-hair-loss-treatments-dermatologist-review
  15. Friedman Y. Drug price trends for NDC 16729-0089. DrugPatentWatch. Accessed February 23, 2022. https://www.drugpatentwatch.com/p/drug-price/ndc/index.php?query=16729-0089
  16. Curtis H, Milner J. Ethical concerns with online direct-to-consumer pharmaceutical companies. J Med Ethics. 2020;46:168-171.
  17. Jain T, Lu RJ, Mehrotra A. Prescriptions on demand: the growth of direct-to-consumer telemedicine companies. JAMA. 2019;322:925-926.
  18. Shahinyan RH, Amighi A, Carey AN, et al. Direct-to-consumer internet prescription platforms overlook crucial pathology found during traditional office evaluation of young men with erectile dysfunction. Urology. 2020;143:165-172.
  19. Ali M. Andrew Dudum—bold strategies that propelled Hims & Hers into unicorn status. Exit Strategy with Moiz Ali. Published April 2020. Accessed February 23, 2022. https://open.spotify.com/episode/6DtaJxwZDjvZSJI88DTf24?si=b3FHQiUIQY62YjfRHmnJBQ
  20. Klara K, Kim J, Ross JS. Direct-to-consumer broadcast advertisements for pharmaceuticals: off-label promotion and adherence to FDA guidelines. J Gen Intern Med. 2018;33:651-658.
  21. Sullivan HW, Aikin KJ, Poehlman J. Communicating risk information in direct-to-consumer prescription drug television ads: a content analysis. Health Commun. 2019;34:212-219.
  22. Applequist J, Ball JG. An updated analysis of direct-to-consumer television advertisements for prescription drugs. Ann Fam Med. 2018;16:211-216.
  23. Resneck JS Jr, Abrouk M, Steuer M, et al. Choice, transparency, coordination, and quality among direct-to-consumer telemedicine websites and apps treating skin disease. JAMA Dermatol. 2016;152:768-775.
  24. Patient safety. World Health Organization. Published September 13, 2019. Accessed February 1, 2022. https://www.who.int/news-room/fact-sheets/detail/patient-safety
  25. Bollmeier SG, Stevenson E, Finnegan P, et al. Direct to consumer telemedicine: is healthcare from home best? Mo Med. 2020;117:303-309.


26. Court E. Bausch yanked online prescribing after dermatologist backlash. Bloomberg.com. Published March 11, 2020. Accessed September 25, 2020. https://www.bloomberg.com/news/articles/2020-03-11/bausch-yanked-online-prescribing-after-dermatologist-backlash

27. Reitano Z. The future of healthcare: how Ro helps providers treat patients 2 minutes, 2 days, 2 weeks, and 2 years at a time. Medium. Published March 4, 2019. Accessed February 1, 2022. https://medium.com/ro-co/the-future-of-healthcare-how-ro-helps-providers-treat-patients-2-mins-2-days-2-weeks-and-2-10efc0679d7

28. Lee I, Kovarik C, Tejasvi T, et al. Telehealth: helping your patients and practice survive and thrive during the COVID-19 crisis with rapid quality implementation. J Am Acad Dermatol. 2020;82:1213-1214.

29. Pifer R. “Weeks where decades happen”: telehealth 6 months into COVID-19. Healthcare Dive. Published July 27, 2020. Accessed February 23, 2022. https://www.healthcaredive.com/news/telehealth-6-months-coronavirus/581447/

30. Bestsennyy O, Gilbert G, Harris A, et al. Telehealth: a quarter-trillion-dollar post-COVID-19 reality? McKinsey & Company. Updated July 9, 2021. Accessed February 23, 2022. https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality

31. Kennedy J, Arey S, Hopkins Z, et al. Dermatologist perceptions of teledermatology implementation and future use after COVID-19: demographics, barriers, and insights. JAMA Dermatol. 2021;157:595-597.

32. Jennings K. Digital health startup Ro raised $500 million at $5 billion valuation. Forbes. March 22, 2021. Accessed March 29, 2022. https://www.forbes.com/sites/katiejennings/2021/03/22/digital-health-startup-ro-raised-500-million-at-5-billion-valuation/?sh=695be0e462f5

33. Hollander JE, Carr BG. Virtually perfect? telemedicine for COVID-19. N Engl J Med. 2020;382:1679-1681.

34. Welch BM, Harvey J, O’Connell NS, et al. Patient preferences for direct-to-consumer telemedicine services: a nationwide survey. BMC Health Serv Res. 2017;17:784.

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Author and Disclosure Information

Mr. Ranpariya and Dr. Kats are from Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey. Dr. Lipoff is from the Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Mr. Ranpariya and Dr. Kats report no conflicts of interest. Dr. Lipoff is the past chair of the American Academy of Dermatology Teledermatology Task Force and a member of the American Academy of Dermatology’s ad hoc COVID-19 task force. He has served as a telemedicine advisor for AcneAway, a direct-to-consumer teledermatology start-up.

Correspondence: Jules B. Lipoff, MD, Department of Dermatology, University of Pennsylvania, Penn Medicine University City, 3737 Market St, Ste 1100, Philadelphia, PA 19104 ([email protected]).

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Author and Disclosure Information

Mr. Ranpariya and Dr. Kats are from Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey. Dr. Lipoff is from the Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Mr. Ranpariya and Dr. Kats report no conflicts of interest. Dr. Lipoff is the past chair of the American Academy of Dermatology Teledermatology Task Force and a member of the American Academy of Dermatology’s ad hoc COVID-19 task force. He has served as a telemedicine advisor for AcneAway, a direct-to-consumer teledermatology start-up.

Correspondence: Jules B. Lipoff, MD, Department of Dermatology, University of Pennsylvania, Penn Medicine University City, 3737 Market St, Ste 1100, Philadelphia, PA 19104 ([email protected]).

Author and Disclosure Information

Mr. Ranpariya and Dr. Kats are from Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey. Dr. Lipoff is from the Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Mr. Ranpariya and Dr. Kats report no conflicts of interest. Dr. Lipoff is the past chair of the American Academy of Dermatology Teledermatology Task Force and a member of the American Academy of Dermatology’s ad hoc COVID-19 task force. He has served as a telemedicine advisor for AcneAway, a direct-to-consumer teledermatology start-up.

Correspondence: Jules B. Lipoff, MD, Department of Dermatology, University of Pennsylvania, Penn Medicine University City, 3737 Market St, Ste 1100, Philadelphia, PA 19104 ([email protected]).

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In recent years, direct-to-consumer (DTC) teledermatology platforms have gained popularity as telehealth business models, allowing patients to directly initiate visits with physicians and purchase medications from single platforms. A shortage of dermatologists, improved technology, drug patent expirations, and rising health care costs accelerated the growth of DTC dermatology.1 During the COVID-19 pandemic, teledermatology adoption surged due to the need to provide care while social distancing and minimizing viral exposure. These needs prompted additional federal funding and loosened regulatory provisions.2 As the userbase of these companies has grown, so have their valuations.3 Although the DTC model has attracted the attention of patients and investors, its rise provokes many questions about patients acting as consumers in health care. Indeed, DTC telemedicine offers greater autonomy and convenience for patients, but it may impact the quality of care and the nature of physician-patient relationships, perhaps making them more transactional.

Evolution of DTC in Health Care

The DTC model emphasizes individual choice and accessible health care. Although the definition has evolved, the core idea is not new.4 Over decades, pharmaceutical companies have spent billions of dollars on DTC advertising, circumventing physicians by directly reaching patients with campaigns on prescription drugs and laboratory tests and shaping public definitions of diseases.5

The DTC model of care is fundamentally different from traditional care models in that it changes the roles of the patient and physician. Whereas early telehealth models required a health care provider to initiate teleconsultations with specialists, DTC telemedicine bypasses this step (eg, the patient can consult a dermatologist without needing a primary care provider’s input first). This care can then be provided by dermatologists with whom patients may or may not have pre-established relationships.4,6

Dermatology was an early adopter of DTC telemedicine. The shortage of dermatologists in the United States created demand for increasing accessibility to dermatologic care. Additionally, the visual nature of diagnosing dermatologic disease was ideal for platforms supporting image sharing.7 Early DTC providers were primarily individual companies offering teledermatology. However, many dermatologists can now offer DTC capabilities via companies such as Amwell and Teladoc Health.8

Over the last 2 decades, start-ups such as Warby Parker (eyeglasses) and Casper (mattresses) defined the DTC industry using borrowed supply chains, cohesive branding, heavy social media marketing, and web-only retail. Scalability, lack of competition, and abundant venture capital created competition across numerous markets.9 Health care capitalized on this DTC model, creating a $700 billion market for products ranging from hearing aids to over-the-counter medications.10

Borrowing from this DTC playbook, platforms were created to offer delivery of generic prescription drugs to patients’ doorsteps. However, unlike with other products bought online, a consumer cannot simply add prescription drugs to their shopping cart and check out. In all models of American medical practice, physicians still serve as gatekeepers, providing a safeguard for patients to ensure appropriate prescription and avoid negative consequences of unnecessary drug use. This new model effectively streamlines diagnosis, prescription, and drug delivery without the patient ever having to leave home. Combining the prescribing and selling of medications (2 tasks that traditionally have been separated) potentially creates financial conflicts of interest (COIs). Additionally, high utilization of health care, including more prescriptions and visits, does not necessarily equal high quality of care. The companies stand to benefit from extra care regardless of need, and thus these models must be scrutinized for any incentives driving unnecessary care and prescriptions.

Ultimately, DTC has evolved to encompass multiple definitions in health care (Table 1). Although all models provide health care, each offers a different modality of delivery. The primary service may be the sale of prescription drugs or simply telemedicine visits. This review primarily discusses DTC pharmaceutical telemedicine platforms that sell private-label drugs and also offer telemedicine services to streamline care. However, the history, risks, and benefits discussed may apply to all models.

Definitions of DTC Business Models in Health Care

 

 

The DTC Landscape

Most DTC companies employ variations on a model with the same 3 main components: a triage questionnaire, telehealth services, and prescription/drug delivery (Figure). The triage questionnaire elicits a history of the patient’s presentation and medical history. Some companies may use artificial intelligence (AI) algorithms to tailor questions to patient needs. There are 2 modalities for patient-provider communication: synchronous and asynchronous. Synchronous communication entails real-time patient-physician conversations via audio only or video call. Asynchronous (or store-and-forward) communication refers to consultations provided via messaging or text-based modality, where a provider may respond to a patient within 24 hours.6 Direct-to-consumer platforms primarily use asynchronous visits (Table 2). However, some also use synchronous modalities if the provider deems it necessary or if state laws require it.

Typical direct-to-consumer (DTC) dermatology model interaction.
Typical direct-to-consumer (DTC) dermatology model interaction.

Once a provider has consulted with the patient, they can prescribe medication as needed. In certain cases, with adequate history, a prescription may be issued without a full physician visit. Furthermore, DTC companies require purchase of their custom-branded generic drugs. Prescriptions are fulfilled by the company’s pharmacy network and directly shipped to patients; few will allow patients to transfer a prescription to a pharmacy of their choice. Some platforms also sell supplements and over-the-counter medications.

List of DTC Companies Offering Dermatology Care and Medication Sales

Payment models vary among these companies, and most do not accept insurance (Table 2). Select models may provide free consultations and only require payment for pharmaceuticals. Others charge for consultations but reallocate payment to the cost of medication if prescribed. Another model involves flat rates for consultations and additional charges for drugs but unlimited messaging with providers for the duration of the prescription. Moreover, patients can subscribe to monthly deliveries of their medications.

Foundation of DTC

Technological advances have enabled patients to receive remote treatment from a single platform offering video calls, AI, electronic medical record interoperability, and integration of drug supply chains. Even in its simplest form, AI is increasingly used, as it allows for programs and chatbots to screen and triage patients.11 Technology also has improved at targeted mass marketing through social media platforms and search engines (eg, companies can use age, interests, location, and other parameters to target individuals likely needing acne treatment).

Drug patent expirations are a key catalyst for the rise of DTC companies, creating an attractive business model with generic drugs as the core product. Since 2008, patents for medications treating chronic conditions, such as erectile dysfunction, have expired. These patent expirations are responsible for $198 billion in projected prescription sales between 2019 and 2024.1 Thus, it follows that DTC companies have seized this opportunity to act as middlemen, taking advantage of these generic medications’ lower costs to create platforms focused on personalization and accessibility.

Rising deductibles have led patients to consider cheaper out-of-pocket alternatives that are not covered by insurance.1 For example, insurers typically do not cover finasteride treatment for conditions deemed cosmetic, such as androgenetic alopecia.12 The low cost of generic drugs creates an attractive business model for patients and investors. According to GoodRx, the average retail price for a 30-day supply of brand-name finasteride (Propecia [Merck]) is $135.92, whereas generic finasteride is $75.24.13 Direct-to-consumer pharmaceutical companies offer a 30-day supply of generic finasteride ranging from $8.33 to $30.14 The average wholesale cost for retailers is an estimated $2.31 for 30 days.15 Although profit margins on generic medications may be lower, more affordable drugs increase the size of the total market. These prescriptions are available as subscription plans, resulting in recurring revenue.

Lax US pharmaceutical marketing regulations allow direct advertising to the general public.16 In 1997, the US Food and Drug Administration allowed DTC advertisements to replace summaries of serious and common adverse effects with short statements covering important risks or referrals to other sources for complete information. In 2015, the US Food and Drug Administration guidelines preventing encouragement of self-diagnosis and self-treatment were withdrawn.5 These changes enable DTC companies to launch large advertising campaigns and to accelerate customer acquisition, as the industry often describes it, with ease.

 

 

Rapid Growth and Implications

Increasing generic drug availability and improving telemedicine capabilities have the potential to reduce costs and barriers but also have the potential for financial gain. Venture capital funds have recognized this opportunity, reflected by millions of dollars of investments, and accelerated the growth of DTC health care start-ups. For example, Ro has raised $376 million from venture capital, valuing the company at $1.5 billion.3

Direct-to-consumer companies require a heavy focus on marketing campaigns for customer acquisition. Their aesthetically pleasing websites and aggressive campaigns target specific audiences based on demographics, digital use habits, and purchasing behavior.4 Some campaigns celebrate the ease of obtaining prescriptions.17 Companies have been effective in recruiting so-called millennial and Generation Z patients, known to search the internet for remedies prior to seeking physician consultations.18 Recognizing these needs, some platforms offer guides on diseases they treat, creating effective customer-acquisition funnels. Recruitment of these technology-friendly patients has proven effective, especially given the largely positive media coverage of DTC platforms––potentially serving as a surrogate for medical credibility for patients.18

Some DTC companies also market physically; skin care ads may be strategically placed in social media feeds, or even found near mirrors in public bathrooms.19 Marketing campaigns also involve disease awareness; such efforts serve to increase diagnoses and prescribed treatments while destigmatizing diseases. Although DTC companies argue this strategy empowers patients, these marketing habits have the potential to take advantage of uninformed patients. Campaigns could potentially medicalize normal experiences and expand disease definitions resulting in overdiagnosis, overtreatment, and wasted resources.5 For example, off-label propranolol use has been advertised to attract patients who might have “nerves that come creeping before an important presentation.”17 Disease awareness campaigns also may lead people to falsely believe unproven drug benefits.5 According to studies, DTC pharmaceutical advertisements are low in informational quality and result in increased patient visits and prescriptions despite cost-effective alternatives.5,20-22

Fragmentation of the health care system is another possible complication of DTC teledermatology. These companies operate as for-profit organizations separated from the rest of the health care system, raising concerns about care coordination.8 Vital health data may not be conveyed as patients move among different providers and pharmacies. One study found DTC teledermatology rarely offered to provide medical records or facilitate a referral to a local physician.23 Such a lack of communication is concerning, as medication errors are the leading cause of avoidable harm in health care.24

Direct-to-consumer care models also seemingly redefine the physician-patient relationship by turning patients into consumers. Patient interactions may seem transactional and streamlined toward sales. For these platforms, a visit often is set up as an evaluation of a patient’s suitability for a prescription, not necessarily for the best treatment modality for the problem. These companies primarily make money through the sale of prescription drugs, creating a potential COI that may undermine the patient-physician relationship. Although some companies have made it clear that medical care and pharmaceutical sales are provided by legally separate business entities and that they do not pay physicians on commission, a conflict may still exist given the financial importance of physicians prescribing medication to the success of the business.16

Even as DTC models advertise upon expanded access and choice, the companies largely prohibit patients from choosing their own pharmacy. Instead, they encourage patients to fill prescriptions with the company’s pharmacy network by claiming lower costs compared with competitors. One DTC company, Hims, is launching a prescription-fulfillment center to further consolidate their business.17,19,25 The inherent COI of issuing and fulfilling prescriptions raises concerns of patient harm.26 For example, when Dermatology.com launched as a DTC prescription skin medication shop backed by Bausch Health Companies Inc, its model included telemedicine consultation. Although consultations were provided by RxDefine, a third party, only Dermatology.com drugs were prescribed. Given the poor quality of care and obvious financial COI, an uproar in the dermatology community and advocacy by the American Academy of Dermatology led to the shutdown of Dermatology.com’s online prescription services.26

The quality of care among DTC telemedicine platforms has been equivocal. Some studies have reported equivalent care in person and online, while others have reported poor adherence to guidelines, overuse of antibiotics, and misdiagnosis.8,23 A vital portion of the DTC experience is the history questionnaire, which is geared to diagnosis and risk assessment.25 Resneck et al23 found diagnostic quality to be adequate for simple dermatologic clinical scenarios but poor for scenarios requiring more than basic histories. Although Ro has reported leveraging data from millions of interactions to ask the right questions and streamline visits, it is still unclear whether history questionnaires are adequate.17,27 Additionally, consultations may lack sufficient counseling on adverse effects, risks, or pregnancy warnings, as well as discussions on alternative treatments and preventative care.17,23 Finally, patients often are limited in their choice of dermatologist; the lack of a fully developed relationship increases concerns of follow-up and monitoring practices. Although some DTC platforms offer unlimited interactions with physicians for the duration of a prescription, it is unknown how often these services are utilized or how adequate the quality of these interactions is. This potential for lax follow-up is especially concerning for prescriptions that autorenew on a monthly basis and could result in unnecessary overtreatment.

 

 

Postpandemic and Future Outlook

The COVID-19 pandemic dramatically impacted the use of telemedicine. To minimize COVID-19 transmission, the Centers for Medicare & Medicaid Services and private payers expanded telehealth coverage and eliminated reimbursement and licensing barriers.28 A decade’s worth of regulatory changes and consumer adoption was accelerated to weeks, resulting in telemedicine companies reaching record-high visit numbers.29 McKinsey & Company estimated that telehealth visit numbers surged 50- to 175-fold compared with pre–COVID-19 numbers. Additionally, 76% of patients were interested in future telehealth use, and 64% of providers were more comfortable using telehealth than before the pandemic.30 For their part, US dermatologists reported an increase in telemedicine use from 14.1% to 96.9% since COVID-19.31

Exactly how much DTC pharmaceutical telemedicine companies are growing is unclear, but private investments may be an indication. A record $14.7 billion was invested in the digital health sector in the first half of 2021; the majority went to telehealth companies.30 Ro, which reported $230 million in revenue in 2020 and has served 6 million visits, raised $200 milllion in July 2020 and $500 million in March 2021.32 Although post–COVID-19 health care will certainly involve increased telemedicine, the extent remains unclear, as telehealth vendors saw decreased usage upon reopening of state economies. Ultimately, the postpandemic regulatory landscape is hard to predict.30

Although COVID-19 appears to have caused rapid growth for DTC platforms, it also may have spurred competition. Telemedicine providers have given independent dermatologists and health care systems the infrastructure to implement custom DTC services.33 Although systems do not directly sell prescription drugs, the target market is essentially the same: patients looking for instant virtual dermatologic care. Therefore, sustained telemedicine services offered by traditional practices and systems may prove detrimental to DTC companies. However, unlike most telemedicine services, DTC models are less affected by certain changes in regulation since they do not rely on insurance. If regulations are tightened and reimbursements for telehealth are not attractive for dermatologists, teledermatology services may see an overall decrease. If so, patients who appreciate teledermatology may shift to using DTC platforms, even if their insurance does not cover them. Still, a nationwide survey found 56% of respondents felt an established relationship with a physician prior to a telemedicine visit is important, which may create a barrier for DTC adoption.34

Conclusion

Direct-to-consumer teledermatology represents a growing for-profit model of health care that provides patients with seemingly affordable and convenient care. However, there is potential for overtreatment, misdiagnosis, and fragmentation of health care. It will be important to monitor and evaluate the quality of care that DTC teledermatology offers and advocate for appropriate regulations and oversight. Eventually, more patients will have medications prescribed and dermatologic care administered through DTC companies. Dermatologists will benefit from this knowledge of DTC models to properly counsel patients on the risks and benefits of their use.

In recent years, direct-to-consumer (DTC) teledermatology platforms have gained popularity as telehealth business models, allowing patients to directly initiate visits with physicians and purchase medications from single platforms. A shortage of dermatologists, improved technology, drug patent expirations, and rising health care costs accelerated the growth of DTC dermatology.1 During the COVID-19 pandemic, teledermatology adoption surged due to the need to provide care while social distancing and minimizing viral exposure. These needs prompted additional federal funding and loosened regulatory provisions.2 As the userbase of these companies has grown, so have their valuations.3 Although the DTC model has attracted the attention of patients and investors, its rise provokes many questions about patients acting as consumers in health care. Indeed, DTC telemedicine offers greater autonomy and convenience for patients, but it may impact the quality of care and the nature of physician-patient relationships, perhaps making them more transactional.

Evolution of DTC in Health Care

The DTC model emphasizes individual choice and accessible health care. Although the definition has evolved, the core idea is not new.4 Over decades, pharmaceutical companies have spent billions of dollars on DTC advertising, circumventing physicians by directly reaching patients with campaigns on prescription drugs and laboratory tests and shaping public definitions of diseases.5

The DTC model of care is fundamentally different from traditional care models in that it changes the roles of the patient and physician. Whereas early telehealth models required a health care provider to initiate teleconsultations with specialists, DTC telemedicine bypasses this step (eg, the patient can consult a dermatologist without needing a primary care provider’s input first). This care can then be provided by dermatologists with whom patients may or may not have pre-established relationships.4,6

Dermatology was an early adopter of DTC telemedicine. The shortage of dermatologists in the United States created demand for increasing accessibility to dermatologic care. Additionally, the visual nature of diagnosing dermatologic disease was ideal for platforms supporting image sharing.7 Early DTC providers were primarily individual companies offering teledermatology. However, many dermatologists can now offer DTC capabilities via companies such as Amwell and Teladoc Health.8

Over the last 2 decades, start-ups such as Warby Parker (eyeglasses) and Casper (mattresses) defined the DTC industry using borrowed supply chains, cohesive branding, heavy social media marketing, and web-only retail. Scalability, lack of competition, and abundant venture capital created competition across numerous markets.9 Health care capitalized on this DTC model, creating a $700 billion market for products ranging from hearing aids to over-the-counter medications.10

Borrowing from this DTC playbook, platforms were created to offer delivery of generic prescription drugs to patients’ doorsteps. However, unlike with other products bought online, a consumer cannot simply add prescription drugs to their shopping cart and check out. In all models of American medical practice, physicians still serve as gatekeepers, providing a safeguard for patients to ensure appropriate prescription and avoid negative consequences of unnecessary drug use. This new model effectively streamlines diagnosis, prescription, and drug delivery without the patient ever having to leave home. Combining the prescribing and selling of medications (2 tasks that traditionally have been separated) potentially creates financial conflicts of interest (COIs). Additionally, high utilization of health care, including more prescriptions and visits, does not necessarily equal high quality of care. The companies stand to benefit from extra care regardless of need, and thus these models must be scrutinized for any incentives driving unnecessary care and prescriptions.

Ultimately, DTC has evolved to encompass multiple definitions in health care (Table 1). Although all models provide health care, each offers a different modality of delivery. The primary service may be the sale of prescription drugs or simply telemedicine visits. This review primarily discusses DTC pharmaceutical telemedicine platforms that sell private-label drugs and also offer telemedicine services to streamline care. However, the history, risks, and benefits discussed may apply to all models.

Definitions of DTC Business Models in Health Care

 

 

The DTC Landscape

Most DTC companies employ variations on a model with the same 3 main components: a triage questionnaire, telehealth services, and prescription/drug delivery (Figure). The triage questionnaire elicits a history of the patient’s presentation and medical history. Some companies may use artificial intelligence (AI) algorithms to tailor questions to patient needs. There are 2 modalities for patient-provider communication: synchronous and asynchronous. Synchronous communication entails real-time patient-physician conversations via audio only or video call. Asynchronous (or store-and-forward) communication refers to consultations provided via messaging or text-based modality, where a provider may respond to a patient within 24 hours.6 Direct-to-consumer platforms primarily use asynchronous visits (Table 2). However, some also use synchronous modalities if the provider deems it necessary or if state laws require it.

Typical direct-to-consumer (DTC) dermatology model interaction.
Typical direct-to-consumer (DTC) dermatology model interaction.

Once a provider has consulted with the patient, they can prescribe medication as needed. In certain cases, with adequate history, a prescription may be issued without a full physician visit. Furthermore, DTC companies require purchase of their custom-branded generic drugs. Prescriptions are fulfilled by the company’s pharmacy network and directly shipped to patients; few will allow patients to transfer a prescription to a pharmacy of their choice. Some platforms also sell supplements and over-the-counter medications.

List of DTC Companies Offering Dermatology Care and Medication Sales

Payment models vary among these companies, and most do not accept insurance (Table 2). Select models may provide free consultations and only require payment for pharmaceuticals. Others charge for consultations but reallocate payment to the cost of medication if prescribed. Another model involves flat rates for consultations and additional charges for drugs but unlimited messaging with providers for the duration of the prescription. Moreover, patients can subscribe to monthly deliveries of their medications.

Foundation of DTC

Technological advances have enabled patients to receive remote treatment from a single platform offering video calls, AI, electronic medical record interoperability, and integration of drug supply chains. Even in its simplest form, AI is increasingly used, as it allows for programs and chatbots to screen and triage patients.11 Technology also has improved at targeted mass marketing through social media platforms and search engines (eg, companies can use age, interests, location, and other parameters to target individuals likely needing acne treatment).

Drug patent expirations are a key catalyst for the rise of DTC companies, creating an attractive business model with generic drugs as the core product. Since 2008, patents for medications treating chronic conditions, such as erectile dysfunction, have expired. These patent expirations are responsible for $198 billion in projected prescription sales between 2019 and 2024.1 Thus, it follows that DTC companies have seized this opportunity to act as middlemen, taking advantage of these generic medications’ lower costs to create platforms focused on personalization and accessibility.

Rising deductibles have led patients to consider cheaper out-of-pocket alternatives that are not covered by insurance.1 For example, insurers typically do not cover finasteride treatment for conditions deemed cosmetic, such as androgenetic alopecia.12 The low cost of generic drugs creates an attractive business model for patients and investors. According to GoodRx, the average retail price for a 30-day supply of brand-name finasteride (Propecia [Merck]) is $135.92, whereas generic finasteride is $75.24.13 Direct-to-consumer pharmaceutical companies offer a 30-day supply of generic finasteride ranging from $8.33 to $30.14 The average wholesale cost for retailers is an estimated $2.31 for 30 days.15 Although profit margins on generic medications may be lower, more affordable drugs increase the size of the total market. These prescriptions are available as subscription plans, resulting in recurring revenue.

Lax US pharmaceutical marketing regulations allow direct advertising to the general public.16 In 1997, the US Food and Drug Administration allowed DTC advertisements to replace summaries of serious and common adverse effects with short statements covering important risks or referrals to other sources for complete information. In 2015, the US Food and Drug Administration guidelines preventing encouragement of self-diagnosis and self-treatment were withdrawn.5 These changes enable DTC companies to launch large advertising campaigns and to accelerate customer acquisition, as the industry often describes it, with ease.

 

 

Rapid Growth and Implications

Increasing generic drug availability and improving telemedicine capabilities have the potential to reduce costs and barriers but also have the potential for financial gain. Venture capital funds have recognized this opportunity, reflected by millions of dollars of investments, and accelerated the growth of DTC health care start-ups. For example, Ro has raised $376 million from venture capital, valuing the company at $1.5 billion.3

Direct-to-consumer companies require a heavy focus on marketing campaigns for customer acquisition. Their aesthetically pleasing websites and aggressive campaigns target specific audiences based on demographics, digital use habits, and purchasing behavior.4 Some campaigns celebrate the ease of obtaining prescriptions.17 Companies have been effective in recruiting so-called millennial and Generation Z patients, known to search the internet for remedies prior to seeking physician consultations.18 Recognizing these needs, some platforms offer guides on diseases they treat, creating effective customer-acquisition funnels. Recruitment of these technology-friendly patients has proven effective, especially given the largely positive media coverage of DTC platforms––potentially serving as a surrogate for medical credibility for patients.18

Some DTC companies also market physically; skin care ads may be strategically placed in social media feeds, or even found near mirrors in public bathrooms.19 Marketing campaigns also involve disease awareness; such efforts serve to increase diagnoses and prescribed treatments while destigmatizing diseases. Although DTC companies argue this strategy empowers patients, these marketing habits have the potential to take advantage of uninformed patients. Campaigns could potentially medicalize normal experiences and expand disease definitions resulting in overdiagnosis, overtreatment, and wasted resources.5 For example, off-label propranolol use has been advertised to attract patients who might have “nerves that come creeping before an important presentation.”17 Disease awareness campaigns also may lead people to falsely believe unproven drug benefits.5 According to studies, DTC pharmaceutical advertisements are low in informational quality and result in increased patient visits and prescriptions despite cost-effective alternatives.5,20-22

Fragmentation of the health care system is another possible complication of DTC teledermatology. These companies operate as for-profit organizations separated from the rest of the health care system, raising concerns about care coordination.8 Vital health data may not be conveyed as patients move among different providers and pharmacies. One study found DTC teledermatology rarely offered to provide medical records or facilitate a referral to a local physician.23 Such a lack of communication is concerning, as medication errors are the leading cause of avoidable harm in health care.24

Direct-to-consumer care models also seemingly redefine the physician-patient relationship by turning patients into consumers. Patient interactions may seem transactional and streamlined toward sales. For these platforms, a visit often is set up as an evaluation of a patient’s suitability for a prescription, not necessarily for the best treatment modality for the problem. These companies primarily make money through the sale of prescription drugs, creating a potential COI that may undermine the patient-physician relationship. Although some companies have made it clear that medical care and pharmaceutical sales are provided by legally separate business entities and that they do not pay physicians on commission, a conflict may still exist given the financial importance of physicians prescribing medication to the success of the business.16

Even as DTC models advertise upon expanded access and choice, the companies largely prohibit patients from choosing their own pharmacy. Instead, they encourage patients to fill prescriptions with the company’s pharmacy network by claiming lower costs compared with competitors. One DTC company, Hims, is launching a prescription-fulfillment center to further consolidate their business.17,19,25 The inherent COI of issuing and fulfilling prescriptions raises concerns of patient harm.26 For example, when Dermatology.com launched as a DTC prescription skin medication shop backed by Bausch Health Companies Inc, its model included telemedicine consultation. Although consultations were provided by RxDefine, a third party, only Dermatology.com drugs were prescribed. Given the poor quality of care and obvious financial COI, an uproar in the dermatology community and advocacy by the American Academy of Dermatology led to the shutdown of Dermatology.com’s online prescription services.26

The quality of care among DTC telemedicine platforms has been equivocal. Some studies have reported equivalent care in person and online, while others have reported poor adherence to guidelines, overuse of antibiotics, and misdiagnosis.8,23 A vital portion of the DTC experience is the history questionnaire, which is geared to diagnosis and risk assessment.25 Resneck et al23 found diagnostic quality to be adequate for simple dermatologic clinical scenarios but poor for scenarios requiring more than basic histories. Although Ro has reported leveraging data from millions of interactions to ask the right questions and streamline visits, it is still unclear whether history questionnaires are adequate.17,27 Additionally, consultations may lack sufficient counseling on adverse effects, risks, or pregnancy warnings, as well as discussions on alternative treatments and preventative care.17,23 Finally, patients often are limited in their choice of dermatologist; the lack of a fully developed relationship increases concerns of follow-up and monitoring practices. Although some DTC platforms offer unlimited interactions with physicians for the duration of a prescription, it is unknown how often these services are utilized or how adequate the quality of these interactions is. This potential for lax follow-up is especially concerning for prescriptions that autorenew on a monthly basis and could result in unnecessary overtreatment.

 

 

Postpandemic and Future Outlook

The COVID-19 pandemic dramatically impacted the use of telemedicine. To minimize COVID-19 transmission, the Centers for Medicare & Medicaid Services and private payers expanded telehealth coverage and eliminated reimbursement and licensing barriers.28 A decade’s worth of regulatory changes and consumer adoption was accelerated to weeks, resulting in telemedicine companies reaching record-high visit numbers.29 McKinsey & Company estimated that telehealth visit numbers surged 50- to 175-fold compared with pre–COVID-19 numbers. Additionally, 76% of patients were interested in future telehealth use, and 64% of providers were more comfortable using telehealth than before the pandemic.30 For their part, US dermatologists reported an increase in telemedicine use from 14.1% to 96.9% since COVID-19.31

Exactly how much DTC pharmaceutical telemedicine companies are growing is unclear, but private investments may be an indication. A record $14.7 billion was invested in the digital health sector in the first half of 2021; the majority went to telehealth companies.30 Ro, which reported $230 million in revenue in 2020 and has served 6 million visits, raised $200 milllion in July 2020 and $500 million in March 2021.32 Although post–COVID-19 health care will certainly involve increased telemedicine, the extent remains unclear, as telehealth vendors saw decreased usage upon reopening of state economies. Ultimately, the postpandemic regulatory landscape is hard to predict.30

Although COVID-19 appears to have caused rapid growth for DTC platforms, it also may have spurred competition. Telemedicine providers have given independent dermatologists and health care systems the infrastructure to implement custom DTC services.33 Although systems do not directly sell prescription drugs, the target market is essentially the same: patients looking for instant virtual dermatologic care. Therefore, sustained telemedicine services offered by traditional practices and systems may prove detrimental to DTC companies. However, unlike most telemedicine services, DTC models are less affected by certain changes in regulation since they do not rely on insurance. If regulations are tightened and reimbursements for telehealth are not attractive for dermatologists, teledermatology services may see an overall decrease. If so, patients who appreciate teledermatology may shift to using DTC platforms, even if their insurance does not cover them. Still, a nationwide survey found 56% of respondents felt an established relationship with a physician prior to a telemedicine visit is important, which may create a barrier for DTC adoption.34

Conclusion

Direct-to-consumer teledermatology represents a growing for-profit model of health care that provides patients with seemingly affordable and convenient care. However, there is potential for overtreatment, misdiagnosis, and fragmentation of health care. It will be important to monitor and evaluate the quality of care that DTC teledermatology offers and advocate for appropriate regulations and oversight. Eventually, more patients will have medications prescribed and dermatologic care administered through DTC companies. Dermatologists will benefit from this knowledge of DTC models to properly counsel patients on the risks and benefits of their use.

References
  1. Vennare J. The DTC healthcare report. Fitt Insider. September 15, 2019. Accessed February 23, 2022. https://insider.fitt.co/direct-to-consumer-healthcare-startups/
  2. Kannampallil T, Ma J. Digital translucence: adapting telemedicine delivery post-COVID-19. Telemed J E Health. 2020;26:1120-1122.
  3. Farr C. Ro, a 3-year-old online health provider, just raised a new round that values it at $1.5 billion. CNBC. July 27, 2020. Accessed February 23, 2022. https://www.cnbc.com/2020/07/27/ro-raises-200-million-at-1point5-billion-valuation-250-million-sales.html
  4. Elliott T, Shih J. Direct to consumer telemedicine. Curr Allergy Asthma Rep. 2019;19:1.
  5. Schwartz LM, Woloshin S. Medical marketing in the United States, 1997-2016. JAMA. 2019;321:80-96.
  6. Peart JM, Kovarik C. Direct-to-patient teledermatology practices. J Am Acad Dermatol. 2015;72:907-909.
  7. Coates SJ, Kvedar J, Granstein RD. Teledermatology: from historical perspective to emerging techniques of the modern era. J Am Acad Dermatol. 2015;72:563-574.
  8. Rheuban KS, Krupinski EA, eds. Understanding Telehealth. McGraw-Hill Education; 2017.
  9. Schlesinger LA, Higgins M, Roseman S. Reinventing the direct-to-consumer business model. Harvard Business Review. March 31, 2020. Accessed February 23, 2022. https://hbr.org/2020/03/reinventing-the-direct-to-consumer-business-model
  10. Cohen AB, Mathews SC, Dorsey ER, et al. Direct-to-consumer digital health. Lancet Digit Health. 2020;2:E163-E165.
  11. 6 telehealth trends for 2020. Wolters Kluwer. Published January 27, 2021. Accessed February 23, 2022. https://www.wolterskluwer.com/en/expert-insights/6-telehealth-trends-for-2020
  12. Jadoo SA, Lipoff JB. Prescribing to save patients money: ethical considerations. J Am Acad Dermatol. 2018;78:826-828.
  13. Propecia. GoodRx. Accessed February 23, 2022. https://www.goodrx.com/propecia
  14. Lauer A. The truth about online hair-loss treatments like Roman and Hims, according to a dermatologist. InsideHook. January 13, 2020. Accessed February 23, 2022. https://www.insidehook.com/article/grooming/men-hair-loss-treatments-dermatologist-review
  15. Friedman Y. Drug price trends for NDC 16729-0089. DrugPatentWatch. Accessed February 23, 2022. https://www.drugpatentwatch.com/p/drug-price/ndc/index.php?query=16729-0089
  16. Curtis H, Milner J. Ethical concerns with online direct-to-consumer pharmaceutical companies. J Med Ethics. 2020;46:168-171.
  17. Jain T, Lu RJ, Mehrotra A. Prescriptions on demand: the growth of direct-to-consumer telemedicine companies. JAMA. 2019;322:925-926.
  18. Shahinyan RH, Amighi A, Carey AN, et al. Direct-to-consumer internet prescription platforms overlook crucial pathology found during traditional office evaluation of young men with erectile dysfunction. Urology. 2020;143:165-172.
  19. Ali M. Andrew Dudum—bold strategies that propelled Hims & Hers into unicorn status. Exit Strategy with Moiz Ali. Published April 2020. Accessed February 23, 2022. https://open.spotify.com/episode/6DtaJxwZDjvZSJI88DTf24?si=b3FHQiUIQY62YjfRHmnJBQ
  20. Klara K, Kim J, Ross JS. Direct-to-consumer broadcast advertisements for pharmaceuticals: off-label promotion and adherence to FDA guidelines. J Gen Intern Med. 2018;33:651-658.
  21. Sullivan HW, Aikin KJ, Poehlman J. Communicating risk information in direct-to-consumer prescription drug television ads: a content analysis. Health Commun. 2019;34:212-219.
  22. Applequist J, Ball JG. An updated analysis of direct-to-consumer television advertisements for prescription drugs. Ann Fam Med. 2018;16:211-216.
  23. Resneck JS Jr, Abrouk M, Steuer M, et al. Choice, transparency, coordination, and quality among direct-to-consumer telemedicine websites and apps treating skin disease. JAMA Dermatol. 2016;152:768-775.
  24. Patient safety. World Health Organization. Published September 13, 2019. Accessed February 1, 2022. https://www.who.int/news-room/fact-sheets/detail/patient-safety
  25. Bollmeier SG, Stevenson E, Finnegan P, et al. Direct to consumer telemedicine: is healthcare from home best? Mo Med. 2020;117:303-309.


26. Court E. Bausch yanked online prescribing after dermatologist backlash. Bloomberg.com. Published March 11, 2020. Accessed September 25, 2020. https://www.bloomberg.com/news/articles/2020-03-11/bausch-yanked-online-prescribing-after-dermatologist-backlash

27. Reitano Z. The future of healthcare: how Ro helps providers treat patients 2 minutes, 2 days, 2 weeks, and 2 years at a time. Medium. Published March 4, 2019. Accessed February 1, 2022. https://medium.com/ro-co/the-future-of-healthcare-how-ro-helps-providers-treat-patients-2-mins-2-days-2-weeks-and-2-10efc0679d7

28. Lee I, Kovarik C, Tejasvi T, et al. Telehealth: helping your patients and practice survive and thrive during the COVID-19 crisis with rapid quality implementation. J Am Acad Dermatol. 2020;82:1213-1214.

29. Pifer R. “Weeks where decades happen”: telehealth 6 months into COVID-19. Healthcare Dive. Published July 27, 2020. Accessed February 23, 2022. https://www.healthcaredive.com/news/telehealth-6-months-coronavirus/581447/

30. Bestsennyy O, Gilbert G, Harris A, et al. Telehealth: a quarter-trillion-dollar post-COVID-19 reality? McKinsey & Company. Updated July 9, 2021. Accessed February 23, 2022. https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality

31. Kennedy J, Arey S, Hopkins Z, et al. Dermatologist perceptions of teledermatology implementation and future use after COVID-19: demographics, barriers, and insights. JAMA Dermatol. 2021;157:595-597.

32. Jennings K. Digital health startup Ro raised $500 million at $5 billion valuation. Forbes. March 22, 2021. Accessed March 29, 2022. https://www.forbes.com/sites/katiejennings/2021/03/22/digital-health-startup-ro-raised-500-million-at-5-billion-valuation/?sh=695be0e462f5

33. Hollander JE, Carr BG. Virtually perfect? telemedicine for COVID-19. N Engl J Med. 2020;382:1679-1681.

34. Welch BM, Harvey J, O’Connell NS, et al. Patient preferences for direct-to-consumer telemedicine services: a nationwide survey. BMC Health Serv Res. 2017;17:784.

References
  1. Vennare J. The DTC healthcare report. Fitt Insider. September 15, 2019. Accessed February 23, 2022. https://insider.fitt.co/direct-to-consumer-healthcare-startups/
  2. Kannampallil T, Ma J. Digital translucence: adapting telemedicine delivery post-COVID-19. Telemed J E Health. 2020;26:1120-1122.
  3. Farr C. Ro, a 3-year-old online health provider, just raised a new round that values it at $1.5 billion. CNBC. July 27, 2020. Accessed February 23, 2022. https://www.cnbc.com/2020/07/27/ro-raises-200-million-at-1point5-billion-valuation-250-million-sales.html
  4. Elliott T, Shih J. Direct to consumer telemedicine. Curr Allergy Asthma Rep. 2019;19:1.
  5. Schwartz LM, Woloshin S. Medical marketing in the United States, 1997-2016. JAMA. 2019;321:80-96.
  6. Peart JM, Kovarik C. Direct-to-patient teledermatology practices. J Am Acad Dermatol. 2015;72:907-909.
  7. Coates SJ, Kvedar J, Granstein RD. Teledermatology: from historical perspective to emerging techniques of the modern era. J Am Acad Dermatol. 2015;72:563-574.
  8. Rheuban KS, Krupinski EA, eds. Understanding Telehealth. McGraw-Hill Education; 2017.
  9. Schlesinger LA, Higgins M, Roseman S. Reinventing the direct-to-consumer business model. Harvard Business Review. March 31, 2020. Accessed February 23, 2022. https://hbr.org/2020/03/reinventing-the-direct-to-consumer-business-model
  10. Cohen AB, Mathews SC, Dorsey ER, et al. Direct-to-consumer digital health. Lancet Digit Health. 2020;2:E163-E165.
  11. 6 telehealth trends for 2020. Wolters Kluwer. Published January 27, 2021. Accessed February 23, 2022. https://www.wolterskluwer.com/en/expert-insights/6-telehealth-trends-for-2020
  12. Jadoo SA, Lipoff JB. Prescribing to save patients money: ethical considerations. J Am Acad Dermatol. 2018;78:826-828.
  13. Propecia. GoodRx. Accessed February 23, 2022. https://www.goodrx.com/propecia
  14. Lauer A. The truth about online hair-loss treatments like Roman and Hims, according to a dermatologist. InsideHook. January 13, 2020. Accessed February 23, 2022. https://www.insidehook.com/article/grooming/men-hair-loss-treatments-dermatologist-review
  15. Friedman Y. Drug price trends for NDC 16729-0089. DrugPatentWatch. Accessed February 23, 2022. https://www.drugpatentwatch.com/p/drug-price/ndc/index.php?query=16729-0089
  16. Curtis H, Milner J. Ethical concerns with online direct-to-consumer pharmaceutical companies. J Med Ethics. 2020;46:168-171.
  17. Jain T, Lu RJ, Mehrotra A. Prescriptions on demand: the growth of direct-to-consumer telemedicine companies. JAMA. 2019;322:925-926.
  18. Shahinyan RH, Amighi A, Carey AN, et al. Direct-to-consumer internet prescription platforms overlook crucial pathology found during traditional office evaluation of young men with erectile dysfunction. Urology. 2020;143:165-172.
  19. Ali M. Andrew Dudum—bold strategies that propelled Hims & Hers into unicorn status. Exit Strategy with Moiz Ali. Published April 2020. Accessed February 23, 2022. https://open.spotify.com/episode/6DtaJxwZDjvZSJI88DTf24?si=b3FHQiUIQY62YjfRHmnJBQ
  20. Klara K, Kim J, Ross JS. Direct-to-consumer broadcast advertisements for pharmaceuticals: off-label promotion and adherence to FDA guidelines. J Gen Intern Med. 2018;33:651-658.
  21. Sullivan HW, Aikin KJ, Poehlman J. Communicating risk information in direct-to-consumer prescription drug television ads: a content analysis. Health Commun. 2019;34:212-219.
  22. Applequist J, Ball JG. An updated analysis of direct-to-consumer television advertisements for prescription drugs. Ann Fam Med. 2018;16:211-216.
  23. Resneck JS Jr, Abrouk M, Steuer M, et al. Choice, transparency, coordination, and quality among direct-to-consumer telemedicine websites and apps treating skin disease. JAMA Dermatol. 2016;152:768-775.
  24. Patient safety. World Health Organization. Published September 13, 2019. Accessed February 1, 2022. https://www.who.int/news-room/fact-sheets/detail/patient-safety
  25. Bollmeier SG, Stevenson E, Finnegan P, et al. Direct to consumer telemedicine: is healthcare from home best? Mo Med. 2020;117:303-309.


26. Court E. Bausch yanked online prescribing after dermatologist backlash. Bloomberg.com. Published March 11, 2020. Accessed September 25, 2020. https://www.bloomberg.com/news/articles/2020-03-11/bausch-yanked-online-prescribing-after-dermatologist-backlash

27. Reitano Z. The future of healthcare: how Ro helps providers treat patients 2 minutes, 2 days, 2 weeks, and 2 years at a time. Medium. Published March 4, 2019. Accessed February 1, 2022. https://medium.com/ro-co/the-future-of-healthcare-how-ro-helps-providers-treat-patients-2-mins-2-days-2-weeks-and-2-10efc0679d7

28. Lee I, Kovarik C, Tejasvi T, et al. Telehealth: helping your patients and practice survive and thrive during the COVID-19 crisis with rapid quality implementation. J Am Acad Dermatol. 2020;82:1213-1214.

29. Pifer R. “Weeks where decades happen”: telehealth 6 months into COVID-19. Healthcare Dive. Published July 27, 2020. Accessed February 23, 2022. https://www.healthcaredive.com/news/telehealth-6-months-coronavirus/581447/

30. Bestsennyy O, Gilbert G, Harris A, et al. Telehealth: a quarter-trillion-dollar post-COVID-19 reality? McKinsey & Company. Updated July 9, 2021. Accessed February 23, 2022. https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality

31. Kennedy J, Arey S, Hopkins Z, et al. Dermatologist perceptions of teledermatology implementation and future use after COVID-19: demographics, barriers, and insights. JAMA Dermatol. 2021;157:595-597.

32. Jennings K. Digital health startup Ro raised $500 million at $5 billion valuation. Forbes. March 22, 2021. Accessed March 29, 2022. https://www.forbes.com/sites/katiejennings/2021/03/22/digital-health-startup-ro-raised-500-million-at-5-billion-valuation/?sh=695be0e462f5

33. Hollander JE, Carr BG. Virtually perfect? telemedicine for COVID-19. N Engl J Med. 2020;382:1679-1681.

34. Welch BM, Harvey J, O’Connell NS, et al. Patient preferences for direct-to-consumer telemedicine services: a nationwide survey. BMC Health Serv Res. 2017;17:784.

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  • Direct-to-consumer (DTC) teledermatology platforms are for-profit companies that provide telemedicine visits and sell prescription drugs directly to patients.
  • Although they are growing in popularity, DTC teledermatology platforms may lead to overdiagnosis, overtreatment, and fragmentation of health care. Knowledge of teledermatology will be vital to counsel patients on the risks and benefits of these platforms.
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COVID vaccines open rifts between parents, children

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The picture of rebellious teenagers sneaking “shots” has widened beyond breaking into Mom and Dad’s liquor cabinet. For some teens now, it means getting a COVID-19 vaccination without their parents’ consent – and, unlike the cabinet raids for the booze, they have adults willing to endorse the practice.

Since the U.S. Food and Drug Administration first granted emergency use authorization to Pfizer’s COVID-19 vaccine for teenagers in mid-2021, health officials have had to deal with a small subset of vaccine hesitancy where minors want the shot over the objections of their reluctant parents. The split has buoyed groups that were formed initially to convince teenagers to get vaccinated against other diseases.

When 14-year-old Arin Parsa of San Jose, California founded Teens for Vaccines in 2019 after a measles outbreak among unvaccinated children, “hardly anyone was interested,” he said. “Many teens were into climate change and other causes. Then, when the pandemic hit, so many were suddenly aware.”
 

Heavy toll on teens

Mr. Parsa’s parents fully supported Teens for Vaccines, he said, but he quickly found out how “politicized” COVID shots had become.

“We find people who are sad, angry, and frustrated at this stage of the pandemic,” he told this news organization. “The anti-vax lobby is riding the coat-tails of other movements. It has a very severe effect on their mental health. They can’t go out with their friends and socialize.”

In the pandemic’s initial stages, children were less likely to fall sick with COVID, but the Omicron variant led to a dramatic increase in illnesses among young people. The American Academy of Pediatrics has found that 3.5 million of the 11.4 million pediatric cases of the virus in the United States were reported in January 2022 alone. Meanwhile, vaccination rates for children aged 12-17, which were only 34% in June 2021 and lagged through the fall, are now at about 61% thanks to a sharp uptick during the Omicron surge, according to polling by the Kaiser Family Foundation.

No statistics are available on how many minors have received a COVID vaccine against their parents’ wishes.

“It’s not like there’s a big movement,” said Arthur Caplan, PhD, who heads the Division of Medical Ethics at the NYU Grossman School of Medicine. He said he noticed a divide around the HPV and hepatitis B vaccines. “They were tied up with sexual behavior,” he said, but “there were also some kids whose parents were really antivaxxers.”

Mr. Parsa said his and similar teen-oriented groups, such as VaxTeen, seek to educate their teen cohort, convince family members of the vaccines’ benefits, and to connect them with resources to get a shot. They also strive to change laws to make it easier for teenagers to receive the vaccine.

Consent laws vary from state to state (and within states), and proposed changes are afoot – some to loosen the laws and some to tighten them. Currently a 14-year-old in Alabama may get a COVID shot without parental permission, according to VaxTeen. In California, minors may receive the HPV shot without parental consent but not a COVID vaccine, although groups like Teens for Vaccines are pushing to change that. A bill now before the state legislature, the Teens Choose Vaccines Act (Senate Bill 866), would allow adolescents aged 12 and older to be able receive any FDA-approved vaccine – including COVID vaccines – without parental consent.

A second bill in California, the Keep Schools Open and Safe Act, would add the COVID-19 vaccines to the required list of immunizations needed to attend school in the state as well as eliminate the “personal belief” exemption against immunization. 

California Sen. Richard Pan, MD (D-6th District), cowrote both bills with fellow Democrat Sen. Scott Wiener (D-11th District) and teen advocates from Teens for Vaccines and Generation Up, who helped draft the language in consultation with the lawmakers.  

“As a pediatrician, I have seen all manner of situations where the requirement for a signed form has prevented teens from being able to get a vaccine that otherwise they and their guardians approved of them getting,” Dr. Pan told this news organization. “As a father, I don’t want to see my kids or any teen that wishes to protect themselves from deadly diseases unable to do so, particularly as we continue to fight off the dangers of the COVID-19 pandemic. I always encourage parents or teens that have questions about vaccines to speak directly with their pediatrician.”

Lawmakers in Philadelphia passed a provision last year to allow anyone age 11 or over to get the COVID vaccine without parental permission, keeping it in line with other vaccinations like hepatitis or HPV. “People from surrounding counties have come into the city, but it hasn’t been a huge rush,” says James Garrow, MPH, a spokesman for the city’s Department of Health.
 

 

 

Strive for collaboration, but listen to the children

Experts say the best solution is to for a doctor to meet with minors and their reluctant parents to get them on board for a COVID shot.

“Physicians are still the trusted messengers,” said Emma Olivera, MD, a pediatrician in suburban Chicago who advises groups that combat COVID misinformation.

Dr. Olivera said she often finds that internet-savvy teenagers have access to more information than older people, including their parents.  

Thanks to COVID policies, office meetings are “difficult to do,” NYU’s Dr. Caplan added. In such a meeting, Dr. Caplan said he would try to convince the parents that the shots are needed for their children to stay in school or play sports. In the end, he said minors should get the shot but would also notify the parents before that happens: “My duty is to them.”

If parents take opposite stances, the pro-vaccine side is likely to prevail, even in California, said Patrick Baghdaserians, JD, a family law attorney in Pasadena. Mr. Baghdaserians said he is now representing a father who wants his teenager to get vaccinated but the mother doesn’t. “The court will fall on our side,” he predicted.

A version of this article first appeared on Medscape.com.

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The picture of rebellious teenagers sneaking “shots” has widened beyond breaking into Mom and Dad’s liquor cabinet. For some teens now, it means getting a COVID-19 vaccination without their parents’ consent – and, unlike the cabinet raids for the booze, they have adults willing to endorse the practice.

Since the U.S. Food and Drug Administration first granted emergency use authorization to Pfizer’s COVID-19 vaccine for teenagers in mid-2021, health officials have had to deal with a small subset of vaccine hesitancy where minors want the shot over the objections of their reluctant parents. The split has buoyed groups that were formed initially to convince teenagers to get vaccinated against other diseases.

When 14-year-old Arin Parsa of San Jose, California founded Teens for Vaccines in 2019 after a measles outbreak among unvaccinated children, “hardly anyone was interested,” he said. “Many teens were into climate change and other causes. Then, when the pandemic hit, so many were suddenly aware.”
 

Heavy toll on teens

Mr. Parsa’s parents fully supported Teens for Vaccines, he said, but he quickly found out how “politicized” COVID shots had become.

“We find people who are sad, angry, and frustrated at this stage of the pandemic,” he told this news organization. “The anti-vax lobby is riding the coat-tails of other movements. It has a very severe effect on their mental health. They can’t go out with their friends and socialize.”

In the pandemic’s initial stages, children were less likely to fall sick with COVID, but the Omicron variant led to a dramatic increase in illnesses among young people. The American Academy of Pediatrics has found that 3.5 million of the 11.4 million pediatric cases of the virus in the United States were reported in January 2022 alone. Meanwhile, vaccination rates for children aged 12-17, which were only 34% in June 2021 and lagged through the fall, are now at about 61% thanks to a sharp uptick during the Omicron surge, according to polling by the Kaiser Family Foundation.

No statistics are available on how many minors have received a COVID vaccine against their parents’ wishes.

“It’s not like there’s a big movement,” said Arthur Caplan, PhD, who heads the Division of Medical Ethics at the NYU Grossman School of Medicine. He said he noticed a divide around the HPV and hepatitis B vaccines. “They were tied up with sexual behavior,” he said, but “there were also some kids whose parents were really antivaxxers.”

Mr. Parsa said his and similar teen-oriented groups, such as VaxTeen, seek to educate their teen cohort, convince family members of the vaccines’ benefits, and to connect them with resources to get a shot. They also strive to change laws to make it easier for teenagers to receive the vaccine.

Consent laws vary from state to state (and within states), and proposed changes are afoot – some to loosen the laws and some to tighten them. Currently a 14-year-old in Alabama may get a COVID shot without parental permission, according to VaxTeen. In California, minors may receive the HPV shot without parental consent but not a COVID vaccine, although groups like Teens for Vaccines are pushing to change that. A bill now before the state legislature, the Teens Choose Vaccines Act (Senate Bill 866), would allow adolescents aged 12 and older to be able receive any FDA-approved vaccine – including COVID vaccines – without parental consent.

A second bill in California, the Keep Schools Open and Safe Act, would add the COVID-19 vaccines to the required list of immunizations needed to attend school in the state as well as eliminate the “personal belief” exemption against immunization. 

California Sen. Richard Pan, MD (D-6th District), cowrote both bills with fellow Democrat Sen. Scott Wiener (D-11th District) and teen advocates from Teens for Vaccines and Generation Up, who helped draft the language in consultation with the lawmakers.  

“As a pediatrician, I have seen all manner of situations where the requirement for a signed form has prevented teens from being able to get a vaccine that otherwise they and their guardians approved of them getting,” Dr. Pan told this news organization. “As a father, I don’t want to see my kids or any teen that wishes to protect themselves from deadly diseases unable to do so, particularly as we continue to fight off the dangers of the COVID-19 pandemic. I always encourage parents or teens that have questions about vaccines to speak directly with their pediatrician.”

Lawmakers in Philadelphia passed a provision last year to allow anyone age 11 or over to get the COVID vaccine without parental permission, keeping it in line with other vaccinations like hepatitis or HPV. “People from surrounding counties have come into the city, but it hasn’t been a huge rush,” says James Garrow, MPH, a spokesman for the city’s Department of Health.
 

 

 

Strive for collaboration, but listen to the children

Experts say the best solution is to for a doctor to meet with minors and their reluctant parents to get them on board for a COVID shot.

“Physicians are still the trusted messengers,” said Emma Olivera, MD, a pediatrician in suburban Chicago who advises groups that combat COVID misinformation.

Dr. Olivera said she often finds that internet-savvy teenagers have access to more information than older people, including their parents.  

Thanks to COVID policies, office meetings are “difficult to do,” NYU’s Dr. Caplan added. In such a meeting, Dr. Caplan said he would try to convince the parents that the shots are needed for their children to stay in school or play sports. In the end, he said minors should get the shot but would also notify the parents before that happens: “My duty is to them.”

If parents take opposite stances, the pro-vaccine side is likely to prevail, even in California, said Patrick Baghdaserians, JD, a family law attorney in Pasadena. Mr. Baghdaserians said he is now representing a father who wants his teenager to get vaccinated but the mother doesn’t. “The court will fall on our side,” he predicted.

A version of this article first appeared on Medscape.com.

The picture of rebellious teenagers sneaking “shots” has widened beyond breaking into Mom and Dad’s liquor cabinet. For some teens now, it means getting a COVID-19 vaccination without their parents’ consent – and, unlike the cabinet raids for the booze, they have adults willing to endorse the practice.

Since the U.S. Food and Drug Administration first granted emergency use authorization to Pfizer’s COVID-19 vaccine for teenagers in mid-2021, health officials have had to deal with a small subset of vaccine hesitancy where minors want the shot over the objections of their reluctant parents. The split has buoyed groups that were formed initially to convince teenagers to get vaccinated against other diseases.

When 14-year-old Arin Parsa of San Jose, California founded Teens for Vaccines in 2019 after a measles outbreak among unvaccinated children, “hardly anyone was interested,” he said. “Many teens were into climate change and other causes. Then, when the pandemic hit, so many were suddenly aware.”
 

Heavy toll on teens

Mr. Parsa’s parents fully supported Teens for Vaccines, he said, but he quickly found out how “politicized” COVID shots had become.

“We find people who are sad, angry, and frustrated at this stage of the pandemic,” he told this news organization. “The anti-vax lobby is riding the coat-tails of other movements. It has a very severe effect on their mental health. They can’t go out with their friends and socialize.”

In the pandemic’s initial stages, children were less likely to fall sick with COVID, but the Omicron variant led to a dramatic increase in illnesses among young people. The American Academy of Pediatrics has found that 3.5 million of the 11.4 million pediatric cases of the virus in the United States were reported in January 2022 alone. Meanwhile, vaccination rates for children aged 12-17, which were only 34% in June 2021 and lagged through the fall, are now at about 61% thanks to a sharp uptick during the Omicron surge, according to polling by the Kaiser Family Foundation.

No statistics are available on how many minors have received a COVID vaccine against their parents’ wishes.

“It’s not like there’s a big movement,” said Arthur Caplan, PhD, who heads the Division of Medical Ethics at the NYU Grossman School of Medicine. He said he noticed a divide around the HPV and hepatitis B vaccines. “They were tied up with sexual behavior,” he said, but “there were also some kids whose parents were really antivaxxers.”

Mr. Parsa said his and similar teen-oriented groups, such as VaxTeen, seek to educate their teen cohort, convince family members of the vaccines’ benefits, and to connect them with resources to get a shot. They also strive to change laws to make it easier for teenagers to receive the vaccine.

Consent laws vary from state to state (and within states), and proposed changes are afoot – some to loosen the laws and some to tighten them. Currently a 14-year-old in Alabama may get a COVID shot without parental permission, according to VaxTeen. In California, minors may receive the HPV shot without parental consent but not a COVID vaccine, although groups like Teens for Vaccines are pushing to change that. A bill now before the state legislature, the Teens Choose Vaccines Act (Senate Bill 866), would allow adolescents aged 12 and older to be able receive any FDA-approved vaccine – including COVID vaccines – without parental consent.

A second bill in California, the Keep Schools Open and Safe Act, would add the COVID-19 vaccines to the required list of immunizations needed to attend school in the state as well as eliminate the “personal belief” exemption against immunization. 

California Sen. Richard Pan, MD (D-6th District), cowrote both bills with fellow Democrat Sen. Scott Wiener (D-11th District) and teen advocates from Teens for Vaccines and Generation Up, who helped draft the language in consultation with the lawmakers.  

“As a pediatrician, I have seen all manner of situations where the requirement for a signed form has prevented teens from being able to get a vaccine that otherwise they and their guardians approved of them getting,” Dr. Pan told this news organization. “As a father, I don’t want to see my kids or any teen that wishes to protect themselves from deadly diseases unable to do so, particularly as we continue to fight off the dangers of the COVID-19 pandemic. I always encourage parents or teens that have questions about vaccines to speak directly with their pediatrician.”

Lawmakers in Philadelphia passed a provision last year to allow anyone age 11 or over to get the COVID vaccine without parental permission, keeping it in line with other vaccinations like hepatitis or HPV. “People from surrounding counties have come into the city, but it hasn’t been a huge rush,” says James Garrow, MPH, a spokesman for the city’s Department of Health.
 

 

 

Strive for collaboration, but listen to the children

Experts say the best solution is to for a doctor to meet with minors and their reluctant parents to get them on board for a COVID shot.

“Physicians are still the trusted messengers,” said Emma Olivera, MD, a pediatrician in suburban Chicago who advises groups that combat COVID misinformation.

Dr. Olivera said she often finds that internet-savvy teenagers have access to more information than older people, including their parents.  

Thanks to COVID policies, office meetings are “difficult to do,” NYU’s Dr. Caplan added. In such a meeting, Dr. Caplan said he would try to convince the parents that the shots are needed for their children to stay in school or play sports. In the end, he said minors should get the shot but would also notify the parents before that happens: “My duty is to them.”

If parents take opposite stances, the pro-vaccine side is likely to prevail, even in California, said Patrick Baghdaserians, JD, a family law attorney in Pasadena. Mr. Baghdaserians said he is now representing a father who wants his teenager to get vaccinated but the mother doesn’t. “The court will fall on our side,” he predicted.

A version of this article first appeared on Medscape.com.

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Long COVID associated with risk of metabolic liver disease

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Tue, 05/24/2022 - 16:27

Postacute COVID syndrome (PACS), an ongoing inflammatory state following infection with SARS-CoV-2, is associated with greater risk of metabolic-associated fatty liver disease (MAFLD), according to an analysis of patients at a single clinic in Canada published in Open Forum Infectious Diseases.

MAFLD, also known as nonalcoholic fatty liver disease (NAFLD), is considered an indicator of general health and is in turn linked to greater risk of cardiovascular complications and mortality. It may be a multisystem disorder with various underlying causes.



PACS includes symptoms that affect various organ systems, with neurocognitive, autonomic, gastrointestinal, respiratory, musculoskeletal, psychological, sensory, and dermatologic clusters. An estimated 50%-80% of COVID-19 patients experience one or more clusters of symptoms 3 months after leaving the hospital.

But liver problems also appear in the acute phase, said Paul Martin, MD, who was asked to comment on the study. “Up to about half the patients during the acute illness may have elevated liver tests, but there seems to be a subset of patients in whom the abnormality persists. And then there are some reports in the literature of patients developing injury to their bile ducts in the liver over the long term, apparently as a consequence of COVID infection. What this paper suggests is that there may be some metabolic derangements associated with COVID infection, which in turn can accentuate or possibly cause fatty liver,” said Dr. Martin in an interview. He is chief of digestive health and liver diseases and a professor of medicine at the University of Miami.

“It highlights the need to get vaccinated against COVID and to take appropriate precautions because contracting the infection may lead to all sorts of consequences quite apart from having a respiratory illness,” said Dr. Martin.

The researchers retrospectively identified 235 patients hospitalized with COVID-19 between July 2020 and April 2021. Overall, 69% were men, and the median age was 61 years; 19.2% underwent mechanical ventilation and the mean duration of hospitalization was 11.7 days. They were seen for PACS symptoms a median 143 days after COVID-19 symptoms began, with 77.5% having symptoms of at least one PACS cluster. Of these clusters, 34.9% were neurocognitive, 53.2% were respiratory, 26.4% were musculoskeletal, 29.4% were psychological, 25.1% were dermatologic, and 17.5% were sensory.

At the later clinical visit for PACS symptoms, all patients underwent screening for MAFLD, which was defined as the presence of liver steatosis plus overweight/obesity or type 2 diabetes. Hepatic steatosis was determined from controlled attenuation parameter using transient elastrography. The analysis excluded patients with significant alcohol intake or hepatitis B or C. All patients with liver steatosis also had MAFLD, and this included 55.3% of the study population.

The hospital was able to obtain hepatic steatosis index (HSI) scores for 103 of 235 patients. Of these, 50% had MAFLD on admission for acute COVID-19, and 48.1% had MAFLD upon discharge based on this criterion. At the PACS follow-up visit, 71.3% were diagnosed with MAFLD. There was no statistically significant difference in the use of glucocorticoids or tocilizumab during hospitalization between those with and without MAFLD, and remdesivir use was insignificant in the patient population.

Given that the prevalence of MAFLD among the study population is more than double that in the general population, the authors suggest that MAFLD may be a new PACS cluster phenotype that could lead to long-term metabolic and cardiovascular complications. A potential explanation is loss of lean body mass during COVID-19 hospitalization followed by liver fat accumulation during recovery.

Other infections have also shown an association with increased MAFLD incidence, including HIV, Heliobacter pylori, and viral hepatitis. The authors worry that COVID-19 infection could exacerbate underlying conditions to a more severe MAFLD disease state.

The study is limited by a small sample size, limited follow-up, and the lack of a control group. Its retrospective nature leaves it vulnerable to biases.

“The natural history of MAFLD in the context of PACS is unknown at this time, and careful follow-up of these patients is needed to understand the clinical implications of this syndrome in the context of long COVID,” the authors wrote. “We speculate that [MAFLD] may be considered as an independent PACS-cluster phenotype, potentially affecting the metabolic and cardiovascular health of patients with PACS.”

One author has relationships with several pharmaceutical companies, but the remaining authors reported no conflicts of interest. Dr. Martin has no relevant financial disclosures.

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Postacute COVID syndrome (PACS), an ongoing inflammatory state following infection with SARS-CoV-2, is associated with greater risk of metabolic-associated fatty liver disease (MAFLD), according to an analysis of patients at a single clinic in Canada published in Open Forum Infectious Diseases.

MAFLD, also known as nonalcoholic fatty liver disease (NAFLD), is considered an indicator of general health and is in turn linked to greater risk of cardiovascular complications and mortality. It may be a multisystem disorder with various underlying causes.



PACS includes symptoms that affect various organ systems, with neurocognitive, autonomic, gastrointestinal, respiratory, musculoskeletal, psychological, sensory, and dermatologic clusters. An estimated 50%-80% of COVID-19 patients experience one or more clusters of symptoms 3 months after leaving the hospital.

But liver problems also appear in the acute phase, said Paul Martin, MD, who was asked to comment on the study. “Up to about half the patients during the acute illness may have elevated liver tests, but there seems to be a subset of patients in whom the abnormality persists. And then there are some reports in the literature of patients developing injury to their bile ducts in the liver over the long term, apparently as a consequence of COVID infection. What this paper suggests is that there may be some metabolic derangements associated with COVID infection, which in turn can accentuate or possibly cause fatty liver,” said Dr. Martin in an interview. He is chief of digestive health and liver diseases and a professor of medicine at the University of Miami.

“It highlights the need to get vaccinated against COVID and to take appropriate precautions because contracting the infection may lead to all sorts of consequences quite apart from having a respiratory illness,” said Dr. Martin.

The researchers retrospectively identified 235 patients hospitalized with COVID-19 between July 2020 and April 2021. Overall, 69% were men, and the median age was 61 years; 19.2% underwent mechanical ventilation and the mean duration of hospitalization was 11.7 days. They were seen for PACS symptoms a median 143 days after COVID-19 symptoms began, with 77.5% having symptoms of at least one PACS cluster. Of these clusters, 34.9% were neurocognitive, 53.2% were respiratory, 26.4% were musculoskeletal, 29.4% were psychological, 25.1% were dermatologic, and 17.5% were sensory.

At the later clinical visit for PACS symptoms, all patients underwent screening for MAFLD, which was defined as the presence of liver steatosis plus overweight/obesity or type 2 diabetes. Hepatic steatosis was determined from controlled attenuation parameter using transient elastrography. The analysis excluded patients with significant alcohol intake or hepatitis B or C. All patients with liver steatosis also had MAFLD, and this included 55.3% of the study population.

The hospital was able to obtain hepatic steatosis index (HSI) scores for 103 of 235 patients. Of these, 50% had MAFLD on admission for acute COVID-19, and 48.1% had MAFLD upon discharge based on this criterion. At the PACS follow-up visit, 71.3% were diagnosed with MAFLD. There was no statistically significant difference in the use of glucocorticoids or tocilizumab during hospitalization between those with and without MAFLD, and remdesivir use was insignificant in the patient population.

Given that the prevalence of MAFLD among the study population is more than double that in the general population, the authors suggest that MAFLD may be a new PACS cluster phenotype that could lead to long-term metabolic and cardiovascular complications. A potential explanation is loss of lean body mass during COVID-19 hospitalization followed by liver fat accumulation during recovery.

Other infections have also shown an association with increased MAFLD incidence, including HIV, Heliobacter pylori, and viral hepatitis. The authors worry that COVID-19 infection could exacerbate underlying conditions to a more severe MAFLD disease state.

The study is limited by a small sample size, limited follow-up, and the lack of a control group. Its retrospective nature leaves it vulnerable to biases.

“The natural history of MAFLD in the context of PACS is unknown at this time, and careful follow-up of these patients is needed to understand the clinical implications of this syndrome in the context of long COVID,” the authors wrote. “We speculate that [MAFLD] may be considered as an independent PACS-cluster phenotype, potentially affecting the metabolic and cardiovascular health of patients with PACS.”

One author has relationships with several pharmaceutical companies, but the remaining authors reported no conflicts of interest. Dr. Martin has no relevant financial disclosures.

Postacute COVID syndrome (PACS), an ongoing inflammatory state following infection with SARS-CoV-2, is associated with greater risk of metabolic-associated fatty liver disease (MAFLD), according to an analysis of patients at a single clinic in Canada published in Open Forum Infectious Diseases.

MAFLD, also known as nonalcoholic fatty liver disease (NAFLD), is considered an indicator of general health and is in turn linked to greater risk of cardiovascular complications and mortality. It may be a multisystem disorder with various underlying causes.



PACS includes symptoms that affect various organ systems, with neurocognitive, autonomic, gastrointestinal, respiratory, musculoskeletal, psychological, sensory, and dermatologic clusters. An estimated 50%-80% of COVID-19 patients experience one or more clusters of symptoms 3 months after leaving the hospital.

But liver problems also appear in the acute phase, said Paul Martin, MD, who was asked to comment on the study. “Up to about half the patients during the acute illness may have elevated liver tests, but there seems to be a subset of patients in whom the abnormality persists. And then there are some reports in the literature of patients developing injury to their bile ducts in the liver over the long term, apparently as a consequence of COVID infection. What this paper suggests is that there may be some metabolic derangements associated with COVID infection, which in turn can accentuate or possibly cause fatty liver,” said Dr. Martin in an interview. He is chief of digestive health and liver diseases and a professor of medicine at the University of Miami.

“It highlights the need to get vaccinated against COVID and to take appropriate precautions because contracting the infection may lead to all sorts of consequences quite apart from having a respiratory illness,” said Dr. Martin.

The researchers retrospectively identified 235 patients hospitalized with COVID-19 between July 2020 and April 2021. Overall, 69% were men, and the median age was 61 years; 19.2% underwent mechanical ventilation and the mean duration of hospitalization was 11.7 days. They were seen for PACS symptoms a median 143 days after COVID-19 symptoms began, with 77.5% having symptoms of at least one PACS cluster. Of these clusters, 34.9% were neurocognitive, 53.2% were respiratory, 26.4% were musculoskeletal, 29.4% were psychological, 25.1% were dermatologic, and 17.5% were sensory.

At the later clinical visit for PACS symptoms, all patients underwent screening for MAFLD, which was defined as the presence of liver steatosis plus overweight/obesity or type 2 diabetes. Hepatic steatosis was determined from controlled attenuation parameter using transient elastrography. The analysis excluded patients with significant alcohol intake or hepatitis B or C. All patients with liver steatosis also had MAFLD, and this included 55.3% of the study population.

The hospital was able to obtain hepatic steatosis index (HSI) scores for 103 of 235 patients. Of these, 50% had MAFLD on admission for acute COVID-19, and 48.1% had MAFLD upon discharge based on this criterion. At the PACS follow-up visit, 71.3% were diagnosed with MAFLD. There was no statistically significant difference in the use of glucocorticoids or tocilizumab during hospitalization between those with and without MAFLD, and remdesivir use was insignificant in the patient population.

Given that the prevalence of MAFLD among the study population is more than double that in the general population, the authors suggest that MAFLD may be a new PACS cluster phenotype that could lead to long-term metabolic and cardiovascular complications. A potential explanation is loss of lean body mass during COVID-19 hospitalization followed by liver fat accumulation during recovery.

Other infections have also shown an association with increased MAFLD incidence, including HIV, Heliobacter pylori, and viral hepatitis. The authors worry that COVID-19 infection could exacerbate underlying conditions to a more severe MAFLD disease state.

The study is limited by a small sample size, limited follow-up, and the lack of a control group. Its retrospective nature leaves it vulnerable to biases.

“The natural history of MAFLD in the context of PACS is unknown at this time, and careful follow-up of these patients is needed to understand the clinical implications of this syndrome in the context of long COVID,” the authors wrote. “We speculate that [MAFLD] may be considered as an independent PACS-cluster phenotype, potentially affecting the metabolic and cardiovascular health of patients with PACS.”

One author has relationships with several pharmaceutical companies, but the remaining authors reported no conflicts of interest. Dr. Martin has no relevant financial disclosures.

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SARS-Co-V2 Deserves Our Respect, Can We Provide It Before the Next Variant Arrives?

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Fri, 02/25/2022 - 16:06
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SARS-Co-V2 Deserves Our Respect, Can We Provide It Before the Next Variant Arrives?

Health care’s modern-day version of the Greek chorus is growing louder and more persistent. My colleagues and I have long been among them.

In news conferences, journal articles, and podcasts, this chorus is pleading with the public to pay attention to its message: SARs-CoV-2 is not done with us. Omicron can kill; it can infect the vaccinated.

We have found, like everyone else, that Omicron runs on its rules; with Delta, two vaccine shots were able to lower the positivity rate. With Omicron, two shots have not been enough.

The WHO used the word “surprise” in its November announcement that Omicron was a variant of “concern.”

So did Trevor Bedford, a computational biologist and infectious disease scientist at the Fred Hutchinson Cancer Center in Seattle, who said that Omicron “took me and everyone by surprise.”1 Speaking on KevinMD’s podcast, he told his host that with the degree of immunity in the global population, he was expecting subsequent evolving strains to have minor, subtle genetic mutations, akin to how flu varies from year to year. What was a surprise was the giant leap in evolution that occurred with Omicron, which contains 36 mutations in the spike protein and approximately 50 mutations in total. Because of these mutations, the original two-shot mRNA COVID vaccines becomes only 40% effective against symptomatic disease after several months (thankfully a booster shot increases this to ~80%).2 But the decreased vaccine protection without a booster, along with relaxation of mitigation measures, brought us to where we are now.

In Chicago, we knew the Omicron variant would move quickly, considering how it moved through South Africa and the United Kingdom. What we didn’t anticipate was that in one week’s time, our hospital would need to add another 100 dedicated COVID ICU beds. Nor did we anticipate the extent that Omicron would affect staffing levels in the same amount of time.

At our hospital, we have eliminated elective surgeries that require a hospital stay, which includes surgeries for cancer. One of my colleagues, Ryan Merkow, MD, a surgical oncologist, remarked recently he had to cancel half of his scheduled surgeries because of a lack of hospital space.3

Dispelling Myths

What is concerning about this current wave is how many unvaccinated are hospitalized. Because Omicron is so infectious and because of lower vaccination rates in younger adults and children, we have a younger group of adults and children admitted with COVID, who had been uninfected by previous surges.

A major myth that makes health care workers so frustrated is the tale that Omicron is milder. Unvaccinated people infected with this variant are seriously ill and are dying. Despite its “mild” label, once a patient is hospitalized, Omicron can be just as severe as its predecessors.4 For many, getting vaccinated is the difference between staying at home with some symptoms and being in the ICU.

As of January 10, according to the CDC, although 88% of people over the age of 65 are vaccinated, only 37.5% have gotten boosters which are key to restoring protection against Omicron. And among children, only 54% between 12- and 17-years-old are fully vaccinated, and a mere 17% of children aged 5 to 11 have gotten both of their shots.

Remember the conversations regarding natural immunity? Omicron has muffled that conversation. Those who have been infected with SARS-Co-V2 before can still get infected and very ill with Omicron. So now is the time to get vaccinated.

Transmissibility

We knew SARS-CoV-2 could spread 1 of 2 ways: large virus-carrying droplets that enter through the nose, mouth, and eyes, as well as miniscule airborne droplets of virus that float in the air and travel further than 6 feet. However, prior to Omicron, transmission of these smaller droplets via the air was not as frequent. But with Omicron, while it still travels by larger respiratory droplets, it appears to have more airborne spread.

In late December, The Lancet Regional Health published results of research conducted one month earlier at a designated quarantine hotel in Hong Kong.5 The index case was housed in the room across a hallway from the second case, who developed their case 8 days into quarantine. Testing showed the Omicron variant in both cases. Environmental testing of the walls and ceiling suggested airborne spread of the virus in places unreachable by large respiratory droplets.

Now with Omicron, people need to wear high-filtering masks that fit tight against the face, such as a N95, KN-95, or KF-94 if possible. And when removing the mask to eat and drink, one should be in well-ventilated areas, away from others.

People should avoid getting Omicron, regardless of vaccination status. This variant is so infectious that, compared to the Delta variant, people are twice as likely to infect others that live with them. And infecting others leads to a chain of transmission that can close schools, take over hospital beds, and disable or kill the most vulnerable in our communities.

Public and private behavior, and public policy

In July, months before that WHO announced Omicron’s existence, Rella and colleagues reported in Scientific Reports on the outcome of a new model designed to show how a vaccine-resistant strain could rapidly transmit through a highly vaccinated population if transmission mitigation interventions are dropped too soon.6

The authors wrote that the success of a vaccine-resistant strain making inroads into a population depends on the obvious – it finds populations with a low rate of vaccination. What is not so obvious, the authors wrote, is that a vaccine-resistant virus does its worst when transmission is not well controlled in a highly vaccinated population. What can prevent a surge like this are social behaviors and public policy that decrease the chain of transmission of SARS-CoV-2, such as vaccination, masking, and testing.

It is people’s behavior, and ineffective public policy, that are so frustrating to us. The WHO’s secretary general warned against relying solely on vaccines in December. “Vaccines alone will not get any country out of this crisis.”

Omicron takes a new mindset. What we were doing before is not protecting now. Unchecked spread is overwhelming our health care systems and putting the vulnerable in our population at risk. The ramification of this unchecked spread reaches everywhere – into the economy, our educational system, and our nation’s mental health.

When the pandemic started, the policies to control its spread rested on local government and public agencies; we all would have been better served had there been a unified, national response to an infectious threat that does not obey municipal or state boundaries.

 The universal sentiment among health care workers is frustration with local and state governments that are either dictating policy that can harm the public we are trying to protect.

As of September, at least 23 state legislatures have passed laws changing a governor’s executive power reach. Many have taken it away. Others are fighting in the courts over mask mandates.

As for when the pandemic will subside, that appears to be up to the public and public policy makers. They will determine how long this will last and how many will die or be disabled before its end.

References

References

  1. KevinMD.com. Trevor Bedford on Omicron and what about Covid keeps him up at night. Dec. 17 podcast. https://www.kevinmd.com/blog/post-author/the-podcast-by-kevinmd/page/2
  2. Andrews N, Stowe J, Kirsebom F, et al. Effectiveness of COVID-19 vaccines against the Omicron (B.1.1.529) variant of concern. MedRxiv. Preprint. doi: https://doi.org/10.1101/2021.12.14.21267615
  3. Weise E and Shamus KJ. (January 13, 2022). As COVID-19 surges, there are no hospital beds for others in need of care. USA Today. As COVID-19 surges, there are no hospital beds for others in need of care (yahoo.com)
  4. Wolter N, Jassat W, Walaza S, et al. Early assessment of the clinical severity of the SARS-CoV-2 Omicron variant in South Africa. MedRxiv. Preprint. doi: https://doi.org/10.1101/2021.12.21.21268116
  5. Shuk-Ching Wong, Albert Ka-Wing Au, Hong Chen et al. Transmission of Omicron (B.1.1.529) - SARS-CoV-2 Variant of Concern in a designated quarantine hotel for travelers: a challenge of elimination strategy of COVID-19. The Lancet Regional Health - Western Pacific.  Available online 23 December 2021
  6. Rella SA, Kulikova YA, Dermitzakis ET, et al. Rates of SARS-CoV-2 transmission and vaccination impact the fate of vaccine-resistant strains. Sci Rep 11, 15729 (2021).
  7. WHO press conference on coronavirus disease (COVID-19) - 14 December 2021.
  8. Telebriefing on Covid-19 Update. https://www.cdc.gov/media/releases/2022/t0107-Covid-update.html
  9. Shuk-Ching Wong, Albert Ka-Wing Au, Hong Chen et al. Transmission of Omicron (B.1.1.529) - SARS-CoV-2 Variant of Concern in a designated quarantine hotel for travelers: a challenge of elimination strategy of COVID-1 The Lancet Regional Health - Western Pacific.  Available online 23 December 2021
  10. CDC. Interim Guidance for Managing Healthcare Personnel with SARS-CoV-2 Infection or Exposure to SARS-CoV-2. Dec. 23, 2021.
  11. Mariah Timms. Tennessee appeals federal court order temporarily blocking new state law on school masks. Nashville Tennessean. Jan. 3, 2022.
  12. Statewide Number of Covid-19 Hospitalized Pediatric Patients. Jan. 4, 2022.
  13. National Conference of State Legislatures. Legislative Oversight of Emergency Executive Powers. Jan. 4, 2022.

https://news.yahoo.com/Covid-surges-others-care-theres-105949790.html

Elizabeth Weise and Kristen Jordan Shamus. As COVID-19 surges, there are no hospital beds for others in need of care. USA Today. Jan. 13, 2022.

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Cheryl K. Lee, MD, Assistant Professor of Medicine - Northwestern Feinberg School of Medicine.

Disclosures: Dr. Lee has disclosed no relevant financial relationships

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Cheryl K. Lee, MD, Assistant Professor of Medicine - Northwestern Feinberg School of Medicine.

Disclosures: Dr. Lee has disclosed no relevant financial relationships

Health care’s modern-day version of the Greek chorus is growing louder and more persistent. My colleagues and I have long been among them.

In news conferences, journal articles, and podcasts, this chorus is pleading with the public to pay attention to its message: SARs-CoV-2 is not done with us. Omicron can kill; it can infect the vaccinated.

We have found, like everyone else, that Omicron runs on its rules; with Delta, two vaccine shots were able to lower the positivity rate. With Omicron, two shots have not been enough.

The WHO used the word “surprise” in its November announcement that Omicron was a variant of “concern.”

So did Trevor Bedford, a computational biologist and infectious disease scientist at the Fred Hutchinson Cancer Center in Seattle, who said that Omicron “took me and everyone by surprise.”1 Speaking on KevinMD’s podcast, he told his host that with the degree of immunity in the global population, he was expecting subsequent evolving strains to have minor, subtle genetic mutations, akin to how flu varies from year to year. What was a surprise was the giant leap in evolution that occurred with Omicron, which contains 36 mutations in the spike protein and approximately 50 mutations in total. Because of these mutations, the original two-shot mRNA COVID vaccines becomes only 40% effective against symptomatic disease after several months (thankfully a booster shot increases this to ~80%).2 But the decreased vaccine protection without a booster, along with relaxation of mitigation measures, brought us to where we are now.

In Chicago, we knew the Omicron variant would move quickly, considering how it moved through South Africa and the United Kingdom. What we didn’t anticipate was that in one week’s time, our hospital would need to add another 100 dedicated COVID ICU beds. Nor did we anticipate the extent that Omicron would affect staffing levels in the same amount of time.

At our hospital, we have eliminated elective surgeries that require a hospital stay, which includes surgeries for cancer. One of my colleagues, Ryan Merkow, MD, a surgical oncologist, remarked recently he had to cancel half of his scheduled surgeries because of a lack of hospital space.3

Dispelling Myths

What is concerning about this current wave is how many unvaccinated are hospitalized. Because Omicron is so infectious and because of lower vaccination rates in younger adults and children, we have a younger group of adults and children admitted with COVID, who had been uninfected by previous surges.

A major myth that makes health care workers so frustrated is the tale that Omicron is milder. Unvaccinated people infected with this variant are seriously ill and are dying. Despite its “mild” label, once a patient is hospitalized, Omicron can be just as severe as its predecessors.4 For many, getting vaccinated is the difference between staying at home with some symptoms and being in the ICU.

As of January 10, according to the CDC, although 88% of people over the age of 65 are vaccinated, only 37.5% have gotten boosters which are key to restoring protection against Omicron. And among children, only 54% between 12- and 17-years-old are fully vaccinated, and a mere 17% of children aged 5 to 11 have gotten both of their shots.

Remember the conversations regarding natural immunity? Omicron has muffled that conversation. Those who have been infected with SARS-Co-V2 before can still get infected and very ill with Omicron. So now is the time to get vaccinated.

Transmissibility

We knew SARS-CoV-2 could spread 1 of 2 ways: large virus-carrying droplets that enter through the nose, mouth, and eyes, as well as miniscule airborne droplets of virus that float in the air and travel further than 6 feet. However, prior to Omicron, transmission of these smaller droplets via the air was not as frequent. But with Omicron, while it still travels by larger respiratory droplets, it appears to have more airborne spread.

In late December, The Lancet Regional Health published results of research conducted one month earlier at a designated quarantine hotel in Hong Kong.5 The index case was housed in the room across a hallway from the second case, who developed their case 8 days into quarantine. Testing showed the Omicron variant in both cases. Environmental testing of the walls and ceiling suggested airborne spread of the virus in places unreachable by large respiratory droplets.

Now with Omicron, people need to wear high-filtering masks that fit tight against the face, such as a N95, KN-95, or KF-94 if possible. And when removing the mask to eat and drink, one should be in well-ventilated areas, away from others.

People should avoid getting Omicron, regardless of vaccination status. This variant is so infectious that, compared to the Delta variant, people are twice as likely to infect others that live with them. And infecting others leads to a chain of transmission that can close schools, take over hospital beds, and disable or kill the most vulnerable in our communities.

Public and private behavior, and public policy

In July, months before that WHO announced Omicron’s existence, Rella and colleagues reported in Scientific Reports on the outcome of a new model designed to show how a vaccine-resistant strain could rapidly transmit through a highly vaccinated population if transmission mitigation interventions are dropped too soon.6

The authors wrote that the success of a vaccine-resistant strain making inroads into a population depends on the obvious – it finds populations with a low rate of vaccination. What is not so obvious, the authors wrote, is that a vaccine-resistant virus does its worst when transmission is not well controlled in a highly vaccinated population. What can prevent a surge like this are social behaviors and public policy that decrease the chain of transmission of SARS-CoV-2, such as vaccination, masking, and testing.

It is people’s behavior, and ineffective public policy, that are so frustrating to us. The WHO’s secretary general warned against relying solely on vaccines in December. “Vaccines alone will not get any country out of this crisis.”

Omicron takes a new mindset. What we were doing before is not protecting now. Unchecked spread is overwhelming our health care systems and putting the vulnerable in our population at risk. The ramification of this unchecked spread reaches everywhere – into the economy, our educational system, and our nation’s mental health.

When the pandemic started, the policies to control its spread rested on local government and public agencies; we all would have been better served had there been a unified, national response to an infectious threat that does not obey municipal or state boundaries.

 The universal sentiment among health care workers is frustration with local and state governments that are either dictating policy that can harm the public we are trying to protect.

As of September, at least 23 state legislatures have passed laws changing a governor’s executive power reach. Many have taken it away. Others are fighting in the courts over mask mandates.

As for when the pandemic will subside, that appears to be up to the public and public policy makers. They will determine how long this will last and how many will die or be disabled before its end.

Health care’s modern-day version of the Greek chorus is growing louder and more persistent. My colleagues and I have long been among them.

In news conferences, journal articles, and podcasts, this chorus is pleading with the public to pay attention to its message: SARs-CoV-2 is not done with us. Omicron can kill; it can infect the vaccinated.

We have found, like everyone else, that Omicron runs on its rules; with Delta, two vaccine shots were able to lower the positivity rate. With Omicron, two shots have not been enough.

The WHO used the word “surprise” in its November announcement that Omicron was a variant of “concern.”

So did Trevor Bedford, a computational biologist and infectious disease scientist at the Fred Hutchinson Cancer Center in Seattle, who said that Omicron “took me and everyone by surprise.”1 Speaking on KevinMD’s podcast, he told his host that with the degree of immunity in the global population, he was expecting subsequent evolving strains to have minor, subtle genetic mutations, akin to how flu varies from year to year. What was a surprise was the giant leap in evolution that occurred with Omicron, which contains 36 mutations in the spike protein and approximately 50 mutations in total. Because of these mutations, the original two-shot mRNA COVID vaccines becomes only 40% effective against symptomatic disease after several months (thankfully a booster shot increases this to ~80%).2 But the decreased vaccine protection without a booster, along with relaxation of mitigation measures, brought us to where we are now.

In Chicago, we knew the Omicron variant would move quickly, considering how it moved through South Africa and the United Kingdom. What we didn’t anticipate was that in one week’s time, our hospital would need to add another 100 dedicated COVID ICU beds. Nor did we anticipate the extent that Omicron would affect staffing levels in the same amount of time.

At our hospital, we have eliminated elective surgeries that require a hospital stay, which includes surgeries for cancer. One of my colleagues, Ryan Merkow, MD, a surgical oncologist, remarked recently he had to cancel half of his scheduled surgeries because of a lack of hospital space.3

Dispelling Myths

What is concerning about this current wave is how many unvaccinated are hospitalized. Because Omicron is so infectious and because of lower vaccination rates in younger adults and children, we have a younger group of adults and children admitted with COVID, who had been uninfected by previous surges.

A major myth that makes health care workers so frustrated is the tale that Omicron is milder. Unvaccinated people infected with this variant are seriously ill and are dying. Despite its “mild” label, once a patient is hospitalized, Omicron can be just as severe as its predecessors.4 For many, getting vaccinated is the difference between staying at home with some symptoms and being in the ICU.

As of January 10, according to the CDC, although 88% of people over the age of 65 are vaccinated, only 37.5% have gotten boosters which are key to restoring protection against Omicron. And among children, only 54% between 12- and 17-years-old are fully vaccinated, and a mere 17% of children aged 5 to 11 have gotten both of their shots.

Remember the conversations regarding natural immunity? Omicron has muffled that conversation. Those who have been infected with SARS-Co-V2 before can still get infected and very ill with Omicron. So now is the time to get vaccinated.

Transmissibility

We knew SARS-CoV-2 could spread 1 of 2 ways: large virus-carrying droplets that enter through the nose, mouth, and eyes, as well as miniscule airborne droplets of virus that float in the air and travel further than 6 feet. However, prior to Omicron, transmission of these smaller droplets via the air was not as frequent. But with Omicron, while it still travels by larger respiratory droplets, it appears to have more airborne spread.

In late December, The Lancet Regional Health published results of research conducted one month earlier at a designated quarantine hotel in Hong Kong.5 The index case was housed in the room across a hallway from the second case, who developed their case 8 days into quarantine. Testing showed the Omicron variant in both cases. Environmental testing of the walls and ceiling suggested airborne spread of the virus in places unreachable by large respiratory droplets.

Now with Omicron, people need to wear high-filtering masks that fit tight against the face, such as a N95, KN-95, or KF-94 if possible. And when removing the mask to eat and drink, one should be in well-ventilated areas, away from others.

People should avoid getting Omicron, regardless of vaccination status. This variant is so infectious that, compared to the Delta variant, people are twice as likely to infect others that live with them. And infecting others leads to a chain of transmission that can close schools, take over hospital beds, and disable or kill the most vulnerable in our communities.

Public and private behavior, and public policy

In July, months before that WHO announced Omicron’s existence, Rella and colleagues reported in Scientific Reports on the outcome of a new model designed to show how a vaccine-resistant strain could rapidly transmit through a highly vaccinated population if transmission mitigation interventions are dropped too soon.6

The authors wrote that the success of a vaccine-resistant strain making inroads into a population depends on the obvious – it finds populations with a low rate of vaccination. What is not so obvious, the authors wrote, is that a vaccine-resistant virus does its worst when transmission is not well controlled in a highly vaccinated population. What can prevent a surge like this are social behaviors and public policy that decrease the chain of transmission of SARS-CoV-2, such as vaccination, masking, and testing.

It is people’s behavior, and ineffective public policy, that are so frustrating to us. The WHO’s secretary general warned against relying solely on vaccines in December. “Vaccines alone will not get any country out of this crisis.”

Omicron takes a new mindset. What we were doing before is not protecting now. Unchecked spread is overwhelming our health care systems and putting the vulnerable in our population at risk. The ramification of this unchecked spread reaches everywhere – into the economy, our educational system, and our nation’s mental health.

When the pandemic started, the policies to control its spread rested on local government and public agencies; we all would have been better served had there been a unified, national response to an infectious threat that does not obey municipal or state boundaries.

 The universal sentiment among health care workers is frustration with local and state governments that are either dictating policy that can harm the public we are trying to protect.

As of September, at least 23 state legislatures have passed laws changing a governor’s executive power reach. Many have taken it away. Others are fighting in the courts over mask mandates.

As for when the pandemic will subside, that appears to be up to the public and public policy makers. They will determine how long this will last and how many will die or be disabled before its end.

References

References

  1. KevinMD.com. Trevor Bedford on Omicron and what about Covid keeps him up at night. Dec. 17 podcast. https://www.kevinmd.com/blog/post-author/the-podcast-by-kevinmd/page/2
  2. Andrews N, Stowe J, Kirsebom F, et al. Effectiveness of COVID-19 vaccines against the Omicron (B.1.1.529) variant of concern. MedRxiv. Preprint. doi: https://doi.org/10.1101/2021.12.14.21267615
  3. Weise E and Shamus KJ. (January 13, 2022). As COVID-19 surges, there are no hospital beds for others in need of care. USA Today. As COVID-19 surges, there are no hospital beds for others in need of care (yahoo.com)
  4. Wolter N, Jassat W, Walaza S, et al. Early assessment of the clinical severity of the SARS-CoV-2 Omicron variant in South Africa. MedRxiv. Preprint. doi: https://doi.org/10.1101/2021.12.21.21268116
  5. Shuk-Ching Wong, Albert Ka-Wing Au, Hong Chen et al. Transmission of Omicron (B.1.1.529) - SARS-CoV-2 Variant of Concern in a designated quarantine hotel for travelers: a challenge of elimination strategy of COVID-19. The Lancet Regional Health - Western Pacific.  Available online 23 December 2021
  6. Rella SA, Kulikova YA, Dermitzakis ET, et al. Rates of SARS-CoV-2 transmission and vaccination impact the fate of vaccine-resistant strains. Sci Rep 11, 15729 (2021).
  7. WHO press conference on coronavirus disease (COVID-19) - 14 December 2021.
  8. Telebriefing on Covid-19 Update. https://www.cdc.gov/media/releases/2022/t0107-Covid-update.html
  9. Shuk-Ching Wong, Albert Ka-Wing Au, Hong Chen et al. Transmission of Omicron (B.1.1.529) - SARS-CoV-2 Variant of Concern in a designated quarantine hotel for travelers: a challenge of elimination strategy of COVID-1 The Lancet Regional Health - Western Pacific.  Available online 23 December 2021
  10. CDC. Interim Guidance for Managing Healthcare Personnel with SARS-CoV-2 Infection or Exposure to SARS-CoV-2. Dec. 23, 2021.
  11. Mariah Timms. Tennessee appeals federal court order temporarily blocking new state law on school masks. Nashville Tennessean. Jan. 3, 2022.
  12. Statewide Number of Covid-19 Hospitalized Pediatric Patients. Jan. 4, 2022.
  13. National Conference of State Legislatures. Legislative Oversight of Emergency Executive Powers. Jan. 4, 2022.

https://news.yahoo.com/Covid-surges-others-care-theres-105949790.html

Elizabeth Weise and Kristen Jordan Shamus. As COVID-19 surges, there are no hospital beds for others in need of care. USA Today. Jan. 13, 2022.

References

References

  1. KevinMD.com. Trevor Bedford on Omicron and what about Covid keeps him up at night. Dec. 17 podcast. https://www.kevinmd.com/blog/post-author/the-podcast-by-kevinmd/page/2
  2. Andrews N, Stowe J, Kirsebom F, et al. Effectiveness of COVID-19 vaccines against the Omicron (B.1.1.529) variant of concern. MedRxiv. Preprint. doi: https://doi.org/10.1101/2021.12.14.21267615
  3. Weise E and Shamus KJ. (January 13, 2022). As COVID-19 surges, there are no hospital beds for others in need of care. USA Today. As COVID-19 surges, there are no hospital beds for others in need of care (yahoo.com)
  4. Wolter N, Jassat W, Walaza S, et al. Early assessment of the clinical severity of the SARS-CoV-2 Omicron variant in South Africa. MedRxiv. Preprint. doi: https://doi.org/10.1101/2021.12.21.21268116
  5. Shuk-Ching Wong, Albert Ka-Wing Au, Hong Chen et al. Transmission of Omicron (B.1.1.529) - SARS-CoV-2 Variant of Concern in a designated quarantine hotel for travelers: a challenge of elimination strategy of COVID-19. The Lancet Regional Health - Western Pacific.  Available online 23 December 2021
  6. Rella SA, Kulikova YA, Dermitzakis ET, et al. Rates of SARS-CoV-2 transmission and vaccination impact the fate of vaccine-resistant strains. Sci Rep 11, 15729 (2021).
  7. WHO press conference on coronavirus disease (COVID-19) - 14 December 2021.
  8. Telebriefing on Covid-19 Update. https://www.cdc.gov/media/releases/2022/t0107-Covid-update.html
  9. Shuk-Ching Wong, Albert Ka-Wing Au, Hong Chen et al. Transmission of Omicron (B.1.1.529) - SARS-CoV-2 Variant of Concern in a designated quarantine hotel for travelers: a challenge of elimination strategy of COVID-1 The Lancet Regional Health - Western Pacific.  Available online 23 December 2021
  10. CDC. Interim Guidance for Managing Healthcare Personnel with SARS-CoV-2 Infection or Exposure to SARS-CoV-2. Dec. 23, 2021.
  11. Mariah Timms. Tennessee appeals federal court order temporarily blocking new state law on school masks. Nashville Tennessean. Jan. 3, 2022.
  12. Statewide Number of Covid-19 Hospitalized Pediatric Patients. Jan. 4, 2022.
  13. National Conference of State Legislatures. Legislative Oversight of Emergency Executive Powers. Jan. 4, 2022.

https://news.yahoo.com/Covid-surges-others-care-theres-105949790.html

Elizabeth Weise and Kristen Jordan Shamus. As COVID-19 surges, there are no hospital beds for others in need of care. USA Today. Jan. 13, 2022.

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Axilla swelling after COVID booster puts focus on mammogram timing

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Thu, 12/15/2022 - 17:24

Axilla swelling, one of the side effects of the initial COVID-19 vaccine series in women, has also materialized with the boosters.

This inflammation is caused by the enlargement of lymph nodes and can show up as an abnormal finding on mammograms and other types of chest scans, causing concern and even the need for additional imaging and follow up, wrote Constance D. Lehman, MD, PhD, and colleagues in an article published in Journal of the American College of Radiology.

Lymph node swelling is a normal immune system reaction to vaccination, and “COVID-19 vaccinations in the arm are a well-documented cause of inflammatory unilateral axillary adenopathy,” noted Dr. Lehman, in an interview. The side effect will occur on the side of the body where the patient received a vaccine, and it is not always noticeable to the woman experiencing it, she said.

“We’re finding that the patients’ bodies are responding to the booster in many ways that are similar to the initial COVID vaccines, with lymph node swelling, muscle aches and pains, headaches, and so on,” said Dr. Lehman, who is chief of breast imaging at the Massachusetts General Hospital, Boston. There have been no real differences in reactions between the Moderna and Pfizer vaccines, she added.

Because axillary lymph node swelling can obscure mammogram results, staff of at least a few imaging centers, including Penn State Breast Center in Hershey, Pa., and Providence Women’s Imaging Center in Torrance, Calif., told this news organization that they are asking women to delay mammogram imaging either 6 weeks or 4-6 weeks after getting a COVID-19 booster.
 

Experts’ suggestions on mammograms, boosters timing

Other experts, including Jessica Leung, MD, acknowledged that vaccine-related reactive adenopathy is seen after the booster dose and provided recommendations for the timing of getting mammograms and the booster with this in mind.

“I would recommend getting the screening mammogram first, which can be followed immediately by vaccination, even on the same day,” said Jessica Leung, MD, a professor of diagnostic radiology at the University of Texas MD Anderson Cancer Center in Houston, Tex.

“If this is not possible from the scheduling perspective, then the patient should consult her health care provider regarding whether it is okay to wait a bit after receiving the vaccine before getting her screening mammogram.”

The answer to that question will likely depend on the time interval since the prior mammogram and the patient’s personal risk factors for developing breast cancer. Dr. Leung noted. “This is all predicated on the assumption that the patient is asymptomatic. If she has any symptoms, for example a palpable breast lump, then she should seek medical attention regardless of timing of vaccination.”

The same holds true for boosters, she said.

She emphasized that careful consideration should be given before delaying the mammogram. “The medical community has a great deal more knowledge at this time than in the early days of COVID-19 vaccination, so we are often able to identify reactive adenopathy related to vaccination. If patients were to delay the mammogram, any reactive adenopathy may persist, on average, for 4-6 weeks.”

Debra Patt, MD, PhD, MBA, executive vice president at Texas Oncology, professor at the University of Texas at Austin, provided a specific example of when a patient should not delay the diagnostic imaging, which is “in the event that there is an abnormal mass in the breast that requires evaluation.”

Providers are now prepared to address these issues, she added.
 

 

 

Dr. Lehman’s nuanced recommendations

“It’s easy to get both a mammogram and booster, and just a matter of timing them – so that the reaction doesn’t interfere with the mammography results,” Dr. Lehman said.

But she emphasized that women should not be choosing between their mammograms or a booster. “We are now saying the same thing that we did with the initial vaccine,” said Dr. Lehman. “We don’t want patients delaying their mammograms, and we don’t want them delaying their boosters – both are critical to staying healthy.”

In her center, a model was developed to navigate vaccine-associated adenopathy. While this approach was developed for the primary vaccine series, the same applies for the booster, which is essentially a third dose of the same vaccine, explained Dr. Lehman.

When patients present for mammography, ultrasound, or MRI, the technologist will document their COVID-19 vaccination status (first or second dose or booster), the date it was given, and the location. Adding vaccination documentation to intake forms helps to support appropriate management of patients who undergo imaging after COVID-19 vaccination. Six weeks is used as the cutoff point for defining “recent” vaccination.

For patients who are getting a screening mammography or MRI, and who have no symptoms beyond unilateral axillary adenopathy on the same side of the body where they received the COVID-19 vaccination (given in the arm) within a 6-week period, the following is included in the screening mammography or screening MRI report: “In the specific setting of a patient with documented recent (within the past 6 weeks) COVID-19 vaccination in the ipsilateral arm, axillary adenopathy is a benign imaging finding. No further imaging is indicated at this time. If there is clinical concern that persists more than 6 weeks after the patient received the final vaccine dose, axillary ultrasound is recommended.”

The experts interviewed reported no conflicts of interest.

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Axilla swelling, one of the side effects of the initial COVID-19 vaccine series in women, has also materialized with the boosters.

This inflammation is caused by the enlargement of lymph nodes and can show up as an abnormal finding on mammograms and other types of chest scans, causing concern and even the need for additional imaging and follow up, wrote Constance D. Lehman, MD, PhD, and colleagues in an article published in Journal of the American College of Radiology.

Lymph node swelling is a normal immune system reaction to vaccination, and “COVID-19 vaccinations in the arm are a well-documented cause of inflammatory unilateral axillary adenopathy,” noted Dr. Lehman, in an interview. The side effect will occur on the side of the body where the patient received a vaccine, and it is not always noticeable to the woman experiencing it, she said.

“We’re finding that the patients’ bodies are responding to the booster in many ways that are similar to the initial COVID vaccines, with lymph node swelling, muscle aches and pains, headaches, and so on,” said Dr. Lehman, who is chief of breast imaging at the Massachusetts General Hospital, Boston. There have been no real differences in reactions between the Moderna and Pfizer vaccines, she added.

Because axillary lymph node swelling can obscure mammogram results, staff of at least a few imaging centers, including Penn State Breast Center in Hershey, Pa., and Providence Women’s Imaging Center in Torrance, Calif., told this news organization that they are asking women to delay mammogram imaging either 6 weeks or 4-6 weeks after getting a COVID-19 booster.
 

Experts’ suggestions on mammograms, boosters timing

Other experts, including Jessica Leung, MD, acknowledged that vaccine-related reactive adenopathy is seen after the booster dose and provided recommendations for the timing of getting mammograms and the booster with this in mind.

“I would recommend getting the screening mammogram first, which can be followed immediately by vaccination, even on the same day,” said Jessica Leung, MD, a professor of diagnostic radiology at the University of Texas MD Anderson Cancer Center in Houston, Tex.

“If this is not possible from the scheduling perspective, then the patient should consult her health care provider regarding whether it is okay to wait a bit after receiving the vaccine before getting her screening mammogram.”

The answer to that question will likely depend on the time interval since the prior mammogram and the patient’s personal risk factors for developing breast cancer. Dr. Leung noted. “This is all predicated on the assumption that the patient is asymptomatic. If she has any symptoms, for example a palpable breast lump, then she should seek medical attention regardless of timing of vaccination.”

The same holds true for boosters, she said.

She emphasized that careful consideration should be given before delaying the mammogram. “The medical community has a great deal more knowledge at this time than in the early days of COVID-19 vaccination, so we are often able to identify reactive adenopathy related to vaccination. If patients were to delay the mammogram, any reactive adenopathy may persist, on average, for 4-6 weeks.”

Debra Patt, MD, PhD, MBA, executive vice president at Texas Oncology, professor at the University of Texas at Austin, provided a specific example of when a patient should not delay the diagnostic imaging, which is “in the event that there is an abnormal mass in the breast that requires evaluation.”

Providers are now prepared to address these issues, she added.
 

 

 

Dr. Lehman’s nuanced recommendations

“It’s easy to get both a mammogram and booster, and just a matter of timing them – so that the reaction doesn’t interfere with the mammography results,” Dr. Lehman said.

But she emphasized that women should not be choosing between their mammograms or a booster. “We are now saying the same thing that we did with the initial vaccine,” said Dr. Lehman. “We don’t want patients delaying their mammograms, and we don’t want them delaying their boosters – both are critical to staying healthy.”

In her center, a model was developed to navigate vaccine-associated adenopathy. While this approach was developed for the primary vaccine series, the same applies for the booster, which is essentially a third dose of the same vaccine, explained Dr. Lehman.

When patients present for mammography, ultrasound, or MRI, the technologist will document their COVID-19 vaccination status (first or second dose or booster), the date it was given, and the location. Adding vaccination documentation to intake forms helps to support appropriate management of patients who undergo imaging after COVID-19 vaccination. Six weeks is used as the cutoff point for defining “recent” vaccination.

For patients who are getting a screening mammography or MRI, and who have no symptoms beyond unilateral axillary adenopathy on the same side of the body where they received the COVID-19 vaccination (given in the arm) within a 6-week period, the following is included in the screening mammography or screening MRI report: “In the specific setting of a patient with documented recent (within the past 6 weeks) COVID-19 vaccination in the ipsilateral arm, axillary adenopathy is a benign imaging finding. No further imaging is indicated at this time. If there is clinical concern that persists more than 6 weeks after the patient received the final vaccine dose, axillary ultrasound is recommended.”

The experts interviewed reported no conflicts of interest.

Axilla swelling, one of the side effects of the initial COVID-19 vaccine series in women, has also materialized with the boosters.

This inflammation is caused by the enlargement of lymph nodes and can show up as an abnormal finding on mammograms and other types of chest scans, causing concern and even the need for additional imaging and follow up, wrote Constance D. Lehman, MD, PhD, and colleagues in an article published in Journal of the American College of Radiology.

Lymph node swelling is a normal immune system reaction to vaccination, and “COVID-19 vaccinations in the arm are a well-documented cause of inflammatory unilateral axillary adenopathy,” noted Dr. Lehman, in an interview. The side effect will occur on the side of the body where the patient received a vaccine, and it is not always noticeable to the woman experiencing it, she said.

“We’re finding that the patients’ bodies are responding to the booster in many ways that are similar to the initial COVID vaccines, with lymph node swelling, muscle aches and pains, headaches, and so on,” said Dr. Lehman, who is chief of breast imaging at the Massachusetts General Hospital, Boston. There have been no real differences in reactions between the Moderna and Pfizer vaccines, she added.

Because axillary lymph node swelling can obscure mammogram results, staff of at least a few imaging centers, including Penn State Breast Center in Hershey, Pa., and Providence Women’s Imaging Center in Torrance, Calif., told this news organization that they are asking women to delay mammogram imaging either 6 weeks or 4-6 weeks after getting a COVID-19 booster.
 

Experts’ suggestions on mammograms, boosters timing

Other experts, including Jessica Leung, MD, acknowledged that vaccine-related reactive adenopathy is seen after the booster dose and provided recommendations for the timing of getting mammograms and the booster with this in mind.

“I would recommend getting the screening mammogram first, which can be followed immediately by vaccination, even on the same day,” said Jessica Leung, MD, a professor of diagnostic radiology at the University of Texas MD Anderson Cancer Center in Houston, Tex.

“If this is not possible from the scheduling perspective, then the patient should consult her health care provider regarding whether it is okay to wait a bit after receiving the vaccine before getting her screening mammogram.”

The answer to that question will likely depend on the time interval since the prior mammogram and the patient’s personal risk factors for developing breast cancer. Dr. Leung noted. “This is all predicated on the assumption that the patient is asymptomatic. If she has any symptoms, for example a palpable breast lump, then she should seek medical attention regardless of timing of vaccination.”

The same holds true for boosters, she said.

She emphasized that careful consideration should be given before delaying the mammogram. “The medical community has a great deal more knowledge at this time than in the early days of COVID-19 vaccination, so we are often able to identify reactive adenopathy related to vaccination. If patients were to delay the mammogram, any reactive adenopathy may persist, on average, for 4-6 weeks.”

Debra Patt, MD, PhD, MBA, executive vice president at Texas Oncology, professor at the University of Texas at Austin, provided a specific example of when a patient should not delay the diagnostic imaging, which is “in the event that there is an abnormal mass in the breast that requires evaluation.”

Providers are now prepared to address these issues, she added.
 

 

 

Dr. Lehman’s nuanced recommendations

“It’s easy to get both a mammogram and booster, and just a matter of timing them – so that the reaction doesn’t interfere with the mammography results,” Dr. Lehman said.

But she emphasized that women should not be choosing between their mammograms or a booster. “We are now saying the same thing that we did with the initial vaccine,” said Dr. Lehman. “We don’t want patients delaying their mammograms, and we don’t want them delaying their boosters – both are critical to staying healthy.”

In her center, a model was developed to navigate vaccine-associated adenopathy. While this approach was developed for the primary vaccine series, the same applies for the booster, which is essentially a third dose of the same vaccine, explained Dr. Lehman.

When patients present for mammography, ultrasound, or MRI, the technologist will document their COVID-19 vaccination status (first or second dose or booster), the date it was given, and the location. Adding vaccination documentation to intake forms helps to support appropriate management of patients who undergo imaging after COVID-19 vaccination. Six weeks is used as the cutoff point for defining “recent” vaccination.

For patients who are getting a screening mammography or MRI, and who have no symptoms beyond unilateral axillary adenopathy on the same side of the body where they received the COVID-19 vaccination (given in the arm) within a 6-week period, the following is included in the screening mammography or screening MRI report: “In the specific setting of a patient with documented recent (within the past 6 weeks) COVID-19 vaccination in the ipsilateral arm, axillary adenopathy is a benign imaging finding. No further imaging is indicated at this time. If there is clinical concern that persists more than 6 weeks after the patient received the final vaccine dose, axillary ultrasound is recommended.”

The experts interviewed reported no conflicts of interest.

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COVID-19 hospital data: New-onset seizures more common than breakthrough seizures

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Fri, 01/28/2022 - 18:14

An analysis of hospitalized patients with COVID-19 finds that those with no history of epilepsy had more than 3 times the odds of suffering a new-onset seizure than patients with epilepsy were to have breakthrough seizures (odds radio [OR] 3.15, P < .0001), researchers reported at the annual meeting of the American Epilepsy Society.

“If you have COVID and you have a seizure, it’s more likely that you’re having it for the first time, and it’s not as likely that you have epilepsy,” study lead author Neeraj Singh, MD, a neurologist at the New York-based Northwell Health system, said in an interview. “That’s new. We don’t normally see that when someone has a bacterial or viral infection. It’s demonstrating that this infection is having direct effect on the brain and brain signals.”

According to Dr. Singh, there’s little data about seizures in patients with COVID-19 because doctors have focused on other symptoms. A 2021 multicenter study found that electrographic seizures were detected in 9.6% of 197 patients with COVID-19 who were referred for cEEG.

For the new study, Dr. Singh and a colleague tracked 917 patients with COVID-19 in the Northwell Health system who were treated from Feb. 14 to June 14, 2020, with antiepileptic medication. Of the patients, 451 had a history of epilepsy, and 466 did not.

According to Dr. Singh, 27.6% of the patients without a history of epilepsy had new-onset seizures, while 10.1% of the patients with history of epilepsy had breakthrough seizures. The difference in odds was more than threefold after adjustment. (Among all COVID-19 patients, he said, perhaps 8%-16% had seizures).

The researchers also found that patients with new-onset seizures stayed in the hospital much longer (average, 26.9 days) than any patients with a known history of epilepsy (12.8 days, P < .0001, for those who had breakthrough seizures and 10.9 days, P < .0001, for those who didn’t).

In addition, the researchers found that having any seizures – new-onset or breakthrough – was linked to higher risk of death (OR 1.41, P = .03).

Antiseizure medications are key treatments for these patients, Dr. Singh said. As for the patients with new-onset seizures who recover from COVID-19, Dr. Singh said, “it’s suspected that these people are going to have a new diagnosis of epilepsy, not just a one-time seizure.”

The findings suggest that some patients with epilepsy are protected against COVID-19-related seizures because they take antiepileptic medications that “protect the brain from getting a trigger for an abnormal signal that leads to a seizure,” he said. “That’s one possibility.”

What can neurologists learn from the study? Dr. Singh recommends a “lower threshold” to recommend or approve EEGs in patients with COVID-19 who are confused/altered when they come in, especially if this is not normal. “They may actually be having silent seizures that no one’s noticing,” he said.

No study funding was reported. The authors reported no relevant disclosures.

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An analysis of hospitalized patients with COVID-19 finds that those with no history of epilepsy had more than 3 times the odds of suffering a new-onset seizure than patients with epilepsy were to have breakthrough seizures (odds radio [OR] 3.15, P < .0001), researchers reported at the annual meeting of the American Epilepsy Society.

“If you have COVID and you have a seizure, it’s more likely that you’re having it for the first time, and it’s not as likely that you have epilepsy,” study lead author Neeraj Singh, MD, a neurologist at the New York-based Northwell Health system, said in an interview. “That’s new. We don’t normally see that when someone has a bacterial or viral infection. It’s demonstrating that this infection is having direct effect on the brain and brain signals.”

According to Dr. Singh, there’s little data about seizures in patients with COVID-19 because doctors have focused on other symptoms. A 2021 multicenter study found that electrographic seizures were detected in 9.6% of 197 patients with COVID-19 who were referred for cEEG.

For the new study, Dr. Singh and a colleague tracked 917 patients with COVID-19 in the Northwell Health system who were treated from Feb. 14 to June 14, 2020, with antiepileptic medication. Of the patients, 451 had a history of epilepsy, and 466 did not.

According to Dr. Singh, 27.6% of the patients without a history of epilepsy had new-onset seizures, while 10.1% of the patients with history of epilepsy had breakthrough seizures. The difference in odds was more than threefold after adjustment. (Among all COVID-19 patients, he said, perhaps 8%-16% had seizures).

The researchers also found that patients with new-onset seizures stayed in the hospital much longer (average, 26.9 days) than any patients with a known history of epilepsy (12.8 days, P < .0001, for those who had breakthrough seizures and 10.9 days, P < .0001, for those who didn’t).

In addition, the researchers found that having any seizures – new-onset or breakthrough – was linked to higher risk of death (OR 1.41, P = .03).

Antiseizure medications are key treatments for these patients, Dr. Singh said. As for the patients with new-onset seizures who recover from COVID-19, Dr. Singh said, “it’s suspected that these people are going to have a new diagnosis of epilepsy, not just a one-time seizure.”

The findings suggest that some patients with epilepsy are protected against COVID-19-related seizures because they take antiepileptic medications that “protect the brain from getting a trigger for an abnormal signal that leads to a seizure,” he said. “That’s one possibility.”

What can neurologists learn from the study? Dr. Singh recommends a “lower threshold” to recommend or approve EEGs in patients with COVID-19 who are confused/altered when they come in, especially if this is not normal. “They may actually be having silent seizures that no one’s noticing,” he said.

No study funding was reported. The authors reported no relevant disclosures.

An analysis of hospitalized patients with COVID-19 finds that those with no history of epilepsy had more than 3 times the odds of suffering a new-onset seizure than patients with epilepsy were to have breakthrough seizures (odds radio [OR] 3.15, P < .0001), researchers reported at the annual meeting of the American Epilepsy Society.

“If you have COVID and you have a seizure, it’s more likely that you’re having it for the first time, and it’s not as likely that you have epilepsy,” study lead author Neeraj Singh, MD, a neurologist at the New York-based Northwell Health system, said in an interview. “That’s new. We don’t normally see that when someone has a bacterial or viral infection. It’s demonstrating that this infection is having direct effect on the brain and brain signals.”

According to Dr. Singh, there’s little data about seizures in patients with COVID-19 because doctors have focused on other symptoms. A 2021 multicenter study found that electrographic seizures were detected in 9.6% of 197 patients with COVID-19 who were referred for cEEG.

For the new study, Dr. Singh and a colleague tracked 917 patients with COVID-19 in the Northwell Health system who were treated from Feb. 14 to June 14, 2020, with antiepileptic medication. Of the patients, 451 had a history of epilepsy, and 466 did not.

According to Dr. Singh, 27.6% of the patients without a history of epilepsy had new-onset seizures, while 10.1% of the patients with history of epilepsy had breakthrough seizures. The difference in odds was more than threefold after adjustment. (Among all COVID-19 patients, he said, perhaps 8%-16% had seizures).

The researchers also found that patients with new-onset seizures stayed in the hospital much longer (average, 26.9 days) than any patients with a known history of epilepsy (12.8 days, P < .0001, for those who had breakthrough seizures and 10.9 days, P < .0001, for those who didn’t).

In addition, the researchers found that having any seizures – new-onset or breakthrough – was linked to higher risk of death (OR 1.41, P = .03).

Antiseizure medications are key treatments for these patients, Dr. Singh said. As for the patients with new-onset seizures who recover from COVID-19, Dr. Singh said, “it’s suspected that these people are going to have a new diagnosis of epilepsy, not just a one-time seizure.”

The findings suggest that some patients with epilepsy are protected against COVID-19-related seizures because they take antiepileptic medications that “protect the brain from getting a trigger for an abnormal signal that leads to a seizure,” he said. “That’s one possibility.”

What can neurologists learn from the study? Dr. Singh recommends a “lower threshold” to recommend or approve EEGs in patients with COVID-19 who are confused/altered when they come in, especially if this is not normal. “They may actually be having silent seizures that no one’s noticing,” he said.

No study funding was reported. The authors reported no relevant disclosures.

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A pandemic silver lining? Dramatic drop in teen drug use

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Illicit drug use among U.S. teenagers dropped sharply in 2021, likely because of stay-at-home orders and other restrictions on social activities due to the COVID-19 pandemic.

The latest findings, from the Monitoring the Future survey, represent the largest 1-year decrease in overall illicit drug use reported since the survey began in 1975.

“We have never seen such dramatic decreases in drug use among teens in just a 1-year period,” Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release

“These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Dr. Volkow.

The annual Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA, to assess drug and alcohol use and related attitudes among adolescent students across the United States.

This year’s self-reported survey included 32,260 students in grades 8, 10, and 12 across 319 public and private schools.



Compared with 2020, the percentage of students reporting any illicit drug use (other than marijuana) in 2021 decreased significantly for 8th graders (down 5.4%), 10th graders (down 11.7%), and 12th graders (down 4.8%).

Significant declines were also seen among the three most commonly used drugs in adolescence: marijuana, alcohol, and vaped nicotine.

For alcohol, about 47% of 12th graders and 29% of 10th graders said they drank alcohol in 2021, down significantly from 55% and 41%, respectively, in 2020. The percentage of 8th graders who said they drank alcohol remained stable (17% in 2021 and 20% in 2020).

For teen vaping, about 27% of 12th graders and 20% of 10th graders said they had vaped nicotine in 2021, down significantly from nearly 35% and 31%, respectively, in 2020. Fewer 8th graders also vaped nicotine in 2021 compared with 2020 (12% vs. 17%).

For marijuana, use dropped significantly for all three grades in 2021 compared with 2020. About 31% of 12th graders and 17% of 10th graders said they used marijuana in 2021, down from 35% and 28% in 2020. Among 8th graders, 7% used marijuana in 2021, down from 11% in 2020.

The latest survey also shows significant declines in use of a range of other drugs for many of the age cohorts, including cocaine, hallucinogens, and nonmedical use of amphetamines, tranquilizers, and prescription opioids.

“We knew that this year’s data would illuminate how the COVID-19 pandemic may have impacted substance use among young people, and in the coming years, we will find out whether those impacts are long-lasting as we continue tracking the drug use patterns of these unique cohorts of adolescents,” Richard A. Miech, PhD, who heads the Monitoring the Future study at the University of Michigan, said in the news release.

“Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use – whether related to drug availability, family involvement, differences in peer pressure, or other factors – and harness them to inform future prevention efforts,” Dr. Volkow added.

In 2021, students across all age groups reported moderate increases in feelings of boredom, anxiety, depression, loneliness, worry, difficulty sleeping, and other negative mental health indicators since the beginning of the pandemic.

A version of this article first appeared on Medscape.com.

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Illicit drug use among U.S. teenagers dropped sharply in 2021, likely because of stay-at-home orders and other restrictions on social activities due to the COVID-19 pandemic.

The latest findings, from the Monitoring the Future survey, represent the largest 1-year decrease in overall illicit drug use reported since the survey began in 1975.

“We have never seen such dramatic decreases in drug use among teens in just a 1-year period,” Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release

“These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Dr. Volkow.

The annual Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA, to assess drug and alcohol use and related attitudes among adolescent students across the United States.

This year’s self-reported survey included 32,260 students in grades 8, 10, and 12 across 319 public and private schools.



Compared with 2020, the percentage of students reporting any illicit drug use (other than marijuana) in 2021 decreased significantly for 8th graders (down 5.4%), 10th graders (down 11.7%), and 12th graders (down 4.8%).

Significant declines were also seen among the three most commonly used drugs in adolescence: marijuana, alcohol, and vaped nicotine.

For alcohol, about 47% of 12th graders and 29% of 10th graders said they drank alcohol in 2021, down significantly from 55% and 41%, respectively, in 2020. The percentage of 8th graders who said they drank alcohol remained stable (17% in 2021 and 20% in 2020).

For teen vaping, about 27% of 12th graders and 20% of 10th graders said they had vaped nicotine in 2021, down significantly from nearly 35% and 31%, respectively, in 2020. Fewer 8th graders also vaped nicotine in 2021 compared with 2020 (12% vs. 17%).

For marijuana, use dropped significantly for all three grades in 2021 compared with 2020. About 31% of 12th graders and 17% of 10th graders said they used marijuana in 2021, down from 35% and 28% in 2020. Among 8th graders, 7% used marijuana in 2021, down from 11% in 2020.

The latest survey also shows significant declines in use of a range of other drugs for many of the age cohorts, including cocaine, hallucinogens, and nonmedical use of amphetamines, tranquilizers, and prescription opioids.

“We knew that this year’s data would illuminate how the COVID-19 pandemic may have impacted substance use among young people, and in the coming years, we will find out whether those impacts are long-lasting as we continue tracking the drug use patterns of these unique cohorts of adolescents,” Richard A. Miech, PhD, who heads the Monitoring the Future study at the University of Michigan, said in the news release.

“Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use – whether related to drug availability, family involvement, differences in peer pressure, or other factors – and harness them to inform future prevention efforts,” Dr. Volkow added.

In 2021, students across all age groups reported moderate increases in feelings of boredom, anxiety, depression, loneliness, worry, difficulty sleeping, and other negative mental health indicators since the beginning of the pandemic.

A version of this article first appeared on Medscape.com.

Illicit drug use among U.S. teenagers dropped sharply in 2021, likely because of stay-at-home orders and other restrictions on social activities due to the COVID-19 pandemic.

The latest findings, from the Monitoring the Future survey, represent the largest 1-year decrease in overall illicit drug use reported since the survey began in 1975.

“We have never seen such dramatic decreases in drug use among teens in just a 1-year period,” Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release

“These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Dr. Volkow.

The annual Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA, to assess drug and alcohol use and related attitudes among adolescent students across the United States.

This year’s self-reported survey included 32,260 students in grades 8, 10, and 12 across 319 public and private schools.



Compared with 2020, the percentage of students reporting any illicit drug use (other than marijuana) in 2021 decreased significantly for 8th graders (down 5.4%), 10th graders (down 11.7%), and 12th graders (down 4.8%).

Significant declines were also seen among the three most commonly used drugs in adolescence: marijuana, alcohol, and vaped nicotine.

For alcohol, about 47% of 12th graders and 29% of 10th graders said they drank alcohol in 2021, down significantly from 55% and 41%, respectively, in 2020. The percentage of 8th graders who said they drank alcohol remained stable (17% in 2021 and 20% in 2020).

For teen vaping, about 27% of 12th graders and 20% of 10th graders said they had vaped nicotine in 2021, down significantly from nearly 35% and 31%, respectively, in 2020. Fewer 8th graders also vaped nicotine in 2021 compared with 2020 (12% vs. 17%).

For marijuana, use dropped significantly for all three grades in 2021 compared with 2020. About 31% of 12th graders and 17% of 10th graders said they used marijuana in 2021, down from 35% and 28% in 2020. Among 8th graders, 7% used marijuana in 2021, down from 11% in 2020.

The latest survey also shows significant declines in use of a range of other drugs for many of the age cohorts, including cocaine, hallucinogens, and nonmedical use of amphetamines, tranquilizers, and prescription opioids.

“We knew that this year’s data would illuminate how the COVID-19 pandemic may have impacted substance use among young people, and in the coming years, we will find out whether those impacts are long-lasting as we continue tracking the drug use patterns of these unique cohorts of adolescents,” Richard A. Miech, PhD, who heads the Monitoring the Future study at the University of Michigan, said in the news release.

“Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use – whether related to drug availability, family involvement, differences in peer pressure, or other factors – and harness them to inform future prevention efforts,” Dr. Volkow added.

In 2021, students across all age groups reported moderate increases in feelings of boredom, anxiety, depression, loneliness, worry, difficulty sleeping, and other negative mental health indicators since the beginning of the pandemic.

A version of this article first appeared on Medscape.com.

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Epilepsy linked to 1.5-fold higher COVID-19 mortality in hospital

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Although their ages were similar, patients with epilepsy were nearly 1.5 times more likely to die of COVID-19 than other infected patients at a hospital system during the first 14 months of the pandemic, according to a new study presented at the annual meeting of the American Epilepsy Society. While the findings are preliminary and not yet adjusted for various confounders, the authors say they are a warning sign that patients with epilepsy may face higher risks.

“These findings suggest that epilepsy may be a pre-existing condition that places patients at increased risk for death if hospitalized with a COVID-19 infection. It may offer neurologists guidance when counseling patients on critical preventative measures such as masking, social distancing, and most importantly, vaccination,” lead author Claire Ufongene, a student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

According to Ms. Ufongene, there’s sparse data about COVID-19 outcomes in patients with epilepsy, although she highlighted a 2021 meta-analysis of 13 studies that found a higher risk of severity (odds ratio, 1.69; 95% confidence interval, 1.11-2.59, P = .010) and mortality (OR, 1.71; 95% CI, 1.14-2.56, P = .010).

For the new study, researchers retrospectively tracked identified 334 patients with epilepsy and COVID-19 and 9,499 other patients with COVID-19 from March 15, 2020, to May 17, 2021. All were treated at hospitals within the New York–based Icahn School of Medicine at Mount Sinai.

The groups of patients with and without epilepsy were similar in some ways: 45% and 46%, respectively, were female (P = .674), and their ages were similar (average, 62 years and 65 years, respectively; P = .02). Racial makeup was also similar (non-Hispanic groups made up 27.8% of those with epilepsy and 24.5% of those without; the difference was not statistically significant).

“In addition, more of those with epilepsy were English speaking [83.2% vs. 77.9%] and had Medicaid insurance [50.9% vs. 38.9%], while fewer of those with epilepsy had private insurance [16.2% vs. 25.5%] or were Spanish speaking [14.0% vs. 9.3%],” study coauthor Nathalie Jette, MD, MSc, a neurologist at Icahn School of Medicine at Mount Sinai, said in an interview.

In terms of outcomes, patients with epilepsy were much more likely to need ventilator support (37.7% vs. 14.3%; P < .001), to be admitted to the ICU (39.2% vs. 17.7%; P < .001), and to die in the hospital (29.6% vs. 19.9%; P < .001).

“Most patients we follow in our practices with epilepsy who experienced COVID-19 in general have had symptoms similar to the general population,” Dr. Jette said. “There are rare instances where COVID-19 can result in an exacerbation of seizures in some with pre-existing epilepsy. This is not surprising as infections in particular can decrease the seizure threshold and result in breakthrough seizures in people living with epilepsy.”
 

Loss of seizure control

How might epilepsy be related to worse outcomes in COVID-19? Andrew Wilner, MD, a neurologist and internist at University of Tennessee Health Science Center, Memphis, who’s familiar with the study findings, said COVID-19 itself may not worsen epilepsy. “Evidence to suggest that COVID-19 directly affects the central nervous system is extremely limited. As such, one would not expect that a COVID-19 infection would cause epilepsy or exacerbate epilepsy,” he said. “However, patients with epilepsy who suffer from infections may be predisposed to decreased seizure control. Consequently, it would not be surprising if patients with epilepsy who also had COVID-19 had loss of seizure control and even status epilepticus, which could adversely affect their hospital course. However, there are no data on this potential phenomenon.”

Dr. Wilner suspected that comorbidities explain the higher mortality in patients with epilepsy. “The findings are probably most useful in that they call attention to the fact that epilepsy patients are more vulnerable to a host of comorbidities and resultant poorer outcomes due to any acute illness.”

As for treatment, Dr. Wilner urged colleagues to make sure that hospitalized patients with epilepsy “continue to receive their antiepileptic medications, which they may no longer be able to take orally. They may need to be switched temporarily to an intravenous formulation.”

In an interview, Selim Benbadis, MD, a neurologist from the University of South Florida, Tampa, suggested that antiseizure medications may play a role in the COVID-19 disease course because they can reduce the efficacy of other medications, although he noted that drug treatments for COVID-19 were limited early on. He recommended that neurologists “avoid old enzyme-inducing seizure medications, as is generally recommended.”

No study funding is reported. The study authors and Dr. Benbadis reported no relevant disclosures. Dr. Wilner is a medical adviser for the epilepsy disease management program for CVS/Health.

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Although their ages were similar, patients with epilepsy were nearly 1.5 times more likely to die of COVID-19 than other infected patients at a hospital system during the first 14 months of the pandemic, according to a new study presented at the annual meeting of the American Epilepsy Society. While the findings are preliminary and not yet adjusted for various confounders, the authors say they are a warning sign that patients with epilepsy may face higher risks.

“These findings suggest that epilepsy may be a pre-existing condition that places patients at increased risk for death if hospitalized with a COVID-19 infection. It may offer neurologists guidance when counseling patients on critical preventative measures such as masking, social distancing, and most importantly, vaccination,” lead author Claire Ufongene, a student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

According to Ms. Ufongene, there’s sparse data about COVID-19 outcomes in patients with epilepsy, although she highlighted a 2021 meta-analysis of 13 studies that found a higher risk of severity (odds ratio, 1.69; 95% confidence interval, 1.11-2.59, P = .010) and mortality (OR, 1.71; 95% CI, 1.14-2.56, P = .010).

For the new study, researchers retrospectively tracked identified 334 patients with epilepsy and COVID-19 and 9,499 other patients with COVID-19 from March 15, 2020, to May 17, 2021. All were treated at hospitals within the New York–based Icahn School of Medicine at Mount Sinai.

The groups of patients with and without epilepsy were similar in some ways: 45% and 46%, respectively, were female (P = .674), and their ages were similar (average, 62 years and 65 years, respectively; P = .02). Racial makeup was also similar (non-Hispanic groups made up 27.8% of those with epilepsy and 24.5% of those without; the difference was not statistically significant).

“In addition, more of those with epilepsy were English speaking [83.2% vs. 77.9%] and had Medicaid insurance [50.9% vs. 38.9%], while fewer of those with epilepsy had private insurance [16.2% vs. 25.5%] or were Spanish speaking [14.0% vs. 9.3%],” study coauthor Nathalie Jette, MD, MSc, a neurologist at Icahn School of Medicine at Mount Sinai, said in an interview.

In terms of outcomes, patients with epilepsy were much more likely to need ventilator support (37.7% vs. 14.3%; P < .001), to be admitted to the ICU (39.2% vs. 17.7%; P < .001), and to die in the hospital (29.6% vs. 19.9%; P < .001).

“Most patients we follow in our practices with epilepsy who experienced COVID-19 in general have had symptoms similar to the general population,” Dr. Jette said. “There are rare instances where COVID-19 can result in an exacerbation of seizures in some with pre-existing epilepsy. This is not surprising as infections in particular can decrease the seizure threshold and result in breakthrough seizures in people living with epilepsy.”
 

Loss of seizure control

How might epilepsy be related to worse outcomes in COVID-19? Andrew Wilner, MD, a neurologist and internist at University of Tennessee Health Science Center, Memphis, who’s familiar with the study findings, said COVID-19 itself may not worsen epilepsy. “Evidence to suggest that COVID-19 directly affects the central nervous system is extremely limited. As such, one would not expect that a COVID-19 infection would cause epilepsy or exacerbate epilepsy,” he said. “However, patients with epilepsy who suffer from infections may be predisposed to decreased seizure control. Consequently, it would not be surprising if patients with epilepsy who also had COVID-19 had loss of seizure control and even status epilepticus, which could adversely affect their hospital course. However, there are no data on this potential phenomenon.”

Dr. Wilner suspected that comorbidities explain the higher mortality in patients with epilepsy. “The findings are probably most useful in that they call attention to the fact that epilepsy patients are more vulnerable to a host of comorbidities and resultant poorer outcomes due to any acute illness.”

As for treatment, Dr. Wilner urged colleagues to make sure that hospitalized patients with epilepsy “continue to receive their antiepileptic medications, which they may no longer be able to take orally. They may need to be switched temporarily to an intravenous formulation.”

In an interview, Selim Benbadis, MD, a neurologist from the University of South Florida, Tampa, suggested that antiseizure medications may play a role in the COVID-19 disease course because they can reduce the efficacy of other medications, although he noted that drug treatments for COVID-19 were limited early on. He recommended that neurologists “avoid old enzyme-inducing seizure medications, as is generally recommended.”

No study funding is reported. The study authors and Dr. Benbadis reported no relevant disclosures. Dr. Wilner is a medical adviser for the epilepsy disease management program for CVS/Health.

Although their ages were similar, patients with epilepsy were nearly 1.5 times more likely to die of COVID-19 than other infected patients at a hospital system during the first 14 months of the pandemic, according to a new study presented at the annual meeting of the American Epilepsy Society. While the findings are preliminary and not yet adjusted for various confounders, the authors say they are a warning sign that patients with epilepsy may face higher risks.

“These findings suggest that epilepsy may be a pre-existing condition that places patients at increased risk for death if hospitalized with a COVID-19 infection. It may offer neurologists guidance when counseling patients on critical preventative measures such as masking, social distancing, and most importantly, vaccination,” lead author Claire Ufongene, a student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

According to Ms. Ufongene, there’s sparse data about COVID-19 outcomes in patients with epilepsy, although she highlighted a 2021 meta-analysis of 13 studies that found a higher risk of severity (odds ratio, 1.69; 95% confidence interval, 1.11-2.59, P = .010) and mortality (OR, 1.71; 95% CI, 1.14-2.56, P = .010).

For the new study, researchers retrospectively tracked identified 334 patients with epilepsy and COVID-19 and 9,499 other patients with COVID-19 from March 15, 2020, to May 17, 2021. All were treated at hospitals within the New York–based Icahn School of Medicine at Mount Sinai.

The groups of patients with and without epilepsy were similar in some ways: 45% and 46%, respectively, were female (P = .674), and their ages were similar (average, 62 years and 65 years, respectively; P = .02). Racial makeup was also similar (non-Hispanic groups made up 27.8% of those with epilepsy and 24.5% of those without; the difference was not statistically significant).

“In addition, more of those with epilepsy were English speaking [83.2% vs. 77.9%] and had Medicaid insurance [50.9% vs. 38.9%], while fewer of those with epilepsy had private insurance [16.2% vs. 25.5%] or were Spanish speaking [14.0% vs. 9.3%],” study coauthor Nathalie Jette, MD, MSc, a neurologist at Icahn School of Medicine at Mount Sinai, said in an interview.

In terms of outcomes, patients with epilepsy were much more likely to need ventilator support (37.7% vs. 14.3%; P < .001), to be admitted to the ICU (39.2% vs. 17.7%; P < .001), and to die in the hospital (29.6% vs. 19.9%; P < .001).

“Most patients we follow in our practices with epilepsy who experienced COVID-19 in general have had symptoms similar to the general population,” Dr. Jette said. “There are rare instances where COVID-19 can result in an exacerbation of seizures in some with pre-existing epilepsy. This is not surprising as infections in particular can decrease the seizure threshold and result in breakthrough seizures in people living with epilepsy.”
 

Loss of seizure control

How might epilepsy be related to worse outcomes in COVID-19? Andrew Wilner, MD, a neurologist and internist at University of Tennessee Health Science Center, Memphis, who’s familiar with the study findings, said COVID-19 itself may not worsen epilepsy. “Evidence to suggest that COVID-19 directly affects the central nervous system is extremely limited. As such, one would not expect that a COVID-19 infection would cause epilepsy or exacerbate epilepsy,” he said. “However, patients with epilepsy who suffer from infections may be predisposed to decreased seizure control. Consequently, it would not be surprising if patients with epilepsy who also had COVID-19 had loss of seizure control and even status epilepticus, which could adversely affect their hospital course. However, there are no data on this potential phenomenon.”

Dr. Wilner suspected that comorbidities explain the higher mortality in patients with epilepsy. “The findings are probably most useful in that they call attention to the fact that epilepsy patients are more vulnerable to a host of comorbidities and resultant poorer outcomes due to any acute illness.”

As for treatment, Dr. Wilner urged colleagues to make sure that hospitalized patients with epilepsy “continue to receive their antiepileptic medications, which they may no longer be able to take orally. They may need to be switched temporarily to an intravenous formulation.”

In an interview, Selim Benbadis, MD, a neurologist from the University of South Florida, Tampa, suggested that antiseizure medications may play a role in the COVID-19 disease course because they can reduce the efficacy of other medications, although he noted that drug treatments for COVID-19 were limited early on. He recommended that neurologists “avoid old enzyme-inducing seizure medications, as is generally recommended.”

No study funding is reported. The study authors and Dr. Benbadis reported no relevant disclosures. Dr. Wilner is a medical adviser for the epilepsy disease management program for CVS/Health.

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What the Future May Hold for Covid-19 Survivors

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What the Future May Hold for Covid-19 Survivors

 

What the Future May Hold for Covid-19 Survivors

More than 3 million Americans1 have been hospitalized with Covid-19, and 770,000 of them have died. 2 As of this writing,  49,000 Americans are hospitalized, with 12,000 remaining in intensive care units.3 With growing numbers of patients being discharged from extensive stays in the ICU for severe Covid, it remains to be seen what the long-term impact will be on these patients, their families and on society writ large.

And these are just the patients with severe Covid: those who were never hospitalized are also showing deleterious effects from the effects of their illness.

Covid in the ICU

 What we know is that prior to Covid, 10% of all patients were admitted to ICU with acute respiratory distress syndrome4 (ARDS), despite receiving such life-saving measures as mechanical ventilation, medication, and supportive nutrition. Those who do survive face a long journey.4 Besides the specific respiratory recovery needed in those with ARDS, patients who have spent time in the ICU can develop multiple non-respiratory complications, including muscle wasting, generalized weakness, and delirium. The physical, cognitive, and psychological impairments that follow an ICU stay are termed postintensive care syndrome (PICS). PICS is an underrecognized phenomenon that describes the immense complications of an ICU stay for any reason. Recognition of this entity, and education of patients, is particularly important now as we face an ongoing pandemic which is creating a burgeoning number of ICU graduates.

PICS

Cognitive dysfunction is one hallmark of PICS. Delirium is a common complication of any hospitalization, with critically ill patients particularly susceptible given the severity of their illness and their exposure to medications such as sedatives. However, persistent global cognitive impairment is unique to PICS. Up to 40% 4 of ICU survivors have been found to have cognitive test results similar to those with moderate traumatic brain injury 3 months after discharge;  approximately 34% were still affected at 1 year. Similar findings were seen in a different study of ARDS patients.5 Hopkins et al. found that in these patients the rate of neurocognitive deficit persisted in 47% of patients at their 2-year follow-up. Patients describe being unable to re-enter their prior lives, troubled by difficulties with complex thinking and activities of daily living.

The second aspect of PICS is its psychological component. In the Hopkins study,5  23% ultimately reported persistent symptoms of depression and/or anxiety two years afterwards. Some patients have described intrusive distorted memories from their time in ICU; one patient detailed a recurring memory of an hallucination in which the nurses were transformed into demons hovering over his bed. Others have described feelings akin to depression, anxiety, and posttraumatic stress syndrome (PTSD).

The final component of PICS is physical impairment. Those who are critically ill commonly suffer intensive care unit-acquired weakness,6 which is a term to describe generalized limb and diaphragmatic weakness with no other medical cause. Risk factors for this entity include sepsis, multi-organ failure, mechanical ventilation, hyperglycemia, extensive immobilization, and exposure to steroids and neuromuscular blocking agents. ICU-acquired weakness can resolve within weeks to months but in some studies can persist for years. It has been observed that survivors of ARDS experience persistent physical limitations, even 5 years later.

Covid in the ICU

Estimates of the incidence of PICS due to Covid are evolving. A report on 1700 Covid hospitalized patients in Wuhan, China demonstrated a large prevalence of residual symptoms at 6 months. The most common symptoms were fatigue and weakness (63%), insomnia (26%), and anxiety or depression (23%).7 Furthermore, one-fourth to one-third of those with severe illness fell below the lower limit of normal for a 6-minute walk test. An Italian study demonstrated decreased global quality of life indices for Covid ICU survivors8 3 months from discharge, particularly with mobility, eating, and resuming usual activities. In a Michigan observational9 study, which included all hospitalized patients with Covid including those never in ICU, one-third of respondents said they continued to cough or have shortness of breath. Only one-fourth had returned to work, with many of them having to modify activities or reduce hours due to their health. Nearly half reported being negatively emotionally impacted by their health issues. Last, a single French hospital10 discovered that Covid patients 4 months after hospital discharge experienced numerous, persistent symptoms. 38% of patients confirmed some form of cognitive impairment, with 17% reporting memory difficulties, 10% mental slowness, and 10% concentration problems. Of patients who were intubated, one-third still reported subjective dyspnea. Nearly a third still struggled with weakness.

As more centers track the progress of their ICU graduates over time, we can better understand the profound impact of critical illness on our Covid patients and better educate our patients and families on what to expect. One might be able to gain some clues from what is known regarding the prior coronavirus epidemics, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). In these diseases, a meta-analysis showed significant rates of      lung function abnormalities,11 physical deconditioning, and mental health disorders during the 6 months after discharge. It might be that the impact of SARS-CoV2 is even more profound on survivors; additional studies need to be done.

Additional issues

What is particularly unique to Covid is the prevalence of long-term symptoms in those who were never hospitalized for Covid. Recent estimates of non-hospitalized patients who had Covid are showing at least 25% of them have had long-lasting effects, including stomach pain and respiratory issues.12 We are continuing to learn more about what is described as “long-haul syndrome.It has been described in both hospitalized and non-hospitalized patients, and therefore it can be hard to distinguish which symptoms are attributable to long-term effects of Covid infection versus the critical illness/PICS itself. These long-haul symptoms range from persistent lack of smell and taste, cognitive dysfunction, fatigue, decreased exercise endurance, and an increase in mental health disorders. The prognosis and spectrum of disease, as well as treatment, have yet to be determined, and the NIH is initiating a multicenter research study, RECOVER, to better characterize this syndrome.13  Patients who are interested in enrolling can fill out an interest form at recoverCovid.org.

Financially 1/314 of patients were impacted by their hospitalization for Covid, with nearly 10% using most or all their savings, despite many being covered by cost-sharing waivers for Covid care. A study reviewing Medicare data noted that the mean cost of a hospitalization for Covid is $21,752,15 increasing to nearly $50,000 if mechanical ventilation is needed. This does not account for the cost of rehabilitative care, as 40%16 of patients are discharged either to home with additional services or to other facilities (skilled nursing facility, hospice). As insurance companies increasingly lift the cost-sharing waivers and patients assume more responsibility for paying more of this cost, the financial burden on individual patients will increase. Furthermore, given a prolonged course of mental and physical disabilities after severe Covid, patients may lose their ability to return to work, their medical insurance, or their ability to provide childcare, further compounding their family’s financial woes.

Conclusion

The long-term effects of hospitalization from Covid argues further for continued work on increasing the vaccination rate of our population. Even with Delta variant, vaccines decrease the risk of hospitalization and death by more than a factor of 10.17 The profound medical and financial effects of severe Covid, and the repercussions on their family, should compel us as health care practitioners to inform those who are vaccine hesitant and to inform patients that they are eligible for vaccine boosters. The combination of colder weather and loosening of social distancing has already led to another surge of Covid infections and makes expedient vaccination the priority.

 

References
  1. CDC. Covid Data Tracker. https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions
  2. CDC. Covid Data Tracker. Trends total death. https://covid.cdc.gov/covid-data-tracker/#trends_totaldeaths_currenthospitaladmissions|tot_deaths|sum_inpatient_beds_used_covid_7DayAvg
  3. Johns Hopkins. Weekly hospital trends. https://coronavirus.jhu.edu/data/hospitalization-7-day-trend
  4. Bellani G, Laffey JG, Pham T, et al.; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients with Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800
  5. Ramona O. Hopkins, Lindell K. Weaver, Dave Collingridge, et al. Two-Year Cognitive, Emotional, and Quality-of-Life Outcomes in Acute Respiratory Distress Syndrome. Amer J Resp Crit Care Med. 2005; (171):4.
  6. Stevens, Robert D, Marshall, Scott A, Cornblath, David R, et al. A framework for diagnosing and classifying intensive care unit-acquired weakness, Critic Care Medic. 2009; (37)10: S299-S308.
  7. Chaolin Huang, Lixue Huang, Yeming Wang, et al. 6-month consequences of COVID-19 in patients discharged from om hospital: a cohort study. The Lancet 2021; 397(10270): 220-232.

 

  1. Gamberini L, Mazzoli CA, Sintonen H, et al.; ICU-RER COVID-19 Collaboration. Quality of life of COVID-19 critically ill survivors after ICU discharge: 90 days follow-up. Qual Life Res. 2021 Oct;30(10):2805-2817.
  2. Chopra V, Flanders SA, O'Malley M, et al. Sixty-Day Outcomes Among Patients Hospitalized With COVID-19. Ann Intern Med. 2021 Apr;174(4):576-578.
  3. The Writing Committee for the COMEBAC Study Group. Four-Month Clinical Status of a Cohort of Patients After Hospitalization for COVID-19. JAMA. 2021;325(15):1525–1534.
  4. Ahmed H, Patel K, Greenwood DC, et al. Long-term clinical outcomes in survivors of severe acute respiratory syndrome and Middle East respiratory syndrome coronavirus outbreaks after hospitalisation or ICU admission: A systematic review and meta-analysis. J Rehabil Med. 2020 May 31;52(5): jrm00063.
  5. Logue JK, Franko NM, McCulloch DJ, et al. Sequelae in Adults at 6 Months After COVID-19 Infection. JAMA Netw Open. 2021;4(2): e210830.

 

  1. Brenda Goodman. Major study will investigate long-haul Covid-19. WebMD News Brief. Sept. 15, 2021. https://www.webmd.com/lung/news/20210915/major-study-will-investigate-long-haul-covid

 

 

  1. Vineet Chopra, Scott A. Flanders, Megan O’Malley, et al. Sixty-Day Outcomes Among Patients Hospitalized With COVID-19. Ann Intern Med. Letters. 2021; Apr.
  2. Yuping Tsai, Tara M. Vogt, Fangjun Zhou. Patient Characteristics and Costs Associated With COVID-19–Related Medical Care Among Medicare Fee-for-Service Beneficiaries. Ann Intern Med. 2021; Aug.
  3.  Lavery AM, Preston LE, Ko JY, et al. Characteristics of Hospitalized COVID-19 Patients Discharged and Experiencing Same-Hospital Readmission — United States, March–August 2020. MMWR Morb Mortal Wkly Rep 2020; 69:1695–1699.
  4. Scobie HM, Johnson AG, Suthar AB, et al. Monitoring Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Status — 13 U.S. Jurisdictions, April 4–July 17, 2021. MMWR Morb Mortal Wkly Rep 2021; 70:1284–1290.

 

 

 

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Cheryl K. Lee, MD, Assistant Professor of Medicine - Northwestern Feinberg School of Medicine.

Disclosures: Dr. Lee has disclosed no relevant financial relationships

Cheryl K. Lee, MD, an Assistant Professor of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.

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Cheryl K. Lee, MD, Assistant Professor of Medicine - Northwestern Feinberg School of Medicine.

Disclosures: Dr. Lee has disclosed no relevant financial relationships

Cheryl K. Lee, MD, an Assistant Professor of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.

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Cheryl K. Lee, MD, Assistant Professor of Medicine - Northwestern Feinberg School of Medicine.

Disclosures: Dr. Lee has disclosed no relevant financial relationships

Cheryl K. Lee, MD, an Assistant Professor of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency.

 

What the Future May Hold for Covid-19 Survivors

More than 3 million Americans1 have been hospitalized with Covid-19, and 770,000 of them have died. 2 As of this writing,  49,000 Americans are hospitalized, with 12,000 remaining in intensive care units.3 With growing numbers of patients being discharged from extensive stays in the ICU for severe Covid, it remains to be seen what the long-term impact will be on these patients, their families and on society writ large.

And these are just the patients with severe Covid: those who were never hospitalized are also showing deleterious effects from the effects of their illness.

Covid in the ICU

 What we know is that prior to Covid, 10% of all patients were admitted to ICU with acute respiratory distress syndrome4 (ARDS), despite receiving such life-saving measures as mechanical ventilation, medication, and supportive nutrition. Those who do survive face a long journey.4 Besides the specific respiratory recovery needed in those with ARDS, patients who have spent time in the ICU can develop multiple non-respiratory complications, including muscle wasting, generalized weakness, and delirium. The physical, cognitive, and psychological impairments that follow an ICU stay are termed postintensive care syndrome (PICS). PICS is an underrecognized phenomenon that describes the immense complications of an ICU stay for any reason. Recognition of this entity, and education of patients, is particularly important now as we face an ongoing pandemic which is creating a burgeoning number of ICU graduates.

PICS

Cognitive dysfunction is one hallmark of PICS. Delirium is a common complication of any hospitalization, with critically ill patients particularly susceptible given the severity of their illness and their exposure to medications such as sedatives. However, persistent global cognitive impairment is unique to PICS. Up to 40% 4 of ICU survivors have been found to have cognitive test results similar to those with moderate traumatic brain injury 3 months after discharge;  approximately 34% were still affected at 1 year. Similar findings were seen in a different study of ARDS patients.5 Hopkins et al. found that in these patients the rate of neurocognitive deficit persisted in 47% of patients at their 2-year follow-up. Patients describe being unable to re-enter their prior lives, troubled by difficulties with complex thinking and activities of daily living.

The second aspect of PICS is its psychological component. In the Hopkins study,5  23% ultimately reported persistent symptoms of depression and/or anxiety two years afterwards. Some patients have described intrusive distorted memories from their time in ICU; one patient detailed a recurring memory of an hallucination in which the nurses were transformed into demons hovering over his bed. Others have described feelings akin to depression, anxiety, and posttraumatic stress syndrome (PTSD).

The final component of PICS is physical impairment. Those who are critically ill commonly suffer intensive care unit-acquired weakness,6 which is a term to describe generalized limb and diaphragmatic weakness with no other medical cause. Risk factors for this entity include sepsis, multi-organ failure, mechanical ventilation, hyperglycemia, extensive immobilization, and exposure to steroids and neuromuscular blocking agents. ICU-acquired weakness can resolve within weeks to months but in some studies can persist for years. It has been observed that survivors of ARDS experience persistent physical limitations, even 5 years later.

Covid in the ICU

Estimates of the incidence of PICS due to Covid are evolving. A report on 1700 Covid hospitalized patients in Wuhan, China demonstrated a large prevalence of residual symptoms at 6 months. The most common symptoms were fatigue and weakness (63%), insomnia (26%), and anxiety or depression (23%).7 Furthermore, one-fourth to one-third of those with severe illness fell below the lower limit of normal for a 6-minute walk test. An Italian study demonstrated decreased global quality of life indices for Covid ICU survivors8 3 months from discharge, particularly with mobility, eating, and resuming usual activities. In a Michigan observational9 study, which included all hospitalized patients with Covid including those never in ICU, one-third of respondents said they continued to cough or have shortness of breath. Only one-fourth had returned to work, with many of them having to modify activities or reduce hours due to their health. Nearly half reported being negatively emotionally impacted by their health issues. Last, a single French hospital10 discovered that Covid patients 4 months after hospital discharge experienced numerous, persistent symptoms. 38% of patients confirmed some form of cognitive impairment, with 17% reporting memory difficulties, 10% mental slowness, and 10% concentration problems. Of patients who were intubated, one-third still reported subjective dyspnea. Nearly a third still struggled with weakness.

As more centers track the progress of their ICU graduates over time, we can better understand the profound impact of critical illness on our Covid patients and better educate our patients and families on what to expect. One might be able to gain some clues from what is known regarding the prior coronavirus epidemics, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). In these diseases, a meta-analysis showed significant rates of      lung function abnormalities,11 physical deconditioning, and mental health disorders during the 6 months after discharge. It might be that the impact of SARS-CoV2 is even more profound on survivors; additional studies need to be done.

Additional issues

What is particularly unique to Covid is the prevalence of long-term symptoms in those who were never hospitalized for Covid. Recent estimates of non-hospitalized patients who had Covid are showing at least 25% of them have had long-lasting effects, including stomach pain and respiratory issues.12 We are continuing to learn more about what is described as “long-haul syndrome.It has been described in both hospitalized and non-hospitalized patients, and therefore it can be hard to distinguish which symptoms are attributable to long-term effects of Covid infection versus the critical illness/PICS itself. These long-haul symptoms range from persistent lack of smell and taste, cognitive dysfunction, fatigue, decreased exercise endurance, and an increase in mental health disorders. The prognosis and spectrum of disease, as well as treatment, have yet to be determined, and the NIH is initiating a multicenter research study, RECOVER, to better characterize this syndrome.13  Patients who are interested in enrolling can fill out an interest form at recoverCovid.org.

Financially 1/314 of patients were impacted by their hospitalization for Covid, with nearly 10% using most or all their savings, despite many being covered by cost-sharing waivers for Covid care. A study reviewing Medicare data noted that the mean cost of a hospitalization for Covid is $21,752,15 increasing to nearly $50,000 if mechanical ventilation is needed. This does not account for the cost of rehabilitative care, as 40%16 of patients are discharged either to home with additional services or to other facilities (skilled nursing facility, hospice). As insurance companies increasingly lift the cost-sharing waivers and patients assume more responsibility for paying more of this cost, the financial burden on individual patients will increase. Furthermore, given a prolonged course of mental and physical disabilities after severe Covid, patients may lose their ability to return to work, their medical insurance, or their ability to provide childcare, further compounding their family’s financial woes.

Conclusion

The long-term effects of hospitalization from Covid argues further for continued work on increasing the vaccination rate of our population. Even with Delta variant, vaccines decrease the risk of hospitalization and death by more than a factor of 10.17 The profound medical and financial effects of severe Covid, and the repercussions on their family, should compel us as health care practitioners to inform those who are vaccine hesitant and to inform patients that they are eligible for vaccine boosters. The combination of colder weather and loosening of social distancing has already led to another surge of Covid infections and makes expedient vaccination the priority.

 

 

What the Future May Hold for Covid-19 Survivors

More than 3 million Americans1 have been hospitalized with Covid-19, and 770,000 of them have died. 2 As of this writing,  49,000 Americans are hospitalized, with 12,000 remaining in intensive care units.3 With growing numbers of patients being discharged from extensive stays in the ICU for severe Covid, it remains to be seen what the long-term impact will be on these patients, their families and on society writ large.

And these are just the patients with severe Covid: those who were never hospitalized are also showing deleterious effects from the effects of their illness.

Covid in the ICU

 What we know is that prior to Covid, 10% of all patients were admitted to ICU with acute respiratory distress syndrome4 (ARDS), despite receiving such life-saving measures as mechanical ventilation, medication, and supportive nutrition. Those who do survive face a long journey.4 Besides the specific respiratory recovery needed in those with ARDS, patients who have spent time in the ICU can develop multiple non-respiratory complications, including muscle wasting, generalized weakness, and delirium. The physical, cognitive, and psychological impairments that follow an ICU stay are termed postintensive care syndrome (PICS). PICS is an underrecognized phenomenon that describes the immense complications of an ICU stay for any reason. Recognition of this entity, and education of patients, is particularly important now as we face an ongoing pandemic which is creating a burgeoning number of ICU graduates.

PICS

Cognitive dysfunction is one hallmark of PICS. Delirium is a common complication of any hospitalization, with critically ill patients particularly susceptible given the severity of their illness and their exposure to medications such as sedatives. However, persistent global cognitive impairment is unique to PICS. Up to 40% 4 of ICU survivors have been found to have cognitive test results similar to those with moderate traumatic brain injury 3 months after discharge;  approximately 34% were still affected at 1 year. Similar findings were seen in a different study of ARDS patients.5 Hopkins et al. found that in these patients the rate of neurocognitive deficit persisted in 47% of patients at their 2-year follow-up. Patients describe being unable to re-enter their prior lives, troubled by difficulties with complex thinking and activities of daily living.

The second aspect of PICS is its psychological component. In the Hopkins study,5  23% ultimately reported persistent symptoms of depression and/or anxiety two years afterwards. Some patients have described intrusive distorted memories from their time in ICU; one patient detailed a recurring memory of an hallucination in which the nurses were transformed into demons hovering over his bed. Others have described feelings akin to depression, anxiety, and posttraumatic stress syndrome (PTSD).

The final component of PICS is physical impairment. Those who are critically ill commonly suffer intensive care unit-acquired weakness,6 which is a term to describe generalized limb and diaphragmatic weakness with no other medical cause. Risk factors for this entity include sepsis, multi-organ failure, mechanical ventilation, hyperglycemia, extensive immobilization, and exposure to steroids and neuromuscular blocking agents. ICU-acquired weakness can resolve within weeks to months but in some studies can persist for years. It has been observed that survivors of ARDS experience persistent physical limitations, even 5 years later.

Covid in the ICU

Estimates of the incidence of PICS due to Covid are evolving. A report on 1700 Covid hospitalized patients in Wuhan, China demonstrated a large prevalence of residual symptoms at 6 months. The most common symptoms were fatigue and weakness (63%), insomnia (26%), and anxiety or depression (23%).7 Furthermore, one-fourth to one-third of those with severe illness fell below the lower limit of normal for a 6-minute walk test. An Italian study demonstrated decreased global quality of life indices for Covid ICU survivors8 3 months from discharge, particularly with mobility, eating, and resuming usual activities. In a Michigan observational9 study, which included all hospitalized patients with Covid including those never in ICU, one-third of respondents said they continued to cough or have shortness of breath. Only one-fourth had returned to work, with many of them having to modify activities or reduce hours due to their health. Nearly half reported being negatively emotionally impacted by their health issues. Last, a single French hospital10 discovered that Covid patients 4 months after hospital discharge experienced numerous, persistent symptoms. 38% of patients confirmed some form of cognitive impairment, with 17% reporting memory difficulties, 10% mental slowness, and 10% concentration problems. Of patients who were intubated, one-third still reported subjective dyspnea. Nearly a third still struggled with weakness.

As more centers track the progress of their ICU graduates over time, we can better understand the profound impact of critical illness on our Covid patients and better educate our patients and families on what to expect. One might be able to gain some clues from what is known regarding the prior coronavirus epidemics, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). In these diseases, a meta-analysis showed significant rates of      lung function abnormalities,11 physical deconditioning, and mental health disorders during the 6 months after discharge. It might be that the impact of SARS-CoV2 is even more profound on survivors; additional studies need to be done.

Additional issues

What is particularly unique to Covid is the prevalence of long-term symptoms in those who were never hospitalized for Covid. Recent estimates of non-hospitalized patients who had Covid are showing at least 25% of them have had long-lasting effects, including stomach pain and respiratory issues.12 We are continuing to learn more about what is described as “long-haul syndrome.It has been described in both hospitalized and non-hospitalized patients, and therefore it can be hard to distinguish which symptoms are attributable to long-term effects of Covid infection versus the critical illness/PICS itself. These long-haul symptoms range from persistent lack of smell and taste, cognitive dysfunction, fatigue, decreased exercise endurance, and an increase in mental health disorders. The prognosis and spectrum of disease, as well as treatment, have yet to be determined, and the NIH is initiating a multicenter research study, RECOVER, to better characterize this syndrome.13  Patients who are interested in enrolling can fill out an interest form at recoverCovid.org.

Financially 1/314 of patients were impacted by their hospitalization for Covid, with nearly 10% using most or all their savings, despite many being covered by cost-sharing waivers for Covid care. A study reviewing Medicare data noted that the mean cost of a hospitalization for Covid is $21,752,15 increasing to nearly $50,000 if mechanical ventilation is needed. This does not account for the cost of rehabilitative care, as 40%16 of patients are discharged either to home with additional services or to other facilities (skilled nursing facility, hospice). As insurance companies increasingly lift the cost-sharing waivers and patients assume more responsibility for paying more of this cost, the financial burden on individual patients will increase. Furthermore, given a prolonged course of mental and physical disabilities after severe Covid, patients may lose their ability to return to work, their medical insurance, or their ability to provide childcare, further compounding their family’s financial woes.

Conclusion

The long-term effects of hospitalization from Covid argues further for continued work on increasing the vaccination rate of our population. Even with Delta variant, vaccines decrease the risk of hospitalization and death by more than a factor of 10.17 The profound medical and financial effects of severe Covid, and the repercussions on their family, should compel us as health care practitioners to inform those who are vaccine hesitant and to inform patients that they are eligible for vaccine boosters. The combination of colder weather and loosening of social distancing has already led to another surge of Covid infections and makes expedient vaccination the priority.

 

References
  1. CDC. Covid Data Tracker. https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions
  2. CDC. Covid Data Tracker. Trends total death. https://covid.cdc.gov/covid-data-tracker/#trends_totaldeaths_currenthospitaladmissions|tot_deaths|sum_inpatient_beds_used_covid_7DayAvg
  3. Johns Hopkins. Weekly hospital trends. https://coronavirus.jhu.edu/data/hospitalization-7-day-trend
  4. Bellani G, Laffey JG, Pham T, et al.; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients with Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800
  5. Ramona O. Hopkins, Lindell K. Weaver, Dave Collingridge, et al. Two-Year Cognitive, Emotional, and Quality-of-Life Outcomes in Acute Respiratory Distress Syndrome. Amer J Resp Crit Care Med. 2005; (171):4.
  6. Stevens, Robert D, Marshall, Scott A, Cornblath, David R, et al. A framework for diagnosing and classifying intensive care unit-acquired weakness, Critic Care Medic. 2009; (37)10: S299-S308.
  7. Chaolin Huang, Lixue Huang, Yeming Wang, et al. 6-month consequences of COVID-19 in patients discharged from om hospital: a cohort study. The Lancet 2021; 397(10270): 220-232.

 

  1. Gamberini L, Mazzoli CA, Sintonen H, et al.; ICU-RER COVID-19 Collaboration. Quality of life of COVID-19 critically ill survivors after ICU discharge: 90 days follow-up. Qual Life Res. 2021 Oct;30(10):2805-2817.
  2. Chopra V, Flanders SA, O'Malley M, et al. Sixty-Day Outcomes Among Patients Hospitalized With COVID-19. Ann Intern Med. 2021 Apr;174(4):576-578.
  3. The Writing Committee for the COMEBAC Study Group. Four-Month Clinical Status of a Cohort of Patients After Hospitalization for COVID-19. JAMA. 2021;325(15):1525–1534.
  4. Ahmed H, Patel K, Greenwood DC, et al. Long-term clinical outcomes in survivors of severe acute respiratory syndrome and Middle East respiratory syndrome coronavirus outbreaks after hospitalisation or ICU admission: A systematic review and meta-analysis. J Rehabil Med. 2020 May 31;52(5): jrm00063.
  5. Logue JK, Franko NM, McCulloch DJ, et al. Sequelae in Adults at 6 Months After COVID-19 Infection. JAMA Netw Open. 2021;4(2): e210830.

 

  1. Brenda Goodman. Major study will investigate long-haul Covid-19. WebMD News Brief. Sept. 15, 2021. https://www.webmd.com/lung/news/20210915/major-study-will-investigate-long-haul-covid

 

 

  1. Vineet Chopra, Scott A. Flanders, Megan O’Malley, et al. Sixty-Day Outcomes Among Patients Hospitalized With COVID-19. Ann Intern Med. Letters. 2021; Apr.
  2. Yuping Tsai, Tara M. Vogt, Fangjun Zhou. Patient Characteristics and Costs Associated With COVID-19–Related Medical Care Among Medicare Fee-for-Service Beneficiaries. Ann Intern Med. 2021; Aug.
  3.  Lavery AM, Preston LE, Ko JY, et al. Characteristics of Hospitalized COVID-19 Patients Discharged and Experiencing Same-Hospital Readmission — United States, March–August 2020. MMWR Morb Mortal Wkly Rep 2020; 69:1695–1699.
  4. Scobie HM, Johnson AG, Suthar AB, et al. Monitoring Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Status — 13 U.S. Jurisdictions, April 4–July 17, 2021. MMWR Morb Mortal Wkly Rep 2021; 70:1284–1290.

 

 

 

References
  1. CDC. Covid Data Tracker. https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions
  2. CDC. Covid Data Tracker. Trends total death. https://covid.cdc.gov/covid-data-tracker/#trends_totaldeaths_currenthospitaladmissions|tot_deaths|sum_inpatient_beds_used_covid_7DayAvg
  3. Johns Hopkins. Weekly hospital trends. https://coronavirus.jhu.edu/data/hospitalization-7-day-trend
  4. Bellani G, Laffey JG, Pham T, et al.; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients with Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800
  5. Ramona O. Hopkins, Lindell K. Weaver, Dave Collingridge, et al. Two-Year Cognitive, Emotional, and Quality-of-Life Outcomes in Acute Respiratory Distress Syndrome. Amer J Resp Crit Care Med. 2005; (171):4.
  6. Stevens, Robert D, Marshall, Scott A, Cornblath, David R, et al. A framework for diagnosing and classifying intensive care unit-acquired weakness, Critic Care Medic. 2009; (37)10: S299-S308.
  7. Chaolin Huang, Lixue Huang, Yeming Wang, et al. 6-month consequences of COVID-19 in patients discharged from om hospital: a cohort study. The Lancet 2021; 397(10270): 220-232.

 

  1. Gamberini L, Mazzoli CA, Sintonen H, et al.; ICU-RER COVID-19 Collaboration. Quality of life of COVID-19 critically ill survivors after ICU discharge: 90 days follow-up. Qual Life Res. 2021 Oct;30(10):2805-2817.
  2. Chopra V, Flanders SA, O'Malley M, et al. Sixty-Day Outcomes Among Patients Hospitalized With COVID-19. Ann Intern Med. 2021 Apr;174(4):576-578.
  3. The Writing Committee for the COMEBAC Study Group. Four-Month Clinical Status of a Cohort of Patients After Hospitalization for COVID-19. JAMA. 2021;325(15):1525–1534.
  4. Ahmed H, Patel K, Greenwood DC, et al. Long-term clinical outcomes in survivors of severe acute respiratory syndrome and Middle East respiratory syndrome coronavirus outbreaks after hospitalisation or ICU admission: A systematic review and meta-analysis. J Rehabil Med. 2020 May 31;52(5): jrm00063.
  5. Logue JK, Franko NM, McCulloch DJ, et al. Sequelae in Adults at 6 Months After COVID-19 Infection. JAMA Netw Open. 2021;4(2): e210830.

 

  1. Brenda Goodman. Major study will investigate long-haul Covid-19. WebMD News Brief. Sept. 15, 2021. https://www.webmd.com/lung/news/20210915/major-study-will-investigate-long-haul-covid

 

 

  1. Vineet Chopra, Scott A. Flanders, Megan O’Malley, et al. Sixty-Day Outcomes Among Patients Hospitalized With COVID-19. Ann Intern Med. Letters. 2021; Apr.
  2. Yuping Tsai, Tara M. Vogt, Fangjun Zhou. Patient Characteristics and Costs Associated With COVID-19–Related Medical Care Among Medicare Fee-for-Service Beneficiaries. Ann Intern Med. 2021; Aug.
  3.  Lavery AM, Preston LE, Ko JY, et al. Characteristics of Hospitalized COVID-19 Patients Discharged and Experiencing Same-Hospital Readmission — United States, March–August 2020. MMWR Morb Mortal Wkly Rep 2020; 69:1695–1699.
  4. Scobie HM, Johnson AG, Suthar AB, et al. Monitoring Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Status — 13 U.S. Jurisdictions, April 4–July 17, 2021. MMWR Morb Mortal Wkly Rep 2021; 70:1284–1290.

 

 

 

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