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Lichen Sclerosus: The Silent Genital Health Concern Often Missed
Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.
In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.
“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.
, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.
“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.
Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.
“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.
Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.
Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.
Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”
Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
Watch Out for Presentation
While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.
“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”
Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.
“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.
For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.
“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.
In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.
“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”
Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.
Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.
“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.
Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.
“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”
If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.
“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.
She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.
“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”
The experts included in the story reported no relevant disclosures.
A version of this article appeared on Medscape.com.
Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.
In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.
“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.
, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.
“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.
Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.
“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.
Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.
Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.
Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”
Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
Watch Out for Presentation
While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.
“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”
Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.
“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.
For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.
“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.
In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.
“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”
Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.
Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.
“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.
Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.
“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”
If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.
“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.
She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.
“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”
The experts included in the story reported no relevant disclosures.
A version of this article appeared on Medscape.com.
Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.
In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.
“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.
, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.
“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.
Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.
“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.
Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.
Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.
Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”
Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
Watch Out for Presentation
While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.
“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”
Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.
“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.
For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.
“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.
In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.
“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”
Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.
Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.
“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.
Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.
“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”
If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.
“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.
She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.
“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”
The experts included in the story reported no relevant disclosures.
A version of this article appeared on Medscape.com.
Urologist Sues Health System Over Noncompete Clause
The lawsuit brings renewed attention to the ongoing public discourse around restrictive covenants for physicians as more state and federal legislators signal plans to limit or ban the practice.
According to a civil suit filed on January 30 in the Court of Common Pleas, Scranton, Pennsylvania, Eric Rottenberg, MD, signed a 3-year employment agreement with Commonwealth Health Physician Network (CPN) in November 2022. He worked for the health system from May to November 2023, seeing patients at several of its locations, including Wilkes-Barre General Hospital and other facilities throughout northeast and central Pennsylvania.
Although Dr. Rottenberg previously practiced in Albany, New York, court records state he did not bring a significant referral or patient base to the new role, receive any specialized training, or have knowledge of CPN’s trade secrets during his tenure.
Instead, he was a “9-to-5 practitioner,” or a physician-employee like a “locum tenens whose replacement would not cost the employer more than his traditional compensation,” the complaint said. Dr. Rottenberg only treated patients assigned to him by CPN and its parent company, Commonwealth Health Systems, and did not take a patient base with him upon his departure from CPN.
Commonwealth Health spokesperson Annmarie Poslock declined to comment on pending litigation.
After becoming frustrated by “restrictions on his ability to practice medicine” at CPN, Dr. Rottenberg submitted the required 90-day written notice to terminate the employment agreement. He subsequently received a letter from Simon Ratliff, CPN’s chief executive officer, confirming that his last day of employment would be February 11, 2024. Ratliff also reiterated that the noncompete clause would be enforced, essentially banning Dr. Rottenberg from practicing within a 20-mile radius of his previous CPN locations for the next 2 years, court documents said.
Dr. Rottenberg was recruited by Lehigh Valley Physician Group (LVPG), part of Lehigh Valley Health Network, in December 2023 for a urology position at its Dickson City and Scranton locations — some of which are within 20 miles of CPN facilities, the complaint said.
Employers often include noncompete terms in physician contracts because they want to keep the departing physician’s patients from following them to a competitor. However, about a dozen states and the District of Columbia have passed legislation that allows physicians and other clinicians to more easily exit contracts and change jobs.
For example, an Indiana law took effect on July 1 that prohibits employers from entering a noncompete agreement with primary care physicians. Minnesota legislators also banned new noncompete agreements for all employees effective July 1.
“There’s actually been a long-standing push for bans on physician noncompetes going back to some of the first states to pass them, like Colorado, Delaware, and Massachusetts, in the late 1970s and early 1980s,” said Evan Starr, PhD, associate professor of management and organization at the Robert H. Smith School of Business at the University of Maryland.
Although New York Governor Kathy Hochul recently vetoed a bill that would have outlawed restrictive covenants, more states may consider passing laws that limit or ban noncompetes amid increasing patient equity and care access concerns. Dr. Starr told this news organization that one reason to eliminate restrictive covenants is because they can cause “third-party harm” to patients. “The patient doesn’t get the choice to sign a noncompete, but they’re going to be impacted by that agreement if the physician has to leave the area,” he said.
Interestingly, one profession — lawyers — is the only occupation in the US for which noncompete agreements are banned, says Dr. Starr. “Basically, the American Medical Association (AMA) and other physician governing bodies haven’t made the same policies to exempt themselves that the lawyers have.”
That may be changing. In June, the AMA’s House of Delegates adopted policies to support the prohibition of noncompete contracts for employed physicians. The change came several months after the Federal Trade Commission (FTC) proposed a new rule that could more broadly ban companies from enforcing noncompete clauses.
Despite Rottenberg’s attorney, Ryan Campbell, Esq, claiming that the noncompete is unenforceable without a protectable business interest, CPN would not release him from the agreement and opted to move forward with litigation, court records said. The suit cites several other cases where Pennsylvania judges have released physicians from similar restrictive covenants.
Mr. Campbell told this news organization that he and his client are “working diligently with CPN and its counsel to resolve the matter amicably and without further litigation.”
As employers await the FTC’s final rule, Dr. Starr says they could take steps to eliminate noncompete agreements altogether in favor of other stipulations. Contract terms prohibiting physicians from soliciting former patients could protect business interests and still allow patients to seek their preferred physician on their own accord.
A version of this article appeared on Medscape.com .
The lawsuit brings renewed attention to the ongoing public discourse around restrictive covenants for physicians as more state and federal legislators signal plans to limit or ban the practice.
According to a civil suit filed on January 30 in the Court of Common Pleas, Scranton, Pennsylvania, Eric Rottenberg, MD, signed a 3-year employment agreement with Commonwealth Health Physician Network (CPN) in November 2022. He worked for the health system from May to November 2023, seeing patients at several of its locations, including Wilkes-Barre General Hospital and other facilities throughout northeast and central Pennsylvania.
Although Dr. Rottenberg previously practiced in Albany, New York, court records state he did not bring a significant referral or patient base to the new role, receive any specialized training, or have knowledge of CPN’s trade secrets during his tenure.
Instead, he was a “9-to-5 practitioner,” or a physician-employee like a “locum tenens whose replacement would not cost the employer more than his traditional compensation,” the complaint said. Dr. Rottenberg only treated patients assigned to him by CPN and its parent company, Commonwealth Health Systems, and did not take a patient base with him upon his departure from CPN.
Commonwealth Health spokesperson Annmarie Poslock declined to comment on pending litigation.
After becoming frustrated by “restrictions on his ability to practice medicine” at CPN, Dr. Rottenberg submitted the required 90-day written notice to terminate the employment agreement. He subsequently received a letter from Simon Ratliff, CPN’s chief executive officer, confirming that his last day of employment would be February 11, 2024. Ratliff also reiterated that the noncompete clause would be enforced, essentially banning Dr. Rottenberg from practicing within a 20-mile radius of his previous CPN locations for the next 2 years, court documents said.
Dr. Rottenberg was recruited by Lehigh Valley Physician Group (LVPG), part of Lehigh Valley Health Network, in December 2023 for a urology position at its Dickson City and Scranton locations — some of which are within 20 miles of CPN facilities, the complaint said.
Employers often include noncompete terms in physician contracts because they want to keep the departing physician’s patients from following them to a competitor. However, about a dozen states and the District of Columbia have passed legislation that allows physicians and other clinicians to more easily exit contracts and change jobs.
For example, an Indiana law took effect on July 1 that prohibits employers from entering a noncompete agreement with primary care physicians. Minnesota legislators also banned new noncompete agreements for all employees effective July 1.
“There’s actually been a long-standing push for bans on physician noncompetes going back to some of the first states to pass them, like Colorado, Delaware, and Massachusetts, in the late 1970s and early 1980s,” said Evan Starr, PhD, associate professor of management and organization at the Robert H. Smith School of Business at the University of Maryland.
Although New York Governor Kathy Hochul recently vetoed a bill that would have outlawed restrictive covenants, more states may consider passing laws that limit or ban noncompetes amid increasing patient equity and care access concerns. Dr. Starr told this news organization that one reason to eliminate restrictive covenants is because they can cause “third-party harm” to patients. “The patient doesn’t get the choice to sign a noncompete, but they’re going to be impacted by that agreement if the physician has to leave the area,” he said.
Interestingly, one profession — lawyers — is the only occupation in the US for which noncompete agreements are banned, says Dr. Starr. “Basically, the American Medical Association (AMA) and other physician governing bodies haven’t made the same policies to exempt themselves that the lawyers have.”
That may be changing. In June, the AMA’s House of Delegates adopted policies to support the prohibition of noncompete contracts for employed physicians. The change came several months after the Federal Trade Commission (FTC) proposed a new rule that could more broadly ban companies from enforcing noncompete clauses.
Despite Rottenberg’s attorney, Ryan Campbell, Esq, claiming that the noncompete is unenforceable without a protectable business interest, CPN would not release him from the agreement and opted to move forward with litigation, court records said. The suit cites several other cases where Pennsylvania judges have released physicians from similar restrictive covenants.
Mr. Campbell told this news organization that he and his client are “working diligently with CPN and its counsel to resolve the matter amicably and without further litigation.”
As employers await the FTC’s final rule, Dr. Starr says they could take steps to eliminate noncompete agreements altogether in favor of other stipulations. Contract terms prohibiting physicians from soliciting former patients could protect business interests and still allow patients to seek their preferred physician on their own accord.
A version of this article appeared on Medscape.com .
The lawsuit brings renewed attention to the ongoing public discourse around restrictive covenants for physicians as more state and federal legislators signal plans to limit or ban the practice.
According to a civil suit filed on January 30 in the Court of Common Pleas, Scranton, Pennsylvania, Eric Rottenberg, MD, signed a 3-year employment agreement with Commonwealth Health Physician Network (CPN) in November 2022. He worked for the health system from May to November 2023, seeing patients at several of its locations, including Wilkes-Barre General Hospital and other facilities throughout northeast and central Pennsylvania.
Although Dr. Rottenberg previously practiced in Albany, New York, court records state he did not bring a significant referral or patient base to the new role, receive any specialized training, or have knowledge of CPN’s trade secrets during his tenure.
Instead, he was a “9-to-5 practitioner,” or a physician-employee like a “locum tenens whose replacement would not cost the employer more than his traditional compensation,” the complaint said. Dr. Rottenberg only treated patients assigned to him by CPN and its parent company, Commonwealth Health Systems, and did not take a patient base with him upon his departure from CPN.
Commonwealth Health spokesperson Annmarie Poslock declined to comment on pending litigation.
After becoming frustrated by “restrictions on his ability to practice medicine” at CPN, Dr. Rottenberg submitted the required 90-day written notice to terminate the employment agreement. He subsequently received a letter from Simon Ratliff, CPN’s chief executive officer, confirming that his last day of employment would be February 11, 2024. Ratliff also reiterated that the noncompete clause would be enforced, essentially banning Dr. Rottenberg from practicing within a 20-mile radius of his previous CPN locations for the next 2 years, court documents said.
Dr. Rottenberg was recruited by Lehigh Valley Physician Group (LVPG), part of Lehigh Valley Health Network, in December 2023 for a urology position at its Dickson City and Scranton locations — some of which are within 20 miles of CPN facilities, the complaint said.
Employers often include noncompete terms in physician contracts because they want to keep the departing physician’s patients from following them to a competitor. However, about a dozen states and the District of Columbia have passed legislation that allows physicians and other clinicians to more easily exit contracts and change jobs.
For example, an Indiana law took effect on July 1 that prohibits employers from entering a noncompete agreement with primary care physicians. Minnesota legislators also banned new noncompete agreements for all employees effective July 1.
“There’s actually been a long-standing push for bans on physician noncompetes going back to some of the first states to pass them, like Colorado, Delaware, and Massachusetts, in the late 1970s and early 1980s,” said Evan Starr, PhD, associate professor of management and organization at the Robert H. Smith School of Business at the University of Maryland.
Although New York Governor Kathy Hochul recently vetoed a bill that would have outlawed restrictive covenants, more states may consider passing laws that limit or ban noncompetes amid increasing patient equity and care access concerns. Dr. Starr told this news organization that one reason to eliminate restrictive covenants is because they can cause “third-party harm” to patients. “The patient doesn’t get the choice to sign a noncompete, but they’re going to be impacted by that agreement if the physician has to leave the area,” he said.
Interestingly, one profession — lawyers — is the only occupation in the US for which noncompete agreements are banned, says Dr. Starr. “Basically, the American Medical Association (AMA) and other physician governing bodies haven’t made the same policies to exempt themselves that the lawyers have.”
That may be changing. In June, the AMA’s House of Delegates adopted policies to support the prohibition of noncompete contracts for employed physicians. The change came several months after the Federal Trade Commission (FTC) proposed a new rule that could more broadly ban companies from enforcing noncompete clauses.
Despite Rottenberg’s attorney, Ryan Campbell, Esq, claiming that the noncompete is unenforceable without a protectable business interest, CPN would not release him from the agreement and opted to move forward with litigation, court records said. The suit cites several other cases where Pennsylvania judges have released physicians from similar restrictive covenants.
Mr. Campbell told this news organization that he and his client are “working diligently with CPN and its counsel to resolve the matter amicably and without further litigation.”
As employers await the FTC’s final rule, Dr. Starr says they could take steps to eliminate noncompete agreements altogether in favor of other stipulations. Contract terms prohibiting physicians from soliciting former patients could protect business interests and still allow patients to seek their preferred physician on their own accord.
A version of this article appeared on Medscape.com .
Nepali IMG Sues NBME for Invalidating USMLE Scores in Cheating Scandal
in response to a widespread cheating scandal.
Latika Giri, MBBS, of Kathmandu, claims the board violated its own procedures by invalidating exam scores before giving examinees a chance to argue and appeal, according to documents filed on February 12 in the US District Court for the District of Columbia. Dr. Giri alleges that the NBME’s actions were discriminatory against Nepali doctors and run afoul of the Civil Rights Act.
Dr. Giri is requesting that the court block NBME from invalidating her scores while the lawsuit continues and restore her original results. The complaint was filed as a class action suit on behalf of Dr. Giri and other as yet unnamed plaintiffs affected by the board’s action.
The lawsuit stems from a January 31 statement from the United States Medical Licensing Examination (USMLE) program that it was voiding scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal.
The announcement came just before the report about the selling and buying of USMLE questions online, and concerns that cheating on the exam had become “rampant” in recent years. The article was cited in Dr. Giri’s lawsuit.
A spokesman for the NBME said the board does not comment on pending litigation.
Kritika Tara Deb, a Washington, DC–based attorney representing Dr. Giri, declined to answer specific questions about the case but expressed confidence in the outcome of the suit.
“A policy that explicitly denies employment to an entire nationality or ethnicity is counter to US law and the USMLE’s non-discrimination principles,” Deb told this news organization in an email. “Such a blatantly discriminatory policy severely punishes honest doctors while unfairly maligning an entire nationality, and we’re confident it will not stand.”
Doctor Says She Didn’t Cheat
Dr. Giri is one of 22,000 foreign medical school graduates who complete the USMLE each year, in addition to the 24,000 US medical school graduates who take the exam.
A 2022 graduate of the Kathmandu University School of Medical Sciences, Dr. Giri completed her board exams in 2023. According to her lawsuit, she studied hard and did not cheat, passing Step 1 and scoring a 252 on Step 2 and a 229 on Step 3. Dr. Giri took Step 1 in Nepal, Step 2 in India, and Step 3 in Connecticut, according to court documents. In January 2024, Dr. Giri was preparing to enter the residency match pool and hoping to start her training in the summer when she received an email from NBME saying her USMLE scores had been invalidated. She was accused of “extremely improbable answer similarity with other examinees testing on the same form at similar times, unusually high performance, and abnormal question response times,” according to the complaint.
Dr. Giri and other examinees affected by the invalidations were given until February 16 to choose from three options. They could request that NBME reconsider its decision, which could take up to 10 weeks; agree to retake the test; or do nothing, in which case their scores would remain invalid and their access to USMLE would be suspended for 3 years.
If examinees chose options 1 or 2, they would be required to waive their right to sue NBME, according to Dr. Giri’s lawsuit.
“Because of the schedule of medical-residency matching, all three options result in graduates being unable to practice medicine for at least a year,” attorneys for Dr. Giri wrote in the complaint. “All three options force many people to abruptly leave the country within 30 days and cause every affected person to lose their jobs or the opportunity to seek a job.”
Lawsuit: Board Did Not Follow Published Practices
Dr. Giri contends that NBME’s handling of the suspected cheating violates its own published procedures and treats the subset of Nepali examinees differently from other medical graduates. Examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal, according to the suit. During the process, the test-taker’s score is treated as valid.
Dr. Giri and others were not provided this same treatment and had their scores invalidated on “the explicit basis that they were associated with Nepal,” the suit claims. The actions are in direct violation of the Civil Rights Act of 1964, which forbids discrimination against “any individual with respect to his terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin,” according to the complaint.
About 800 people are in the subset of Nepali test-takers targeted by the NBME, according to the suit.
Dr. Giri said the score invalidations will cause plaintiffs “irreparable harm” if the NBME’s actions are not promptly halted.
“As of January 31, 2024, plaintiffs who are applying to medical residencies are all ineligible for the Match, the deadline for which is February 28, 2024,” attorneys for Dr. Giri wrote. “All plaintiffs will thus miss this year’s Match no matter what. And NBME has offered no explanation for why it waited until the day before the Match opened to abruptly suspended plaintiffs’ scores: Dr. Giri and many others took some of the invalidated exams more than a year ago.”
Dr. Giri is requesting a decision by the court by February 21. The NBME meanwhile, plans to issue a legal response by February 19, according to court documents.
Meanwhile, a petition started on change.org by a US emergency physician born calls for the USMLE program to degeneralize the wording of its January 31 statement. The USMLE statement “casts a shadow over the achievement of a supermajority of physicians from Nepal who succeeded through perseverance, honesty, and intelligence,” according to the petition. Petitioners want the USMLE program to change and clarify that it does “not mean to malign physicians from the entire country of Nepal.” More than 2700 people have signed the petition.
A version of this article appeared on Medscape.com.
in response to a widespread cheating scandal.
Latika Giri, MBBS, of Kathmandu, claims the board violated its own procedures by invalidating exam scores before giving examinees a chance to argue and appeal, according to documents filed on February 12 in the US District Court for the District of Columbia. Dr. Giri alleges that the NBME’s actions were discriminatory against Nepali doctors and run afoul of the Civil Rights Act.
Dr. Giri is requesting that the court block NBME from invalidating her scores while the lawsuit continues and restore her original results. The complaint was filed as a class action suit on behalf of Dr. Giri and other as yet unnamed plaintiffs affected by the board’s action.
The lawsuit stems from a January 31 statement from the United States Medical Licensing Examination (USMLE) program that it was voiding scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal.
The announcement came just before the report about the selling and buying of USMLE questions online, and concerns that cheating on the exam had become “rampant” in recent years. The article was cited in Dr. Giri’s lawsuit.
A spokesman for the NBME said the board does not comment on pending litigation.
Kritika Tara Deb, a Washington, DC–based attorney representing Dr. Giri, declined to answer specific questions about the case but expressed confidence in the outcome of the suit.
“A policy that explicitly denies employment to an entire nationality or ethnicity is counter to US law and the USMLE’s non-discrimination principles,” Deb told this news organization in an email. “Such a blatantly discriminatory policy severely punishes honest doctors while unfairly maligning an entire nationality, and we’re confident it will not stand.”
Doctor Says She Didn’t Cheat
Dr. Giri is one of 22,000 foreign medical school graduates who complete the USMLE each year, in addition to the 24,000 US medical school graduates who take the exam.
A 2022 graduate of the Kathmandu University School of Medical Sciences, Dr. Giri completed her board exams in 2023. According to her lawsuit, she studied hard and did not cheat, passing Step 1 and scoring a 252 on Step 2 and a 229 on Step 3. Dr. Giri took Step 1 in Nepal, Step 2 in India, and Step 3 in Connecticut, according to court documents. In January 2024, Dr. Giri was preparing to enter the residency match pool and hoping to start her training in the summer when she received an email from NBME saying her USMLE scores had been invalidated. She was accused of “extremely improbable answer similarity with other examinees testing on the same form at similar times, unusually high performance, and abnormal question response times,” according to the complaint.
Dr. Giri and other examinees affected by the invalidations were given until February 16 to choose from three options. They could request that NBME reconsider its decision, which could take up to 10 weeks; agree to retake the test; or do nothing, in which case their scores would remain invalid and their access to USMLE would be suspended for 3 years.
If examinees chose options 1 or 2, they would be required to waive their right to sue NBME, according to Dr. Giri’s lawsuit.
“Because of the schedule of medical-residency matching, all three options result in graduates being unable to practice medicine for at least a year,” attorneys for Dr. Giri wrote in the complaint. “All three options force many people to abruptly leave the country within 30 days and cause every affected person to lose their jobs or the opportunity to seek a job.”
Lawsuit: Board Did Not Follow Published Practices
Dr. Giri contends that NBME’s handling of the suspected cheating violates its own published procedures and treats the subset of Nepali examinees differently from other medical graduates. Examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal, according to the suit. During the process, the test-taker’s score is treated as valid.
Dr. Giri and others were not provided this same treatment and had their scores invalidated on “the explicit basis that they were associated with Nepal,” the suit claims. The actions are in direct violation of the Civil Rights Act of 1964, which forbids discrimination against “any individual with respect to his terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin,” according to the complaint.
About 800 people are in the subset of Nepali test-takers targeted by the NBME, according to the suit.
Dr. Giri said the score invalidations will cause plaintiffs “irreparable harm” if the NBME’s actions are not promptly halted.
“As of January 31, 2024, plaintiffs who are applying to medical residencies are all ineligible for the Match, the deadline for which is February 28, 2024,” attorneys for Dr. Giri wrote. “All plaintiffs will thus miss this year’s Match no matter what. And NBME has offered no explanation for why it waited until the day before the Match opened to abruptly suspended plaintiffs’ scores: Dr. Giri and many others took some of the invalidated exams more than a year ago.”
Dr. Giri is requesting a decision by the court by February 21. The NBME meanwhile, plans to issue a legal response by February 19, according to court documents.
Meanwhile, a petition started on change.org by a US emergency physician born calls for the USMLE program to degeneralize the wording of its January 31 statement. The USMLE statement “casts a shadow over the achievement of a supermajority of physicians from Nepal who succeeded through perseverance, honesty, and intelligence,” according to the petition. Petitioners want the USMLE program to change and clarify that it does “not mean to malign physicians from the entire country of Nepal.” More than 2700 people have signed the petition.
A version of this article appeared on Medscape.com.
in response to a widespread cheating scandal.
Latika Giri, MBBS, of Kathmandu, claims the board violated its own procedures by invalidating exam scores before giving examinees a chance to argue and appeal, according to documents filed on February 12 in the US District Court for the District of Columbia. Dr. Giri alleges that the NBME’s actions were discriminatory against Nepali doctors and run afoul of the Civil Rights Act.
Dr. Giri is requesting that the court block NBME from invalidating her scores while the lawsuit continues and restore her original results. The complaint was filed as a class action suit on behalf of Dr. Giri and other as yet unnamed plaintiffs affected by the board’s action.
The lawsuit stems from a January 31 statement from the United States Medical Licensing Examination (USMLE) program that it was voiding scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal.
The announcement came just before the report about the selling and buying of USMLE questions online, and concerns that cheating on the exam had become “rampant” in recent years. The article was cited in Dr. Giri’s lawsuit.
A spokesman for the NBME said the board does not comment on pending litigation.
Kritika Tara Deb, a Washington, DC–based attorney representing Dr. Giri, declined to answer specific questions about the case but expressed confidence in the outcome of the suit.
“A policy that explicitly denies employment to an entire nationality or ethnicity is counter to US law and the USMLE’s non-discrimination principles,” Deb told this news organization in an email. “Such a blatantly discriminatory policy severely punishes honest doctors while unfairly maligning an entire nationality, and we’re confident it will not stand.”
Doctor Says She Didn’t Cheat
Dr. Giri is one of 22,000 foreign medical school graduates who complete the USMLE each year, in addition to the 24,000 US medical school graduates who take the exam.
A 2022 graduate of the Kathmandu University School of Medical Sciences, Dr. Giri completed her board exams in 2023. According to her lawsuit, she studied hard and did not cheat, passing Step 1 and scoring a 252 on Step 2 and a 229 on Step 3. Dr. Giri took Step 1 in Nepal, Step 2 in India, and Step 3 in Connecticut, according to court documents. In January 2024, Dr. Giri was preparing to enter the residency match pool and hoping to start her training in the summer when she received an email from NBME saying her USMLE scores had been invalidated. She was accused of “extremely improbable answer similarity with other examinees testing on the same form at similar times, unusually high performance, and abnormal question response times,” according to the complaint.
Dr. Giri and other examinees affected by the invalidations were given until February 16 to choose from three options. They could request that NBME reconsider its decision, which could take up to 10 weeks; agree to retake the test; or do nothing, in which case their scores would remain invalid and their access to USMLE would be suspended for 3 years.
If examinees chose options 1 or 2, they would be required to waive their right to sue NBME, according to Dr. Giri’s lawsuit.
“Because of the schedule of medical-residency matching, all three options result in graduates being unable to practice medicine for at least a year,” attorneys for Dr. Giri wrote in the complaint. “All three options force many people to abruptly leave the country within 30 days and cause every affected person to lose their jobs or the opportunity to seek a job.”
Lawsuit: Board Did Not Follow Published Practices
Dr. Giri contends that NBME’s handling of the suspected cheating violates its own published procedures and treats the subset of Nepali examinees differently from other medical graduates. Examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal, according to the suit. During the process, the test-taker’s score is treated as valid.
Dr. Giri and others were not provided this same treatment and had their scores invalidated on “the explicit basis that they were associated with Nepal,” the suit claims. The actions are in direct violation of the Civil Rights Act of 1964, which forbids discrimination against “any individual with respect to his terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin,” according to the complaint.
About 800 people are in the subset of Nepali test-takers targeted by the NBME, according to the suit.
Dr. Giri said the score invalidations will cause plaintiffs “irreparable harm” if the NBME’s actions are not promptly halted.
“As of January 31, 2024, plaintiffs who are applying to medical residencies are all ineligible for the Match, the deadline for which is February 28, 2024,” attorneys for Dr. Giri wrote. “All plaintiffs will thus miss this year’s Match no matter what. And NBME has offered no explanation for why it waited until the day before the Match opened to abruptly suspended plaintiffs’ scores: Dr. Giri and many others took some of the invalidated exams more than a year ago.”
Dr. Giri is requesting a decision by the court by February 21. The NBME meanwhile, plans to issue a legal response by February 19, according to court documents.
Meanwhile, a petition started on change.org by a US emergency physician born calls for the USMLE program to degeneralize the wording of its January 31 statement. The USMLE statement “casts a shadow over the achievement of a supermajority of physicians from Nepal who succeeded through perseverance, honesty, and intelligence,” according to the petition. Petitioners want the USMLE program to change and clarify that it does “not mean to malign physicians from the entire country of Nepal.” More than 2700 people have signed the petition.
A version of this article appeared on Medscape.com.
Hyperbaric Oxygen: Effective Against Cancer Radiation Harm?
Although a new study of hyperbaric oxygen therapy in JAMA Oncology has been “ anxiously awaited” by breast radiation oncologists, the trial does not provide the smoking gun evidence that would justify its routine use, according to experts.
Here’s a snapshot of the current state of affairs regarding hyperbaric oxygen therapy in breast radiation oncology.
What Is Hyperbaric Oxygen Therapy?
Hyperbaric oxygen therapy is a medical procedure aimed at reducing the late toxic effects of breast irradiation, including pain, fibrosis, and edema. Patients breathe pure oxygen at greater than atmospheric pressure in a specialized chamber or room. The process leads to increased partial pressures of oxygen in blood and tissues, which can help form new blood vessels and repair damaged irradiated tissue.
What Is the Current State of Play?
In 2021, the US Food and Drug Administration (FDA) cleared the therapy for a variety of disorders, including radiation injuries. Some health insurers may cover the procedure as well.
Still, the FDA has cautioned clinicians “to be wary of unproven claims of effect,” University of Toronto radiation oncologist Ezra Hahn, MD, and colleagues Aron Popovtzer, MD, and Benjamin W. Corn, MD, said in a JAMA Oncology editorial.
While the procedure is “seldom used by many in practice,” there is growing industry for the procedure. More than 1000 facilities in the United States offer hyperbaric oxygen therapy, but only about 15% are accredited by the Undersea and Hyperbaric Medical Society, which may signal misuse of the procedure.
Does the Latest Study Clarify Whether This Therapy Works?
The most recent evidence on hyperbaric oxygen therapy comes from a single-institution, randomized trial from the Netherlands, dubbed HONEY. In the trial, 189 women who experienced late toxic effects following adjuvant breast radiation were randomized 2:1 to hyperbaric oxygen therapy or a control arm. Of the 125 women offered hyperbaric oxygen therapy, only 25% (31 patients) accepted and completed treatment; those who declined received usual follow-up care.
Among women who completed hyperbaric oxygen therapy, 32% (10 of 31) reported moderate or severe pain at follow-up vs 75% of controls — a 66% reduction. Similarly, 17% of women who completed hyperbaric oxygen therapy reported moderate or severe fibrosis at follow-up vs 86% among the hypothetical treatment-completing controls — an 86% reduction. However, the authors did not observe a significant effect of hyperbaric oxygen therapy on breast edema, movement restriction, or overall quality of life.
The authors also included an intention-to-treat analysis, which included patients who declined hyperbaric oxygen therapy as part of the intervention group. This analysis estimated clinical outcomes among patients who had the intervention available to them, with some taking advantage and others not.
Overall, hyperbaric oxygen therapy “seems effective for reducing pain and fibrosis in women with late local toxic effects after breast irradiation,” concluded investigators led by Dieuwke R. Mink van der Molen, PhD, a researcher at the University Medical Centre Utrecht, the Netherlands. However, most patients offered the therapy declined the invitation, largely because of the “high treatment intensity” burden.
What Are the Limitations of the Current Study?
The investigators and editorialists highlighted a handful of limitations.
For one, the trial had no sham hyperbaric oxygen therapy procedure in the control group. In fact, control patients were selected from a larger cohort of ongoing studies in the Netherlands who were not aware the trial was being conducted.
Because radiation toxicity fluctuates over time and can improve on its own, “a high-quality control arm” would be needed in such a trial, especially to account for subjective and patient-reported outcomes, the editorialists said.
Another key issue: Only a quarter of women offered hyperbaric oxygen therapy agreed to and completed treatment. The treatment burden was the most common reason for declining the procedure. Study participants underwent 30-40 2-hour sessions over 6-8 weeks.
Will the Latest Evidence Usher This Therapy Into More Standard Use?
Probably not, the editorialists concluded.
The HONEY trial “reminds us that convenience has become a factor weighted heavily by patients during the process of decision-making,” Dr. Hahn and colleagues wrote. “Despite experiencing relatively severe symptoms, many declined hyperbaric therapy after being counseled by HONEY investigators about the time commitment.”
Despite its limitations, the trial does offer “modest evidence to justify the use of [hyperbaric oxygen therapy] in treating the chronic morbidities associated with breast irradiation,” the editorialists said. But an “adequately powered randomized, sham-controlled, double-blind trials will be necessary to truly determine the benefit.”
HONEY was partially funded by The Da Vinci Clinic, the Netherlands. The investigators didn’t have any disclosures. One of Dr. Hahn’s coauthors reported personal fees from Lutris Pharma as Chief Medical Officer.
A version of this article appeared on Medscape.com.
Although a new study of hyperbaric oxygen therapy in JAMA Oncology has been “ anxiously awaited” by breast radiation oncologists, the trial does not provide the smoking gun evidence that would justify its routine use, according to experts.
Here’s a snapshot of the current state of affairs regarding hyperbaric oxygen therapy in breast radiation oncology.
What Is Hyperbaric Oxygen Therapy?
Hyperbaric oxygen therapy is a medical procedure aimed at reducing the late toxic effects of breast irradiation, including pain, fibrosis, and edema. Patients breathe pure oxygen at greater than atmospheric pressure in a specialized chamber or room. The process leads to increased partial pressures of oxygen in blood and tissues, which can help form new blood vessels and repair damaged irradiated tissue.
What Is the Current State of Play?
In 2021, the US Food and Drug Administration (FDA) cleared the therapy for a variety of disorders, including radiation injuries. Some health insurers may cover the procedure as well.
Still, the FDA has cautioned clinicians “to be wary of unproven claims of effect,” University of Toronto radiation oncologist Ezra Hahn, MD, and colleagues Aron Popovtzer, MD, and Benjamin W. Corn, MD, said in a JAMA Oncology editorial.
While the procedure is “seldom used by many in practice,” there is growing industry for the procedure. More than 1000 facilities in the United States offer hyperbaric oxygen therapy, but only about 15% are accredited by the Undersea and Hyperbaric Medical Society, which may signal misuse of the procedure.
Does the Latest Study Clarify Whether This Therapy Works?
The most recent evidence on hyperbaric oxygen therapy comes from a single-institution, randomized trial from the Netherlands, dubbed HONEY. In the trial, 189 women who experienced late toxic effects following adjuvant breast radiation were randomized 2:1 to hyperbaric oxygen therapy or a control arm. Of the 125 women offered hyperbaric oxygen therapy, only 25% (31 patients) accepted and completed treatment; those who declined received usual follow-up care.
Among women who completed hyperbaric oxygen therapy, 32% (10 of 31) reported moderate or severe pain at follow-up vs 75% of controls — a 66% reduction. Similarly, 17% of women who completed hyperbaric oxygen therapy reported moderate or severe fibrosis at follow-up vs 86% among the hypothetical treatment-completing controls — an 86% reduction. However, the authors did not observe a significant effect of hyperbaric oxygen therapy on breast edema, movement restriction, or overall quality of life.
The authors also included an intention-to-treat analysis, which included patients who declined hyperbaric oxygen therapy as part of the intervention group. This analysis estimated clinical outcomes among patients who had the intervention available to them, with some taking advantage and others not.
Overall, hyperbaric oxygen therapy “seems effective for reducing pain and fibrosis in women with late local toxic effects after breast irradiation,” concluded investigators led by Dieuwke R. Mink van der Molen, PhD, a researcher at the University Medical Centre Utrecht, the Netherlands. However, most patients offered the therapy declined the invitation, largely because of the “high treatment intensity” burden.
What Are the Limitations of the Current Study?
The investigators and editorialists highlighted a handful of limitations.
For one, the trial had no sham hyperbaric oxygen therapy procedure in the control group. In fact, control patients were selected from a larger cohort of ongoing studies in the Netherlands who were not aware the trial was being conducted.
Because radiation toxicity fluctuates over time and can improve on its own, “a high-quality control arm” would be needed in such a trial, especially to account for subjective and patient-reported outcomes, the editorialists said.
Another key issue: Only a quarter of women offered hyperbaric oxygen therapy agreed to and completed treatment. The treatment burden was the most common reason for declining the procedure. Study participants underwent 30-40 2-hour sessions over 6-8 weeks.
Will the Latest Evidence Usher This Therapy Into More Standard Use?
Probably not, the editorialists concluded.
The HONEY trial “reminds us that convenience has become a factor weighted heavily by patients during the process of decision-making,” Dr. Hahn and colleagues wrote. “Despite experiencing relatively severe symptoms, many declined hyperbaric therapy after being counseled by HONEY investigators about the time commitment.”
Despite its limitations, the trial does offer “modest evidence to justify the use of [hyperbaric oxygen therapy] in treating the chronic morbidities associated with breast irradiation,” the editorialists said. But an “adequately powered randomized, sham-controlled, double-blind trials will be necessary to truly determine the benefit.”
HONEY was partially funded by The Da Vinci Clinic, the Netherlands. The investigators didn’t have any disclosures. One of Dr. Hahn’s coauthors reported personal fees from Lutris Pharma as Chief Medical Officer.
A version of this article appeared on Medscape.com.
Although a new study of hyperbaric oxygen therapy in JAMA Oncology has been “ anxiously awaited” by breast radiation oncologists, the trial does not provide the smoking gun evidence that would justify its routine use, according to experts.
Here’s a snapshot of the current state of affairs regarding hyperbaric oxygen therapy in breast radiation oncology.
What Is Hyperbaric Oxygen Therapy?
Hyperbaric oxygen therapy is a medical procedure aimed at reducing the late toxic effects of breast irradiation, including pain, fibrosis, and edema. Patients breathe pure oxygen at greater than atmospheric pressure in a specialized chamber or room. The process leads to increased partial pressures of oxygen in blood and tissues, which can help form new blood vessels and repair damaged irradiated tissue.
What Is the Current State of Play?
In 2021, the US Food and Drug Administration (FDA) cleared the therapy for a variety of disorders, including radiation injuries. Some health insurers may cover the procedure as well.
Still, the FDA has cautioned clinicians “to be wary of unproven claims of effect,” University of Toronto radiation oncologist Ezra Hahn, MD, and colleagues Aron Popovtzer, MD, and Benjamin W. Corn, MD, said in a JAMA Oncology editorial.
While the procedure is “seldom used by many in practice,” there is growing industry for the procedure. More than 1000 facilities in the United States offer hyperbaric oxygen therapy, but only about 15% are accredited by the Undersea and Hyperbaric Medical Society, which may signal misuse of the procedure.
Does the Latest Study Clarify Whether This Therapy Works?
The most recent evidence on hyperbaric oxygen therapy comes from a single-institution, randomized trial from the Netherlands, dubbed HONEY. In the trial, 189 women who experienced late toxic effects following adjuvant breast radiation were randomized 2:1 to hyperbaric oxygen therapy or a control arm. Of the 125 women offered hyperbaric oxygen therapy, only 25% (31 patients) accepted and completed treatment; those who declined received usual follow-up care.
Among women who completed hyperbaric oxygen therapy, 32% (10 of 31) reported moderate or severe pain at follow-up vs 75% of controls — a 66% reduction. Similarly, 17% of women who completed hyperbaric oxygen therapy reported moderate or severe fibrosis at follow-up vs 86% among the hypothetical treatment-completing controls — an 86% reduction. However, the authors did not observe a significant effect of hyperbaric oxygen therapy on breast edema, movement restriction, or overall quality of life.
The authors also included an intention-to-treat analysis, which included patients who declined hyperbaric oxygen therapy as part of the intervention group. This analysis estimated clinical outcomes among patients who had the intervention available to them, with some taking advantage and others not.
Overall, hyperbaric oxygen therapy “seems effective for reducing pain and fibrosis in women with late local toxic effects after breast irradiation,” concluded investigators led by Dieuwke R. Mink van der Molen, PhD, a researcher at the University Medical Centre Utrecht, the Netherlands. However, most patients offered the therapy declined the invitation, largely because of the “high treatment intensity” burden.
What Are the Limitations of the Current Study?
The investigators and editorialists highlighted a handful of limitations.
For one, the trial had no sham hyperbaric oxygen therapy procedure in the control group. In fact, control patients were selected from a larger cohort of ongoing studies in the Netherlands who were not aware the trial was being conducted.
Because radiation toxicity fluctuates over time and can improve on its own, “a high-quality control arm” would be needed in such a trial, especially to account for subjective and patient-reported outcomes, the editorialists said.
Another key issue: Only a quarter of women offered hyperbaric oxygen therapy agreed to and completed treatment. The treatment burden was the most common reason for declining the procedure. Study participants underwent 30-40 2-hour sessions over 6-8 weeks.
Will the Latest Evidence Usher This Therapy Into More Standard Use?
Probably not, the editorialists concluded.
The HONEY trial “reminds us that convenience has become a factor weighted heavily by patients during the process of decision-making,” Dr. Hahn and colleagues wrote. “Despite experiencing relatively severe symptoms, many declined hyperbaric therapy after being counseled by HONEY investigators about the time commitment.”
Despite its limitations, the trial does offer “modest evidence to justify the use of [hyperbaric oxygen therapy] in treating the chronic morbidities associated with breast irradiation,” the editorialists said. But an “adequately powered randomized, sham-controlled, double-blind trials will be necessary to truly determine the benefit.”
HONEY was partially funded by The Da Vinci Clinic, the Netherlands. The investigators didn’t have any disclosures. One of Dr. Hahn’s coauthors reported personal fees from Lutris Pharma as Chief Medical Officer.
A version of this article appeared on Medscape.com.
Playing Music Tied to Better Cognition in Later Life
TOPLINE:
METHODOLOGY:
- This was a nested study within PROTECT-UK, a longitudinal cohort study designed to examine aging and brain health. Participants completed three tests for working memory and one for executive function up to three times a year between 2019 and 2022.
- A group of 1107 participants (83% female; mean age 68 years) completed the Edinburgh Lifetime Musical Experience Questionnaire, which posed questions about playing musical instruments, singing, listening to music, and self-reported musical ability.
- Participants were split into two groups, namely, those who reported singing or playing a musical instrument (89%) or not (11%), and compared.
TAKEAWAY:
- Participants who reported playing a musical instrument performed significantly better on working memory (P < .0001) and executive function tasks (P < .0005) than those who didn’t play an instrument.
- The effect on working memory was the most heightened in those who reported playing keyboard (P < .0001), while those who played a woodwind instrument (P < .04) and/or sang (P < .014) showed significantly better performance on the executive function task.
- Nearly 90% of the sample had experience playing a musical instrument, with 44% playing currently. The majority of participants reported playing either one (28%) or two (23%) instruments.
IN PRACTICE:
Public health interventions might promote dementia risk reduction by incorporating music into programming, the authors concluded. “There is considerable evidence for the benefit of music group activities for individuals with dementia, and this approach could be extended as part of a health aging package for healthy older adults to enable them to proactively reduce their risk and to promote brain health,” they wrote.
SOURCE:
Gaia Vetere, MD, of the University of Exeter in Exeter, England, led the study, which was published online on January 28, 2024, in the International Journal of Geriatric Psychiatry.
LIMITATIONS:
The data were self-reported so may be subject to bias, and the size of the comparison group (those who didn’t play an instrument or sing) was much smaller.
DISCLOSURES:
The study was funded by the National Institute for Health and Care Research Exeter Biomedical Research Centre. Disclosures were noted in the original article.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- This was a nested study within PROTECT-UK, a longitudinal cohort study designed to examine aging and brain health. Participants completed three tests for working memory and one for executive function up to three times a year between 2019 and 2022.
- A group of 1107 participants (83% female; mean age 68 years) completed the Edinburgh Lifetime Musical Experience Questionnaire, which posed questions about playing musical instruments, singing, listening to music, and self-reported musical ability.
- Participants were split into two groups, namely, those who reported singing or playing a musical instrument (89%) or not (11%), and compared.
TAKEAWAY:
- Participants who reported playing a musical instrument performed significantly better on working memory (P < .0001) and executive function tasks (P < .0005) than those who didn’t play an instrument.
- The effect on working memory was the most heightened in those who reported playing keyboard (P < .0001), while those who played a woodwind instrument (P < .04) and/or sang (P < .014) showed significantly better performance on the executive function task.
- Nearly 90% of the sample had experience playing a musical instrument, with 44% playing currently. The majority of participants reported playing either one (28%) or two (23%) instruments.
IN PRACTICE:
Public health interventions might promote dementia risk reduction by incorporating music into programming, the authors concluded. “There is considerable evidence for the benefit of music group activities for individuals with dementia, and this approach could be extended as part of a health aging package for healthy older adults to enable them to proactively reduce their risk and to promote brain health,” they wrote.
SOURCE:
Gaia Vetere, MD, of the University of Exeter in Exeter, England, led the study, which was published online on January 28, 2024, in the International Journal of Geriatric Psychiatry.
LIMITATIONS:
The data were self-reported so may be subject to bias, and the size of the comparison group (those who didn’t play an instrument or sing) was much smaller.
DISCLOSURES:
The study was funded by the National Institute for Health and Care Research Exeter Biomedical Research Centre. Disclosures were noted in the original article.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- This was a nested study within PROTECT-UK, a longitudinal cohort study designed to examine aging and brain health. Participants completed three tests for working memory and one for executive function up to three times a year between 2019 and 2022.
- A group of 1107 participants (83% female; mean age 68 years) completed the Edinburgh Lifetime Musical Experience Questionnaire, which posed questions about playing musical instruments, singing, listening to music, and self-reported musical ability.
- Participants were split into two groups, namely, those who reported singing or playing a musical instrument (89%) or not (11%), and compared.
TAKEAWAY:
- Participants who reported playing a musical instrument performed significantly better on working memory (P < .0001) and executive function tasks (P < .0005) than those who didn’t play an instrument.
- The effect on working memory was the most heightened in those who reported playing keyboard (P < .0001), while those who played a woodwind instrument (P < .04) and/or sang (P < .014) showed significantly better performance on the executive function task.
- Nearly 90% of the sample had experience playing a musical instrument, with 44% playing currently. The majority of participants reported playing either one (28%) or two (23%) instruments.
IN PRACTICE:
Public health interventions might promote dementia risk reduction by incorporating music into programming, the authors concluded. “There is considerable evidence for the benefit of music group activities for individuals with dementia, and this approach could be extended as part of a health aging package for healthy older adults to enable them to proactively reduce their risk and to promote brain health,” they wrote.
SOURCE:
Gaia Vetere, MD, of the University of Exeter in Exeter, England, led the study, which was published online on January 28, 2024, in the International Journal of Geriatric Psychiatry.
LIMITATIONS:
The data were self-reported so may be subject to bias, and the size of the comparison group (those who didn’t play an instrument or sing) was much smaller.
DISCLOSURES:
The study was funded by the National Institute for Health and Care Research Exeter Biomedical Research Centre. Disclosures were noted in the original article.
A version of this article appeared on Medscape.com.
Stimulant Medications for ADHD — the Good, the Bad, and the Ugly
Children with attention-deficit/hyperactivity disorder (ADHD) are mainly cared for in primary care settings by us. Management of this chronic neurodevelopmental condition that affects 5+% of children worldwide should include proper diagnosis, assessment for contributing and comorbid conditions, behavioral intervention (the primary treatment for preschoolers), ensuring good sleep and nutrition, and usually medication.
Because stimulants are very effective for reducing ADHD symptoms, we may readily begin these first-line medications even on the initial visit when the diagnosis is determined. But are we really thoughtful about knowing and explaining the potential short- and long-term side effects of these medications that may then be used for many years? Considerable discussion with the child and parents may be needed to address their concerns, balanced with benefits, and to make a plan for their access and use of stimulants (and other medications for ADHD not the topic here).
Consider the Side Effects
In children older than 6 years, some form of either a methylphenidate (MPH) or a dextroamphetamine (DA) class of stimulant have been shown to be equally effective in reducing symptoms of ADHD in about 77% of cases, but side effects are common, mostly mild, and mostly in the first months of use. These include reduced appetite, abdominal pain, headache, weight loss, tics, jitteriness, and delays in falling asleep. About half of all children treated will have one of these adverse effects over 5 years, with reduced appetite the most common. There is no difference in effectiveness or side effects by presentation type, i.e. hyperactive, inattentive, or combined, but the DA forms are associated with more side effects than MPH (10% vs. 6%). Medicated preschoolers have more and different side effects which, in addition to those above, may include listlessness, social withdrawal, and repetitive movements. Fortunately, we can reassure families that side effects can usually be readily managed by slower ramp up of dose, spacing to ensure appetite for meals, extra snacks, attention to bowel patterns and bedtime routines, or change in medication class.
Rates of tics while on stimulants are low irrespective of whether DA or MPH is used, and are usually transient, but difficult cases may occur, sometimes as part of Tourette’s, although not a contraindication. Additional side effects of concern are anxiety, irritability, sadness, and overfocusing that may require a change in class of stimulant or to a nonstimulant. Keep in mind that these symptoms may represent comorbid conditions to ADHD, warranting counseling intervention rather than being a medication side effect. Both initial assessment for ADHD and monitoring should look for comorbidities whether medication is used or not.
Measuring height, weight, pulse, and blood pressure should be part of ADHD care. How concerned should you and the family be about variations? Growth rate declines are more common in preschool children; in the PATS study height varied by 20.3%, and weight by 55.2%, more in heavier children. Growth can be protected by providing favored food for school, encouraging eating when hungry, and an evening fourth meal. You can reassure families that, even with continual use of stimulant medicines for years and initial deficits of 2 cm and 2.7 kg compared to expected, no significant differences remain in adulthood.
This longitudinal growth data was collected when short-acting stimulants were the usual, rather than the now common long-acting stimulants given 7 days per week, however. Children on transdermal MPH with 12-hour release over 3 years showed a small but significant delay in growth with the mean deficit rates 1.3 kg/year mainly in the first year, and 0.68 cm/year in height in the second year. If we see growth not recovering as it is expected to after the first year of treatment, we can advise shorter-acting forms, and medication “holidays” on weekends or vacations, that reduce but do not end the deficits. When concerned, a nonstimulant can be selected.
Blood pressure and pulse rate are predictably slightly increased on stimulants (about 2-4 mm Hg and about 3-6 bpm) but not clinically significantly. Although ECGs are not routinely recommended, careful consideration and consultation is warranted before starting stimulants for any patient with structural cardiac abnormalities, unexplained syncope, exertional chest pain, or a family history of sudden death in children or young adults. Neither current nor former users of stimulants for ADHD were found to have greater rates of cardiac events than the general population, however.
Misuse and abuse
Misuse and diversion of stimulants is common (e.g. 26% diverted MPH in the past month; 14% of 12th graders divert DA), often undetected, and potentially dangerous. And the problem is not limited to just the kids. Sixteen percent of parents reported diversion of stimulant medication to another household member, mainly to themselves. Stimulant overdose can occur, especially taken parenterally, and presents with dilated pupils, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and/or seizures. Fortunately, overdose of prescribed stimulants is rarely fatal if medically managed, but recent “fake” Adderall (not from pharmacies) has been circulating. These fake drugs may contain lethal amounts of fentanyl or methamphetamine. Point out to families that a peer-provided stimulant not prescribed for them may have underlying medical or psychiatric issues that increase adverse events. Selling stimulants can have serious legal implications, with punishments ranging from fines to incarceration. A record of arrest during adolescence increases the likelihood of high school dropout, lack of 4-year college education, and later employment barriers. Besides these serious outcomes, it is useful to remind patients that if they deviate from your recommended dosing that you, and others, will not prescribe for them in the future the medication that has been supporting their successful functioning.
You can be fooled about being able to tell if your patients are misusing or diverting the stimulants you prescribe. Most (59%) physicians suspect that more than one of their patients with ADHD has diverted or feigned symptoms (66%) to get a prescription. Women were less likely to suspect their patients than are men, though, so be vigilant! Child psychiatrists had the highest suspicion with their greater proportion of patients with ADHD plus conduct or substance use disorder, who account for 83% of misusers/diverters. We can use education about misuse, pill counts, contracts on dosing, or switching to long-acting or nonstimulants to curb this.
Additional concerns
With more ADHD diagnosis and stimulants used for many years should we worry about longer-term issues? There have been reports in rodent models and a few children of chromosomal changes with stimulant exposure, but reviewers do not interpret these as an individual cancer risk. Record review of patients who received stimulants showed lower numbers of cancer than expected. Nor is there evidence of reproductive effects of stimulants, although use during pregnancy is not cleared.
Stimulants carry a boxed warning as having high potential for abuse and psychological or physical dependence, which is unsurprising given their effects on brain reward pathways. However, neither past nor present use of stimulants for ADHD has been associated with greater substance use long term.
To top off these issues, recent shortages of stimulants complicate ADHD management. Most states require electronic prescribing, US rules only allowing one transfer of such e-prescriptions. With many pharmacies refusing to tell families about availability, we must make multiple calls to locate a source. Pharmacists could help us by looking up patient names of abusers on the registry and identifying sites with adequate supplies.
Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Children with attention-deficit/hyperactivity disorder (ADHD) are mainly cared for in primary care settings by us. Management of this chronic neurodevelopmental condition that affects 5+% of children worldwide should include proper diagnosis, assessment for contributing and comorbid conditions, behavioral intervention (the primary treatment for preschoolers), ensuring good sleep and nutrition, and usually medication.
Because stimulants are very effective for reducing ADHD symptoms, we may readily begin these first-line medications even on the initial visit when the diagnosis is determined. But are we really thoughtful about knowing and explaining the potential short- and long-term side effects of these medications that may then be used for many years? Considerable discussion with the child and parents may be needed to address their concerns, balanced with benefits, and to make a plan for their access and use of stimulants (and other medications for ADHD not the topic here).
Consider the Side Effects
In children older than 6 years, some form of either a methylphenidate (MPH) or a dextroamphetamine (DA) class of stimulant have been shown to be equally effective in reducing symptoms of ADHD in about 77% of cases, but side effects are common, mostly mild, and mostly in the first months of use. These include reduced appetite, abdominal pain, headache, weight loss, tics, jitteriness, and delays in falling asleep. About half of all children treated will have one of these adverse effects over 5 years, with reduced appetite the most common. There is no difference in effectiveness or side effects by presentation type, i.e. hyperactive, inattentive, or combined, but the DA forms are associated with more side effects than MPH (10% vs. 6%). Medicated preschoolers have more and different side effects which, in addition to those above, may include listlessness, social withdrawal, and repetitive movements. Fortunately, we can reassure families that side effects can usually be readily managed by slower ramp up of dose, spacing to ensure appetite for meals, extra snacks, attention to bowel patterns and bedtime routines, or change in medication class.
Rates of tics while on stimulants are low irrespective of whether DA or MPH is used, and are usually transient, but difficult cases may occur, sometimes as part of Tourette’s, although not a contraindication. Additional side effects of concern are anxiety, irritability, sadness, and overfocusing that may require a change in class of stimulant or to a nonstimulant. Keep in mind that these symptoms may represent comorbid conditions to ADHD, warranting counseling intervention rather than being a medication side effect. Both initial assessment for ADHD and monitoring should look for comorbidities whether medication is used or not.
Measuring height, weight, pulse, and blood pressure should be part of ADHD care. How concerned should you and the family be about variations? Growth rate declines are more common in preschool children; in the PATS study height varied by 20.3%, and weight by 55.2%, more in heavier children. Growth can be protected by providing favored food for school, encouraging eating when hungry, and an evening fourth meal. You can reassure families that, even with continual use of stimulant medicines for years and initial deficits of 2 cm and 2.7 kg compared to expected, no significant differences remain in adulthood.
This longitudinal growth data was collected when short-acting stimulants were the usual, rather than the now common long-acting stimulants given 7 days per week, however. Children on transdermal MPH with 12-hour release over 3 years showed a small but significant delay in growth with the mean deficit rates 1.3 kg/year mainly in the first year, and 0.68 cm/year in height in the second year. If we see growth not recovering as it is expected to after the first year of treatment, we can advise shorter-acting forms, and medication “holidays” on weekends or vacations, that reduce but do not end the deficits. When concerned, a nonstimulant can be selected.
Blood pressure and pulse rate are predictably slightly increased on stimulants (about 2-4 mm Hg and about 3-6 bpm) but not clinically significantly. Although ECGs are not routinely recommended, careful consideration and consultation is warranted before starting stimulants for any patient with structural cardiac abnormalities, unexplained syncope, exertional chest pain, or a family history of sudden death in children or young adults. Neither current nor former users of stimulants for ADHD were found to have greater rates of cardiac events than the general population, however.
Misuse and abuse
Misuse and diversion of stimulants is common (e.g. 26% diverted MPH in the past month; 14% of 12th graders divert DA), often undetected, and potentially dangerous. And the problem is not limited to just the kids. Sixteen percent of parents reported diversion of stimulant medication to another household member, mainly to themselves. Stimulant overdose can occur, especially taken parenterally, and presents with dilated pupils, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and/or seizures. Fortunately, overdose of prescribed stimulants is rarely fatal if medically managed, but recent “fake” Adderall (not from pharmacies) has been circulating. These fake drugs may contain lethal amounts of fentanyl or methamphetamine. Point out to families that a peer-provided stimulant not prescribed for them may have underlying medical or psychiatric issues that increase adverse events. Selling stimulants can have serious legal implications, with punishments ranging from fines to incarceration. A record of arrest during adolescence increases the likelihood of high school dropout, lack of 4-year college education, and later employment barriers. Besides these serious outcomes, it is useful to remind patients that if they deviate from your recommended dosing that you, and others, will not prescribe for them in the future the medication that has been supporting their successful functioning.
You can be fooled about being able to tell if your patients are misusing or diverting the stimulants you prescribe. Most (59%) physicians suspect that more than one of their patients with ADHD has diverted or feigned symptoms (66%) to get a prescription. Women were less likely to suspect their patients than are men, though, so be vigilant! Child psychiatrists had the highest suspicion with their greater proportion of patients with ADHD plus conduct or substance use disorder, who account for 83% of misusers/diverters. We can use education about misuse, pill counts, contracts on dosing, or switching to long-acting or nonstimulants to curb this.
Additional concerns
With more ADHD diagnosis and stimulants used for many years should we worry about longer-term issues? There have been reports in rodent models and a few children of chromosomal changes with stimulant exposure, but reviewers do not interpret these as an individual cancer risk. Record review of patients who received stimulants showed lower numbers of cancer than expected. Nor is there evidence of reproductive effects of stimulants, although use during pregnancy is not cleared.
Stimulants carry a boxed warning as having high potential for abuse and psychological or physical dependence, which is unsurprising given their effects on brain reward pathways. However, neither past nor present use of stimulants for ADHD has been associated with greater substance use long term.
To top off these issues, recent shortages of stimulants complicate ADHD management. Most states require electronic prescribing, US rules only allowing one transfer of such e-prescriptions. With many pharmacies refusing to tell families about availability, we must make multiple calls to locate a source. Pharmacists could help us by looking up patient names of abusers on the registry and identifying sites with adequate supplies.
Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Children with attention-deficit/hyperactivity disorder (ADHD) are mainly cared for in primary care settings by us. Management of this chronic neurodevelopmental condition that affects 5+% of children worldwide should include proper diagnosis, assessment for contributing and comorbid conditions, behavioral intervention (the primary treatment for preschoolers), ensuring good sleep and nutrition, and usually medication.
Because stimulants are very effective for reducing ADHD symptoms, we may readily begin these first-line medications even on the initial visit when the diagnosis is determined. But are we really thoughtful about knowing and explaining the potential short- and long-term side effects of these medications that may then be used for many years? Considerable discussion with the child and parents may be needed to address their concerns, balanced with benefits, and to make a plan for their access and use of stimulants (and other medications for ADHD not the topic here).
Consider the Side Effects
In children older than 6 years, some form of either a methylphenidate (MPH) or a dextroamphetamine (DA) class of stimulant have been shown to be equally effective in reducing symptoms of ADHD in about 77% of cases, but side effects are common, mostly mild, and mostly in the first months of use. These include reduced appetite, abdominal pain, headache, weight loss, tics, jitteriness, and delays in falling asleep. About half of all children treated will have one of these adverse effects over 5 years, with reduced appetite the most common. There is no difference in effectiveness or side effects by presentation type, i.e. hyperactive, inattentive, or combined, but the DA forms are associated with more side effects than MPH (10% vs. 6%). Medicated preschoolers have more and different side effects which, in addition to those above, may include listlessness, social withdrawal, and repetitive movements. Fortunately, we can reassure families that side effects can usually be readily managed by slower ramp up of dose, spacing to ensure appetite for meals, extra snacks, attention to bowel patterns and bedtime routines, or change in medication class.
Rates of tics while on stimulants are low irrespective of whether DA or MPH is used, and are usually transient, but difficult cases may occur, sometimes as part of Tourette’s, although not a contraindication. Additional side effects of concern are anxiety, irritability, sadness, and overfocusing that may require a change in class of stimulant or to a nonstimulant. Keep in mind that these symptoms may represent comorbid conditions to ADHD, warranting counseling intervention rather than being a medication side effect. Both initial assessment for ADHD and monitoring should look for comorbidities whether medication is used or not.
Measuring height, weight, pulse, and blood pressure should be part of ADHD care. How concerned should you and the family be about variations? Growth rate declines are more common in preschool children; in the PATS study height varied by 20.3%, and weight by 55.2%, more in heavier children. Growth can be protected by providing favored food for school, encouraging eating when hungry, and an evening fourth meal. You can reassure families that, even with continual use of stimulant medicines for years and initial deficits of 2 cm and 2.7 kg compared to expected, no significant differences remain in adulthood.
This longitudinal growth data was collected when short-acting stimulants were the usual, rather than the now common long-acting stimulants given 7 days per week, however. Children on transdermal MPH with 12-hour release over 3 years showed a small but significant delay in growth with the mean deficit rates 1.3 kg/year mainly in the first year, and 0.68 cm/year in height in the second year. If we see growth not recovering as it is expected to after the first year of treatment, we can advise shorter-acting forms, and medication “holidays” on weekends or vacations, that reduce but do not end the deficits. When concerned, a nonstimulant can be selected.
Blood pressure and pulse rate are predictably slightly increased on stimulants (about 2-4 mm Hg and about 3-6 bpm) but not clinically significantly. Although ECGs are not routinely recommended, careful consideration and consultation is warranted before starting stimulants for any patient with structural cardiac abnormalities, unexplained syncope, exertional chest pain, or a family history of sudden death in children or young adults. Neither current nor former users of stimulants for ADHD were found to have greater rates of cardiac events than the general population, however.
Misuse and abuse
Misuse and diversion of stimulants is common (e.g. 26% diverted MPH in the past month; 14% of 12th graders divert DA), often undetected, and potentially dangerous. And the problem is not limited to just the kids. Sixteen percent of parents reported diversion of stimulant medication to another household member, mainly to themselves. Stimulant overdose can occur, especially taken parenterally, and presents with dilated pupils, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and/or seizures. Fortunately, overdose of prescribed stimulants is rarely fatal if medically managed, but recent “fake” Adderall (not from pharmacies) has been circulating. These fake drugs may contain lethal amounts of fentanyl or methamphetamine. Point out to families that a peer-provided stimulant not prescribed for them may have underlying medical or psychiatric issues that increase adverse events. Selling stimulants can have serious legal implications, with punishments ranging from fines to incarceration. A record of arrest during adolescence increases the likelihood of high school dropout, lack of 4-year college education, and later employment barriers. Besides these serious outcomes, it is useful to remind patients that if they deviate from your recommended dosing that you, and others, will not prescribe for them in the future the medication that has been supporting their successful functioning.
You can be fooled about being able to tell if your patients are misusing or diverting the stimulants you prescribe. Most (59%) physicians suspect that more than one of their patients with ADHD has diverted or feigned symptoms (66%) to get a prescription. Women were less likely to suspect their patients than are men, though, so be vigilant! Child psychiatrists had the highest suspicion with their greater proportion of patients with ADHD plus conduct or substance use disorder, who account for 83% of misusers/diverters. We can use education about misuse, pill counts, contracts on dosing, or switching to long-acting or nonstimulants to curb this.
Additional concerns
With more ADHD diagnosis and stimulants used for many years should we worry about longer-term issues? There have been reports in rodent models and a few children of chromosomal changes with stimulant exposure, but reviewers do not interpret these as an individual cancer risk. Record review of patients who received stimulants showed lower numbers of cancer than expected. Nor is there evidence of reproductive effects of stimulants, although use during pregnancy is not cleared.
Stimulants carry a boxed warning as having high potential for abuse and psychological or physical dependence, which is unsurprising given their effects on brain reward pathways. However, neither past nor present use of stimulants for ADHD has been associated with greater substance use long term.
To top off these issues, recent shortages of stimulants complicate ADHD management. Most states require electronic prescribing, US rules only allowing one transfer of such e-prescriptions. With many pharmacies refusing to tell families about availability, we must make multiple calls to locate a source. Pharmacists could help us by looking up patient names of abusers on the registry and identifying sites with adequate supplies.
Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Despite Good Prognosis, Early Melanoma Sparks Fear of Recurrence
Localized melanoma of the skin is highly curable with surgery, especially when the malignancy is in its early stages. Yet .
These findings come from a study of 51 patients who were treated for stage 0 (melanoma in situ) to stage IIA (Breslow thickness 1.01-2.0 mm without lymph node invasion or metastasis) disease, and who were interviewed about their experiences as survivors and their fear of recurrence.
“Consistent themes and subthemes brought up by participants included anxiety associated with follow-up skin examinations, frequent biopsy procedures attributable to screening intensity, fear of the sun, changes in sun exposure behavior, and increasing thoughts about death. Many of these experiences profoundly affected participants’ lives, despite the favorable prognosis for this group,” wrote Ayisha N. Mahama, MD, MPH, from the Dell Medical School at the University of Texas at Austin, and colleagues, in an article published online in JAMA Dermatology.
Interviews and Inventory
The investigators sought to characterize the psychological well-being of localized melanoma survivors who were treated in their practice. Participants took part in a semistructured interview and the Fear of Cancer Recurrence Inventory short form, with a score of 13 or greater indicating potential cases of clinically significant fear of recurrence.
The mean patient age was 48.5 years, and there were twice as many women as men (34 and 17, respectively). In all, 17 of the patients were treated for stage 0 melanoma, and the remainder were treated for stage I-IIA disease.
The interviews and survey revealed four main “themes” among the patients: anxiety surrounding follow-up appointments and relief after a normal examination; concerns about intensity of melanoma surveillance, including anxiety or reassurance about frequent biopsies and worries regarding familial melanoma risk; lifestyle changes related to sun exposure, such as limiting time outdoors, using sunscreen, and wearing protective clothing; and thoughts about life and death.
On the Fear of Cancer Recurrence Inventory short form, 38 of the 51 participants (75%) had a score of 13 or more points, indicating clinically significant fear of cancer recurrence, and when a higher threshold of 16 or more points were was applied, 34 participants (67%) still met the definition for clinically significant fear of recurrence.
Inform, Reassure, Counsel
“Given the crucial role that dermatologists play in diagnosing melanomas, there may be an opportunity to provide reassurance and support for patients to mitigate the psychological consequences of the diagnosis, by emphasizing the excellent life expectancy at a localized stage, particularly at stage 0. In addition, a referral to a mental health practitioner could be placed for patients with higher levels of anxiety and fear of recurrence,” Dr. Mahama and her coauthors wrote.
They also noted that their findings suggest that some individuals who undergo screening for melanoma might experience “psychological harms” from receiving a melanoma diagnosis “particularly given that many or most screening-detected early-stage melanomas will not progress.”
In an interview seeking objective commentary, a surgical oncologist who was not involved in the study said that anxiety about recurrence is common among patients with melanoma, many of whom may be unfamiliar with significant recent advances such as immunotherapy in the care of patients with more advanced disease.
“Often what we will do in addition to just sharing statistics, which are historical and don’t even necessarily reflect how much better we can do for patients now if the melanoma does recur or metastasize, is recommend close surveillance by their dermatologist,” said Sonia Cohen, MD, PhD, from the Mass General Cancer Center in Boston.
“The earlier we capture a recurrence the better we can help the patients. So that’s something we’ll recommend for patients to help give them a sense of control, and that they’re doing everything they can to capture current or new skin cancers,” she said.
Dr. Cohen and colleagues also instruct patients how to look for potential signs of recurrence, such as swollen lymph nodes or suspicious lesions. Patients who express extreme anxiety may also be referred to an oncology social worker or other support services, she said.
Also asked to comment on the results, Allison Dibiaso MSW, LICSW, a social worker at Dana-Farber Cancer Institute, Boston, Massachusetts, who specializes in melanoma, said that she often sees patients who have been successfully treated for early localized malignant melanoma who experience a fear of recurrence. “These patients frequently express feelings of uncertainty and worry, with the fear of another occurrence always on their mind. Managing this fear on a day-to-day basis can be challenging,” she told this news organization.
Moreover, patients with previous treatment for melanoma often experience significant anxiety before skin exams. “Some may feel anxious and worried a few days or weeks before their appointment wondering if something will reoccur and be discovered during the examination,” she said. “While some individuals develop coping skills to manage their anxiety beforehand, many still feel anxious about the possibility of recurrence until after the exam is over and results are confirmed.”
At Dana-Farber, patients with completely resected lesions are provided with individual counseling and have access to support groups specifically designed for patients with melanoma. In addition, a caregiver group is also available for those supporting patients with melanoma, and, “if needed, we provide referrals to therapists in their local community,” Ms. Dibiaso said.
The study was supported by awards/grants to senior author Adewole S. Adamson, MD, MPP from the Robert Wood Johnson Foundation, Dermatology Foundation, National Institutes of Health, and the American Cancer Society. All authors reported having no conflicts of interest. Dr. Cohen had no relevant conflicts of interest to disclose. Ms. Dibiaso had no relevant conflicts to disclose.
Localized melanoma of the skin is highly curable with surgery, especially when the malignancy is in its early stages. Yet .
These findings come from a study of 51 patients who were treated for stage 0 (melanoma in situ) to stage IIA (Breslow thickness 1.01-2.0 mm without lymph node invasion or metastasis) disease, and who were interviewed about their experiences as survivors and their fear of recurrence.
“Consistent themes and subthemes brought up by participants included anxiety associated with follow-up skin examinations, frequent biopsy procedures attributable to screening intensity, fear of the sun, changes in sun exposure behavior, and increasing thoughts about death. Many of these experiences profoundly affected participants’ lives, despite the favorable prognosis for this group,” wrote Ayisha N. Mahama, MD, MPH, from the Dell Medical School at the University of Texas at Austin, and colleagues, in an article published online in JAMA Dermatology.
Interviews and Inventory
The investigators sought to characterize the psychological well-being of localized melanoma survivors who were treated in their practice. Participants took part in a semistructured interview and the Fear of Cancer Recurrence Inventory short form, with a score of 13 or greater indicating potential cases of clinically significant fear of recurrence.
The mean patient age was 48.5 years, and there were twice as many women as men (34 and 17, respectively). In all, 17 of the patients were treated for stage 0 melanoma, and the remainder were treated for stage I-IIA disease.
The interviews and survey revealed four main “themes” among the patients: anxiety surrounding follow-up appointments and relief after a normal examination; concerns about intensity of melanoma surveillance, including anxiety or reassurance about frequent biopsies and worries regarding familial melanoma risk; lifestyle changes related to sun exposure, such as limiting time outdoors, using sunscreen, and wearing protective clothing; and thoughts about life and death.
On the Fear of Cancer Recurrence Inventory short form, 38 of the 51 participants (75%) had a score of 13 or more points, indicating clinically significant fear of cancer recurrence, and when a higher threshold of 16 or more points were was applied, 34 participants (67%) still met the definition for clinically significant fear of recurrence.
Inform, Reassure, Counsel
“Given the crucial role that dermatologists play in diagnosing melanomas, there may be an opportunity to provide reassurance and support for patients to mitigate the psychological consequences of the diagnosis, by emphasizing the excellent life expectancy at a localized stage, particularly at stage 0. In addition, a referral to a mental health practitioner could be placed for patients with higher levels of anxiety and fear of recurrence,” Dr. Mahama and her coauthors wrote.
They also noted that their findings suggest that some individuals who undergo screening for melanoma might experience “psychological harms” from receiving a melanoma diagnosis “particularly given that many or most screening-detected early-stage melanomas will not progress.”
In an interview seeking objective commentary, a surgical oncologist who was not involved in the study said that anxiety about recurrence is common among patients with melanoma, many of whom may be unfamiliar with significant recent advances such as immunotherapy in the care of patients with more advanced disease.
“Often what we will do in addition to just sharing statistics, which are historical and don’t even necessarily reflect how much better we can do for patients now if the melanoma does recur or metastasize, is recommend close surveillance by their dermatologist,” said Sonia Cohen, MD, PhD, from the Mass General Cancer Center in Boston.
“The earlier we capture a recurrence the better we can help the patients. So that’s something we’ll recommend for patients to help give them a sense of control, and that they’re doing everything they can to capture current or new skin cancers,” she said.
Dr. Cohen and colleagues also instruct patients how to look for potential signs of recurrence, such as swollen lymph nodes or suspicious lesions. Patients who express extreme anxiety may also be referred to an oncology social worker or other support services, she said.
Also asked to comment on the results, Allison Dibiaso MSW, LICSW, a social worker at Dana-Farber Cancer Institute, Boston, Massachusetts, who specializes in melanoma, said that she often sees patients who have been successfully treated for early localized malignant melanoma who experience a fear of recurrence. “These patients frequently express feelings of uncertainty and worry, with the fear of another occurrence always on their mind. Managing this fear on a day-to-day basis can be challenging,” she told this news organization.
Moreover, patients with previous treatment for melanoma often experience significant anxiety before skin exams. “Some may feel anxious and worried a few days or weeks before their appointment wondering if something will reoccur and be discovered during the examination,” she said. “While some individuals develop coping skills to manage their anxiety beforehand, many still feel anxious about the possibility of recurrence until after the exam is over and results are confirmed.”
At Dana-Farber, patients with completely resected lesions are provided with individual counseling and have access to support groups specifically designed for patients with melanoma. In addition, a caregiver group is also available for those supporting patients with melanoma, and, “if needed, we provide referrals to therapists in their local community,” Ms. Dibiaso said.
The study was supported by awards/grants to senior author Adewole S. Adamson, MD, MPP from the Robert Wood Johnson Foundation, Dermatology Foundation, National Institutes of Health, and the American Cancer Society. All authors reported having no conflicts of interest. Dr. Cohen had no relevant conflicts of interest to disclose. Ms. Dibiaso had no relevant conflicts to disclose.
Localized melanoma of the skin is highly curable with surgery, especially when the malignancy is in its early stages. Yet .
These findings come from a study of 51 patients who were treated for stage 0 (melanoma in situ) to stage IIA (Breslow thickness 1.01-2.0 mm without lymph node invasion or metastasis) disease, and who were interviewed about their experiences as survivors and their fear of recurrence.
“Consistent themes and subthemes brought up by participants included anxiety associated with follow-up skin examinations, frequent biopsy procedures attributable to screening intensity, fear of the sun, changes in sun exposure behavior, and increasing thoughts about death. Many of these experiences profoundly affected participants’ lives, despite the favorable prognosis for this group,” wrote Ayisha N. Mahama, MD, MPH, from the Dell Medical School at the University of Texas at Austin, and colleagues, in an article published online in JAMA Dermatology.
Interviews and Inventory
The investigators sought to characterize the psychological well-being of localized melanoma survivors who were treated in their practice. Participants took part in a semistructured interview and the Fear of Cancer Recurrence Inventory short form, with a score of 13 or greater indicating potential cases of clinically significant fear of recurrence.
The mean patient age was 48.5 years, and there were twice as many women as men (34 and 17, respectively). In all, 17 of the patients were treated for stage 0 melanoma, and the remainder were treated for stage I-IIA disease.
The interviews and survey revealed four main “themes” among the patients: anxiety surrounding follow-up appointments and relief after a normal examination; concerns about intensity of melanoma surveillance, including anxiety or reassurance about frequent biopsies and worries regarding familial melanoma risk; lifestyle changes related to sun exposure, such as limiting time outdoors, using sunscreen, and wearing protective clothing; and thoughts about life and death.
On the Fear of Cancer Recurrence Inventory short form, 38 of the 51 participants (75%) had a score of 13 or more points, indicating clinically significant fear of cancer recurrence, and when a higher threshold of 16 or more points were was applied, 34 participants (67%) still met the definition for clinically significant fear of recurrence.
Inform, Reassure, Counsel
“Given the crucial role that dermatologists play in diagnosing melanomas, there may be an opportunity to provide reassurance and support for patients to mitigate the psychological consequences of the diagnosis, by emphasizing the excellent life expectancy at a localized stage, particularly at stage 0. In addition, a referral to a mental health practitioner could be placed for patients with higher levels of anxiety and fear of recurrence,” Dr. Mahama and her coauthors wrote.
They also noted that their findings suggest that some individuals who undergo screening for melanoma might experience “psychological harms” from receiving a melanoma diagnosis “particularly given that many or most screening-detected early-stage melanomas will not progress.”
In an interview seeking objective commentary, a surgical oncologist who was not involved in the study said that anxiety about recurrence is common among patients with melanoma, many of whom may be unfamiliar with significant recent advances such as immunotherapy in the care of patients with more advanced disease.
“Often what we will do in addition to just sharing statistics, which are historical and don’t even necessarily reflect how much better we can do for patients now if the melanoma does recur or metastasize, is recommend close surveillance by their dermatologist,” said Sonia Cohen, MD, PhD, from the Mass General Cancer Center in Boston.
“The earlier we capture a recurrence the better we can help the patients. So that’s something we’ll recommend for patients to help give them a sense of control, and that they’re doing everything they can to capture current or new skin cancers,” she said.
Dr. Cohen and colleagues also instruct patients how to look for potential signs of recurrence, such as swollen lymph nodes or suspicious lesions. Patients who express extreme anxiety may also be referred to an oncology social worker or other support services, she said.
Also asked to comment on the results, Allison Dibiaso MSW, LICSW, a social worker at Dana-Farber Cancer Institute, Boston, Massachusetts, who specializes in melanoma, said that she often sees patients who have been successfully treated for early localized malignant melanoma who experience a fear of recurrence. “These patients frequently express feelings of uncertainty and worry, with the fear of another occurrence always on their mind. Managing this fear on a day-to-day basis can be challenging,” she told this news organization.
Moreover, patients with previous treatment for melanoma often experience significant anxiety before skin exams. “Some may feel anxious and worried a few days or weeks before their appointment wondering if something will reoccur and be discovered during the examination,” she said. “While some individuals develop coping skills to manage their anxiety beforehand, many still feel anxious about the possibility of recurrence until after the exam is over and results are confirmed.”
At Dana-Farber, patients with completely resected lesions are provided with individual counseling and have access to support groups specifically designed for patients with melanoma. In addition, a caregiver group is also available for those supporting patients with melanoma, and, “if needed, we provide referrals to therapists in their local community,” Ms. Dibiaso said.
The study was supported by awards/grants to senior author Adewole S. Adamson, MD, MPP from the Robert Wood Johnson Foundation, Dermatology Foundation, National Institutes of Health, and the American Cancer Society. All authors reported having no conflicts of interest. Dr. Cohen had no relevant conflicts of interest to disclose. Ms. Dibiaso had no relevant conflicts to disclose.
FROM JAMA DERMATOLOGY
Beware the Letter of Intent
I recently received an email from a distraught physician. Several months previously, He could continue running his office any way he wished, set his own hours and fees, and keep his employees. All his overhead expenses would disappear. His income would remain the same, maybe even increase. He signed it eagerly.
When he received the actual sale and employment contracts, none of the details promised in the LOI were included; but he figured that since they were spelled out in the LOI, which both he and the buyer had signed, he was covered. His attorney — a family friend with no experience in medical practice transactions — approved the documents.
The deal seemed too good to be true, and it was. The day after the sale closed, all his employees received termination notices. The group offered to rehire some of them, but at lower salaries and reduced benefits. (Most declined.) The new staffers he received were inadequately trained and unfamiliar with his standard office procedures. Patients complained that fees had increased substantially. His own compensation was contingent on meeting strict billing and performance goals. Malpractice premiums remained his responsibility. His office hours were lengthened to include evenings and Saturday mornings.
When he complained to the group that none of the things promised in the LOI had been delivered, he was informed that the LOI was not legally binding. In fact, the sale and employment contracts both clearly specified that they “replaced any previous written or oral agreements between the parties.”
There are some valuable lessons to be learned here. First, whether you are a young physician seeking a new job with a hospital or large practice, or an older one looking to sell an established practice, retain an attorney experienced in medical transactions early, before you sign anything, binding or not. Second, recognize that any promises made in an LOI must be spelled out in the employment and/or sale contract as well.
You might ask, if the terms in an LOI are not binding, why bother with one at all? For one thing, you want to make sure that you and your potential employer or buyer are on the same page with respect to major terms before you get down to details in the employment agreement and/or the medical practice sale agreement. For another, in most states certain LOI provisions are legally binding. For example, the document will most likely provide that each party is responsible for its own attorneys’ fees and for maintaining confidentiality during the negotiations, and that you will not negotiate with any other parties for some specified period of time. In most cases, such provisions are binding whether you go on to sign a formal contract or not.
When you receive an LOI, go through it carefully and identify areas of concern. The offering party will likely be in a rush to sign you up; but once you sign, you won’t be able to negotiate with anyone else for a while, which weakens your negotiating position. Regardless of what is said about time being “of the essence,” proceed slowly and with caution.
Bear in mind that employers and buyers never begin with their best offer. Unless you have been through this before, it is unlikely that you will know your value as an employee or the value of your practice, or what exactly you are entitled to ask for. Rather than signing something you don’t completely understand, explain to the offering party that you need time to consider and evaluate their offer.
This is the time to hire a competent medical attorney to do some due diligence on the offering party and review their offer, and to educate yourself about practice value and compensation benchmarks in your area. You and your counsel should assemble a list of things that you want changed in the LOI, then present them to the other side. They should be amenable to negotiation. If they are not (as was the case in the example presented earlier), you should reconsider whether you really want to be associated with that particular buyer or employer.
Once you have signed the LOI, experts say speed then works to your advantage. “Time kills all deals,” as one lawyer put it. “The longer it takes to close the transaction, the more that can go wrong.” The prospective employer or buyer could uncover information about you or your practice that decreases their perception of value, or economic conditions might change.
While speed is now important, and most of the core issues should already have been resolved in the LOI, don’t be afraid to ask for everything you want, whether it’s a better sale price, higher compensation, a favorable call schedule, more vacation time, or anything else. You won’t know what you can get if you don’t ask for it.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
I recently received an email from a distraught physician. Several months previously, He could continue running his office any way he wished, set his own hours and fees, and keep his employees. All his overhead expenses would disappear. His income would remain the same, maybe even increase. He signed it eagerly.
When he received the actual sale and employment contracts, none of the details promised in the LOI were included; but he figured that since they were spelled out in the LOI, which both he and the buyer had signed, he was covered. His attorney — a family friend with no experience in medical practice transactions — approved the documents.
The deal seemed too good to be true, and it was. The day after the sale closed, all his employees received termination notices. The group offered to rehire some of them, but at lower salaries and reduced benefits. (Most declined.) The new staffers he received were inadequately trained and unfamiliar with his standard office procedures. Patients complained that fees had increased substantially. His own compensation was contingent on meeting strict billing and performance goals. Malpractice premiums remained his responsibility. His office hours were lengthened to include evenings and Saturday mornings.
When he complained to the group that none of the things promised in the LOI had been delivered, he was informed that the LOI was not legally binding. In fact, the sale and employment contracts both clearly specified that they “replaced any previous written or oral agreements between the parties.”
There are some valuable lessons to be learned here. First, whether you are a young physician seeking a new job with a hospital or large practice, or an older one looking to sell an established practice, retain an attorney experienced in medical transactions early, before you sign anything, binding or not. Second, recognize that any promises made in an LOI must be spelled out in the employment and/or sale contract as well.
You might ask, if the terms in an LOI are not binding, why bother with one at all? For one thing, you want to make sure that you and your potential employer or buyer are on the same page with respect to major terms before you get down to details in the employment agreement and/or the medical practice sale agreement. For another, in most states certain LOI provisions are legally binding. For example, the document will most likely provide that each party is responsible for its own attorneys’ fees and for maintaining confidentiality during the negotiations, and that you will not negotiate with any other parties for some specified period of time. In most cases, such provisions are binding whether you go on to sign a formal contract or not.
When you receive an LOI, go through it carefully and identify areas of concern. The offering party will likely be in a rush to sign you up; but once you sign, you won’t be able to negotiate with anyone else for a while, which weakens your negotiating position. Regardless of what is said about time being “of the essence,” proceed slowly and with caution.
Bear in mind that employers and buyers never begin with their best offer. Unless you have been through this before, it is unlikely that you will know your value as an employee or the value of your practice, or what exactly you are entitled to ask for. Rather than signing something you don’t completely understand, explain to the offering party that you need time to consider and evaluate their offer.
This is the time to hire a competent medical attorney to do some due diligence on the offering party and review their offer, and to educate yourself about practice value and compensation benchmarks in your area. You and your counsel should assemble a list of things that you want changed in the LOI, then present them to the other side. They should be amenable to negotiation. If they are not (as was the case in the example presented earlier), you should reconsider whether you really want to be associated with that particular buyer or employer.
Once you have signed the LOI, experts say speed then works to your advantage. “Time kills all deals,” as one lawyer put it. “The longer it takes to close the transaction, the more that can go wrong.” The prospective employer or buyer could uncover information about you or your practice that decreases their perception of value, or economic conditions might change.
While speed is now important, and most of the core issues should already have been resolved in the LOI, don’t be afraid to ask for everything you want, whether it’s a better sale price, higher compensation, a favorable call schedule, more vacation time, or anything else. You won’t know what you can get if you don’t ask for it.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
I recently received an email from a distraught physician. Several months previously, He could continue running his office any way he wished, set his own hours and fees, and keep his employees. All his overhead expenses would disappear. His income would remain the same, maybe even increase. He signed it eagerly.
When he received the actual sale and employment contracts, none of the details promised in the LOI were included; but he figured that since they were spelled out in the LOI, which both he and the buyer had signed, he was covered. His attorney — a family friend with no experience in medical practice transactions — approved the documents.
The deal seemed too good to be true, and it was. The day after the sale closed, all his employees received termination notices. The group offered to rehire some of them, but at lower salaries and reduced benefits. (Most declined.) The new staffers he received were inadequately trained and unfamiliar with his standard office procedures. Patients complained that fees had increased substantially. His own compensation was contingent on meeting strict billing and performance goals. Malpractice premiums remained his responsibility. His office hours were lengthened to include evenings and Saturday mornings.
When he complained to the group that none of the things promised in the LOI had been delivered, he was informed that the LOI was not legally binding. In fact, the sale and employment contracts both clearly specified that they “replaced any previous written or oral agreements between the parties.”
There are some valuable lessons to be learned here. First, whether you are a young physician seeking a new job with a hospital or large practice, or an older one looking to sell an established practice, retain an attorney experienced in medical transactions early, before you sign anything, binding or not. Second, recognize that any promises made in an LOI must be spelled out in the employment and/or sale contract as well.
You might ask, if the terms in an LOI are not binding, why bother with one at all? For one thing, you want to make sure that you and your potential employer or buyer are on the same page with respect to major terms before you get down to details in the employment agreement and/or the medical practice sale agreement. For another, in most states certain LOI provisions are legally binding. For example, the document will most likely provide that each party is responsible for its own attorneys’ fees and for maintaining confidentiality during the negotiations, and that you will not negotiate with any other parties for some specified period of time. In most cases, such provisions are binding whether you go on to sign a formal contract or not.
When you receive an LOI, go through it carefully and identify areas of concern. The offering party will likely be in a rush to sign you up; but once you sign, you won’t be able to negotiate with anyone else for a while, which weakens your negotiating position. Regardless of what is said about time being “of the essence,” proceed slowly and with caution.
Bear in mind that employers and buyers never begin with their best offer. Unless you have been through this before, it is unlikely that you will know your value as an employee or the value of your practice, or what exactly you are entitled to ask for. Rather than signing something you don’t completely understand, explain to the offering party that you need time to consider and evaluate their offer.
This is the time to hire a competent medical attorney to do some due diligence on the offering party and review their offer, and to educate yourself about practice value and compensation benchmarks in your area. You and your counsel should assemble a list of things that you want changed in the LOI, then present them to the other side. They should be amenable to negotiation. If they are not (as was the case in the example presented earlier), you should reconsider whether you really want to be associated with that particular buyer or employer.
Once you have signed the LOI, experts say speed then works to your advantage. “Time kills all deals,” as one lawyer put it. “The longer it takes to close the transaction, the more that can go wrong.” The prospective employer or buyer could uncover information about you or your practice that decreases their perception of value, or economic conditions might change.
While speed is now important, and most of the core issues should already have been resolved in the LOI, don’t be afraid to ask for everything you want, whether it’s a better sale price, higher compensation, a favorable call schedule, more vacation time, or anything else. You won’t know what you can get if you don’t ask for it.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
New Trials in Gynecologic Cancers: Could Your Patient Benefit?
Persistent or recurrent endometrial cancer or any advanced solid gynecologic tumor with appropriate ATR mutations. Patients with one of these diagnoses may be eligible to join a phase 2, randomized, open-label study of an experimental drug called ART0380. ART0380 inhibits the ability of cancer cells to repair DNA damage by targeting a DNA repair kinase called ATR (ataxia telangiectasia–mutated and Rad3-related) protein, which is faulty in some tumors. The hope is that ART0380 will overwhelm the inadequate DNA repair processes of these cancer cells while sparing the more robust DNA repair in healthy cells.
All participants in the trial will take daily oral ART0380 until disease progression, withdrawal of consent, or unacceptable toxicity, whichever happens first. Some individuals will receive the treatment for 3 weeks out of every 4. Sites in California, Illinois, Massachusetts, New York, Oklahoma, Pennsylvania, Rhode Island, and France started recruiting 60 participants with endometrial cancer or any solid tumor in September 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and quality of life (QOL) is not assessed. More details at ClinicalTrials.gov
Maurie Markman, MD, president of medicine and science at City of Hope, Atlanta, who is not involved in this trial, explained that because “ a meaningful proportion of this population may have a defect in this DNA repair mechanism,” this hypothesis seems “worthy of clinical exploration.”
Cancer of the endometrium, cervix, vagina, or vulva. Women with one of these types of cancer who can read and understand English or Spanish can join a randomized, open-label phase 2 trial to determine whether Reiki therapy can reduce pain and distress associated with brachytherapy.
Reiki is a complementary therapy that involves a Reiki practitioner holding their hands lightly on or above the patient’s body for several minutes. Some hospitals in the US and the UK offer Reiki as a relaxation aid, although high-quality science is lacking.
In this study, one group of participants will each undergo Reiki in a quiet clinic room during the lengthy waiting period between placement of the vaginal cylinder and infusion of the radiation source, which is a time of anxiety and discomfort for many women. A second group of women will simply lie and wait in a clinic room, if desired accompanied by a friend or family member.
The Huntsman Cancer Institute, Salt Lake City, Utah, started recruiting its 68 participants in October 2023. The primary outcome is self-reported anxiety. The secondary outcomes are other validated measures of anxiety, pain, and depression. Overall survival and broader measures of QOL will not be assessed. More details at ClinicalTrials.gov
Dr. Markman said that the benefits of Reiki may be “nothing more than a placebo effect.” But he highlighted the novelty of conducting a randomized trial to scientifically test Reiki’s “widely applied (without any real evidence) ‘integrative medicine’ approach to symptom management.”
Unresectable or metastatic endometrial cancer with deficient mismatch repair /high microsatellite instability. People in this clinical situation whose disease has progressed after one or two lines of prior chemotherapy, including platinum-based treatment, may be interested in an open-label nonrandomized, phase 2 investigation of bispecific antibody acasunlimab in combination with pembrolizumab (Keytruda).
Acasunlimab stimulates T-cell antitumor activity as well as blocking programmed death ligand 1 (PD-L1) and is being tested in several types of solid-tumor cancer. For up to 2 years, all participants will receive intravenous (IV) infusions of the drug combination. Study sites in Florida and Europe opened in January 2024, ready for 80 participants. The primary outcome is objective response rate. Overall survival will not be assessed. More details at ClinicalTrials.gov
“In the absence of a randomized population to compare treatment outcomes, the results of this trial will likely provide limited data upon which to determine the clinical benefits of this novel drug combination strategy,” said Dr. Markman. However, he added, “the results will be helpful in assessing the potential toxicity of this approach.”
Recurrent or metastatic endometrial cancer with proficient mismatch repair. Women with this diagnosis who have progressed after one prior platinum chemotherapy regimen in any setting may wish to consider a randomized, triple-blind, phase 2 trial of pembrolizumab plus favezelimab. Favezelimab, which blocks the lymphocyte activation gene 3 (LAG3), appears to boost the antitumor activity of programmed cell death protein 1 (PD-1) inhibition in other cancers such as classic Hodgkin lymphoma.
In the trial, participants will be assigned to one of four groups. One group will receive 17 doses of the combination treatment IV every 3 weeks — three doses in the neoadjuvant period and 14 as adjuvant therapy. A second group of individuals will receive IV pembrolizumab monotherapy on the same schedule. A third will be given up to 35 doses of the combo therapy every 3 weeks plus a daily capsule of lenvatinib (Lenvima). The fourth group will receive 35 doses of pembrolizumab plus daily lenvatinib.
Sites in North Carolina, New Jersey, Pennsylvania, and four countries other than the US started recruiting 60 participants with a solid tumor in September 2023. Pathologic complete response and objective response rate are the primary endpoints. Overall survival over approximately 3.5 years is a secondary endpoint, and QOL will not be measured. More details at ClinicalTrials.gov
Unresectable advanced or metastatic HER2-positive endometrial or ovarian cancer. Adults with one of these diagnoses in whom failed platinum-based therapy has failed may enroll in an open-label, phase 2 study to see whether their disease will respond to the antibody-drug conjugate disitamab vedotin. Everyone in the trial will receive IV disitamab vedotin every 2 weeks for up to approximately 5 years.
Study sites in California, Connecticut, Michigan, Minnesota, Montana, New York, Ohio, Texas, and Canada began welcoming their 190 participants with one of a range of solid cancers in November 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and QOL will not be tracked. More details at ClinicalTrials.gov
High-risk locally advanced cervical cancer. Girls and women older than 14 years with this cancer that has not progressed after platinum-based chemoradiation are sought for a randomized, quadruple-blind, phase 3 trial to determine whether the investigational immunotherapy volrustomig can slow disease progression. Volrustomig targets PD-1 and cytotoxic T lymphocyte protein 4 (CTLA4) and is being tested in a wide range of solid cancers.
For approximately 3 years or until disease progression or death, whichever happens first, half of participants will receive IV infusions of volrustomig while the others will receive saline. Asian research sites started seeking the study’s 1000 participants in September 2023, while centers in 12 US states and eight other countries are gearing up for patient enrollment. Progression-free survival in participants with PD-L1 expression is the primary endpoint; overall survival and QOL are secondary endpoints. More details at ClinicalTrials.gov
All trial information is from the National Institutes of Health US National Library of Medicine (online at ClinicalTrials.gov). Dr. Markman declared he is not involved with these trials.
A version of this article appeared on Medscape.com .
Persistent or recurrent endometrial cancer or any advanced solid gynecologic tumor with appropriate ATR mutations. Patients with one of these diagnoses may be eligible to join a phase 2, randomized, open-label study of an experimental drug called ART0380. ART0380 inhibits the ability of cancer cells to repair DNA damage by targeting a DNA repair kinase called ATR (ataxia telangiectasia–mutated and Rad3-related) protein, which is faulty in some tumors. The hope is that ART0380 will overwhelm the inadequate DNA repair processes of these cancer cells while sparing the more robust DNA repair in healthy cells.
All participants in the trial will take daily oral ART0380 until disease progression, withdrawal of consent, or unacceptable toxicity, whichever happens first. Some individuals will receive the treatment for 3 weeks out of every 4. Sites in California, Illinois, Massachusetts, New York, Oklahoma, Pennsylvania, Rhode Island, and France started recruiting 60 participants with endometrial cancer or any solid tumor in September 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and quality of life (QOL) is not assessed. More details at ClinicalTrials.gov
Maurie Markman, MD, president of medicine and science at City of Hope, Atlanta, who is not involved in this trial, explained that because “ a meaningful proportion of this population may have a defect in this DNA repair mechanism,” this hypothesis seems “worthy of clinical exploration.”
Cancer of the endometrium, cervix, vagina, or vulva. Women with one of these types of cancer who can read and understand English or Spanish can join a randomized, open-label phase 2 trial to determine whether Reiki therapy can reduce pain and distress associated with brachytherapy.
Reiki is a complementary therapy that involves a Reiki practitioner holding their hands lightly on or above the patient’s body for several minutes. Some hospitals in the US and the UK offer Reiki as a relaxation aid, although high-quality science is lacking.
In this study, one group of participants will each undergo Reiki in a quiet clinic room during the lengthy waiting period between placement of the vaginal cylinder and infusion of the radiation source, which is a time of anxiety and discomfort for many women. A second group of women will simply lie and wait in a clinic room, if desired accompanied by a friend or family member.
The Huntsman Cancer Institute, Salt Lake City, Utah, started recruiting its 68 participants in October 2023. The primary outcome is self-reported anxiety. The secondary outcomes are other validated measures of anxiety, pain, and depression. Overall survival and broader measures of QOL will not be assessed. More details at ClinicalTrials.gov
Dr. Markman said that the benefits of Reiki may be “nothing more than a placebo effect.” But he highlighted the novelty of conducting a randomized trial to scientifically test Reiki’s “widely applied (without any real evidence) ‘integrative medicine’ approach to symptom management.”
Unresectable or metastatic endometrial cancer with deficient mismatch repair /high microsatellite instability. People in this clinical situation whose disease has progressed after one or two lines of prior chemotherapy, including platinum-based treatment, may be interested in an open-label nonrandomized, phase 2 investigation of bispecific antibody acasunlimab in combination with pembrolizumab (Keytruda).
Acasunlimab stimulates T-cell antitumor activity as well as blocking programmed death ligand 1 (PD-L1) and is being tested in several types of solid-tumor cancer. For up to 2 years, all participants will receive intravenous (IV) infusions of the drug combination. Study sites in Florida and Europe opened in January 2024, ready for 80 participants. The primary outcome is objective response rate. Overall survival will not be assessed. More details at ClinicalTrials.gov
“In the absence of a randomized population to compare treatment outcomes, the results of this trial will likely provide limited data upon which to determine the clinical benefits of this novel drug combination strategy,” said Dr. Markman. However, he added, “the results will be helpful in assessing the potential toxicity of this approach.”
Recurrent or metastatic endometrial cancer with proficient mismatch repair. Women with this diagnosis who have progressed after one prior platinum chemotherapy regimen in any setting may wish to consider a randomized, triple-blind, phase 2 trial of pembrolizumab plus favezelimab. Favezelimab, which blocks the lymphocyte activation gene 3 (LAG3), appears to boost the antitumor activity of programmed cell death protein 1 (PD-1) inhibition in other cancers such as classic Hodgkin lymphoma.
In the trial, participants will be assigned to one of four groups. One group will receive 17 doses of the combination treatment IV every 3 weeks — three doses in the neoadjuvant period and 14 as adjuvant therapy. A second group of individuals will receive IV pembrolizumab monotherapy on the same schedule. A third will be given up to 35 doses of the combo therapy every 3 weeks plus a daily capsule of lenvatinib (Lenvima). The fourth group will receive 35 doses of pembrolizumab plus daily lenvatinib.
Sites in North Carolina, New Jersey, Pennsylvania, and four countries other than the US started recruiting 60 participants with a solid tumor in September 2023. Pathologic complete response and objective response rate are the primary endpoints. Overall survival over approximately 3.5 years is a secondary endpoint, and QOL will not be measured. More details at ClinicalTrials.gov
Unresectable advanced or metastatic HER2-positive endometrial or ovarian cancer. Adults with one of these diagnoses in whom failed platinum-based therapy has failed may enroll in an open-label, phase 2 study to see whether their disease will respond to the antibody-drug conjugate disitamab vedotin. Everyone in the trial will receive IV disitamab vedotin every 2 weeks for up to approximately 5 years.
Study sites in California, Connecticut, Michigan, Minnesota, Montana, New York, Ohio, Texas, and Canada began welcoming their 190 participants with one of a range of solid cancers in November 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and QOL will not be tracked. More details at ClinicalTrials.gov
High-risk locally advanced cervical cancer. Girls and women older than 14 years with this cancer that has not progressed after platinum-based chemoradiation are sought for a randomized, quadruple-blind, phase 3 trial to determine whether the investigational immunotherapy volrustomig can slow disease progression. Volrustomig targets PD-1 and cytotoxic T lymphocyte protein 4 (CTLA4) and is being tested in a wide range of solid cancers.
For approximately 3 years or until disease progression or death, whichever happens first, half of participants will receive IV infusions of volrustomig while the others will receive saline. Asian research sites started seeking the study’s 1000 participants in September 2023, while centers in 12 US states and eight other countries are gearing up for patient enrollment. Progression-free survival in participants with PD-L1 expression is the primary endpoint; overall survival and QOL are secondary endpoints. More details at ClinicalTrials.gov
All trial information is from the National Institutes of Health US National Library of Medicine (online at ClinicalTrials.gov). Dr. Markman declared he is not involved with these trials.
A version of this article appeared on Medscape.com .
Persistent or recurrent endometrial cancer or any advanced solid gynecologic tumor with appropriate ATR mutations. Patients with one of these diagnoses may be eligible to join a phase 2, randomized, open-label study of an experimental drug called ART0380. ART0380 inhibits the ability of cancer cells to repair DNA damage by targeting a DNA repair kinase called ATR (ataxia telangiectasia–mutated and Rad3-related) protein, which is faulty in some tumors. The hope is that ART0380 will overwhelm the inadequate DNA repair processes of these cancer cells while sparing the more robust DNA repair in healthy cells.
All participants in the trial will take daily oral ART0380 until disease progression, withdrawal of consent, or unacceptable toxicity, whichever happens first. Some individuals will receive the treatment for 3 weeks out of every 4. Sites in California, Illinois, Massachusetts, New York, Oklahoma, Pennsylvania, Rhode Island, and France started recruiting 60 participants with endometrial cancer or any solid tumor in September 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and quality of life (QOL) is not assessed. More details at ClinicalTrials.gov
Maurie Markman, MD, president of medicine and science at City of Hope, Atlanta, who is not involved in this trial, explained that because “ a meaningful proportion of this population may have a defect in this DNA repair mechanism,” this hypothesis seems “worthy of clinical exploration.”
Cancer of the endometrium, cervix, vagina, or vulva. Women with one of these types of cancer who can read and understand English or Spanish can join a randomized, open-label phase 2 trial to determine whether Reiki therapy can reduce pain and distress associated with brachytherapy.
Reiki is a complementary therapy that involves a Reiki practitioner holding their hands lightly on or above the patient’s body for several minutes. Some hospitals in the US and the UK offer Reiki as a relaxation aid, although high-quality science is lacking.
In this study, one group of participants will each undergo Reiki in a quiet clinic room during the lengthy waiting period between placement of the vaginal cylinder and infusion of the radiation source, which is a time of anxiety and discomfort for many women. A second group of women will simply lie and wait in a clinic room, if desired accompanied by a friend or family member.
The Huntsman Cancer Institute, Salt Lake City, Utah, started recruiting its 68 participants in October 2023. The primary outcome is self-reported anxiety. The secondary outcomes are other validated measures of anxiety, pain, and depression. Overall survival and broader measures of QOL will not be assessed. More details at ClinicalTrials.gov
Dr. Markman said that the benefits of Reiki may be “nothing more than a placebo effect.” But he highlighted the novelty of conducting a randomized trial to scientifically test Reiki’s “widely applied (without any real evidence) ‘integrative medicine’ approach to symptom management.”
Unresectable or metastatic endometrial cancer with deficient mismatch repair /high microsatellite instability. People in this clinical situation whose disease has progressed after one or two lines of prior chemotherapy, including platinum-based treatment, may be interested in an open-label nonrandomized, phase 2 investigation of bispecific antibody acasunlimab in combination with pembrolizumab (Keytruda).
Acasunlimab stimulates T-cell antitumor activity as well as blocking programmed death ligand 1 (PD-L1) and is being tested in several types of solid-tumor cancer. For up to 2 years, all participants will receive intravenous (IV) infusions of the drug combination. Study sites in Florida and Europe opened in January 2024, ready for 80 participants. The primary outcome is objective response rate. Overall survival will not be assessed. More details at ClinicalTrials.gov
“In the absence of a randomized population to compare treatment outcomes, the results of this trial will likely provide limited data upon which to determine the clinical benefits of this novel drug combination strategy,” said Dr. Markman. However, he added, “the results will be helpful in assessing the potential toxicity of this approach.”
Recurrent or metastatic endometrial cancer with proficient mismatch repair. Women with this diagnosis who have progressed after one prior platinum chemotherapy regimen in any setting may wish to consider a randomized, triple-blind, phase 2 trial of pembrolizumab plus favezelimab. Favezelimab, which blocks the lymphocyte activation gene 3 (LAG3), appears to boost the antitumor activity of programmed cell death protein 1 (PD-1) inhibition in other cancers such as classic Hodgkin lymphoma.
In the trial, participants will be assigned to one of four groups. One group will receive 17 doses of the combination treatment IV every 3 weeks — three doses in the neoadjuvant period and 14 as adjuvant therapy. A second group of individuals will receive IV pembrolizumab monotherapy on the same schedule. A third will be given up to 35 doses of the combo therapy every 3 weeks plus a daily capsule of lenvatinib (Lenvima). The fourth group will receive 35 doses of pembrolizumab plus daily lenvatinib.
Sites in North Carolina, New Jersey, Pennsylvania, and four countries other than the US started recruiting 60 participants with a solid tumor in September 2023. Pathologic complete response and objective response rate are the primary endpoints. Overall survival over approximately 3.5 years is a secondary endpoint, and QOL will not be measured. More details at ClinicalTrials.gov
Unresectable advanced or metastatic HER2-positive endometrial or ovarian cancer. Adults with one of these diagnoses in whom failed platinum-based therapy has failed may enroll in an open-label, phase 2 study to see whether their disease will respond to the antibody-drug conjugate disitamab vedotin. Everyone in the trial will receive IV disitamab vedotin every 2 weeks for up to approximately 5 years.
Study sites in California, Connecticut, Michigan, Minnesota, Montana, New York, Ohio, Texas, and Canada began welcoming their 190 participants with one of a range of solid cancers in November 2023. The primary outcome is objective response rate. Overall survival is a secondary measure and QOL will not be tracked. More details at ClinicalTrials.gov
High-risk locally advanced cervical cancer. Girls and women older than 14 years with this cancer that has not progressed after platinum-based chemoradiation are sought for a randomized, quadruple-blind, phase 3 trial to determine whether the investigational immunotherapy volrustomig can slow disease progression. Volrustomig targets PD-1 and cytotoxic T lymphocyte protein 4 (CTLA4) and is being tested in a wide range of solid cancers.
For approximately 3 years or until disease progression or death, whichever happens first, half of participants will receive IV infusions of volrustomig while the others will receive saline. Asian research sites started seeking the study’s 1000 participants in September 2023, while centers in 12 US states and eight other countries are gearing up for patient enrollment. Progression-free survival in participants with PD-L1 expression is the primary endpoint; overall survival and QOL are secondary endpoints. More details at ClinicalTrials.gov
All trial information is from the National Institutes of Health US National Library of Medicine (online at ClinicalTrials.gov). Dr. Markman declared he is not involved with these trials.
A version of this article appeared on Medscape.com .
Long-Term Follow-Up Emphasizes HPV Vaccination Importance
This transcript has been edited for clarity.
I want to briefly discuss a critically important topic that cannot be overly emphasized. It is the relevance, the importance, the benefits, and the outcome of HPV vaccination.
The paper I’m referring to was published in Pediatrics in October 2023. It’s titled, “Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.”
Let me emphasize that we’re talking about a 10-year follow-up. In this particular paper and analysis, 301 boys — I emphasize boys — were included and 971 girls at 40 different sites in 13 countries, who received the 9-valent vaccine, which includes HPV 16, 18, and seven other types.
Most importantly, there was not a single case. Not one. Let me repeat this: There was not a single case of high-grade intraepithelial neoplasia, or worse, or condyloma in either males or females. There was not a single case in over 1000 individuals with a follow-up of more than 10 years.
It is difficult to overstate the magnitude of the benefit associated with HPV vaccination for our children and young adults on their risk of developing highly relevant, life-changing, potentially deadly cancers.
For those of you who are interested in this topic — which should include almost all of you, if not all of you — I encourage you to read this very important follow-up paper, again, demonstrating the simple, overwhelming magnitude of the benefit of HPV vaccination. I thank you for your attention.
Dr. Markman is a professor in the department of medical oncology and therapeutics research, City of Hope, Duarte, California, and president of medicine and science, City of Hope Atlanta, Chicago, and Phoenix. He disclosed ties with GlaxoSmithKline; AstraZeneca.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I want to briefly discuss a critically important topic that cannot be overly emphasized. It is the relevance, the importance, the benefits, and the outcome of HPV vaccination.
The paper I’m referring to was published in Pediatrics in October 2023. It’s titled, “Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.”
Let me emphasize that we’re talking about a 10-year follow-up. In this particular paper and analysis, 301 boys — I emphasize boys — were included and 971 girls at 40 different sites in 13 countries, who received the 9-valent vaccine, which includes HPV 16, 18, and seven other types.
Most importantly, there was not a single case. Not one. Let me repeat this: There was not a single case of high-grade intraepithelial neoplasia, or worse, or condyloma in either males or females. There was not a single case in over 1000 individuals with a follow-up of more than 10 years.
It is difficult to overstate the magnitude of the benefit associated with HPV vaccination for our children and young adults on their risk of developing highly relevant, life-changing, potentially deadly cancers.
For those of you who are interested in this topic — which should include almost all of you, if not all of you — I encourage you to read this very important follow-up paper, again, demonstrating the simple, overwhelming magnitude of the benefit of HPV vaccination. I thank you for your attention.
Dr. Markman is a professor in the department of medical oncology and therapeutics research, City of Hope, Duarte, California, and president of medicine and science, City of Hope Atlanta, Chicago, and Phoenix. He disclosed ties with GlaxoSmithKline; AstraZeneca.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I want to briefly discuss a critically important topic that cannot be overly emphasized. It is the relevance, the importance, the benefits, and the outcome of HPV vaccination.
The paper I’m referring to was published in Pediatrics in October 2023. It’s titled, “Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.”
Let me emphasize that we’re talking about a 10-year follow-up. In this particular paper and analysis, 301 boys — I emphasize boys — were included and 971 girls at 40 different sites in 13 countries, who received the 9-valent vaccine, which includes HPV 16, 18, and seven other types.
Most importantly, there was not a single case. Not one. Let me repeat this: There was not a single case of high-grade intraepithelial neoplasia, or worse, or condyloma in either males or females. There was not a single case in over 1000 individuals with a follow-up of more than 10 years.
It is difficult to overstate the magnitude of the benefit associated with HPV vaccination for our children and young adults on their risk of developing highly relevant, life-changing, potentially deadly cancers.
For those of you who are interested in this topic — which should include almost all of you, if not all of you — I encourage you to read this very important follow-up paper, again, demonstrating the simple, overwhelming magnitude of the benefit of HPV vaccination. I thank you for your attention.
Dr. Markman is a professor in the department of medical oncology and therapeutics research, City of Hope, Duarte, California, and president of medicine and science, City of Hope Atlanta, Chicago, and Phoenix. He disclosed ties with GlaxoSmithKline; AstraZeneca.
A version of this article appeared on Medscape.com.