Kerry Dooley Young

U.S. regulators this year will begin to demand reports from cosmetics manufacturers about the ingredients used in their products. They are also preparing to assess potential risks of so-called forever chemicals in these products.

The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.

Yulia Lisitsa/iStock/Getty Images Plus

“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.

In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.

“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.

The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.

MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.

The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.

The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.

PFAS, or ‘forever chemicals’

Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.

MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.

The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”

The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.

PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.

PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.

This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.

But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.

“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
 

Interest from a U.S. senator

Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.

In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.

Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.

“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”

In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.

But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.

The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
 

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

U.S. regulators this year will begin to demand reports from cosmetics manufacturers about the ingredients used in their products. They are also preparing to assess potential risks of so-called forever chemicals in these products.

The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.

Yulia Lisitsa/iStock/Getty Images Plus

“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.

In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.

“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.

The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.

MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.

The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.

The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.

PFAS, or ‘forever chemicals’

Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.

MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.

The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”

The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.

PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.

PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.

This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.

But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.

“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
 

Interest from a U.S. senator

Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.

In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.

Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.

“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”

In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.

But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.

The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
 

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

U.S. regulators this year will begin to demand reports from cosmetics manufacturers about the ingredients used in their products. They are also preparing to assess potential risks of so-called forever chemicals in these products.

The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.

Yulia Lisitsa/iStock/Getty Images Plus

“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.

In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.

“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.

The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.

MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.

The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.

The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.

PFAS, or ‘forever chemicals’

Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.

MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.

The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”

The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.

PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.

PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.

This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.

But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.

“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
 

Interest from a U.S. senator

Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.

In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.

Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.

“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”

In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.

But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.

The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
 

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

People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.

The Biden administration on Aug. 29 revealed the first 10 drugs selected for direct Medicare price negotiations in accordance with a process mandated by the Inflation Reduction Act of 2022.

It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.

While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.

CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
 

• Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
• Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
• Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
• Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
• Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
• Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
• Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
• Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
• Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.

A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.

“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.

According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.

Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.

The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.

Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.

In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.

This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).

Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.

“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.

In addition, AARP issued a statement of its continued support for Medicare drug negotiations.

“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”

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

People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.

The Biden administration on Aug. 29 revealed the first 10 drugs selected for direct Medicare price negotiations in accordance with a process mandated by the Inflation Reduction Act of 2022.

It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.

While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.

CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
 

• Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
• Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
• Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
• Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
• Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
• Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
• Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
• Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
• Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.

A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.

“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.

According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.

Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.

The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.

Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.

In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.

This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).

Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.

“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.

In addition, AARP issued a statement of its continued support for Medicare drug negotiations.

“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”

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

People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.

The Biden administration on Aug. 29 revealed the first 10 drugs selected for direct Medicare price negotiations in accordance with a process mandated by the Inflation Reduction Act of 2022.

It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.

While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.

CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
 

• Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
• Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
• Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
• Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
• Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
• Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
• Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
• Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
• Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.

A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.

“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.

According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.

Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.

The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.

Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.

In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.

This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).

Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.

“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.

In addition, AARP issued a statement of its continued support for Medicare drug negotiations.

“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”

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

Clinical trials of treatments for rheumatologic conditions appear especially vulnerable to inadvertent unblinding, because of noticeable side effects of some drugs and subjective outcome measures, according to a new analysis.

Until more is known about the potential for unblinding, clinicians need to keep in mind that patients and physicians could often guess accurately who was getting placebo or active drug, first author Cody Bruggemeyer, MD, a resident at the Medical College of Wisconsin, Milwaukee, said in an interview.

Dr. Bruggemeyer

“It’s important that rheumatologists be aware of this potential issue and use their clinical reasoning and their ability to critically assess papers to evaluate the study design” of research on treatments, he said in an interview.

Dr. Bruggemeyer and coauthors at the Medical College of Wisconsin presented their assessment of the potential for unblinding in a Viewpoint article in The Lancet Rheumatology.
 

A sample of pivotal clinical trials

The authors selected a sample of pivotal studies of 14 commonly prescribed drugs for rheumatic conditions for which double-blind randomized controlled trials (RCTs) that compared the active ingredient with a placebo were available.

The 14 trials involved treatments classified as disease-modifying antirheumatic drugs (DMARDs), some of which were likely to produce side effects that placebos would not mimic, such as injection site and infusion reactions and difference in readings in lab reports, the authors wrote.

In their analysis, Dr. Bruggemeyer and colleagues evaluated discrepancies in the rates of adverse events reported between active drugs and placebos and classified the 14 studies as follows:

• High unblinding risk: Nine studies had a high estimated risk of unblinding, including trials of adalimumab with citrate (Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), ixekizumab (Taltz), leflunomide (Arava), methotrexate, risankizumab (Skyrizi) and tofacitinib (Xeljanz).
• Moderate unblinding risk: Three studies had a moderate estimated risk of unblinding, including trials of azathioprine (Imuran), mycophenolate mofetil and tocilizumab (Actemra).
• Low unblinding risk: Two studies had a low estimated risk of unblinding. These involved tests of belimumab (Benlysta) and rituximab (Rituxan).

Many of the effectiveness measurements of treatments used in rheumatology depend on patients’ reports of relief of pain and other disease symptoms. For example, the widely used American College of Rheumatology 20% response for rheumatoid arthritis includes components that rely on patient and physician assessment of disease activity.
 

Unblinding risk to clinical trial validity

CTs are the highest level of evidence to establish efficacy, because the study design aims to mask whether the experimental treatment is a drug or placebo. In cases where patients and physicians are more likely to correctly detect use of an active drug, there can be biases that skew results toward reports of symptom improvement. Other patients’ views of their treatment may be distorted by accurate guesses that they have been given placebo, Dr. Bruggemeyer and coauthors wrote.

“The degree of these effects cannot be predicted, but they tend to erroneously inflate the perceived benefit of novel interventions,” they wrote.

The consequences of this unblinding may be minimal in cases where there’s a clear difference between the placebo and active drug, they said. As an example, they cited trials of interleukin-23 inhibitors for psoriasis, where skin clearance as measured by the Psoriatic Area and Severity Index 75 differed by more than 50% in absolute terms between the treatment and placebo groups.

But in other cases, there needs to be more attention paid to the potential role of unblinding, they wrote.

“Studies where effect sizes were small, contradictory, or dependent on subgroup analyses might be especially problematic, but commentary rarely reflects this issue or acknowledges the potential influence of unblinding,” they wrote.

In the paper, they call for more analysis of previous trials to look for unreported assessments of unblinding, while also asking that researchers consider surveying participants in future trials to evaluate the degree to which unblinding occurs.

“Advocacy from professional societies and the U.S. Food and Drug Administration itself might be necessary, but in the interim, rheumatologists should assume unblinding has occurred to some degree in most trials,” they wrote.
 

Unblinding measure needs validation

In an interview, Roy M. Fleischmann, MD, co–medical director of the Metroplex Clinical Research Center in Dallas, raised some objections to the paper. The paper addresses an interesting question about unblinding, but there should have been more work done, such as finding “a measure that is validated that can say whether you’ve been unblinded or not.”

He added that he was surprised the paper on unblinding in rheumatology trials was published in its current form.

“I would have sent it for a major rewrite” if asked to review this paper before publication, said Dr. Fleischmann, who as a reviewer for Lancet Rheumatology. “I would have said: ‘Okay, 90% of this paper is okay, but your gist is not correct.’ It should be: ‘Is this a problem?’ ”

Dr. Fleischmann said he would have recommended a different perspective to the paper. “That is, this could occur. Should we be looking at this, and how would we look at this?”

In the paper, the authors acknowledge their approach has not been validated, “but it highlights the potential effect of idiosyncratic adverse events,” they wrote.

There’s less funding in general for meta-research than for studies involving treatments, so researchers look for approaches that can be handled without requiring significant funding, and much of the research on the quality of research is conducted like this analysis of rheumatology trials, Michael Putman, MD, the corresponding author and is a rheumatologist and an assistant professor at the Medical College of Wisconsin, said in an interview.

“You’re mostly doing on a shoestring budget with yourself and trainees,” he said. Dr. Putman is an associate editor at the journal Rheumatology and also involved in meta-research, or efforts to understand how studies and trials answer questions about how medical treatments work.

In an Aug. 16 tweet, Dr. Putman said this issue of unintentional unblinding with rheumatology trials was something he’d “been ruminating about for awhile; took two all star trainees to push it over the top!”

One of the barriers to funding of meta-research is a tendency for major funding for medical studies to be focused on specific diseases or targets. With meta-research, it may be more difficult to explain how a specific project will advance efforts to treat or prevent a certain disease, Dr. Putman said.

“It’s a little more esoteric and maybe not quite as clear how these projects will move things forward,” Dr. Putman said.

In addition, the nature of meta-research is to question and often be critical of work that’s already been published, adding another hurdle in attempts to secure funding, he said.

Dr. Putman is supported by a Rheumatology Research Foundation Scientist Development Grant, receives research funding related to clinical trials by AbbVie and AstraZeneca, and consulting fees from Novartis. The other authors declared no competing interests.

Clinical trials of treatments for rheumatologic conditions appear especially vulnerable to inadvertent unblinding, because of noticeable side effects of some drugs and subjective outcome measures, according to a new analysis.

Until more is known about the potential for unblinding, clinicians need to keep in mind that patients and physicians could often guess accurately who was getting placebo or active drug, first author Cody Bruggemeyer, MD, a resident at the Medical College of Wisconsin, Milwaukee, said in an interview.

Dr. Bruggemeyer

“It’s important that rheumatologists be aware of this potential issue and use their clinical reasoning and their ability to critically assess papers to evaluate the study design” of research on treatments, he said in an interview.

Dr. Bruggemeyer and coauthors at the Medical College of Wisconsin presented their assessment of the potential for unblinding in a Viewpoint article in The Lancet Rheumatology.
 

A sample of pivotal clinical trials

The authors selected a sample of pivotal studies of 14 commonly prescribed drugs for rheumatic conditions for which double-blind randomized controlled trials (RCTs) that compared the active ingredient with a placebo were available.

The 14 trials involved treatments classified as disease-modifying antirheumatic drugs (DMARDs), some of which were likely to produce side effects that placebos would not mimic, such as injection site and infusion reactions and difference in readings in lab reports, the authors wrote.

In their analysis, Dr. Bruggemeyer and colleagues evaluated discrepancies in the rates of adverse events reported between active drugs and placebos and classified the 14 studies as follows:

• High unblinding risk: Nine studies had a high estimated risk of unblinding, including trials of adalimumab with citrate (Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), ixekizumab (Taltz), leflunomide (Arava), methotrexate, risankizumab (Skyrizi) and tofacitinib (Xeljanz).
• Moderate unblinding risk: Three studies had a moderate estimated risk of unblinding, including trials of azathioprine (Imuran), mycophenolate mofetil and tocilizumab (Actemra).
• Low unblinding risk: Two studies had a low estimated risk of unblinding. These involved tests of belimumab (Benlysta) and rituximab (Rituxan).

Many of the effectiveness measurements of treatments used in rheumatology depend on patients’ reports of relief of pain and other disease symptoms. For example, the widely used American College of Rheumatology 20% response for rheumatoid arthritis includes components that rely on patient and physician assessment of disease activity.
 

Unblinding risk to clinical trial validity

CTs are the highest level of evidence to establish efficacy, because the study design aims to mask whether the experimental treatment is a drug or placebo. In cases where patients and physicians are more likely to correctly detect use of an active drug, there can be biases that skew results toward reports of symptom improvement. Other patients’ views of their treatment may be distorted by accurate guesses that they have been given placebo, Dr. Bruggemeyer and coauthors wrote.

“The degree of these effects cannot be predicted, but they tend to erroneously inflate the perceived benefit of novel interventions,” they wrote.

The consequences of this unblinding may be minimal in cases where there’s a clear difference between the placebo and active drug, they said. As an example, they cited trials of interleukin-23 inhibitors for psoriasis, where skin clearance as measured by the Psoriatic Area and Severity Index 75 differed by more than 50% in absolute terms between the treatment and placebo groups.

But in other cases, there needs to be more attention paid to the potential role of unblinding, they wrote.

“Studies where effect sizes were small, contradictory, or dependent on subgroup analyses might be especially problematic, but commentary rarely reflects this issue or acknowledges the potential influence of unblinding,” they wrote.

In the paper, they call for more analysis of previous trials to look for unreported assessments of unblinding, while also asking that researchers consider surveying participants in future trials to evaluate the degree to which unblinding occurs.

“Advocacy from professional societies and the U.S. Food and Drug Administration itself might be necessary, but in the interim, rheumatologists should assume unblinding has occurred to some degree in most trials,” they wrote.
 

Unblinding measure needs validation

In an interview, Roy M. Fleischmann, MD, co–medical director of the Metroplex Clinical Research Center in Dallas, raised some objections to the paper. The paper addresses an interesting question about unblinding, but there should have been more work done, such as finding “a measure that is validated that can say whether you’ve been unblinded or not.”

He added that he was surprised the paper on unblinding in rheumatology trials was published in its current form.

“I would have sent it for a major rewrite” if asked to review this paper before publication, said Dr. Fleischmann, who as a reviewer for Lancet Rheumatology. “I would have said: ‘Okay, 90% of this paper is okay, but your gist is not correct.’ It should be: ‘Is this a problem?’ ”

Dr. Fleischmann said he would have recommended a different perspective to the paper. “That is, this could occur. Should we be looking at this, and how would we look at this?”

In the paper, the authors acknowledge their approach has not been validated, “but it highlights the potential effect of idiosyncratic adverse events,” they wrote.

There’s less funding in general for meta-research than for studies involving treatments, so researchers look for approaches that can be handled without requiring significant funding, and much of the research on the quality of research is conducted like this analysis of rheumatology trials, Michael Putman, MD, the corresponding author and is a rheumatologist and an assistant professor at the Medical College of Wisconsin, said in an interview.

“You’re mostly doing on a shoestring budget with yourself and trainees,” he said. Dr. Putman is an associate editor at the journal Rheumatology and also involved in meta-research, or efforts to understand how studies and trials answer questions about how medical treatments work.

In an Aug. 16 tweet, Dr. Putman said this issue of unintentional unblinding with rheumatology trials was something he’d “been ruminating about for awhile; took two all star trainees to push it over the top!”

One of the barriers to funding of meta-research is a tendency for major funding for medical studies to be focused on specific diseases or targets. With meta-research, it may be more difficult to explain how a specific project will advance efforts to treat or prevent a certain disease, Dr. Putman said.

“It’s a little more esoteric and maybe not quite as clear how these projects will move things forward,” Dr. Putman said.

In addition, the nature of meta-research is to question and often be critical of work that’s already been published, adding another hurdle in attempts to secure funding, he said.

Dr. Putman is supported by a Rheumatology Research Foundation Scientist Development Grant, receives research funding related to clinical trials by AbbVie and AstraZeneca, and consulting fees from Novartis. The other authors declared no competing interests.

Clinical trials of treatments for rheumatologic conditions appear especially vulnerable to inadvertent unblinding, because of noticeable side effects of some drugs and subjective outcome measures, according to a new analysis.

Until more is known about the potential for unblinding, clinicians need to keep in mind that patients and physicians could often guess accurately who was getting placebo or active drug, first author Cody Bruggemeyer, MD, a resident at the Medical College of Wisconsin, Milwaukee, said in an interview.

Dr. Bruggemeyer

“It’s important that rheumatologists be aware of this potential issue and use their clinical reasoning and their ability to critically assess papers to evaluate the study design” of research on treatments, he said in an interview.

Dr. Bruggemeyer and coauthors at the Medical College of Wisconsin presented their assessment of the potential for unblinding in a Viewpoint article in The Lancet Rheumatology.
 

A sample of pivotal clinical trials

The authors selected a sample of pivotal studies of 14 commonly prescribed drugs for rheumatic conditions for which double-blind randomized controlled trials (RCTs) that compared the active ingredient with a placebo were available.

The 14 trials involved treatments classified as disease-modifying antirheumatic drugs (DMARDs), some of which were likely to produce side effects that placebos would not mimic, such as injection site and infusion reactions and difference in readings in lab reports, the authors wrote.

In their analysis, Dr. Bruggemeyer and colleagues evaluated discrepancies in the rates of adverse events reported between active drugs and placebos and classified the 14 studies as follows:

• High unblinding risk: Nine studies had a high estimated risk of unblinding, including trials of adalimumab with citrate (Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), ixekizumab (Taltz), leflunomide (Arava), methotrexate, risankizumab (Skyrizi) and tofacitinib (Xeljanz).
• Moderate unblinding risk: Three studies had a moderate estimated risk of unblinding, including trials of azathioprine (Imuran), mycophenolate mofetil and tocilizumab (Actemra).
• Low unblinding risk: Two studies had a low estimated risk of unblinding. These involved tests of belimumab (Benlysta) and rituximab (Rituxan).

Many of the effectiveness measurements of treatments used in rheumatology depend on patients’ reports of relief of pain and other disease symptoms. For example, the widely used American College of Rheumatology 20% response for rheumatoid arthritis includes components that rely on patient and physician assessment of disease activity.
 

Unblinding risk to clinical trial validity

CTs are the highest level of evidence to establish efficacy, because the study design aims to mask whether the experimental treatment is a drug or placebo. In cases where patients and physicians are more likely to correctly detect use of an active drug, there can be biases that skew results toward reports of symptom improvement. Other patients’ views of their treatment may be distorted by accurate guesses that they have been given placebo, Dr. Bruggemeyer and coauthors wrote.

“The degree of these effects cannot be predicted, but they tend to erroneously inflate the perceived benefit of novel interventions,” they wrote.

The consequences of this unblinding may be minimal in cases where there’s a clear difference between the placebo and active drug, they said. As an example, they cited trials of interleukin-23 inhibitors for psoriasis, where skin clearance as measured by the Psoriatic Area and Severity Index 75 differed by more than 50% in absolute terms between the treatment and placebo groups.

But in other cases, there needs to be more attention paid to the potential role of unblinding, they wrote.

“Studies where effect sizes were small, contradictory, or dependent on subgroup analyses might be especially problematic, but commentary rarely reflects this issue or acknowledges the potential influence of unblinding,” they wrote.

In the paper, they call for more analysis of previous trials to look for unreported assessments of unblinding, while also asking that researchers consider surveying participants in future trials to evaluate the degree to which unblinding occurs.

“Advocacy from professional societies and the U.S. Food and Drug Administration itself might be necessary, but in the interim, rheumatologists should assume unblinding has occurred to some degree in most trials,” they wrote.
 

Unblinding measure needs validation

In an interview, Roy M. Fleischmann, MD, co–medical director of the Metroplex Clinical Research Center in Dallas, raised some objections to the paper. The paper addresses an interesting question about unblinding, but there should have been more work done, such as finding “a measure that is validated that can say whether you’ve been unblinded or not.”

He added that he was surprised the paper on unblinding in rheumatology trials was published in its current form.

“I would have sent it for a major rewrite” if asked to review this paper before publication, said Dr. Fleischmann, who as a reviewer for Lancet Rheumatology. “I would have said: ‘Okay, 90% of this paper is okay, but your gist is not correct.’ It should be: ‘Is this a problem?’ ”

Dr. Fleischmann said he would have recommended a different perspective to the paper. “That is, this could occur. Should we be looking at this, and how would we look at this?”

In the paper, the authors acknowledge their approach has not been validated, “but it highlights the potential effect of idiosyncratic adverse events,” they wrote.

There’s less funding in general for meta-research than for studies involving treatments, so researchers look for approaches that can be handled without requiring significant funding, and much of the research on the quality of research is conducted like this analysis of rheumatology trials, Michael Putman, MD, the corresponding author and is a rheumatologist and an assistant professor at the Medical College of Wisconsin, said in an interview.

“You’re mostly doing on a shoestring budget with yourself and trainees,” he said. Dr. Putman is an associate editor at the journal Rheumatology and also involved in meta-research, or efforts to understand how studies and trials answer questions about how medical treatments work.

In an Aug. 16 tweet, Dr. Putman said this issue of unintentional unblinding with rheumatology trials was something he’d “been ruminating about for awhile; took two all star trainees to push it over the top!”

One of the barriers to funding of meta-research is a tendency for major funding for medical studies to be focused on specific diseases or targets. With meta-research, it may be more difficult to explain how a specific project will advance efforts to treat or prevent a certain disease, Dr. Putman said.

“It’s a little more esoteric and maybe not quite as clear how these projects will move things forward,” Dr. Putman said.

In addition, the nature of meta-research is to question and often be critical of work that’s already been published, adding another hurdle in attempts to secure funding, he said.

Dr. Putman is supported by a Rheumatology Research Foundation Scientist Development Grant, receives research funding related to clinical trials by AbbVie and AstraZeneca, and consulting fees from Novartis. The other authors declared no competing interests.

A consumer watchdog group is pressing for broader public access to a confidential federal database that tracks disciplinary records for physicians in a new report, arguing that extra public scrutiny could pressure state medical boards to be more aggressive watchdogs.

Public Citizen’s report includes an analysis of how frequently medical boards sanctioned physicians in 2019, 2020, and 2021. These sanctions include license revocations, suspensions, voluntary surrenders of licenses, and limitations on practice while under investigation.

The report used data from the National Practitioner Data Bank (NPDB), a federal repository of reports about state licensure, discipline, and certification actions as well as medical malpractice payments. The database is closed to the public, but hospitals, malpractice insurers, and investigators can query it.

According to Public Citizen’s calculations, states most likely to take serious disciplinary action against physicians were:

• Michigan: 1.74 serious disciplinary actions per 1,000 physicians per year
• Ohio: 1.61
• North Dakota: 1.60
• Colorado: 1.55
• Arizona: 1.53
• The states least likely to do so were:
• Nevada: 0.24 serious disciplinary actions per 1,000 physicians per year
• New Hampshire: 0.25
• Georgia: 0.27
• Indiana: 0.28
• Nebraska: 0.32
• California, the largest U.S. state by both population and number of physicians, landed near the middle, ranking 27th with a rate of 0.83 serious actions per 1,000 physicians, Public Citizen said.

“There is no evidence that physicians in any state are, overall, more or less likely to be incompetent or miscreant than the physicians in any other state,” said Robert Oshel, PhD, a former NPDB associate director for research and an author of the report.

The differences instead reflect variations in boards’ enforcement of medical practice laws, domination of licensing boards by physicians, and inadequate budgets, he noted.

Public Citizen said Congress should change federal law to let members of the public get information from the NPDB to do a background check on physicians whom they are considering seeing or are already seeing. This would not only help individuals but also would spur state licensing boards to do their own checks with the NPDB, the group said.

“If licensing boards routinely queried the NPDB, they would not be faulted by the public and state legislators for not knowing about malpractice payments or disciplinary actions affecting their licensees and therefore not taking reasonable actions concerning their licensees found to have poor records,” the report said.
 

Questioning NPDB access for consumers

Michelle Mello, JD, PhD, a professor of law and health policy at Stanford (Calif.) University, has studied the current applications of the NPDB. In 2019, she published an article in The New England Journal of Medicine examining changes in practice patterns for clinicians who faced multiple malpractice claims.

Dr. Mello questioned what benefit consumers would get from direct access to the NPDB’s information.

“It provides almost no context for the information it reports, making it even harder for patients to make sense of what they see there,” Dr. Mello said in an interview.

Hospitals are already required to routinely query the NPDB. This legal requirement should be expanded to include licensing boards, which the report called “the last line of defense for the public from incompetent and miscreant physicians,” Public Citizen said.

“Ideally, this amendment should include free continuous query access by medical boards for all their licensees,” the report said. “In the absence of any action by Congress, individual state legislatures should require their licensing boards to query all their licensees or enroll in continuous query, as a few states already do.”

The Federation of State Medical Boards agreed with some of the other suggestions Public Citizen offered in the report. The two concur on the need for increased funding to state medical boards to ensure that they have adequate resources and staffing to fulfill their duties, FSMB said in a statement.

But FSMB disagreed with Public Citizens’ approach to ranking boards, saying it could mislead. The report lacks context about how boards’ funding and authority vary, Humayun Chaudhry, DO, FSMB’s chief executive officer, said. He also questioned the decision to focus only on serious disciplinary actions.

“The Public Citizen report does not take into account the wide range of disciplinary steps boards can take such as letters of reprimand or fines, which are often enough to stop problem behaviors – preempting further problems in the future,” Dr. Chaudhry said.
 

D.C. gets worst rating

The District of Columbia earned the worst mark in the Public Citizen ranking, holding the 51st spot, the same place it held in the group’s similar ranking on actions taken in the 2017-2019 period. There were 0.19 serious disciplinary actions per 1,000 physicians a year in Washington, Public Citizen said.

In an email to this news organization, Dr. Oshel said that the Public Citizen analysis focused on the number of licensed physicians in each state and D.C. that can be obtained and compared reliably. It avoided using the term “practicing physicians” owing in part to doubts about the reliability of these counts, he said.

As many as 20% of physicians nationwide are focused primarily on work outside of clinical care, Dr. Oshel estimated. In D.C., perhaps 40% of physicians may fall into this category. Of the more than 13,700 physicians licensed in D.C., there may be only about 8,126 actively practicing, according to Dr. Oshel.

But even using that lower estimate of practicing physicians would only raise D.C.’s ranking to 46, signaling a need for stepped-up enforcement, Dr. Oshel said.

“[Whether it’s] 46th or 51st, both are bad,” Dr. Oshel said.

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

A consumer watchdog group is pressing for broader public access to a confidential federal database that tracks disciplinary records for physicians in a new report, arguing that extra public scrutiny could pressure state medical boards to be more aggressive watchdogs.

Public Citizen’s report includes an analysis of how frequently medical boards sanctioned physicians in 2019, 2020, and 2021. These sanctions include license revocations, suspensions, voluntary surrenders of licenses, and limitations on practice while under investigation.

The report used data from the National Practitioner Data Bank (NPDB), a federal repository of reports about state licensure, discipline, and certification actions as well as medical malpractice payments. The database is closed to the public, but hospitals, malpractice insurers, and investigators can query it.

According to Public Citizen’s calculations, states most likely to take serious disciplinary action against physicians were:

• Michigan: 1.74 serious disciplinary actions per 1,000 physicians per year
• Ohio: 1.61
• North Dakota: 1.60
• Colorado: 1.55
• Arizona: 1.53
• The states least likely to do so were:
• Nevada: 0.24 serious disciplinary actions per 1,000 physicians per year
• New Hampshire: 0.25
• Georgia: 0.27
• Indiana: 0.28
• Nebraska: 0.32
• California, the largest U.S. state by both population and number of physicians, landed near the middle, ranking 27th with a rate of 0.83 serious actions per 1,000 physicians, Public Citizen said.

“There is no evidence that physicians in any state are, overall, more or less likely to be incompetent or miscreant than the physicians in any other state,” said Robert Oshel, PhD, a former NPDB associate director for research and an author of the report.

The differences instead reflect variations in boards’ enforcement of medical practice laws, domination of licensing boards by physicians, and inadequate budgets, he noted.

Public Citizen said Congress should change federal law to let members of the public get information from the NPDB to do a background check on physicians whom they are considering seeing or are already seeing. This would not only help individuals but also would spur state licensing boards to do their own checks with the NPDB, the group said.

“If licensing boards routinely queried the NPDB, they would not be faulted by the public and state legislators for not knowing about malpractice payments or disciplinary actions affecting their licensees and therefore not taking reasonable actions concerning their licensees found to have poor records,” the report said.
 

Questioning NPDB access for consumers

Michelle Mello, JD, PhD, a professor of law and health policy at Stanford (Calif.) University, has studied the current applications of the NPDB. In 2019, she published an article in The New England Journal of Medicine examining changes in practice patterns for clinicians who faced multiple malpractice claims.

Dr. Mello questioned what benefit consumers would get from direct access to the NPDB’s information.

“It provides almost no context for the information it reports, making it even harder for patients to make sense of what they see there,” Dr. Mello said in an interview.

Hospitals are already required to routinely query the NPDB. This legal requirement should be expanded to include licensing boards, which the report called “the last line of defense for the public from incompetent and miscreant physicians,” Public Citizen said.

“Ideally, this amendment should include free continuous query access by medical boards for all their licensees,” the report said. “In the absence of any action by Congress, individual state legislatures should require their licensing boards to query all their licensees or enroll in continuous query, as a few states already do.”

The Federation of State Medical Boards agreed with some of the other suggestions Public Citizen offered in the report. The two concur on the need for increased funding to state medical boards to ensure that they have adequate resources and staffing to fulfill their duties, FSMB said in a statement.

But FSMB disagreed with Public Citizens’ approach to ranking boards, saying it could mislead. The report lacks context about how boards’ funding and authority vary, Humayun Chaudhry, DO, FSMB’s chief executive officer, said. He also questioned the decision to focus only on serious disciplinary actions.

“The Public Citizen report does not take into account the wide range of disciplinary steps boards can take such as letters of reprimand or fines, which are often enough to stop problem behaviors – preempting further problems in the future,” Dr. Chaudhry said.
 

D.C. gets worst rating

The District of Columbia earned the worst mark in the Public Citizen ranking, holding the 51st spot, the same place it held in the group’s similar ranking on actions taken in the 2017-2019 period. There were 0.19 serious disciplinary actions per 1,000 physicians a year in Washington, Public Citizen said.

In an email to this news organization, Dr. Oshel said that the Public Citizen analysis focused on the number of licensed physicians in each state and D.C. that can be obtained and compared reliably. It avoided using the term “practicing physicians” owing in part to doubts about the reliability of these counts, he said.

As many as 20% of physicians nationwide are focused primarily on work outside of clinical care, Dr. Oshel estimated. In D.C., perhaps 40% of physicians may fall into this category. Of the more than 13,700 physicians licensed in D.C., there may be only about 8,126 actively practicing, according to Dr. Oshel.

But even using that lower estimate of practicing physicians would only raise D.C.’s ranking to 46, signaling a need for stepped-up enforcement, Dr. Oshel said.

“[Whether it’s] 46th or 51st, both are bad,” Dr. Oshel said.

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

A consumer watchdog group is pressing for broader public access to a confidential federal database that tracks disciplinary records for physicians in a new report, arguing that extra public scrutiny could pressure state medical boards to be more aggressive watchdogs.

Public Citizen’s report includes an analysis of how frequently medical boards sanctioned physicians in 2019, 2020, and 2021. These sanctions include license revocations, suspensions, voluntary surrenders of licenses, and limitations on practice while under investigation.

The report used data from the National Practitioner Data Bank (NPDB), a federal repository of reports about state licensure, discipline, and certification actions as well as medical malpractice payments. The database is closed to the public, but hospitals, malpractice insurers, and investigators can query it.

According to Public Citizen’s calculations, states most likely to take serious disciplinary action against physicians were:

• Michigan: 1.74 serious disciplinary actions per 1,000 physicians per year
• Ohio: 1.61
• North Dakota: 1.60
• Colorado: 1.55
• Arizona: 1.53
• The states least likely to do so were:
• Nevada: 0.24 serious disciplinary actions per 1,000 physicians per year
• New Hampshire: 0.25
• Georgia: 0.27
• Indiana: 0.28
• Nebraska: 0.32
• California, the largest U.S. state by both population and number of physicians, landed near the middle, ranking 27th with a rate of 0.83 serious actions per 1,000 physicians, Public Citizen said.

“There is no evidence that physicians in any state are, overall, more or less likely to be incompetent or miscreant than the physicians in any other state,” said Robert Oshel, PhD, a former NPDB associate director for research and an author of the report.

The differences instead reflect variations in boards’ enforcement of medical practice laws, domination of licensing boards by physicians, and inadequate budgets, he noted.

Public Citizen said Congress should change federal law to let members of the public get information from the NPDB to do a background check on physicians whom they are considering seeing or are already seeing. This would not only help individuals but also would spur state licensing boards to do their own checks with the NPDB, the group said.

“If licensing boards routinely queried the NPDB, they would not be faulted by the public and state legislators for not knowing about malpractice payments or disciplinary actions affecting their licensees and therefore not taking reasonable actions concerning their licensees found to have poor records,” the report said.
 

Questioning NPDB access for consumers

Michelle Mello, JD, PhD, a professor of law and health policy at Stanford (Calif.) University, has studied the current applications of the NPDB. In 2019, she published an article in The New England Journal of Medicine examining changes in practice patterns for clinicians who faced multiple malpractice claims.

Dr. Mello questioned what benefit consumers would get from direct access to the NPDB’s information.

“It provides almost no context for the information it reports, making it even harder for patients to make sense of what they see there,” Dr. Mello said in an interview.

Hospitals are already required to routinely query the NPDB. This legal requirement should be expanded to include licensing boards, which the report called “the last line of defense for the public from incompetent and miscreant physicians,” Public Citizen said.

“Ideally, this amendment should include free continuous query access by medical boards for all their licensees,” the report said. “In the absence of any action by Congress, individual state legislatures should require their licensing boards to query all their licensees or enroll in continuous query, as a few states already do.”

The Federation of State Medical Boards agreed with some of the other suggestions Public Citizen offered in the report. The two concur on the need for increased funding to state medical boards to ensure that they have adequate resources and staffing to fulfill their duties, FSMB said in a statement.

But FSMB disagreed with Public Citizens’ approach to ranking boards, saying it could mislead. The report lacks context about how boards’ funding and authority vary, Humayun Chaudhry, DO, FSMB’s chief executive officer, said. He also questioned the decision to focus only on serious disciplinary actions.

“The Public Citizen report does not take into account the wide range of disciplinary steps boards can take such as letters of reprimand or fines, which are often enough to stop problem behaviors – preempting further problems in the future,” Dr. Chaudhry said.
 

D.C. gets worst rating

The District of Columbia earned the worst mark in the Public Citizen ranking, holding the 51st spot, the same place it held in the group’s similar ranking on actions taken in the 2017-2019 period. There were 0.19 serious disciplinary actions per 1,000 physicians a year in Washington, Public Citizen said.

In an email to this news organization, Dr. Oshel said that the Public Citizen analysis focused on the number of licensed physicians in each state and D.C. that can be obtained and compared reliably. It avoided using the term “practicing physicians” owing in part to doubts about the reliability of these counts, he said.

As many as 20% of physicians nationwide are focused primarily on work outside of clinical care, Dr. Oshel estimated. In D.C., perhaps 40% of physicians may fall into this category. Of the more than 13,700 physicians licensed in D.C., there may be only about 8,126 actively practicing, according to Dr. Oshel.

But even using that lower estimate of practicing physicians would only raise D.C.’s ranking to 46, signaling a need for stepped-up enforcement, Dr. Oshel said.

“[Whether it’s] 46th or 51st, both are bad,” Dr. Oshel said.

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

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.
 

Melatonin gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
 

Educating consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

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

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.
 

Melatonin gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
 

Educating consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

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

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.
 

Melatonin gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
 

Educating consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

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

An influential Nature paper predicted in 2017 that advances in artificial intelligence (AI) could unleash remarkable changes in dermatology, such as using phones to help detect skin cancer earlier.

Given that about 6.3 billion smartphones would soon be in use, this AI approach could provide a gateway for “low-cost universal access to vital diagnostic care,” wrote Justin M. Ko, MD, MBA, a dermatologist, and colleagues from Stanford (Calif.) University that included other dermatologists and engineers.

Dr. Ko and his coauthors described how they trained a computer system to identify both benign and cancerous skin lesions. They used an approach known as a convolutional neural network, often deployed for projects seeking to train computers to “see” through image analysis. They said that their test of this system found it to be on par with the performance of 21 board-certified dermatologists.

“This fast, scalable method is deployable on mobile devices and holds the potential for substantial clinical impact, including broadening the scope of primary care practice and augmenting clinical decision-making for dermatology specialists,” they wrote in their paper.

More than 6 years later, there are signs that companies are making progress toward moving skin checks using this technology into U.S. primary care settings – but only with devices that employ special tools.

It may prove tougher for companies to eventually secure the sign-off of the U.S. Food and Drug Administration for mobile apps intended to let consumers handle this task with smartphones.

Such tools would need to be proven highly accurate before release, because too many false positives mean that people would be needlessly exposed to biopsies, said Sancy A. Leachman, MD, PhD, director of the melanoma research program and chair of the department of dermatology at Oregon Health & Science University, Portland.

And false-negative readings would allow melanoma to advance and even be fatal, Dr. Leachman told this news organization.

Roxana Daneshjou, MD, PhD, a dermatologist at Stanford who has studied the promise and the pitfalls of AI in medicine, said that developers of a consumer skin-check app would need to know how people would react to their readings. That includes a good sense of how often they would appropriately seek medical care for a concerning reading. (She was not an author of the previously cited Nature paper but has published widely on AI.)

Christopher Smith

“The direct-to-consumer diagnostic space makes me nervous,” Dr. Daneshjou said in an interview. “In order to do it, you really need to have good studies in consumer populations prior to release. You need to show how effective it is with follow up.”
 

FDA shows interest – and reservations

As of July, the FDA had not yet given its okay for marketing of any consumer apps intended to help people detect signs of skin cancer, an agency spokesperson told this news organization.

To date, the agency has only cleared two AI-based products for this task, both meant to be used by dermatologists. And only one of these two products, Scibase’s Nevisense, remains in use in the United States. The other, MelaFind, has been discontinued. In 2017, Strata Skin Sciences said that the product did not win “a significant enough level of acceptance by dermatologists to justify the continued investment” in it. And the company said it notified the 90 owners of MelaFind devices in the United States that it would no longer support the device.

But another company, DermaSensor, said in a 2021 press release that it expects its AI-powered tool, also named DermaSensor, to be the “first ever FDA cleared or approved skin cancer detection device for primary care providers.”

The Miami-based firm said that the FDA had granted its product a “breakthrough” device designation. A breakthrough designation means that agency staff will offer extra help and guidance to companies in developing a product, because of its expected benefit for patients.

In a 2020 press release, 3Derm Systems, now owned by Digital Diagnostics, made a similar announcement about winning FDA breakthrough designation for an AI-powered tool intended to allow skin checks in primary care settings.

(The FDA generally does not comment on its reviews of experimental drugs and devices, but companies can do so. Several other companies have announced FDA breakthrough designations for AI-driven products intended to check for skin lesions, but these might be used in settings other than primary care.)

Both DermaSensor and Digital Diagnostics have chairs with notable track records for winning FDA approvals of other devices. DermaSensor’s Maurice Ferre, MD, also is the chairman of Insightec, which in 2016 won the first FDA approval for a device with a breakthrough designation device that uses ultrasound to treat tremors.

In 2018, the FDA allowed Digital Diagnostics, then called IDx, to introduce in the United States the first medical device using AI in primary care offices to check for signs of diabetic retinopathy. This product also had an FDA breakthrough designation. The executive chairman and founder of Digital Diagnostics is Michael Abramoff, MD, PhD, professor of engineering and ophthalmology at the University of Iowa, Iowa City. Dr. Abramoff and the team behind the AI tool for retinopathy, now called the LumineticsCore system, also scored a notable win with Medicare, which agreed to cover use of the product through a dedicated CPT code.
 

FDA draft guidance

The FDA has acknowledged the interest in broadening access to skin checks via AI.

This was a topic of discussion at a 2-day advisory committee meeting the FDA held last year. In April 2023, the FDA outlined some of its expectations for future regulation of skin-analyzing tools as part of a wide-ranging draft guidance document intended to aid companies in their efforts to develop products using a form of AI known as machine learning.

In the document, the FDA described how it might approach applications for “hypothetical” devices using this kind of AI, such as a special tool to help primary care clinicians identify lesions in need of further investigation. Such a product would use a specific camera for gathering data for its initial clearance, in the FDA’s hypothetical scenario.

The FDA staff offered technical suggestions about what the developer of this hypothetical device would have to do to extend its use to smartphones and tablets while keeping clinicians as the intended users.

Some of these expanded uses could fall within the bounds of the FDA’s initial clearance and thus not trigger a need for a new marketing submission, the agency said. But seeking to shift this hypothetical product to “patient-facing” use would require a new marketing submission to the FDA, the agency said.

In this scenario, a company would expect people to follow up with a dermatologist after receiving a report suggesting cancer. Thus, this kind of a change could expose patients to “many new, unconsidered risks,” the FDA said.
 

Reality check?

The state of current efforts to develop consumer apps for checking for skin cancer seems to be summarized well on the website for the MoleMapper. The app was developed by researchers at OHSU to help people track how their moles change over time.

“Mole Mapper is NOT designed to provide medical advice, professional diagnosis, opinion, or treatment. Currently, there is not enough data to develop an app that can diagnose melanoma, but if enough data is collected through Mole Mapper and shared with researchers, it may be possible in the future,” the app’s website says.

OHSU released MoleMapper as an iPhone app in 2015. The aim of this project was to help people track the moles on their skin while also fostering an experiment in “citizen science,” OHSU’s Dr. Leachman told this news organization.

OHSU researchers hoped that the digital images taken by members of the public on cell phones could one day be used to develop diagnostic algorithms for melanoma.

But around 2017, the MoleMapper team realized that they would not be able to create a diagnostic app at this time, Dr. Leachman explained. They could not collect enough data of adequate quality.

And by 2021, it was clear that they could not even develop a successful app to triage patients to assess who needs to be seen quickly. The amount of data required was, at this point, beyond what the team could collect, Dr. Leachman said in an interview.

That was a disappointment because the team had successfully completed the difficult task of creating a confidential pathway for collecting these images via both iPhones and smartphones run on Android.

“We thought if we built it, people would come, but that’s not what happened,” Dr. Leachman said. Many patients didn’t want their images used for research or would fail to follow up with details of biopsy reports. Sometimes images were not captured well enough to be of use.

“You need at least hundreds of thousands, if not millions, of data points that have been verified with pathologies, and nobody was giving us back that data. That was the reality,” Dr. Leachman said.

There were valuable lessons in that setback. The OHSU team now has a better grasp of the challenges of trying to build a data-collection system that could prove helpful in assessing skin lesions.

“If you don’t build it, you don’t know” what can go wrong, she said.

Dr. Leachman said other scientists who have worked on similar projects to build skin-analyzing apps have probably encountered the same difficulties, although they may not reveal these issues. “I think that a lot of people build these things and then they try to make it into something that it’s not,” she said.

In addition to the challenges with gathering images, dermatologists frequently need to rely on touch and other clues from in-person visits when diagnosing a suspicious lesion. “There’s something about seeing and feeling the skin in person that can’t be captured completely with an image,” Dr. Leachman said.
 

Public demand

Still, regulators must face the strong and immediate interest consumers have in using AI to check on moles and skin conditions, despite continuing questions about how well this approach might work.

In June, Google announced in a blog post that its Google Lens tool can help people research skin conditions.

“Just take a picture or upload a photo through Lens, and you’ll find visual matches to inform your search,” Google said in a blog post. “This feature also works if you’re not sure how to describe something else on your body, like a bump on your lip, a line on your nails or hair loss on your head. This feature is currently available in the U.S.”

Google also continues work on DermAssist, an app that’s intended to help people get personalized information about skin concerns using three photos. It is not currently publicly available, a Google spokesperson told this news organization.

Several skin-analyzing apps are already available in the Apple and Google Play stores. The British Association of Dermatologists last year issued a press release warning consumers that these apps may not be safe or effective and thus may put patients at risk for misdiagnosis.

“Unfortunately, AI-based apps which do not appear to meet regulatory requirements crop up more often than we would like,” the association said. “Additionally, the evidence to support the use of AI to diagnose skin conditions is weak which means that when it is used, it may not be safe or effective and it is possible that AI is putting patients at risk of misdiagnosis.”

Delicate and difficult balancing act

At this time, regulators, entrepreneurs, and the medical community face a delicate balancing act in considering how best to deploy AI in skin care, Dr. Ko said in an interview. (In addition to being one of the authors on the widely cited 2017 Nature paper mentioned above, Dr. Ko served until March as the initial chair of the American Academy of Dermatology’s Augmented Intelligence Committee.)

There are many solid reasons why there hasn’t been speedy progress to deploy AI in dermatology, as many envisioned a few years ago, Dr. Ko said.

Some of those reasons are specific to dermatology; this field doesn’t have a ready set of robust data from which to build AI-driven tools. In this aspect, dermatology is decades behind specialties like radiology, pathology, and ophthalmology, where clinicians have long been accumulating and storing images and other data in more standardized ways, Dr. Ko said.

“If you went to most dermatology practices and said, ‘Hey, let me learn from the data accumulated over the course of your 30-year practice to help us develop new tools,’” there may not be a whole lot there,” Dr. Ko said.

Beyond the start-up hurdles is the larger concern Dr. Ko shares with other dermatologists who work in this field, such as Dr. Daneshjou and Dr. Leachman. What would clinicians without much dermatology training and patients do with the readings from AI-driven tools and apps?

There would need to be significant research to show that such products actually help get people treated for skin diseases, including skin cancer.

Dr. Ko praised Google for being open about the stumbles with its efforts to use its AI tool for identifying diabetic retinopathy in a test in Thailand. Real-world hitches included poor Internet connections and poor image quality.

Developing reliable systems, processes, and workflows will be paramount for eventual widespread use of AI-driven tools, Dr. Ko said.

“It’s all those hidden things that are not sexy,” as are announcements about algorithms working about as well as clinicians in diagnosis, Dr. Ko said. “They don’t get the media attention, but they’re going to be make or break for AI, not just in our field but [for] AI in general.”

But he added that there also needs to be a recognition that AI-driven tools and products, even if somewhat imperfect, can help people get access to care.

In many cases, shortages of specialists prevent people from getting screened for treatable conditions such as skin cancer and retinopathy. The challenge is setting an appropriate standard to make sure that AI-driven products would help most patients in practice, without raising it so high that no such products emerge.

“There’s a risk of holding too high of a bar,” Dr. Ko said. “There is harm in not moving forward as well.”

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

An influential Nature paper predicted in 2017 that advances in artificial intelligence (AI) could unleash remarkable changes in dermatology, such as using phones to help detect skin cancer earlier.

Given that about 6.3 billion smartphones would soon be in use, this AI approach could provide a gateway for “low-cost universal access to vital diagnostic care,” wrote Justin M. Ko, MD, MBA, a dermatologist, and colleagues from Stanford (Calif.) University that included other dermatologists and engineers.

Dr. Ko and his coauthors described how they trained a computer system to identify both benign and cancerous skin lesions. They used an approach known as a convolutional neural network, often deployed for projects seeking to train computers to “see” through image analysis. They said that their test of this system found it to be on par with the performance of 21 board-certified dermatologists.

“This fast, scalable method is deployable on mobile devices and holds the potential for substantial clinical impact, including broadening the scope of primary care practice and augmenting clinical decision-making for dermatology specialists,” they wrote in their paper.

More than 6 years later, there are signs that companies are making progress toward moving skin checks using this technology into U.S. primary care settings – but only with devices that employ special tools.

It may prove tougher for companies to eventually secure the sign-off of the U.S. Food and Drug Administration for mobile apps intended to let consumers handle this task with smartphones.

Such tools would need to be proven highly accurate before release, because too many false positives mean that people would be needlessly exposed to biopsies, said Sancy A. Leachman, MD, PhD, director of the melanoma research program and chair of the department of dermatology at Oregon Health & Science University, Portland.

And false-negative readings would allow melanoma to advance and even be fatal, Dr. Leachman told this news organization.

Roxana Daneshjou, MD, PhD, a dermatologist at Stanford who has studied the promise and the pitfalls of AI in medicine, said that developers of a consumer skin-check app would need to know how people would react to their readings. That includes a good sense of how often they would appropriately seek medical care for a concerning reading. (She was not an author of the previously cited Nature paper but has published widely on AI.)

Christopher Smith

“The direct-to-consumer diagnostic space makes me nervous,” Dr. Daneshjou said in an interview. “In order to do it, you really need to have good studies in consumer populations prior to release. You need to show how effective it is with follow up.”
 

FDA shows interest – and reservations

As of July, the FDA had not yet given its okay for marketing of any consumer apps intended to help people detect signs of skin cancer, an agency spokesperson told this news organization.

To date, the agency has only cleared two AI-based products for this task, both meant to be used by dermatologists. And only one of these two products, Scibase’s Nevisense, remains in use in the United States. The other, MelaFind, has been discontinued. In 2017, Strata Skin Sciences said that the product did not win “a significant enough level of acceptance by dermatologists to justify the continued investment” in it. And the company said it notified the 90 owners of MelaFind devices in the United States that it would no longer support the device.

But another company, DermaSensor, said in a 2021 press release that it expects its AI-powered tool, also named DermaSensor, to be the “first ever FDA cleared or approved skin cancer detection device for primary care providers.”

The Miami-based firm said that the FDA had granted its product a “breakthrough” device designation. A breakthrough designation means that agency staff will offer extra help and guidance to companies in developing a product, because of its expected benefit for patients.

In a 2020 press release, 3Derm Systems, now owned by Digital Diagnostics, made a similar announcement about winning FDA breakthrough designation for an AI-powered tool intended to allow skin checks in primary care settings.

(The FDA generally does not comment on its reviews of experimental drugs and devices, but companies can do so. Several other companies have announced FDA breakthrough designations for AI-driven products intended to check for skin lesions, but these might be used in settings other than primary care.)

Both DermaSensor and Digital Diagnostics have chairs with notable track records for winning FDA approvals of other devices. DermaSensor’s Maurice Ferre, MD, also is the chairman of Insightec, which in 2016 won the first FDA approval for a device with a breakthrough designation device that uses ultrasound to treat tremors.

In 2018, the FDA allowed Digital Diagnostics, then called IDx, to introduce in the United States the first medical device using AI in primary care offices to check for signs of diabetic retinopathy. This product also had an FDA breakthrough designation. The executive chairman and founder of Digital Diagnostics is Michael Abramoff, MD, PhD, professor of engineering and ophthalmology at the University of Iowa, Iowa City. Dr. Abramoff and the team behind the AI tool for retinopathy, now called the LumineticsCore system, also scored a notable win with Medicare, which agreed to cover use of the product through a dedicated CPT code.
 

FDA draft guidance

The FDA has acknowledged the interest in broadening access to skin checks via AI.

This was a topic of discussion at a 2-day advisory committee meeting the FDA held last year. In April 2023, the FDA outlined some of its expectations for future regulation of skin-analyzing tools as part of a wide-ranging draft guidance document intended to aid companies in their efforts to develop products using a form of AI known as machine learning.

In the document, the FDA described how it might approach applications for “hypothetical” devices using this kind of AI, such as a special tool to help primary care clinicians identify lesions in need of further investigation. Such a product would use a specific camera for gathering data for its initial clearance, in the FDA’s hypothetical scenario.

The FDA staff offered technical suggestions about what the developer of this hypothetical device would have to do to extend its use to smartphones and tablets while keeping clinicians as the intended users.

Some of these expanded uses could fall within the bounds of the FDA’s initial clearance and thus not trigger a need for a new marketing submission, the agency said. But seeking to shift this hypothetical product to “patient-facing” use would require a new marketing submission to the FDA, the agency said.

In this scenario, a company would expect people to follow up with a dermatologist after receiving a report suggesting cancer. Thus, this kind of a change could expose patients to “many new, unconsidered risks,” the FDA said.
 

Reality check?

The state of current efforts to develop consumer apps for checking for skin cancer seems to be summarized well on the website for the MoleMapper. The app was developed by researchers at OHSU to help people track how their moles change over time.

“Mole Mapper is NOT designed to provide medical advice, professional diagnosis, opinion, or treatment. Currently, there is not enough data to develop an app that can diagnose melanoma, but if enough data is collected through Mole Mapper and shared with researchers, it may be possible in the future,” the app’s website says.

OHSU released MoleMapper as an iPhone app in 2015. The aim of this project was to help people track the moles on their skin while also fostering an experiment in “citizen science,” OHSU’s Dr. Leachman told this news organization.

OHSU researchers hoped that the digital images taken by members of the public on cell phones could one day be used to develop diagnostic algorithms for melanoma.

But around 2017, the MoleMapper team realized that they would not be able to create a diagnostic app at this time, Dr. Leachman explained. They could not collect enough data of adequate quality.

And by 2021, it was clear that they could not even develop a successful app to triage patients to assess who needs to be seen quickly. The amount of data required was, at this point, beyond what the team could collect, Dr. Leachman said in an interview.

That was a disappointment because the team had successfully completed the difficult task of creating a confidential pathway for collecting these images via both iPhones and smartphones run on Android.

“We thought if we built it, people would come, but that’s not what happened,” Dr. Leachman said. Many patients didn’t want their images used for research or would fail to follow up with details of biopsy reports. Sometimes images were not captured well enough to be of use.

“You need at least hundreds of thousands, if not millions, of data points that have been verified with pathologies, and nobody was giving us back that data. That was the reality,” Dr. Leachman said.

There were valuable lessons in that setback. The OHSU team now has a better grasp of the challenges of trying to build a data-collection system that could prove helpful in assessing skin lesions.

“If you don’t build it, you don’t know” what can go wrong, she said.

Dr. Leachman said other scientists who have worked on similar projects to build skin-analyzing apps have probably encountered the same difficulties, although they may not reveal these issues. “I think that a lot of people build these things and then they try to make it into something that it’s not,” she said.

In addition to the challenges with gathering images, dermatologists frequently need to rely on touch and other clues from in-person visits when diagnosing a suspicious lesion. “There’s something about seeing and feeling the skin in person that can’t be captured completely with an image,” Dr. Leachman said.
 

Public demand

Still, regulators must face the strong and immediate interest consumers have in using AI to check on moles and skin conditions, despite continuing questions about how well this approach might work.

In June, Google announced in a blog post that its Google Lens tool can help people research skin conditions.

“Just take a picture or upload a photo through Lens, and you’ll find visual matches to inform your search,” Google said in a blog post. “This feature also works if you’re not sure how to describe something else on your body, like a bump on your lip, a line on your nails or hair loss on your head. This feature is currently available in the U.S.”

Google also continues work on DermAssist, an app that’s intended to help people get personalized information about skin concerns using three photos. It is not currently publicly available, a Google spokesperson told this news organization.

Several skin-analyzing apps are already available in the Apple and Google Play stores. The British Association of Dermatologists last year issued a press release warning consumers that these apps may not be safe or effective and thus may put patients at risk for misdiagnosis.

“Unfortunately, AI-based apps which do not appear to meet regulatory requirements crop up more often than we would like,” the association said. “Additionally, the evidence to support the use of AI to diagnose skin conditions is weak which means that when it is used, it may not be safe or effective and it is possible that AI is putting patients at risk of misdiagnosis.”

Delicate and difficult balancing act

At this time, regulators, entrepreneurs, and the medical community face a delicate balancing act in considering how best to deploy AI in skin care, Dr. Ko said in an interview. (In addition to being one of the authors on the widely cited 2017 Nature paper mentioned above, Dr. Ko served until March as the initial chair of the American Academy of Dermatology’s Augmented Intelligence Committee.)

There are many solid reasons why there hasn’t been speedy progress to deploy AI in dermatology, as many envisioned a few years ago, Dr. Ko said.

Some of those reasons are specific to dermatology; this field doesn’t have a ready set of robust data from which to build AI-driven tools. In this aspect, dermatology is decades behind specialties like radiology, pathology, and ophthalmology, where clinicians have long been accumulating and storing images and other data in more standardized ways, Dr. Ko said.

“If you went to most dermatology practices and said, ‘Hey, let me learn from the data accumulated over the course of your 30-year practice to help us develop new tools,’” there may not be a whole lot there,” Dr. Ko said.

Beyond the start-up hurdles is the larger concern Dr. Ko shares with other dermatologists who work in this field, such as Dr. Daneshjou and Dr. Leachman. What would clinicians without much dermatology training and patients do with the readings from AI-driven tools and apps?

There would need to be significant research to show that such products actually help get people treated for skin diseases, including skin cancer.

Dr. Ko praised Google for being open about the stumbles with its efforts to use its AI tool for identifying diabetic retinopathy in a test in Thailand. Real-world hitches included poor Internet connections and poor image quality.

Developing reliable systems, processes, and workflows will be paramount for eventual widespread use of AI-driven tools, Dr. Ko said.

“It’s all those hidden things that are not sexy,” as are announcements about algorithms working about as well as clinicians in diagnosis, Dr. Ko said. “They don’t get the media attention, but they’re going to be make or break for AI, not just in our field but [for] AI in general.”

But he added that there also needs to be a recognition that AI-driven tools and products, even if somewhat imperfect, can help people get access to care.

In many cases, shortages of specialists prevent people from getting screened for treatable conditions such as skin cancer and retinopathy. The challenge is setting an appropriate standard to make sure that AI-driven products would help most patients in practice, without raising it so high that no such products emerge.

“There’s a risk of holding too high of a bar,” Dr. Ko said. “There is harm in not moving forward as well.”

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

An influential Nature paper predicted in 2017 that advances in artificial intelligence (AI) could unleash remarkable changes in dermatology, such as using phones to help detect skin cancer earlier.

Given that about 6.3 billion smartphones would soon be in use, this AI approach could provide a gateway for “low-cost universal access to vital diagnostic care,” wrote Justin M. Ko, MD, MBA, a dermatologist, and colleagues from Stanford (Calif.) University that included other dermatologists and engineers.

Dr. Ko and his coauthors described how they trained a computer system to identify both benign and cancerous skin lesions. They used an approach known as a convolutional neural network, often deployed for projects seeking to train computers to “see” through image analysis. They said that their test of this system found it to be on par with the performance of 21 board-certified dermatologists.

“This fast, scalable method is deployable on mobile devices and holds the potential for substantial clinical impact, including broadening the scope of primary care practice and augmenting clinical decision-making for dermatology specialists,” they wrote in their paper.

More than 6 years later, there are signs that companies are making progress toward moving skin checks using this technology into U.S. primary care settings – but only with devices that employ special tools.

It may prove tougher for companies to eventually secure the sign-off of the U.S. Food and Drug Administration for mobile apps intended to let consumers handle this task with smartphones.

Such tools would need to be proven highly accurate before release, because too many false positives mean that people would be needlessly exposed to biopsies, said Sancy A. Leachman, MD, PhD, director of the melanoma research program and chair of the department of dermatology at Oregon Health & Science University, Portland.

And false-negative readings would allow melanoma to advance and even be fatal, Dr. Leachman told this news organization.

Roxana Daneshjou, MD, PhD, a dermatologist at Stanford who has studied the promise and the pitfalls of AI in medicine, said that developers of a consumer skin-check app would need to know how people would react to their readings. That includes a good sense of how often they would appropriately seek medical care for a concerning reading. (She was not an author of the previously cited Nature paper but has published widely on AI.)

Christopher Smith

“The direct-to-consumer diagnostic space makes me nervous,” Dr. Daneshjou said in an interview. “In order to do it, you really need to have good studies in consumer populations prior to release. You need to show how effective it is with follow up.”
 

FDA shows interest – and reservations

As of July, the FDA had not yet given its okay for marketing of any consumer apps intended to help people detect signs of skin cancer, an agency spokesperson told this news organization.

To date, the agency has only cleared two AI-based products for this task, both meant to be used by dermatologists. And only one of these two products, Scibase’s Nevisense, remains in use in the United States. The other, MelaFind, has been discontinued. In 2017, Strata Skin Sciences said that the product did not win “a significant enough level of acceptance by dermatologists to justify the continued investment” in it. And the company said it notified the 90 owners of MelaFind devices in the United States that it would no longer support the device.

But another company, DermaSensor, said in a 2021 press release that it expects its AI-powered tool, also named DermaSensor, to be the “first ever FDA cleared or approved skin cancer detection device for primary care providers.”

The Miami-based firm said that the FDA had granted its product a “breakthrough” device designation. A breakthrough designation means that agency staff will offer extra help and guidance to companies in developing a product, because of its expected benefit for patients.

In a 2020 press release, 3Derm Systems, now owned by Digital Diagnostics, made a similar announcement about winning FDA breakthrough designation for an AI-powered tool intended to allow skin checks in primary care settings.

(The FDA generally does not comment on its reviews of experimental drugs and devices, but companies can do so. Several other companies have announced FDA breakthrough designations for AI-driven products intended to check for skin lesions, but these might be used in settings other than primary care.)

Both DermaSensor and Digital Diagnostics have chairs with notable track records for winning FDA approvals of other devices. DermaSensor’s Maurice Ferre, MD, also is the chairman of Insightec, which in 2016 won the first FDA approval for a device with a breakthrough designation device that uses ultrasound to treat tremors.

In 2018, the FDA allowed Digital Diagnostics, then called IDx, to introduce in the United States the first medical device using AI in primary care offices to check for signs of diabetic retinopathy. This product also had an FDA breakthrough designation. The executive chairman and founder of Digital Diagnostics is Michael Abramoff, MD, PhD, professor of engineering and ophthalmology at the University of Iowa, Iowa City. Dr. Abramoff and the team behind the AI tool for retinopathy, now called the LumineticsCore system, also scored a notable win with Medicare, which agreed to cover use of the product through a dedicated CPT code.
 

FDA draft guidance

The FDA has acknowledged the interest in broadening access to skin checks via AI.

This was a topic of discussion at a 2-day advisory committee meeting the FDA held last year. In April 2023, the FDA outlined some of its expectations for future regulation of skin-analyzing tools as part of a wide-ranging draft guidance document intended to aid companies in their efforts to develop products using a form of AI known as machine learning.

In the document, the FDA described how it might approach applications for “hypothetical” devices using this kind of AI, such as a special tool to help primary care clinicians identify lesions in need of further investigation. Such a product would use a specific camera for gathering data for its initial clearance, in the FDA’s hypothetical scenario.

The FDA staff offered technical suggestions about what the developer of this hypothetical device would have to do to extend its use to smartphones and tablets while keeping clinicians as the intended users.

Some of these expanded uses could fall within the bounds of the FDA’s initial clearance and thus not trigger a need for a new marketing submission, the agency said. But seeking to shift this hypothetical product to “patient-facing” use would require a new marketing submission to the FDA, the agency said.

In this scenario, a company would expect people to follow up with a dermatologist after receiving a report suggesting cancer. Thus, this kind of a change could expose patients to “many new, unconsidered risks,” the FDA said.
 

Reality check?

The state of current efforts to develop consumer apps for checking for skin cancer seems to be summarized well on the website for the MoleMapper. The app was developed by researchers at OHSU to help people track how their moles change over time.

“Mole Mapper is NOT designed to provide medical advice, professional diagnosis, opinion, or treatment. Currently, there is not enough data to develop an app that can diagnose melanoma, but if enough data is collected through Mole Mapper and shared with researchers, it may be possible in the future,” the app’s website says.

OHSU released MoleMapper as an iPhone app in 2015. The aim of this project was to help people track the moles on their skin while also fostering an experiment in “citizen science,” OHSU’s Dr. Leachman told this news organization.

OHSU researchers hoped that the digital images taken by members of the public on cell phones could one day be used to develop diagnostic algorithms for melanoma.

But around 2017, the MoleMapper team realized that they would not be able to create a diagnostic app at this time, Dr. Leachman explained. They could not collect enough data of adequate quality.

And by 2021, it was clear that they could not even develop a successful app to triage patients to assess who needs to be seen quickly. The amount of data required was, at this point, beyond what the team could collect, Dr. Leachman said in an interview.

That was a disappointment because the team had successfully completed the difficult task of creating a confidential pathway for collecting these images via both iPhones and smartphones run on Android.

“We thought if we built it, people would come, but that’s not what happened,” Dr. Leachman said. Many patients didn’t want their images used for research or would fail to follow up with details of biopsy reports. Sometimes images were not captured well enough to be of use.

“You need at least hundreds of thousands, if not millions, of data points that have been verified with pathologies, and nobody was giving us back that data. That was the reality,” Dr. Leachman said.

There were valuable lessons in that setback. The OHSU team now has a better grasp of the challenges of trying to build a data-collection system that could prove helpful in assessing skin lesions.

“If you don’t build it, you don’t know” what can go wrong, she said.

Dr. Leachman said other scientists who have worked on similar projects to build skin-analyzing apps have probably encountered the same difficulties, although they may not reveal these issues. “I think that a lot of people build these things and then they try to make it into something that it’s not,” she said.

In addition to the challenges with gathering images, dermatologists frequently need to rely on touch and other clues from in-person visits when diagnosing a suspicious lesion. “There’s something about seeing and feeling the skin in person that can’t be captured completely with an image,” Dr. Leachman said.
 

Public demand

Still, regulators must face the strong and immediate interest consumers have in using AI to check on moles and skin conditions, despite continuing questions about how well this approach might work.

In June, Google announced in a blog post that its Google Lens tool can help people research skin conditions.

“Just take a picture or upload a photo through Lens, and you’ll find visual matches to inform your search,” Google said in a blog post. “This feature also works if you’re not sure how to describe something else on your body, like a bump on your lip, a line on your nails or hair loss on your head. This feature is currently available in the U.S.”

Google also continues work on DermAssist, an app that’s intended to help people get personalized information about skin concerns using three photos. It is not currently publicly available, a Google spokesperson told this news organization.

Several skin-analyzing apps are already available in the Apple and Google Play stores. The British Association of Dermatologists last year issued a press release warning consumers that these apps may not be safe or effective and thus may put patients at risk for misdiagnosis.

“Unfortunately, AI-based apps which do not appear to meet regulatory requirements crop up more often than we would like,” the association said. “Additionally, the evidence to support the use of AI to diagnose skin conditions is weak which means that when it is used, it may not be safe or effective and it is possible that AI is putting patients at risk of misdiagnosis.”

Delicate and difficult balancing act

At this time, regulators, entrepreneurs, and the medical community face a delicate balancing act in considering how best to deploy AI in skin care, Dr. Ko said in an interview. (In addition to being one of the authors on the widely cited 2017 Nature paper mentioned above, Dr. Ko served until March as the initial chair of the American Academy of Dermatology’s Augmented Intelligence Committee.)

There are many solid reasons why there hasn’t been speedy progress to deploy AI in dermatology, as many envisioned a few years ago, Dr. Ko said.

Some of those reasons are specific to dermatology; this field doesn’t have a ready set of robust data from which to build AI-driven tools. In this aspect, dermatology is decades behind specialties like radiology, pathology, and ophthalmology, where clinicians have long been accumulating and storing images and other data in more standardized ways, Dr. Ko said.

“If you went to most dermatology practices and said, ‘Hey, let me learn from the data accumulated over the course of your 30-year practice to help us develop new tools,’” there may not be a whole lot there,” Dr. Ko said.

Beyond the start-up hurdles is the larger concern Dr. Ko shares with other dermatologists who work in this field, such as Dr. Daneshjou and Dr. Leachman. What would clinicians without much dermatology training and patients do with the readings from AI-driven tools and apps?

There would need to be significant research to show that such products actually help get people treated for skin diseases, including skin cancer.

Dr. Ko praised Google for being open about the stumbles with its efforts to use its AI tool for identifying diabetic retinopathy in a test in Thailand. Real-world hitches included poor Internet connections and poor image quality.

Developing reliable systems, processes, and workflows will be paramount for eventual widespread use of AI-driven tools, Dr. Ko said.

“It’s all those hidden things that are not sexy,” as are announcements about algorithms working about as well as clinicians in diagnosis, Dr. Ko said. “They don’t get the media attention, but they’re going to be make or break for AI, not just in our field but [for] AI in general.”

But he added that there also needs to be a recognition that AI-driven tools and products, even if somewhat imperfect, can help people get access to care.

In many cases, shortages of specialists prevent people from getting screened for treatable conditions such as skin cancer and retinopathy. The challenge is setting an appropriate standard to make sure that AI-driven products would help most patients in practice, without raising it so high that no such products emerge.

“There’s a risk of holding too high of a bar,” Dr. Ko said. “There is harm in not moving forward as well.”

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

Private equity ownership of medical practices was linked to consumer price increases for 8 of 10 specialties examined in a new report, with the most notable gains reported for oncology and gastroenterology.

The report was a collaboration of University of California, Berkeley, staff and researchers from two nonprofits, the American Antitrust Institute and the Washington Center for Equitable Growth. It provides “convincing evidence that incentives to put profits before patients have grown stronger with an increase in private equity ownership of physician practices,” lead author Richard Scheffler, PhD, of UC Berkeley said in a statement.

The report also noted that private equity acquisitions of physician groups have risen sixfold in just a decade, increasing from 75 deals in 2012 to 484 deals in 2021.

Separately, the American Medical Association earlier released a separate report on trends in physician practice arrangements, finding that the percentage of physicians working in private equity–owned groups was 4.5% in 2022, the same as in its previous 2020 report. The share of physicians working in private practices fell by 13 percentage points from 60.1% to 46.7% between 2012 and 2022, the AMA reported.

The Berkeley report and the AMA update come amid rising concerns about the effects of the decline of independent physician practices. The U.S. Senate Finance Committee, which oversees most federal health spending, held a June hearing examining the causes and consequences of increased corporate ownership in health care, including a look at physician practices.

“It’s increasingly clear that consolidation in health care is not lowering costs or increasing the quality of Americans’ health care,” Senate Finance Chairman Ron Wyden (D-Ore.) said in an email. “For private equity in health care in particular, there needs to be more transparency around ownership so the effect on these business relationships can be better understood.”

Federal and state agencies do not generally track acquisitions of physician practices.

The UC Berkeley report impressively documents the rising influence of private equity in health care, for which it’s tough to find good data, said Karen Joynt Maddox, MD, MPH, of Washington University in St. Louis. Dr. Maddox, a cardiologist and policy researcher who also has studied the effects of consolidation in health care, examined the new report at the request of this news organization.

“They did a great job with the data,” Dr. Maddox said. “One of the big issues around private equity, and in general, ‘corporatization’ and consolidation of health care, is that there’s not a great way to track ownership changes. It’s really difficult to study.”

Dr. Scheffler and colleagues used data from the commercial firm PitchBook to identify acquisitions of physician practices by private equity firms. They consulted IQVIA’s physician databases – OneKey and SK&A Office-Based Physicians Database – to learn about the location, size, and specialties of acquired practices. They also used data from the nonprofit Health Care Cost Institute, which tracks commercial health plan claims, to assess how private equity acquisitions affected prices.

The researchers then matched the findings for practices acquired by private equity firms from 2015 to 2021 against those for comparable physician practices that remained independent from 2012 to 2021.

The authors then tied private-equity ownership to the following price increases:

• Gastroenterology (14%; 95% confidence interval, 7.9%-20.4%
• Oncology (16.4%; 95% CI, 5.5%-28.4%)
• Dermatology (4.0%; 95% CI, 1%-7.1%)
• Ob.gyn. (8.8%; 95% CI, 3.8%-14%)
• Ophthalmology (8.7%; 95% CI, 5.1%-12.3%)
• Radiology (8.2%; 95% CI, 0.8%-16.1%)
• Orthopedics (7.1%; 95% CI, 2.2%-12.3%)
• Primary care (4.1%; 95% CI, 1.3%-7%)

The analysis also found higher prices for cardiology (8.7%; 95% CI, –6.4% to 26.1%) and urology (4.2%; 95% CI, –2.3% to 11.1%), but neither of these findings was statistically significant, one of the authors, Daniel R. Arnold, PhD, of UC Berkeley, said in an email. This was most likely caused by smaller sample sizes for these fields.
 

Factors driving consolidation

The two reports and the Senate Finance consolidation hearing raised similar issues, including calls to look at the factors driving more physicians out of independent practice, including Medicare reimbursement that may not keep up with rising inflation.

The Berkeley report authors called for Congress to add a broad inflation component to the Medicare physician fee schedule. It also called on Congress to add cases where Medicare, the biggest U.S. purchaser of health care, pays less for services when performed in independent practices than in hospital-affiliated ones.

Shawn Martin, executive vice president and CEO of the American Academy of Family Physicians, said his group appreciates how the report from UC Berkeley and nonprofit groups echoed recommendations many clinicians have made, including the call for a broad inflation adjustment for the fee schedule.

“To move the needle forward, Congress must advance site-neutral payment policies while also addressing the administrative requirements that take physicians away from the important work of caring for patients,” Mr. Martin said in an email.

Arnold Ventures provided funding for the report, which was a joint project of the American Antitrust Institute, the Nicholas C. Petris Center on Health Care Markets and Consumer Welfare, UC Berkeley, and the Washington Center for Equitable Growth.

A version of this article appeared on Medscape.com.

Private equity ownership of medical practices was linked to consumer price increases for 8 of 10 specialties examined in a new report, with the most notable gains reported for oncology and gastroenterology.

The report was a collaboration of University of California, Berkeley, staff and researchers from two nonprofits, the American Antitrust Institute and the Washington Center for Equitable Growth. It provides “convincing evidence that incentives to put profits before patients have grown stronger with an increase in private equity ownership of physician practices,” lead author Richard Scheffler, PhD, of UC Berkeley said in a statement.

The report also noted that private equity acquisitions of physician groups have risen sixfold in just a decade, increasing from 75 deals in 2012 to 484 deals in 2021.

Separately, the American Medical Association earlier released a separate report on trends in physician practice arrangements, finding that the percentage of physicians working in private equity–owned groups was 4.5% in 2022, the same as in its previous 2020 report. The share of physicians working in private practices fell by 13 percentage points from 60.1% to 46.7% between 2012 and 2022, the AMA reported.

The Berkeley report and the AMA update come amid rising concerns about the effects of the decline of independent physician practices. The U.S. Senate Finance Committee, which oversees most federal health spending, held a June hearing examining the causes and consequences of increased corporate ownership in health care, including a look at physician practices.

“It’s increasingly clear that consolidation in health care is not lowering costs or increasing the quality of Americans’ health care,” Senate Finance Chairman Ron Wyden (D-Ore.) said in an email. “For private equity in health care in particular, there needs to be more transparency around ownership so the effect on these business relationships can be better understood.”

Federal and state agencies do not generally track acquisitions of physician practices.

The UC Berkeley report impressively documents the rising influence of private equity in health care, for which it’s tough to find good data, said Karen Joynt Maddox, MD, MPH, of Washington University in St. Louis. Dr. Maddox, a cardiologist and policy researcher who also has studied the effects of consolidation in health care, examined the new report at the request of this news organization.

“They did a great job with the data,” Dr. Maddox said. “One of the big issues around private equity, and in general, ‘corporatization’ and consolidation of health care, is that there’s not a great way to track ownership changes. It’s really difficult to study.”

Dr. Scheffler and colleagues used data from the commercial firm PitchBook to identify acquisitions of physician practices by private equity firms. They consulted IQVIA’s physician databases – OneKey and SK&A Office-Based Physicians Database – to learn about the location, size, and specialties of acquired practices. They also used data from the nonprofit Health Care Cost Institute, which tracks commercial health plan claims, to assess how private equity acquisitions affected prices.

The researchers then matched the findings for practices acquired by private equity firms from 2015 to 2021 against those for comparable physician practices that remained independent from 2012 to 2021.

The authors then tied private-equity ownership to the following price increases:

• Gastroenterology (14%; 95% confidence interval, 7.9%-20.4%
• Oncology (16.4%; 95% CI, 5.5%-28.4%)
• Dermatology (4.0%; 95% CI, 1%-7.1%)
• Ob.gyn. (8.8%; 95% CI, 3.8%-14%)
• Ophthalmology (8.7%; 95% CI, 5.1%-12.3%)
• Radiology (8.2%; 95% CI, 0.8%-16.1%)
• Orthopedics (7.1%; 95% CI, 2.2%-12.3%)
• Primary care (4.1%; 95% CI, 1.3%-7%)

The analysis also found higher prices for cardiology (8.7%; 95% CI, –6.4% to 26.1%) and urology (4.2%; 95% CI, –2.3% to 11.1%), but neither of these findings was statistically significant, one of the authors, Daniel R. Arnold, PhD, of UC Berkeley, said in an email. This was most likely caused by smaller sample sizes for these fields.
 

Factors driving consolidation

The two reports and the Senate Finance consolidation hearing raised similar issues, including calls to look at the factors driving more physicians out of independent practice, including Medicare reimbursement that may not keep up with rising inflation.

The Berkeley report authors called for Congress to add a broad inflation component to the Medicare physician fee schedule. It also called on Congress to add cases where Medicare, the biggest U.S. purchaser of health care, pays less for services when performed in independent practices than in hospital-affiliated ones.

Shawn Martin, executive vice president and CEO of the American Academy of Family Physicians, said his group appreciates how the report from UC Berkeley and nonprofit groups echoed recommendations many clinicians have made, including the call for a broad inflation adjustment for the fee schedule.

“To move the needle forward, Congress must advance site-neutral payment policies while also addressing the administrative requirements that take physicians away from the important work of caring for patients,” Mr. Martin said in an email.

Arnold Ventures provided funding for the report, which was a joint project of the American Antitrust Institute, the Nicholas C. Petris Center on Health Care Markets and Consumer Welfare, UC Berkeley, and the Washington Center for Equitable Growth.

A version of this article appeared on Medscape.com.

Private equity ownership of medical practices was linked to consumer price increases for 8 of 10 specialties examined in a new report, with the most notable gains reported for oncology and gastroenterology.

The report was a collaboration of University of California, Berkeley, staff and researchers from two nonprofits, the American Antitrust Institute and the Washington Center for Equitable Growth. It provides “convincing evidence that incentives to put profits before patients have grown stronger with an increase in private equity ownership of physician practices,” lead author Richard Scheffler, PhD, of UC Berkeley said in a statement.

The report also noted that private equity acquisitions of physician groups have risen sixfold in just a decade, increasing from 75 deals in 2012 to 484 deals in 2021.

Separately, the American Medical Association earlier released a separate report on trends in physician practice arrangements, finding that the percentage of physicians working in private equity–owned groups was 4.5% in 2022, the same as in its previous 2020 report. The share of physicians working in private practices fell by 13 percentage points from 60.1% to 46.7% between 2012 and 2022, the AMA reported.

The Berkeley report and the AMA update come amid rising concerns about the effects of the decline of independent physician practices. The U.S. Senate Finance Committee, which oversees most federal health spending, held a June hearing examining the causes and consequences of increased corporate ownership in health care, including a look at physician practices.

“It’s increasingly clear that consolidation in health care is not lowering costs or increasing the quality of Americans’ health care,” Senate Finance Chairman Ron Wyden (D-Ore.) said in an email. “For private equity in health care in particular, there needs to be more transparency around ownership so the effect on these business relationships can be better understood.”

Federal and state agencies do not generally track acquisitions of physician practices.

The UC Berkeley report impressively documents the rising influence of private equity in health care, for which it’s tough to find good data, said Karen Joynt Maddox, MD, MPH, of Washington University in St. Louis. Dr. Maddox, a cardiologist and policy researcher who also has studied the effects of consolidation in health care, examined the new report at the request of this news organization.

“They did a great job with the data,” Dr. Maddox said. “One of the big issues around private equity, and in general, ‘corporatization’ and consolidation of health care, is that there’s not a great way to track ownership changes. It’s really difficult to study.”

Dr. Scheffler and colleagues used data from the commercial firm PitchBook to identify acquisitions of physician practices by private equity firms. They consulted IQVIA’s physician databases – OneKey and SK&A Office-Based Physicians Database – to learn about the location, size, and specialties of acquired practices. They also used data from the nonprofit Health Care Cost Institute, which tracks commercial health plan claims, to assess how private equity acquisitions affected prices.

The researchers then matched the findings for practices acquired by private equity firms from 2015 to 2021 against those for comparable physician practices that remained independent from 2012 to 2021.

The authors then tied private-equity ownership to the following price increases:

• Gastroenterology (14%; 95% confidence interval, 7.9%-20.4%
• Oncology (16.4%; 95% CI, 5.5%-28.4%)
• Dermatology (4.0%; 95% CI, 1%-7.1%)
• Ob.gyn. (8.8%; 95% CI, 3.8%-14%)
• Ophthalmology (8.7%; 95% CI, 5.1%-12.3%)
• Radiology (8.2%; 95% CI, 0.8%-16.1%)
• Orthopedics (7.1%; 95% CI, 2.2%-12.3%)
• Primary care (4.1%; 95% CI, 1.3%-7%)

The analysis also found higher prices for cardiology (8.7%; 95% CI, –6.4% to 26.1%) and urology (4.2%; 95% CI, –2.3% to 11.1%), but neither of these findings was statistically significant, one of the authors, Daniel R. Arnold, PhD, of UC Berkeley, said in an email. This was most likely caused by smaller sample sizes for these fields.
 

Factors driving consolidation

The two reports and the Senate Finance consolidation hearing raised similar issues, including calls to look at the factors driving more physicians out of independent practice, including Medicare reimbursement that may not keep up with rising inflation.

The Berkeley report authors called for Congress to add a broad inflation component to the Medicare physician fee schedule. It also called on Congress to add cases where Medicare, the biggest U.S. purchaser of health care, pays less for services when performed in independent practices than in hospital-affiliated ones.

Shawn Martin, executive vice president and CEO of the American Academy of Family Physicians, said his group appreciates how the report from UC Berkeley and nonprofit groups echoed recommendations many clinicians have made, including the call for a broad inflation adjustment for the fee schedule.

“To move the needle forward, Congress must advance site-neutral payment policies while also addressing the administrative requirements that take physicians away from the important work of caring for patients,” Mr. Martin said in an email.

Arnold Ventures provided funding for the report, which was a joint project of the American Antitrust Institute, the Nicholas C. Petris Center on Health Care Markets and Consumer Welfare, UC Berkeley, and the Washington Center for Equitable Growth.

A version of this article appeared on Medscape.com.

A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.
 

The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.

The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.

The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.

For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.

However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screening mammogram.

A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.

“The study’s central finding that some women who have an abnormal result on a mammogram may not get appropriate follow-up because of cost is worrisome,” said Dr. Fendrick and Ilana B. Richman, MD, MHS, in an accompanying commentary to the JAMA analysis. “On an individual level, high out-of-pocket costs may directly contribute to worse health outcomes or require individuals to use scarce financial resources that may otherwise be used for critical items such as food or rent.”

For patients to fully benefit from early detection, the USPSTF would also need to make clear that follow-up diagnostic mammograms are covered, Dr. Fendrick said.
 

The ongoing debates

Concerns over the costs of potential follow-up tests are not the only issues experts have highlighted since USPSTF released its updated draft guidance on screening mammography.

The task force’s proposed update has also reignited questions and uncertainties surrounding when to screen, how often, and what types are best.

When it comes to frequency, the major organizations that provide screening guidance don’t see eye to eye. The USPSTF recommends breast cancer screening every other year, while the American College of Radiology recommends screening every year because that approach leads to saves “the most lives.”

At this time, the American College of Obstetricians and Gynecologists guidance currently teeters in the middle, suggesting either annual or biennial screening and highlighting the pros and cons of either approach. According to ACOG, “annual screening intervals appear to result in the least number of breast cancer deaths, particularly in younger women, but at the cost of additional callbacks and biopsies.”

When to begin screening represents another point of contention. While some experts, such as ACOG, agree with the task force’s decision to lower the screening start age to 40, others point to the need for greater nuance on setting the appropriate screening age. The main issue: the task force’s draft sets a uniform age to begin screening, but the risk for breast cancer and breast cancer mortality is not uniform across different racial and ethnic groups.

A recent study published in JAMA Network Open found that, among women aged 40-49, breast cancer mortality was highest among Black women (27 deaths per 100,000 person-years) followed by White women (15 deaths per 100,000 person-years). Based on a recommended screening age of 50, the authors suggested that Black women should start screening at age 42, whereas White women could start at 51.

“These findings suggest that health policy makers and clinicians could consider an alternative, race and ethnicity–adapted approach in which Black female patients start screening earlier,” writes Tianhui Chen, PhD, of China’s Zhejiang Cancer Hospital and coauthor of the study.

Weighing in on the guidance, the nonprofit National Center for Health Research urged the task force to consider suggesting different screening schedules based on race and ethnicity data. That would mean the recommendation to start at age 40 should only apply to Black women and other groups with higher-than-average risk for breast cancer at a younger age.

“Women are capable of understanding why the age to start mammography screening may be different for women with different risk factors,” the National Center for Health Research wrote in a comment to USPSTF, provided to this news organization by request. “What is confusing is when some physician groups recommend annual mammograms for all women starting at age 40, even though the data do not support that recommendation.”

While the ACR agreed with the task force’s recommendation to lower the screening age, the organization suggested starting risk assessments based on racial variations in breast cancer incidence and death even earlier. Specifically, the ACR recommended that high-risk groups, such as Black women, get risk assessments by age 25 to determine whether mammography before age 40 is needed.

Screening options for women with dense breasts may be some of the most challenging to weigh. Having dense breasts increases an individual’s risk for breast cancer, and mammography alone is not as effective at identifying breast cancer among these women. However, the evidence on the benefits vs. harms of additional screening beyond mammography remains mixed.

As a result, the task force decided to maintain its “I” grade on additional screening beyond mammography for these women – a grade that indicates insufficient evidence to determine the benefits and harms for a service.

The task force largely based its decision on the findings of two key reports. One report from the Cancer Intervention and Surveillance Modeling Network, which modeled potential outcomes of different screening strategies, indicated that extra screening might reduce breast cancer mortality in those with dense breasts, but at a cost of more false-positive reports.

The second report, a review from the Kaiser Permanente Evidence-based Practice Center, reaffirmed the benefits of routine mammography for reducing deaths from breast cancer, but found no solid evidence that different strategies – including supplemental screening in women with denser breasts – lowered breast cancer mortality or the risk of progression to advanced cancer. Further studies may show which approaches work best to reduce breast cancer deaths, the report said.

In this instance, ACOG agreed with USPSTF: “Based on the lack of data, ACOG does not recommend routine use of alternative or adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.”

Women with dense breasts should still be encouraged to receive regular screening mammography, even if the results they get may not be as accurate as those for women with less dense breasts, said Diana L. Miglioretti, PhD, of the University of California, Davis, who worked on a report for the USPSTF guidelines.
 

What’s next?

Despite ongoing debate and uncertainties surrounding some breast screening guidance, support for ending copay requirements for follow-up tests after a positive mammogram finding is widespread.

According to Dr. Fendrick, the USPSTF should expand coverage of follow-up testing after a positive mammogram to ensure people receive routine screening and any necessary diagnostic tests, as it did with colon cancer.

Before 2021, patients could face high costs for a colonoscopy following a positive stool-based Cologuard test. But in 2021, the USPSTF said that positive results on stool-based tests would require follow-up with colonoscopy, defining this follow-up as part of the screening benefit. In 2022, Medicare followed by setting a policy that ended the copay for these follow-up colonoscopies.

For breast screening, there are efforts underway in Congress to end copays for breast screening. In May, Rep. Rosa DeLauro (D-Conn.) introduced a bill, the Find It Early Act, that would require both private and government insurers to cover the out-of-pocket costs for many women receiving screening with ultrasound and MRI.

When the USPSTF finalizes its breast screening guidelines, the recommendations will be woven into discussions between primary care physicians and patients about breast cancer screening.

As guidelines and evidence evolve, “we’re learning to adjust” and communicate these changes to patients, said Tochi Iroku-Malize, MD, president of the American Academy of Family Physicians.

However, gaps in the guidance will leave some open-ended questions about optimal screening practices and how much screening may cost.

Given that, Dr. Iroku-Malize takes many factors into account when discussing screening options with her patients. Based on the new information and the patient’s information, she said she will tell her patients, “We’re going to adjust our guidance as to what you need.”

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

A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.
 

The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.

The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.

The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.

For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.

However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screening mammogram.

A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.

“The study’s central finding that some women who have an abnormal result on a mammogram may not get appropriate follow-up because of cost is worrisome,” said Dr. Fendrick and Ilana B. Richman, MD, MHS, in an accompanying commentary to the JAMA analysis. “On an individual level, high out-of-pocket costs may directly contribute to worse health outcomes or require individuals to use scarce financial resources that may otherwise be used for critical items such as food or rent.”

For patients to fully benefit from early detection, the USPSTF would also need to make clear that follow-up diagnostic mammograms are covered, Dr. Fendrick said.
 

The ongoing debates

Concerns over the costs of potential follow-up tests are not the only issues experts have highlighted since USPSTF released its updated draft guidance on screening mammography.

The task force’s proposed update has also reignited questions and uncertainties surrounding when to screen, how often, and what types are best.

When it comes to frequency, the major organizations that provide screening guidance don’t see eye to eye. The USPSTF recommends breast cancer screening every other year, while the American College of Radiology recommends screening every year because that approach leads to saves “the most lives.”

At this time, the American College of Obstetricians and Gynecologists guidance currently teeters in the middle, suggesting either annual or biennial screening and highlighting the pros and cons of either approach. According to ACOG, “annual screening intervals appear to result in the least number of breast cancer deaths, particularly in younger women, but at the cost of additional callbacks and biopsies.”

When to begin screening represents another point of contention. While some experts, such as ACOG, agree with the task force’s decision to lower the screening start age to 40, others point to the need for greater nuance on setting the appropriate screening age. The main issue: the task force’s draft sets a uniform age to begin screening, but the risk for breast cancer and breast cancer mortality is not uniform across different racial and ethnic groups.

A recent study published in JAMA Network Open found that, among women aged 40-49, breast cancer mortality was highest among Black women (27 deaths per 100,000 person-years) followed by White women (15 deaths per 100,000 person-years). Based on a recommended screening age of 50, the authors suggested that Black women should start screening at age 42, whereas White women could start at 51.

“These findings suggest that health policy makers and clinicians could consider an alternative, race and ethnicity–adapted approach in which Black female patients start screening earlier,” writes Tianhui Chen, PhD, of China’s Zhejiang Cancer Hospital and coauthor of the study.

Weighing in on the guidance, the nonprofit National Center for Health Research urged the task force to consider suggesting different screening schedules based on race and ethnicity data. That would mean the recommendation to start at age 40 should only apply to Black women and other groups with higher-than-average risk for breast cancer at a younger age.

“Women are capable of understanding why the age to start mammography screening may be different for women with different risk factors,” the National Center for Health Research wrote in a comment to USPSTF, provided to this news organization by request. “What is confusing is when some physician groups recommend annual mammograms for all women starting at age 40, even though the data do not support that recommendation.”

While the ACR agreed with the task force’s recommendation to lower the screening age, the organization suggested starting risk assessments based on racial variations in breast cancer incidence and death even earlier. Specifically, the ACR recommended that high-risk groups, such as Black women, get risk assessments by age 25 to determine whether mammography before age 40 is needed.

Screening options for women with dense breasts may be some of the most challenging to weigh. Having dense breasts increases an individual’s risk for breast cancer, and mammography alone is not as effective at identifying breast cancer among these women. However, the evidence on the benefits vs. harms of additional screening beyond mammography remains mixed.

As a result, the task force decided to maintain its “I” grade on additional screening beyond mammography for these women – a grade that indicates insufficient evidence to determine the benefits and harms for a service.

The task force largely based its decision on the findings of two key reports. One report from the Cancer Intervention and Surveillance Modeling Network, which modeled potential outcomes of different screening strategies, indicated that extra screening might reduce breast cancer mortality in those with dense breasts, but at a cost of more false-positive reports.

The second report, a review from the Kaiser Permanente Evidence-based Practice Center, reaffirmed the benefits of routine mammography for reducing deaths from breast cancer, but found no solid evidence that different strategies – including supplemental screening in women with denser breasts – lowered breast cancer mortality or the risk of progression to advanced cancer. Further studies may show which approaches work best to reduce breast cancer deaths, the report said.

In this instance, ACOG agreed with USPSTF: “Based on the lack of data, ACOG does not recommend routine use of alternative or adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.”

Women with dense breasts should still be encouraged to receive regular screening mammography, even if the results they get may not be as accurate as those for women with less dense breasts, said Diana L. Miglioretti, PhD, of the University of California, Davis, who worked on a report for the USPSTF guidelines.
 

What’s next?

Despite ongoing debate and uncertainties surrounding some breast screening guidance, support for ending copay requirements for follow-up tests after a positive mammogram finding is widespread.

According to Dr. Fendrick, the USPSTF should expand coverage of follow-up testing after a positive mammogram to ensure people receive routine screening and any necessary diagnostic tests, as it did with colon cancer.

Before 2021, patients could face high costs for a colonoscopy following a positive stool-based Cologuard test. But in 2021, the USPSTF said that positive results on stool-based tests would require follow-up with colonoscopy, defining this follow-up as part of the screening benefit. In 2022, Medicare followed by setting a policy that ended the copay for these follow-up colonoscopies.

For breast screening, there are efforts underway in Congress to end copays for breast screening. In May, Rep. Rosa DeLauro (D-Conn.) introduced a bill, the Find It Early Act, that would require both private and government insurers to cover the out-of-pocket costs for many women receiving screening with ultrasound and MRI.

When the USPSTF finalizes its breast screening guidelines, the recommendations will be woven into discussions between primary care physicians and patients about breast cancer screening.

As guidelines and evidence evolve, “we’re learning to adjust” and communicate these changes to patients, said Tochi Iroku-Malize, MD, president of the American Academy of Family Physicians.

However, gaps in the guidance will leave some open-ended questions about optimal screening practices and how much screening may cost.

Given that, Dr. Iroku-Malize takes many factors into account when discussing screening options with her patients. Based on the new information and the patient’s information, she said she will tell her patients, “We’re going to adjust our guidance as to what you need.”

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

A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.
 

The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.

The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.

The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.

For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.

However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screening mammogram.

A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.

“The study’s central finding that some women who have an abnormal result on a mammogram may not get appropriate follow-up because of cost is worrisome,” said Dr. Fendrick and Ilana B. Richman, MD, MHS, in an accompanying commentary to the JAMA analysis. “On an individual level, high out-of-pocket costs may directly contribute to worse health outcomes or require individuals to use scarce financial resources that may otherwise be used for critical items such as food or rent.”

For patients to fully benefit from early detection, the USPSTF would also need to make clear that follow-up diagnostic mammograms are covered, Dr. Fendrick said.
 

The ongoing debates

Concerns over the costs of potential follow-up tests are not the only issues experts have highlighted since USPSTF released its updated draft guidance on screening mammography.

The task force’s proposed update has also reignited questions and uncertainties surrounding when to screen, how often, and what types are best.

When it comes to frequency, the major organizations that provide screening guidance don’t see eye to eye. The USPSTF recommends breast cancer screening every other year, while the American College of Radiology recommends screening every year because that approach leads to saves “the most lives.”

At this time, the American College of Obstetricians and Gynecologists guidance currently teeters in the middle, suggesting either annual or biennial screening and highlighting the pros and cons of either approach. According to ACOG, “annual screening intervals appear to result in the least number of breast cancer deaths, particularly in younger women, but at the cost of additional callbacks and biopsies.”

When to begin screening represents another point of contention. While some experts, such as ACOG, agree with the task force’s decision to lower the screening start age to 40, others point to the need for greater nuance on setting the appropriate screening age. The main issue: the task force’s draft sets a uniform age to begin screening, but the risk for breast cancer and breast cancer mortality is not uniform across different racial and ethnic groups.

A recent study published in JAMA Network Open found that, among women aged 40-49, breast cancer mortality was highest among Black women (27 deaths per 100,000 person-years) followed by White women (15 deaths per 100,000 person-years). Based on a recommended screening age of 50, the authors suggested that Black women should start screening at age 42, whereas White women could start at 51.

“These findings suggest that health policy makers and clinicians could consider an alternative, race and ethnicity–adapted approach in which Black female patients start screening earlier,” writes Tianhui Chen, PhD, of China’s Zhejiang Cancer Hospital and coauthor of the study.

Weighing in on the guidance, the nonprofit National Center for Health Research urged the task force to consider suggesting different screening schedules based on race and ethnicity data. That would mean the recommendation to start at age 40 should only apply to Black women and other groups with higher-than-average risk for breast cancer at a younger age.

“Women are capable of understanding why the age to start mammography screening may be different for women with different risk factors,” the National Center for Health Research wrote in a comment to USPSTF, provided to this news organization by request. “What is confusing is when some physician groups recommend annual mammograms for all women starting at age 40, even though the data do not support that recommendation.”

While the ACR agreed with the task force’s recommendation to lower the screening age, the organization suggested starting risk assessments based on racial variations in breast cancer incidence and death even earlier. Specifically, the ACR recommended that high-risk groups, such as Black women, get risk assessments by age 25 to determine whether mammography before age 40 is needed.

Screening options for women with dense breasts may be some of the most challenging to weigh. Having dense breasts increases an individual’s risk for breast cancer, and mammography alone is not as effective at identifying breast cancer among these women. However, the evidence on the benefits vs. harms of additional screening beyond mammography remains mixed.

As a result, the task force decided to maintain its “I” grade on additional screening beyond mammography for these women – a grade that indicates insufficient evidence to determine the benefits and harms for a service.

The task force largely based its decision on the findings of two key reports. One report from the Cancer Intervention and Surveillance Modeling Network, which modeled potential outcomes of different screening strategies, indicated that extra screening might reduce breast cancer mortality in those with dense breasts, but at a cost of more false-positive reports.

The second report, a review from the Kaiser Permanente Evidence-based Practice Center, reaffirmed the benefits of routine mammography for reducing deaths from breast cancer, but found no solid evidence that different strategies – including supplemental screening in women with denser breasts – lowered breast cancer mortality or the risk of progression to advanced cancer. Further studies may show which approaches work best to reduce breast cancer deaths, the report said.

In this instance, ACOG agreed with USPSTF: “Based on the lack of data, ACOG does not recommend routine use of alternative or adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.”

Women with dense breasts should still be encouraged to receive regular screening mammography, even if the results they get may not be as accurate as those for women with less dense breasts, said Diana L. Miglioretti, PhD, of the University of California, Davis, who worked on a report for the USPSTF guidelines.
 

What’s next?

Despite ongoing debate and uncertainties surrounding some breast screening guidance, support for ending copay requirements for follow-up tests after a positive mammogram finding is widespread.

According to Dr. Fendrick, the USPSTF should expand coverage of follow-up testing after a positive mammogram to ensure people receive routine screening and any necessary diagnostic tests, as it did with colon cancer.

Before 2021, patients could face high costs for a colonoscopy following a positive stool-based Cologuard test. But in 2021, the USPSTF said that positive results on stool-based tests would require follow-up with colonoscopy, defining this follow-up as part of the screening benefit. In 2022, Medicare followed by setting a policy that ended the copay for these follow-up colonoscopies.

For breast screening, there are efforts underway in Congress to end copays for breast screening. In May, Rep. Rosa DeLauro (D-Conn.) introduced a bill, the Find It Early Act, that would require both private and government insurers to cover the out-of-pocket costs for many women receiving screening with ultrasound and MRI.

When the USPSTF finalizes its breast screening guidelines, the recommendations will be woven into discussions between primary care physicians and patients about breast cancer screening.

As guidelines and evidence evolve, “we’re learning to adjust” and communicate these changes to patients, said Tochi Iroku-Malize, MD, president of the American Academy of Family Physicians.

However, gaps in the guidance will leave some open-ended questions about optimal screening practices and how much screening may cost.

Given that, Dr. Iroku-Malize takes many factors into account when discussing screening options with her patients. Based on the new information and the patient’s information, she said she will tell her patients, “We’re going to adjust our guidance as to what you need.”

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

An influential panel proposed capping Medicare Part B pay for some drugs, arguing this would remove financial incentives to use more costly medicines when there are less expensive equivalents.

Medical groups have objected to both this recommendation from the Medicare Payment Advisory Commission (MedPAC) and the panel’s underlying premise. MedPAC said financial as well as clinical factors can come into play in clinicians’ choices of drugs for patients.

In an interview, Christina Downey, MD, chair of the Government Affairs Committee of the American College of Rheumatology, said physicians in her field cannot switch patients’ medicines to try to make a profit.

“Patients only respond to the drugs that they respond to,” Dr. Downey said. “It’s frankly very insulting to say that physicians just force patients to go on medicines that are going to make them a bunch of money.”

In a June report to Congress, MedPAC recommended reducing the add-on payment for many drugs given in hospitals and clinics, which are thus covered by Part B, as part of a package of suggestions for addressing rising costs. Part B drug spending grew about 9% annually between 2009 and 2021, rising from $15.4 billion to $42.9 billion, MedPAC said.

Medicare’s current Part B drug pricing model starts with the reported average sales price (ASP) and then adds about 4.3% or 6%, depending on current budget-sequester law, to the cost of medicines.

MedPAC members voted 17-0 in April in favor of a general recommendation to revise the Part B payment approach. In the June report, MedPAC fleshes out this idea. It mentions a model in which the add-on Part B payment would be the lesser of either 6% of the ASP, 3% plus $24, or $220.

The majority of Part B drug administrations are for very low-priced drugs, MedPAC said. But for some of the more costly ones, annual prices can be more than $400,000 per patient, and future launch prices may be even higher for certain types of products, such as gene therapies, MedPAC said.

“There is no evidence that the costs of a drug’s administration are proportionate to the price of the drug,” MedPAC said.

Concerns about how well Medicare covers the cost of drug administration should be addressed through other pathways, such as the American Medical

Association’s Specialty Society Relative Value Scale Update Committee (RUC), MedPAC said. AMA’s RUC advises the Centers for Medicare & Medicaid Services on the physician fee schedule.

Congress is not obliged to act on or to even consider MedPAC’s work. In general, lawmakers and CMS often pay heed to the panel’s recommendations, sometimes incorporating them into new policy.

But this new MedPAC Part B recommendation has drawn strong opposition, similar to the response to a 2016 CMS plan to cut the Part B add-on payment. That plan, which CMS later abandoned, would have cut the markup on Part B drugs to 2.5% and added a flat fee to cover administration costs.
 

Why not focus on PBMs instead?

The timing of the MedPAC recommendation is poor, given that CMS already is trying to implement the Inflation Reduction Act and create a new system of direct Medicare drug price negotiations, as ordered by Congress, said Madelaine A. Feldman, MD, a rheumatologist based in New Orleans.

A better approach for lowering drug prices would be to focus more on the operations of pharmacy benefit managers (PBMs), said Dr. Feldman, who also is vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations. A pending bipartisan Senate bill, for example, would prohibit PBM compensation based on the price of a drug as a condition of entering into a contract with a Medicare Part D plan.

Congress needs to take steps to unlink the profits of PBMs from higher drug prices, Dr. Feldman said.

“Until that happens, we can put all the lipstick we want on this big pig, but it’s not going to really fix the problem,” she said.
 

Reduced pay for drugs acquired through 340B program?

In an interview about the new MedPAC proposal, Ted Okon, executive director of the Community Oncology Alliance, urged renewed attention to what he sees as unintended consequences of the 340B discount drug program.

Under this program, certain hospitals can acquire drugs at steeply reduced prices, but they are not obliged to share those discounts with patients. Hospitals that participate in the 340B program can gain funds when patients and their insurers, including Medicare, pay more for the medicines hospitals and other organizations acquired with the 340B discount. Hospitals say they use the money from the 340B program to expand resources in their communities.

But rapid growth of the program in recent years has led to questions, especially about the role of contract pharmacies that manage the program. Congress created the 340B program in 1992 as a workaround to then new rules on Medicaid drug coverage.

In 2021, participating hospitals and clinics and organizations purchased about $44 billion worth of medicines through the 340B drug program. This was an increase of 16% from the previous year, according to a report from the nonprofit Commonwealth Fund. The number of sites, including hospitals and pharmacies, enrolled in the 340B program rose from 8,100 in 2000 to 50,000 by 2020, the report said.

MedPAC in 2016 urged CMS to reduce the amount Medicare pays for drugs acquired through the 340B program. CMS did so during the Trump administration, a policy later defended by the Biden administration.

But the U.S. Supreme Court last year said Medicare erred in its approach to making this cut, as earlier reported. Federal law required that the Department of Health and Human Services conduct a survey to support such a step, and HHS did not do this, the court said. CMS thus was ordered to return Medicare to the ASP+6% payment model for drugs purchased through the 340B discount program.

In the June report, though, MedPAC stuck by its 2016 recommendation that Medicare reduce its payments for drugs purchased through the 340B discount program despite this setback.

“We continue to believe that this approach is appropriate, and the specific level of payment reduction could be considered further as newer data become available,” MedPAC said.
 

Hospital, PhRMA split

Hospitals would certainly contest any renewed bid by CMS to drop Medicare’s pay for drugs purchased through the 340B program. The American Hospital Association objected to the MedPAC proposal regarding the add-on payment in Part B drug pricing.

MedPAC commissioners discussed this idea at a January meeting, prompting a February letter from the AHA to the panel. Like Dr. Feldman, AHA said it would be “premature” to launch into a revision of Part B drug pricing while the impact of the IRA on drug prices was still unclear.

AHA also noted that a reduction in Part B drug reimbursement would “shift the responsibility for the rapid increase in drug prices away from drug manufacturers, and instead places the burden on hospitals and patients.”

But the AHA gave a much warmer reception to another proposal MedPAC considered this year and that it included in its June report, which is a plan to address the high cost of certain drugs of as yet unconfirmed clinical benefit.

In April, the AHA said it supports a move toward a “value-based approach” in certain cases in which first-in-class medicines are sold under U.S. Food and Drug Administration’s accelerated approvals. Medicare could then cap payment for such drugs that have excessively high launch prices and uncertain clinical benefit, AHA said.

In the June report, MedPAC recommended that Medicare be able to place such a limit on Part B payments in certain cases, including ones in which companies do not meet FDA deadlines for postmarketing confirmatory trials.

The Pharmaceutical Research and Manufacturers of America (PhRMA) objected to this proposed change. The trade group for drugmakers said the FDA often revises and extends enrollment milestones for pending confirmatory trials when companies hit snags, such as challenges in enrolling patients, PhRMA said.

Reducing Part B payment for drugs for which confirmatory trials have been delayed would have a “disproportionate impact” on smaller and rural communities, where independent practices struggle to keep their doors open as it is, PhRMA spokeswoman Nicole Longo wrote in a blog post.

“If physicians can’t afford to administer a medicine, then they won’t and that means their patients won’t have access to them either,” Ms. Longo wrote.

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

An influential panel proposed capping Medicare Part B pay for some drugs, arguing this would remove financial incentives to use more costly medicines when there are less expensive equivalents.

Medical groups have objected to both this recommendation from the Medicare Payment Advisory Commission (MedPAC) and the panel’s underlying premise. MedPAC said financial as well as clinical factors can come into play in clinicians’ choices of drugs for patients.

In an interview, Christina Downey, MD, chair of the Government Affairs Committee of the American College of Rheumatology, said physicians in her field cannot switch patients’ medicines to try to make a profit.

“Patients only respond to the drugs that they respond to,” Dr. Downey said. “It’s frankly very insulting to say that physicians just force patients to go on medicines that are going to make them a bunch of money.”

In a June report to Congress, MedPAC recommended reducing the add-on payment for many drugs given in hospitals and clinics, which are thus covered by Part B, as part of a package of suggestions for addressing rising costs. Part B drug spending grew about 9% annually between 2009 and 2021, rising from $15.4 billion to $42.9 billion, MedPAC said.

Medicare’s current Part B drug pricing model starts with the reported average sales price (ASP) and then adds about 4.3% or 6%, depending on current budget-sequester law, to the cost of medicines.

MedPAC members voted 17-0 in April in favor of a general recommendation to revise the Part B payment approach. In the June report, MedPAC fleshes out this idea. It mentions a model in which the add-on Part B payment would be the lesser of either 6% of the ASP, 3% plus $24, or $220.

The majority of Part B drug administrations are for very low-priced drugs, MedPAC said. But for some of the more costly ones, annual prices can be more than $400,000 per patient, and future launch prices may be even higher for certain types of products, such as gene therapies, MedPAC said.

“There is no evidence that the costs of a drug’s administration are proportionate to the price of the drug,” MedPAC said.

Concerns about how well Medicare covers the cost of drug administration should be addressed through other pathways, such as the American Medical

Association’s Specialty Society Relative Value Scale Update Committee (RUC), MedPAC said. AMA’s RUC advises the Centers for Medicare & Medicaid Services on the physician fee schedule.

Congress is not obliged to act on or to even consider MedPAC’s work. In general, lawmakers and CMS often pay heed to the panel’s recommendations, sometimes incorporating them into new policy.

But this new MedPAC Part B recommendation has drawn strong opposition, similar to the response to a 2016 CMS plan to cut the Part B add-on payment. That plan, which CMS later abandoned, would have cut the markup on Part B drugs to 2.5% and added a flat fee to cover administration costs.
 

Why not focus on PBMs instead?

The timing of the MedPAC recommendation is poor, given that CMS already is trying to implement the Inflation Reduction Act and create a new system of direct Medicare drug price negotiations, as ordered by Congress, said Madelaine A. Feldman, MD, a rheumatologist based in New Orleans.

A better approach for lowering drug prices would be to focus more on the operations of pharmacy benefit managers (PBMs), said Dr. Feldman, who also is vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations. A pending bipartisan Senate bill, for example, would prohibit PBM compensation based on the price of a drug as a condition of entering into a contract with a Medicare Part D plan.

Congress needs to take steps to unlink the profits of PBMs from higher drug prices, Dr. Feldman said.

“Until that happens, we can put all the lipstick we want on this big pig, but it’s not going to really fix the problem,” she said.
 

Reduced pay for drugs acquired through 340B program?

In an interview about the new MedPAC proposal, Ted Okon, executive director of the Community Oncology Alliance, urged renewed attention to what he sees as unintended consequences of the 340B discount drug program.

Under this program, certain hospitals can acquire drugs at steeply reduced prices, but they are not obliged to share those discounts with patients. Hospitals that participate in the 340B program can gain funds when patients and their insurers, including Medicare, pay more for the medicines hospitals and other organizations acquired with the 340B discount. Hospitals say they use the money from the 340B program to expand resources in their communities.

But rapid growth of the program in recent years has led to questions, especially about the role of contract pharmacies that manage the program. Congress created the 340B program in 1992 as a workaround to then new rules on Medicaid drug coverage.

In 2021, participating hospitals and clinics and organizations purchased about $44 billion worth of medicines through the 340B drug program. This was an increase of 16% from the previous year, according to a report from the nonprofit Commonwealth Fund. The number of sites, including hospitals and pharmacies, enrolled in the 340B program rose from 8,100 in 2000 to 50,000 by 2020, the report said.

MedPAC in 2016 urged CMS to reduce the amount Medicare pays for drugs acquired through the 340B program. CMS did so during the Trump administration, a policy later defended by the Biden administration.

But the U.S. Supreme Court last year said Medicare erred in its approach to making this cut, as earlier reported. Federal law required that the Department of Health and Human Services conduct a survey to support such a step, and HHS did not do this, the court said. CMS thus was ordered to return Medicare to the ASP+6% payment model for drugs purchased through the 340B discount program.

In the June report, though, MedPAC stuck by its 2016 recommendation that Medicare reduce its payments for drugs purchased through the 340B discount program despite this setback.

“We continue to believe that this approach is appropriate, and the specific level of payment reduction could be considered further as newer data become available,” MedPAC said.
 

Hospital, PhRMA split

Hospitals would certainly contest any renewed bid by CMS to drop Medicare’s pay for drugs purchased through the 340B program. The American Hospital Association objected to the MedPAC proposal regarding the add-on payment in Part B drug pricing.

MedPAC commissioners discussed this idea at a January meeting, prompting a February letter from the AHA to the panel. Like Dr. Feldman, AHA said it would be “premature” to launch into a revision of Part B drug pricing while the impact of the IRA on drug prices was still unclear.

AHA also noted that a reduction in Part B drug reimbursement would “shift the responsibility for the rapid increase in drug prices away from drug manufacturers, and instead places the burden on hospitals and patients.”

But the AHA gave a much warmer reception to another proposal MedPAC considered this year and that it included in its June report, which is a plan to address the high cost of certain drugs of as yet unconfirmed clinical benefit.

In April, the AHA said it supports a move toward a “value-based approach” in certain cases in which first-in-class medicines are sold under U.S. Food and Drug Administration’s accelerated approvals. Medicare could then cap payment for such drugs that have excessively high launch prices and uncertain clinical benefit, AHA said.

In the June report, MedPAC recommended that Medicare be able to place such a limit on Part B payments in certain cases, including ones in which companies do not meet FDA deadlines for postmarketing confirmatory trials.

The Pharmaceutical Research and Manufacturers of America (PhRMA) objected to this proposed change. The trade group for drugmakers said the FDA often revises and extends enrollment milestones for pending confirmatory trials when companies hit snags, such as challenges in enrolling patients, PhRMA said.

Reducing Part B payment for drugs for which confirmatory trials have been delayed would have a “disproportionate impact” on smaller and rural communities, where independent practices struggle to keep their doors open as it is, PhRMA spokeswoman Nicole Longo wrote in a blog post.

“If physicians can’t afford to administer a medicine, then they won’t and that means their patients won’t have access to them either,” Ms. Longo wrote.

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

An influential panel proposed capping Medicare Part B pay for some drugs, arguing this would remove financial incentives to use more costly medicines when there are less expensive equivalents.

Medical groups have objected to both this recommendation from the Medicare Payment Advisory Commission (MedPAC) and the panel’s underlying premise. MedPAC said financial as well as clinical factors can come into play in clinicians’ choices of drugs for patients.

In an interview, Christina Downey, MD, chair of the Government Affairs Committee of the American College of Rheumatology, said physicians in her field cannot switch patients’ medicines to try to make a profit.

“Patients only respond to the drugs that they respond to,” Dr. Downey said. “It’s frankly very insulting to say that physicians just force patients to go on medicines that are going to make them a bunch of money.”

In a June report to Congress, MedPAC recommended reducing the add-on payment for many drugs given in hospitals and clinics, which are thus covered by Part B, as part of a package of suggestions for addressing rising costs. Part B drug spending grew about 9% annually between 2009 and 2021, rising from $15.4 billion to $42.9 billion, MedPAC said.

Medicare’s current Part B drug pricing model starts with the reported average sales price (ASP) and then adds about 4.3% or 6%, depending on current budget-sequester law, to the cost of medicines.

MedPAC members voted 17-0 in April in favor of a general recommendation to revise the Part B payment approach. In the June report, MedPAC fleshes out this idea. It mentions a model in which the add-on Part B payment would be the lesser of either 6% of the ASP, 3% plus $24, or $220.

The majority of Part B drug administrations are for very low-priced drugs, MedPAC said. But for some of the more costly ones, annual prices can be more than $400,000 per patient, and future launch prices may be even higher for certain types of products, such as gene therapies, MedPAC said.

“There is no evidence that the costs of a drug’s administration are proportionate to the price of the drug,” MedPAC said.

Concerns about how well Medicare covers the cost of drug administration should be addressed through other pathways, such as the American Medical

Association’s Specialty Society Relative Value Scale Update Committee (RUC), MedPAC said. AMA’s RUC advises the Centers for Medicare & Medicaid Services on the physician fee schedule.

Congress is not obliged to act on or to even consider MedPAC’s work. In general, lawmakers and CMS often pay heed to the panel’s recommendations, sometimes incorporating them into new policy.

But this new MedPAC Part B recommendation has drawn strong opposition, similar to the response to a 2016 CMS plan to cut the Part B add-on payment. That plan, which CMS later abandoned, would have cut the markup on Part B drugs to 2.5% and added a flat fee to cover administration costs.
 

Why not focus on PBMs instead?

The timing of the MedPAC recommendation is poor, given that CMS already is trying to implement the Inflation Reduction Act and create a new system of direct Medicare drug price negotiations, as ordered by Congress, said Madelaine A. Feldman, MD, a rheumatologist based in New Orleans.

A better approach for lowering drug prices would be to focus more on the operations of pharmacy benefit managers (PBMs), said Dr. Feldman, who also is vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations. A pending bipartisan Senate bill, for example, would prohibit PBM compensation based on the price of a drug as a condition of entering into a contract with a Medicare Part D plan.

Congress needs to take steps to unlink the profits of PBMs from higher drug prices, Dr. Feldman said.

“Until that happens, we can put all the lipstick we want on this big pig, but it’s not going to really fix the problem,” she said.
 

Reduced pay for drugs acquired through 340B program?

In an interview about the new MedPAC proposal, Ted Okon, executive director of the Community Oncology Alliance, urged renewed attention to what he sees as unintended consequences of the 340B discount drug program.

Under this program, certain hospitals can acquire drugs at steeply reduced prices, but they are not obliged to share those discounts with patients. Hospitals that participate in the 340B program can gain funds when patients and their insurers, including Medicare, pay more for the medicines hospitals and other organizations acquired with the 340B discount. Hospitals say they use the money from the 340B program to expand resources in their communities.

But rapid growth of the program in recent years has led to questions, especially about the role of contract pharmacies that manage the program. Congress created the 340B program in 1992 as a workaround to then new rules on Medicaid drug coverage.

In 2021, participating hospitals and clinics and organizations purchased about $44 billion worth of medicines through the 340B drug program. This was an increase of 16% from the previous year, according to a report from the nonprofit Commonwealth Fund. The number of sites, including hospitals and pharmacies, enrolled in the 340B program rose from 8,100 in 2000 to 50,000 by 2020, the report said.

MedPAC in 2016 urged CMS to reduce the amount Medicare pays for drugs acquired through the 340B program. CMS did so during the Trump administration, a policy later defended by the Biden administration.

But the U.S. Supreme Court last year said Medicare erred in its approach to making this cut, as earlier reported. Federal law required that the Department of Health and Human Services conduct a survey to support such a step, and HHS did not do this, the court said. CMS thus was ordered to return Medicare to the ASP+6% payment model for drugs purchased through the 340B discount program.

In the June report, though, MedPAC stuck by its 2016 recommendation that Medicare reduce its payments for drugs purchased through the 340B discount program despite this setback.

“We continue to believe that this approach is appropriate, and the specific level of payment reduction could be considered further as newer data become available,” MedPAC said.
 

Hospital, PhRMA split

Hospitals would certainly contest any renewed bid by CMS to drop Medicare’s pay for drugs purchased through the 340B program. The American Hospital Association objected to the MedPAC proposal regarding the add-on payment in Part B drug pricing.

MedPAC commissioners discussed this idea at a January meeting, prompting a February letter from the AHA to the panel. Like Dr. Feldman, AHA said it would be “premature” to launch into a revision of Part B drug pricing while the impact of the IRA on drug prices was still unclear.

AHA also noted that a reduction in Part B drug reimbursement would “shift the responsibility for the rapid increase in drug prices away from drug manufacturers, and instead places the burden on hospitals and patients.”

But the AHA gave a much warmer reception to another proposal MedPAC considered this year and that it included in its June report, which is a plan to address the high cost of certain drugs of as yet unconfirmed clinical benefit.

In April, the AHA said it supports a move toward a “value-based approach” in certain cases in which first-in-class medicines are sold under U.S. Food and Drug Administration’s accelerated approvals. Medicare could then cap payment for such drugs that have excessively high launch prices and uncertain clinical benefit, AHA said.

In the June report, MedPAC recommended that Medicare be able to place such a limit on Part B payments in certain cases, including ones in which companies do not meet FDA deadlines for postmarketing confirmatory trials.

The Pharmaceutical Research and Manufacturers of America (PhRMA) objected to this proposed change. The trade group for drugmakers said the FDA often revises and extends enrollment milestones for pending confirmatory trials when companies hit snags, such as challenges in enrolling patients, PhRMA said.

Reducing Part B payment for drugs for which confirmatory trials have been delayed would have a “disproportionate impact” on smaller and rural communities, where independent practices struggle to keep their doors open as it is, PhRMA spokeswoman Nicole Longo wrote in a blog post.

“If physicians can’t afford to administer a medicine, then they won’t and that means their patients won’t have access to them either,” Ms. Longo wrote.

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

A panel of advisers to the Food and Drug Administration unanimously has agreed that the next COVID-19 vaccines should target the XBB variants of the SARS-CoV-2 virus now in circulation in the United States, but questioned whether the population as a whole needs booster shots and how often they should be given.

The Vaccines and Related Biological Products Advisory Committee of the FDA voted 21-0 in favor of the recommendation about the strain to be used in the next crop of vaccines.

In the briefing document for the meeting, FDA staff said the available evidence suggests that a monovalent (single-strain) XBB-lineage vaccine “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus and two strains from the Omicron variant.

FDA staff also noted how such a shift would be in line with the World Health Organization toward targeting the XBB family of subvariants. European regulators have done this as well. 

The FDA is not obligated to act on the panel’s recommendations. But the agency often does and is highly likely to do so in this case. Vaccine companies will need the recommendation from the FDA to begin making vaccines for the fall.
 

New shot every year?

The FDA asked its expert panel to vote only on the question about the makeup of future vaccines in terms of which strain to include. 

But panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual flu shots. 

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, argued for greater focus on the response of T cells after vaccination, even in light of the already recognized waning of antibody protection. 

In a recent Substack article, Dr. Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived,” and their “protection against severe disease often lasts for years and sometimes decades.”

Dr. Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the one now in place for influenza vaccines.

The Centers for Disease Control and Prevention recommends flu shots for everyone 6 months and older, with rare exceptions. 

“We need to continue to define who those high-risk groups are and not make this a recommendation for everybody every season,” he said.

Dr. Offit offered his own experience as an example. While he had been vaccinated against the virus’s early Wuhan strain, he still was infected, most likely with a variant that emerged later. 

“That was a drifted virus. That’s why I had a mild infection but I didn’t have a severe infection, because presumably I had T cells which prevented that severe infection, which may last for years,” Dr. Offit said.

Pfizer and Moderna, the two companies that make mRNA-based COVID vaccines, are working on experimental products meant to protect against both flu and SARS-COv-2 in one shot. Novavax, maker of a more traditional protein-based COVID shot, is doing the same. 

The idea of these combination products is to make it more convenient for people to protect against both viruses, while also offering companies some marketing advantages.

But without referring to these drugmakers’ plans for future combo flu-COVID shots, members of the FDA panel raised objections to an assumption of routine annual vaccines against variants of SARS-CoV-2. 

Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices. 

Bernstein questioned the approach of dubbing these the “2023-2024 formulas,” as this approach conveyed a sense of an expectation for a need for annual vaccines, as happens with flu. 

“It’s not clear to me that this is a seasonal virus yet,” said Dr. Bernstein, who is also a professor of pediatrics at Hofstra University, Hempstead, N.Y..

In response to Dr. Bernstein’s point, Arnold Monto, MD, the acting chair of the FDA panel, suggested such a pattern could emerge, while also agreeing that it’s too soon to say for sure.

A professor emeritus at the University of Michigan, Ann Arbor, Dr. Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.

“I think it’s premature to say that this virus will not become seasonal,” Dr. Monto said about SARS-CoV-2. “I agree. We’re not there yet, but we may be.”

At the end of the meeting, Dr. Monto recapped the meeting’s key points, noting that there was a general consensus that the XBB.1.5 subvariant would be the best to use in future COVID shots. 

He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, already have honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.

“The fact that most of the manufacturers are ready to work on an XBB 1.5 [vaccine] is an added reason to select this strain or this variant, given the immunologic data,” Dr. Monto said. 

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the demands involved in manufacturing vaccines tilts toward annual changes.

“Practically, we’re going to have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.

Dr. Marks questioned the panelists’ concerns about likening flu and COVID vaccination practices. The FDA staff’s intent was to try to help the public understand the need for follow-on vaccination.

“I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza. People understand a yearly influenza vaccine,” Dr. Marks said. 

And it’s not certain when another major change in the COVID virus will follow the XBB subvariant, but it’s likely one will – and soon, Dr. Marks said. 

“It looks like, probably by next fall, there’ll be further drift from this,” he said.
 

Informing the public 

Dr. Marks also stressed the need to better convey the benefits of vaccination to people in the United States. 

CDC data estimate that 70% of the U.S. population completed an initial series of the original monovalent vaccines, with only 17% then getting bivalent shots. There’s even a decline among people ages 65 and older. CDC estimates 94% of this group completed their primary series, but only 43% got the bivalent booster dose.

“We have to do better because we have not done a good job today communicating to the American public what’s going on here,” Marks said.

Researchers also are still trying to determine the best timing for people to get additional COVID shots. Finding the “sweet spot” where people can maximize additional protection is tricky, with people most protected if they happen to get shot near the beginning of an uptick in viral spread, the CDC’s Ruth Link-Gelles, PhD, MPH, told the panel during a presentation. 

“You’re going to get the best incremental benefit if it’s been longer since your last vaccine,” she said. “But of course, if you wait too long since your last vaccine, you’re left with very little protection, and so you’re at higher risk of severe illness.”

Like Dr. Marks, Dr. Link-Gelles stressed the need for persuading more people to get follow-on vaccines. 

“Most Americans, at this point, haven’t even received the bivalent and so are a year or more out from their monovalent dose and so have relatively little protection left,” she said.

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

A panel of advisers to the Food and Drug Administration unanimously has agreed that the next COVID-19 vaccines should target the XBB variants of the SARS-CoV-2 virus now in circulation in the United States, but questioned whether the population as a whole needs booster shots and how often they should be given.

The Vaccines and Related Biological Products Advisory Committee of the FDA voted 21-0 in favor of the recommendation about the strain to be used in the next crop of vaccines.

In the briefing document for the meeting, FDA staff said the available evidence suggests that a monovalent (single-strain) XBB-lineage vaccine “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus and two strains from the Omicron variant.

FDA staff also noted how such a shift would be in line with the World Health Organization toward targeting the XBB family of subvariants. European regulators have done this as well. 

The FDA is not obligated to act on the panel’s recommendations. But the agency often does and is highly likely to do so in this case. Vaccine companies will need the recommendation from the FDA to begin making vaccines for the fall.
 

New shot every year?

The FDA asked its expert panel to vote only on the question about the makeup of future vaccines in terms of which strain to include. 

But panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual flu shots. 

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, argued for greater focus on the response of T cells after vaccination, even in light of the already recognized waning of antibody protection. 

In a recent Substack article, Dr. Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived,” and their “protection against severe disease often lasts for years and sometimes decades.”

Dr. Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the one now in place for influenza vaccines.

The Centers for Disease Control and Prevention recommends flu shots for everyone 6 months and older, with rare exceptions. 

“We need to continue to define who those high-risk groups are and not make this a recommendation for everybody every season,” he said.

Dr. Offit offered his own experience as an example. While he had been vaccinated against the virus’s early Wuhan strain, he still was infected, most likely with a variant that emerged later. 

“That was a drifted virus. That’s why I had a mild infection but I didn’t have a severe infection, because presumably I had T cells which prevented that severe infection, which may last for years,” Dr. Offit said.

Pfizer and Moderna, the two companies that make mRNA-based COVID vaccines, are working on experimental products meant to protect against both flu and SARS-COv-2 in one shot. Novavax, maker of a more traditional protein-based COVID shot, is doing the same. 

The idea of these combination products is to make it more convenient for people to protect against both viruses, while also offering companies some marketing advantages.

But without referring to these drugmakers’ plans for future combo flu-COVID shots, members of the FDA panel raised objections to an assumption of routine annual vaccines against variants of SARS-CoV-2. 

Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices. 

Bernstein questioned the approach of dubbing these the “2023-2024 formulas,” as this approach conveyed a sense of an expectation for a need for annual vaccines, as happens with flu. 

“It’s not clear to me that this is a seasonal virus yet,” said Dr. Bernstein, who is also a professor of pediatrics at Hofstra University, Hempstead, N.Y..

In response to Dr. Bernstein’s point, Arnold Monto, MD, the acting chair of the FDA panel, suggested such a pattern could emerge, while also agreeing that it’s too soon to say for sure.

A professor emeritus at the University of Michigan, Ann Arbor, Dr. Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.

“I think it’s premature to say that this virus will not become seasonal,” Dr. Monto said about SARS-CoV-2. “I agree. We’re not there yet, but we may be.”

At the end of the meeting, Dr. Monto recapped the meeting’s key points, noting that there was a general consensus that the XBB.1.5 subvariant would be the best to use in future COVID shots. 

He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, already have honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.

“The fact that most of the manufacturers are ready to work on an XBB 1.5 [vaccine] is an added reason to select this strain or this variant, given the immunologic data,” Dr. Monto said. 

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the demands involved in manufacturing vaccines tilts toward annual changes.

“Practically, we’re going to have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.

Dr. Marks questioned the panelists’ concerns about likening flu and COVID vaccination practices. The FDA staff’s intent was to try to help the public understand the need for follow-on vaccination.

“I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza. People understand a yearly influenza vaccine,” Dr. Marks said. 

And it’s not certain when another major change in the COVID virus will follow the XBB subvariant, but it’s likely one will – and soon, Dr. Marks said. 

“It looks like, probably by next fall, there’ll be further drift from this,” he said.
 

Informing the public 

Dr. Marks also stressed the need to better convey the benefits of vaccination to people in the United States. 

CDC data estimate that 70% of the U.S. population completed an initial series of the original monovalent vaccines, with only 17% then getting bivalent shots. There’s even a decline among people ages 65 and older. CDC estimates 94% of this group completed their primary series, but only 43% got the bivalent booster dose.

“We have to do better because we have not done a good job today communicating to the American public what’s going on here,” Marks said.

Researchers also are still trying to determine the best timing for people to get additional COVID shots. Finding the “sweet spot” where people can maximize additional protection is tricky, with people most protected if they happen to get shot near the beginning of an uptick in viral spread, the CDC’s Ruth Link-Gelles, PhD, MPH, told the panel during a presentation. 

“You’re going to get the best incremental benefit if it’s been longer since your last vaccine,” she said. “But of course, if you wait too long since your last vaccine, you’re left with very little protection, and so you’re at higher risk of severe illness.”

Like Dr. Marks, Dr. Link-Gelles stressed the need for persuading more people to get follow-on vaccines. 

“Most Americans, at this point, haven’t even received the bivalent and so are a year or more out from their monovalent dose and so have relatively little protection left,” she said.

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

A panel of advisers to the Food and Drug Administration unanimously has agreed that the next COVID-19 vaccines should target the XBB variants of the SARS-CoV-2 virus now in circulation in the United States, but questioned whether the population as a whole needs booster shots and how often they should be given.

The Vaccines and Related Biological Products Advisory Committee of the FDA voted 21-0 in favor of the recommendation about the strain to be used in the next crop of vaccines.

In the briefing document for the meeting, FDA staff said the available evidence suggests that a monovalent (single-strain) XBB-lineage vaccine “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus and two strains from the Omicron variant.

FDA staff also noted how such a shift would be in line with the World Health Organization toward targeting the XBB family of subvariants. European regulators have done this as well. 

The FDA is not obligated to act on the panel’s recommendations. But the agency often does and is highly likely to do so in this case. Vaccine companies will need the recommendation from the FDA to begin making vaccines for the fall.
 

New shot every year?

The FDA asked its expert panel to vote only on the question about the makeup of future vaccines in terms of which strain to include. 

But panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual flu shots. 

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, argued for greater focus on the response of T cells after vaccination, even in light of the already recognized waning of antibody protection. 

In a recent Substack article, Dr. Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived,” and their “protection against severe disease often lasts for years and sometimes decades.”

Dr. Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the one now in place for influenza vaccines.

The Centers for Disease Control and Prevention recommends flu shots for everyone 6 months and older, with rare exceptions. 

“We need to continue to define who those high-risk groups are and not make this a recommendation for everybody every season,” he said.

Dr. Offit offered his own experience as an example. While he had been vaccinated against the virus’s early Wuhan strain, he still was infected, most likely with a variant that emerged later. 

“That was a drifted virus. That’s why I had a mild infection but I didn’t have a severe infection, because presumably I had T cells which prevented that severe infection, which may last for years,” Dr. Offit said.

Pfizer and Moderna, the two companies that make mRNA-based COVID vaccines, are working on experimental products meant to protect against both flu and SARS-COv-2 in one shot. Novavax, maker of a more traditional protein-based COVID shot, is doing the same. 

The idea of these combination products is to make it more convenient for people to protect against both viruses, while also offering companies some marketing advantages.

But without referring to these drugmakers’ plans for future combo flu-COVID shots, members of the FDA panel raised objections to an assumption of routine annual vaccines against variants of SARS-CoV-2. 

Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices. 

Bernstein questioned the approach of dubbing these the “2023-2024 formulas,” as this approach conveyed a sense of an expectation for a need for annual vaccines, as happens with flu. 

“It’s not clear to me that this is a seasonal virus yet,” said Dr. Bernstein, who is also a professor of pediatrics at Hofstra University, Hempstead, N.Y..

In response to Dr. Bernstein’s point, Arnold Monto, MD, the acting chair of the FDA panel, suggested such a pattern could emerge, while also agreeing that it’s too soon to say for sure.

A professor emeritus at the University of Michigan, Ann Arbor, Dr. Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.

“I think it’s premature to say that this virus will not become seasonal,” Dr. Monto said about SARS-CoV-2. “I agree. We’re not there yet, but we may be.”

At the end of the meeting, Dr. Monto recapped the meeting’s key points, noting that there was a general consensus that the XBB.1.5 subvariant would be the best to use in future COVID shots. 

He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, already have honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.

“The fact that most of the manufacturers are ready to work on an XBB 1.5 [vaccine] is an added reason to select this strain or this variant, given the immunologic data,” Dr. Monto said. 

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the demands involved in manufacturing vaccines tilts toward annual changes.

“Practically, we’re going to have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.

Dr. Marks questioned the panelists’ concerns about likening flu and COVID vaccination practices. The FDA staff’s intent was to try to help the public understand the need for follow-on vaccination.

“I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza. People understand a yearly influenza vaccine,” Dr. Marks said. 

And it’s not certain when another major change in the COVID virus will follow the XBB subvariant, but it’s likely one will – and soon, Dr. Marks said. 

“It looks like, probably by next fall, there’ll be further drift from this,” he said.
 

Informing the public 

Dr. Marks also stressed the need to better convey the benefits of vaccination to people in the United States. 

CDC data estimate that 70% of the U.S. population completed an initial series of the original monovalent vaccines, with only 17% then getting bivalent shots. There’s even a decline among people ages 65 and older. CDC estimates 94% of this group completed their primary series, but only 43% got the bivalent booster dose.

“We have to do better because we have not done a good job today communicating to the American public what’s going on here,” Marks said.

Researchers also are still trying to determine the best timing for people to get additional COVID shots. Finding the “sweet spot” where people can maximize additional protection is tricky, with people most protected if they happen to get shot near the beginning of an uptick in viral spread, the CDC’s Ruth Link-Gelles, PhD, MPH, told the panel during a presentation. 

“You’re going to get the best incremental benefit if it’s been longer since your last vaccine,” she said. “But of course, if you wait too long since your last vaccine, you’re left with very little protection, and so you’re at higher risk of severe illness.”

Like Dr. Marks, Dr. Link-Gelles stressed the need for persuading more people to get follow-on vaccines. 

“Most Americans, at this point, haven’t even received the bivalent and so are a year or more out from their monovalent dose and so have relatively little protection left,” she said.

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