Dermatology News

When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.

“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.

The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.

While Sartain said he trusted his carrier-provided attorney, he would have considered hiring his own attorney as well if a criminal issue was also alleged.

“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
 

How Medical Board and Malpractice Insurer Investigations Differ

Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.

When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.

Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.

When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.

The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.

Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.

Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.

“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.

If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.

Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.

If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.
 

Who Is Your Attorney Really Working for?

The doctor should understand whose interests the attorney represents. In a medical board claim, the attorney — even if defense is paid by the carrier — represents the doctor.

Frisella said her organization provides pass-through coverage, meaning it reimburses the doctor for medical board defense costs. “Because the carrier isn’t directing the medical board defense, it is not generally privy to the work product.”

If a patient files a malpractice claim, however, the attorney ultimately represents the insurance company.

“The panel counsel who works for the insurer does not work for the doctor, and that’s always important to remember,” Keoskey said. While the attorney will do their best to aggressively defend the doctor, “he’s going to protect the insurer’s interest before the doctor’s.”

Physicians who find any conflict of interest with their insurer should seek counsel.

Such conflicts could include:

• Disagreements over the case’s ultimate worth. For example, a physician might want a case to settle for less than their carrier is willing to pay.
• The legal judgment may exceed the carrier’s policy limits, or there are punitive damages or allegations of criminal acts that the insurer does not cover.

In these cases, the insurance company should recommend the doctor get personal counsel. They will send a reservation of rights letter saying they will defend the doctor for now, but if the facts show the doctor committed some type of misconduct, they may decline coverage, said Keoskey. Some states, including California, require that the carrier pay for this independent counsel.

Unless there is a conflict of interest, though, having a personal attorney just makes the situation more complicated, said Frisella.

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

When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.

“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.

The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.

While Sartain said he trusted his carrier-provided attorney, he would have considered hiring his own attorney as well if a criminal issue was also alleged.

“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
 

How Medical Board and Malpractice Insurer Investigations Differ

Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.

When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.

Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.

When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.

The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.

Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.

Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.

“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.

If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.

Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.

If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.
 

Who Is Your Attorney Really Working for?

The doctor should understand whose interests the attorney represents. In a medical board claim, the attorney — even if defense is paid by the carrier — represents the doctor.

Frisella said her organization provides pass-through coverage, meaning it reimburses the doctor for medical board defense costs. “Because the carrier isn’t directing the medical board defense, it is not generally privy to the work product.”

If a patient files a malpractice claim, however, the attorney ultimately represents the insurance company.

“The panel counsel who works for the insurer does not work for the doctor, and that’s always important to remember,” Keoskey said. While the attorney will do their best to aggressively defend the doctor, “he’s going to protect the insurer’s interest before the doctor’s.”

Physicians who find any conflict of interest with their insurer should seek counsel.

Such conflicts could include:

• Disagreements over the case’s ultimate worth. For example, a physician might want a case to settle for less than their carrier is willing to pay.
• The legal judgment may exceed the carrier’s policy limits, or there are punitive damages or allegations of criminal acts that the insurer does not cover.

In these cases, the insurance company should recommend the doctor get personal counsel. They will send a reservation of rights letter saying they will defend the doctor for now, but if the facts show the doctor committed some type of misconduct, they may decline coverage, said Keoskey. Some states, including California, require that the carrier pay for this independent counsel.

Unless there is a conflict of interest, though, having a personal attorney just makes the situation more complicated, said Frisella.

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

When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.

“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.

The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.

While Sartain said he trusted his carrier-provided attorney, he would have considered hiring his own attorney as well if a criminal issue was also alleged.

“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
 

How Medical Board and Malpractice Insurer Investigations Differ

Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.

When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.

Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.

When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.

The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.

Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.

Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.

“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.

If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.

Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.

If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.
 

Who Is Your Attorney Really Working for?

The doctor should understand whose interests the attorney represents. In a medical board claim, the attorney — even if defense is paid by the carrier — represents the doctor.

Frisella said her organization provides pass-through coverage, meaning it reimburses the doctor for medical board defense costs. “Because the carrier isn’t directing the medical board defense, it is not generally privy to the work product.”

If a patient files a malpractice claim, however, the attorney ultimately represents the insurance company.

“The panel counsel who works for the insurer does not work for the doctor, and that’s always important to remember,” Keoskey said. While the attorney will do their best to aggressively defend the doctor, “he’s going to protect the insurer’s interest before the doctor’s.”

Physicians who find any conflict of interest with their insurer should seek counsel.

Such conflicts could include:

• Disagreements over the case’s ultimate worth. For example, a physician might want a case to settle for less than their carrier is willing to pay.
• The legal judgment may exceed the carrier’s policy limits, or there are punitive damages or allegations of criminal acts that the insurer does not cover.

In these cases, the insurance company should recommend the doctor get personal counsel. They will send a reservation of rights letter saying they will defend the doctor for now, but if the facts show the doctor committed some type of misconduct, they may decline coverage, said Keoskey. Some states, including California, require that the carrier pay for this independent counsel.

Unless there is a conflict of interest, though, having a personal attorney just makes the situation more complicated, said Frisella.

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

While a medical peer review occurs once a patient, fellow doctor, or staff member reports that a physician failed to treat a patient up to standards or acted improperly, a “sham peer review” is undertaken for ulterior motives.

Sham peer reviews can be used to attack a doctor for unrelated professional, personal, or nonmedical reasons; intimidate, silence, or target a physician; or to carry out a personal vendetta. They’re typically undertaken due to professional competition or institutional politics rather than to promote quality care or uphold professional standards.

Physicians should be concerned. In a soon-to-be-published Medscape report on peer reviews, 56% of US physicians surveyed expressed higher levels of concern that a peer review could be misused to punish a physician for reasons unrelated to the matter being reviewed.

This is a troublesome issue, and many doctors may not be aware of it or how often it occurs.

“The biggest misconception about sham peer reviews is a denial of how pervasive they are,” said Andy Schlafly, general counsel for the Association of American Physicians and Surgeons (AAPS), which offers a free legal consultation service for physicians facing a sham peer review. “Many hospital administrations are as dangerous to good physicians as street gangs can be in a crime-ridden neighborhood.”

“Physicians should become aware of whether sham peer reviews are prevalent at their hospital and, if so, those physicians should look to practice somewhere else,” Schlafly said in an interview.

Unfortunately, there are limited data on how often this happens. When it does, it can be a career killer, said Lawrence Huntoon, MD, PhD, who has run the AAPS sham peer review hotline for over 20 years.

The physicians at the most risk for a sham peer review tend to be those who work for large hospital systems — as this is one way for hospitals to get rid of the doctors they don’t want to retain on staff, Huntoon said.

“Hospitals want a model whereby every physician on the medical staff is an employee,” Huntoon added. “This gives them complete power and control over these physicians, including the way they practice and how many patients they see per day, which, for some, is 20-50 a day to generate sufficient revenue.”

Complaints are generally filed via incident reporting software.

“The complaint could be that the physician is ‘disruptive,’ which can include facial expression, tone of voice, and body language — for example, ‘I found his facial expression demeaning’ or ‘I found her tone condescending’ — and this can be used to prosecute a doctor,” Huntoon said.

After the complaint is filed, the leaders of a hospital’s peer review committee meet to discuss the incident, followed by a panel of fellow physicians convened to review the matter. Once the date for a meeting is set, the accused doctor is allowed to testify, offer evidence, and have attorney representation.

The entire experience can take a physician by surprise.

“A sham peer review is difficult to prepare for because no physician thinks this is going to happen to them,” said Laurie L. York, a medical law attorney in Austin, Texas.

York added that there may also be a misperception of what is actually happening.

“When a physician becomes aware of an investigation, it initially may look like a regular peer review, and the physician may feel there has been a ‘misunderstanding’ that they can make right by explaining things,” York said. “The window of opportunity to shut down a sham peer review happens quickly. That’s why the physician needs the help of an experienced attorney as early in the process as possible.”
 

If You’re a Victim of a Sham Peer Review

Be vigilant. The most important thing you should think about when it comes to sham peer reviews is that this can, indeed, happen to you, Huntoon said. “I’ve written articles to help educate physicians about the tactics that are used,” he said. “You need to be educated and read medical staff bylaws to know your rights before something bad happens.”

Stay in your job. No matter what, if you’re under review, do not resign your position, no matter how difficult this may be. “A resignation during a sham peer review triggers an adverse report to the National Practitioner Data Bank [NPDB],” Schlafly said. The NPDB is a flagging system created by Congress to improve healthcare quality and reduce healthcare fraud and abuse. “A resignation also waives the physician’s right to contest the unfair review. In addition, leverage to negotiate a favorable settlement is lost if the physician simply resigns.”

Get a lawyer on board early. This is the only way to protect your rights. “Don’t wait a year to get an attorney involved,” Huntoon said. But this also can’t be any lawyer. It’s critical to find someone who specializes in sham peer reviews, so be sure to ask about their experience in handling peer review matters in hospitals and how knowledgeable they are about databank reporting requirements. “Sometimes, doctors will hire a malpractice attorney with no knowledge of what happens with sham peer reviews, and they may give bad advice,” he said. “Others may hire an employment attorney and that attorney will be up on employment law but has no experience with peer review matters in hospitals.”

Given the seriousness of a sham peer review, following these guidelines can help.

Contact the AAPA right away. There are things that can be done early on like getting a withdrawal of the request for corrective action as well as obtaining a preliminary injunction. Preparing for the fallout that may occur can be just as challenging.

“After this situation, the doctor is damaged goods,” Huntoon said. “What hospital will want to hire damaged goods to be part of their medical staff? Finding employment is going to be challenging and opening your own practice may also be difficult because the insurers have access to data bank reports.”

Ultimately, the best advice Huntoon can offer is to do your best to stay one step ahead of any work issues that could even lead to a sham peer review.

“Try and shield yourself from a sham peer review and be prepared should it happen,” he said. “I’ve seen careers end in the blink of an eye — wrongfully.”

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

While a medical peer review occurs once a patient, fellow doctor, or staff member reports that a physician failed to treat a patient up to standards or acted improperly, a “sham peer review” is undertaken for ulterior motives.

Sham peer reviews can be used to attack a doctor for unrelated professional, personal, or nonmedical reasons; intimidate, silence, or target a physician; or to carry out a personal vendetta. They’re typically undertaken due to professional competition or institutional politics rather than to promote quality care or uphold professional standards.

Physicians should be concerned. In a soon-to-be-published Medscape report on peer reviews, 56% of US physicians surveyed expressed higher levels of concern that a peer review could be misused to punish a physician for reasons unrelated to the matter being reviewed.

This is a troublesome issue, and many doctors may not be aware of it or how often it occurs.

“The biggest misconception about sham peer reviews is a denial of how pervasive they are,” said Andy Schlafly, general counsel for the Association of American Physicians and Surgeons (AAPS), which offers a free legal consultation service for physicians facing a sham peer review. “Many hospital administrations are as dangerous to good physicians as street gangs can be in a crime-ridden neighborhood.”

“Physicians should become aware of whether sham peer reviews are prevalent at their hospital and, if so, those physicians should look to practice somewhere else,” Schlafly said in an interview.

Unfortunately, there are limited data on how often this happens. When it does, it can be a career killer, said Lawrence Huntoon, MD, PhD, who has run the AAPS sham peer review hotline for over 20 years.

The physicians at the most risk for a sham peer review tend to be those who work for large hospital systems — as this is one way for hospitals to get rid of the doctors they don’t want to retain on staff, Huntoon said.

“Hospitals want a model whereby every physician on the medical staff is an employee,” Huntoon added. “This gives them complete power and control over these physicians, including the way they practice and how many patients they see per day, which, for some, is 20-50 a day to generate sufficient revenue.”

Complaints are generally filed via incident reporting software.

“The complaint could be that the physician is ‘disruptive,’ which can include facial expression, tone of voice, and body language — for example, ‘I found his facial expression demeaning’ or ‘I found her tone condescending’ — and this can be used to prosecute a doctor,” Huntoon said.

After the complaint is filed, the leaders of a hospital’s peer review committee meet to discuss the incident, followed by a panel of fellow physicians convened to review the matter. Once the date for a meeting is set, the accused doctor is allowed to testify, offer evidence, and have attorney representation.

The entire experience can take a physician by surprise.

“A sham peer review is difficult to prepare for because no physician thinks this is going to happen to them,” said Laurie L. York, a medical law attorney in Austin, Texas.

York added that there may also be a misperception of what is actually happening.

“When a physician becomes aware of an investigation, it initially may look like a regular peer review, and the physician may feel there has been a ‘misunderstanding’ that they can make right by explaining things,” York said. “The window of opportunity to shut down a sham peer review happens quickly. That’s why the physician needs the help of an experienced attorney as early in the process as possible.”
 

If You’re a Victim of a Sham Peer Review

Be vigilant. The most important thing you should think about when it comes to sham peer reviews is that this can, indeed, happen to you, Huntoon said. “I’ve written articles to help educate physicians about the tactics that are used,” he said. “You need to be educated and read medical staff bylaws to know your rights before something bad happens.”

Stay in your job. No matter what, if you’re under review, do not resign your position, no matter how difficult this may be. “A resignation during a sham peer review triggers an adverse report to the National Practitioner Data Bank [NPDB],” Schlafly said. The NPDB is a flagging system created by Congress to improve healthcare quality and reduce healthcare fraud and abuse. “A resignation also waives the physician’s right to contest the unfair review. In addition, leverage to negotiate a favorable settlement is lost if the physician simply resigns.”

Get a lawyer on board early. This is the only way to protect your rights. “Don’t wait a year to get an attorney involved,” Huntoon said. But this also can’t be any lawyer. It’s critical to find someone who specializes in sham peer reviews, so be sure to ask about their experience in handling peer review matters in hospitals and how knowledgeable they are about databank reporting requirements. “Sometimes, doctors will hire a malpractice attorney with no knowledge of what happens with sham peer reviews, and they may give bad advice,” he said. “Others may hire an employment attorney and that attorney will be up on employment law but has no experience with peer review matters in hospitals.”

Given the seriousness of a sham peer review, following these guidelines can help.

Contact the AAPA right away. There are things that can be done early on like getting a withdrawal of the request for corrective action as well as obtaining a preliminary injunction. Preparing for the fallout that may occur can be just as challenging.

“After this situation, the doctor is damaged goods,” Huntoon said. “What hospital will want to hire damaged goods to be part of their medical staff? Finding employment is going to be challenging and opening your own practice may also be difficult because the insurers have access to data bank reports.”

Ultimately, the best advice Huntoon can offer is to do your best to stay one step ahead of any work issues that could even lead to a sham peer review.

“Try and shield yourself from a sham peer review and be prepared should it happen,” he said. “I’ve seen careers end in the blink of an eye — wrongfully.”

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

While a medical peer review occurs once a patient, fellow doctor, or staff member reports that a physician failed to treat a patient up to standards or acted improperly, a “sham peer review” is undertaken for ulterior motives.

Sham peer reviews can be used to attack a doctor for unrelated professional, personal, or nonmedical reasons; intimidate, silence, or target a physician; or to carry out a personal vendetta. They’re typically undertaken due to professional competition or institutional politics rather than to promote quality care or uphold professional standards.

Physicians should be concerned. In a soon-to-be-published Medscape report on peer reviews, 56% of US physicians surveyed expressed higher levels of concern that a peer review could be misused to punish a physician for reasons unrelated to the matter being reviewed.

This is a troublesome issue, and many doctors may not be aware of it or how often it occurs.

“The biggest misconception about sham peer reviews is a denial of how pervasive they are,” said Andy Schlafly, general counsel for the Association of American Physicians and Surgeons (AAPS), which offers a free legal consultation service for physicians facing a sham peer review. “Many hospital administrations are as dangerous to good physicians as street gangs can be in a crime-ridden neighborhood.”

“Physicians should become aware of whether sham peer reviews are prevalent at their hospital and, if so, those physicians should look to practice somewhere else,” Schlafly said in an interview.

Unfortunately, there are limited data on how often this happens. When it does, it can be a career killer, said Lawrence Huntoon, MD, PhD, who has run the AAPS sham peer review hotline for over 20 years.

The physicians at the most risk for a sham peer review tend to be those who work for large hospital systems — as this is one way for hospitals to get rid of the doctors they don’t want to retain on staff, Huntoon said.

“Hospitals want a model whereby every physician on the medical staff is an employee,” Huntoon added. “This gives them complete power and control over these physicians, including the way they practice and how many patients they see per day, which, for some, is 20-50 a day to generate sufficient revenue.”

Complaints are generally filed via incident reporting software.

“The complaint could be that the physician is ‘disruptive,’ which can include facial expression, tone of voice, and body language — for example, ‘I found his facial expression demeaning’ or ‘I found her tone condescending’ — and this can be used to prosecute a doctor,” Huntoon said.

After the complaint is filed, the leaders of a hospital’s peer review committee meet to discuss the incident, followed by a panel of fellow physicians convened to review the matter. Once the date for a meeting is set, the accused doctor is allowed to testify, offer evidence, and have attorney representation.

The entire experience can take a physician by surprise.

“A sham peer review is difficult to prepare for because no physician thinks this is going to happen to them,” said Laurie L. York, a medical law attorney in Austin, Texas.

York added that there may also be a misperception of what is actually happening.

“When a physician becomes aware of an investigation, it initially may look like a regular peer review, and the physician may feel there has been a ‘misunderstanding’ that they can make right by explaining things,” York said. “The window of opportunity to shut down a sham peer review happens quickly. That’s why the physician needs the help of an experienced attorney as early in the process as possible.”
 

If You’re a Victim of a Sham Peer Review

Be vigilant. The most important thing you should think about when it comes to sham peer reviews is that this can, indeed, happen to you, Huntoon said. “I’ve written articles to help educate physicians about the tactics that are used,” he said. “You need to be educated and read medical staff bylaws to know your rights before something bad happens.”

Stay in your job. No matter what, if you’re under review, do not resign your position, no matter how difficult this may be. “A resignation during a sham peer review triggers an adverse report to the National Practitioner Data Bank [NPDB],” Schlafly said. The NPDB is a flagging system created by Congress to improve healthcare quality and reduce healthcare fraud and abuse. “A resignation also waives the physician’s right to contest the unfair review. In addition, leverage to negotiate a favorable settlement is lost if the physician simply resigns.”

Get a lawyer on board early. This is the only way to protect your rights. “Don’t wait a year to get an attorney involved,” Huntoon said. But this also can’t be any lawyer. It’s critical to find someone who specializes in sham peer reviews, so be sure to ask about their experience in handling peer review matters in hospitals and how knowledgeable they are about databank reporting requirements. “Sometimes, doctors will hire a malpractice attorney with no knowledge of what happens with sham peer reviews, and they may give bad advice,” he said. “Others may hire an employment attorney and that attorney will be up on employment law but has no experience with peer review matters in hospitals.”

Given the seriousness of a sham peer review, following these guidelines can help.

Contact the AAPA right away. There are things that can be done early on like getting a withdrawal of the request for corrective action as well as obtaining a preliminary injunction. Preparing for the fallout that may occur can be just as challenging.

“After this situation, the doctor is damaged goods,” Huntoon said. “What hospital will want to hire damaged goods to be part of their medical staff? Finding employment is going to be challenging and opening your own practice may also be difficult because the insurers have access to data bank reports.”

Ultimately, the best advice Huntoon can offer is to do your best to stay one step ahead of any work issues that could even lead to a sham peer review.

“Try and shield yourself from a sham peer review and be prepared should it happen,” he said. “I’ve seen careers end in the blink of an eye — wrongfully.”

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

A member of the Elaeagnaceae family, Hippophae rhamnoides, better known as sea buckthorn, is a high-altitude wild shrub endemic to Europe and Asia with edible fruits and a lengthy record of use in traditional Chinese medicine.^1-6 Used as a health supplement and consumed in the diet throughout the world,⁵ sea buckthorn berries, seeds, and leaves have been used in traditional medicine to treat burns/injuries, edema, hypertension, inflammation, skin grafts, ulcers, and wounds.^4,7

This hardy plant is associated with a wide range of biologic activities, including anti-atherogenic, anti-atopic dermatitis, antibacterial, anticancer, antifungal, anti-inflammatory, antimicrobial, antioxidant, anti-psoriasis, anti-sebum, anti-stress, anti-tumor, cytoprotective, hepatoprotective, immunomodulatory, neuroprotective, radioprotective, and tissue regenerative functions.^4,5,8-11Sea buckthorn has also been included in several cosmeceutical formulations to treat wrinkles, scars, pigmentary conditions, and hair disorders, as well as to rejuvenate, even, and smooth the skin.⁴

Indre Brazauskaite/EyeEm/Getty Images

Key Constituents

Functional constituents identified in sea buckthorn include alkaloids, carotenoids, flavonoids, lignans, organic acids, phenolic acids, proanthocyanidins, polyunsaturated acids (including omega-3, -6, -7, and -9), steroids, tannins, terpenoids, and volatile oils, as well as nutritional compounds such as minerals, proteins, and vitamins.^4,5,11 Sea buckthorn pericarp oil contains copious amounts of saturated palmitic acid (29%-36%) and omega-7 unsaturated palmitoleic acid (36%-48%), which fosters cutaneous and mucosal epithelialization, as well as linoleic (10%-12%) and oleic (4%-6%) acids.^12,6 Significant amounts of carotenoids as well as alpha‐linolenic fatty acid (38%), linoleic (36%), oleic (13%), and palmitic (7%) acids are present in sea buckthorn seed oil.⁶

Polysaccharides

In an expansive review on the pharmacological activities of sea buckthorn polysaccharides, Teng and colleagues reported in April 2024 that 20 diverse polysaccharides have been culled from sea buckthorn and exhibited various healthy activities, including antioxidant, anti-fatigue, anti-inflammatory, anti-obesity, anti-tumor, hepatoprotective, hypoglycemic, and immunoregulation, and regulation of intestinal flora activities.¹

Proanthocyanidins and Anti-Aging

In 2023, Liu and colleagues investigated the anti–skin aging impact of sea buckthorn proanthocyanidins in D-galactose-induced aging in mice given the known free radical scavenging activity of these compounds. They found the proanthocyanidins mitigated D-galactose-induced aging and can augment the total antioxidant capacity of the body. Sea buckthorn proanthocyanidins can further attenuate the effects of skin aging by regulating the TGF-beta¹/Smads pathway and MMPs/TIMP system, thus amplifying collagen I and tropoelastin content.¹³

Baumann Cosmetic & Research Institute

A year earlier, many of the same investigators assessed the possible protective activity of sea buckthorn proanthocyanidins against cutaneous aging engendered by oxidative stress from hydrogen peroxide. The compounds amplified superoxide dismutase and glutathione antioxidant functions. The extracts also fostered collagen I production in aging human skin fibroblasts via the TGF-beta1/Smads pathway and hindered collagen I degradation by regulating the MMPs/TIMPs system, which maintained extracellular matrix integrity. Senescent cell migration was also promoted with 100 mcg/mL of sea buckthorn proanthocyanidins. The researchers concluded that this sets the stage for investigating how sea buckthorn proanthocyanidins can be incorporated in cosmetic formulations.14 In a separate study, Liu and colleagues demonstrated that sea buckthorn proanthocyanidins can attenuate oxidative damage and protect mitochondrial function.⁹

Acne and Barrier Functions

The extracts of H rhamnoides and Cassia fistula in a combined formulation were found to be effective in lowering skin sebum content in humans with grade I and grade II acne vulgaris in a 2014 single-blind, randomized, placebo-controlled, split-face study with two groups of 25 patients each (aged 18-37 years).¹⁵ Khan and colleagues have also reported that a sea buckthorn oil-in-water emulsion improved barrier function in human skin as tested by a tewameter and corneometer (noninvasive probes) in 13 healthy males with a mean age of 27 ± 4.8 years.¹⁶

Anti-Aging, Antioxidant, Antibacterial, Skin-Whitening Activity

Zaman and colleagues reported in 2011 that results from an in vivo study of the effects of a sea buckthorn fruit extract topical cream on stratum corneum water content and transepidermal water loss indicated that the formulation enhanced cell surface integrin expression thus facilitating collagen contraction.¹⁷

In 2012, Khan and colleagues reported amelioration in skin elasticity, thus achieving an anti-aging result, from the use of a water-in-oil–based hydroalcoholic cream loaded with fruit extract of H rhamnoides, as measured with a Cutometer.¹⁸ The previous year, some of the same researchers reported that the antioxidants and flavonoids found in a topical sea buckthorn formulation could decrease cutaneous melanin and erythema levels.

More recently, Gęgotek and colleagues found that sea buckthorn seed oil prevented redox balance and lipid metabolism disturbances in skin fibroblasts and keratinocytes caused by UVA or UVB. They suggested that such findings point to the potential of this natural agent to confer anti-inflammatory properties and photoprotection to the skin.¹⁹

In 2020, Ivanišová and colleagues investigated the antioxidant and antimicrobial activities of H rhamnoides 100% oil, 100% juice, dry berries, and tea (dry berries, leaves, and twigs). They found that all of the studied sea buckthorn products displayed high antioxidant activity (identified through DPPH radical scavenging and molybdenum reducing antioxidant power tests). Sea buckthorn juice contained the highest total content of polyphenols, flavonoids, and carotenoids. All of the tested products also exhibited substantial antibacterial activity against the tested microbes.²⁰

Burns and Wound Healing

In a preclinical study of the effects of sea buckthorn leaf extracts on wound healing in albino rats using an excision-punch wound model in 2005, Gupta and colleagues found that twice daily topical application of the aqueous leaf extract fostered wound healing. This was indicated by higher hydroxyproline and protein levels, a diminished wound area, and lower lipid peroxide levels. The investigators suggested that sea buckthorn may facilitate wound healing at least in part because of elevated antioxidant activity in the granulation tissue.³

A year later, Wang and colleagues reported on observations of using H rhamnoides oil, a traditional Chinese herbal medicine derived from sea buckthorn fruit, as a burn treatment. In the study, 151 burn patients received an H rhamnoides oil dressing (changed every other day until wound healing) that was covered with a disinfecting dressing. The dressing reduced swelling and effusion, and alleviated pain, with patients receiving the sea buckthorn dressing experiencing greater apparent exudation reduction, pain reduction, and more rapid epithelial cell growth and wound healing than controls (treated only with Vaseline gauze). The difference between the two groups was statistically significant.²¹

Conclusion

Sea buckthorn has been used for hundreds if not thousands of years in traditional medical applications, including for dermatologic purposes. Emerging data appear to support the use of this dynamic plant for consideration in dermatologic applications. As is often the case, much more work is necessary in the form of randomized controlled trials to determine the effectiveness of sea buckthorn formulations as well as the most appropriate avenues of research or uses for dermatologic application of this traditionally used botanical agent.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as a e-commerce solution. Write to her at [email protected].

References

1. Teng H et al. J Ethnopharmacol. 2024 Apr 24;324:117809. doi: 10.1016/j.jep.2024.117809.

2. Wang Z et al. Int J Biol Macromol. 2024 Apr;263(Pt 1):130206. doi: 10.1016/j.ijbiomac.2024.130206.

3. Gupta A et al. Int J Low Extrem Wounds. 2005 Jun;4(2):88-92. doi: 10.1177/1534734605277401.

4. Pundir S et al. J Ethnopharmacol. 2021 Feb 10;266:113434. doi: 10.1016/j.jep.2020.113434.

5. Ma QG et al. J Agric Food Chem. 2023 Mar 29;71(12):4769-4788. doi: 10.1021/acs.jafc.2c06916.

6. Poljšak N et al. Phytother Res. 2020 Feb;34(2):254-269. doi: 10.1002/ptr.6524. doi: 10.1002/ptr.6524.

7. Upadhyay NK et al. Evid Based Complement Alternat Med. 2011;2011:659705. doi: 10.1093/ecam/nep189.

8. Suryakumar G, Gupta A. J Ethnopharmacol. 2011 Nov 18;138(2):268-78. doi: 10.1016/j.jep.2011.09.024.

9. Liu K et al. Front Pharmacol. 2022 Jul 8;13:914146. doi: 10.3389/fphar.2022.914146.

10. Akhtar N et al. J Pharm Bioallied Sci. 2010 Jan;2(1):13-7. doi: 10.4103/0975-7406.62698.

11. Ren R et al. RSC Adv. 2020 Dec 17;10(73):44654-44671. doi: 10.1039/d0ra06488b.

12. Ito H et al. Burns. 2014 May;40(3):511-9. doi: 10.1016/j.burns.2013.08.011.

13. Liu X et al. Food Sci Nutr. 2023 Dec 7;12(2):1082-1094. doi: 10.1002/fsn3.3823.

14. Liu X at al. Antioxidants (Basel). 2022 Sep 25;11(10):1900. doi: 10.3390/antiox11101900.

15. Khan BA, Akhtar N. Postepy Dermatol Alergol. 2014 Aug;31(4):229-234. doi: 10.5114/pdia.2014.40934.

16. Khan BA, Akhtar N. Pak J Pharm Sci. 2014 Nov;27(6):1919-22.

17. Khan AB et al. African J Pharm Pharmacol. 2011 Aug;5(8):1092-5.

18. Khan BA, Akhtar N, Braga VA. Trop J Pharm Res. 2012;11(6):955-62.

19. Gęgotek A et al. Antioxidants (Basel). 2018 Aug 23;7(9):110. doi: 10.3390/antiox7090110.

20. Ivanišová E et al. Acta Sci Pol Technol Aliment. 2020 Apr-Jun;19(2):195-205. doi: 10.17306/J.AFS.0809.

21. Wang ZY, Luo XL, He CP. Nan Fang Yi Ke Da Xue Xue Bao. 2006 Jan;26(1):124-5.

A member of the Elaeagnaceae family, Hippophae rhamnoides, better known as sea buckthorn, is a high-altitude wild shrub endemic to Europe and Asia with edible fruits and a lengthy record of use in traditional Chinese medicine.^1-6 Used as a health supplement and consumed in the diet throughout the world,⁵ sea buckthorn berries, seeds, and leaves have been used in traditional medicine to treat burns/injuries, edema, hypertension, inflammation, skin grafts, ulcers, and wounds.^4,7

This hardy plant is associated with a wide range of biologic activities, including anti-atherogenic, anti-atopic dermatitis, antibacterial, anticancer, antifungal, anti-inflammatory, antimicrobial, antioxidant, anti-psoriasis, anti-sebum, anti-stress, anti-tumor, cytoprotective, hepatoprotective, immunomodulatory, neuroprotective, radioprotective, and tissue regenerative functions.^4,5,8-11Sea buckthorn has also been included in several cosmeceutical formulations to treat wrinkles, scars, pigmentary conditions, and hair disorders, as well as to rejuvenate, even, and smooth the skin.⁴

Indre Brazauskaite/EyeEm/Getty Images

Key Constituents

Functional constituents identified in sea buckthorn include alkaloids, carotenoids, flavonoids, lignans, organic acids, phenolic acids, proanthocyanidins, polyunsaturated acids (including omega-3, -6, -7, and -9), steroids, tannins, terpenoids, and volatile oils, as well as nutritional compounds such as minerals, proteins, and vitamins.^4,5,11 Sea buckthorn pericarp oil contains copious amounts of saturated palmitic acid (29%-36%) and omega-7 unsaturated palmitoleic acid (36%-48%), which fosters cutaneous and mucosal epithelialization, as well as linoleic (10%-12%) and oleic (4%-6%) acids.^12,6 Significant amounts of carotenoids as well as alpha‐linolenic fatty acid (38%), linoleic (36%), oleic (13%), and palmitic (7%) acids are present in sea buckthorn seed oil.⁶

Polysaccharides

In an expansive review on the pharmacological activities of sea buckthorn polysaccharides, Teng and colleagues reported in April 2024 that 20 diverse polysaccharides have been culled from sea buckthorn and exhibited various healthy activities, including antioxidant, anti-fatigue, anti-inflammatory, anti-obesity, anti-tumor, hepatoprotective, hypoglycemic, and immunoregulation, and regulation of intestinal flora activities.¹

Proanthocyanidins and Anti-Aging

In 2023, Liu and colleagues investigated the anti–skin aging impact of sea buckthorn proanthocyanidins in D-galactose-induced aging in mice given the known free radical scavenging activity of these compounds. They found the proanthocyanidins mitigated D-galactose-induced aging and can augment the total antioxidant capacity of the body. Sea buckthorn proanthocyanidins can further attenuate the effects of skin aging by regulating the TGF-beta¹/Smads pathway and MMPs/TIMP system, thus amplifying collagen I and tropoelastin content.¹³

Baumann Cosmetic & Research Institute

A year earlier, many of the same investigators assessed the possible protective activity of sea buckthorn proanthocyanidins against cutaneous aging engendered by oxidative stress from hydrogen peroxide. The compounds amplified superoxide dismutase and glutathione antioxidant functions. The extracts also fostered collagen I production in aging human skin fibroblasts via the TGF-beta1/Smads pathway and hindered collagen I degradation by regulating the MMPs/TIMPs system, which maintained extracellular matrix integrity. Senescent cell migration was also promoted with 100 mcg/mL of sea buckthorn proanthocyanidins. The researchers concluded that this sets the stage for investigating how sea buckthorn proanthocyanidins can be incorporated in cosmetic formulations.14 In a separate study, Liu and colleagues demonstrated that sea buckthorn proanthocyanidins can attenuate oxidative damage and protect mitochondrial function.⁹

Acne and Barrier Functions

The extracts of H rhamnoides and Cassia fistula in a combined formulation were found to be effective in lowering skin sebum content in humans with grade I and grade II acne vulgaris in a 2014 single-blind, randomized, placebo-controlled, split-face study with two groups of 25 patients each (aged 18-37 years).¹⁵ Khan and colleagues have also reported that a sea buckthorn oil-in-water emulsion improved barrier function in human skin as tested by a tewameter and corneometer (noninvasive probes) in 13 healthy males with a mean age of 27 ± 4.8 years.¹⁶

Anti-Aging, Antioxidant, Antibacterial, Skin-Whitening Activity

Zaman and colleagues reported in 2011 that results from an in vivo study of the effects of a sea buckthorn fruit extract topical cream on stratum corneum water content and transepidermal water loss indicated that the formulation enhanced cell surface integrin expression thus facilitating collagen contraction.¹⁷

In 2012, Khan and colleagues reported amelioration in skin elasticity, thus achieving an anti-aging result, from the use of a water-in-oil–based hydroalcoholic cream loaded with fruit extract of H rhamnoides, as measured with a Cutometer.¹⁸ The previous year, some of the same researchers reported that the antioxidants and flavonoids found in a topical sea buckthorn formulation could decrease cutaneous melanin and erythema levels.

More recently, Gęgotek and colleagues found that sea buckthorn seed oil prevented redox balance and lipid metabolism disturbances in skin fibroblasts and keratinocytes caused by UVA or UVB. They suggested that such findings point to the potential of this natural agent to confer anti-inflammatory properties and photoprotection to the skin.¹⁹

In 2020, Ivanišová and colleagues investigated the antioxidant and antimicrobial activities of H rhamnoides 100% oil, 100% juice, dry berries, and tea (dry berries, leaves, and twigs). They found that all of the studied sea buckthorn products displayed high antioxidant activity (identified through DPPH radical scavenging and molybdenum reducing antioxidant power tests). Sea buckthorn juice contained the highest total content of polyphenols, flavonoids, and carotenoids. All of the tested products also exhibited substantial antibacterial activity against the tested microbes.²⁰

Burns and Wound Healing

In a preclinical study of the effects of sea buckthorn leaf extracts on wound healing in albino rats using an excision-punch wound model in 2005, Gupta and colleagues found that twice daily topical application of the aqueous leaf extract fostered wound healing. This was indicated by higher hydroxyproline and protein levels, a diminished wound area, and lower lipid peroxide levels. The investigators suggested that sea buckthorn may facilitate wound healing at least in part because of elevated antioxidant activity in the granulation tissue.³

A year later, Wang and colleagues reported on observations of using H rhamnoides oil, a traditional Chinese herbal medicine derived from sea buckthorn fruit, as a burn treatment. In the study, 151 burn patients received an H rhamnoides oil dressing (changed every other day until wound healing) that was covered with a disinfecting dressing. The dressing reduced swelling and effusion, and alleviated pain, with patients receiving the sea buckthorn dressing experiencing greater apparent exudation reduction, pain reduction, and more rapid epithelial cell growth and wound healing than controls (treated only with Vaseline gauze). The difference between the two groups was statistically significant.²¹

Conclusion

Sea buckthorn has been used for hundreds if not thousands of years in traditional medical applications, including for dermatologic purposes. Emerging data appear to support the use of this dynamic plant for consideration in dermatologic applications. As is often the case, much more work is necessary in the form of randomized controlled trials to determine the effectiveness of sea buckthorn formulations as well as the most appropriate avenues of research or uses for dermatologic application of this traditionally used botanical agent.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as a e-commerce solution. Write to her at [email protected].

References

1. Teng H et al. J Ethnopharmacol. 2024 Apr 24;324:117809. doi: 10.1016/j.jep.2024.117809.

2. Wang Z et al. Int J Biol Macromol. 2024 Apr;263(Pt 1):130206. doi: 10.1016/j.ijbiomac.2024.130206.

3. Gupta A et al. Int J Low Extrem Wounds. 2005 Jun;4(2):88-92. doi: 10.1177/1534734605277401.

4. Pundir S et al. J Ethnopharmacol. 2021 Feb 10;266:113434. doi: 10.1016/j.jep.2020.113434.

5. Ma QG et al. J Agric Food Chem. 2023 Mar 29;71(12):4769-4788. doi: 10.1021/acs.jafc.2c06916.

6. Poljšak N et al. Phytother Res. 2020 Feb;34(2):254-269. doi: 10.1002/ptr.6524. doi: 10.1002/ptr.6524.

7. Upadhyay NK et al. Evid Based Complement Alternat Med. 2011;2011:659705. doi: 10.1093/ecam/nep189.

8. Suryakumar G, Gupta A. J Ethnopharmacol. 2011 Nov 18;138(2):268-78. doi: 10.1016/j.jep.2011.09.024.

9. Liu K et al. Front Pharmacol. 2022 Jul 8;13:914146. doi: 10.3389/fphar.2022.914146.

10. Akhtar N et al. J Pharm Bioallied Sci. 2010 Jan;2(1):13-7. doi: 10.4103/0975-7406.62698.

11. Ren R et al. RSC Adv. 2020 Dec 17;10(73):44654-44671. doi: 10.1039/d0ra06488b.

12. Ito H et al. Burns. 2014 May;40(3):511-9. doi: 10.1016/j.burns.2013.08.011.

13. Liu X et al. Food Sci Nutr. 2023 Dec 7;12(2):1082-1094. doi: 10.1002/fsn3.3823.

14. Liu X at al. Antioxidants (Basel). 2022 Sep 25;11(10):1900. doi: 10.3390/antiox11101900.

15. Khan BA, Akhtar N. Postepy Dermatol Alergol. 2014 Aug;31(4):229-234. doi: 10.5114/pdia.2014.40934.

16. Khan BA, Akhtar N. Pak J Pharm Sci. 2014 Nov;27(6):1919-22.

17. Khan AB et al. African J Pharm Pharmacol. 2011 Aug;5(8):1092-5.

18. Khan BA, Akhtar N, Braga VA. Trop J Pharm Res. 2012;11(6):955-62.

19. Gęgotek A et al. Antioxidants (Basel). 2018 Aug 23;7(9):110. doi: 10.3390/antiox7090110.

20. Ivanišová E et al. Acta Sci Pol Technol Aliment. 2020 Apr-Jun;19(2):195-205. doi: 10.17306/J.AFS.0809.

21. Wang ZY, Luo XL, He CP. Nan Fang Yi Ke Da Xue Xue Bao. 2006 Jan;26(1):124-5.

A member of the Elaeagnaceae family, Hippophae rhamnoides, better known as sea buckthorn, is a high-altitude wild shrub endemic to Europe and Asia with edible fruits and a lengthy record of use in traditional Chinese medicine.^1-6 Used as a health supplement and consumed in the diet throughout the world,⁵ sea buckthorn berries, seeds, and leaves have been used in traditional medicine to treat burns/injuries, edema, hypertension, inflammation, skin grafts, ulcers, and wounds.^4,7

This hardy plant is associated with a wide range of biologic activities, including anti-atherogenic, anti-atopic dermatitis, antibacterial, anticancer, antifungal, anti-inflammatory, antimicrobial, antioxidant, anti-psoriasis, anti-sebum, anti-stress, anti-tumor, cytoprotective, hepatoprotective, immunomodulatory, neuroprotective, radioprotective, and tissue regenerative functions.^4,5,8-11Sea buckthorn has also been included in several cosmeceutical formulations to treat wrinkles, scars, pigmentary conditions, and hair disorders, as well as to rejuvenate, even, and smooth the skin.⁴

Indre Brazauskaite/EyeEm/Getty Images

Key Constituents

Functional constituents identified in sea buckthorn include alkaloids, carotenoids, flavonoids, lignans, organic acids, phenolic acids, proanthocyanidins, polyunsaturated acids (including omega-3, -6, -7, and -9), steroids, tannins, terpenoids, and volatile oils, as well as nutritional compounds such as minerals, proteins, and vitamins.^4,5,11 Sea buckthorn pericarp oil contains copious amounts of saturated palmitic acid (29%-36%) and omega-7 unsaturated palmitoleic acid (36%-48%), which fosters cutaneous and mucosal epithelialization, as well as linoleic (10%-12%) and oleic (4%-6%) acids.^12,6 Significant amounts of carotenoids as well as alpha‐linolenic fatty acid (38%), linoleic (36%), oleic (13%), and palmitic (7%) acids are present in sea buckthorn seed oil.⁶

Polysaccharides

In an expansive review on the pharmacological activities of sea buckthorn polysaccharides, Teng and colleagues reported in April 2024 that 20 diverse polysaccharides have been culled from sea buckthorn and exhibited various healthy activities, including antioxidant, anti-fatigue, anti-inflammatory, anti-obesity, anti-tumor, hepatoprotective, hypoglycemic, and immunoregulation, and regulation of intestinal flora activities.¹

Proanthocyanidins and Anti-Aging

In 2023, Liu and colleagues investigated the anti–skin aging impact of sea buckthorn proanthocyanidins in D-galactose-induced aging in mice given the known free radical scavenging activity of these compounds. They found the proanthocyanidins mitigated D-galactose-induced aging and can augment the total antioxidant capacity of the body. Sea buckthorn proanthocyanidins can further attenuate the effects of skin aging by regulating the TGF-beta¹/Smads pathway and MMPs/TIMP system, thus amplifying collagen I and tropoelastin content.¹³

Baumann Cosmetic & Research Institute

A year earlier, many of the same investigators assessed the possible protective activity of sea buckthorn proanthocyanidins against cutaneous aging engendered by oxidative stress from hydrogen peroxide. The compounds amplified superoxide dismutase and glutathione antioxidant functions. The extracts also fostered collagen I production in aging human skin fibroblasts via the TGF-beta1/Smads pathway and hindered collagen I degradation by regulating the MMPs/TIMPs system, which maintained extracellular matrix integrity. Senescent cell migration was also promoted with 100 mcg/mL of sea buckthorn proanthocyanidins. The researchers concluded that this sets the stage for investigating how sea buckthorn proanthocyanidins can be incorporated in cosmetic formulations.14 In a separate study, Liu and colleagues demonstrated that sea buckthorn proanthocyanidins can attenuate oxidative damage and protect mitochondrial function.⁹

Acne and Barrier Functions

The extracts of H rhamnoides and Cassia fistula in a combined formulation were found to be effective in lowering skin sebum content in humans with grade I and grade II acne vulgaris in a 2014 single-blind, randomized, placebo-controlled, split-face study with two groups of 25 patients each (aged 18-37 years).¹⁵ Khan and colleagues have also reported that a sea buckthorn oil-in-water emulsion improved barrier function in human skin as tested by a tewameter and corneometer (noninvasive probes) in 13 healthy males with a mean age of 27 ± 4.8 years.¹⁶

Anti-Aging, Antioxidant, Antibacterial, Skin-Whitening Activity

Zaman and colleagues reported in 2011 that results from an in vivo study of the effects of a sea buckthorn fruit extract topical cream on stratum corneum water content and transepidermal water loss indicated that the formulation enhanced cell surface integrin expression thus facilitating collagen contraction.¹⁷

In 2012, Khan and colleagues reported amelioration in skin elasticity, thus achieving an anti-aging result, from the use of a water-in-oil–based hydroalcoholic cream loaded with fruit extract of H rhamnoides, as measured with a Cutometer.¹⁸ The previous year, some of the same researchers reported that the antioxidants and flavonoids found in a topical sea buckthorn formulation could decrease cutaneous melanin and erythema levels.

More recently, Gęgotek and colleagues found that sea buckthorn seed oil prevented redox balance and lipid metabolism disturbances in skin fibroblasts and keratinocytes caused by UVA or UVB. They suggested that such findings point to the potential of this natural agent to confer anti-inflammatory properties and photoprotection to the skin.¹⁹

In 2020, Ivanišová and colleagues investigated the antioxidant and antimicrobial activities of H rhamnoides 100% oil, 100% juice, dry berries, and tea (dry berries, leaves, and twigs). They found that all of the studied sea buckthorn products displayed high antioxidant activity (identified through DPPH radical scavenging and molybdenum reducing antioxidant power tests). Sea buckthorn juice contained the highest total content of polyphenols, flavonoids, and carotenoids. All of the tested products also exhibited substantial antibacterial activity against the tested microbes.²⁰

Burns and Wound Healing

In a preclinical study of the effects of sea buckthorn leaf extracts on wound healing in albino rats using an excision-punch wound model in 2005, Gupta and colleagues found that twice daily topical application of the aqueous leaf extract fostered wound healing. This was indicated by higher hydroxyproline and protein levels, a diminished wound area, and lower lipid peroxide levels. The investigators suggested that sea buckthorn may facilitate wound healing at least in part because of elevated antioxidant activity in the granulation tissue.³

A year later, Wang and colleagues reported on observations of using H rhamnoides oil, a traditional Chinese herbal medicine derived from sea buckthorn fruit, as a burn treatment. In the study, 151 burn patients received an H rhamnoides oil dressing (changed every other day until wound healing) that was covered with a disinfecting dressing. The dressing reduced swelling and effusion, and alleviated pain, with patients receiving the sea buckthorn dressing experiencing greater apparent exudation reduction, pain reduction, and more rapid epithelial cell growth and wound healing than controls (treated only with Vaseline gauze). The difference between the two groups was statistically significant.²¹

Conclusion

Sea buckthorn has been used for hundreds if not thousands of years in traditional medical applications, including for dermatologic purposes. Emerging data appear to support the use of this dynamic plant for consideration in dermatologic applications. As is often the case, much more work is necessary in the form of randomized controlled trials to determine the effectiveness of sea buckthorn formulations as well as the most appropriate avenues of research or uses for dermatologic application of this traditionally used botanical agent.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as a e-commerce solution. Write to her at [email protected].

References

1. Teng H et al. J Ethnopharmacol. 2024 Apr 24;324:117809. doi: 10.1016/j.jep.2024.117809.

2. Wang Z et al. Int J Biol Macromol. 2024 Apr;263(Pt 1):130206. doi: 10.1016/j.ijbiomac.2024.130206.

3. Gupta A et al. Int J Low Extrem Wounds. 2005 Jun;4(2):88-92. doi: 10.1177/1534734605277401.

4. Pundir S et al. J Ethnopharmacol. 2021 Feb 10;266:113434. doi: 10.1016/j.jep.2020.113434.

5. Ma QG et al. J Agric Food Chem. 2023 Mar 29;71(12):4769-4788. doi: 10.1021/acs.jafc.2c06916.

6. Poljšak N et al. Phytother Res. 2020 Feb;34(2):254-269. doi: 10.1002/ptr.6524. doi: 10.1002/ptr.6524.

7. Upadhyay NK et al. Evid Based Complement Alternat Med. 2011;2011:659705. doi: 10.1093/ecam/nep189.

8. Suryakumar G, Gupta A. J Ethnopharmacol. 2011 Nov 18;138(2):268-78. doi: 10.1016/j.jep.2011.09.024.

9. Liu K et al. Front Pharmacol. 2022 Jul 8;13:914146. doi: 10.3389/fphar.2022.914146.

10. Akhtar N et al. J Pharm Bioallied Sci. 2010 Jan;2(1):13-7. doi: 10.4103/0975-7406.62698.

11. Ren R et al. RSC Adv. 2020 Dec 17;10(73):44654-44671. doi: 10.1039/d0ra06488b.

12. Ito H et al. Burns. 2014 May;40(3):511-9. doi: 10.1016/j.burns.2013.08.011.

13. Liu X et al. Food Sci Nutr. 2023 Dec 7;12(2):1082-1094. doi: 10.1002/fsn3.3823.

14. Liu X at al. Antioxidants (Basel). 2022 Sep 25;11(10):1900. doi: 10.3390/antiox11101900.

15. Khan BA, Akhtar N. Postepy Dermatol Alergol. 2014 Aug;31(4):229-234. doi: 10.5114/pdia.2014.40934.

16. Khan BA, Akhtar N. Pak J Pharm Sci. 2014 Nov;27(6):1919-22.

17. Khan AB et al. African J Pharm Pharmacol. 2011 Aug;5(8):1092-5.

18. Khan BA, Akhtar N, Braga VA. Trop J Pharm Res. 2012;11(6):955-62.

19. Gęgotek A et al. Antioxidants (Basel). 2018 Aug 23;7(9):110. doi: 10.3390/antiox7090110.

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TOPLINE:

An estimated 72 million ambulatory visits for superficial cutaneous fungal infections (SCFIs) in the United States were recorded during 2005-2016, with an increasing trend over the years. Tinea unguium, tinea pedis, and tinea corporis were among the most common infections.

METHODOLOGY:

• Researchers analyzed data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey from 2005 to 2016, to evaluate trends in the prevalence of SCFIs during this period.
• The analysis included over 13 billion ambulatory visits to nonfederally funded community, office-based physician practices, and emergency or outpatient departments in the United States, with an estimated 1,104,258,333 annual average.
• The Jonckheere-Terpstra nonparametric test for trend was used to determine the pattern of SCFI prevalence over the 12-year period.

TAKEAWAY:

• SCFIs constituted approximately 0.54% of all annual ambulatory visits, with an estimated 6,001,852 visits for SCFIs per year and over 72 million total visits for the infections during the study period.
• Tinea unguium, tinea pedis, and tinea corporis were the most common infections, comprising 20.5%, 12.2%, and 12.0% of the total visits, respectively.
• Researchers noted an increasing trend in annual SCFIs (P = .03).

IN PRACTICE:

“We observed a high burden of SCFIs among outpatient visits in the United States and an increasing trend in their prevalence,” the authors wrote. These results, they added, “highlight the importance of healthcare providers being able to identify, treat, and, when necessary, refer patients with SCFIs, as a high burden of disease is associated with a significant negative impact on the individual and population levels.”

SOURCE:

The study was co-led by Sarah L. Spaulding, BS, and A. Mitchel Wride, BA, from the Yale School of Medicine, New Haven, Connecticut, and was published online October 30 in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The authors did not list any study limitations.

DISCLOSURES:

The lead authors were supported by Yale School of Medicine Medical Student Research Fellowships. Two other authors declared receiving consulting fees, research funding, and licensing fees outside the submitted work and also served on a data and safety monitoring board for Advarra Inc.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

An estimated 72 million ambulatory visits for superficial cutaneous fungal infections (SCFIs) in the United States were recorded during 2005-2016, with an increasing trend over the years. Tinea unguium, tinea pedis, and tinea corporis were among the most common infections.

METHODOLOGY:

• Researchers analyzed data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey from 2005 to 2016, to evaluate trends in the prevalence of SCFIs during this period.
• The analysis included over 13 billion ambulatory visits to nonfederally funded community, office-based physician practices, and emergency or outpatient departments in the United States, with an estimated 1,104,258,333 annual average.
• The Jonckheere-Terpstra nonparametric test for trend was used to determine the pattern of SCFI prevalence over the 12-year period.

TAKEAWAY:

• SCFIs constituted approximately 0.54% of all annual ambulatory visits, with an estimated 6,001,852 visits for SCFIs per year and over 72 million total visits for the infections during the study period.
• Tinea unguium, tinea pedis, and tinea corporis were the most common infections, comprising 20.5%, 12.2%, and 12.0% of the total visits, respectively.
• Researchers noted an increasing trend in annual SCFIs (P = .03).

IN PRACTICE:

“We observed a high burden of SCFIs among outpatient visits in the United States and an increasing trend in their prevalence,” the authors wrote. These results, they added, “highlight the importance of healthcare providers being able to identify, treat, and, when necessary, refer patients with SCFIs, as a high burden of disease is associated with a significant negative impact on the individual and population levels.”

SOURCE:

The study was co-led by Sarah L. Spaulding, BS, and A. Mitchel Wride, BA, from the Yale School of Medicine, New Haven, Connecticut, and was published online October 30 in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The authors did not list any study limitations.

DISCLOSURES:

The lead authors were supported by Yale School of Medicine Medical Student Research Fellowships. Two other authors declared receiving consulting fees, research funding, and licensing fees outside the submitted work and also served on a data and safety monitoring board for Advarra Inc.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

An estimated 72 million ambulatory visits for superficial cutaneous fungal infections (SCFIs) in the United States were recorded during 2005-2016, with an increasing trend over the years. Tinea unguium, tinea pedis, and tinea corporis were among the most common infections.

METHODOLOGY:

• Researchers analyzed data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey from 2005 to 2016, to evaluate trends in the prevalence of SCFIs during this period.
• The analysis included over 13 billion ambulatory visits to nonfederally funded community, office-based physician practices, and emergency or outpatient departments in the United States, with an estimated 1,104,258,333 annual average.
• The Jonckheere-Terpstra nonparametric test for trend was used to determine the pattern of SCFI prevalence over the 12-year period.

TAKEAWAY:

• SCFIs constituted approximately 0.54% of all annual ambulatory visits, with an estimated 6,001,852 visits for SCFIs per year and over 72 million total visits for the infections during the study period.
• Tinea unguium, tinea pedis, and tinea corporis were the most common infections, comprising 20.5%, 12.2%, and 12.0% of the total visits, respectively.
• Researchers noted an increasing trend in annual SCFIs (P = .03).

IN PRACTICE:

“We observed a high burden of SCFIs among outpatient visits in the United States and an increasing trend in their prevalence,” the authors wrote. These results, they added, “highlight the importance of healthcare providers being able to identify, treat, and, when necessary, refer patients with SCFIs, as a high burden of disease is associated with a significant negative impact on the individual and population levels.”

SOURCE:

The study was co-led by Sarah L. Spaulding, BS, and A. Mitchel Wride, BA, from the Yale School of Medicine, New Haven, Connecticut, and was published online October 30 in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The authors did not list any study limitations.

DISCLOSURES:

The lead authors were supported by Yale School of Medicine Medical Student Research Fellowships. Two other authors declared receiving consulting fees, research funding, and licensing fees outside the submitted work and also served on a data and safety monitoring board for Advarra Inc.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Individuals with hidradenitis suppurativa (HS) face a significantly increased risk for bulimia nervosa and binge eating disorder, an analysis of national data showed.

“Clinicians should actively screen for eating disorders,” particularly bulimia nervosa and binge eating disorder, in patients with HS,” lead study author Christopher Guirguis, DMD, a student at Georgetown University School of Medicine, Washington, DC, told this news organization in advance of the annual Symposium on Hidradenitis Suppurative Advances, where the study was presented during an oral abstract session. “The significant psychological burden in these patients requires a holistic approach that integrates both dermatologic and psychosocial care. Addressing their mental health needs is essential for improving overall patient outcomes and quality of life,” he added.

Chrisopher Guirguis

In collaboration with fellow Georgetown medical student and first author Lauren Chin and Mikael Horissian, MD, a dermatologist and director of the HS Clinic at Gesinger Health System, Danville, Pennsylvania, Guirguis drew from the National Institutes of Health’s All of Us Research Program to identify 1653 individuals with a diagnosis of HS and a control group of 8265 individuals without a diagnosis of HS. They used the Observational Medical Outcomes Partnership to identify anorexia nervosa, bulimia nervosa, body dysmorphic disorder, binge eating disorder, and eating disorder, unspecified. Obsessive-compulsive disorder (OCD) was also included because of its association with bulimia. They used statistical models to compare cohorts and comorbidities. “What makes this work unique is its focus on the link between HS and eating disorders, a relationship previously underexplored,” he said.

The mean age of the overall study cohort was 46.8 years, and 78.6% were female. Univariate analysis revealed that, compared with controls, individuals in the HS cohort showed significantly increased diagnoses of bulimia, binge eating disorder, OCD, and eating disorder, unspecified, by 2.6, 5.48, 2.50, and 2.43 times, respectively (P < .05 for all associations). After adjusting for age, race, sex, and ethnicity, the researchers observed that patients with HS were 4.46 times as likely to have a diagnosis of binge eating disorder and 3.51 times as likely to have a diagnosis of bulimia as those who did not have HS (P < .05 for both associations).

Guirguis said that the absence of body dysmorphic disorder diagnoses in the HS cohort was unexpected. “Given HS’s known association with body image issues, we anticipated a higher prevalence of BDD,” he said. “This discrepancy may reflect underreporting or diagnostic overshadowing, where the physical symptoms of HS dominate clinical attention, potentially masking or complicating the identification of psychological conditions like BDD.”

He acknowledged certain limitations of the study, including the potential for variations in documentation practices in the database. “Additionally, there may be bias due to underrepresentation of certain demographic groups or underreporting of psychological comorbidities, which could influence the findings.”

Patricia M. Richey, MD, assistant professor of dermatology, at Boston University School of Medicine in Massachusetts, who was asked to comment on the study, said the results “should affect how physicians discuss lifestyle recommendations in those already at increased risk of psychiatric disease and disrupted body image.” The findings should also “prompt physicians to screen this patient population more thoroughly for eating disorders as we know they are an underrecognized and often undertreated entity,” she added.

Neither the study authors nor Richey reported having relevant disclosures.

A version of this article appeared on Medscape.com.

Individuals with hidradenitis suppurativa (HS) face a significantly increased risk for bulimia nervosa and binge eating disorder, an analysis of national data showed.

“Clinicians should actively screen for eating disorders,” particularly bulimia nervosa and binge eating disorder, in patients with HS,” lead study author Christopher Guirguis, DMD, a student at Georgetown University School of Medicine, Washington, DC, told this news organization in advance of the annual Symposium on Hidradenitis Suppurative Advances, where the study was presented during an oral abstract session. “The significant psychological burden in these patients requires a holistic approach that integrates both dermatologic and psychosocial care. Addressing their mental health needs is essential for improving overall patient outcomes and quality of life,” he added.

Chrisopher Guirguis

In collaboration with fellow Georgetown medical student and first author Lauren Chin and Mikael Horissian, MD, a dermatologist and director of the HS Clinic at Gesinger Health System, Danville, Pennsylvania, Guirguis drew from the National Institutes of Health’s All of Us Research Program to identify 1653 individuals with a diagnosis of HS and a control group of 8265 individuals without a diagnosis of HS. They used the Observational Medical Outcomes Partnership to identify anorexia nervosa, bulimia nervosa, body dysmorphic disorder, binge eating disorder, and eating disorder, unspecified. Obsessive-compulsive disorder (OCD) was also included because of its association with bulimia. They used statistical models to compare cohorts and comorbidities. “What makes this work unique is its focus on the link between HS and eating disorders, a relationship previously underexplored,” he said.

The mean age of the overall study cohort was 46.8 years, and 78.6% were female. Univariate analysis revealed that, compared with controls, individuals in the HS cohort showed significantly increased diagnoses of bulimia, binge eating disorder, OCD, and eating disorder, unspecified, by 2.6, 5.48, 2.50, and 2.43 times, respectively (P < .05 for all associations). After adjusting for age, race, sex, and ethnicity, the researchers observed that patients with HS were 4.46 times as likely to have a diagnosis of binge eating disorder and 3.51 times as likely to have a diagnosis of bulimia as those who did not have HS (P < .05 for both associations).

Guirguis said that the absence of body dysmorphic disorder diagnoses in the HS cohort was unexpected. “Given HS’s known association with body image issues, we anticipated a higher prevalence of BDD,” he said. “This discrepancy may reflect underreporting or diagnostic overshadowing, where the physical symptoms of HS dominate clinical attention, potentially masking or complicating the identification of psychological conditions like BDD.”

He acknowledged certain limitations of the study, including the potential for variations in documentation practices in the database. “Additionally, there may be bias due to underrepresentation of certain demographic groups or underreporting of psychological comorbidities, which could influence the findings.”

Patricia M. Richey, MD, assistant professor of dermatology, at Boston University School of Medicine in Massachusetts, who was asked to comment on the study, said the results “should affect how physicians discuss lifestyle recommendations in those already at increased risk of psychiatric disease and disrupted body image.” The findings should also “prompt physicians to screen this patient population more thoroughly for eating disorders as we know they are an underrecognized and often undertreated entity,” she added.

Neither the study authors nor Richey reported having relevant disclosures.

A version of this article appeared on Medscape.com.

Individuals with hidradenitis suppurativa (HS) face a significantly increased risk for bulimia nervosa and binge eating disorder, an analysis of national data showed.

“Clinicians should actively screen for eating disorders,” particularly bulimia nervosa and binge eating disorder, in patients with HS,” lead study author Christopher Guirguis, DMD, a student at Georgetown University School of Medicine, Washington, DC, told this news organization in advance of the annual Symposium on Hidradenitis Suppurative Advances, where the study was presented during an oral abstract session. “The significant psychological burden in these patients requires a holistic approach that integrates both dermatologic and psychosocial care. Addressing their mental health needs is essential for improving overall patient outcomes and quality of life,” he added.

Chrisopher Guirguis

In collaboration with fellow Georgetown medical student and first author Lauren Chin and Mikael Horissian, MD, a dermatologist and director of the HS Clinic at Gesinger Health System, Danville, Pennsylvania, Guirguis drew from the National Institutes of Health’s All of Us Research Program to identify 1653 individuals with a diagnosis of HS and a control group of 8265 individuals without a diagnosis of HS. They used the Observational Medical Outcomes Partnership to identify anorexia nervosa, bulimia nervosa, body dysmorphic disorder, binge eating disorder, and eating disorder, unspecified. Obsessive-compulsive disorder (OCD) was also included because of its association with bulimia. They used statistical models to compare cohorts and comorbidities. “What makes this work unique is its focus on the link between HS and eating disorders, a relationship previously underexplored,” he said.

The mean age of the overall study cohort was 46.8 years, and 78.6% were female. Univariate analysis revealed that, compared with controls, individuals in the HS cohort showed significantly increased diagnoses of bulimia, binge eating disorder, OCD, and eating disorder, unspecified, by 2.6, 5.48, 2.50, and 2.43 times, respectively (P < .05 for all associations). After adjusting for age, race, sex, and ethnicity, the researchers observed that patients with HS were 4.46 times as likely to have a diagnosis of binge eating disorder and 3.51 times as likely to have a diagnosis of bulimia as those who did not have HS (P < .05 for both associations).

Guirguis said that the absence of body dysmorphic disorder diagnoses in the HS cohort was unexpected. “Given HS’s known association with body image issues, we anticipated a higher prevalence of BDD,” he said. “This discrepancy may reflect underreporting or diagnostic overshadowing, where the physical symptoms of HS dominate clinical attention, potentially masking or complicating the identification of psychological conditions like BDD.”

He acknowledged certain limitations of the study, including the potential for variations in documentation practices in the database. “Additionally, there may be bias due to underrepresentation of certain demographic groups or underreporting of psychological comorbidities, which could influence the findings.”

Patricia M. Richey, MD, assistant professor of dermatology, at Boston University School of Medicine in Massachusetts, who was asked to comment on the study, said the results “should affect how physicians discuss lifestyle recommendations in those already at increased risk of psychiatric disease and disrupted body image.” The findings should also “prompt physicians to screen this patient population more thoroughly for eating disorders as we know they are an underrecognized and often undertreated entity,” she added.

Neither the study authors nor Richey reported having relevant disclosures.

A version of this article appeared on Medscape.com.

AMSTERDAM — The monoclonal antibody bimekizumab (Bimzelx) achieves significant and clinically meaningful improvements in moderate to severe hidradenitis suppurativa (HS) that are maintained well beyond the initial 1-year clinical trial treatment period, according to new data from an open-label extension period.

“Efficacy and health-related quality-of-life outcomes were maintained through 2 years of treatment,” study presenter Christos C. Zouboulis, MD, professor of dermatology, venereology, and allergology, Brandenburg Medical School Theodor Fontane, Dessau, Germany, said at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.

“No new safety signals were observed,” he added. “These data highlight the durability and consistency of bimekizumab treatment in patients with moderate to severe hidradenitis suppurativa,” Zouboulis concluded.
 

Efficacy Maintained

“This is the type of long-term data that clinicians hope to see in large phase 3 trials for hidradenitis suppurativa medications,” commented Jennifer L. Hsiao, MD, clinical associate professor of dermatology, University of Southern California, Los Angeles, who was not involved in the study.

She told this news organization that, beyond maintained improvement of patient-reported quality of life, the results are “raising the bar in terms of measuring treatment success,” with over three quarters of patients achieving a high level of response on the Hidradenitis Suppurativa Clinical Response (HiSCR) scale at the final 96-week follow-up.

“Clinicians and patients have struggled with maintaining treatment efficacy over time with the first [Food and Drug Administration]–approved class of biologics for hidradenitis suppurativa — TNF [tumor necrosis factor]–alpha antagonists,” Hsiao said. She emphasized that sustained treatment efficacy will reduce the need for continued treatment switching and “hopefully improve treatment adherence.”

“It was also helpful to see that, consistent with studies of bimekizumab in psoriasis, rates of oral candidiasis appear to decrease with prolonged exposure over 2 years, though as with any open-label extension study, study dropout is a limitation,” she said.

“The availability of long-term efficacy and safety data, such as those shown in this study, will help guide shared decision-making discussions with our patients.” Overall, Hsiao believes there is “much to be excited about in the field of hidradenitis suppurativa, with a robust pipeline of potential treatments.”
 

One-Year Extension Study

HS is a “chronic and debilitating inflammatory skin disease,” Zouboulis told the audience. He noted that interleukin (IL)–17F and IL-17A are highly expressed in lesional skin and play a role in the disease immunopathogenesis.

Bimekizumab is a humanized immunoglobulin G1 monoclonal antibody that selectively inhibits both IL-17F and IL-17A. It has previously demonstrated clinically meaningful improvements in patients with moderate to severe HS in the phase 3 BE HEARD I and BE HEARD II trials evaluating several dosing regimens.

Zouboulis said the current analysis combines data from the two phase 3 studies with the BE HEARD EXT open-label extension study, in which patients from both trials were continued on bimekizumab 320 mg every 2 weeks.

Of the 1014 patients initially enrolled in the two trials, 556 continued into the open-label extension. Their average age was 36.6 years, and 53.8% were women. The majority (80.6%) were White. Of the 556 patients enrolled in the extension, 446 completed the 1-year extension study.

The average draining tunnel count at baseline was 3.8, and 54.5% had Hurley stage II disease; the remaining 45.5% had stage III disease. The mean total Dermatology Life Quality Index (DLQI) score at baseline was 11.0, indicating the HS was having a very large impact on the patients’ lives.

After the 16-week initial treatment period and the maintenance treatment period out to 48 weeks, 64.0% of patients achieved HiSCR75, indicating at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, rising to 77.1% at the end of the open-label extension, after a total follow-up of 96 weeks.

HiSCR100 scores, indicating a 100% reduction in total abscess and inflammatory nodule counts, were achieved by 30.2% of 556 patients after 48 weeks and 44.2% of 446 at the 96-week follow-up.

These findings were mirrored by substantial reductions on the International HS Severity Score System, with a 70.3% reduction over baseline at 48 weeks and a 79.8% reduction at the final follow-up.

There were also “clinically meaningful” reductions in the total draining tunnel count at 1 year that were further reduced at 2 years, Zouboulis reported, at a 57.5% reduction over baseline, increasing to 73.7% by 96 weeks. The mean draining tunnel count at the end of follow-up was 1.1.

Over the full 96 weeks, the mean DLQI score reduced from 11.0 to 4.7, with 33.9% of patients achieving a score of 0 or 1 on the scale, which he said is basically patients saying: “I don’t have disease now.”

Finally, the safety data showed that there were “no differences compared to what we knew before,” Zouboulis said, with the most common treatment-related adverse events being hidradenitis, coronavirus infection, and oral candidiasis. There were few serious and severe treatment-related adverse events, and few that led to treatment discontinuation.

The study was funded by UCB.Zouboulis declared relationships with AstraZeneca, Boehringer Ingelheim, Brandenburg Medical School Theodor Fontane, EAD, European Union, German Federal Ministry of Education and Research, GSK, InflaRx, MSD, Novartis, Relaxera, UCB, Almirall, Boehringer Ingelheim, Eli Lilly, Idorsia, Incyte, L’Oréal, NAOS-BIODERMA, Pfizer, PM, Sanofi. Hsiao is on the board of directors for the Hidradenitis Suppurativa Foundation and has declared relationships with AbbVie, Aclaris Therapeutics, Amgen, Boehringer Ingelheim, Incyte, Novartis, Sanofi-Regeneron, and UCB.

A version of this article appeared on Medscape.com.

AMSTERDAM — The monoclonal antibody bimekizumab (Bimzelx) achieves significant and clinically meaningful improvements in moderate to severe hidradenitis suppurativa (HS) that are maintained well beyond the initial 1-year clinical trial treatment period, according to new data from an open-label extension period.

“Efficacy and health-related quality-of-life outcomes were maintained through 2 years of treatment,” study presenter Christos C. Zouboulis, MD, professor of dermatology, venereology, and allergology, Brandenburg Medical School Theodor Fontane, Dessau, Germany, said at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.

“No new safety signals were observed,” he added. “These data highlight the durability and consistency of bimekizumab treatment in patients with moderate to severe hidradenitis suppurativa,” Zouboulis concluded.
 

Efficacy Maintained

“This is the type of long-term data that clinicians hope to see in large phase 3 trials for hidradenitis suppurativa medications,” commented Jennifer L. Hsiao, MD, clinical associate professor of dermatology, University of Southern California, Los Angeles, who was not involved in the study.

She told this news organization that, beyond maintained improvement of patient-reported quality of life, the results are “raising the bar in terms of measuring treatment success,” with over three quarters of patients achieving a high level of response on the Hidradenitis Suppurativa Clinical Response (HiSCR) scale at the final 96-week follow-up.

“Clinicians and patients have struggled with maintaining treatment efficacy over time with the first [Food and Drug Administration]–approved class of biologics for hidradenitis suppurativa — TNF [tumor necrosis factor]–alpha antagonists,” Hsiao said. She emphasized that sustained treatment efficacy will reduce the need for continued treatment switching and “hopefully improve treatment adherence.”

“It was also helpful to see that, consistent with studies of bimekizumab in psoriasis, rates of oral candidiasis appear to decrease with prolonged exposure over 2 years, though as with any open-label extension study, study dropout is a limitation,” she said.

“The availability of long-term efficacy and safety data, such as those shown in this study, will help guide shared decision-making discussions with our patients.” Overall, Hsiao believes there is “much to be excited about in the field of hidradenitis suppurativa, with a robust pipeline of potential treatments.”
 

One-Year Extension Study

HS is a “chronic and debilitating inflammatory skin disease,” Zouboulis told the audience. He noted that interleukin (IL)–17F and IL-17A are highly expressed in lesional skin and play a role in the disease immunopathogenesis.

Bimekizumab is a humanized immunoglobulin G1 monoclonal antibody that selectively inhibits both IL-17F and IL-17A. It has previously demonstrated clinically meaningful improvements in patients with moderate to severe HS in the phase 3 BE HEARD I and BE HEARD II trials evaluating several dosing regimens.

Zouboulis said the current analysis combines data from the two phase 3 studies with the BE HEARD EXT open-label extension study, in which patients from both trials were continued on bimekizumab 320 mg every 2 weeks.

Of the 1014 patients initially enrolled in the two trials, 556 continued into the open-label extension. Their average age was 36.6 years, and 53.8% were women. The majority (80.6%) were White. Of the 556 patients enrolled in the extension, 446 completed the 1-year extension study.

The average draining tunnel count at baseline was 3.8, and 54.5% had Hurley stage II disease; the remaining 45.5% had stage III disease. The mean total Dermatology Life Quality Index (DLQI) score at baseline was 11.0, indicating the HS was having a very large impact on the patients’ lives.

After the 16-week initial treatment period and the maintenance treatment period out to 48 weeks, 64.0% of patients achieved HiSCR75, indicating at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, rising to 77.1% at the end of the open-label extension, after a total follow-up of 96 weeks.

HiSCR100 scores, indicating a 100% reduction in total abscess and inflammatory nodule counts, were achieved by 30.2% of 556 patients after 48 weeks and 44.2% of 446 at the 96-week follow-up.

These findings were mirrored by substantial reductions on the International HS Severity Score System, with a 70.3% reduction over baseline at 48 weeks and a 79.8% reduction at the final follow-up.

There were also “clinically meaningful” reductions in the total draining tunnel count at 1 year that were further reduced at 2 years, Zouboulis reported, at a 57.5% reduction over baseline, increasing to 73.7% by 96 weeks. The mean draining tunnel count at the end of follow-up was 1.1.

Over the full 96 weeks, the mean DLQI score reduced from 11.0 to 4.7, with 33.9% of patients achieving a score of 0 or 1 on the scale, which he said is basically patients saying: “I don’t have disease now.”

Finally, the safety data showed that there were “no differences compared to what we knew before,” Zouboulis said, with the most common treatment-related adverse events being hidradenitis, coronavirus infection, and oral candidiasis. There were few serious and severe treatment-related adverse events, and few that led to treatment discontinuation.

The study was funded by UCB.Zouboulis declared relationships with AstraZeneca, Boehringer Ingelheim, Brandenburg Medical School Theodor Fontane, EAD, European Union, German Federal Ministry of Education and Research, GSK, InflaRx, MSD, Novartis, Relaxera, UCB, Almirall, Boehringer Ingelheim, Eli Lilly, Idorsia, Incyte, L’Oréal, NAOS-BIODERMA, Pfizer, PM, Sanofi. Hsiao is on the board of directors for the Hidradenitis Suppurativa Foundation and has declared relationships with AbbVie, Aclaris Therapeutics, Amgen, Boehringer Ingelheim, Incyte, Novartis, Sanofi-Regeneron, and UCB.

A version of this article appeared on Medscape.com.

AMSTERDAM — The monoclonal antibody bimekizumab (Bimzelx) achieves significant and clinically meaningful improvements in moderate to severe hidradenitis suppurativa (HS) that are maintained well beyond the initial 1-year clinical trial treatment period, according to new data from an open-label extension period.

“Efficacy and health-related quality-of-life outcomes were maintained through 2 years of treatment,” study presenter Christos C. Zouboulis, MD, professor of dermatology, venereology, and allergology, Brandenburg Medical School Theodor Fontane, Dessau, Germany, said at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.

“No new safety signals were observed,” he added. “These data highlight the durability and consistency of bimekizumab treatment in patients with moderate to severe hidradenitis suppurativa,” Zouboulis concluded.
 

Efficacy Maintained

“This is the type of long-term data that clinicians hope to see in large phase 3 trials for hidradenitis suppurativa medications,” commented Jennifer L. Hsiao, MD, clinical associate professor of dermatology, University of Southern California, Los Angeles, who was not involved in the study.

She told this news organization that, beyond maintained improvement of patient-reported quality of life, the results are “raising the bar in terms of measuring treatment success,” with over three quarters of patients achieving a high level of response on the Hidradenitis Suppurativa Clinical Response (HiSCR) scale at the final 96-week follow-up.

“Clinicians and patients have struggled with maintaining treatment efficacy over time with the first [Food and Drug Administration]–approved class of biologics for hidradenitis suppurativa — TNF [tumor necrosis factor]–alpha antagonists,” Hsiao said. She emphasized that sustained treatment efficacy will reduce the need for continued treatment switching and “hopefully improve treatment adherence.”

“It was also helpful to see that, consistent with studies of bimekizumab in psoriasis, rates of oral candidiasis appear to decrease with prolonged exposure over 2 years, though as with any open-label extension study, study dropout is a limitation,” she said.

“The availability of long-term efficacy and safety data, such as those shown in this study, will help guide shared decision-making discussions with our patients.” Overall, Hsiao believes there is “much to be excited about in the field of hidradenitis suppurativa, with a robust pipeline of potential treatments.”
 

One-Year Extension Study

HS is a “chronic and debilitating inflammatory skin disease,” Zouboulis told the audience. He noted that interleukin (IL)–17F and IL-17A are highly expressed in lesional skin and play a role in the disease immunopathogenesis.

Bimekizumab is a humanized immunoglobulin G1 monoclonal antibody that selectively inhibits both IL-17F and IL-17A. It has previously demonstrated clinically meaningful improvements in patients with moderate to severe HS in the phase 3 BE HEARD I and BE HEARD II trials evaluating several dosing regimens.

Zouboulis said the current analysis combines data from the two phase 3 studies with the BE HEARD EXT open-label extension study, in which patients from both trials were continued on bimekizumab 320 mg every 2 weeks.

Of the 1014 patients initially enrolled in the two trials, 556 continued into the open-label extension. Their average age was 36.6 years, and 53.8% were women. The majority (80.6%) were White. Of the 556 patients enrolled in the extension, 446 completed the 1-year extension study.

The average draining tunnel count at baseline was 3.8, and 54.5% had Hurley stage II disease; the remaining 45.5% had stage III disease. The mean total Dermatology Life Quality Index (DLQI) score at baseline was 11.0, indicating the HS was having a very large impact on the patients’ lives.

After the 16-week initial treatment period and the maintenance treatment period out to 48 weeks, 64.0% of patients achieved HiSCR75, indicating at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, rising to 77.1% at the end of the open-label extension, after a total follow-up of 96 weeks.

HiSCR100 scores, indicating a 100% reduction in total abscess and inflammatory nodule counts, were achieved by 30.2% of 556 patients after 48 weeks and 44.2% of 446 at the 96-week follow-up.

These findings were mirrored by substantial reductions on the International HS Severity Score System, with a 70.3% reduction over baseline at 48 weeks and a 79.8% reduction at the final follow-up.

There were also “clinically meaningful” reductions in the total draining tunnel count at 1 year that were further reduced at 2 years, Zouboulis reported, at a 57.5% reduction over baseline, increasing to 73.7% by 96 weeks. The mean draining tunnel count at the end of follow-up was 1.1.

Over the full 96 weeks, the mean DLQI score reduced from 11.0 to 4.7, with 33.9% of patients achieving a score of 0 or 1 on the scale, which he said is basically patients saying: “I don’t have disease now.”

Finally, the safety data showed that there were “no differences compared to what we knew before,” Zouboulis said, with the most common treatment-related adverse events being hidradenitis, coronavirus infection, and oral candidiasis. There were few serious and severe treatment-related adverse events, and few that led to treatment discontinuation.

The study was funded by UCB.Zouboulis declared relationships with AstraZeneca, Boehringer Ingelheim, Brandenburg Medical School Theodor Fontane, EAD, European Union, German Federal Ministry of Education and Research, GSK, InflaRx, MSD, Novartis, Relaxera, UCB, Almirall, Boehringer Ingelheim, Eli Lilly, Idorsia, Incyte, L’Oréal, NAOS-BIODERMA, Pfizer, PM, Sanofi. Hsiao is on the board of directors for the Hidradenitis Suppurativa Foundation and has declared relationships with AbbVie, Aclaris Therapeutics, Amgen, Boehringer Ingelheim, Incyte, Novartis, Sanofi-Regeneron, and UCB.

A version of this article appeared on Medscape.com.

Only 12% of the nurses providing patient care at hospitals and health clinics today are men. Although the percentage of nurses has increased — men made up just 2.7% of nurses in 1970 — nursing is still considered a “pink collar” profession, a female-dominated field.

“We’ve made strides over the last couple of decades, but [the number of men pursuing nursing careers] is leveling out,” said Jason Dunne, DNP, MSN, RN, chief academic officer at the Arizona College of Nursing, Phoenix. “There continues to be persistent gender stereotypes that [have] discouraged men from entering the profession.”

A nationwide nursing shortage has led to increased efforts to attract more men to the profession and ensure that men in nursing feel valued and supported and want to continue their careers long term.

“The nursing shortage is very real,” Dunne said. “We need to be highly focused on the shortage and look at opportunities to bring diversity into the profession, and one big way to solve it is bringing more men into nursing.”
 

Representation Matters

Colleges recognize the need to diversify their nursing student population and have turned their attention to increasing the number of men attending informational sessions and career days. Dunne believes, “There is a general lack of awareness of nursing as a career choice [for men].”

The Nursing Consortium of Florida hosts a “Day in the Life of a Nurse” program to introduce high school students to nursing careers, and the University of Virginia School of Nursing invites male nursing students to speak at educational events to promote workforce diversity.

“When I was growing up, the males wouldn’t have been included in those sessions,” said Melissa Gilbert Gomes, PhD, APRN, PMHNP-BC, FNAP, FAAN, associate dean for diversity, equity, and inclusion at the University of Virginia School of Nursing, Charlottesville, Virginia. “It was nice to see their interest and to have a male student there for them to ask questions and to help them see that this could be a place for them.”

Nursing schools have also engaged in other efforts to encourage more men to consider nursing careers, from highlighting male nurses in marketing materials and engaging with men at career fairs to updating course curriculum to include content on men’s health and connecting male nursing students with men in nursing faculty or clinical settings.

Focusing on nursing as a lucrative career choice could also attract more men to the profession. On average, male registered nurses (RNs) make $7300 per year more than their female counterparts due to the gender pay gap. The median wage for male RNs in acute care, cardiology, and perioperative specialties is $90,000 annually.

At the University of Virginia School of Nursing, which the American Association for Men in Nursing (AAMN) named “Best School for Men in Nursing” in 2023, 20% of nursing students are men.

The school has a Men Advancing Nursing club and is in the process of chartering a new AAMN chapter. The goal, according to Gomes, is to create an environment where male nursing students feel represented and supported.

“Valuing the perspective that men bring [to nursing] is important,” she said. “Coming together [and] having that camaraderie and intrinsic motivation to specifically speak to areas that impact men ... is important.”
 

Promoting Patient Care

Highlighting the diversity of career options within the nursing profession is also essential. RNs can pursue careers in specialties ranging from pediatrics, orthopedics, and occupational health to anesthesia, cardiology, and nephrology. The specialty with the highest number of male RNs tends to be acute care, which encompasses emergency/trauma and medical-surgical.

John Schmidt, DNP, MSN, BSN, faculty member and program lead for the acute care nurse practitioner program at Purdue Global School of Nursing, refers to these specialties as having a high excitement factor.

“Men gravitate to nursing to help people,” he said. “In critical care, there is instant gratification. You see patients get better. It’s the same in the [intensive care unit] and the emergency department. We take care of them and can see how we made a difference.”

When hospitals and health systems create environments that support men in nursing, patients also benefit. Research shows that patients often prefer nurses of the same gender, and a more diverse healthcare workforce has been linked to improved patient outcomes. Reducing gender inequities among nursing staff could also improve job satisfaction and retention rates for men in nursing.

“When you’re in a vulnerable space as a patient ... it’s important to know that your care provider understands you [and] having men as nurses is a part of that,” said Gomes. “Even though patients might not be used to having a male nurse at the bedside, once they have the experience, it challenges preconceived notions [and] that connection is important.”

Hospitals must proactively support men in nursing to achieve the benefits of greater gender diversity in the nursing workforce. Male nurses have fewer role models and report higher levels of loneliness, isolation, and role strain.

Groups such as NYC Men in Nursing and mentorship programs such as Men in Nursing at RUSH University College of Nursing and RUSH University Medical Center, and the North Carolina Healthcare Association Diverse Healthcare Leaders Mentorship Program were designed to provide coaching, education, and networking opportunities and connect men in nursing.

Male nurses, Dunne added, must be role models and must take the lead in changing the conversations about gender roles in nursing. Establishing support systems and mentorship opportunities is instrumental in inspiring men to pursue nursing careers and creating visibility into the profession and “would create a level of parity for men in the profession and encourage them to want to stay in nursing as a long-term career.”

He told this news organization that creating scholarships for men enrolled in nursing school, increasing the involvement of male nurse leaders in recruitment efforts, and updating curriculum to ensure men are reflected in the materials is also essential.

“We’ve got to be willing and open to having the conversations to end the stereotypes that have plagued the profession,” said Dunne. “And we’ve got to push men in nursing to be front and center so folks see that there are opportunities for men in nursing.”
 

A version of this article appeared on Medscape.com.

Only 12% of the nurses providing patient care at hospitals and health clinics today are men. Although the percentage of nurses has increased — men made up just 2.7% of nurses in 1970 — nursing is still considered a “pink collar” profession, a female-dominated field.

“We’ve made strides over the last couple of decades, but [the number of men pursuing nursing careers] is leveling out,” said Jason Dunne, DNP, MSN, RN, chief academic officer at the Arizona College of Nursing, Phoenix. “There continues to be persistent gender stereotypes that [have] discouraged men from entering the profession.”

A nationwide nursing shortage has led to increased efforts to attract more men to the profession and ensure that men in nursing feel valued and supported and want to continue their careers long term.

“The nursing shortage is very real,” Dunne said. “We need to be highly focused on the shortage and look at opportunities to bring diversity into the profession, and one big way to solve it is bringing more men into nursing.”
 

Representation Matters

Colleges recognize the need to diversify their nursing student population and have turned their attention to increasing the number of men attending informational sessions and career days. Dunne believes, “There is a general lack of awareness of nursing as a career choice [for men].”

The Nursing Consortium of Florida hosts a “Day in the Life of a Nurse” program to introduce high school students to nursing careers, and the University of Virginia School of Nursing invites male nursing students to speak at educational events to promote workforce diversity.

“When I was growing up, the males wouldn’t have been included in those sessions,” said Melissa Gilbert Gomes, PhD, APRN, PMHNP-BC, FNAP, FAAN, associate dean for diversity, equity, and inclusion at the University of Virginia School of Nursing, Charlottesville, Virginia. “It was nice to see their interest and to have a male student there for them to ask questions and to help them see that this could be a place for them.”

Nursing schools have also engaged in other efforts to encourage more men to consider nursing careers, from highlighting male nurses in marketing materials and engaging with men at career fairs to updating course curriculum to include content on men’s health and connecting male nursing students with men in nursing faculty or clinical settings.

Focusing on nursing as a lucrative career choice could also attract more men to the profession. On average, male registered nurses (RNs) make $7300 per year more than their female counterparts due to the gender pay gap. The median wage for male RNs in acute care, cardiology, and perioperative specialties is $90,000 annually.

At the University of Virginia School of Nursing, which the American Association for Men in Nursing (AAMN) named “Best School for Men in Nursing” in 2023, 20% of nursing students are men.

The school has a Men Advancing Nursing club and is in the process of chartering a new AAMN chapter. The goal, according to Gomes, is to create an environment where male nursing students feel represented and supported.

“Valuing the perspective that men bring [to nursing] is important,” she said. “Coming together [and] having that camaraderie and intrinsic motivation to specifically speak to areas that impact men ... is important.”
 

Promoting Patient Care

Highlighting the diversity of career options within the nursing profession is also essential. RNs can pursue careers in specialties ranging from pediatrics, orthopedics, and occupational health to anesthesia, cardiology, and nephrology. The specialty with the highest number of male RNs tends to be acute care, which encompasses emergency/trauma and medical-surgical.

John Schmidt, DNP, MSN, BSN, faculty member and program lead for the acute care nurse practitioner program at Purdue Global School of Nursing, refers to these specialties as having a high excitement factor.

“Men gravitate to nursing to help people,” he said. “In critical care, there is instant gratification. You see patients get better. It’s the same in the [intensive care unit] and the emergency department. We take care of them and can see how we made a difference.”

When hospitals and health systems create environments that support men in nursing, patients also benefit. Research shows that patients often prefer nurses of the same gender, and a more diverse healthcare workforce has been linked to improved patient outcomes. Reducing gender inequities among nursing staff could also improve job satisfaction and retention rates for men in nursing.

“When you’re in a vulnerable space as a patient ... it’s important to know that your care provider understands you [and] having men as nurses is a part of that,” said Gomes. “Even though patients might not be used to having a male nurse at the bedside, once they have the experience, it challenges preconceived notions [and] that connection is important.”

Hospitals must proactively support men in nursing to achieve the benefits of greater gender diversity in the nursing workforce. Male nurses have fewer role models and report higher levels of loneliness, isolation, and role strain.

Groups such as NYC Men in Nursing and mentorship programs such as Men in Nursing at RUSH University College of Nursing and RUSH University Medical Center, and the North Carolina Healthcare Association Diverse Healthcare Leaders Mentorship Program were designed to provide coaching, education, and networking opportunities and connect men in nursing.

Male nurses, Dunne added, must be role models and must take the lead in changing the conversations about gender roles in nursing. Establishing support systems and mentorship opportunities is instrumental in inspiring men to pursue nursing careers and creating visibility into the profession and “would create a level of parity for men in the profession and encourage them to want to stay in nursing as a long-term career.”

He told this news organization that creating scholarships for men enrolled in nursing school, increasing the involvement of male nurse leaders in recruitment efforts, and updating curriculum to ensure men are reflected in the materials is also essential.

“We’ve got to be willing and open to having the conversations to end the stereotypes that have plagued the profession,” said Dunne. “And we’ve got to push men in nursing to be front and center so folks see that there are opportunities for men in nursing.”
 

A version of this article appeared on Medscape.com.

Only 12% of the nurses providing patient care at hospitals and health clinics today are men. Although the percentage of nurses has increased — men made up just 2.7% of nurses in 1970 — nursing is still considered a “pink collar” profession, a female-dominated field.

“We’ve made strides over the last couple of decades, but [the number of men pursuing nursing careers] is leveling out,” said Jason Dunne, DNP, MSN, RN, chief academic officer at the Arizona College of Nursing, Phoenix. “There continues to be persistent gender stereotypes that [have] discouraged men from entering the profession.”

A nationwide nursing shortage has led to increased efforts to attract more men to the profession and ensure that men in nursing feel valued and supported and want to continue their careers long term.

“The nursing shortage is very real,” Dunne said. “We need to be highly focused on the shortage and look at opportunities to bring diversity into the profession, and one big way to solve it is bringing more men into nursing.”
 

Representation Matters

Colleges recognize the need to diversify their nursing student population and have turned their attention to increasing the number of men attending informational sessions and career days. Dunne believes, “There is a general lack of awareness of nursing as a career choice [for men].”

The Nursing Consortium of Florida hosts a “Day in the Life of a Nurse” program to introduce high school students to nursing careers, and the University of Virginia School of Nursing invites male nursing students to speak at educational events to promote workforce diversity.

“When I was growing up, the males wouldn’t have been included in those sessions,” said Melissa Gilbert Gomes, PhD, APRN, PMHNP-BC, FNAP, FAAN, associate dean for diversity, equity, and inclusion at the University of Virginia School of Nursing, Charlottesville, Virginia. “It was nice to see their interest and to have a male student there for them to ask questions and to help them see that this could be a place for them.”

Nursing schools have also engaged in other efforts to encourage more men to consider nursing careers, from highlighting male nurses in marketing materials and engaging with men at career fairs to updating course curriculum to include content on men’s health and connecting male nursing students with men in nursing faculty or clinical settings.

Focusing on nursing as a lucrative career choice could also attract more men to the profession. On average, male registered nurses (RNs) make $7300 per year more than their female counterparts due to the gender pay gap. The median wage for male RNs in acute care, cardiology, and perioperative specialties is $90,000 annually.

At the University of Virginia School of Nursing, which the American Association for Men in Nursing (AAMN) named “Best School for Men in Nursing” in 2023, 20% of nursing students are men.

The school has a Men Advancing Nursing club and is in the process of chartering a new AAMN chapter. The goal, according to Gomes, is to create an environment where male nursing students feel represented and supported.

“Valuing the perspective that men bring [to nursing] is important,” she said. “Coming together [and] having that camaraderie and intrinsic motivation to specifically speak to areas that impact men ... is important.”
 

Promoting Patient Care

Highlighting the diversity of career options within the nursing profession is also essential. RNs can pursue careers in specialties ranging from pediatrics, orthopedics, and occupational health to anesthesia, cardiology, and nephrology. The specialty with the highest number of male RNs tends to be acute care, which encompasses emergency/trauma and medical-surgical.

John Schmidt, DNP, MSN, BSN, faculty member and program lead for the acute care nurse practitioner program at Purdue Global School of Nursing, refers to these specialties as having a high excitement factor.

“Men gravitate to nursing to help people,” he said. “In critical care, there is instant gratification. You see patients get better. It’s the same in the [intensive care unit] and the emergency department. We take care of them and can see how we made a difference.”

When hospitals and health systems create environments that support men in nursing, patients also benefit. Research shows that patients often prefer nurses of the same gender, and a more diverse healthcare workforce has been linked to improved patient outcomes. Reducing gender inequities among nursing staff could also improve job satisfaction and retention rates for men in nursing.

“When you’re in a vulnerable space as a patient ... it’s important to know that your care provider understands you [and] having men as nurses is a part of that,” said Gomes. “Even though patients might not be used to having a male nurse at the bedside, once they have the experience, it challenges preconceived notions [and] that connection is important.”

Hospitals must proactively support men in nursing to achieve the benefits of greater gender diversity in the nursing workforce. Male nurses have fewer role models and report higher levels of loneliness, isolation, and role strain.

Groups such as NYC Men in Nursing and mentorship programs such as Men in Nursing at RUSH University College of Nursing and RUSH University Medical Center, and the North Carolina Healthcare Association Diverse Healthcare Leaders Mentorship Program were designed to provide coaching, education, and networking opportunities and connect men in nursing.

Male nurses, Dunne added, must be role models and must take the lead in changing the conversations about gender roles in nursing. Establishing support systems and mentorship opportunities is instrumental in inspiring men to pursue nursing careers and creating visibility into the profession and “would create a level of parity for men in the profession and encourage them to want to stay in nursing as a long-term career.”

He told this news organization that creating scholarships for men enrolled in nursing school, increasing the involvement of male nurse leaders in recruitment efforts, and updating curriculum to ensure men are reflected in the materials is also essential.

“We’ve got to be willing and open to having the conversations to end the stereotypes that have plagued the profession,” said Dunne. “And we’ve got to push men in nursing to be front and center so folks see that there are opportunities for men in nursing.”
 

A version of this article appeared on Medscape.com.

Federal lawmakers are rushing to soften the blow of Medicare’s 2025 effective pay cut for doctors in 2025, introducing a bill that could limit the cut. But they have little time to act.

In 2025, the conversion factor used to calculate payment to doctors and hospitals caring for Medicare patients will drop to $32.35, a nearly 3% decrease from the current level. 

Congress likely will act before the cuts take effect, said Rep. Larry Bucshon, MD (R-IN), who specialized in cardiothoracic surgery before joining Congress. Lawmakers in past years have typically tinkered with the Medicare physician fee schedule at the last minute, tucking in fixes to December legislative packages and spending bills. 

“I’m pretty optimistic that a good portion of the fee cuts will be mitigated and they won’t go through,” Bucshon told this news organization in an interview.

Bruce A. Scott, MD, president of the American Medical Association (AMA) said in a statement that CMS’ release of the final fee schedule on November 1 should trigger serious work on a change to the 2025 Medicare physician fee schedule.

“The fee schedule rule released [on November 1] starts the clock — with January 1 looming,” Scott said. “A legislative remedy will require hard work and compromise. The 66 million patients who rely on Medicare are counting on that.”

Both Bucshon and Scott also joined many lawmakers and medical associations in calling on Congress for a larger overhaul of the Medicare physician fee schedule, well beyond whatever temporary adjustment may be made in the months ahead to avoid or soften the 2025 cuts.

The physician fee schedule sets formulas and rules regarding how the largest US buyer of health services pays the almost 1.3 million clinicians who bill Medicare. Of these, 51% are physicians. The physician fee schedule also covers payments for nurse practitioners, physician assistants, physical therapists, and other health professionals.
 

Last Major Overhaul Unpopular

There’s broad dissatisfaction with Congress’ last major overhaul of the Medicare physician fee schedule. The 2015 Medicare Access and CHIP Reauthorization Act (MACRA) aimed to shift clinicians toward programs tying pay increases to quality measures. But the implementation of that aim through the Merit-based Incentive Payment System is widely considered a disappointment.

MACRA was intended to end the need for annual “doc fixes,” as Congress’ last-minute Medicare adjustments are known. Seventeen such tweaks passed before MACRA took effect. 

But MACRA did not include a broad-based inflation adjuster, and some clinicians’ incomes are lagging as inflation rates — and practice costs — have risen. Scott said the Medicare Economic Index, which is a measure used to gauge increases in practice costs for clinicians, is expected to rise by 3.5%.

“To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” Scott said. “For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas.”

In a statement, Jen Brull, MD, president of the American Academy of Family Physicians, noted that this likely will be the fifth year in a row that Congress will need to do a patch to prevent cuts in pay to clinicians. 

Bucshon, who will retire from the House in January, said he expects Congress to pass legislation tying Medicare payment rates to inflation — eventually.

“People want to find a way to fix this problem, but also do it in a way that does not cut benefits to anyone, and that’s the key,” Bucshon said. “We’re going to have to find a way to make sure that providers are properly reimbursed.”

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

Federal lawmakers are rushing to soften the blow of Medicare’s 2025 effective pay cut for doctors in 2025, introducing a bill that could limit the cut. But they have little time to act.

In 2025, the conversion factor used to calculate payment to doctors and hospitals caring for Medicare patients will drop to $32.35, a nearly 3% decrease from the current level. 

Congress likely will act before the cuts take effect, said Rep. Larry Bucshon, MD (R-IN), who specialized in cardiothoracic surgery before joining Congress. Lawmakers in past years have typically tinkered with the Medicare physician fee schedule at the last minute, tucking in fixes to December legislative packages and spending bills. 

“I’m pretty optimistic that a good portion of the fee cuts will be mitigated and they won’t go through,” Bucshon told this news organization in an interview.

Bruce A. Scott, MD, president of the American Medical Association (AMA) said in a statement that CMS’ release of the final fee schedule on November 1 should trigger serious work on a change to the 2025 Medicare physician fee schedule.

“The fee schedule rule released [on November 1] starts the clock — with January 1 looming,” Scott said. “A legislative remedy will require hard work and compromise. The 66 million patients who rely on Medicare are counting on that.”

Both Bucshon and Scott also joined many lawmakers and medical associations in calling on Congress for a larger overhaul of the Medicare physician fee schedule, well beyond whatever temporary adjustment may be made in the months ahead to avoid or soften the 2025 cuts.

The physician fee schedule sets formulas and rules regarding how the largest US buyer of health services pays the almost 1.3 million clinicians who bill Medicare. Of these, 51% are physicians. The physician fee schedule also covers payments for nurse practitioners, physician assistants, physical therapists, and other health professionals.
 

Last Major Overhaul Unpopular

There’s broad dissatisfaction with Congress’ last major overhaul of the Medicare physician fee schedule. The 2015 Medicare Access and CHIP Reauthorization Act (MACRA) aimed to shift clinicians toward programs tying pay increases to quality measures. But the implementation of that aim through the Merit-based Incentive Payment System is widely considered a disappointment.

MACRA was intended to end the need for annual “doc fixes,” as Congress’ last-minute Medicare adjustments are known. Seventeen such tweaks passed before MACRA took effect. 

But MACRA did not include a broad-based inflation adjuster, and some clinicians’ incomes are lagging as inflation rates — and practice costs — have risen. Scott said the Medicare Economic Index, which is a measure used to gauge increases in practice costs for clinicians, is expected to rise by 3.5%.

“To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” Scott said. “For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas.”

In a statement, Jen Brull, MD, president of the American Academy of Family Physicians, noted that this likely will be the fifth year in a row that Congress will need to do a patch to prevent cuts in pay to clinicians. 

Bucshon, who will retire from the House in January, said he expects Congress to pass legislation tying Medicare payment rates to inflation — eventually.

“People want to find a way to fix this problem, but also do it in a way that does not cut benefits to anyone, and that’s the key,” Bucshon said. “We’re going to have to find a way to make sure that providers are properly reimbursed.”

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

Federal lawmakers are rushing to soften the blow of Medicare’s 2025 effective pay cut for doctors in 2025, introducing a bill that could limit the cut. But they have little time to act.

In 2025, the conversion factor used to calculate payment to doctors and hospitals caring for Medicare patients will drop to $32.35, a nearly 3% decrease from the current level. 

Congress likely will act before the cuts take effect, said Rep. Larry Bucshon, MD (R-IN), who specialized in cardiothoracic surgery before joining Congress. Lawmakers in past years have typically tinkered with the Medicare physician fee schedule at the last minute, tucking in fixes to December legislative packages and spending bills. 

“I’m pretty optimistic that a good portion of the fee cuts will be mitigated and they won’t go through,” Bucshon told this news organization in an interview.

Bruce A. Scott, MD, president of the American Medical Association (AMA) said in a statement that CMS’ release of the final fee schedule on November 1 should trigger serious work on a change to the 2025 Medicare physician fee schedule.

“The fee schedule rule released [on November 1] starts the clock — with January 1 looming,” Scott said. “A legislative remedy will require hard work and compromise. The 66 million patients who rely on Medicare are counting on that.”

Both Bucshon and Scott also joined many lawmakers and medical associations in calling on Congress for a larger overhaul of the Medicare physician fee schedule, well beyond whatever temporary adjustment may be made in the months ahead to avoid or soften the 2025 cuts.

The physician fee schedule sets formulas and rules regarding how the largest US buyer of health services pays the almost 1.3 million clinicians who bill Medicare. Of these, 51% are physicians. The physician fee schedule also covers payments for nurse practitioners, physician assistants, physical therapists, and other health professionals.
 

Last Major Overhaul Unpopular

There’s broad dissatisfaction with Congress’ last major overhaul of the Medicare physician fee schedule. The 2015 Medicare Access and CHIP Reauthorization Act (MACRA) aimed to shift clinicians toward programs tying pay increases to quality measures. But the implementation of that aim through the Merit-based Incentive Payment System is widely considered a disappointment.

MACRA was intended to end the need for annual “doc fixes,” as Congress’ last-minute Medicare adjustments are known. Seventeen such tweaks passed before MACRA took effect. 

But MACRA did not include a broad-based inflation adjuster, and some clinicians’ incomes are lagging as inflation rates — and practice costs — have risen. Scott said the Medicare Economic Index, which is a measure used to gauge increases in practice costs for clinicians, is expected to rise by 3.5%.

“To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” Scott said. “For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas.”

In a statement, Jen Brull, MD, president of the American Academy of Family Physicians, noted that this likely will be the fifth year in a row that Congress will need to do a patch to prevent cuts in pay to clinicians. 

Bucshon, who will retire from the House in January, said he expects Congress to pass legislation tying Medicare payment rates to inflation — eventually.

“People want to find a way to fix this problem, but also do it in a way that does not cut benefits to anyone, and that’s the key,” Bucshon said. “We’re going to have to find a way to make sure that providers are properly reimbursed.”

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

Misinformation and outdated protocols contribute to the suboptimal management of anaphylaxis by patients and healthcare professionals, based on data from two new studies presented at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting.

Anaphylaxis can strike suddenly, and many patients and caregivers at risk do not know which symptoms to treat with epinephrine, said Joni Chow, DO, of Baylor College of Medicine, San Antonio, Texas, in her presentation at the meeting.

“Early identification of anaphylaxis and early intervention with epinephrine are critical for improving patient outcomes,” Chow said in an interview.

“Many allergic reactions occur in community settings, where written action plans serve to instruct patients and caregivers on how to recognize and respond to these emergencies,” she said. “Currently, anaphylaxis action plans are developed based on the consensus of healthcare professionals, with limited information available on the preferences of patients and caregivers,” she noted. However, even with action plans, many patients and families struggle to recognize and manage severe allergic reactions effectively, she added.

In response to this issue, Chow and colleagues created a survey designed to assess the understanding of anaphylaxis recognition and management by patients and caregivers and to identify their preferences regarding the elements included in the action plans.

In the study, Chow and colleagues surveyed 96 patients and caregivers in an allergy clinic waiting room. The majority (95%) of the patients were prescribed epinephrine. Although 73% said they were comfortable identifying signs of anaphylaxis, only 14% said they were likely to use epinephrine as a first-line treatment.

The most common reason given for avoiding epinephrine was uncertainty over which symptoms to treat (40.6%), followed by hesitancy to visit an emergency department (24%), hesitancy to call 911 (17.7%), uncertainty about how to use epinephrine auto-injectors (11.5%), and fear of needles (5.2%).

Although 85% of the respondents understood that antihistamine use does not prevent the need for epinephrine in cases of anaphylactic reactions, 23.7% said they would use an antihistamine as the first treatment in these cases.

For patients with rash and wheezing after a suspected allergen exposure, approximately two thirds (64.5%) of the respondents said they would inject epinephrine and 10.8% would drive to the emergency room before taking any action, Chow said in her presentation.

The relatively low impact of fear of needles was unexpected, as fear of needles is considered a significant deterrent to epinephrine use, Chow told this news organization. “However, our respondents were more inclined to acknowledge a reluctance to escalate to emergency response as the major barrier to treatment,” she said.

The survey also asked patients what features of an anaphylaxis action plan would be most helpful. A majority of respondents (93%) rated a section for the management of mild (non-anaphylactic) allergic reaction symptoms as somewhat or very important. Visual aids for injection of epinephrine and visuals of anaphylaxis symptoms also ranked as somewhat or very important for 87.6% and 81% of respondents, respectively.

The study highlights the importance of educating allergy patients on recognizing and treating anaphylaxis and demonstrates that visuals were preferred in this survey population, Chow said. “Most patients and caregivers from our surveyed population report knowing how to treat anaphylaxis, but many would not use epinephrine as the first treatment,” she noted.

“The study focused on a single community clinic, and it would be beneficial to gather feedback from patients and caregivers representing a wider variety of educational, cultural, social, and socioeconomic backgrounds,” Chow told this news organization. “Additionally, input from other stakeholders, such as school nurses, would enhance knowledge,” she said.
 

Clinical Anaphylaxis Protocols Fall Short

A second study presented at the meeting showed the need to improve anaphylaxis education for clinicians.

Discrepancies in anaphylaxis management include variations in the definition and treatment of the condition, according to Carly Gunderson, DO, of Memorial Healthcare System, Pembroke Pines, Florida, who presented the study at the meeting.

“So often, we see patients in our office with a history of symptoms that meet criteria for anaphylaxis, yet when they call 911 and emergency medical services (EMS) arrive, they never receive epinephrine,” Gunderson said in an interview. “They receive antihistamines, steroids, everything except epinephrine, which is incredibly concerning given that epinephrine is always the first-line treatment for anaphylaxis,” she said.

“Because EMS providers are often the first healthcare professionals to assess patients experiencing anaphylaxis, their ability to recognize and appropriately treat anaphylaxis is essential,” Gunderson emphasized.

Gunderson and colleagues analyzed data from 30 states with mandatory Advanced Cardiac Life Support protocols to identify gaps in recognizing anaphylaxis and areas for improvement in prehospital management.

Only 15 states (50%) included gastrointestinal symptoms in the definition of anaphylaxis, 40% included neurologic manifestations, and 47% used a two-organ system definition, Gunderson noted in her presentation.

All 30 state protocols recommended diphenhydramine and epinephrine for anaphylactic reactions, 90% recommended albuterol if respiratory symptoms were present, 73% recommended intravenous fluids, and 60% recommended steroids. All but one of the state protocols listed epinephrine as the first-line recommendation for anaphylaxis; 25 states allowed epinephrine autoinjectors and 17 provided autoinjectors.

“We were shocked by how many protocols didn’t include gastrointestinal (abdominal pain, vomiting) or neurologic (lethargy, altered mental status) manifestations, when these are common presenting symptoms of anaphylaxis,” Gunderson told this news organization.

“We were also disappointed by how many protocols continue to recommend outdated interventions such as first-generation antihistamines and corticosteroids in the treatment of anaphylaxis,” she said.

Although anaphylaxis management has come a long way, the current study suggests that there is clearly room for improvement in the education of healthcare providers on how to identify and treat anaphylaxis, said Gunderson. “Most people think of anaphylaxis as the typical ‘face swelling up, throat closing’ type of reaction, which it can be, but in reality, there are so many other ways that it can present,” she said. “Healthcare providers must be aware of all of these possible manifestations so that we can treat in a timely manner to improve outcomes,” she added.

Limitations of the study included the focus only on states with mandatory or model EMS protocols, Gunderson told this news organization. As for additional research, the most important next steps are practical ones, namely, identifying ways to realistically implement necessary protocol changes, she said.
 

Real-World Data Support Need for Education

Real-world studies are important to identify current practice and opportunities for improvement, S. Shahzad Mustafa, MD, lead physician in allergy, immunology, and rheumatology at Rochester Regional Health and clinical associate professor of medicine at the University of Rochester School of Medicine and Dentistry, Rochester, New York, said in an interview.

“Management of anaphylaxis continues to evolve, and studies like these can help standardize evidence-based care across different medical settings, such as emergency medical services, urgent care, and emergency departments,” said Mustafa, who was not involved in either study.

The findings of the two studies were not unexpected, Mustafa said. “Heterogeneity in medical care is well recognized in numerous conditions, and anaphylaxis is no different. Patients and healthcare providers continue to have hesitation to use epinephrine and continue to overly rely on antihistamines and/or systemic steroids,” he noted.

For both studies, the takeaway message is that education is paramount to optimize anaphylaxis management, Mustafa told this news organization. “Education needs to focus on timely recognition of anaphylaxis, including atypical features such as gastrointestinal symptoms, and appropriate therapy with epinephrine,” he said.

Looking ahead, “research demonstrating differences in clinical outcomes with differing approaches to anaphylaxis may highlight the importance of early recognition and treatment with epinephrine,” said Mustafa. Management of anaphylaxis also lends itself to quality improvement studies, he added.

Neither of the studies received any outside funding. The researchers had no financial conflicts to disclose. Mustafa had no disclosures related to anaphylaxis but disclosed serving on the speakers’ bureau for Genentech, GSK, AstraZeneca, Regeneron/Sanofi, and CSL Behring and received grants from Takeda.
 

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

Misinformation and outdated protocols contribute to the suboptimal management of anaphylaxis by patients and healthcare professionals, based on data from two new studies presented at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting.

Anaphylaxis can strike suddenly, and many patients and caregivers at risk do not know which symptoms to treat with epinephrine, said Joni Chow, DO, of Baylor College of Medicine, San Antonio, Texas, in her presentation at the meeting.

“Early identification of anaphylaxis and early intervention with epinephrine are critical for improving patient outcomes,” Chow said in an interview.

“Many allergic reactions occur in community settings, where written action plans serve to instruct patients and caregivers on how to recognize and respond to these emergencies,” she said. “Currently, anaphylaxis action plans are developed based on the consensus of healthcare professionals, with limited information available on the preferences of patients and caregivers,” she noted. However, even with action plans, many patients and families struggle to recognize and manage severe allergic reactions effectively, she added.

In response to this issue, Chow and colleagues created a survey designed to assess the understanding of anaphylaxis recognition and management by patients and caregivers and to identify their preferences regarding the elements included in the action plans.

In the study, Chow and colleagues surveyed 96 patients and caregivers in an allergy clinic waiting room. The majority (95%) of the patients were prescribed epinephrine. Although 73% said they were comfortable identifying signs of anaphylaxis, only 14% said they were likely to use epinephrine as a first-line treatment.

The most common reason given for avoiding epinephrine was uncertainty over which symptoms to treat (40.6%), followed by hesitancy to visit an emergency department (24%), hesitancy to call 911 (17.7%), uncertainty about how to use epinephrine auto-injectors (11.5%), and fear of needles (5.2%).

Although 85% of the respondents understood that antihistamine use does not prevent the need for epinephrine in cases of anaphylactic reactions, 23.7% said they would use an antihistamine as the first treatment in these cases.

For patients with rash and wheezing after a suspected allergen exposure, approximately two thirds (64.5%) of the respondents said they would inject epinephrine and 10.8% would drive to the emergency room before taking any action, Chow said in her presentation.

The relatively low impact of fear of needles was unexpected, as fear of needles is considered a significant deterrent to epinephrine use, Chow told this news organization. “However, our respondents were more inclined to acknowledge a reluctance to escalate to emergency response as the major barrier to treatment,” she said.

The survey also asked patients what features of an anaphylaxis action plan would be most helpful. A majority of respondents (93%) rated a section for the management of mild (non-anaphylactic) allergic reaction symptoms as somewhat or very important. Visual aids for injection of epinephrine and visuals of anaphylaxis symptoms also ranked as somewhat or very important for 87.6% and 81% of respondents, respectively.

The study highlights the importance of educating allergy patients on recognizing and treating anaphylaxis and demonstrates that visuals were preferred in this survey population, Chow said. “Most patients and caregivers from our surveyed population report knowing how to treat anaphylaxis, but many would not use epinephrine as the first treatment,” she noted.

“The study focused on a single community clinic, and it would be beneficial to gather feedback from patients and caregivers representing a wider variety of educational, cultural, social, and socioeconomic backgrounds,” Chow told this news organization. “Additionally, input from other stakeholders, such as school nurses, would enhance knowledge,” she said.
 

Clinical Anaphylaxis Protocols Fall Short

A second study presented at the meeting showed the need to improve anaphylaxis education for clinicians.

Discrepancies in anaphylaxis management include variations in the definition and treatment of the condition, according to Carly Gunderson, DO, of Memorial Healthcare System, Pembroke Pines, Florida, who presented the study at the meeting.

“So often, we see patients in our office with a history of symptoms that meet criteria for anaphylaxis, yet when they call 911 and emergency medical services (EMS) arrive, they never receive epinephrine,” Gunderson said in an interview. “They receive antihistamines, steroids, everything except epinephrine, which is incredibly concerning given that epinephrine is always the first-line treatment for anaphylaxis,” she said.

“Because EMS providers are often the first healthcare professionals to assess patients experiencing anaphylaxis, their ability to recognize and appropriately treat anaphylaxis is essential,” Gunderson emphasized.

Gunderson and colleagues analyzed data from 30 states with mandatory Advanced Cardiac Life Support protocols to identify gaps in recognizing anaphylaxis and areas for improvement in prehospital management.

Only 15 states (50%) included gastrointestinal symptoms in the definition of anaphylaxis, 40% included neurologic manifestations, and 47% used a two-organ system definition, Gunderson noted in her presentation.

All 30 state protocols recommended diphenhydramine and epinephrine for anaphylactic reactions, 90% recommended albuterol if respiratory symptoms were present, 73% recommended intravenous fluids, and 60% recommended steroids. All but one of the state protocols listed epinephrine as the first-line recommendation for anaphylaxis; 25 states allowed epinephrine autoinjectors and 17 provided autoinjectors.

“We were shocked by how many protocols didn’t include gastrointestinal (abdominal pain, vomiting) or neurologic (lethargy, altered mental status) manifestations, when these are common presenting symptoms of anaphylaxis,” Gunderson told this news organization.

“We were also disappointed by how many protocols continue to recommend outdated interventions such as first-generation antihistamines and corticosteroids in the treatment of anaphylaxis,” she said.

Although anaphylaxis management has come a long way, the current study suggests that there is clearly room for improvement in the education of healthcare providers on how to identify and treat anaphylaxis, said Gunderson. “Most people think of anaphylaxis as the typical ‘face swelling up, throat closing’ type of reaction, which it can be, but in reality, there are so many other ways that it can present,” she said. “Healthcare providers must be aware of all of these possible manifestations so that we can treat in a timely manner to improve outcomes,” she added.

Limitations of the study included the focus only on states with mandatory or model EMS protocols, Gunderson told this news organization. As for additional research, the most important next steps are practical ones, namely, identifying ways to realistically implement necessary protocol changes, she said.
 

Real-World Data Support Need for Education

Real-world studies are important to identify current practice and opportunities for improvement, S. Shahzad Mustafa, MD, lead physician in allergy, immunology, and rheumatology at Rochester Regional Health and clinical associate professor of medicine at the University of Rochester School of Medicine and Dentistry, Rochester, New York, said in an interview.

“Management of anaphylaxis continues to evolve, and studies like these can help standardize evidence-based care across different medical settings, such as emergency medical services, urgent care, and emergency departments,” said Mustafa, who was not involved in either study.

The findings of the two studies were not unexpected, Mustafa said. “Heterogeneity in medical care is well recognized in numerous conditions, and anaphylaxis is no different. Patients and healthcare providers continue to have hesitation to use epinephrine and continue to overly rely on antihistamines and/or systemic steroids,” he noted.

For both studies, the takeaway message is that education is paramount to optimize anaphylaxis management, Mustafa told this news organization. “Education needs to focus on timely recognition of anaphylaxis, including atypical features such as gastrointestinal symptoms, and appropriate therapy with epinephrine,” he said.

Looking ahead, “research demonstrating differences in clinical outcomes with differing approaches to anaphylaxis may highlight the importance of early recognition and treatment with epinephrine,” said Mustafa. Management of anaphylaxis also lends itself to quality improvement studies, he added.

Neither of the studies received any outside funding. The researchers had no financial conflicts to disclose. Mustafa had no disclosures related to anaphylaxis but disclosed serving on the speakers’ bureau for Genentech, GSK, AstraZeneca, Regeneron/Sanofi, and CSL Behring and received grants from Takeda.
 

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

Misinformation and outdated protocols contribute to the suboptimal management of anaphylaxis by patients and healthcare professionals, based on data from two new studies presented at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting.

Anaphylaxis can strike suddenly, and many patients and caregivers at risk do not know which symptoms to treat with epinephrine, said Joni Chow, DO, of Baylor College of Medicine, San Antonio, Texas, in her presentation at the meeting.

“Early identification of anaphylaxis and early intervention with epinephrine are critical for improving patient outcomes,” Chow said in an interview.

“Many allergic reactions occur in community settings, where written action plans serve to instruct patients and caregivers on how to recognize and respond to these emergencies,” she said. “Currently, anaphylaxis action plans are developed based on the consensus of healthcare professionals, with limited information available on the preferences of patients and caregivers,” she noted. However, even with action plans, many patients and families struggle to recognize and manage severe allergic reactions effectively, she added.

In response to this issue, Chow and colleagues created a survey designed to assess the understanding of anaphylaxis recognition and management by patients and caregivers and to identify their preferences regarding the elements included in the action plans.

In the study, Chow and colleagues surveyed 96 patients and caregivers in an allergy clinic waiting room. The majority (95%) of the patients were prescribed epinephrine. Although 73% said they were comfortable identifying signs of anaphylaxis, only 14% said they were likely to use epinephrine as a first-line treatment.

The most common reason given for avoiding epinephrine was uncertainty over which symptoms to treat (40.6%), followed by hesitancy to visit an emergency department (24%), hesitancy to call 911 (17.7%), uncertainty about how to use epinephrine auto-injectors (11.5%), and fear of needles (5.2%).

Although 85% of the respondents understood that antihistamine use does not prevent the need for epinephrine in cases of anaphylactic reactions, 23.7% said they would use an antihistamine as the first treatment in these cases.

For patients with rash and wheezing after a suspected allergen exposure, approximately two thirds (64.5%) of the respondents said they would inject epinephrine and 10.8% would drive to the emergency room before taking any action, Chow said in her presentation.

The relatively low impact of fear of needles was unexpected, as fear of needles is considered a significant deterrent to epinephrine use, Chow told this news organization. “However, our respondents were more inclined to acknowledge a reluctance to escalate to emergency response as the major barrier to treatment,” she said.

The survey also asked patients what features of an anaphylaxis action plan would be most helpful. A majority of respondents (93%) rated a section for the management of mild (non-anaphylactic) allergic reaction symptoms as somewhat or very important. Visual aids for injection of epinephrine and visuals of anaphylaxis symptoms also ranked as somewhat or very important for 87.6% and 81% of respondents, respectively.

The study highlights the importance of educating allergy patients on recognizing and treating anaphylaxis and demonstrates that visuals were preferred in this survey population, Chow said. “Most patients and caregivers from our surveyed population report knowing how to treat anaphylaxis, but many would not use epinephrine as the first treatment,” she noted.

“The study focused on a single community clinic, and it would be beneficial to gather feedback from patients and caregivers representing a wider variety of educational, cultural, social, and socioeconomic backgrounds,” Chow told this news organization. “Additionally, input from other stakeholders, such as school nurses, would enhance knowledge,” she said.
 

Clinical Anaphylaxis Protocols Fall Short

A second study presented at the meeting showed the need to improve anaphylaxis education for clinicians.

Discrepancies in anaphylaxis management include variations in the definition and treatment of the condition, according to Carly Gunderson, DO, of Memorial Healthcare System, Pembroke Pines, Florida, who presented the study at the meeting.

“So often, we see patients in our office with a history of symptoms that meet criteria for anaphylaxis, yet when they call 911 and emergency medical services (EMS) arrive, they never receive epinephrine,” Gunderson said in an interview. “They receive antihistamines, steroids, everything except epinephrine, which is incredibly concerning given that epinephrine is always the first-line treatment for anaphylaxis,” she said.

“Because EMS providers are often the first healthcare professionals to assess patients experiencing anaphylaxis, their ability to recognize and appropriately treat anaphylaxis is essential,” Gunderson emphasized.

Gunderson and colleagues analyzed data from 30 states with mandatory Advanced Cardiac Life Support protocols to identify gaps in recognizing anaphylaxis and areas for improvement in prehospital management.

Only 15 states (50%) included gastrointestinal symptoms in the definition of anaphylaxis, 40% included neurologic manifestations, and 47% used a two-organ system definition, Gunderson noted in her presentation.

All 30 state protocols recommended diphenhydramine and epinephrine for anaphylactic reactions, 90% recommended albuterol if respiratory symptoms were present, 73% recommended intravenous fluids, and 60% recommended steroids. All but one of the state protocols listed epinephrine as the first-line recommendation for anaphylaxis; 25 states allowed epinephrine autoinjectors and 17 provided autoinjectors.

“We were shocked by how many protocols didn’t include gastrointestinal (abdominal pain, vomiting) or neurologic (lethargy, altered mental status) manifestations, when these are common presenting symptoms of anaphylaxis,” Gunderson told this news organization.

“We were also disappointed by how many protocols continue to recommend outdated interventions such as first-generation antihistamines and corticosteroids in the treatment of anaphylaxis,” she said.

Although anaphylaxis management has come a long way, the current study suggests that there is clearly room for improvement in the education of healthcare providers on how to identify and treat anaphylaxis, said Gunderson. “Most people think of anaphylaxis as the typical ‘face swelling up, throat closing’ type of reaction, which it can be, but in reality, there are so many other ways that it can present,” she said. “Healthcare providers must be aware of all of these possible manifestations so that we can treat in a timely manner to improve outcomes,” she added.

Limitations of the study included the focus only on states with mandatory or model EMS protocols, Gunderson told this news organization. As for additional research, the most important next steps are practical ones, namely, identifying ways to realistically implement necessary protocol changes, she said.
 

Real-World Data Support Need for Education

Real-world studies are important to identify current practice and opportunities for improvement, S. Shahzad Mustafa, MD, lead physician in allergy, immunology, and rheumatology at Rochester Regional Health and clinical associate professor of medicine at the University of Rochester School of Medicine and Dentistry, Rochester, New York, said in an interview.

“Management of anaphylaxis continues to evolve, and studies like these can help standardize evidence-based care across different medical settings, such as emergency medical services, urgent care, and emergency departments,” said Mustafa, who was not involved in either study.

The findings of the two studies were not unexpected, Mustafa said. “Heterogeneity in medical care is well recognized in numerous conditions, and anaphylaxis is no different. Patients and healthcare providers continue to have hesitation to use epinephrine and continue to overly rely on antihistamines and/or systemic steroids,” he noted.

For both studies, the takeaway message is that education is paramount to optimize anaphylaxis management, Mustafa told this news organization. “Education needs to focus on timely recognition of anaphylaxis, including atypical features such as gastrointestinal symptoms, and appropriate therapy with epinephrine,” he said.

Looking ahead, “research demonstrating differences in clinical outcomes with differing approaches to anaphylaxis may highlight the importance of early recognition and treatment with epinephrine,” said Mustafa. Management of anaphylaxis also lends itself to quality improvement studies, he added.

Neither of the studies received any outside funding. The researchers had no financial conflicts to disclose. Mustafa had no disclosures related to anaphylaxis but disclosed serving on the speakers’ bureau for Genentech, GSK, AstraZeneca, Regeneron/Sanofi, and CSL Behring and received grants from Takeda.
 

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

Vaccination against human papilloma virus (HPV), a group of more than 200 viruses infecting at least 50% of sexually active people over their lifetimes, has proved more than 90% effective for preventing several diseases caused by high-risk HPV types. 

Gardasil 4: 2006 

It started in 2006 with the approval of Human Papillomavirus Quadrivalent, types 6, 11, 16, and 18 (Gardasil 4). Merck’s vaccine began to lower rates of cervical cancer, a major global killer of women.

“It’s fair to say the vaccine has been an American and a global public health success story in reducing rates of cervical cancer,” Paula M. Cuccaro, PhD, assistant professor of health promotion and behavioral sciences at University of Texas School of Public Health, Houston, said in an interview.

How does a common virus trigger such a lethal gynecologic malignancy? “It knocks out two important cancer suppressor genes in cells,” explained Christina Annunziata,MD, PhD, a medical oncologist and senior vice president of extramural discovery science for the American Cancer Society. HPV oncoproteins are encoded by the E6 and E7 genes. As in other DNA tumor viruses, the E6 and E7 proteins functionally inactivate the tumor suppressor proteins p53 and pRB, respectively.
 

US Prevalence

Despite screening and vaccination, cervical cancer is still very much around. This year, 13,820 new cases of invasive cervical cancer will be diagnosed in the United States, and approximately 4360 women will die of it, according to the American Cancer Society. Even before the advent of Gardasil 4, incidence rates had already decreased by more than half from the mid-1970s to the mid-2000s, thanks largely to Pap smear screening programs for treatable premalignant lesions. “The US rate had dropped to about 20 per 100,000 women even before Gardasil 4,” said Annunziata. “After the introduction of the first vaccine, it decreased to 7 per 100,000, a decrease of about 30%, but it remains plateaued now at about the same level.”

Although the past decade has seen rates generally stabilize, there have been some changes in different age groups. In women ages 30-44, rates increased 1.7% each year from 2012 to 2019, while rates declined 11% each year for women ages 20-24— probably reflecting the impact of the first wave of prevention from Gardasil 4.

In one 2021 population-based study of US cancer registry data from 1999 to 2017, rates of both cervical squamous cell carcinoma and adenocarcinoma dropped. The largest declines occurred in females 15-20 years old, the age group most likely to be vaccinated against HPV but not typically screened, suggesting a vaccine-related effect.
 

Gardasil 9: 2014

With the 2014 approval of the vaccine’s second iteration, Gardasil 9, which replaced Gardasil 4 and targeted 9 HPV strains, immunization has taken broader aim. The strains covered by Gardasil 9 protect against oropharyngeal and other head and neck cancers — as well as penile, anal, vulvar, and vaginal malignancies and premalignancies, and genital warts in both sexes ages 9-45. 

It may be years, however, before the impact of the newer polyvalent formulation is felt. “While the first vaccine has been successful against the prevalent strains of HPV linked to cervical cancer, it’s a little early to call it for the newer vaccine since oropharyngeal cancers tend to develop later in older men,” Cuccaro said. “But the types of HPV linked to mouth and throat cancers and covered by the newer vaccines are much less prevalent in those who are vaccinated. The strains not covered in the vaccine you see are equally present in the vaccinated and non-vaccinated.”

Angela L. Myers, MD, MPH, division director of infectious diseases and medical director of the Center for Wellbeing at Children’s Mercy in Kansas City, Missouri, added, “Unlike for cervical cancer, there are no screening programs for oropharyngeal lesions, so you have to wait to see rates until actual cancer develops.”

A 2023 review reported that HPV vaccination reduced levels of oropharyngeal HPV positivity in men, strengthening the case for pangender immunization. 

And in a recent phase 3 doubled-blind trial, GARDASIL 9 reduced the incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo. 
 

Increasing Uptake

The current public health aim is to have 80% of young people in the targeted age group vaccinated with two doses. Today, uptake among those 9-26 years old stands at about 78% of girls and 75% of boys for the first dose, said Annunziata. “But it’s only about 61% for the two doses in the current series, and we want to improve that.” 

Some parents may still harbor fears that immunizing teens and tweens — both the American Academy of Pediatrics and the American Cancer Society recommend immunization at age 9 — will open the door to precocious sexual activity. 

“But overall, uptake in tweens and young teens has increased because the messaging has changed,” said Myers, with the rationale now focusing on cancer prevention not sexual-infection prophylaxis. “This is similar to the hepatitis B vaccine, which used to be given to young adults and is now given to newborns to prevent cancer.” 

Cuccaro added that a proactive presentation by healthcare professionals has a significant effect on vaccine uptake and increases the odds of vaccination ninefold. “Providers should take a presumptive approach and avoid just offering the vaccine as an option. It should be included with regular childhood vaccinations,” she said. “And the advantage of starting early at age 9 is that you can spread the doses out across other regular childhood vaccinations, whereas if you start at age 11, you need to add the HPV vaccine to three other vaccines that are given at that time.” 

After age 15, three doses are necessary. “Providers should stress to parents that it’s most effective when given before young people become sexually active and exposed to HPV,” Cuccaro said. And Myers stressed that despite the vaccine’s effectiveness, routine screening for cervical premalignancies is still important. 

Despite increasing coverage, vaccination rates have some distance to go before the public health target of at least 80% uptake of the series in the targeted age group, Cuccaro cautioned.

On the global stage, barriers to immunization remain, but the World Health Organization has endorsed a campaign to eradicate cervical cancer through HPV vaccination. It has predicted that the 21st century may be the last to experience HPV-associated cancers, currently responsible for more than 300,000 annual deaths worldwide.
 

A Brief History of HPV Vaccines

• 1951. Cervical cancer patient Henrietta Lacks’ rapidly dividing cervical cells are collected by George Otto Gey at Johns Hopkins Hospital. They create the first immortal cell line (HeLa) used to study cancers and vaccines worldwide.
• 1976. Harald zur Hausen suggests that genital wart-associated HPV, not herpes simplex, is the probable cause of cervical cancer.
• 1983. HPV is confirmed as a cause of cancer.
• 1991. The first HPV vaccine is developed.
• 2002. Proof of principle and protective efficacy for the monovalent HPV 16 are shown.
• 2006. Merck’s Gardasil 4 (HPV 4) is FDA approved in girls ages 9-26 for protection against strains 6, 11, 16, and 18 — the cause of more than 70% of cervical cancer cases.
• 2009. Approval of Gardasil 4 is expanded to boys ages 9-26 for the prevention of genital warts.
• 2009. The FDA approves GlaxoSmithKline’s Cervarix (HPV 16 and 18) for girls and young women. The vaccine was withdrawn from the US market in 2016 following the success of Gardasil 9 but is used abroad for HPV cancer prevention.
• 2014. The 9-valent recombinant vaccine Gardasil 9 is FDA approved for protection against several low-risk, wart-causing HPV strains as well as the high-risk cancer strains targeted by HPV 4.
• 2018. The FDA expands approval to include females and males 27-45 years old.
• 2020. The FDA extends approval of Gardasil 9 to include prevention not only of cervical cancer but also, vaginal, vulvar, anal, oropharyngeal, and other head and neck cancers.

Annunziata, Cuccaro, and Myers had no competing interests to declare.
 

A version of this article appeared on Medscape.com.

Vaccination against human papilloma virus (HPV), a group of more than 200 viruses infecting at least 50% of sexually active people over their lifetimes, has proved more than 90% effective for preventing several diseases caused by high-risk HPV types. 

Gardasil 4: 2006 

It started in 2006 with the approval of Human Papillomavirus Quadrivalent, types 6, 11, 16, and 18 (Gardasil 4). Merck’s vaccine began to lower rates of cervical cancer, a major global killer of women.

“It’s fair to say the vaccine has been an American and a global public health success story in reducing rates of cervical cancer,” Paula M. Cuccaro, PhD, assistant professor of health promotion and behavioral sciences at University of Texas School of Public Health, Houston, said in an interview.

How does a common virus trigger such a lethal gynecologic malignancy? “It knocks out two important cancer suppressor genes in cells,” explained Christina Annunziata,MD, PhD, a medical oncologist and senior vice president of extramural discovery science for the American Cancer Society. HPV oncoproteins are encoded by the E6 and E7 genes. As in other DNA tumor viruses, the E6 and E7 proteins functionally inactivate the tumor suppressor proteins p53 and pRB, respectively.
 

US Prevalence

Despite screening and vaccination, cervical cancer is still very much around. This year, 13,820 new cases of invasive cervical cancer will be diagnosed in the United States, and approximately 4360 women will die of it, according to the American Cancer Society. Even before the advent of Gardasil 4, incidence rates had already decreased by more than half from the mid-1970s to the mid-2000s, thanks largely to Pap smear screening programs for treatable premalignant lesions. “The US rate had dropped to about 20 per 100,000 women even before Gardasil 4,” said Annunziata. “After the introduction of the first vaccine, it decreased to 7 per 100,000, a decrease of about 30%, but it remains plateaued now at about the same level.”

Although the past decade has seen rates generally stabilize, there have been some changes in different age groups. In women ages 30-44, rates increased 1.7% each year from 2012 to 2019, while rates declined 11% each year for women ages 20-24— probably reflecting the impact of the first wave of prevention from Gardasil 4.

In one 2021 population-based study of US cancer registry data from 1999 to 2017, rates of both cervical squamous cell carcinoma and adenocarcinoma dropped. The largest declines occurred in females 15-20 years old, the age group most likely to be vaccinated against HPV but not typically screened, suggesting a vaccine-related effect.
 

Gardasil 9: 2014

With the 2014 approval of the vaccine’s second iteration, Gardasil 9, which replaced Gardasil 4 and targeted 9 HPV strains, immunization has taken broader aim. The strains covered by Gardasil 9 protect against oropharyngeal and other head and neck cancers — as well as penile, anal, vulvar, and vaginal malignancies and premalignancies, and genital warts in both sexes ages 9-45. 

It may be years, however, before the impact of the newer polyvalent formulation is felt. “While the first vaccine has been successful against the prevalent strains of HPV linked to cervical cancer, it’s a little early to call it for the newer vaccine since oropharyngeal cancers tend to develop later in older men,” Cuccaro said. “But the types of HPV linked to mouth and throat cancers and covered by the newer vaccines are much less prevalent in those who are vaccinated. The strains not covered in the vaccine you see are equally present in the vaccinated and non-vaccinated.”

Angela L. Myers, MD, MPH, division director of infectious diseases and medical director of the Center for Wellbeing at Children’s Mercy in Kansas City, Missouri, added, “Unlike for cervical cancer, there are no screening programs for oropharyngeal lesions, so you have to wait to see rates until actual cancer develops.”

A 2023 review reported that HPV vaccination reduced levels of oropharyngeal HPV positivity in men, strengthening the case for pangender immunization. 

And in a recent phase 3 doubled-blind trial, GARDASIL 9 reduced the incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo. 
 

Increasing Uptake

The current public health aim is to have 80% of young people in the targeted age group vaccinated with two doses. Today, uptake among those 9-26 years old stands at about 78% of girls and 75% of boys for the first dose, said Annunziata. “But it’s only about 61% for the two doses in the current series, and we want to improve that.” 

Some parents may still harbor fears that immunizing teens and tweens — both the American Academy of Pediatrics and the American Cancer Society recommend immunization at age 9 — will open the door to precocious sexual activity. 

“But overall, uptake in tweens and young teens has increased because the messaging has changed,” said Myers, with the rationale now focusing on cancer prevention not sexual-infection prophylaxis. “This is similar to the hepatitis B vaccine, which used to be given to young adults and is now given to newborns to prevent cancer.” 

Cuccaro added that a proactive presentation by healthcare professionals has a significant effect on vaccine uptake and increases the odds of vaccination ninefold. “Providers should take a presumptive approach and avoid just offering the vaccine as an option. It should be included with regular childhood vaccinations,” she said. “And the advantage of starting early at age 9 is that you can spread the doses out across other regular childhood vaccinations, whereas if you start at age 11, you need to add the HPV vaccine to three other vaccines that are given at that time.” 

After age 15, three doses are necessary. “Providers should stress to parents that it’s most effective when given before young people become sexually active and exposed to HPV,” Cuccaro said. And Myers stressed that despite the vaccine’s effectiveness, routine screening for cervical premalignancies is still important. 

Despite increasing coverage, vaccination rates have some distance to go before the public health target of at least 80% uptake of the series in the targeted age group, Cuccaro cautioned.

On the global stage, barriers to immunization remain, but the World Health Organization has endorsed a campaign to eradicate cervical cancer through HPV vaccination. It has predicted that the 21st century may be the last to experience HPV-associated cancers, currently responsible for more than 300,000 annual deaths worldwide.
 

A Brief History of HPV Vaccines

• 1951. Cervical cancer patient Henrietta Lacks’ rapidly dividing cervical cells are collected by George Otto Gey at Johns Hopkins Hospital. They create the first immortal cell line (HeLa) used to study cancers and vaccines worldwide.
• 1976. Harald zur Hausen suggests that genital wart-associated HPV, not herpes simplex, is the probable cause of cervical cancer.
• 1983. HPV is confirmed as a cause of cancer.
• 1991. The first HPV vaccine is developed.
• 2002. Proof of principle and protective efficacy for the monovalent HPV 16 are shown.
• 2006. Merck’s Gardasil 4 (HPV 4) is FDA approved in girls ages 9-26 for protection against strains 6, 11, 16, and 18 — the cause of more than 70% of cervical cancer cases.
• 2009. Approval of Gardasil 4 is expanded to boys ages 9-26 for the prevention of genital warts.
• 2009. The FDA approves GlaxoSmithKline’s Cervarix (HPV 16 and 18) for girls and young women. The vaccine was withdrawn from the US market in 2016 following the success of Gardasil 9 but is used abroad for HPV cancer prevention.
• 2014. The 9-valent recombinant vaccine Gardasil 9 is FDA approved for protection against several low-risk, wart-causing HPV strains as well as the high-risk cancer strains targeted by HPV 4.
• 2018. The FDA expands approval to include females and males 27-45 years old.
• 2020. The FDA extends approval of Gardasil 9 to include prevention not only of cervical cancer but also, vaginal, vulvar, anal, oropharyngeal, and other head and neck cancers.

Annunziata, Cuccaro, and Myers had no competing interests to declare.
 

A version of this article appeared on Medscape.com.

Vaccination against human papilloma virus (HPV), a group of more than 200 viruses infecting at least 50% of sexually active people over their lifetimes, has proved more than 90% effective for preventing several diseases caused by high-risk HPV types. 

Gardasil 4: 2006 

It started in 2006 with the approval of Human Papillomavirus Quadrivalent, types 6, 11, 16, and 18 (Gardasil 4). Merck’s vaccine began to lower rates of cervical cancer, a major global killer of women.

“It’s fair to say the vaccine has been an American and a global public health success story in reducing rates of cervical cancer,” Paula M. Cuccaro, PhD, assistant professor of health promotion and behavioral sciences at University of Texas School of Public Health, Houston, said in an interview.

How does a common virus trigger such a lethal gynecologic malignancy? “It knocks out two important cancer suppressor genes in cells,” explained Christina Annunziata,MD, PhD, a medical oncologist and senior vice president of extramural discovery science for the American Cancer Society. HPV oncoproteins are encoded by the E6 and E7 genes. As in other DNA tumor viruses, the E6 and E7 proteins functionally inactivate the tumor suppressor proteins p53 and pRB, respectively.
 

US Prevalence

Despite screening and vaccination, cervical cancer is still very much around. This year, 13,820 new cases of invasive cervical cancer will be diagnosed in the United States, and approximately 4360 women will die of it, according to the American Cancer Society. Even before the advent of Gardasil 4, incidence rates had already decreased by more than half from the mid-1970s to the mid-2000s, thanks largely to Pap smear screening programs for treatable premalignant lesions. “The US rate had dropped to about 20 per 100,000 women even before Gardasil 4,” said Annunziata. “After the introduction of the first vaccine, it decreased to 7 per 100,000, a decrease of about 30%, but it remains plateaued now at about the same level.”

Although the past decade has seen rates generally stabilize, there have been some changes in different age groups. In women ages 30-44, rates increased 1.7% each year from 2012 to 2019, while rates declined 11% each year for women ages 20-24— probably reflecting the impact of the first wave of prevention from Gardasil 4.

In one 2021 population-based study of US cancer registry data from 1999 to 2017, rates of both cervical squamous cell carcinoma and adenocarcinoma dropped. The largest declines occurred in females 15-20 years old, the age group most likely to be vaccinated against HPV but not typically screened, suggesting a vaccine-related effect.
 

Gardasil 9: 2014

With the 2014 approval of the vaccine’s second iteration, Gardasil 9, which replaced Gardasil 4 and targeted 9 HPV strains, immunization has taken broader aim. The strains covered by Gardasil 9 protect against oropharyngeal and other head and neck cancers — as well as penile, anal, vulvar, and vaginal malignancies and premalignancies, and genital warts in both sexes ages 9-45. 

It may be years, however, before the impact of the newer polyvalent formulation is felt. “While the first vaccine has been successful against the prevalent strains of HPV linked to cervical cancer, it’s a little early to call it for the newer vaccine since oropharyngeal cancers tend to develop later in older men,” Cuccaro said. “But the types of HPV linked to mouth and throat cancers and covered by the newer vaccines are much less prevalent in those who are vaccinated. The strains not covered in the vaccine you see are equally present in the vaccinated and non-vaccinated.”

Angela L. Myers, MD, MPH, division director of infectious diseases and medical director of the Center for Wellbeing at Children’s Mercy in Kansas City, Missouri, added, “Unlike for cervical cancer, there are no screening programs for oropharyngeal lesions, so you have to wait to see rates until actual cancer develops.”

A 2023 review reported that HPV vaccination reduced levels of oropharyngeal HPV positivity in men, strengthening the case for pangender immunization. 

And in a recent phase 3 doubled-blind trial, GARDASIL 9 reduced the incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo. 
 

Increasing Uptake

The current public health aim is to have 80% of young people in the targeted age group vaccinated with two doses. Today, uptake among those 9-26 years old stands at about 78% of girls and 75% of boys for the first dose, said Annunziata. “But it’s only about 61% for the two doses in the current series, and we want to improve that.” 

Some parents may still harbor fears that immunizing teens and tweens — both the American Academy of Pediatrics and the American Cancer Society recommend immunization at age 9 — will open the door to precocious sexual activity. 

“But overall, uptake in tweens and young teens has increased because the messaging has changed,” said Myers, with the rationale now focusing on cancer prevention not sexual-infection prophylaxis. “This is similar to the hepatitis B vaccine, which used to be given to young adults and is now given to newborns to prevent cancer.” 

Cuccaro added that a proactive presentation by healthcare professionals has a significant effect on vaccine uptake and increases the odds of vaccination ninefold. “Providers should take a presumptive approach and avoid just offering the vaccine as an option. It should be included with regular childhood vaccinations,” she said. “And the advantage of starting early at age 9 is that you can spread the doses out across other regular childhood vaccinations, whereas if you start at age 11, you need to add the HPV vaccine to three other vaccines that are given at that time.” 

After age 15, three doses are necessary. “Providers should stress to parents that it’s most effective when given before young people become sexually active and exposed to HPV,” Cuccaro said. And Myers stressed that despite the vaccine’s effectiveness, routine screening for cervical premalignancies is still important. 

Despite increasing coverage, vaccination rates have some distance to go before the public health target of at least 80% uptake of the series in the targeted age group, Cuccaro cautioned.

On the global stage, barriers to immunization remain, but the World Health Organization has endorsed a campaign to eradicate cervical cancer through HPV vaccination. It has predicted that the 21st century may be the last to experience HPV-associated cancers, currently responsible for more than 300,000 annual deaths worldwide.
 

A Brief History of HPV Vaccines

• 1951. Cervical cancer patient Henrietta Lacks’ rapidly dividing cervical cells are collected by George Otto Gey at Johns Hopkins Hospital. They create the first immortal cell line (HeLa) used to study cancers and vaccines worldwide.
• 1976. Harald zur Hausen suggests that genital wart-associated HPV, not herpes simplex, is the probable cause of cervical cancer.
• 1983. HPV is confirmed as a cause of cancer.
• 1991. The first HPV vaccine is developed.
• 2002. Proof of principle and protective efficacy for the monovalent HPV 16 are shown.
• 2006. Merck’s Gardasil 4 (HPV 4) is FDA approved in girls ages 9-26 for protection against strains 6, 11, 16, and 18 — the cause of more than 70% of cervical cancer cases.
• 2009. Approval of Gardasil 4 is expanded to boys ages 9-26 for the prevention of genital warts.
• 2009. The FDA approves GlaxoSmithKline’s Cervarix (HPV 16 and 18) for girls and young women. The vaccine was withdrawn from the US market in 2016 following the success of Gardasil 9 but is used abroad for HPV cancer prevention.
• 2014. The 9-valent recombinant vaccine Gardasil 9 is FDA approved for protection against several low-risk, wart-causing HPV strains as well as the high-risk cancer strains targeted by HPV 4.
• 2018. The FDA expands approval to include females and males 27-45 years old.
• 2020. The FDA extends approval of Gardasil 9 to include prevention not only of cervical cancer but also, vaginal, vulvar, anal, oropharyngeal, and other head and neck cancers.

Annunziata, Cuccaro, and Myers had no competing interests to declare.
 

A version of this article appeared on Medscape.com.