Federal Practitioner

Lack of contact with the outside world and an active lifestyle could play a role in why indigenous groups in the remote Amazon of Bolivia have some of the lowest rates of dementia in the world.   

What to know

• Only about 1% of members of the Tsimane and Moseten peoples of the Bolivian Amazon suffer from dementia, compared with 11% of people aged 65 and older in the United States.
• Underscoring the profound relationship between lifestyle and cognitive health, something about the preindustrial subsistence lifestyle of the groups appears to protect older tribe members from dementia.
• The rate of  generally accepted as typical in aging is comparable between the tribes and rates in developed countries such as the United States.
• The Tsimane and Moseten people remain very physically active throughout their lives by fishing, hunting, and farming and experience less brain atrophy than their American and European peers.
• Indigenous populations elsewhere in the world have been found to have high rates of dementia, which are attributed to more contact with their nonindigenous neighbors and adoption of their lifestyles.

--From staff reports

This is a summary of the article, “Study: Some of the world’s lowest rates of dementia found in Amazonian indigenous groups,” published by Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, on March 9, 2022. The full article can be found on news.ucsb.edu.



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

Lack of contact with the outside world and an active lifestyle could play a role in why indigenous groups in the remote Amazon of Bolivia have some of the lowest rates of dementia in the world.   

What to know

• Only about 1% of members of the Tsimane and Moseten peoples of the Bolivian Amazon suffer from dementia, compared with 11% of people aged 65 and older in the United States.
• Underscoring the profound relationship between lifestyle and cognitive health, something about the preindustrial subsistence lifestyle of the groups appears to protect older tribe members from dementia.
• The rate of  generally accepted as typical in aging is comparable between the tribes and rates in developed countries such as the United States.
• The Tsimane and Moseten people remain very physically active throughout their lives by fishing, hunting, and farming and experience less brain atrophy than their American and European peers.
• Indigenous populations elsewhere in the world have been found to have high rates of dementia, which are attributed to more contact with their nonindigenous neighbors and adoption of their lifestyles.

--From staff reports

This is a summary of the article, “Study: Some of the world’s lowest rates of dementia found in Amazonian indigenous groups,” published by Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, on March 9, 2022. The full article can be found on news.ucsb.edu.



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

Lack of contact with the outside world and an active lifestyle could play a role in why indigenous groups in the remote Amazon of Bolivia have some of the lowest rates of dementia in the world.   

What to know

• Only about 1% of members of the Tsimane and Moseten peoples of the Bolivian Amazon suffer from dementia, compared with 11% of people aged 65 and older in the United States.
• Underscoring the profound relationship between lifestyle and cognitive health, something about the preindustrial subsistence lifestyle of the groups appears to protect older tribe members from dementia.
• The rate of  generally accepted as typical in aging is comparable between the tribes and rates in developed countries such as the United States.
• The Tsimane and Moseten people remain very physically active throughout their lives by fishing, hunting, and farming and experience less brain atrophy than their American and European peers.
• Indigenous populations elsewhere in the world have been found to have high rates of dementia, which are attributed to more contact with their nonindigenous neighbors and adoption of their lifestyles.

--From staff reports

This is a summary of the article, “Study: Some of the world’s lowest rates of dementia found in Amazonian indigenous groups,” published by Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, on March 9, 2022. The full article can be found on news.ucsb.edu.



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

It’s now known that tinnitus may be an unexpected side effect of SARS-CoV-2 vaccination, and there is an urgent need to understand the precise mechanisms and best treatment for vaccine-associated tinnitus, researchers say.

As of mid-September 2021, 12,247 cases of tinnitus, or ringing in the ears, following COVID-19 vaccination had been reported to the Vaccine Adverse Event Reporting System of the U.S. Centers for Disease Control and Prevention.

“Despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear,” write Syed Hassan Ahmed, 3rd-year MBBS student, Dow University of Health Sciences, Karachi, Pakistan, and coauthors.

The researchers review what is known and unknown about SARS-CoV-2 vaccine-associated tinnitus in an article published online Feb. 11 in Annals of Medicine and Surgery.
 

Molecular mimicry?

The researchers say cross-reactivity between anti-spike SARS-CoV-2 antibodies and otologic antigens is one possibility, based on the mechanisms behind other COVID-19 vaccine–induced disorders and the phenomenon of molecular mimicry.

“The heptapeptide resemblance between coronavirus spike glycoprotein and numerous human proteins further supports molecular mimicry as a potential mechanism behind such vaccine-induced disorders,” they write.

Anti-spike antibodies may react with antigens anywhere along the auditory pathway and fuel an inflammatory reaction, they point out.

“Therefore, understanding the phenomenon of cross-reactivity and molecular mimicry may be helpful in postulating potential treatment behind not only tinnitus but also the rare events of vaccination associated hearing loss and other otologic manifestations,” the authors say.

Genetic predispositions and associated conditions may also play a significant role in determining whether an individual develops vaccine-induced tinnitus.

Stress and anxiety following COVID vaccination may also play a role, inasmuch as anxiety-related adverse events following vaccination have been reported. Vaccine-related anxiety as a potential cause of tinnitus developing after vaccination needs to be explored, they write.
 

Jury out on best management

How best to manage COVID vaccine-associated tinnitus also remains unclear, but it starts with a well-established diagnosis, the authors say.

A well-focused and detailed history and examination are essential, with particular emphasis placed on preexisting health conditions, specifically, autoimmune diseases, such as Hashimoto thyroiditis; otologic conditions, such as sensorineural hearing loss; glaucoma; and psychological well-being. According to the review, patients often present with a history of one or more of these disorders.

“However, any such association has not yet been established and requires further investigation to be concluded as potential risk factors for vaccine-induced tinnitus,” they caution.

Routine cranial nerve examination, otoscopy, Weber test, and Rinne test, which are used for tinnitus diagnosis in general, may be helpful for confirmation of vaccine-associated tinnitus.

Owing to the significant association between tinnitus and hearing impairment, audiology should also performed, the authors say.

Although treatments for non–vaccine-induced tinnitus vary significantly, corticosteroids are the top treatment choice for SARS-CoV-2 vaccine-induced tinnitus reported in the literature.

Trials of other drug and nondrug interventions that may uniquely help with vaccine-associated tinnitus are urgently needed, the authors say.

Summing up, the reviewers say, “Although the incidence of COVID-19 vaccine-associated tinnitus is rare, there is an overwhelming need to discern the precise pathophysiology and clinical management as a better understanding of adverse events may help in encountering vaccine hesitancy and hence fostering the COVID-19 global vaccination program.

“Despite the incidence of adverse events, the benefits of the SARS-CoV-2 vaccine in reducing hospitalization and deaths continue to outweigh the rare ramifications,” they conclude.

The research had no specific funding. The authors have disclosed no relevant financial relationships.

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

It’s now known that tinnitus may be an unexpected side effect of SARS-CoV-2 vaccination, and there is an urgent need to understand the precise mechanisms and best treatment for vaccine-associated tinnitus, researchers say.

As of mid-September 2021, 12,247 cases of tinnitus, or ringing in the ears, following COVID-19 vaccination had been reported to the Vaccine Adverse Event Reporting System of the U.S. Centers for Disease Control and Prevention.

“Despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear,” write Syed Hassan Ahmed, 3rd-year MBBS student, Dow University of Health Sciences, Karachi, Pakistan, and coauthors.

The researchers review what is known and unknown about SARS-CoV-2 vaccine-associated tinnitus in an article published online Feb. 11 in Annals of Medicine and Surgery.
 

Molecular mimicry?

The researchers say cross-reactivity between anti-spike SARS-CoV-2 antibodies and otologic antigens is one possibility, based on the mechanisms behind other COVID-19 vaccine–induced disorders and the phenomenon of molecular mimicry.

“The heptapeptide resemblance between coronavirus spike glycoprotein and numerous human proteins further supports molecular mimicry as a potential mechanism behind such vaccine-induced disorders,” they write.

Anti-spike antibodies may react with antigens anywhere along the auditory pathway and fuel an inflammatory reaction, they point out.

“Therefore, understanding the phenomenon of cross-reactivity and molecular mimicry may be helpful in postulating potential treatment behind not only tinnitus but also the rare events of vaccination associated hearing loss and other otologic manifestations,” the authors say.

Genetic predispositions and associated conditions may also play a significant role in determining whether an individual develops vaccine-induced tinnitus.

Stress and anxiety following COVID vaccination may also play a role, inasmuch as anxiety-related adverse events following vaccination have been reported. Vaccine-related anxiety as a potential cause of tinnitus developing after vaccination needs to be explored, they write.
 

Jury out on best management

How best to manage COVID vaccine-associated tinnitus also remains unclear, but it starts with a well-established diagnosis, the authors say.

A well-focused and detailed history and examination are essential, with particular emphasis placed on preexisting health conditions, specifically, autoimmune diseases, such as Hashimoto thyroiditis; otologic conditions, such as sensorineural hearing loss; glaucoma; and psychological well-being. According to the review, patients often present with a history of one or more of these disorders.

“However, any such association has not yet been established and requires further investigation to be concluded as potential risk factors for vaccine-induced tinnitus,” they caution.

Routine cranial nerve examination, otoscopy, Weber test, and Rinne test, which are used for tinnitus diagnosis in general, may be helpful for confirmation of vaccine-associated tinnitus.

Owing to the significant association between tinnitus and hearing impairment, audiology should also performed, the authors say.

Although treatments for non–vaccine-induced tinnitus vary significantly, corticosteroids are the top treatment choice for SARS-CoV-2 vaccine-induced tinnitus reported in the literature.

Trials of other drug and nondrug interventions that may uniquely help with vaccine-associated tinnitus are urgently needed, the authors say.

Summing up, the reviewers say, “Although the incidence of COVID-19 vaccine-associated tinnitus is rare, there is an overwhelming need to discern the precise pathophysiology and clinical management as a better understanding of adverse events may help in encountering vaccine hesitancy and hence fostering the COVID-19 global vaccination program.

“Despite the incidence of adverse events, the benefits of the SARS-CoV-2 vaccine in reducing hospitalization and deaths continue to outweigh the rare ramifications,” they conclude.

The research had no specific funding. The authors have disclosed no relevant financial relationships.

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

It’s now known that tinnitus may be an unexpected side effect of SARS-CoV-2 vaccination, and there is an urgent need to understand the precise mechanisms and best treatment for vaccine-associated tinnitus, researchers say.

As of mid-September 2021, 12,247 cases of tinnitus, or ringing in the ears, following COVID-19 vaccination had been reported to the Vaccine Adverse Event Reporting System of the U.S. Centers for Disease Control and Prevention.

“Despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear,” write Syed Hassan Ahmed, 3rd-year MBBS student, Dow University of Health Sciences, Karachi, Pakistan, and coauthors.

The researchers review what is known and unknown about SARS-CoV-2 vaccine-associated tinnitus in an article published online Feb. 11 in Annals of Medicine and Surgery.
 

Molecular mimicry?

The researchers say cross-reactivity between anti-spike SARS-CoV-2 antibodies and otologic antigens is one possibility, based on the mechanisms behind other COVID-19 vaccine–induced disorders and the phenomenon of molecular mimicry.

“The heptapeptide resemblance between coronavirus spike glycoprotein and numerous human proteins further supports molecular mimicry as a potential mechanism behind such vaccine-induced disorders,” they write.

Anti-spike antibodies may react with antigens anywhere along the auditory pathway and fuel an inflammatory reaction, they point out.

“Therefore, understanding the phenomenon of cross-reactivity and molecular mimicry may be helpful in postulating potential treatment behind not only tinnitus but also the rare events of vaccination associated hearing loss and other otologic manifestations,” the authors say.

Genetic predispositions and associated conditions may also play a significant role in determining whether an individual develops vaccine-induced tinnitus.

Stress and anxiety following COVID vaccination may also play a role, inasmuch as anxiety-related adverse events following vaccination have been reported. Vaccine-related anxiety as a potential cause of tinnitus developing after vaccination needs to be explored, they write.
 

Jury out on best management

How best to manage COVID vaccine-associated tinnitus also remains unclear, but it starts with a well-established diagnosis, the authors say.

A well-focused and detailed history and examination are essential, with particular emphasis placed on preexisting health conditions, specifically, autoimmune diseases, such as Hashimoto thyroiditis; otologic conditions, such as sensorineural hearing loss; glaucoma; and psychological well-being. According to the review, patients often present with a history of one or more of these disorders.

“However, any such association has not yet been established and requires further investigation to be concluded as potential risk factors for vaccine-induced tinnitus,” they caution.

Routine cranial nerve examination, otoscopy, Weber test, and Rinne test, which are used for tinnitus diagnosis in general, may be helpful for confirmation of vaccine-associated tinnitus.

Owing to the significant association between tinnitus and hearing impairment, audiology should also performed, the authors say.

Although treatments for non–vaccine-induced tinnitus vary significantly, corticosteroids are the top treatment choice for SARS-CoV-2 vaccine-induced tinnitus reported in the literature.

Trials of other drug and nondrug interventions that may uniquely help with vaccine-associated tinnitus are urgently needed, the authors say.

Summing up, the reviewers say, “Although the incidence of COVID-19 vaccine-associated tinnitus is rare, there is an overwhelming need to discern the precise pathophysiology and clinical management as a better understanding of adverse events may help in encountering vaccine hesitancy and hence fostering the COVID-19 global vaccination program.

“Despite the incidence of adverse events, the benefits of the SARS-CoV-2 vaccine in reducing hospitalization and deaths continue to outweigh the rare ramifications,” they conclude.

The research had no specific funding. The authors have disclosed no relevant financial relationships.

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

The Biden administration’s new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.

But the program is not that simple to groups representing physicians and pharmacists.

One large physicians’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are adverse effects from the medications. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.

Recently, the White House announced that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN. Ordering of the drugs is underway in many of these clinics, a White House official told the network.

Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to a statement from the U.S. Department of Health and Human Services.

The two antiviral pills authorized by the U.S. Food and Drug Administration include Pfizer’s Paxlovid, for people 12 and older, and Merck’s molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be effective in preventing serious illness.

The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have publicly criticized the administration’s approach.

The pharmacists’ groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups, including the NCPA and the APhA, have also sent a letter to the Biden administration urging it to remove barriers to pharmacies ordering the medications.

The groups also want permission as “clinically trained medication experts” to prescribe the drugs and ensure their safe use.

The AMA on March 4 took issue with the prescribing component, saying that “the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes.”

In the AMA’s view, prescribing Paxlovid without a patient’s physician being present poses a risk for adverse drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drug have full knowledge of a patient›s medical history.

The next day, the AMA released another statement, saying it was reassured by comments from administration officials “that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options.”
 

“Traditional doctor-only approach”

Having patients call their doctors after testing positive for COVID in a pharmacy “strikes me as unnecessary in the vast majority of cases, and it will delay treatment,” Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, said in an interview. “In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It’s much more of a team sport than an individual sport, the way it was years ago.”

Dr. Wachter said he has the utmost respect for pharmacists’ ability to screen prescriptions for adverse drug interactions. “We’re required to do medication reconciliation when patients see us,” he says. “And in many hospitals, we delegate that to pharmacists. They’re at least as good at it if not better than physicians are.”

While it’s essential to know what other medications a patient is taking, he noted, pharmacies have computer records of all the prescriptions they’ve filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
 

Drug interactions “not trivial”

Preeti Malani, MD, the chief health officer and a professor of medicine in the division of infectious diseases at the University of Michigan in Ann Arbor, told this news organization that the potential interactions between Paxlovid and some other medications are “not trivial.”

However, she said, “The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren’t individuals who are going to shop at a pharmacy.”

Besides the antirejection drugs, Dr. Wachter said, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, “Someone would have to make the decision on whether it’s ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody.”

Except for these potential drug interactions with Paxlovid, the antiviral medications are “quite safe,” he said, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor. That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.

Both Dr. Wachter and Dr. Malani said that the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can’t easily leave work or travel far to visit a physician.

Dr. Malani cautioned that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don’t have clinics on site.

Still, she said people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it’s not clear where the antivirals will be available in the near term.

“Right now, we’re playing catch-up,” Dr. Malani said. “But pharmacies are an important piece of the puzzle.”

Looking at the big picture, she said, “We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you’re talking about millions of cases, as we were having a few months ago, the health system can’t field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment.”

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

The Biden administration’s new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.

But the program is not that simple to groups representing physicians and pharmacists.

One large physicians’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are adverse effects from the medications. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.

Recently, the White House announced that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN. Ordering of the drugs is underway in many of these clinics, a White House official told the network.

Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to a statement from the U.S. Department of Health and Human Services.

The two antiviral pills authorized by the U.S. Food and Drug Administration include Pfizer’s Paxlovid, for people 12 and older, and Merck’s molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be effective in preventing serious illness.

The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have publicly criticized the administration’s approach.

The pharmacists’ groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups, including the NCPA and the APhA, have also sent a letter to the Biden administration urging it to remove barriers to pharmacies ordering the medications.

The groups also want permission as “clinically trained medication experts” to prescribe the drugs and ensure their safe use.

The AMA on March 4 took issue with the prescribing component, saying that “the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes.”

In the AMA’s view, prescribing Paxlovid without a patient’s physician being present poses a risk for adverse drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drug have full knowledge of a patient›s medical history.

The next day, the AMA released another statement, saying it was reassured by comments from administration officials “that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options.”
 

“Traditional doctor-only approach”

Having patients call their doctors after testing positive for COVID in a pharmacy “strikes me as unnecessary in the vast majority of cases, and it will delay treatment,” Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, said in an interview. “In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It’s much more of a team sport than an individual sport, the way it was years ago.”

Dr. Wachter said he has the utmost respect for pharmacists’ ability to screen prescriptions for adverse drug interactions. “We’re required to do medication reconciliation when patients see us,” he says. “And in many hospitals, we delegate that to pharmacists. They’re at least as good at it if not better than physicians are.”

While it’s essential to know what other medications a patient is taking, he noted, pharmacies have computer records of all the prescriptions they’ve filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
 

Drug interactions “not trivial”

Preeti Malani, MD, the chief health officer and a professor of medicine in the division of infectious diseases at the University of Michigan in Ann Arbor, told this news organization that the potential interactions between Paxlovid and some other medications are “not trivial.”

However, she said, “The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren’t individuals who are going to shop at a pharmacy.”

Besides the antirejection drugs, Dr. Wachter said, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, “Someone would have to make the decision on whether it’s ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody.”

Except for these potential drug interactions with Paxlovid, the antiviral medications are “quite safe,” he said, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor. That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.

Both Dr. Wachter and Dr. Malani said that the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can’t easily leave work or travel far to visit a physician.

Dr. Malani cautioned that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don’t have clinics on site.

Still, she said people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it’s not clear where the antivirals will be available in the near term.

“Right now, we’re playing catch-up,” Dr. Malani said. “But pharmacies are an important piece of the puzzle.”

Looking at the big picture, she said, “We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you’re talking about millions of cases, as we were having a few months ago, the health system can’t field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment.”

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

The Biden administration’s new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.

But the program is not that simple to groups representing physicians and pharmacists.

One large physicians’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are adverse effects from the medications. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.

Recently, the White House announced that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN. Ordering of the drugs is underway in many of these clinics, a White House official told the network.

Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to a statement from the U.S. Department of Health and Human Services.

The two antiviral pills authorized by the U.S. Food and Drug Administration include Pfizer’s Paxlovid, for people 12 and older, and Merck’s molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be effective in preventing serious illness.

The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have publicly criticized the administration’s approach.

The pharmacists’ groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups, including the NCPA and the APhA, have also sent a letter to the Biden administration urging it to remove barriers to pharmacies ordering the medications.

The groups also want permission as “clinically trained medication experts” to prescribe the drugs and ensure their safe use.

The AMA on March 4 took issue with the prescribing component, saying that “the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes.”

In the AMA’s view, prescribing Paxlovid without a patient’s physician being present poses a risk for adverse drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drug have full knowledge of a patient›s medical history.

The next day, the AMA released another statement, saying it was reassured by comments from administration officials “that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options.”
 

“Traditional doctor-only approach”

Having patients call their doctors after testing positive for COVID in a pharmacy “strikes me as unnecessary in the vast majority of cases, and it will delay treatment,” Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, said in an interview. “In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It’s much more of a team sport than an individual sport, the way it was years ago.”

Dr. Wachter said he has the utmost respect for pharmacists’ ability to screen prescriptions for adverse drug interactions. “We’re required to do medication reconciliation when patients see us,” he says. “And in many hospitals, we delegate that to pharmacists. They’re at least as good at it if not better than physicians are.”

While it’s essential to know what other medications a patient is taking, he noted, pharmacies have computer records of all the prescriptions they’ve filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
 

Drug interactions “not trivial”

Preeti Malani, MD, the chief health officer and a professor of medicine in the division of infectious diseases at the University of Michigan in Ann Arbor, told this news organization that the potential interactions between Paxlovid and some other medications are “not trivial.”

However, she said, “The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren’t individuals who are going to shop at a pharmacy.”

Besides the antirejection drugs, Dr. Wachter said, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, “Someone would have to make the decision on whether it’s ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody.”

Except for these potential drug interactions with Paxlovid, the antiviral medications are “quite safe,” he said, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor. That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.

Both Dr. Wachter and Dr. Malani said that the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can’t easily leave work or travel far to visit a physician.

Dr. Malani cautioned that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don’t have clinics on site.

Still, she said people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it’s not clear where the antivirals will be available in the near term.

“Right now, we’re playing catch-up,” Dr. Malani said. “But pharmacies are an important piece of the puzzle.”

Looking at the big picture, she said, “We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you’re talking about millions of cases, as we were having a few months ago, the health system can’t field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment.”

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

Should pharmaceutical companies continue to do business in Russia, running ongoing clinical trials, starting new ones, or continuing to sell their products there?

Some argue that medicine and science must not get enmeshed in politics, staying above the fray to protect their independence and credibility. Other defenders of business-as-usual say the pharmaceutical industry deals in health and aids the vulnerable. Humanitarianism requires continued interaction with Russia.

I think both arguments fail. Pharma should follow the lead of other Western companies and suspend their involvement with Putin’s Russia.

We are fighting a war with Russia. It is a war of economic strangulation, social isolation, and pushing Russia as hard as we can to become a pariah state so that internal pressure on Putin will cause him to rethink his cruel, unjustified invasion or the Russian people to replace him. This pressure must be harsh and it must happen quickly. Why?

Having failed to rapidly defeat the Ukrainian army in the war’s first weeks, Russian commanders are now resorting to the horrible barbarism they used in previous wars in Chechnya and Syria: flattening cities, attacking civilians, killing children with massive and indiscriminate firepower.

To mention one recent horror among many, Russian shelling destroyed a maternity hospital in Mariupol. Ukraine’s president, Volodymyr Zelensky, in bemoaning the Russians for their continuing series of war crimes called on the world to act.

“Mariupol. Direct Strike of Russian troops at the maternity hospital,” he wrote in a Twitter post. “People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror?”

The Russian government’s response: “It is not the first time we have seen pathetic outcries concerning the so-called atrocities,” said Minister of Foreign Affairs Sergei Lavrov, claiming the hospital was being used as a base by an “ultra-radical” Ukrainian battalion.

Health and its preservation are key parts of the aim of medicine and science. There is no way that medicine and science can ignore what war does to health, what attacks on hospitals do to the sick and those who serve them there, the psychological toll that intentional terrorism takes on civilians and their defenders, and what the destruction of infrastructure means for the long-term well-being of Ukrainians.

There can be no collusion with war criminals. There can be no denial of the inextricable link between medicine, science, and politics. Medicine and science are controlled by political forces; their use for good or evil is driven by political considerations, and each doctor, scientist, and scientific society must take a stand when politics corrodes the underlying aims of research and healing.

How far does noncooperation with Russia go? Very, very far. All research, both ongoing and new, must cease immediately. Whatever can be done to minimize harm to existing subjects in a short period of time ought to be done, but that is it.

Similarly, no sale of medicines or therapies ought to be occurring, be they life-saving or consumer products. Putin will see to it that such shipments go to the military or are sold on the black market for revenue, and there is nothing pharma companies can do to stop that.

The Russian people need to be pinched not only by the loss of cheeseburgers and boutique coffee but by products they use to maintain their well-being. War is cruel that way, but if you tolerate a government that is bombing and shelling a peaceful neighbor to oblivion, then pharma must ensure that efforts to make Putin and his kleptocratic goons feel the wrath of their fellow citizens.

Given the realities of nuclear Armageddon, the civilized world must fight obvious barbarity as best it can with sanctions, financial assaults, property seizures, and forgoing commerce, including important raw materials and health products. War, even in a fiscal form, is not without terrible costs; but achieving a rapid, just resolution against tyranny permits no exceptions for pharma or any other business if it is a war that must be fought.

Dr. Caplan is director of the division of medical ethics at New York University. He has consulted with Johnson & Johnson’s Panel for Compassionate Drug Use.



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

Should pharmaceutical companies continue to do business in Russia, running ongoing clinical trials, starting new ones, or continuing to sell their products there?

Some argue that medicine and science must not get enmeshed in politics, staying above the fray to protect their independence and credibility. Other defenders of business-as-usual say the pharmaceutical industry deals in health and aids the vulnerable. Humanitarianism requires continued interaction with Russia.

I think both arguments fail. Pharma should follow the lead of other Western companies and suspend their involvement with Putin’s Russia.

We are fighting a war with Russia. It is a war of economic strangulation, social isolation, and pushing Russia as hard as we can to become a pariah state so that internal pressure on Putin will cause him to rethink his cruel, unjustified invasion or the Russian people to replace him. This pressure must be harsh and it must happen quickly. Why?

Having failed to rapidly defeat the Ukrainian army in the war’s first weeks, Russian commanders are now resorting to the horrible barbarism they used in previous wars in Chechnya and Syria: flattening cities, attacking civilians, killing children with massive and indiscriminate firepower.

To mention one recent horror among many, Russian shelling destroyed a maternity hospital in Mariupol. Ukraine’s president, Volodymyr Zelensky, in bemoaning the Russians for their continuing series of war crimes called on the world to act.

“Mariupol. Direct Strike of Russian troops at the maternity hospital,” he wrote in a Twitter post. “People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror?”

The Russian government’s response: “It is not the first time we have seen pathetic outcries concerning the so-called atrocities,” said Minister of Foreign Affairs Sergei Lavrov, claiming the hospital was being used as a base by an “ultra-radical” Ukrainian battalion.

Health and its preservation are key parts of the aim of medicine and science. There is no way that medicine and science can ignore what war does to health, what attacks on hospitals do to the sick and those who serve them there, the psychological toll that intentional terrorism takes on civilians and their defenders, and what the destruction of infrastructure means for the long-term well-being of Ukrainians.

There can be no collusion with war criminals. There can be no denial of the inextricable link between medicine, science, and politics. Medicine and science are controlled by political forces; their use for good or evil is driven by political considerations, and each doctor, scientist, and scientific society must take a stand when politics corrodes the underlying aims of research and healing.

How far does noncooperation with Russia go? Very, very far. All research, both ongoing and new, must cease immediately. Whatever can be done to minimize harm to existing subjects in a short period of time ought to be done, but that is it.

Similarly, no sale of medicines or therapies ought to be occurring, be they life-saving or consumer products. Putin will see to it that such shipments go to the military or are sold on the black market for revenue, and there is nothing pharma companies can do to stop that.

The Russian people need to be pinched not only by the loss of cheeseburgers and boutique coffee but by products they use to maintain their well-being. War is cruel that way, but if you tolerate a government that is bombing and shelling a peaceful neighbor to oblivion, then pharma must ensure that efforts to make Putin and his kleptocratic goons feel the wrath of their fellow citizens.

Given the realities of nuclear Armageddon, the civilized world must fight obvious barbarity as best it can with sanctions, financial assaults, property seizures, and forgoing commerce, including important raw materials and health products. War, even in a fiscal form, is not without terrible costs; but achieving a rapid, just resolution against tyranny permits no exceptions for pharma or any other business if it is a war that must be fought.

Dr. Caplan is director of the division of medical ethics at New York University. He has consulted with Johnson & Johnson’s Panel for Compassionate Drug Use.



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

Should pharmaceutical companies continue to do business in Russia, running ongoing clinical trials, starting new ones, or continuing to sell their products there?

Some argue that medicine and science must not get enmeshed in politics, staying above the fray to protect their independence and credibility. Other defenders of business-as-usual say the pharmaceutical industry deals in health and aids the vulnerable. Humanitarianism requires continued interaction with Russia.

I think both arguments fail. Pharma should follow the lead of other Western companies and suspend their involvement with Putin’s Russia.

We are fighting a war with Russia. It is a war of economic strangulation, social isolation, and pushing Russia as hard as we can to become a pariah state so that internal pressure on Putin will cause him to rethink his cruel, unjustified invasion or the Russian people to replace him. This pressure must be harsh and it must happen quickly. Why?

Having failed to rapidly defeat the Ukrainian army in the war’s first weeks, Russian commanders are now resorting to the horrible barbarism they used in previous wars in Chechnya and Syria: flattening cities, attacking civilians, killing children with massive and indiscriminate firepower.

To mention one recent horror among many, Russian shelling destroyed a maternity hospital in Mariupol. Ukraine’s president, Volodymyr Zelensky, in bemoaning the Russians for their continuing series of war crimes called on the world to act.

“Mariupol. Direct Strike of Russian troops at the maternity hospital,” he wrote in a Twitter post. “People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror?”

The Russian government’s response: “It is not the first time we have seen pathetic outcries concerning the so-called atrocities,” said Minister of Foreign Affairs Sergei Lavrov, claiming the hospital was being used as a base by an “ultra-radical” Ukrainian battalion.

Health and its preservation are key parts of the aim of medicine and science. There is no way that medicine and science can ignore what war does to health, what attacks on hospitals do to the sick and those who serve them there, the psychological toll that intentional terrorism takes on civilians and their defenders, and what the destruction of infrastructure means for the long-term well-being of Ukrainians.

There can be no collusion with war criminals. There can be no denial of the inextricable link between medicine, science, and politics. Medicine and science are controlled by political forces; their use for good or evil is driven by political considerations, and each doctor, scientist, and scientific society must take a stand when politics corrodes the underlying aims of research and healing.

How far does noncooperation with Russia go? Very, very far. All research, both ongoing and new, must cease immediately. Whatever can be done to minimize harm to existing subjects in a short period of time ought to be done, but that is it.

Similarly, no sale of medicines or therapies ought to be occurring, be they life-saving or consumer products. Putin will see to it that such shipments go to the military or are sold on the black market for revenue, and there is nothing pharma companies can do to stop that.

The Russian people need to be pinched not only by the loss of cheeseburgers and boutique coffee but by products they use to maintain their well-being. War is cruel that way, but if you tolerate a government that is bombing and shelling a peaceful neighbor to oblivion, then pharma must ensure that efforts to make Putin and his kleptocratic goons feel the wrath of their fellow citizens.

Given the realities of nuclear Armageddon, the civilized world must fight obvious barbarity as best it can with sanctions, financial assaults, property seizures, and forgoing commerce, including important raw materials and health products. War, even in a fiscal form, is not without terrible costs; but achieving a rapid, just resolution against tyranny permits no exceptions for pharma or any other business if it is a war that must be fought.

Dr. Caplan is director of the division of medical ethics at New York University. He has consulted with Johnson & Johnson’s Panel for Compassionate Drug Use.



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

Survival rates of biologics and other novel immunomodulatory drugs vary substantially across chronic inflammatory diseases, and rates are highest for rituximab in rheumatoid arthritis (RA) and golimumab in axial spondyloarthritis (axSpA), but with similar rates seen for most drugs used in the treatment of psoriasis and psoriatic arthritis (PsA), according to findings from a study of two Danish registries.

Drug survival refers to “the probability that patients will remain on a given drug, and is a proxy for efficacy as well as safety in daily clinical practice,” wrote Alexander Egeberg, MD, PhD, of the department of dermatology at Copenhagen University Hospital–Bispebjerg, and colleagues. Although the use of biologics has expanded for inflammatory diseases, real-world data on drug survival in newer agents such as interleukin (IL)-17, IL-23, and Janus kinase inhibitors are lacking, they said.

In a study published in Seminars in Arthritis and Rheumatism, the researchers reviewed data from the DANBIO and DERMBIO registries of patients in Denmark with inflammatory diseases including rheumatoid arthritis (RA), axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), and psoriasis.

The study population included 12,089 adults: 5,104 with RA, 2,157 with AxSpA, 2,251 with PsA, and 2,577 with psoriasis. Patients’ mean age at the time of first treatment for these conditions was 57.8 years, 42.3 years, 49 years, and 45 years, respectively. Participants were treated with biologics or novel small molecule therapies for RA, AxSpA, PsA, or psoriasis between January 2015 and May 2021 (from the DANBIO database) and November 2009 to November 2019 (DERMBIO database).

In adjusted models, drug survival in RA was highest for rituximab followed by baricitinib, etanercept, and tocilizumab. Drug survival in AxSpA was highest for golimumab, compared with all other drugs, followed by secukinumab and etanercept. Survival was lowest for infliximab. In PsA, drug survival was roughly equal for most drugs, including golimumab, secukinumab, and ixekizumab, with the lowest survival observed for tofacitinib and infliximab, compared with all other drugs. Drug survival in psoriasis was highest with guselkumab, followed by ustekinumab and IL-17 inhibitors.

However, the number of treatment series “was low for some drugs, and not all differences were statistically significant, which could influence the overall interpretability of these findings,” the researchers noted in their discussion.

Notably, the high treatment persistence for rituximab in RA patients needs further confirmation, the researchers said. “In Denmark, rituximab is often the biologic drug of choice in RA patients with a history of cancer while there is a reluctancy to use TNF [tumor necrosis factor] inhibitors in such patients; this may have prolonged the drug survival for rituximab treated patients due to limited treatment alternatives,” they said.

The findings were limited by several factors, including the observational study design and changes in guidelines over the course of the study, the researchers noted. Other limitations included the inability to adjust for certain variables, such as antibody status, body weight, and smoking, because of missing data, and a lack of data on the underlying reasons for drug discontinuation, they said.

However, the results were strengthened by the large number of patients and completeness of the registries, the researchers emphasized. The range in responses to different drug types across diseases supports the need for individualized treatments with attention to underlying disease, patient profile, and treatment history, they concluded.

The study received no outside funding. Eight coauthors reported financial ties to a number of pharmaceutical companies.

Survival rates of biologics and other novel immunomodulatory drugs vary substantially across chronic inflammatory diseases, and rates are highest for rituximab in rheumatoid arthritis (RA) and golimumab in axial spondyloarthritis (axSpA), but with similar rates seen for most drugs used in the treatment of psoriasis and psoriatic arthritis (PsA), according to findings from a study of two Danish registries.

Drug survival refers to “the probability that patients will remain on a given drug, and is a proxy for efficacy as well as safety in daily clinical practice,” wrote Alexander Egeberg, MD, PhD, of the department of dermatology at Copenhagen University Hospital–Bispebjerg, and colleagues. Although the use of biologics has expanded for inflammatory diseases, real-world data on drug survival in newer agents such as interleukin (IL)-17, IL-23, and Janus kinase inhibitors are lacking, they said.

In a study published in Seminars in Arthritis and Rheumatism, the researchers reviewed data from the DANBIO and DERMBIO registries of patients in Denmark with inflammatory diseases including rheumatoid arthritis (RA), axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), and psoriasis.

The study population included 12,089 adults: 5,104 with RA, 2,157 with AxSpA, 2,251 with PsA, and 2,577 with psoriasis. Patients’ mean age at the time of first treatment for these conditions was 57.8 years, 42.3 years, 49 years, and 45 years, respectively. Participants were treated with biologics or novel small molecule therapies for RA, AxSpA, PsA, or psoriasis between January 2015 and May 2021 (from the DANBIO database) and November 2009 to November 2019 (DERMBIO database).

In adjusted models, drug survival in RA was highest for rituximab followed by baricitinib, etanercept, and tocilizumab. Drug survival in AxSpA was highest for golimumab, compared with all other drugs, followed by secukinumab and etanercept. Survival was lowest for infliximab. In PsA, drug survival was roughly equal for most drugs, including golimumab, secukinumab, and ixekizumab, with the lowest survival observed for tofacitinib and infliximab, compared with all other drugs. Drug survival in psoriasis was highest with guselkumab, followed by ustekinumab and IL-17 inhibitors.

However, the number of treatment series “was low for some drugs, and not all differences were statistically significant, which could influence the overall interpretability of these findings,” the researchers noted in their discussion.

Notably, the high treatment persistence for rituximab in RA patients needs further confirmation, the researchers said. “In Denmark, rituximab is often the biologic drug of choice in RA patients with a history of cancer while there is a reluctancy to use TNF [tumor necrosis factor] inhibitors in such patients; this may have prolonged the drug survival for rituximab treated patients due to limited treatment alternatives,” they said.

The findings were limited by several factors, including the observational study design and changes in guidelines over the course of the study, the researchers noted. Other limitations included the inability to adjust for certain variables, such as antibody status, body weight, and smoking, because of missing data, and a lack of data on the underlying reasons for drug discontinuation, they said.

However, the results were strengthened by the large number of patients and completeness of the registries, the researchers emphasized. The range in responses to different drug types across diseases supports the need for individualized treatments with attention to underlying disease, patient profile, and treatment history, they concluded.

The study received no outside funding. Eight coauthors reported financial ties to a number of pharmaceutical companies.

Survival rates of biologics and other novel immunomodulatory drugs vary substantially across chronic inflammatory diseases, and rates are highest for rituximab in rheumatoid arthritis (RA) and golimumab in axial spondyloarthritis (axSpA), but with similar rates seen for most drugs used in the treatment of psoriasis and psoriatic arthritis (PsA), according to findings from a study of two Danish registries.

Drug survival refers to “the probability that patients will remain on a given drug, and is a proxy for efficacy as well as safety in daily clinical practice,” wrote Alexander Egeberg, MD, PhD, of the department of dermatology at Copenhagen University Hospital–Bispebjerg, and colleagues. Although the use of biologics has expanded for inflammatory diseases, real-world data on drug survival in newer agents such as interleukin (IL)-17, IL-23, and Janus kinase inhibitors are lacking, they said.

In a study published in Seminars in Arthritis and Rheumatism, the researchers reviewed data from the DANBIO and DERMBIO registries of patients in Denmark with inflammatory diseases including rheumatoid arthritis (RA), axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), and psoriasis.

The study population included 12,089 adults: 5,104 with RA, 2,157 with AxSpA, 2,251 with PsA, and 2,577 with psoriasis. Patients’ mean age at the time of first treatment for these conditions was 57.8 years, 42.3 years, 49 years, and 45 years, respectively. Participants were treated with biologics or novel small molecule therapies for RA, AxSpA, PsA, or psoriasis between January 2015 and May 2021 (from the DANBIO database) and November 2009 to November 2019 (DERMBIO database).

In adjusted models, drug survival in RA was highest for rituximab followed by baricitinib, etanercept, and tocilizumab. Drug survival in AxSpA was highest for golimumab, compared with all other drugs, followed by secukinumab and etanercept. Survival was lowest for infliximab. In PsA, drug survival was roughly equal for most drugs, including golimumab, secukinumab, and ixekizumab, with the lowest survival observed for tofacitinib and infliximab, compared with all other drugs. Drug survival in psoriasis was highest with guselkumab, followed by ustekinumab and IL-17 inhibitors.

However, the number of treatment series “was low for some drugs, and not all differences were statistically significant, which could influence the overall interpretability of these findings,” the researchers noted in their discussion.

Notably, the high treatment persistence for rituximab in RA patients needs further confirmation, the researchers said. “In Denmark, rituximab is often the biologic drug of choice in RA patients with a history of cancer while there is a reluctancy to use TNF [tumor necrosis factor] inhibitors in such patients; this may have prolonged the drug survival for rituximab treated patients due to limited treatment alternatives,” they said.

The findings were limited by several factors, including the observational study design and changes in guidelines over the course of the study, the researchers noted. Other limitations included the inability to adjust for certain variables, such as antibody status, body weight, and smoking, because of missing data, and a lack of data on the underlying reasons for drug discontinuation, they said.

However, the results were strengthened by the large number of patients and completeness of the registries, the researchers emphasized. The range in responses to different drug types across diseases supports the need for individualized treatments with attention to underlying disease, patient profile, and treatment history, they concluded.

The study received no outside funding. Eight coauthors reported financial ties to a number of pharmaceutical companies.

Three widely followed diets for nonconstipated irritable bowel syndrome (IBS) produce similar results, but traditional dietary advice (TDA) is easier to follow, researchers say.

“We recommend TDA as the first-choice dietary option due to its widespread availability and patient friendliness,” Anupam Rej, MBChB, from Teaching Hospitals NHS Foundation Trust in Sheffield, England, and colleagues write.

AlexRaths/Getty Images

They noted, however, that the low-FODMAP diet produced the most improvement in depression and dysphoria.

The study was published online in Clinical Gastroenterology and Hepatology.
 

What the dietary options entailed

The three diets have different origins and methodologies, but all are designed to reduce the abdominal pain, bloating, and altered bowel habits that characterize IBS.

TDA is based on recommendations of the UK National Institute for Health and Care Excellence and the British Dietetic Association. It includes “sensible eating patterns,” such as regular meals, never having too much or too little, and sufficient hydration. It calls for a reduction in alcoholic, caffeinated, and “fizzy” drinks; spicy, fatty, and processed foods; fresh fruit (a maximum of three per day); and fiber and other gas-producing foods, such as beans, bread, and sweeteners. It also asks people to address any perceived food intolerance, such as dairy.

In North America, the low-FODMAP diet is prescribed as first-line therapy, and the American College of Gastroenterology has given it a conditional recommendation.

FODMAPs are short-chain fermentable carbohydrates found in many fruits, vegetables, dairy products, artificial sweeteners, and wheat. They increase small intestinal water volume and colonic gas production that can induce gastrointestinal symptoms in people with visceral hypersensitivity.

People following the low-FODMAP diet start by eliminating all FODMAPs for 4-6 weeks, then gradually reintroducing them to determine which are most likely to trigger symptoms.

A gluten-free diet, inspired by what is prescribed to treat celiac disease, has gained popularity in recent years. Although researchers debate the mechanism by which this diet improves symptoms, one leading theory is a reduction in fructans that accompany gluten in foods such as bread.

A rare head-to-head comparison trial

The low-FODMAP diet has proved itself in more clinical trials than the other two approaches, but few, if any, trials have compared them head-to-head in a pragmatic randomized trial, Dr. Rej and colleagues found after reviewing the literature.

They set about filling this gap by recruiting 114 people with IBS and randomly assigning each of them to one of the diets. Ninety-nine people finished the trial, with 33 following each of the diets. People with IBS-constipation were excluded.

Participants were a mean age of 37 years. Seventy-one percent were female, and 88% were White. Their mean IBS symptom severity score was 301, with 9% rating their symptoms as mild, 47% as moderate, and 45% as severe.

The proportion who reported at least a 50% reduction in their symptoms was 58% for the gluten-free diet, 55% for the low-FODMAP diet, and 42% for the TDA. The differences in these proportions were not significant (P = .43).

The diets worked about as well regardless of whether the patients had IBS with diarrhea or IBS with mixed diarrhea and constipation.

More of the people on the low-FODMAP diet reported significant improvement in their depression and dysphoria than people on the other two diets.

Changes in anxiety, somatization, and other aspects of IBS quality of life didn’t differ significantly with diet.
 

Where the diets differ: cost and ease

Fewer people following the TDA rated it as expensive, difficult, or socially awkward, compared with the people following the other two diets.

More of those following the TDA and gluten-free diet found them easy to incorporate into their lives than those following the low-FODMAP diet. About two-thirds of the people in each of these groups said they would consider continuing their diets after the end of the study.

The proportion of people consuming the recommended dietary reference values for macronutrients did not change with any of the diets. However, those in the TDA group reduced their intake of potassium and iron. In the other groups, the researchers noted a reduction in thiamine and magnesium.

Because of COVID-19 restrictions, the researchers were able to collect stool samples from only half of participants. What they did collect showed no difference among the groups in dysbiosis index or functional bacterial profiles.

Baseline factors such as age, gender, IBS subtype, dysbiosis index, somatization, and mood did not predict response to the three diets.

Participants improved as much whether they received dietary instructions face-to-face or through a live virtual consultation.
 

Applications and limitations

At least one previous study showed that the low-FODMAP diet produced better results than the standard diets patients had been following, said Brian E. Lacy, MD, PhD, a professor of medicine at the Mayo Clinic in Jacksonville, Fla., who was not involved in the current study.

He agreed with the study’s conclusion that the TDA could be a good place for people with IBS to start.

“Based on their research, and the findings that patients thought the diet was less expensive, easier to follow, and easier to shop for, this is a reasonable approach,” he told this news organization. “However, if there’s no benefit with the traditional diet, then moving on to the more rigorous low-FODMAP diet makes sense to me.”

Study limitations include a short duration, lack of information about how patients can add foods back into their diet (particularly with the low-FODMAP diet), and insufficient sample size and lack of a placebo group contributing to an inability to detect all clinically significant differences among the diets, he said.

“Although this study is not definitive and doesn’t answer all key questions about which diet is best and how each performs in the long run, it does provide important information for patients and providers,” said Dr. Lacy.

The study was funded by Schaer. One of the study authors has reported receiving an educational grant from Schaer. Dr. Lacy has reported being on scientific advisory boards for Ironwood, Salix, and Allakos.

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

Three widely followed diets for nonconstipated irritable bowel syndrome (IBS) produce similar results, but traditional dietary advice (TDA) is easier to follow, researchers say.

“We recommend TDA as the first-choice dietary option due to its widespread availability and patient friendliness,” Anupam Rej, MBChB, from Teaching Hospitals NHS Foundation Trust in Sheffield, England, and colleagues write.

AlexRaths/Getty Images

They noted, however, that the low-FODMAP diet produced the most improvement in depression and dysphoria.

The study was published online in Clinical Gastroenterology and Hepatology.
 

What the dietary options entailed

The three diets have different origins and methodologies, but all are designed to reduce the abdominal pain, bloating, and altered bowel habits that characterize IBS.

TDA is based on recommendations of the UK National Institute for Health and Care Excellence and the British Dietetic Association. It includes “sensible eating patterns,” such as regular meals, never having too much or too little, and sufficient hydration. It calls for a reduction in alcoholic, caffeinated, and “fizzy” drinks; spicy, fatty, and processed foods; fresh fruit (a maximum of three per day); and fiber and other gas-producing foods, such as beans, bread, and sweeteners. It also asks people to address any perceived food intolerance, such as dairy.

In North America, the low-FODMAP diet is prescribed as first-line therapy, and the American College of Gastroenterology has given it a conditional recommendation.

FODMAPs are short-chain fermentable carbohydrates found in many fruits, vegetables, dairy products, artificial sweeteners, and wheat. They increase small intestinal water volume and colonic gas production that can induce gastrointestinal symptoms in people with visceral hypersensitivity.

People following the low-FODMAP diet start by eliminating all FODMAPs for 4-6 weeks, then gradually reintroducing them to determine which are most likely to trigger symptoms.

A gluten-free diet, inspired by what is prescribed to treat celiac disease, has gained popularity in recent years. Although researchers debate the mechanism by which this diet improves symptoms, one leading theory is a reduction in fructans that accompany gluten in foods such as bread.

A rare head-to-head comparison trial

The low-FODMAP diet has proved itself in more clinical trials than the other two approaches, but few, if any, trials have compared them head-to-head in a pragmatic randomized trial, Dr. Rej and colleagues found after reviewing the literature.

They set about filling this gap by recruiting 114 people with IBS and randomly assigning each of them to one of the diets. Ninety-nine people finished the trial, with 33 following each of the diets. People with IBS-constipation were excluded.

Participants were a mean age of 37 years. Seventy-one percent were female, and 88% were White. Their mean IBS symptom severity score was 301, with 9% rating their symptoms as mild, 47% as moderate, and 45% as severe.

The proportion who reported at least a 50% reduction in their symptoms was 58% for the gluten-free diet, 55% for the low-FODMAP diet, and 42% for the TDA. The differences in these proportions were not significant (P = .43).

The diets worked about as well regardless of whether the patients had IBS with diarrhea or IBS with mixed diarrhea and constipation.

More of the people on the low-FODMAP diet reported significant improvement in their depression and dysphoria than people on the other two diets.

Changes in anxiety, somatization, and other aspects of IBS quality of life didn’t differ significantly with diet.
 

Where the diets differ: cost and ease

Fewer people following the TDA rated it as expensive, difficult, or socially awkward, compared with the people following the other two diets.

More of those following the TDA and gluten-free diet found them easy to incorporate into their lives than those following the low-FODMAP diet. About two-thirds of the people in each of these groups said they would consider continuing their diets after the end of the study.

The proportion of people consuming the recommended dietary reference values for macronutrients did not change with any of the diets. However, those in the TDA group reduced their intake of potassium and iron. In the other groups, the researchers noted a reduction in thiamine and magnesium.

Because of COVID-19 restrictions, the researchers were able to collect stool samples from only half of participants. What they did collect showed no difference among the groups in dysbiosis index or functional bacterial profiles.

Baseline factors such as age, gender, IBS subtype, dysbiosis index, somatization, and mood did not predict response to the three diets.

Participants improved as much whether they received dietary instructions face-to-face or through a live virtual consultation.
 

Applications and limitations

At least one previous study showed that the low-FODMAP diet produced better results than the standard diets patients had been following, said Brian E. Lacy, MD, PhD, a professor of medicine at the Mayo Clinic in Jacksonville, Fla., who was not involved in the current study.

He agreed with the study’s conclusion that the TDA could be a good place for people with IBS to start.

“Based on their research, and the findings that patients thought the diet was less expensive, easier to follow, and easier to shop for, this is a reasonable approach,” he told this news organization. “However, if there’s no benefit with the traditional diet, then moving on to the more rigorous low-FODMAP diet makes sense to me.”

Study limitations include a short duration, lack of information about how patients can add foods back into their diet (particularly with the low-FODMAP diet), and insufficient sample size and lack of a placebo group contributing to an inability to detect all clinically significant differences among the diets, he said.

“Although this study is not definitive and doesn’t answer all key questions about which diet is best and how each performs in the long run, it does provide important information for patients and providers,” said Dr. Lacy.

The study was funded by Schaer. One of the study authors has reported receiving an educational grant from Schaer. Dr. Lacy has reported being on scientific advisory boards for Ironwood, Salix, and Allakos.

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

Three widely followed diets for nonconstipated irritable bowel syndrome (IBS) produce similar results, but traditional dietary advice (TDA) is easier to follow, researchers say.

“We recommend TDA as the first-choice dietary option due to its widespread availability and patient friendliness,” Anupam Rej, MBChB, from Teaching Hospitals NHS Foundation Trust in Sheffield, England, and colleagues write.

AlexRaths/Getty Images

They noted, however, that the low-FODMAP diet produced the most improvement in depression and dysphoria.

The study was published online in Clinical Gastroenterology and Hepatology.
 

What the dietary options entailed

The three diets have different origins and methodologies, but all are designed to reduce the abdominal pain, bloating, and altered bowel habits that characterize IBS.

TDA is based on recommendations of the UK National Institute for Health and Care Excellence and the British Dietetic Association. It includes “sensible eating patterns,” such as regular meals, never having too much or too little, and sufficient hydration. It calls for a reduction in alcoholic, caffeinated, and “fizzy” drinks; spicy, fatty, and processed foods; fresh fruit (a maximum of three per day); and fiber and other gas-producing foods, such as beans, bread, and sweeteners. It also asks people to address any perceived food intolerance, such as dairy.

In North America, the low-FODMAP diet is prescribed as first-line therapy, and the American College of Gastroenterology has given it a conditional recommendation.

FODMAPs are short-chain fermentable carbohydrates found in many fruits, vegetables, dairy products, artificial sweeteners, and wheat. They increase small intestinal water volume and colonic gas production that can induce gastrointestinal symptoms in people with visceral hypersensitivity.

People following the low-FODMAP diet start by eliminating all FODMAPs for 4-6 weeks, then gradually reintroducing them to determine which are most likely to trigger symptoms.

A gluten-free diet, inspired by what is prescribed to treat celiac disease, has gained popularity in recent years. Although researchers debate the mechanism by which this diet improves symptoms, one leading theory is a reduction in fructans that accompany gluten in foods such as bread.

A rare head-to-head comparison trial

The low-FODMAP diet has proved itself in more clinical trials than the other two approaches, but few, if any, trials have compared them head-to-head in a pragmatic randomized trial, Dr. Rej and colleagues found after reviewing the literature.

They set about filling this gap by recruiting 114 people with IBS and randomly assigning each of them to one of the diets. Ninety-nine people finished the trial, with 33 following each of the diets. People with IBS-constipation were excluded.

Participants were a mean age of 37 years. Seventy-one percent were female, and 88% were White. Their mean IBS symptom severity score was 301, with 9% rating their symptoms as mild, 47% as moderate, and 45% as severe.

The proportion who reported at least a 50% reduction in their symptoms was 58% for the gluten-free diet, 55% for the low-FODMAP diet, and 42% for the TDA. The differences in these proportions were not significant (P = .43).

The diets worked about as well regardless of whether the patients had IBS with diarrhea or IBS with mixed diarrhea and constipation.

More of the people on the low-FODMAP diet reported significant improvement in their depression and dysphoria than people on the other two diets.

Changes in anxiety, somatization, and other aspects of IBS quality of life didn’t differ significantly with diet.
 

Where the diets differ: cost and ease

Fewer people following the TDA rated it as expensive, difficult, or socially awkward, compared with the people following the other two diets.

More of those following the TDA and gluten-free diet found them easy to incorporate into their lives than those following the low-FODMAP diet. About two-thirds of the people in each of these groups said they would consider continuing their diets after the end of the study.

The proportion of people consuming the recommended dietary reference values for macronutrients did not change with any of the diets. However, those in the TDA group reduced their intake of potassium and iron. In the other groups, the researchers noted a reduction in thiamine and magnesium.

Because of COVID-19 restrictions, the researchers were able to collect stool samples from only half of participants. What they did collect showed no difference among the groups in dysbiosis index or functional bacterial profiles.

Baseline factors such as age, gender, IBS subtype, dysbiosis index, somatization, and mood did not predict response to the three diets.

Participants improved as much whether they received dietary instructions face-to-face or through a live virtual consultation.
 

Applications and limitations

At least one previous study showed that the low-FODMAP diet produced better results than the standard diets patients had been following, said Brian E. Lacy, MD, PhD, a professor of medicine at the Mayo Clinic in Jacksonville, Fla., who was not involved in the current study.

He agreed with the study’s conclusion that the TDA could be a good place for people with IBS to start.

“Based on their research, and the findings that patients thought the diet was less expensive, easier to follow, and easier to shop for, this is a reasonable approach,” he told this news organization. “However, if there’s no benefit with the traditional diet, then moving on to the more rigorous low-FODMAP diet makes sense to me.”

Study limitations include a short duration, lack of information about how patients can add foods back into their diet (particularly with the low-FODMAP diet), and insufficient sample size and lack of a placebo group contributing to an inability to detect all clinically significant differences among the diets, he said.

“Although this study is not definitive and doesn’t answer all key questions about which diet is best and how each performs in the long run, it does provide important information for patients and providers,” said Dr. Lacy.

The study was funded by Schaer. One of the study authors has reported receiving an educational grant from Schaer. Dr. Lacy has reported being on scientific advisory boards for Ironwood, Salix, and Allakos.

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

Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.

The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.

The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.

At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.

AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.

The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.

They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.

“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”

AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
 

Triggered by cost cutting

The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”

Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”

There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”

Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”

As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.

“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”

Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”

The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).

This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”

“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.

In fact, the medical center hired seven new oncologists to replace them.
 

Noncompete covenant

In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.

“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”

The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.

“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “

In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.

Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.

“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”

Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.

“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
 

Telemedicine added to the mix

Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.

As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.

“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.

Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.

One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.

A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.

“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”

Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.

Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.

“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.

Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.

“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.

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

Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.

The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.

The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.

At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.

AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.

The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.

They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.

“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”

AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
 

Triggered by cost cutting

The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”

Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”

There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”

Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”

As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.

“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”

Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”

The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).

This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”

“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.

In fact, the medical center hired seven new oncologists to replace them.
 

Noncompete covenant

In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.

“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”

The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.

“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “

In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.

Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.

“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”

Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.

“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
 

Telemedicine added to the mix

Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.

As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.

“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.

Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.

One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.

A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.

“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”

Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.

Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.

“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.

Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.

“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.

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

Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.

The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.

The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.

At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.

AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.

The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.

They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.

“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”

AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
 

Triggered by cost cutting

The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”

Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”

There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”

Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”

As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.

“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”

Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”

The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).

This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”

“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.

In fact, the medical center hired seven new oncologists to replace them.
 

Noncompete covenant

In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.

“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”

The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.

“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “

In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.

Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.

“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”

Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.

“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
 

Telemedicine added to the mix

Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.

As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.

“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.

Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.

One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.

A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.

“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”

Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.

Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.

“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.

Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.

“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.

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

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

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

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

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

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

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

Heterosexuals with HIV have lower CD4 counts at diagnosis than their gay and bisexual male peers, according to an analysis of more than 300,000 people living with HIV globally.

“It was quite a startling finding for us, because it’s now telling everybody, ‘Look, if you have MSM [men who have sex with men] coming into your clinic, expect CD4 counts at diagnosis to be higher than if the person got the infection as a heterosexual,’” Narendra Dixit, PhD, senior fellow at the Indian Institute of Science’s Centre for Biosystems Science and Engineering, Bangalore, India, said in an interview.

And that means, he said, that the pattern may appear in local clinics.

“If they find that there are differences in the CD4 counts between heterosexuals and MSMs, they should not be surprised anymore,” he said.

Dr. Dixit proposed that the reason for this may be that the viruses transmitted among heterosexuals are more virulent, but the study didn’t provide evidence of that.
 

Immune health at HIV diagnosis

In this study, which was published online March 10 in PLOS Pathogens, Dr. Dixit and colleague Anathu James, PhD, a data scientist and an epidemiologist at the Indian Institute of Science, culled data from 337,119 people captured in studies in the United Kingdom, the United States, Europe, Australia, and China. For all participants, CD4 counts were drawn at the time of diagnosis and before starting HIV treatment. Dr. Dixit and Dr. James then divided the studies by HIV transmission group – gay and bisexual men versus heterosexuals – and then averaged CD4 counts in each study.

Then they created a mathematical model to estimate how quickly each group might progress to an AIDS-defining illness, given those initial CD4 counts.

What they found was that the mean CD4 count was consistently higher in the gay and bisexual males than in the heterosexuals, no matter where they lived. For instance, mean CD4 counts at diagnosis were a mean of 437 cells/mm³ among gay and bisexual men in one European cohort, compared to a mean of 307 among heterosexuals. In the U.S. data, the mean CD4 count for gay and bisexual men was 390, compared to 314 among heterosexuals. In China, the same held true: Gay men had a mean CD4 count of 368 cells/mm³; heterosexuals had a mean CD4 count of 270.

This remained true when they only looked at people between the ages of 13 and 29 years in the United States or whether they were younger than 40 in Europe and Australia. In Europe and Australia, though, heterosexual women younger than 40 had higher CD4 counts than either straight or gay men. But this difference did not reach statistical significance, and gay men had higher CD4 counts overall when the investigators didn’t segregate the data by age group.

“We were stunned,” Dr. Dixit told this news organization. “People never thought there could be a difference in the CD4 counts just because the mode of transmission is different – or, in this case, because the risk groups are different.”

There was no difference, though, in viral load at diagnosis.

In their mathematical model on progression to AIDS, the investigators estimated that these lower CD4 counts at diagnosis would lead to a progression to AIDS that was 19% higher for straight people than for gay and bisexual men. What this implies for practice is less clear. Right now, Dr. Dixit hopes the data will be used to conduct molecular analysis of HIV strains in heterosexuals and gay and bisexual men to see if the HIV circulating in straight communities is different – and perhaps more virulent – than the HIV circulating among gay and bisexual men. Previous research has suggested that CD4 counts can be used as a proxy for virulence.

Dr. Dixit’s mathematical model follows recent news of a highly virulent strain of HIV that’s been present in the Netherlands for decades. “More virulent” in that case meant that it was more highly transmissible and led to higher viral loads and a quicker decline of the immune CD4 cells. So when news of Dr. Dixit’s study went out, it was accompanied by a press release stating as fact that “HIV-1 infections are more virulent when transmitted through penile-vaginal intercourse.” The study’s title states that HIV is “more virulent” in heterosexuals.

But this study doesn’t actually show that, said virology researcher Timothy Henrich, MD, associate professor of medicine at the University of California, San Francisco, in an interview. In the Netherlands study, investigators took the additional step of analyzing HIV genomes. But this was not done in the recent PLOS Pathogens study.

“This was essentially a large meta-analysis of multiple large cohorts across many different countries,” said Dr. Henrich, who was not involved in the study. “There was no in-depth sequence analysis to say, ‘Oh yeah, this is because of a difference in the viruses that are being transmitted.’ If I were reviewing this paper, I probably would have said, ‘This is an interesting observation, but please don’t go overboard in your conclusions.’”

The study made Dr. Henrich want to know more. For instance, what method did each study use to determine CD4 counts? Did they control for the length of time since acquisition? Dr. Henrich said that if they didn’t differentiate between acute infection and chronic infection, he wasn’t sure what conclusions could be drawn from the data. Dr. Dixit told this news organization that they used the plateau level – the point after acute infection when CD4 counts settle into a consistent level. But it’s unclear how far from HIV acquisition each of the people in these studies was.

What Dr. Henrich does know, he said, is that big data are going to continue to change how we think about and investigate HIV transmission and virulence and what it could mean for clinical practice. The National Institutes of Health, for instance, will soon require all researchers receiving their funding to make their raw data publicly available soon after publication.

“We’re going to see a lot more of these large studies going forward,” he said. And if molecular analyses bear out Dr. Dixit’s conclusion – which he called “a big if” – “maybe we could use this study as a way” to do this work in the future.

The study was funded by DBT Network and the Wellcome Trust India Alliance Senior Fellowship. Dr. Dixit has disclosed no relevant financial relationships. Dr. Henrich is conducting studies funded in whole or in part by Merck and Gilead Sciences.

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