Rheumatology News

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Enrollment is opening for four clinical trials that will evaluate new treatments for long COVID, the National Institutes of Health announced at a media briefing today. Additional clinical trials to test at least seven more treatments are expected to launch in the coming months, officials said.

The trials are part of the NIH’s research effort known as the Researching COVID to Enhance Recovery (RECOVER) Initiative. In December 2020, Congress approved $1.15 billion for the NIH to research and test treatments for long COVID. The new clinical trials are in phase 2 and will test safety and effectiveness.

“The condition affects nearly all body systems and presents with more than 200 symptoms,” said Walter J. Koroshetz, MD, director of the NIH National Institute of Neurological Disorders and Stroke and colead of the RECOVER Initiative. How many people have long COVID is uncertain, he told attendees at the briefing. “The answer kind of depends on how you define the problem and also what variant caused it. The incidence was higher in Delta.” Some estimates suggest that 5%-10% of those infected develop long COVID. “I don’t think we have solid numbers, as it’s a moving target,” Dr. Koroshetz said.

Patients with long COVID have grown increasingly frustrated at the lack of effective treatments. Some doctors have turned to off-label use of some drugs to treat them.

The four trials include the following:

• RECOVER-VITAL will focus on a treatment for viral persistence, which can occur if the virus lingers and causes the immune system to not work properly. One treatment will test a longer dose regimen of the antiviral Paxlovid (nirmatrelvir and ritonavir), which is currently used to treat mild to moderate COVID to halt progression to severe COVID.
• RECOVER-NEURO will target treatments for symptoms such as brain fog, memory problems, and attention challenges. Among the potential treatments are a program called BrainHQ, which provides Web-based training, and PASC-Cognitive Recovery (post-acute sequelae of COVID), a Web-based program developed by Mount Sinai Health System in New York. Also being tested is a direct current stimulation program to improve brain activity.
• RECOVER-SLEEP will evaluate treatments for sleep problems, which can include daytime sleepiness and other problems. According to Dr. Koroshetz, melatonin, light therapy, and an educational coaching system are among the treatments that will be studied.
• RECOVER-AUTONOMIC will evaluate treatments to address symptoms linked with problems of the autonomic nervous system. The first trial will target postural orthostatic tachycardia syndrome (POTS), which can include irregular heartbeat, fatigue, and dizziness. A treatment for immune disease and a drug currently used to treat chronic heart failure will be tested.

Timelines

The first trial, on viral persistence, has launched, said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute, the clinical trials data coordinating center for the trials. “We are actively working to launch the second on cognitive dysfunction.” The sleep and autonomic trials will launch in the coming months, she said. Also planned is a trial to study exercise intolerance, which is reported by many with long COVID.

Information on how to join long COVID trials is available here.

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

Enrollment is opening for four clinical trials that will evaluate new treatments for long COVID, the National Institutes of Health announced at a media briefing today. Additional clinical trials to test at least seven more treatments are expected to launch in the coming months, officials said.

The trials are part of the NIH’s research effort known as the Researching COVID to Enhance Recovery (RECOVER) Initiative. In December 2020, Congress approved $1.15 billion for the NIH to research and test treatments for long COVID. The new clinical trials are in phase 2 and will test safety and effectiveness.

“The condition affects nearly all body systems and presents with more than 200 symptoms,” said Walter J. Koroshetz, MD, director of the NIH National Institute of Neurological Disorders and Stroke and colead of the RECOVER Initiative. How many people have long COVID is uncertain, he told attendees at the briefing. “The answer kind of depends on how you define the problem and also what variant caused it. The incidence was higher in Delta.” Some estimates suggest that 5%-10% of those infected develop long COVID. “I don’t think we have solid numbers, as it’s a moving target,” Dr. Koroshetz said.

Patients with long COVID have grown increasingly frustrated at the lack of effective treatments. Some doctors have turned to off-label use of some drugs to treat them.

The four trials include the following:

• RECOVER-VITAL will focus on a treatment for viral persistence, which can occur if the virus lingers and causes the immune system to not work properly. One treatment will test a longer dose regimen of the antiviral Paxlovid (nirmatrelvir and ritonavir), which is currently used to treat mild to moderate COVID to halt progression to severe COVID.
• RECOVER-NEURO will target treatments for symptoms such as brain fog, memory problems, and attention challenges. Among the potential treatments are a program called BrainHQ, which provides Web-based training, and PASC-Cognitive Recovery (post-acute sequelae of COVID), a Web-based program developed by Mount Sinai Health System in New York. Also being tested is a direct current stimulation program to improve brain activity.
• RECOVER-SLEEP will evaluate treatments for sleep problems, which can include daytime sleepiness and other problems. According to Dr. Koroshetz, melatonin, light therapy, and an educational coaching system are among the treatments that will be studied.
• RECOVER-AUTONOMIC will evaluate treatments to address symptoms linked with problems of the autonomic nervous system. The first trial will target postural orthostatic tachycardia syndrome (POTS), which can include irregular heartbeat, fatigue, and dizziness. A treatment for immune disease and a drug currently used to treat chronic heart failure will be tested.

Timelines

The first trial, on viral persistence, has launched, said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute, the clinical trials data coordinating center for the trials. “We are actively working to launch the second on cognitive dysfunction.” The sleep and autonomic trials will launch in the coming months, she said. Also planned is a trial to study exercise intolerance, which is reported by many with long COVID.

Information on how to join long COVID trials is available here.

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

Enrollment is opening for four clinical trials that will evaluate new treatments for long COVID, the National Institutes of Health announced at a media briefing today. Additional clinical trials to test at least seven more treatments are expected to launch in the coming months, officials said.

The trials are part of the NIH’s research effort known as the Researching COVID to Enhance Recovery (RECOVER) Initiative. In December 2020, Congress approved $1.15 billion for the NIH to research and test treatments for long COVID. The new clinical trials are in phase 2 and will test safety and effectiveness.

“The condition affects nearly all body systems and presents with more than 200 symptoms,” said Walter J. Koroshetz, MD, director of the NIH National Institute of Neurological Disorders and Stroke and colead of the RECOVER Initiative. How many people have long COVID is uncertain, he told attendees at the briefing. “The answer kind of depends on how you define the problem and also what variant caused it. The incidence was higher in Delta.” Some estimates suggest that 5%-10% of those infected develop long COVID. “I don’t think we have solid numbers, as it’s a moving target,” Dr. Koroshetz said.

Patients with long COVID have grown increasingly frustrated at the lack of effective treatments. Some doctors have turned to off-label use of some drugs to treat them.

The four trials include the following:

• RECOVER-VITAL will focus on a treatment for viral persistence, which can occur if the virus lingers and causes the immune system to not work properly. One treatment will test a longer dose regimen of the antiviral Paxlovid (nirmatrelvir and ritonavir), which is currently used to treat mild to moderate COVID to halt progression to severe COVID.
• RECOVER-NEURO will target treatments for symptoms such as brain fog, memory problems, and attention challenges. Among the potential treatments are a program called BrainHQ, which provides Web-based training, and PASC-Cognitive Recovery (post-acute sequelae of COVID), a Web-based program developed by Mount Sinai Health System in New York. Also being tested is a direct current stimulation program to improve brain activity.
• RECOVER-SLEEP will evaluate treatments for sleep problems, which can include daytime sleepiness and other problems. According to Dr. Koroshetz, melatonin, light therapy, and an educational coaching system are among the treatments that will be studied.
• RECOVER-AUTONOMIC will evaluate treatments to address symptoms linked with problems of the autonomic nervous system. The first trial will target postural orthostatic tachycardia syndrome (POTS), which can include irregular heartbeat, fatigue, and dizziness. A treatment for immune disease and a drug currently used to treat chronic heart failure will be tested.

Timelines

The first trial, on viral persistence, has launched, said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute, the clinical trials data coordinating center for the trials. “We are actively working to launch the second on cognitive dysfunction.” The sleep and autonomic trials will launch in the coming months, she said. Also planned is a trial to study exercise intolerance, which is reported by many with long COVID.

Information on how to join long COVID trials is available here.

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

A new model can predict which patients are more likely to experience side effects from long-term methotrexate (MTX) use, research suggests. Patients with a lower risk profile may benefit from less frequent testing, the authors hypothesize.

Most recommendations advise that patients initiating MTX therapy should get blood testing every 2-4 weeks to monitor for full blood count, liver function, urea electrolytes, and creatinine. After 6 months taking MTX, monitoring can be tapered to every 3 months. But Abhishek Abhishek, MD, PhD, professor of rheumatology and honorary consultant rheumatologist at Nottingham (England) University Hospitals NHS Trust and colleagues argue that abnormal results after the initial 6 months of treatment are “infrequent,” and patients may benefit from fewer tests throughout the year.

ftwitty/E+/Getty Images

“Unnecessary blood tests waste patients’ time and health care resources, including the time of general practitioners and phlebotomists,” Dr. Abhishek and associates write. “It would be beneficial to predict the risk of clinically significant abnormal blood test results during long-term methotrexate treatment to inform the frequency of testing for individuals.”
 

Stratifying risk

In the study, published in the BMJ, researchers used the UK’s Clinical Practice Research Datalink (CPRD) to identify the electronic medical records of over 37,000 adult patients with an immune-mediated inflammatory disease who were prescribed MTX during 2007-2019. All included patients were prescribed MTX for at least 6 months. The main outcome was discontinuation of methotrexate because of abnormal blood test results. Around 62% of patients had rheumatoid arthritis and 22% had psoriasis or psoriatic arthritis.

Using these anonymized data, the group developed a risk stratification model using 11 clinical predictors. “The factors that went in the model are simple things that most patients can self-report or doctors can get from their patient’s medical records,” Dr. Abhishek told this news organization, including methotrexate dose, age, sex, and comorbidities. Dr. Abhishek emphasized that the model should be used only in patients who have continued taking MTX for at least 6 months and have already undergone more frequent initial testing.

The strongest individual predictors were diabetes (hazard ratio, 1.25), chronic kidney disease stage 3 (HR, 2.01), and previous cytopenia or raised liver enzyme levels during the first 6 months of MTX therapy (HR, 2.97). However, Dr. Abhishek emphasized that the individual factors were less important, noting that the model sums the risks to predict outcomes more accurately. Most patients (68.4%) were sorted into the low-risk cohort, with a less than 10% estimated risk of discontinuing MTX over the next 5 years. About one-fifth (20.9%) were categorized as moderate risk (10%-20% estimated risk over 5 years), and 10.7% were high risk, with a greater than 20% estimated risk of discontinuing the drug over 5 years.

The authors argue that low-risk patients could receive less frequent testing – perhaps every 6 months or annually, while moderate-risk patients would continue to be tested every 3 months. High-risk patients could potentially be tested with even greater frequently.
 

More research needed

The research involved “incredibly sophisticated statistical analysis,” said Daniel E. Furst, MD, professor emeritus of medicine at the University of California, Los Angeles, who was not involved with the study. However, the data do not yet support altering blood testing frequency based on this model.

“The hypothesis that not all patients have to be examined so frequently is a very reasonable hypothesis,” Dr. Furst said in an interview, and additional research is needed to corroborate it. The model also needs to be validated in patient populations outside of the United Kingdom, he added.

Dr. Abhishek agreed that validating the model in other patient populations is an important next step. “When we develop a tool [using] a one-nation data set, we want other researchers to then validate it in other countries’ data sets to make sure there is nothing odd about patients in the U.K. that makes the tool work well here but not in [the] U.S., Europe, or Asia, for example,” he said. Doing so should be relatively easy, he said, as the model is publicly available, and the information required is routinely collected during clinic visits.

To understand if less frequent testing might be appropriate for some patients, researchers would need to look at data registries like the Brigham and Women’s Hospital Rheumatoid Arthritis Sequential Study (BRASS) registry or CorEvitas registries “where the testing is done in a very regular way over the long haul,” Dr. Furst said. Analyzing these datasets, researchers could determine the testing intervals that would be most efficient for low- and high-risk patients.
 

A word of caution

While less frequent testing for long-term MTX therapy could likely have benefits, there is still some risk involved, cautioned Prabha Ranganathan, MD, professor of medicine at Washington University in St. Louis.

“Although most methotrexate toxicity occurs within the first 6 months of starting treatment, rare idiosyncratic toxicity can occur that does not correlate with the dose, duration, or method of how methotrexate is administered,” she wrote in an accompanying editorial. “Most rheumatologists can identify a handful of patients who receive methotrexate in their practice who develop sudden leukopenia or thrombocytopenia or transaminitis that is severe enough to warrant drug discontinuation.” While tools like this prediction model can be useful, clinicians need to consider each patient individually and use shared decision-making when monitoring for MTX toxicity, she advised.

“As in most of areas of medicine, the one-size-fits-all approach does not work for methotrexate users,” she noted.

This study was funded by the U.K. National Institute for Health and Care Research and Health Technology Assessment. Dr. Abhishek has received institutional research grants from AstraZeneca and Oxford Immunotech and personal fees from UpToDate, Springer, Cadila Pharmaceuticals, NGM Bio, Limbic, and Inflazome. Dr. Furst and Dr. Ranganathan report no relevant financial relationships.

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

A new model can predict which patients are more likely to experience side effects from long-term methotrexate (MTX) use, research suggests. Patients with a lower risk profile may benefit from less frequent testing, the authors hypothesize.

Most recommendations advise that patients initiating MTX therapy should get blood testing every 2-4 weeks to monitor for full blood count, liver function, urea electrolytes, and creatinine. After 6 months taking MTX, monitoring can be tapered to every 3 months. But Abhishek Abhishek, MD, PhD, professor of rheumatology and honorary consultant rheumatologist at Nottingham (England) University Hospitals NHS Trust and colleagues argue that abnormal results after the initial 6 months of treatment are “infrequent,” and patients may benefit from fewer tests throughout the year.

ftwitty/E+/Getty Images

“Unnecessary blood tests waste patients’ time and health care resources, including the time of general practitioners and phlebotomists,” Dr. Abhishek and associates write. “It would be beneficial to predict the risk of clinically significant abnormal blood test results during long-term methotrexate treatment to inform the frequency of testing for individuals.”
 

Stratifying risk

In the study, published in the BMJ, researchers used the UK’s Clinical Practice Research Datalink (CPRD) to identify the electronic medical records of over 37,000 adult patients with an immune-mediated inflammatory disease who were prescribed MTX during 2007-2019. All included patients were prescribed MTX for at least 6 months. The main outcome was discontinuation of methotrexate because of abnormal blood test results. Around 62% of patients had rheumatoid arthritis and 22% had psoriasis or psoriatic arthritis.

Using these anonymized data, the group developed a risk stratification model using 11 clinical predictors. “The factors that went in the model are simple things that most patients can self-report or doctors can get from their patient’s medical records,” Dr. Abhishek told this news organization, including methotrexate dose, age, sex, and comorbidities. Dr. Abhishek emphasized that the model should be used only in patients who have continued taking MTX for at least 6 months and have already undergone more frequent initial testing.

The strongest individual predictors were diabetes (hazard ratio, 1.25), chronic kidney disease stage 3 (HR, 2.01), and previous cytopenia or raised liver enzyme levels during the first 6 months of MTX therapy (HR, 2.97). However, Dr. Abhishek emphasized that the individual factors were less important, noting that the model sums the risks to predict outcomes more accurately. Most patients (68.4%) were sorted into the low-risk cohort, with a less than 10% estimated risk of discontinuing MTX over the next 5 years. About one-fifth (20.9%) were categorized as moderate risk (10%-20% estimated risk over 5 years), and 10.7% were high risk, with a greater than 20% estimated risk of discontinuing the drug over 5 years.

The authors argue that low-risk patients could receive less frequent testing – perhaps every 6 months or annually, while moderate-risk patients would continue to be tested every 3 months. High-risk patients could potentially be tested with even greater frequently.
 

More research needed

The research involved “incredibly sophisticated statistical analysis,” said Daniel E. Furst, MD, professor emeritus of medicine at the University of California, Los Angeles, who was not involved with the study. However, the data do not yet support altering blood testing frequency based on this model.

“The hypothesis that not all patients have to be examined so frequently is a very reasonable hypothesis,” Dr. Furst said in an interview, and additional research is needed to corroborate it. The model also needs to be validated in patient populations outside of the United Kingdom, he added.

Dr. Abhishek agreed that validating the model in other patient populations is an important next step. “When we develop a tool [using] a one-nation data set, we want other researchers to then validate it in other countries’ data sets to make sure there is nothing odd about patients in the U.K. that makes the tool work well here but not in [the] U.S., Europe, or Asia, for example,” he said. Doing so should be relatively easy, he said, as the model is publicly available, and the information required is routinely collected during clinic visits.

To understand if less frequent testing might be appropriate for some patients, researchers would need to look at data registries like the Brigham and Women’s Hospital Rheumatoid Arthritis Sequential Study (BRASS) registry or CorEvitas registries “where the testing is done in a very regular way over the long haul,” Dr. Furst said. Analyzing these datasets, researchers could determine the testing intervals that would be most efficient for low- and high-risk patients.
 

A word of caution

While less frequent testing for long-term MTX therapy could likely have benefits, there is still some risk involved, cautioned Prabha Ranganathan, MD, professor of medicine at Washington University in St. Louis.

“Although most methotrexate toxicity occurs within the first 6 months of starting treatment, rare idiosyncratic toxicity can occur that does not correlate with the dose, duration, or method of how methotrexate is administered,” she wrote in an accompanying editorial. “Most rheumatologists can identify a handful of patients who receive methotrexate in their practice who develop sudden leukopenia or thrombocytopenia or transaminitis that is severe enough to warrant drug discontinuation.” While tools like this prediction model can be useful, clinicians need to consider each patient individually and use shared decision-making when monitoring for MTX toxicity, she advised.

“As in most of areas of medicine, the one-size-fits-all approach does not work for methotrexate users,” she noted.

This study was funded by the U.K. National Institute for Health and Care Research and Health Technology Assessment. Dr. Abhishek has received institutional research grants from AstraZeneca and Oxford Immunotech and personal fees from UpToDate, Springer, Cadila Pharmaceuticals, NGM Bio, Limbic, and Inflazome. Dr. Furst and Dr. Ranganathan report no relevant financial relationships.

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

A new model can predict which patients are more likely to experience side effects from long-term methotrexate (MTX) use, research suggests. Patients with a lower risk profile may benefit from less frequent testing, the authors hypothesize.

Most recommendations advise that patients initiating MTX therapy should get blood testing every 2-4 weeks to monitor for full blood count, liver function, urea electrolytes, and creatinine. After 6 months taking MTX, monitoring can be tapered to every 3 months. But Abhishek Abhishek, MD, PhD, professor of rheumatology and honorary consultant rheumatologist at Nottingham (England) University Hospitals NHS Trust and colleagues argue that abnormal results after the initial 6 months of treatment are “infrequent,” and patients may benefit from fewer tests throughout the year.

ftwitty/E+/Getty Images

“Unnecessary blood tests waste patients’ time and health care resources, including the time of general practitioners and phlebotomists,” Dr. Abhishek and associates write. “It would be beneficial to predict the risk of clinically significant abnormal blood test results during long-term methotrexate treatment to inform the frequency of testing for individuals.”
 

Stratifying risk

In the study, published in the BMJ, researchers used the UK’s Clinical Practice Research Datalink (CPRD) to identify the electronic medical records of over 37,000 adult patients with an immune-mediated inflammatory disease who were prescribed MTX during 2007-2019. All included patients were prescribed MTX for at least 6 months. The main outcome was discontinuation of methotrexate because of abnormal blood test results. Around 62% of patients had rheumatoid arthritis and 22% had psoriasis or psoriatic arthritis.

Using these anonymized data, the group developed a risk stratification model using 11 clinical predictors. “The factors that went in the model are simple things that most patients can self-report or doctors can get from their patient’s medical records,” Dr. Abhishek told this news organization, including methotrexate dose, age, sex, and comorbidities. Dr. Abhishek emphasized that the model should be used only in patients who have continued taking MTX for at least 6 months and have already undergone more frequent initial testing.

The strongest individual predictors were diabetes (hazard ratio, 1.25), chronic kidney disease stage 3 (HR, 2.01), and previous cytopenia or raised liver enzyme levels during the first 6 months of MTX therapy (HR, 2.97). However, Dr. Abhishek emphasized that the individual factors were less important, noting that the model sums the risks to predict outcomes more accurately. Most patients (68.4%) were sorted into the low-risk cohort, with a less than 10% estimated risk of discontinuing MTX over the next 5 years. About one-fifth (20.9%) were categorized as moderate risk (10%-20% estimated risk over 5 years), and 10.7% were high risk, with a greater than 20% estimated risk of discontinuing the drug over 5 years.

The authors argue that low-risk patients could receive less frequent testing – perhaps every 6 months or annually, while moderate-risk patients would continue to be tested every 3 months. High-risk patients could potentially be tested with even greater frequently.
 

More research needed

The research involved “incredibly sophisticated statistical analysis,” said Daniel E. Furst, MD, professor emeritus of medicine at the University of California, Los Angeles, who was not involved with the study. However, the data do not yet support altering blood testing frequency based on this model.

“The hypothesis that not all patients have to be examined so frequently is a very reasonable hypothesis,” Dr. Furst said in an interview, and additional research is needed to corroborate it. The model also needs to be validated in patient populations outside of the United Kingdom, he added.

Dr. Abhishek agreed that validating the model in other patient populations is an important next step. “When we develop a tool [using] a one-nation data set, we want other researchers to then validate it in other countries’ data sets to make sure there is nothing odd about patients in the U.K. that makes the tool work well here but not in [the] U.S., Europe, or Asia, for example,” he said. Doing so should be relatively easy, he said, as the model is publicly available, and the information required is routinely collected during clinic visits.

To understand if less frequent testing might be appropriate for some patients, researchers would need to look at data registries like the Brigham and Women’s Hospital Rheumatoid Arthritis Sequential Study (BRASS) registry or CorEvitas registries “where the testing is done in a very regular way over the long haul,” Dr. Furst said. Analyzing these datasets, researchers could determine the testing intervals that would be most efficient for low- and high-risk patients.
 

A word of caution

While less frequent testing for long-term MTX therapy could likely have benefits, there is still some risk involved, cautioned Prabha Ranganathan, MD, professor of medicine at Washington University in St. Louis.

“Although most methotrexate toxicity occurs within the first 6 months of starting treatment, rare idiosyncratic toxicity can occur that does not correlate with the dose, duration, or method of how methotrexate is administered,” she wrote in an accompanying editorial. “Most rheumatologists can identify a handful of patients who receive methotrexate in their practice who develop sudden leukopenia or thrombocytopenia or transaminitis that is severe enough to warrant drug discontinuation.” While tools like this prediction model can be useful, clinicians need to consider each patient individually and use shared decision-making when monitoring for MTX toxicity, she advised.

“As in most of areas of medicine, the one-size-fits-all approach does not work for methotrexate users,” she noted.

This study was funded by the U.K. National Institute for Health and Care Research and Health Technology Assessment. Dr. Abhishek has received institutional research grants from AstraZeneca and Oxford Immunotech and personal fees from UpToDate, Springer, Cadila Pharmaceuticals, NGM Bio, Limbic, and Inflazome. Dr. Furst and Dr. Ranganathan report no relevant financial relationships.

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

Doctors who treat patients with long COVID, hampered by a lack of federally approved treatments, are turning to off-label use of drugs designed for addiction, diabetes, and other conditions.

Those with long COVID for years now are engaging in robust online conversations about a range of treatments not formally approved by the Food and Drug Administration for the condition, reporting good and bad results.

High on the current list: low-dose naltrexone (LDN). A version of drug developed to help addicts has been shown to help some long COVID patients.

But evidence is building for other treatments, many of them targeted to treat brain fog or one of the other long-term symptoms in individuals 3 months or more after acute COVID infection.

Some patients are taking metformin, which studies have found to be effective at lowering long COVID risk. Paxlovid is being tested for long COVID.  Antivirals are also on the list.

Alba Azola, MD, said she has treated long COVID patients with brain fog and dizziness who have postural orthostatic tachycardia syndrome (POTS).

Dr. Azola said she asked the staff at Johns Hopkins Medicine in Baltimore, where she is a rehabilitation specialist, to teach her how to treat the condition. Since there is no approved treatment for POTS, that meant using off-label drugs, she said. 

“It was super scary as a provider to start doing that, but my patients were suffering so much,” she  said, noting the wait for patients to get into the POTS clinic at Hopkins was 2 years.

Dr. Azola was the lead author on guidelines published by the American Academy of Physical Medicine and Rehabilitation (AAPM&R) last September on how to treat autonomic dysfunction, a common symptom of long COVID. 

The guidelines she helped write include drugs designed for blood pressure – such as midodrine – and steroids.

Dr. Azola noted the medications are prescribed on a case-by-case basis because the same drug that works for one patient may have awful side effects for another patient, she said. At the same time, some of these drugs have helped her patients go back to living relatively normal lives.

The first time JD Davids of Brooklyn, N.Y., took LDN, it was for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and he couldn’t tolerate it. He had nightmares. But when he took it for long COVID, he started out at a low dose and worked his way up, at his doctor’s advice. 

“It’s been a game-changer,” said Mr. Davids, cofounder of Long COVID Justice, an activist group. He has ME/CFS and several other chronic conditions, including long COVID. But, since he started taking LDN for long COVID, Mr. Davids said he has more energy and less pain. 

Technically, evidence is required to show off-label drug use could be effective in treating conditions for which the drug is not formally approved. Research suggests that 20%-30% of drugs are prescribed off-label.

No formal data exist on how widespread the use of off-label drugs for long COVID may be. But LDN is a major topic of discussion on public patient groups on Facebook. 

A recent study in The Lancet Infectious Diseases suggested that the diabetes drug metformin could be helpful. (The same study found no benefit from ivermectin, a drug since dismissed as a possible COVID treatment.)

Patients who testified at a virtual FDA hearing on drug development in April reported using vitamins, herbal supplements, over-the-counter medications and off-label drugs such as gabapentin and beta-blockers. Both of those drugs were on a list of potential treatments published in a January Nature Review article, along with LDN and Paxlovid.

Currently, Paxlovid is approved for acute COVID, and is in clinical trials as a treatment for long COVID as part of the federal government’s RECOVER Initiative. While only small studies of LDN have been conducted for long COVID, doctors are already prescribing the treatment. Mr. Davids said his primary care doctor recommended it.

Some doctors, such as Michael Peluso, MD, are comparing the trend to the early days of the AIDS epidemic, when the federal government was slow to recognize the viral disease. Patients banded together to protest and gain access to experimental treatments. 

Dr. Peluso, who treats long COVID patients at the University of California, San Francisco, said that without any approved treatment, patients are turning to one another to find out what works.

“A lot of people experiencing long COVID are looking for ways to feel better now, rather than waiting for the science or the guidelines to catch up,” he said in an interview.

In some cases, the drugs are backed by small studies, he said. 

“While we still need clinical trials to prove what will work, the drugs tested in these trials are also being informed by anecdotes shared by patients,” Dr. Peluso said.

Gail Van Norman, MD, of the University of Washington, Seattle, also said the long COVID situation today is reminiscent of the AIDS movement, which was “one of the times in history where we saw a real response to patient advocacy groups in terms of access to drugs.” Since then, the FDA has set up multiple programs to expand access to experimental drugs, added Dr. Van Norman, author of a recent study on off-label drug use.

But off-label use needs to be supervised by a physician, she and others said. Many patients get their information from social media, which Dr. Van Norman sees as a double-edged sword. Patients can share information, do their own research online, and alert practitioners to new findings, she said. But social media also promotes misinformation.

“People with no expertise have the same level of voice, and they are magnified,” Dr. Van Norman said.

The FDA requires doctors to have some evidence to support off-label use, she said. Doctors should talk to patients who want to try-off label drugs about what has been studied and what has not been studied.

“If I had [long COVID], I would be asking questions about all these drugs,” Dr. Van Norman said.

Mr. Davids has been asking questions like this for years. Diagnosed in 2019 with ME/CFS, he developed long COVID during the pandemic. Once he began started taking LDN, he started feeling better.

As someone with multiple chronic illnesses, Mr. Davids has tried a lot of treatments – he’s currently on two intravenous drugs and two compounded drugs, including LDN. But when his doctor first suggested it, he was wary. 

“I’ve worked with her to help increase the dosage slowly over time,” he said. “It’s very important for many people to start low and slow and work their way up.”

He hears stories of people who can’t get it from their physicians. Some, he said, think it may be because of the association of the drug with opioid abuse. 

Mr. Davids said long COVID patients have no other choice but to turn to alternative treatments. 
 

“I think we’ve been ill-served by our research establishment,” he said. “It is not set up for complex chronic conditions.”

Mr. Davids said he doesn’t know if LDN helps with underlying conditions or treats the symptoms – such as pain and fatigue – that keep him from doing things such as typing. 

“My understanding is that it may be doing both,” he said. “I sure am happy that it allows me to do things like keep my job.”

Dr. Azola and others said patients need to be monitored closely if they are taking an off-label drug. She recommends primary care doctors become familiar with them so they can offer patients some relief.

“It’s about the relationship between the patient and the provider and the provider being comfortable,” she said. “l was very transparent with my patients.”
 

A version of this article appeared on Medscape.com.

Doctors who treat patients with long COVID, hampered by a lack of federally approved treatments, are turning to off-label use of drugs designed for addiction, diabetes, and other conditions.

Those with long COVID for years now are engaging in robust online conversations about a range of treatments not formally approved by the Food and Drug Administration for the condition, reporting good and bad results.

High on the current list: low-dose naltrexone (LDN). A version of drug developed to help addicts has been shown to help some long COVID patients.

But evidence is building for other treatments, many of them targeted to treat brain fog or one of the other long-term symptoms in individuals 3 months or more after acute COVID infection.

Some patients are taking metformin, which studies have found to be effective at lowering long COVID risk. Paxlovid is being tested for long COVID.  Antivirals are also on the list.

Alba Azola, MD, said she has treated long COVID patients with brain fog and dizziness who have postural orthostatic tachycardia syndrome (POTS).

Dr. Azola said she asked the staff at Johns Hopkins Medicine in Baltimore, where she is a rehabilitation specialist, to teach her how to treat the condition. Since there is no approved treatment for POTS, that meant using off-label drugs, she said. 

“It was super scary as a provider to start doing that, but my patients were suffering so much,” she  said, noting the wait for patients to get into the POTS clinic at Hopkins was 2 years.

Dr. Azola was the lead author on guidelines published by the American Academy of Physical Medicine and Rehabilitation (AAPM&R) last September on how to treat autonomic dysfunction, a common symptom of long COVID. 

The guidelines she helped write include drugs designed for blood pressure – such as midodrine – and steroids.

Dr. Azola noted the medications are prescribed on a case-by-case basis because the same drug that works for one patient may have awful side effects for another patient, she said. At the same time, some of these drugs have helped her patients go back to living relatively normal lives.

The first time JD Davids of Brooklyn, N.Y., took LDN, it was for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and he couldn’t tolerate it. He had nightmares. But when he took it for long COVID, he started out at a low dose and worked his way up, at his doctor’s advice. 

“It’s been a game-changer,” said Mr. Davids, cofounder of Long COVID Justice, an activist group. He has ME/CFS and several other chronic conditions, including long COVID. But, since he started taking LDN for long COVID, Mr. Davids said he has more energy and less pain. 

Technically, evidence is required to show off-label drug use could be effective in treating conditions for which the drug is not formally approved. Research suggests that 20%-30% of drugs are prescribed off-label.

No formal data exist on how widespread the use of off-label drugs for long COVID may be. But LDN is a major topic of discussion on public patient groups on Facebook. 

A recent study in The Lancet Infectious Diseases suggested that the diabetes drug metformin could be helpful. (The same study found no benefit from ivermectin, a drug since dismissed as a possible COVID treatment.)

Patients who testified at a virtual FDA hearing on drug development in April reported using vitamins, herbal supplements, over-the-counter medications and off-label drugs such as gabapentin and beta-blockers. Both of those drugs were on a list of potential treatments published in a January Nature Review article, along with LDN and Paxlovid.

Currently, Paxlovid is approved for acute COVID, and is in clinical trials as a treatment for long COVID as part of the federal government’s RECOVER Initiative. While only small studies of LDN have been conducted for long COVID, doctors are already prescribing the treatment. Mr. Davids said his primary care doctor recommended it.

Some doctors, such as Michael Peluso, MD, are comparing the trend to the early days of the AIDS epidemic, when the federal government was slow to recognize the viral disease. Patients banded together to protest and gain access to experimental treatments. 

Dr. Peluso, who treats long COVID patients at the University of California, San Francisco, said that without any approved treatment, patients are turning to one another to find out what works.

“A lot of people experiencing long COVID are looking for ways to feel better now, rather than waiting for the science or the guidelines to catch up,” he said in an interview.

In some cases, the drugs are backed by small studies, he said. 

“While we still need clinical trials to prove what will work, the drugs tested in these trials are also being informed by anecdotes shared by patients,” Dr. Peluso said.

Gail Van Norman, MD, of the University of Washington, Seattle, also said the long COVID situation today is reminiscent of the AIDS movement, which was “one of the times in history where we saw a real response to patient advocacy groups in terms of access to drugs.” Since then, the FDA has set up multiple programs to expand access to experimental drugs, added Dr. Van Norman, author of a recent study on off-label drug use.

But off-label use needs to be supervised by a physician, she and others said. Many patients get their information from social media, which Dr. Van Norman sees as a double-edged sword. Patients can share information, do their own research online, and alert practitioners to new findings, she said. But social media also promotes misinformation.

“People with no expertise have the same level of voice, and they are magnified,” Dr. Van Norman said.

The FDA requires doctors to have some evidence to support off-label use, she said. Doctors should talk to patients who want to try-off label drugs about what has been studied and what has not been studied.

“If I had [long COVID], I would be asking questions about all these drugs,” Dr. Van Norman said.

Mr. Davids has been asking questions like this for years. Diagnosed in 2019 with ME/CFS, he developed long COVID during the pandemic. Once he began started taking LDN, he started feeling better.

As someone with multiple chronic illnesses, Mr. Davids has tried a lot of treatments – he’s currently on two intravenous drugs and two compounded drugs, including LDN. But when his doctor first suggested it, he was wary. 

“I’ve worked with her to help increase the dosage slowly over time,” he said. “It’s very important for many people to start low and slow and work their way up.”

He hears stories of people who can’t get it from their physicians. Some, he said, think it may be because of the association of the drug with opioid abuse. 

Mr. Davids said long COVID patients have no other choice but to turn to alternative treatments. 
 

“I think we’ve been ill-served by our research establishment,” he said. “It is not set up for complex chronic conditions.”

Mr. Davids said he doesn’t know if LDN helps with underlying conditions or treats the symptoms – such as pain and fatigue – that keep him from doing things such as typing. 

“My understanding is that it may be doing both,” he said. “I sure am happy that it allows me to do things like keep my job.”

Dr. Azola and others said patients need to be monitored closely if they are taking an off-label drug. She recommends primary care doctors become familiar with them so they can offer patients some relief.

“It’s about the relationship between the patient and the provider and the provider being comfortable,” she said. “l was very transparent with my patients.”
 

A version of this article appeared on Medscape.com.

Doctors who treat patients with long COVID, hampered by a lack of federally approved treatments, are turning to off-label use of drugs designed for addiction, diabetes, and other conditions.

Those with long COVID for years now are engaging in robust online conversations about a range of treatments not formally approved by the Food and Drug Administration for the condition, reporting good and bad results.

High on the current list: low-dose naltrexone (LDN). A version of drug developed to help addicts has been shown to help some long COVID patients.

But evidence is building for other treatments, many of them targeted to treat brain fog or one of the other long-term symptoms in individuals 3 months or more after acute COVID infection.

Some patients are taking metformin, which studies have found to be effective at lowering long COVID risk. Paxlovid is being tested for long COVID.  Antivirals are also on the list.

Alba Azola, MD, said she has treated long COVID patients with brain fog and dizziness who have postural orthostatic tachycardia syndrome (POTS).

Dr. Azola said she asked the staff at Johns Hopkins Medicine in Baltimore, where she is a rehabilitation specialist, to teach her how to treat the condition. Since there is no approved treatment for POTS, that meant using off-label drugs, she said. 

“It was super scary as a provider to start doing that, but my patients were suffering so much,” she  said, noting the wait for patients to get into the POTS clinic at Hopkins was 2 years.

Dr. Azola was the lead author on guidelines published by the American Academy of Physical Medicine and Rehabilitation (AAPM&R) last September on how to treat autonomic dysfunction, a common symptom of long COVID. 

The guidelines she helped write include drugs designed for blood pressure – such as midodrine – and steroids.

Dr. Azola noted the medications are prescribed on a case-by-case basis because the same drug that works for one patient may have awful side effects for another patient, she said. At the same time, some of these drugs have helped her patients go back to living relatively normal lives.

The first time JD Davids of Brooklyn, N.Y., took LDN, it was for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and he couldn’t tolerate it. He had nightmares. But when he took it for long COVID, he started out at a low dose and worked his way up, at his doctor’s advice. 

“It’s been a game-changer,” said Mr. Davids, cofounder of Long COVID Justice, an activist group. He has ME/CFS and several other chronic conditions, including long COVID. But, since he started taking LDN for long COVID, Mr. Davids said he has more energy and less pain. 

Technically, evidence is required to show off-label drug use could be effective in treating conditions for which the drug is not formally approved. Research suggests that 20%-30% of drugs are prescribed off-label.

No formal data exist on how widespread the use of off-label drugs for long COVID may be. But LDN is a major topic of discussion on public patient groups on Facebook. 

A recent study in The Lancet Infectious Diseases suggested that the diabetes drug metformin could be helpful. (The same study found no benefit from ivermectin, a drug since dismissed as a possible COVID treatment.)

Patients who testified at a virtual FDA hearing on drug development in April reported using vitamins, herbal supplements, over-the-counter medications and off-label drugs such as gabapentin and beta-blockers. Both of those drugs were on a list of potential treatments published in a January Nature Review article, along with LDN and Paxlovid.

Currently, Paxlovid is approved for acute COVID, and is in clinical trials as a treatment for long COVID as part of the federal government’s RECOVER Initiative. While only small studies of LDN have been conducted for long COVID, doctors are already prescribing the treatment. Mr. Davids said his primary care doctor recommended it.

Some doctors, such as Michael Peluso, MD, are comparing the trend to the early days of the AIDS epidemic, when the federal government was slow to recognize the viral disease. Patients banded together to protest and gain access to experimental treatments. 

Dr. Peluso, who treats long COVID patients at the University of California, San Francisco, said that without any approved treatment, patients are turning to one another to find out what works.

“A lot of people experiencing long COVID are looking for ways to feel better now, rather than waiting for the science or the guidelines to catch up,” he said in an interview.

In some cases, the drugs are backed by small studies, he said. 

“While we still need clinical trials to prove what will work, the drugs tested in these trials are also being informed by anecdotes shared by patients,” Dr. Peluso said.

Gail Van Norman, MD, of the University of Washington, Seattle, also said the long COVID situation today is reminiscent of the AIDS movement, which was “one of the times in history where we saw a real response to patient advocacy groups in terms of access to drugs.” Since then, the FDA has set up multiple programs to expand access to experimental drugs, added Dr. Van Norman, author of a recent study on off-label drug use.

But off-label use needs to be supervised by a physician, she and others said. Many patients get their information from social media, which Dr. Van Norman sees as a double-edged sword. Patients can share information, do their own research online, and alert practitioners to new findings, she said. But social media also promotes misinformation.

“People with no expertise have the same level of voice, and they are magnified,” Dr. Van Norman said.

The FDA requires doctors to have some evidence to support off-label use, she said. Doctors should talk to patients who want to try-off label drugs about what has been studied and what has not been studied.

“If I had [long COVID], I would be asking questions about all these drugs,” Dr. Van Norman said.

Mr. Davids has been asking questions like this for years. Diagnosed in 2019 with ME/CFS, he developed long COVID during the pandemic. Once he began started taking LDN, he started feeling better.

As someone with multiple chronic illnesses, Mr. Davids has tried a lot of treatments – he’s currently on two intravenous drugs and two compounded drugs, including LDN. But when his doctor first suggested it, he was wary. 

“I’ve worked with her to help increase the dosage slowly over time,” he said. “It’s very important for many people to start low and slow and work their way up.”

He hears stories of people who can’t get it from their physicians. Some, he said, think it may be because of the association of the drug with opioid abuse. 

Mr. Davids said long COVID patients have no other choice but to turn to alternative treatments. 
 

“I think we’ve been ill-served by our research establishment,” he said. “It is not set up for complex chronic conditions.”

Mr. Davids said he doesn’t know if LDN helps with underlying conditions or treats the symptoms – such as pain and fatigue – that keep him from doing things such as typing. 

“My understanding is that it may be doing both,” he said. “I sure am happy that it allows me to do things like keep my job.”

Dr. Azola and others said patients need to be monitored closely if they are taking an off-label drug. She recommends primary care doctors become familiar with them so they can offer patients some relief.

“It’s about the relationship between the patient and the provider and the provider being comfortable,” she said. “l was very transparent with my patients.”
 

A version of this article appeared on Medscape.com.

Investigators have found a correlation between vitamin D deficiency and psoriasis severity, suggesting that some people who increase their intake of the vitamin could better control this skin condition that affects up to 8 million people in the United States alone. 

Brown University researchers studied almost 500 psoriasis cases taken from the National Health and Nutrition Examination Survey (NHANES), the scientists told attendees at the conference of the American Society for Nutrition. They compared the peoples’ reports on how much of their body surface was affected by psoriasis to vitamin D levels collected in blood samples.

“After adjusting for lifestyle factors such as smoking, the analysis showed that lower vitamin D levels and vitamin D deficiency were significantly associated with greater psoriasis severity,” the ASN said in a news release. “The researchers also found that patients with the least amount of body surface affected by psoriasis had the highest average vitamin D levels while those with the greatest affected area had the lowest average levels of vitamin D.”

The researchers said that people with psoriasis might improve their condition by getting more vitamin D in their diet and through supplements.

“Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor’s prescription,” said researcher Rachel K. Lim, an MD candidate at Brown University, Providence, R.I. “Our results suggest that a vitamin D–rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients.”

The researchers said that vitamin D toxicity is rare but that people should consult with their medical caregivers before they start taking supplements.

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

Investigators have found a correlation between vitamin D deficiency and psoriasis severity, suggesting that some people who increase their intake of the vitamin could better control this skin condition that affects up to 8 million people in the United States alone. 

Brown University researchers studied almost 500 psoriasis cases taken from the National Health and Nutrition Examination Survey (NHANES), the scientists told attendees at the conference of the American Society for Nutrition. They compared the peoples’ reports on how much of their body surface was affected by psoriasis to vitamin D levels collected in blood samples.

“After adjusting for lifestyle factors such as smoking, the analysis showed that lower vitamin D levels and vitamin D deficiency were significantly associated with greater psoriasis severity,” the ASN said in a news release. “The researchers also found that patients with the least amount of body surface affected by psoriasis had the highest average vitamin D levels while those with the greatest affected area had the lowest average levels of vitamin D.”

The researchers said that people with psoriasis might improve their condition by getting more vitamin D in their diet and through supplements.

“Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor’s prescription,” said researcher Rachel K. Lim, an MD candidate at Brown University, Providence, R.I. “Our results suggest that a vitamin D–rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients.”

The researchers said that vitamin D toxicity is rare but that people should consult with their medical caregivers before they start taking supplements.

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

Investigators have found a correlation between vitamin D deficiency and psoriasis severity, suggesting that some people who increase their intake of the vitamin could better control this skin condition that affects up to 8 million people in the United States alone. 

Brown University researchers studied almost 500 psoriasis cases taken from the National Health and Nutrition Examination Survey (NHANES), the scientists told attendees at the conference of the American Society for Nutrition. They compared the peoples’ reports on how much of their body surface was affected by psoriasis to vitamin D levels collected in blood samples.

“After adjusting for lifestyle factors such as smoking, the analysis showed that lower vitamin D levels and vitamin D deficiency were significantly associated with greater psoriasis severity,” the ASN said in a news release. “The researchers also found that patients with the least amount of body surface affected by psoriasis had the highest average vitamin D levels while those with the greatest affected area had the lowest average levels of vitamin D.”

The researchers said that people with psoriasis might improve their condition by getting more vitamin D in their diet and through supplements.

“Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor’s prescription,” said researcher Rachel K. Lim, an MD candidate at Brown University, Providence, R.I. “Our results suggest that a vitamin D–rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients.”

The researchers said that vitamin D toxicity is rare but that people should consult with their medical caregivers before they start taking supplements.

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

Could glucagon-like peptide-1 receptor agonists, such as liraglutide and semaglutide, also be potential disease-modifying treatments for knee osteoarthritis (KOA)?

Weight loss is recommended for patients with KOA, and GLP-1 receptor agonists are approved for weight loss. New early research suggests these drugs might have a disease-modifying effect for KOA.

Three recently published studies investigated this:

• The LOSEIT phase 4, randomized controlled trial of liraglutide vs. placebo in patients with obesity/overweight and KOA.
• A large observational study out of China in patients with KOA and type 2 diabetes.
• A preclinical trial of liraglutide in mouse models of KOA.

The preclinical trial and the observational study report promising results, and the lack of KOA pain relief in patients in the phase 4 trial may be explained by the trial design. Three other trials are in the works.

This news organization invited two researchers and two outside experts to discuss these studies and potential future treatment of KOA with GLP-1 receptor agonists.
 

The big picture, as seen by two experts

The GLP-1 receptor agonists liraglutide (Victoza) and semaglutide (Ozempic) are approved for type 2 diabetes, and, in higher doses, liraglutide (Saxenda) and semaglutide (Wegovy) are approved for weight loss in patients with obesity (or overweight with comorbidities), and given as weekly injections.

ljubaphoto/E+/Getty Images

Victoza and Saxenda are expected to come off patent in December 2023, and in 2026, respectively.

Lauren King, MD, PhD, a rheumatologist and clinician scientist who was not involved with the recent investigational studies of GLP-1 receptor agonists for KOA, noted that obesity is the most important, guideline-recommended, modifiable risk factor for KOA.

“In people with overweight and obesity, losing weight can improve knee osteoarthritis symptoms, and some evidence supports that it may also slow joint structural changes,” Dr. King, of the department of medicine at the University of Toronto, said in an interview.

Large trials of GLP-1 receptor agonists in people with overweight and obesity, such as the STEP trials of semaglutide, she noted, “provide evidence that these medications are safe and effective, facilitating clinically relevant and sustained weight loss.”

Further research is needed, she said, to better understand disease-modifying effects of GLP-1 receptor agonists in patients with KOA.  

Similarly, W. Timothy Garvey, MD, professor in the department of nutrition sciences at the University of Alabama at Birmingham and director of the UAB Diabetes Research Center, who was not involved with this research, noted that weight loss improves KOA symptoms.

Dr. Garvey was lead investigator in the STEP 5 trial of semaglutide and lead author of the American Association of Clinical Endocrinologists 2016 Obesity Management guidelines.

“The question is whether these GLP-1 receptor agonists have anything to offer over and above weight loss per se, and we don’t know for sure,” he said.

They “do have anti-inflammatory actions,” and “there are GLP-1 receptors in locations where you think GLP-1 receptor agonism may help inflammation in the knee, in joints, and in other tissues,” he noted.

He looks forward to results of the phase 3 trial of semaglutide in patients with KOA, expected this fall.
 

Three published studies

LOSEIT: RCT of liraglutide for pain and weight control in KOA

Henrik Rindel Gudbergsen, MD, PhD, and colleagues published results of the only randomized controlled trial of a GLP-1 receptor agonist (liraglutide, Saxenda) vs. placebo in patients with overweight/obesity and KOA, the LOSEIT trial.

All patients first entered an 8-week, pre-randomization phase where they had strict caloric restriction (and ate meal replacements) and lost at least 5% of their initial weight. They also had less knee pain at the end of this phase.

Then they were randomly assigned to receive 3 mg liraglutide or placebo daily injections for 1 year.

From randomization until week 52, the liraglutide group had greater mean weight loss than the placebo group (but this was < 5% of their weight). They did not have greater reduction in knee pain than patients in the placebo group.

“Our interpretation was that dieting results in weight loss and diminishes knee pain (which we knew), and that the impact of liraglutide following severe calorie restriction and weight loss and improvement of pain was limited,” Dr. Gudbergsen, a physician and associate professor at The Parker Institute, University of Copenhagen, told this news organization.

“That was the surprise for us as investigators,” he said, “and, I assume, why Novo Nordisk is now pursuing the investigation of semaglutide for KOA, as this is expected to create a larger effect on body weight and knee symptoms.”

The weight loss was about 12.5 kg (27.5 pounds) prior to randomization, and the subsequent weight loss with liraglutide was about 2.8 kg (6 pounds; about 4% of their weight). “Thus, it could seem that the participants’ potential for weight loss as well as symptom reduction was fully exploited in the pre–random assignment dietary intervention period,” according to the researchers.

“It seems highly relevant to use liraglutide or semaglutide for patients impacted by obesity and KOA, as it is in line with guidelines suggesting weight loss for this group,” Dr. Gudbergsen said. “However, whether liraglutide and/or semaglutide, acting via an anti-inflammatory effect, for example, has an added positive impact on cartilage quality remains to be clarified,” he said.

Others who were not involved in this study suggest that the lack of pain-reduction benefit with liraglutide vs. placebo can be explained by the short-term use of liraglutide (1 year), small weight loss (< 5%), and systemic rather than intraarticular injection.

The LOSEIT trial design “is problematic and could not provide a confirmative conclusion,” Hongyi Zhu, MD, PhD, Shanghai Sixth People’s Hospital, China, and colleagues wrote in their observational study. The small weight loss of < 5% in the liraglutide group may explain why the pain relief was not better than with placebo. A longer study duration with significant weight loss/maintenance may be needed, they noted.

Francis Berenbaum, MD, PhD, senior author of a preclinical study of liraglutide, said that in the LOSEIT trial, “daily systemic injections of liraglutide did not ameliorate OA-related pain, probably because of poor access and hence poor local concentrations of liraglutide in the knee joint.”

Dr. Berenbaum is professor of rheumatology at Sorbonne University and director of the department of rheumatology at AP-HP Saint-Antoine Hospital in Paris. He is cofounder and CEO of 4Moving Biotech (a subsidiary of 4P Pharma, an innovator accelerator biotech company), which is testing liraglutide for KOA.

In experiments in mice, systemic injections of liraglutide did not lead to high enough concentration in synovial fluid to show efficacy for pain relief, he told this news organization. “In order to get the direct effect of liraglutide, it should be injected intraarticularly,” he said.
 

Observational study of patients with diabetes and KOA

Dr. Zhu and colleagues recently published results of the first clinical investigation of long-term effects of GLP-1 receptor agonists on KOA in patients with comorbid type 2 diabetes.

They analyzed data from a subset of patients with KOA and type 2 diabetes from the Shanghai Osteoarthritis Cohort, including 233 patients who received a GLP-1 receptor agonist (semaglutide, liraglutide, or dulaglutide [Trulicity]) for at least 2 years and 1,574 patients who did not receive this therapy.

The patients had a mean weight of 66 kg (145 pounds), a mean body mass index of 27 kg/m², and a mean A1c of 7.3%.

“According to conventional wisdom, a weight change greater than 5% is considered clinically relevant for KOA,” the researchers wrote. They found that patients had substantial weight loss after GLP-1 receptor agonist therapy.

The primary outcome, the incidence of knee surgery, was lower in the patients who received a GLP-1 receptor agonist than in the other patients (1.7% vs. 5.9%; adjusted P = .014).

Patients who received a GLP-1 receptor agonist also had greater improvements in secondary outcomes than did other patients, including pain subscale scores and cartilage-loss velocity of the medial femorotibial joint in patients with predominantly lateral OA.

“The effects of GLP-1 receptor agonists on arthritic knees were largely mediated by weight loss instead of glycemic control,” Dr. Zhu and colleagues reported.

They concluded that with long-enough treatment, “GLP-1 receptor agonist therapies might be disease-modifying for KOA patients with comorbid [type 2 diabetes mellitus].”

They called for further research to elucidate the effects of GLP-1 receptor agonists on the disease process, joint structure, and patient-reported outcomes of OA.

Dr. Garvey noted that “whether your BMI is 30 or 40, if there are complications, that tells you that degree of adiposity is sufficient to impair health.” So, if a patient in southeast China has a BMI of 27 kg/m² and has osteoarthritis, he or she could still benefit from weight loss, he said.
 

Liraglutide and pain-related behavior in mouse models of OA

Dr. Berenbaum and colleagues reported that liraglutide alleviated pain-related behavior in sodium monoiodoacetate mouse models of KOA.

In addition, liraglutide had anti-inflammatory and anticatabolic effects in synovial fluid from the knees of six patients with OA of varying severity.

The researchers analyzed generic liraglutide (from Hybio Pharmaceuticals, Shenzhen, China) and nongeneric liraglutide (from Novo Nordisk, Bagsværd, Denmark).

They found that “when injected intra-articularly, liraglutide blunts the inflammatory process that is present in OA synovial tissue, explaining the acute analgesic effect,” Dr. Berenbaum said.

“Liraglutide could be a game-changer,” he said, “by demonstrating not only an effect on joint structures like synovial tissue and cartilage, but also on symptoms in a short-term period.”

Dr. Garvey said the symptom improvements after intrasynovial infusion of liraglutide in this trial were “impressive.” This study “adds credence to the hypothesis that these GLP-1 receptor agonists could have effects above and beyond weight loss,” he said.
 

Two trials near completion, one is upcoming

Phase 1 and 2 trials of 4P-004

“We are now in a phase 1 clinical trial [of 4P-004/liraglutide] in patients suffering from knee OA and should start a large phase 2 trial next year,” said Dr. Berenbaum.  

The phase 1 LASARE trial, sponsored by 4Moving Biotech, planned to enroll 32 patients with KOA.

The primary outcome is safety and tolerability of single IA administration of 4P-004 at escalating doses in patients with KOA. Secondary outcomes include plasma concentration of liraglutide when administered this way.
 

Phase 3 trial of semaglutide for KOA

Novo Nordisk is performing a phase 3 study, “Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis,” with an expected enrollment of 407 patients with KOA and estimated trial completion in September.

Eligible patients were aged 18 and older, with BMI > 30 kg/m² and KOA with Kellgren-Lawrence grades 2 or 3. The co-primary outcomes are change in body weight and change in WOMAC pain score, from baseline to 68 weeks.

The LOSEIT trial was supported by Novo Nordisk and the Cambridge Weight Plan. The observational study in China was supported by the Shanghai Shenkang Hospital Development Centre, the Clinical Research Plan of SHDC, and the National Natural Science Foundation of China. The preclinical trial was supported by 4P Pharma/4Moving Biotech.

Dr. Berenbaum is CEO of 4Moving Biotech and chair of the scientific advisory board of 4P Pharma. He has received personal fees from 4P Pharma as well as numerous other pharmaceutical companies. Dr. Garvey has reported being a consultant to Boehringer Ingelheim, Novo Nordisk, Eli Lilly, Merck, Fractyl Health, and Alnylam Pharmaceuticals, and reported being an investigator for studies sponsored by Novo Nordisk, Eli Lilly, Pfizer, and Epitomee. Dr. Gudbergsen, Dr. King, and Dr. Zhu report no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Could glucagon-like peptide-1 receptor agonists, such as liraglutide and semaglutide, also be potential disease-modifying treatments for knee osteoarthritis (KOA)?

Weight loss is recommended for patients with KOA, and GLP-1 receptor agonists are approved for weight loss. New early research suggests these drugs might have a disease-modifying effect for KOA.

Three recently published studies investigated this:

• The LOSEIT phase 4, randomized controlled trial of liraglutide vs. placebo in patients with obesity/overweight and KOA.
• A large observational study out of China in patients with KOA and type 2 diabetes.
• A preclinical trial of liraglutide in mouse models of KOA.

The preclinical trial and the observational study report promising results, and the lack of KOA pain relief in patients in the phase 4 trial may be explained by the trial design. Three other trials are in the works.

This news organization invited two researchers and two outside experts to discuss these studies and potential future treatment of KOA with GLP-1 receptor agonists.
 

The big picture, as seen by two experts

The GLP-1 receptor agonists liraglutide (Victoza) and semaglutide (Ozempic) are approved for type 2 diabetes, and, in higher doses, liraglutide (Saxenda) and semaglutide (Wegovy) are approved for weight loss in patients with obesity (or overweight with comorbidities), and given as weekly injections.

ljubaphoto/E+/Getty Images

Victoza and Saxenda are expected to come off patent in December 2023, and in 2026, respectively.

Lauren King, MD, PhD, a rheumatologist and clinician scientist who was not involved with the recent investigational studies of GLP-1 receptor agonists for KOA, noted that obesity is the most important, guideline-recommended, modifiable risk factor for KOA.

“In people with overweight and obesity, losing weight can improve knee osteoarthritis symptoms, and some evidence supports that it may also slow joint structural changes,” Dr. King, of the department of medicine at the University of Toronto, said in an interview.

Large trials of GLP-1 receptor agonists in people with overweight and obesity, such as the STEP trials of semaglutide, she noted, “provide evidence that these medications are safe and effective, facilitating clinically relevant and sustained weight loss.”

Further research is needed, she said, to better understand disease-modifying effects of GLP-1 receptor agonists in patients with KOA.  

Similarly, W. Timothy Garvey, MD, professor in the department of nutrition sciences at the University of Alabama at Birmingham and director of the UAB Diabetes Research Center, who was not involved with this research, noted that weight loss improves KOA symptoms.

Dr. Garvey was lead investigator in the STEP 5 trial of semaglutide and lead author of the American Association of Clinical Endocrinologists 2016 Obesity Management guidelines.

“The question is whether these GLP-1 receptor agonists have anything to offer over and above weight loss per se, and we don’t know for sure,” he said.

They “do have anti-inflammatory actions,” and “there are GLP-1 receptors in locations where you think GLP-1 receptor agonism may help inflammation in the knee, in joints, and in other tissues,” he noted.

He looks forward to results of the phase 3 trial of semaglutide in patients with KOA, expected this fall.
 

Three published studies

LOSEIT: RCT of liraglutide for pain and weight control in KOA

Henrik Rindel Gudbergsen, MD, PhD, and colleagues published results of the only randomized controlled trial of a GLP-1 receptor agonist (liraglutide, Saxenda) vs. placebo in patients with overweight/obesity and KOA, the LOSEIT trial.

All patients first entered an 8-week, pre-randomization phase where they had strict caloric restriction (and ate meal replacements) and lost at least 5% of their initial weight. They also had less knee pain at the end of this phase.

Then they were randomly assigned to receive 3 mg liraglutide or placebo daily injections for 1 year.

From randomization until week 52, the liraglutide group had greater mean weight loss than the placebo group (but this was < 5% of their weight). They did not have greater reduction in knee pain than patients in the placebo group.

“Our interpretation was that dieting results in weight loss and diminishes knee pain (which we knew), and that the impact of liraglutide following severe calorie restriction and weight loss and improvement of pain was limited,” Dr. Gudbergsen, a physician and associate professor at The Parker Institute, University of Copenhagen, told this news organization.

“That was the surprise for us as investigators,” he said, “and, I assume, why Novo Nordisk is now pursuing the investigation of semaglutide for KOA, as this is expected to create a larger effect on body weight and knee symptoms.”

The weight loss was about 12.5 kg (27.5 pounds) prior to randomization, and the subsequent weight loss with liraglutide was about 2.8 kg (6 pounds; about 4% of their weight). “Thus, it could seem that the participants’ potential for weight loss as well as symptom reduction was fully exploited in the pre–random assignment dietary intervention period,” according to the researchers.

“It seems highly relevant to use liraglutide or semaglutide for patients impacted by obesity and KOA, as it is in line with guidelines suggesting weight loss for this group,” Dr. Gudbergsen said. “However, whether liraglutide and/or semaglutide, acting via an anti-inflammatory effect, for example, has an added positive impact on cartilage quality remains to be clarified,” he said.

Others who were not involved in this study suggest that the lack of pain-reduction benefit with liraglutide vs. placebo can be explained by the short-term use of liraglutide (1 year), small weight loss (< 5%), and systemic rather than intraarticular injection.

The LOSEIT trial design “is problematic and could not provide a confirmative conclusion,” Hongyi Zhu, MD, PhD, Shanghai Sixth People’s Hospital, China, and colleagues wrote in their observational study. The small weight loss of < 5% in the liraglutide group may explain why the pain relief was not better than with placebo. A longer study duration with significant weight loss/maintenance may be needed, they noted.

Francis Berenbaum, MD, PhD, senior author of a preclinical study of liraglutide, said that in the LOSEIT trial, “daily systemic injections of liraglutide did not ameliorate OA-related pain, probably because of poor access and hence poor local concentrations of liraglutide in the knee joint.”

Dr. Berenbaum is professor of rheumatology at Sorbonne University and director of the department of rheumatology at AP-HP Saint-Antoine Hospital in Paris. He is cofounder and CEO of 4Moving Biotech (a subsidiary of 4P Pharma, an innovator accelerator biotech company), which is testing liraglutide for KOA.

In experiments in mice, systemic injections of liraglutide did not lead to high enough concentration in synovial fluid to show efficacy for pain relief, he told this news organization. “In order to get the direct effect of liraglutide, it should be injected intraarticularly,” he said.
 

Observational study of patients with diabetes and KOA

Dr. Zhu and colleagues recently published results of the first clinical investigation of long-term effects of GLP-1 receptor agonists on KOA in patients with comorbid type 2 diabetes.

They analyzed data from a subset of patients with KOA and type 2 diabetes from the Shanghai Osteoarthritis Cohort, including 233 patients who received a GLP-1 receptor agonist (semaglutide, liraglutide, or dulaglutide [Trulicity]) for at least 2 years and 1,574 patients who did not receive this therapy.

The patients had a mean weight of 66 kg (145 pounds), a mean body mass index of 27 kg/m², and a mean A1c of 7.3%.

“According to conventional wisdom, a weight change greater than 5% is considered clinically relevant for KOA,” the researchers wrote. They found that patients had substantial weight loss after GLP-1 receptor agonist therapy.

The primary outcome, the incidence of knee surgery, was lower in the patients who received a GLP-1 receptor agonist than in the other patients (1.7% vs. 5.9%; adjusted P = .014).

Patients who received a GLP-1 receptor agonist also had greater improvements in secondary outcomes than did other patients, including pain subscale scores and cartilage-loss velocity of the medial femorotibial joint in patients with predominantly lateral OA.

“The effects of GLP-1 receptor agonists on arthritic knees were largely mediated by weight loss instead of glycemic control,” Dr. Zhu and colleagues reported.

They concluded that with long-enough treatment, “GLP-1 receptor agonist therapies might be disease-modifying for KOA patients with comorbid [type 2 diabetes mellitus].”

They called for further research to elucidate the effects of GLP-1 receptor agonists on the disease process, joint structure, and patient-reported outcomes of OA.

Dr. Garvey noted that “whether your BMI is 30 or 40, if there are complications, that tells you that degree of adiposity is sufficient to impair health.” So, if a patient in southeast China has a BMI of 27 kg/m² and has osteoarthritis, he or she could still benefit from weight loss, he said.
 

Liraglutide and pain-related behavior in mouse models of OA

Dr. Berenbaum and colleagues reported that liraglutide alleviated pain-related behavior in sodium monoiodoacetate mouse models of KOA.

In addition, liraglutide had anti-inflammatory and anticatabolic effects in synovial fluid from the knees of six patients with OA of varying severity.

The researchers analyzed generic liraglutide (from Hybio Pharmaceuticals, Shenzhen, China) and nongeneric liraglutide (from Novo Nordisk, Bagsværd, Denmark).

They found that “when injected intra-articularly, liraglutide blunts the inflammatory process that is present in OA synovial tissue, explaining the acute analgesic effect,” Dr. Berenbaum said.

“Liraglutide could be a game-changer,” he said, “by demonstrating not only an effect on joint structures like synovial tissue and cartilage, but also on symptoms in a short-term period.”

Dr. Garvey said the symptom improvements after intrasynovial infusion of liraglutide in this trial were “impressive.” This study “adds credence to the hypothesis that these GLP-1 receptor agonists could have effects above and beyond weight loss,” he said.
 

Two trials near completion, one is upcoming

Phase 1 and 2 trials of 4P-004

“We are now in a phase 1 clinical trial [of 4P-004/liraglutide] in patients suffering from knee OA and should start a large phase 2 trial next year,” said Dr. Berenbaum.  

The phase 1 LASARE trial, sponsored by 4Moving Biotech, planned to enroll 32 patients with KOA.

The primary outcome is safety and tolerability of single IA administration of 4P-004 at escalating doses in patients with KOA. Secondary outcomes include plasma concentration of liraglutide when administered this way.
 

Phase 3 trial of semaglutide for KOA

Novo Nordisk is performing a phase 3 study, “Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis,” with an expected enrollment of 407 patients with KOA and estimated trial completion in September.

Eligible patients were aged 18 and older, with BMI > 30 kg/m² and KOA with Kellgren-Lawrence grades 2 or 3. The co-primary outcomes are change in body weight and change in WOMAC pain score, from baseline to 68 weeks.

The LOSEIT trial was supported by Novo Nordisk and the Cambridge Weight Plan. The observational study in China was supported by the Shanghai Shenkang Hospital Development Centre, the Clinical Research Plan of SHDC, and the National Natural Science Foundation of China. The preclinical trial was supported by 4P Pharma/4Moving Biotech.

Dr. Berenbaum is CEO of 4Moving Biotech and chair of the scientific advisory board of 4P Pharma. He has received personal fees from 4P Pharma as well as numerous other pharmaceutical companies. Dr. Garvey has reported being a consultant to Boehringer Ingelheim, Novo Nordisk, Eli Lilly, Merck, Fractyl Health, and Alnylam Pharmaceuticals, and reported being an investigator for studies sponsored by Novo Nordisk, Eli Lilly, Pfizer, and Epitomee. Dr. Gudbergsen, Dr. King, and Dr. Zhu report no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Could glucagon-like peptide-1 receptor agonists, such as liraglutide and semaglutide, also be potential disease-modifying treatments for knee osteoarthritis (KOA)?

Weight loss is recommended for patients with KOA, and GLP-1 receptor agonists are approved for weight loss. New early research suggests these drugs might have a disease-modifying effect for KOA.

Three recently published studies investigated this:

• The LOSEIT phase 4, randomized controlled trial of liraglutide vs. placebo in patients with obesity/overweight and KOA.
• A large observational study out of China in patients with KOA and type 2 diabetes.
• A preclinical trial of liraglutide in mouse models of KOA.

The preclinical trial and the observational study report promising results, and the lack of KOA pain relief in patients in the phase 4 trial may be explained by the trial design. Three other trials are in the works.

This news organization invited two researchers and two outside experts to discuss these studies and potential future treatment of KOA with GLP-1 receptor agonists.
 

The big picture, as seen by two experts

The GLP-1 receptor agonists liraglutide (Victoza) and semaglutide (Ozempic) are approved for type 2 diabetes, and, in higher doses, liraglutide (Saxenda) and semaglutide (Wegovy) are approved for weight loss in patients with obesity (or overweight with comorbidities), and given as weekly injections.

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Victoza and Saxenda are expected to come off patent in December 2023, and in 2026, respectively.

Lauren King, MD, PhD, a rheumatologist and clinician scientist who was not involved with the recent investigational studies of GLP-1 receptor agonists for KOA, noted that obesity is the most important, guideline-recommended, modifiable risk factor for KOA.

“In people with overweight and obesity, losing weight can improve knee osteoarthritis symptoms, and some evidence supports that it may also slow joint structural changes,” Dr. King, of the department of medicine at the University of Toronto, said in an interview.

Large trials of GLP-1 receptor agonists in people with overweight and obesity, such as the STEP trials of semaglutide, she noted, “provide evidence that these medications are safe and effective, facilitating clinically relevant and sustained weight loss.”

Further research is needed, she said, to better understand disease-modifying effects of GLP-1 receptor agonists in patients with KOA.  

Similarly, W. Timothy Garvey, MD, professor in the department of nutrition sciences at the University of Alabama at Birmingham and director of the UAB Diabetes Research Center, who was not involved with this research, noted that weight loss improves KOA symptoms.

Dr. Garvey was lead investigator in the STEP 5 trial of semaglutide and lead author of the American Association of Clinical Endocrinologists 2016 Obesity Management guidelines.

“The question is whether these GLP-1 receptor agonists have anything to offer over and above weight loss per se, and we don’t know for sure,” he said.

They “do have anti-inflammatory actions,” and “there are GLP-1 receptors in locations where you think GLP-1 receptor agonism may help inflammation in the knee, in joints, and in other tissues,” he noted.

He looks forward to results of the phase 3 trial of semaglutide in patients with KOA, expected this fall.
 

Three published studies

LOSEIT: RCT of liraglutide for pain and weight control in KOA

Henrik Rindel Gudbergsen, MD, PhD, and colleagues published results of the only randomized controlled trial of a GLP-1 receptor agonist (liraglutide, Saxenda) vs. placebo in patients with overweight/obesity and KOA, the LOSEIT trial.

All patients first entered an 8-week, pre-randomization phase where they had strict caloric restriction (and ate meal replacements) and lost at least 5% of their initial weight. They also had less knee pain at the end of this phase.

Then they were randomly assigned to receive 3 mg liraglutide or placebo daily injections for 1 year.

From randomization until week 52, the liraglutide group had greater mean weight loss than the placebo group (but this was < 5% of their weight). They did not have greater reduction in knee pain than patients in the placebo group.

“Our interpretation was that dieting results in weight loss and diminishes knee pain (which we knew), and that the impact of liraglutide following severe calorie restriction and weight loss and improvement of pain was limited,” Dr. Gudbergsen, a physician and associate professor at The Parker Institute, University of Copenhagen, told this news organization.

“That was the surprise for us as investigators,” he said, “and, I assume, why Novo Nordisk is now pursuing the investigation of semaglutide for KOA, as this is expected to create a larger effect on body weight and knee symptoms.”

The weight loss was about 12.5 kg (27.5 pounds) prior to randomization, and the subsequent weight loss with liraglutide was about 2.8 kg (6 pounds; about 4% of their weight). “Thus, it could seem that the participants’ potential for weight loss as well as symptom reduction was fully exploited in the pre–random assignment dietary intervention period,” according to the researchers.

“It seems highly relevant to use liraglutide or semaglutide for patients impacted by obesity and KOA, as it is in line with guidelines suggesting weight loss for this group,” Dr. Gudbergsen said. “However, whether liraglutide and/or semaglutide, acting via an anti-inflammatory effect, for example, has an added positive impact on cartilage quality remains to be clarified,” he said.

Others who were not involved in this study suggest that the lack of pain-reduction benefit with liraglutide vs. placebo can be explained by the short-term use of liraglutide (1 year), small weight loss (< 5%), and systemic rather than intraarticular injection.

The LOSEIT trial design “is problematic and could not provide a confirmative conclusion,” Hongyi Zhu, MD, PhD, Shanghai Sixth People’s Hospital, China, and colleagues wrote in their observational study. The small weight loss of < 5% in the liraglutide group may explain why the pain relief was not better than with placebo. A longer study duration with significant weight loss/maintenance may be needed, they noted.

Francis Berenbaum, MD, PhD, senior author of a preclinical study of liraglutide, said that in the LOSEIT trial, “daily systemic injections of liraglutide did not ameliorate OA-related pain, probably because of poor access and hence poor local concentrations of liraglutide in the knee joint.”

Dr. Berenbaum is professor of rheumatology at Sorbonne University and director of the department of rheumatology at AP-HP Saint-Antoine Hospital in Paris. He is cofounder and CEO of 4Moving Biotech (a subsidiary of 4P Pharma, an innovator accelerator biotech company), which is testing liraglutide for KOA.

In experiments in mice, systemic injections of liraglutide did not lead to high enough concentration in synovial fluid to show efficacy for pain relief, he told this news organization. “In order to get the direct effect of liraglutide, it should be injected intraarticularly,” he said.
 

Observational study of patients with diabetes and KOA

Dr. Zhu and colleagues recently published results of the first clinical investigation of long-term effects of GLP-1 receptor agonists on KOA in patients with comorbid type 2 diabetes.

They analyzed data from a subset of patients with KOA and type 2 diabetes from the Shanghai Osteoarthritis Cohort, including 233 patients who received a GLP-1 receptor agonist (semaglutide, liraglutide, or dulaglutide [Trulicity]) for at least 2 years and 1,574 patients who did not receive this therapy.

The patients had a mean weight of 66 kg (145 pounds), a mean body mass index of 27 kg/m², and a mean A1c of 7.3%.

“According to conventional wisdom, a weight change greater than 5% is considered clinically relevant for KOA,” the researchers wrote. They found that patients had substantial weight loss after GLP-1 receptor agonist therapy.

The primary outcome, the incidence of knee surgery, was lower in the patients who received a GLP-1 receptor agonist than in the other patients (1.7% vs. 5.9%; adjusted P = .014).

Patients who received a GLP-1 receptor agonist also had greater improvements in secondary outcomes than did other patients, including pain subscale scores and cartilage-loss velocity of the medial femorotibial joint in patients with predominantly lateral OA.

“The effects of GLP-1 receptor agonists on arthritic knees were largely mediated by weight loss instead of glycemic control,” Dr. Zhu and colleagues reported.

They concluded that with long-enough treatment, “GLP-1 receptor agonist therapies might be disease-modifying for KOA patients with comorbid [type 2 diabetes mellitus].”

They called for further research to elucidate the effects of GLP-1 receptor agonists on the disease process, joint structure, and patient-reported outcomes of OA.

Dr. Garvey noted that “whether your BMI is 30 or 40, if there are complications, that tells you that degree of adiposity is sufficient to impair health.” So, if a patient in southeast China has a BMI of 27 kg/m² and has osteoarthritis, he or she could still benefit from weight loss, he said.
 

Liraglutide and pain-related behavior in mouse models of OA

Dr. Berenbaum and colleagues reported that liraglutide alleviated pain-related behavior in sodium monoiodoacetate mouse models of KOA.

In addition, liraglutide had anti-inflammatory and anticatabolic effects in synovial fluid from the knees of six patients with OA of varying severity.

The researchers analyzed generic liraglutide (from Hybio Pharmaceuticals, Shenzhen, China) and nongeneric liraglutide (from Novo Nordisk, Bagsværd, Denmark).

They found that “when injected intra-articularly, liraglutide blunts the inflammatory process that is present in OA synovial tissue, explaining the acute analgesic effect,” Dr. Berenbaum said.

“Liraglutide could be a game-changer,” he said, “by demonstrating not only an effect on joint structures like synovial tissue and cartilage, but also on symptoms in a short-term period.”

Dr. Garvey said the symptom improvements after intrasynovial infusion of liraglutide in this trial were “impressive.” This study “adds credence to the hypothesis that these GLP-1 receptor agonists could have effects above and beyond weight loss,” he said.
 

Two trials near completion, one is upcoming

Phase 1 and 2 trials of 4P-004

“We are now in a phase 1 clinical trial [of 4P-004/liraglutide] in patients suffering from knee OA and should start a large phase 2 trial next year,” said Dr. Berenbaum.  

The phase 1 LASARE trial, sponsored by 4Moving Biotech, planned to enroll 32 patients with KOA.

The primary outcome is safety and tolerability of single IA administration of 4P-004 at escalating doses in patients with KOA. Secondary outcomes include plasma concentration of liraglutide when administered this way.
 

Phase 3 trial of semaglutide for KOA

Novo Nordisk is performing a phase 3 study, “Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis,” with an expected enrollment of 407 patients with KOA and estimated trial completion in September.

Eligible patients were aged 18 and older, with BMI > 30 kg/m² and KOA with Kellgren-Lawrence grades 2 or 3. The co-primary outcomes are change in body weight and change in WOMAC pain score, from baseline to 68 weeks.

The LOSEIT trial was supported by Novo Nordisk and the Cambridge Weight Plan. The observational study in China was supported by the Shanghai Shenkang Hospital Development Centre, the Clinical Research Plan of SHDC, and the National Natural Science Foundation of China. The preclinical trial was supported by 4P Pharma/4Moving Biotech.

Dr. Berenbaum is CEO of 4Moving Biotech and chair of the scientific advisory board of 4P Pharma. He has received personal fees from 4P Pharma as well as numerous other pharmaceutical companies. Dr. Garvey has reported being a consultant to Boehringer Ingelheim, Novo Nordisk, Eli Lilly, Merck, Fractyl Health, and Alnylam Pharmaceuticals, and reported being an investigator for studies sponsored by Novo Nordisk, Eli Lilly, Pfizer, and Epitomee. Dr. Gudbergsen, Dr. King, and Dr. Zhu report no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

One has to be living off the grid to not be bombarded with direct-to-consumer (DTC) pharmaceutical advertising. Since 1997, when the Food and Drug Administration eased restrictions on this prohibition and allowed pharmaceutical companies to promote prescription-only medications to the public, there has been a deluge of ads in magazines, on the Internet, and, most annoying, on commercial television.

These television ads are quite formulaic:

We are initially introduced to a number of highly functioning patients (typically actors) who are engaged in rewarding pursuits. A voiceover narration then presents the pharmaceutical to be promoted, suggesting (not so subtly) to consumers that taking the advertised drug will improve one’s disease outlook or quality of life such that they too, just like the actors in the minidrama, can lead such highly productive lives.

The potential best-case scenarios of these new treatments may be stated. There then follows a litany of side effects – some of them life threatening – warnings, and contraindications. We’re again treated to another 5 or 10 seconds of patients leading “the good life,” and almost all of the ads end with the narrator concluding: “Ask your doctor (sometimes ‘provider’) if _____ is right for you.”

Big pharma spends nearly $10 billion on DTC advertising, with television ads accounting for the vast majority of these dollars. Is this type of advertising appropriate? Or even ethical?

Americans spend more money on their prescriptions than do citizens of any other highly developed nation. I have personally heard from patients who get their prescriptions from other countries, where they are more affordable. These patients will also cut their pills in half or take a medication every other day instead of every day, to economize on drug costs.

Another “trick” they use to save money – and I have heard pharmacists and pharmaceutical reps themselves recommend this – is to ask for a higher dose of a medication, usually double, and then use a pill cutter to divide a tablet in half, thus making their prescription last twice as long. Why do Americans have to resort to such “workarounds”?

Many of the medications advertised are for relatively rare conditions, such as thyroid eye disease or myasthenia gravis (which affects up to about 60,000 patients in the United States). Why not spend these advertising dollars on programs to make drugs taken by the millions of Americans with common conditions (for example, hypertension, diabetes, heart failure) more affordable?

Very often the television ads contain medical jargon, such as: “If you have the EGFR mutation, or if your cancer is HER2 negative ...”

Do most patients truly understand what these terms mean? And what happens when a patient’s physician doesn’t prescribe a medication that a patient has seen on TV and asks for, or when the physician believes that a generic (nonadvertised) medication might work just as well? This creates conflict and potential discord, adversely affecting the doctor-patient relationship.

An oncologist colleague related to me that he often has to spend time correcting patients’ misperceptions of potential miracle cures offered by these ads, and that several patients have left his practice because he would not prescribe a drug they saw advertised.

Further, while these ads urge patients to try expensive “newest and latest” treatments, pharmacy benefit plans are working with health care insurance conglomerates to reduce costs of pharmaceuticals.

How does this juxtaposition of opposing forces make any sense?

It is time for us to put an end to DTC advertising, at least on television. It will require legislative action by our federal government to end this practice (legal, by the way, only in the United States and New Zealand), and hence the willingness of our politicians to get behind legislation to do so.

Just as a law was passed to prohibit tobacco advertising on television, so should a law be passed to regulate DTC pharmaceutical advertising.

The time to end DTC advertising has come!
 

Lloyd Alterman, MD, is a retired physician and chairman of the New Jersey Universal Healthcare Coalition. He disclosed having no relevant financial relationships.

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

One has to be living off the grid to not be bombarded with direct-to-consumer (DTC) pharmaceutical advertising. Since 1997, when the Food and Drug Administration eased restrictions on this prohibition and allowed pharmaceutical companies to promote prescription-only medications to the public, there has been a deluge of ads in magazines, on the Internet, and, most annoying, on commercial television.

These television ads are quite formulaic:

We are initially introduced to a number of highly functioning patients (typically actors) who are engaged in rewarding pursuits. A voiceover narration then presents the pharmaceutical to be promoted, suggesting (not so subtly) to consumers that taking the advertised drug will improve one’s disease outlook or quality of life such that they too, just like the actors in the minidrama, can lead such highly productive lives.

The potential best-case scenarios of these new treatments may be stated. There then follows a litany of side effects – some of them life threatening – warnings, and contraindications. We’re again treated to another 5 or 10 seconds of patients leading “the good life,” and almost all of the ads end with the narrator concluding: “Ask your doctor (sometimes ‘provider’) if _____ is right for you.”

Big pharma spends nearly $10 billion on DTC advertising, with television ads accounting for the vast majority of these dollars. Is this type of advertising appropriate? Or even ethical?

Americans spend more money on their prescriptions than do citizens of any other highly developed nation. I have personally heard from patients who get their prescriptions from other countries, where they are more affordable. These patients will also cut their pills in half or take a medication every other day instead of every day, to economize on drug costs.

Another “trick” they use to save money – and I have heard pharmacists and pharmaceutical reps themselves recommend this – is to ask for a higher dose of a medication, usually double, and then use a pill cutter to divide a tablet in half, thus making their prescription last twice as long. Why do Americans have to resort to such “workarounds”?

Many of the medications advertised are for relatively rare conditions, such as thyroid eye disease or myasthenia gravis (which affects up to about 60,000 patients in the United States). Why not spend these advertising dollars on programs to make drugs taken by the millions of Americans with common conditions (for example, hypertension, diabetes, heart failure) more affordable?

Very often the television ads contain medical jargon, such as: “If you have the EGFR mutation, or if your cancer is HER2 negative ...”

Do most patients truly understand what these terms mean? And what happens when a patient’s physician doesn’t prescribe a medication that a patient has seen on TV and asks for, or when the physician believes that a generic (nonadvertised) medication might work just as well? This creates conflict and potential discord, adversely affecting the doctor-patient relationship.

An oncologist colleague related to me that he often has to spend time correcting patients’ misperceptions of potential miracle cures offered by these ads, and that several patients have left his practice because he would not prescribe a drug they saw advertised.

Further, while these ads urge patients to try expensive “newest and latest” treatments, pharmacy benefit plans are working with health care insurance conglomerates to reduce costs of pharmaceuticals.

How does this juxtaposition of opposing forces make any sense?

It is time for us to put an end to DTC advertising, at least on television. It will require legislative action by our federal government to end this practice (legal, by the way, only in the United States and New Zealand), and hence the willingness of our politicians to get behind legislation to do so.

Just as a law was passed to prohibit tobacco advertising on television, so should a law be passed to regulate DTC pharmaceutical advertising.

The time to end DTC advertising has come!
 

Lloyd Alterman, MD, is a retired physician and chairman of the New Jersey Universal Healthcare Coalition. He disclosed having no relevant financial relationships.

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

One has to be living off the grid to not be bombarded with direct-to-consumer (DTC) pharmaceutical advertising. Since 1997, when the Food and Drug Administration eased restrictions on this prohibition and allowed pharmaceutical companies to promote prescription-only medications to the public, there has been a deluge of ads in magazines, on the Internet, and, most annoying, on commercial television.

These television ads are quite formulaic:

We are initially introduced to a number of highly functioning patients (typically actors) who are engaged in rewarding pursuits. A voiceover narration then presents the pharmaceutical to be promoted, suggesting (not so subtly) to consumers that taking the advertised drug will improve one’s disease outlook or quality of life such that they too, just like the actors in the minidrama, can lead such highly productive lives.

The potential best-case scenarios of these new treatments may be stated. There then follows a litany of side effects – some of them life threatening – warnings, and contraindications. We’re again treated to another 5 or 10 seconds of patients leading “the good life,” and almost all of the ads end with the narrator concluding: “Ask your doctor (sometimes ‘provider’) if _____ is right for you.”

Big pharma spends nearly $10 billion on DTC advertising, with television ads accounting for the vast majority of these dollars. Is this type of advertising appropriate? Or even ethical?

Americans spend more money on their prescriptions than do citizens of any other highly developed nation. I have personally heard from patients who get their prescriptions from other countries, where they are more affordable. These patients will also cut their pills in half or take a medication every other day instead of every day, to economize on drug costs.

Another “trick” they use to save money – and I have heard pharmacists and pharmaceutical reps themselves recommend this – is to ask for a higher dose of a medication, usually double, and then use a pill cutter to divide a tablet in half, thus making their prescription last twice as long. Why do Americans have to resort to such “workarounds”?

Many of the medications advertised are for relatively rare conditions, such as thyroid eye disease or myasthenia gravis (which affects up to about 60,000 patients in the United States). Why not spend these advertising dollars on programs to make drugs taken by the millions of Americans with common conditions (for example, hypertension, diabetes, heart failure) more affordable?

Very often the television ads contain medical jargon, such as: “If you have the EGFR mutation, or if your cancer is HER2 negative ...”

Do most patients truly understand what these terms mean? And what happens when a patient’s physician doesn’t prescribe a medication that a patient has seen on TV and asks for, or when the physician believes that a generic (nonadvertised) medication might work just as well? This creates conflict and potential discord, adversely affecting the doctor-patient relationship.

An oncologist colleague related to me that he often has to spend time correcting patients’ misperceptions of potential miracle cures offered by these ads, and that several patients have left his practice because he would not prescribe a drug they saw advertised.

Further, while these ads urge patients to try expensive “newest and latest” treatments, pharmacy benefit plans are working with health care insurance conglomerates to reduce costs of pharmaceuticals.

How does this juxtaposition of opposing forces make any sense?

It is time for us to put an end to DTC advertising, at least on television. It will require legislative action by our federal government to end this practice (legal, by the way, only in the United States and New Zealand), and hence the willingness of our politicians to get behind legislation to do so.

Just as a law was passed to prohibit tobacco advertising on television, so should a law be passed to regulate DTC pharmaceutical advertising.

The time to end DTC advertising has come!
 

Lloyd Alterman, MD, is a retired physician and chairman of the New Jersey Universal Healthcare Coalition. He disclosed having no relevant financial relationships.

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