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Gabapentinoids Increase Exacerbation in COPD
TOPLINE:
Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).
METHODOLOGY:
- Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
- The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
- The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study.
TAKEAWAY:
- The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
- Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
- Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.
IN PRACTICE:
“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote.
SOURCE:
The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine.
LIMITATIONS:
A lack of data on smoking status and other residual confounding factors limited the study findings.
DISCLOSURES:
The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.
A version of this article appeared on Medscape.com.
TOPLINE:
Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).
METHODOLOGY:
- Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
- The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
- The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study.
TAKEAWAY:
- The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
- Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
- Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.
IN PRACTICE:
“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote.
SOURCE:
The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine.
LIMITATIONS:
A lack of data on smoking status and other residual confounding factors limited the study findings.
DISCLOSURES:
The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.
A version of this article appeared on Medscape.com.
TOPLINE:
Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).
METHODOLOGY:
- Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
- The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
- The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study.
TAKEAWAY:
- The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
- Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
- Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.
IN PRACTICE:
“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote.
SOURCE:
The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine.
LIMITATIONS:
A lack of data on smoking status and other residual confounding factors limited the study findings.
DISCLOSURES:
The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.
A version of this article appeared on Medscape.com.
Top US Oncology Regulator Seeks Changes in Drug Studies
Richard Pazdur, MD, who leads the cancer division at the US Food and Drug Administration (FDA), said there’s a need to simplify the paperwork involved in clinical trials. Before joining the FDA in 1999, Dr. Pazdur participated in and published cancer research. He says the informed consent forms used for studies have grown too elaborate over the years, such that they can intimidate even experts.
“When I read informed consents now in clinical trials, folks, it gives me a headache. Okay, I can’t follow them,” Dr. Pazdur said.
Dr. Pazdur said informed consent forms can be “mind-boggling” these days.
“They’re so damn complicated with so many damn questions being answered,” he said. “So our point is what’s the essential question that you need answered and what’s the quickest way of answering that question with the least amount of data that can be collected?”
Dr. Pazdur made these comments during a joint meeting of the FDA and the European Medicines Agency (EMA).
The meeting was a broad discussion about how to build on the successes seen in treatment of blood cancers in the past two decades. No formal recommendations were introduced or considered at the meeting. Instead, the meeting served as a chance for oncologists and patients to discuss ways to more quickly and efficiently address the key questions in drug research: Do medicines deliver a significant benefit to patients?
Dr. Pazdur also said at the meeting that there needs to be a way to attract more people to enroll in clinical trials.
“When I started in oncology, it was about 5%. When I’m sitting here now, 40 years later, it’s 5%. Basically it hasn’t moved,” he said at the discussion, held on February 1.
Ellin Berman, MD, of Memorial Sloan Kettering Cancer Center in New York, spoke at the meeting about the changes she has witnessed in her career in oncology. Until 2001, there were limited drug options, and physicians tried to get patients to transplant teams as possible. Then the FDA in 2001 approved imatinib to treat patients with chronic myelogenous leukemia (CML) that has the Philadelphia chromosome. That set the stage, Dr. Berman said, for a sea change in treatment of CML.
“The fellows now have no idea what it is like to talk to a CML patient about transplant and the question is which among the treasures we have of drugs do we start people on? And that’s always a conversation,” Dr. Berman said.
She noted that advances in treatment have also let some female patients get pregnant and have children.
“We have at least half a dozen women who bring their kids to clinic. And boy, if that doesn’t bring tears to our eyes, our collective eyes, I don’t know what does,” she said.
Dr. Pazdur also recalled his experience treating patients in the 1970s and 1980s for cancers for which “you had nothing so to speak” in terms of effective treatment.
“So then ask yourself the question, what would their stories be now?” with the many options available, Dr. Pazdur said.
Seeking clinician feedback
To try to improve the development and testing of cancer drugs, the FDA is seeking to get more feedback from clinicians about which questions trials should address, Dr. Pazdur said.
The agency is considering a way to poll clinicians on what their most crucial questions are about the medicines, he said. Better design of trial questions might serve to improve enrollment in studies.
“What we’re thinking of doing is taking the common disease areas and asking clinicians what are the five basic questions that you want answered in the next 5 years,” he said.
He cited PD-1 drugs as a possible example of a class where regulators could consider new approaches. There could be a discussion about the safety data collection for this class of drugs, which has been used by millions of patients.
Dr. Pazdur said he has been discussing these kinds of themes with his European and Japanese counterparts, who also are interested in simplifying clinical trials.
The goal is to have trials better represent real-world experiences rather than “artificial” ones created when patients must meet extensive eligibility requirements. Improved use of emerging technologies could aid in the needed streamlining, Dr. Pazdur said.
“As an oncology community, we have made our lives somewhat too complicated and need to draw back and ask the basic questions,” Dr. Pazdur said.
Richard Pazdur, MD, who leads the cancer division at the US Food and Drug Administration (FDA), said there’s a need to simplify the paperwork involved in clinical trials. Before joining the FDA in 1999, Dr. Pazdur participated in and published cancer research. He says the informed consent forms used for studies have grown too elaborate over the years, such that they can intimidate even experts.
“When I read informed consents now in clinical trials, folks, it gives me a headache. Okay, I can’t follow them,” Dr. Pazdur said.
Dr. Pazdur said informed consent forms can be “mind-boggling” these days.
“They’re so damn complicated with so many damn questions being answered,” he said. “So our point is what’s the essential question that you need answered and what’s the quickest way of answering that question with the least amount of data that can be collected?”
Dr. Pazdur made these comments during a joint meeting of the FDA and the European Medicines Agency (EMA).
The meeting was a broad discussion about how to build on the successes seen in treatment of blood cancers in the past two decades. No formal recommendations were introduced or considered at the meeting. Instead, the meeting served as a chance for oncologists and patients to discuss ways to more quickly and efficiently address the key questions in drug research: Do medicines deliver a significant benefit to patients?
Dr. Pazdur also said at the meeting that there needs to be a way to attract more people to enroll in clinical trials.
“When I started in oncology, it was about 5%. When I’m sitting here now, 40 years later, it’s 5%. Basically it hasn’t moved,” he said at the discussion, held on February 1.
Ellin Berman, MD, of Memorial Sloan Kettering Cancer Center in New York, spoke at the meeting about the changes she has witnessed in her career in oncology. Until 2001, there were limited drug options, and physicians tried to get patients to transplant teams as possible. Then the FDA in 2001 approved imatinib to treat patients with chronic myelogenous leukemia (CML) that has the Philadelphia chromosome. That set the stage, Dr. Berman said, for a sea change in treatment of CML.
“The fellows now have no idea what it is like to talk to a CML patient about transplant and the question is which among the treasures we have of drugs do we start people on? And that’s always a conversation,” Dr. Berman said.
She noted that advances in treatment have also let some female patients get pregnant and have children.
“We have at least half a dozen women who bring their kids to clinic. And boy, if that doesn’t bring tears to our eyes, our collective eyes, I don’t know what does,” she said.
Dr. Pazdur also recalled his experience treating patients in the 1970s and 1980s for cancers for which “you had nothing so to speak” in terms of effective treatment.
“So then ask yourself the question, what would their stories be now?” with the many options available, Dr. Pazdur said.
Seeking clinician feedback
To try to improve the development and testing of cancer drugs, the FDA is seeking to get more feedback from clinicians about which questions trials should address, Dr. Pazdur said.
The agency is considering a way to poll clinicians on what their most crucial questions are about the medicines, he said. Better design of trial questions might serve to improve enrollment in studies.
“What we’re thinking of doing is taking the common disease areas and asking clinicians what are the five basic questions that you want answered in the next 5 years,” he said.
He cited PD-1 drugs as a possible example of a class where regulators could consider new approaches. There could be a discussion about the safety data collection for this class of drugs, which has been used by millions of patients.
Dr. Pazdur said he has been discussing these kinds of themes with his European and Japanese counterparts, who also are interested in simplifying clinical trials.
The goal is to have trials better represent real-world experiences rather than “artificial” ones created when patients must meet extensive eligibility requirements. Improved use of emerging technologies could aid in the needed streamlining, Dr. Pazdur said.
“As an oncology community, we have made our lives somewhat too complicated and need to draw back and ask the basic questions,” Dr. Pazdur said.
Richard Pazdur, MD, who leads the cancer division at the US Food and Drug Administration (FDA), said there’s a need to simplify the paperwork involved in clinical trials. Before joining the FDA in 1999, Dr. Pazdur participated in and published cancer research. He says the informed consent forms used for studies have grown too elaborate over the years, such that they can intimidate even experts.
“When I read informed consents now in clinical trials, folks, it gives me a headache. Okay, I can’t follow them,” Dr. Pazdur said.
Dr. Pazdur said informed consent forms can be “mind-boggling” these days.
“They’re so damn complicated with so many damn questions being answered,” he said. “So our point is what’s the essential question that you need answered and what’s the quickest way of answering that question with the least amount of data that can be collected?”
Dr. Pazdur made these comments during a joint meeting of the FDA and the European Medicines Agency (EMA).
The meeting was a broad discussion about how to build on the successes seen in treatment of blood cancers in the past two decades. No formal recommendations were introduced or considered at the meeting. Instead, the meeting served as a chance for oncologists and patients to discuss ways to more quickly and efficiently address the key questions in drug research: Do medicines deliver a significant benefit to patients?
Dr. Pazdur also said at the meeting that there needs to be a way to attract more people to enroll in clinical trials.
“When I started in oncology, it was about 5%. When I’m sitting here now, 40 years later, it’s 5%. Basically it hasn’t moved,” he said at the discussion, held on February 1.
Ellin Berman, MD, of Memorial Sloan Kettering Cancer Center in New York, spoke at the meeting about the changes she has witnessed in her career in oncology. Until 2001, there were limited drug options, and physicians tried to get patients to transplant teams as possible. Then the FDA in 2001 approved imatinib to treat patients with chronic myelogenous leukemia (CML) that has the Philadelphia chromosome. That set the stage, Dr. Berman said, for a sea change in treatment of CML.
“The fellows now have no idea what it is like to talk to a CML patient about transplant and the question is which among the treasures we have of drugs do we start people on? And that’s always a conversation,” Dr. Berman said.
She noted that advances in treatment have also let some female patients get pregnant and have children.
“We have at least half a dozen women who bring their kids to clinic. And boy, if that doesn’t bring tears to our eyes, our collective eyes, I don’t know what does,” she said.
Dr. Pazdur also recalled his experience treating patients in the 1970s and 1980s for cancers for which “you had nothing so to speak” in terms of effective treatment.
“So then ask yourself the question, what would their stories be now?” with the many options available, Dr. Pazdur said.
Seeking clinician feedback
To try to improve the development and testing of cancer drugs, the FDA is seeking to get more feedback from clinicians about which questions trials should address, Dr. Pazdur said.
The agency is considering a way to poll clinicians on what their most crucial questions are about the medicines, he said. Better design of trial questions might serve to improve enrollment in studies.
“What we’re thinking of doing is taking the common disease areas and asking clinicians what are the five basic questions that you want answered in the next 5 years,” he said.
He cited PD-1 drugs as a possible example of a class where regulators could consider new approaches. There could be a discussion about the safety data collection for this class of drugs, which has been used by millions of patients.
Dr. Pazdur said he has been discussing these kinds of themes with his European and Japanese counterparts, who also are interested in simplifying clinical trials.
The goal is to have trials better represent real-world experiences rather than “artificial” ones created when patients must meet extensive eligibility requirements. Improved use of emerging technologies could aid in the needed streamlining, Dr. Pazdur said.
“As an oncology community, we have made our lives somewhat too complicated and need to draw back and ask the basic questions,” Dr. Pazdur said.
Doc Sues State Over ‘Antiquated’ Telehealth Rules
Telemedicine visits skyrocketed during the pandemic, but
In the complaint filed on December 13 in New Jersey District Court, plaintiff Shannon MacDonald, MD, radiation oncologist at Massachusetts General Hospital, Boston, said that New Jersey’s telehealth rules make it illegal for her and other out-of-state specialists to consult with and treat residents who could benefit from their unique expertise, unless they first obtain licensure through the medical board.
While she currently maintains licenses in six states, New Jersey’s application process can take several months and requires an initial fee of $550, plus additional expenses for a background check and fingerprinting, court documents said.
Physicians providing telehealth services to New Jersey residents without a state-authorized medical license are subject to up to 5 years in prison and criminal and civil fines exceeding $10,000.
“Every day, my ethical obligations to my patients are in direct conflict with the legal framework,” said Dr. MacDonald.
She and coplaintiff Paul Gardner, MD, neurosurgical codirector of the Center for Cranial Base Surgery at the University of Pittsburgh Medical Center, are represented by the public interest law firm Pacific Legal Foundation, which recently sued Louisiana’s governor over its medical board diversity rules.
The lawsuit names Otto Sabando, DO, president of the New Jersey State Board of Medical Examiners. Representatives for Dr. Sabando and the medical board did not respond to a request for comment.
The complaint describes the care Dr. MacDonald provided several years before the pandemic for an out-of-state patient, J.A., also named as a plaintiff, who was diagnosed with pineoblastoma at 18 months old.
After initially undergoing treatment in New York, court documents indicate that J.A.’s medical team referred him to Dr. MacDonald “because of her nationally recognized expertise in proton therapy” targeting rare childhood cancers. Dr. MacDonald remotely reviewed J.A.’s scans and discussed options before his family pursued treatment with her in Boston.
Dr. MacDonald said that allowing more patients like J.A. to use telehealth to access services when specialists are unavailable in their state would go a long way toward achieving health equity. She says it could reduce the financial burden of travel and lodging expenses and provide timely consultations and follow-up care.
Many states, including New Jersey, waived or eased licensing regulations during the pandemic so physicians could temporarily practice in other states. Since those emergency orders have ended, physicians must again seek licensure in the states where their patients are located or potentially be subjected to fines or other penalties by state medical boards.
New Jersey Governor Phil Murphy signed a law in 2022 joining the Interstate Medical Licensure Compact, an agreement that offers a streamlined process for physicians already licensed in their home states to obtain licensure in 37 other member states as well as the District of Columbia and Territory of Guam. However, the lawsuit alleges that applications still take weeks and pose significant administrative and financial barriers for physicians.
Telehealth in a Post-COVID World
“Until COVID, we didn’t realize that a telephone call really was practicing medicine,” said Dr. MacDonald. “After being allowed to do telemedicine consultations across state lines for a year and 2 years for follow-ups, I thought it would last forever, but it’s placed a spotlight on what we cannot do.”
Dr. MacDonald, who recently penned a related editorial in the Wall Street Journal, said laws regarding interstate practice are outdated.
“They made sense in the preindustrial era when you had to be in the same location as your patient, but they make little sense in the modern era when distance disappears over the Internet or telephone,” she said.
The issue isn’t unique to New Jersey. Caleb Trotter, JD, attorney for the Pacific Legal Foundation, said that 30 states prohibit doctors from conducting telemedicine services in states where they are not licensed.
“Some hospitals instruct doctors and administrators to ask the patient where they are physically located at the beginning of a telehealth appointment, and if it isn’t a state where the physician is licensed, they are instructed to end the appointment immediately,” Mr. Trotter said. “A win in New Jersey would solve a very real problem for these [patients] of not having convenient legal access to specialists.”
Neither Dr. MacDonald nor Dr. Gardner have had any enforcement actions taken against them, said Mr. Trotter. Still, he said the New Jersey attorney general’s office reminded physicians last year that state licensure rules apply to out-of-state doctors using telemedicine to conduct follow-up appointments.
In November, the Center for Health Law and Policy Innovation at Harvard Law School, Cambridge, Massachusetts, proposed telemedicine reforms, including exceptions for the care of established patients and screening for specialty referrals.
Dr. MacDonald hopes the lawsuit will increase awareness of telehealth laws and spur changes.
A version of this article appeared on Medscape.com.
Telemedicine visits skyrocketed during the pandemic, but
In the complaint filed on December 13 in New Jersey District Court, plaintiff Shannon MacDonald, MD, radiation oncologist at Massachusetts General Hospital, Boston, said that New Jersey’s telehealth rules make it illegal for her and other out-of-state specialists to consult with and treat residents who could benefit from their unique expertise, unless they first obtain licensure through the medical board.
While she currently maintains licenses in six states, New Jersey’s application process can take several months and requires an initial fee of $550, plus additional expenses for a background check and fingerprinting, court documents said.
Physicians providing telehealth services to New Jersey residents without a state-authorized medical license are subject to up to 5 years in prison and criminal and civil fines exceeding $10,000.
“Every day, my ethical obligations to my patients are in direct conflict with the legal framework,” said Dr. MacDonald.
She and coplaintiff Paul Gardner, MD, neurosurgical codirector of the Center for Cranial Base Surgery at the University of Pittsburgh Medical Center, are represented by the public interest law firm Pacific Legal Foundation, which recently sued Louisiana’s governor over its medical board diversity rules.
The lawsuit names Otto Sabando, DO, president of the New Jersey State Board of Medical Examiners. Representatives for Dr. Sabando and the medical board did not respond to a request for comment.
The complaint describes the care Dr. MacDonald provided several years before the pandemic for an out-of-state patient, J.A., also named as a plaintiff, who was diagnosed with pineoblastoma at 18 months old.
After initially undergoing treatment in New York, court documents indicate that J.A.’s medical team referred him to Dr. MacDonald “because of her nationally recognized expertise in proton therapy” targeting rare childhood cancers. Dr. MacDonald remotely reviewed J.A.’s scans and discussed options before his family pursued treatment with her in Boston.
Dr. MacDonald said that allowing more patients like J.A. to use telehealth to access services when specialists are unavailable in their state would go a long way toward achieving health equity. She says it could reduce the financial burden of travel and lodging expenses and provide timely consultations and follow-up care.
Many states, including New Jersey, waived or eased licensing regulations during the pandemic so physicians could temporarily practice in other states. Since those emergency orders have ended, physicians must again seek licensure in the states where their patients are located or potentially be subjected to fines or other penalties by state medical boards.
New Jersey Governor Phil Murphy signed a law in 2022 joining the Interstate Medical Licensure Compact, an agreement that offers a streamlined process for physicians already licensed in their home states to obtain licensure in 37 other member states as well as the District of Columbia and Territory of Guam. However, the lawsuit alleges that applications still take weeks and pose significant administrative and financial barriers for physicians.
Telehealth in a Post-COVID World
“Until COVID, we didn’t realize that a telephone call really was practicing medicine,” said Dr. MacDonald. “After being allowed to do telemedicine consultations across state lines for a year and 2 years for follow-ups, I thought it would last forever, but it’s placed a spotlight on what we cannot do.”
Dr. MacDonald, who recently penned a related editorial in the Wall Street Journal, said laws regarding interstate practice are outdated.
“They made sense in the preindustrial era when you had to be in the same location as your patient, but they make little sense in the modern era when distance disappears over the Internet or telephone,” she said.
The issue isn’t unique to New Jersey. Caleb Trotter, JD, attorney for the Pacific Legal Foundation, said that 30 states prohibit doctors from conducting telemedicine services in states where they are not licensed.
“Some hospitals instruct doctors and administrators to ask the patient where they are physically located at the beginning of a telehealth appointment, and if it isn’t a state where the physician is licensed, they are instructed to end the appointment immediately,” Mr. Trotter said. “A win in New Jersey would solve a very real problem for these [patients] of not having convenient legal access to specialists.”
Neither Dr. MacDonald nor Dr. Gardner have had any enforcement actions taken against them, said Mr. Trotter. Still, he said the New Jersey attorney general’s office reminded physicians last year that state licensure rules apply to out-of-state doctors using telemedicine to conduct follow-up appointments.
In November, the Center for Health Law and Policy Innovation at Harvard Law School, Cambridge, Massachusetts, proposed telemedicine reforms, including exceptions for the care of established patients and screening for specialty referrals.
Dr. MacDonald hopes the lawsuit will increase awareness of telehealth laws and spur changes.
A version of this article appeared on Medscape.com.
Telemedicine visits skyrocketed during the pandemic, but
In the complaint filed on December 13 in New Jersey District Court, plaintiff Shannon MacDonald, MD, radiation oncologist at Massachusetts General Hospital, Boston, said that New Jersey’s telehealth rules make it illegal for her and other out-of-state specialists to consult with and treat residents who could benefit from their unique expertise, unless they first obtain licensure through the medical board.
While she currently maintains licenses in six states, New Jersey’s application process can take several months and requires an initial fee of $550, plus additional expenses for a background check and fingerprinting, court documents said.
Physicians providing telehealth services to New Jersey residents without a state-authorized medical license are subject to up to 5 years in prison and criminal and civil fines exceeding $10,000.
“Every day, my ethical obligations to my patients are in direct conflict with the legal framework,” said Dr. MacDonald.
She and coplaintiff Paul Gardner, MD, neurosurgical codirector of the Center for Cranial Base Surgery at the University of Pittsburgh Medical Center, are represented by the public interest law firm Pacific Legal Foundation, which recently sued Louisiana’s governor over its medical board diversity rules.
The lawsuit names Otto Sabando, DO, president of the New Jersey State Board of Medical Examiners. Representatives for Dr. Sabando and the medical board did not respond to a request for comment.
The complaint describes the care Dr. MacDonald provided several years before the pandemic for an out-of-state patient, J.A., also named as a plaintiff, who was diagnosed with pineoblastoma at 18 months old.
After initially undergoing treatment in New York, court documents indicate that J.A.’s medical team referred him to Dr. MacDonald “because of her nationally recognized expertise in proton therapy” targeting rare childhood cancers. Dr. MacDonald remotely reviewed J.A.’s scans and discussed options before his family pursued treatment with her in Boston.
Dr. MacDonald said that allowing more patients like J.A. to use telehealth to access services when specialists are unavailable in their state would go a long way toward achieving health equity. She says it could reduce the financial burden of travel and lodging expenses and provide timely consultations and follow-up care.
Many states, including New Jersey, waived or eased licensing regulations during the pandemic so physicians could temporarily practice in other states. Since those emergency orders have ended, physicians must again seek licensure in the states where their patients are located or potentially be subjected to fines or other penalties by state medical boards.
New Jersey Governor Phil Murphy signed a law in 2022 joining the Interstate Medical Licensure Compact, an agreement that offers a streamlined process for physicians already licensed in their home states to obtain licensure in 37 other member states as well as the District of Columbia and Territory of Guam. However, the lawsuit alleges that applications still take weeks and pose significant administrative and financial barriers for physicians.
Telehealth in a Post-COVID World
“Until COVID, we didn’t realize that a telephone call really was practicing medicine,” said Dr. MacDonald. “After being allowed to do telemedicine consultations across state lines for a year and 2 years for follow-ups, I thought it would last forever, but it’s placed a spotlight on what we cannot do.”
Dr. MacDonald, who recently penned a related editorial in the Wall Street Journal, said laws regarding interstate practice are outdated.
“They made sense in the preindustrial era when you had to be in the same location as your patient, but they make little sense in the modern era when distance disappears over the Internet or telephone,” she said.
The issue isn’t unique to New Jersey. Caleb Trotter, JD, attorney for the Pacific Legal Foundation, said that 30 states prohibit doctors from conducting telemedicine services in states where they are not licensed.
“Some hospitals instruct doctors and administrators to ask the patient where they are physically located at the beginning of a telehealth appointment, and if it isn’t a state where the physician is licensed, they are instructed to end the appointment immediately,” Mr. Trotter said. “A win in New Jersey would solve a very real problem for these [patients] of not having convenient legal access to specialists.”
Neither Dr. MacDonald nor Dr. Gardner have had any enforcement actions taken against them, said Mr. Trotter. Still, he said the New Jersey attorney general’s office reminded physicians last year that state licensure rules apply to out-of-state doctors using telemedicine to conduct follow-up appointments.
In November, the Center for Health Law and Policy Innovation at Harvard Law School, Cambridge, Massachusetts, proposed telemedicine reforms, including exceptions for the care of established patients and screening for specialty referrals.
Dr. MacDonald hopes the lawsuit will increase awareness of telehealth laws and spur changes.
A version of this article appeared on Medscape.com.
Mega Malpractice Verdicts Against Physicians on the Rise
In December, in what’s known as the “Take Care of Maya” case, a Florida jury returned a record $261 million verdict against Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, for its treatment of a young patient and her family after an emergency room visit.
A month earlier, in New York, a jury ordered Westchester Medical Center Health Network to pay $120 million to a patient and his family following delayed stroke care that resulted in brain damage.
Mega malpractice awards like these are rising against physicians and hospitals around the country, according to new data from TransRe, an international reinsurance company that tracks large verdicts.
“2023 blew away every record previously set among high medical malpractice verdicts,” said Richard Henderson, senior vice president for TransRe.
In 2023, there were 57 medical malpractice verdicts of $10 million or more in the United States, the data showed. Slightly more than half of those reached $25 million or more.
From 2012 to 2022, verdicts of $10 million or more ranged from 34 in 2013 to 52 in 2022, TransRe research found.
While New York, Illinois, and Florida typically saw the highest dollar verdicts in previous years, so-called “nuclear” verdicts now occur in states like Utah and Georgia where they once were uncommon, said Robert E. White Jr., president of TDC Group and The Doctors Company, a national medical liability insurer for physicians.
A rollback of tort reforms across the country is one contributor, he said. For example, Georgia’s cap on noneconomic damages is among those that have been ruled unconstitutional by courts. Utah’s cap on noneconomic damages still stands, but the limit was deemed unconstitutional in wrongful death cases. In 2019, a portion of Utah›s pre-litigation panel process was also struck down by the state’s Supreme Court.
“We used to be able to predict where these high verdicts would occur,” Mr. White said. “We can’t predict it anymore.”
Research shows a majority of malpractice cases are dropped or settled before trial, and claims that go before juries usually end in doctors’ favor. Plaintiffs’ attorneys cite large jury verdicts in similar cases to induce settlements and higher payouts, Mr. White said.
And while mega verdicts rarely stick, they can have lasting effects on future claims. The awards lead to larger settlement demands from plaintiffs and drive up the cost to resolve claims, according to Mr. Henderson and Mr. White.
“Verdicts are the yardstick by which all settlements are measured,” Mr. White said. “That’s where the damage is done.” The prospect of a mega verdict can make insurers leery of fighting some malpractice cases and motivate them to offer bigger settlements to stay out of the courtroom, he added.
Why Are Juries Awarding Higher Verdicts?
There’s no single reason for the rise in nuclear verdicts, Mr. Henderson said.
One theory is that plaintiffs’ attorneys held back on resolving high-dollar cases during the COVID pandemic and let loose with high-demand claims when courts returned to normal, he said.
Another theory is that people emerged from the pandemic angrier.
“Whether it was political dynamics, masking [mandates], or differences in opinions, people came out of it angry, and generally speaking, you don’t want an angry jury,” Mr. Henderson said. “For a while, there was the halo effect, where health professionals were seen as heroes. That went away, and all of a sudden [they] became ‘the bad guys.’ ”
“People are angry at the healthcare system, and this anger manifests itself in [liability] suits,” added Bill Burns, vice president of research for the Medical Professional Liability Association, an industry group for medical liability insurers.
Hospital and medical group consolidation also reduces the personal connection juries may have with healthcare providers, Mr. Burns said.
“Healthcare has become a big business, and the corporatization of medicine now puts companies on the stand and not your local community hospital or your family doctor that you have known since birth,” he said.
Plaintiffs’ attorneys also deploy tactics that can prompt higher verdicts, Mr. White said. They may tell a jury that the provider or hospital is a threat to the community and that awarding a large verdict will deter others in the healthcare community from repeating the same actions.
Juries may then want to punish the defendant in addition to assessing damages for economic harm or pain and suffering, Mr. White said.
“I am concerned that jurors are trying to right social wrongs rather than judging cases on the facts presented to them,” added Mike Stinson, vice president for policy and legal affairs for the Medical Professional Liability Association.
Third-party litigation financing also can lead to mega verdicts. That’s an emerging practice in which companies unrelated to a lawsuit provide capital to plaintiffs in return for a portion of any financial award. The firms essentially “invest” in the litigation.
“What this does is provide an additional financial backdrop for plaintiffs,” Mr. Henderson said. “It allows them to dig in harder on cases. They can hold out for higher numbers, and if nothing else, it can prolong litigation.”
Do High Awards Actually Stick?
Multimillion-dollar verdicts may grab headlines, but do plaintiffs actually receive them?
Rarely, said TransRe, which tracks the final outcomes of verdicts. In many cases, large verdicts are reduced on appeal.
In the Maya case, which involved child protection authorities, a judge later lowered the damages against Johns Hopkins All Children’s Hospital by $47.5 million.
A federal judge in October, for example, rejected a record $110 million medical malpractice award in Minnesota, reducing it to $10 million. The district judge ruled the award was “shockingly excessive” and that the plaintiff should either accept the $10 million award or retry the case.
After a verdict is awarded, the defendant typically challenges the award, and the case goes through the appellate pipeline, Mr. Henderson explained. A judge may reduce some elements of the verdict, he said, but more often, the plaintiff and defendant agree on a compromised figure.
Seattle medical liability defense attorney Jennifer Crisera has experienced this firsthand. She recalled a recent case where a plaintiff’s attorney demanded what she describes as an unreasonable amount to settle a claim. Ms. Crisera did not want to give exact numbers but said the plaintiff made an 8-figure demand and the defense offered a low 7-figure range.
“My impression was that plaintiff’s counsel believed that they could get a nuclear verdict from the jury, so they kept their settlement demand artificially high,” she said. “The division between the numbers was way too high. Ultimately, we had to let a jury decide the value.”
The plaintiff won the case, and the verdict was much less than the settlement demand, she said. Even so, the defense incurred trial costs, and the health provider was forced to endure the emotional stress of a trial that could have been avoided, Ms. Crisera said.
Higher medical malpractice premiums are another consequence of massive awards.
Premium rates are associated with how much insurers pay on average for cases and how frequently they are making payouts, Mr. White said.
Medical liability insurance premiums for physicians have steadily increased since 2019, according to data from the Medical Liability Monitor, a national publication that analyzes liability insurance premiums. The Monitor studies insurance premium data from insurers that cover internists, general surgeons, and obstetrician-gynecologists.
From 2019 to 2023, average premium rates for physicians increased between 1.1% and 3% each year in states without patient compensation funds, according to Monitor data.
“Nuclear verdicts are a real driver of the industry’s underwriting losses and remain top of mind for every malpractice insurance company,” said Michael Matray, editor for the Medical Liability Monitor. “Responses to this year’s rate survey questionnaire indicate that most responding companies have experienced an increase in claims greater than $1 million and claims greater than $5 million during the past 2 years.”
However, increases vary widely by region and among counties. In Montgomery County, Alabama, for instance, premiums for internists rose by 24% from 2022 to 2023, from $8,231 to $10,240. Premiums for Montgomery County general surgeons rose by 11.9% from 2022 to 2023, from $30,761 to $34,426, according to survey data.
In several counties in Illinois (Adams, Knox, Peoria, and Rock Island), premiums for some internists rose by 15% from $24,041 to $27,783, and premiums for some surgeons increased by 27% from $60,202 to $76,461, according to survey data. Some internists in Catoosa County, Georgia, meanwhile, paid $17,831 in 2023, up from $16,313 in 2022. Some surgeons in Catoosa County paid $65,616 in 2023, up from $60,032 in 2022. Inflation could be one factor behind higher liability premium rates. Claim severity is a key driver of higher premium rates, Mr. White added.
“We have not seen stability in claims severity,” he said. “It is continuing to go up and, in all likelihood, it will drive [premium] rates up further from this point.”
A version of this article appeared on Medscape.com.
In December, in what’s known as the “Take Care of Maya” case, a Florida jury returned a record $261 million verdict against Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, for its treatment of a young patient and her family after an emergency room visit.
A month earlier, in New York, a jury ordered Westchester Medical Center Health Network to pay $120 million to a patient and his family following delayed stroke care that resulted in brain damage.
Mega malpractice awards like these are rising against physicians and hospitals around the country, according to new data from TransRe, an international reinsurance company that tracks large verdicts.
“2023 blew away every record previously set among high medical malpractice verdicts,” said Richard Henderson, senior vice president for TransRe.
In 2023, there were 57 medical malpractice verdicts of $10 million or more in the United States, the data showed. Slightly more than half of those reached $25 million or more.
From 2012 to 2022, verdicts of $10 million or more ranged from 34 in 2013 to 52 in 2022, TransRe research found.
While New York, Illinois, and Florida typically saw the highest dollar verdicts in previous years, so-called “nuclear” verdicts now occur in states like Utah and Georgia where they once were uncommon, said Robert E. White Jr., president of TDC Group and The Doctors Company, a national medical liability insurer for physicians.
A rollback of tort reforms across the country is one contributor, he said. For example, Georgia’s cap on noneconomic damages is among those that have been ruled unconstitutional by courts. Utah’s cap on noneconomic damages still stands, but the limit was deemed unconstitutional in wrongful death cases. In 2019, a portion of Utah›s pre-litigation panel process was also struck down by the state’s Supreme Court.
“We used to be able to predict where these high verdicts would occur,” Mr. White said. “We can’t predict it anymore.”
Research shows a majority of malpractice cases are dropped or settled before trial, and claims that go before juries usually end in doctors’ favor. Plaintiffs’ attorneys cite large jury verdicts in similar cases to induce settlements and higher payouts, Mr. White said.
And while mega verdicts rarely stick, they can have lasting effects on future claims. The awards lead to larger settlement demands from plaintiffs and drive up the cost to resolve claims, according to Mr. Henderson and Mr. White.
“Verdicts are the yardstick by which all settlements are measured,” Mr. White said. “That’s where the damage is done.” The prospect of a mega verdict can make insurers leery of fighting some malpractice cases and motivate them to offer bigger settlements to stay out of the courtroom, he added.
Why Are Juries Awarding Higher Verdicts?
There’s no single reason for the rise in nuclear verdicts, Mr. Henderson said.
One theory is that plaintiffs’ attorneys held back on resolving high-dollar cases during the COVID pandemic and let loose with high-demand claims when courts returned to normal, he said.
Another theory is that people emerged from the pandemic angrier.
“Whether it was political dynamics, masking [mandates], or differences in opinions, people came out of it angry, and generally speaking, you don’t want an angry jury,” Mr. Henderson said. “For a while, there was the halo effect, where health professionals were seen as heroes. That went away, and all of a sudden [they] became ‘the bad guys.’ ”
“People are angry at the healthcare system, and this anger manifests itself in [liability] suits,” added Bill Burns, vice president of research for the Medical Professional Liability Association, an industry group for medical liability insurers.
Hospital and medical group consolidation also reduces the personal connection juries may have with healthcare providers, Mr. Burns said.
“Healthcare has become a big business, and the corporatization of medicine now puts companies on the stand and not your local community hospital or your family doctor that you have known since birth,” he said.
Plaintiffs’ attorneys also deploy tactics that can prompt higher verdicts, Mr. White said. They may tell a jury that the provider or hospital is a threat to the community and that awarding a large verdict will deter others in the healthcare community from repeating the same actions.
Juries may then want to punish the defendant in addition to assessing damages for economic harm or pain and suffering, Mr. White said.
“I am concerned that jurors are trying to right social wrongs rather than judging cases on the facts presented to them,” added Mike Stinson, vice president for policy and legal affairs for the Medical Professional Liability Association.
Third-party litigation financing also can lead to mega verdicts. That’s an emerging practice in which companies unrelated to a lawsuit provide capital to plaintiffs in return for a portion of any financial award. The firms essentially “invest” in the litigation.
“What this does is provide an additional financial backdrop for plaintiffs,” Mr. Henderson said. “It allows them to dig in harder on cases. They can hold out for higher numbers, and if nothing else, it can prolong litigation.”
Do High Awards Actually Stick?
Multimillion-dollar verdicts may grab headlines, but do plaintiffs actually receive them?
Rarely, said TransRe, which tracks the final outcomes of verdicts. In many cases, large verdicts are reduced on appeal.
In the Maya case, which involved child protection authorities, a judge later lowered the damages against Johns Hopkins All Children’s Hospital by $47.5 million.
A federal judge in October, for example, rejected a record $110 million medical malpractice award in Minnesota, reducing it to $10 million. The district judge ruled the award was “shockingly excessive” and that the plaintiff should either accept the $10 million award or retry the case.
After a verdict is awarded, the defendant typically challenges the award, and the case goes through the appellate pipeline, Mr. Henderson explained. A judge may reduce some elements of the verdict, he said, but more often, the plaintiff and defendant agree on a compromised figure.
Seattle medical liability defense attorney Jennifer Crisera has experienced this firsthand. She recalled a recent case where a plaintiff’s attorney demanded what she describes as an unreasonable amount to settle a claim. Ms. Crisera did not want to give exact numbers but said the plaintiff made an 8-figure demand and the defense offered a low 7-figure range.
“My impression was that plaintiff’s counsel believed that they could get a nuclear verdict from the jury, so they kept their settlement demand artificially high,” she said. “The division between the numbers was way too high. Ultimately, we had to let a jury decide the value.”
The plaintiff won the case, and the verdict was much less than the settlement demand, she said. Even so, the defense incurred trial costs, and the health provider was forced to endure the emotional stress of a trial that could have been avoided, Ms. Crisera said.
Higher medical malpractice premiums are another consequence of massive awards.
Premium rates are associated with how much insurers pay on average for cases and how frequently they are making payouts, Mr. White said.
Medical liability insurance premiums for physicians have steadily increased since 2019, according to data from the Medical Liability Monitor, a national publication that analyzes liability insurance premiums. The Monitor studies insurance premium data from insurers that cover internists, general surgeons, and obstetrician-gynecologists.
From 2019 to 2023, average premium rates for physicians increased between 1.1% and 3% each year in states without patient compensation funds, according to Monitor data.
“Nuclear verdicts are a real driver of the industry’s underwriting losses and remain top of mind for every malpractice insurance company,” said Michael Matray, editor for the Medical Liability Monitor. “Responses to this year’s rate survey questionnaire indicate that most responding companies have experienced an increase in claims greater than $1 million and claims greater than $5 million during the past 2 years.”
However, increases vary widely by region and among counties. In Montgomery County, Alabama, for instance, premiums for internists rose by 24% from 2022 to 2023, from $8,231 to $10,240. Premiums for Montgomery County general surgeons rose by 11.9% from 2022 to 2023, from $30,761 to $34,426, according to survey data.
In several counties in Illinois (Adams, Knox, Peoria, and Rock Island), premiums for some internists rose by 15% from $24,041 to $27,783, and premiums for some surgeons increased by 27% from $60,202 to $76,461, according to survey data. Some internists in Catoosa County, Georgia, meanwhile, paid $17,831 in 2023, up from $16,313 in 2022. Some surgeons in Catoosa County paid $65,616 in 2023, up from $60,032 in 2022. Inflation could be one factor behind higher liability premium rates. Claim severity is a key driver of higher premium rates, Mr. White added.
“We have not seen stability in claims severity,” he said. “It is continuing to go up and, in all likelihood, it will drive [premium] rates up further from this point.”
A version of this article appeared on Medscape.com.
In December, in what’s known as the “Take Care of Maya” case, a Florida jury returned a record $261 million verdict against Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, for its treatment of a young patient and her family after an emergency room visit.
A month earlier, in New York, a jury ordered Westchester Medical Center Health Network to pay $120 million to a patient and his family following delayed stroke care that resulted in brain damage.
Mega malpractice awards like these are rising against physicians and hospitals around the country, according to new data from TransRe, an international reinsurance company that tracks large verdicts.
“2023 blew away every record previously set among high medical malpractice verdicts,” said Richard Henderson, senior vice president for TransRe.
In 2023, there were 57 medical malpractice verdicts of $10 million or more in the United States, the data showed. Slightly more than half of those reached $25 million or more.
From 2012 to 2022, verdicts of $10 million or more ranged from 34 in 2013 to 52 in 2022, TransRe research found.
While New York, Illinois, and Florida typically saw the highest dollar verdicts in previous years, so-called “nuclear” verdicts now occur in states like Utah and Georgia where they once were uncommon, said Robert E. White Jr., president of TDC Group and The Doctors Company, a national medical liability insurer for physicians.
A rollback of tort reforms across the country is one contributor, he said. For example, Georgia’s cap on noneconomic damages is among those that have been ruled unconstitutional by courts. Utah’s cap on noneconomic damages still stands, but the limit was deemed unconstitutional in wrongful death cases. In 2019, a portion of Utah›s pre-litigation panel process was also struck down by the state’s Supreme Court.
“We used to be able to predict where these high verdicts would occur,” Mr. White said. “We can’t predict it anymore.”
Research shows a majority of malpractice cases are dropped or settled before trial, and claims that go before juries usually end in doctors’ favor. Plaintiffs’ attorneys cite large jury verdicts in similar cases to induce settlements and higher payouts, Mr. White said.
And while mega verdicts rarely stick, they can have lasting effects on future claims. The awards lead to larger settlement demands from plaintiffs and drive up the cost to resolve claims, according to Mr. Henderson and Mr. White.
“Verdicts are the yardstick by which all settlements are measured,” Mr. White said. “That’s where the damage is done.” The prospect of a mega verdict can make insurers leery of fighting some malpractice cases and motivate them to offer bigger settlements to stay out of the courtroom, he added.
Why Are Juries Awarding Higher Verdicts?
There’s no single reason for the rise in nuclear verdicts, Mr. Henderson said.
One theory is that plaintiffs’ attorneys held back on resolving high-dollar cases during the COVID pandemic and let loose with high-demand claims when courts returned to normal, he said.
Another theory is that people emerged from the pandemic angrier.
“Whether it was political dynamics, masking [mandates], or differences in opinions, people came out of it angry, and generally speaking, you don’t want an angry jury,” Mr. Henderson said. “For a while, there was the halo effect, where health professionals were seen as heroes. That went away, and all of a sudden [they] became ‘the bad guys.’ ”
“People are angry at the healthcare system, and this anger manifests itself in [liability] suits,” added Bill Burns, vice president of research for the Medical Professional Liability Association, an industry group for medical liability insurers.
Hospital and medical group consolidation also reduces the personal connection juries may have with healthcare providers, Mr. Burns said.
“Healthcare has become a big business, and the corporatization of medicine now puts companies on the stand and not your local community hospital or your family doctor that you have known since birth,” he said.
Plaintiffs’ attorneys also deploy tactics that can prompt higher verdicts, Mr. White said. They may tell a jury that the provider or hospital is a threat to the community and that awarding a large verdict will deter others in the healthcare community from repeating the same actions.
Juries may then want to punish the defendant in addition to assessing damages for economic harm or pain and suffering, Mr. White said.
“I am concerned that jurors are trying to right social wrongs rather than judging cases on the facts presented to them,” added Mike Stinson, vice president for policy and legal affairs for the Medical Professional Liability Association.
Third-party litigation financing also can lead to mega verdicts. That’s an emerging practice in which companies unrelated to a lawsuit provide capital to plaintiffs in return for a portion of any financial award. The firms essentially “invest” in the litigation.
“What this does is provide an additional financial backdrop for plaintiffs,” Mr. Henderson said. “It allows them to dig in harder on cases. They can hold out for higher numbers, and if nothing else, it can prolong litigation.”
Do High Awards Actually Stick?
Multimillion-dollar verdicts may grab headlines, but do plaintiffs actually receive them?
Rarely, said TransRe, which tracks the final outcomes of verdicts. In many cases, large verdicts are reduced on appeal.
In the Maya case, which involved child protection authorities, a judge later lowered the damages against Johns Hopkins All Children’s Hospital by $47.5 million.
A federal judge in October, for example, rejected a record $110 million medical malpractice award in Minnesota, reducing it to $10 million. The district judge ruled the award was “shockingly excessive” and that the plaintiff should either accept the $10 million award or retry the case.
After a verdict is awarded, the defendant typically challenges the award, and the case goes through the appellate pipeline, Mr. Henderson explained. A judge may reduce some elements of the verdict, he said, but more often, the plaintiff and defendant agree on a compromised figure.
Seattle medical liability defense attorney Jennifer Crisera has experienced this firsthand. She recalled a recent case where a plaintiff’s attorney demanded what she describes as an unreasonable amount to settle a claim. Ms. Crisera did not want to give exact numbers but said the plaintiff made an 8-figure demand and the defense offered a low 7-figure range.
“My impression was that plaintiff’s counsel believed that they could get a nuclear verdict from the jury, so they kept their settlement demand artificially high,” she said. “The division between the numbers was way too high. Ultimately, we had to let a jury decide the value.”
The plaintiff won the case, and the verdict was much less than the settlement demand, she said. Even so, the defense incurred trial costs, and the health provider was forced to endure the emotional stress of a trial that could have been avoided, Ms. Crisera said.
Higher medical malpractice premiums are another consequence of massive awards.
Premium rates are associated with how much insurers pay on average for cases and how frequently they are making payouts, Mr. White said.
Medical liability insurance premiums for physicians have steadily increased since 2019, according to data from the Medical Liability Monitor, a national publication that analyzes liability insurance premiums. The Monitor studies insurance premium data from insurers that cover internists, general surgeons, and obstetrician-gynecologists.
From 2019 to 2023, average premium rates for physicians increased between 1.1% and 3% each year in states without patient compensation funds, according to Monitor data.
“Nuclear verdicts are a real driver of the industry’s underwriting losses and remain top of mind for every malpractice insurance company,” said Michael Matray, editor for the Medical Liability Monitor. “Responses to this year’s rate survey questionnaire indicate that most responding companies have experienced an increase in claims greater than $1 million and claims greater than $5 million during the past 2 years.”
However, increases vary widely by region and among counties. In Montgomery County, Alabama, for instance, premiums for internists rose by 24% from 2022 to 2023, from $8,231 to $10,240. Premiums for Montgomery County general surgeons rose by 11.9% from 2022 to 2023, from $30,761 to $34,426, according to survey data.
In several counties in Illinois (Adams, Knox, Peoria, and Rock Island), premiums for some internists rose by 15% from $24,041 to $27,783, and premiums for some surgeons increased by 27% from $60,202 to $76,461, according to survey data. Some internists in Catoosa County, Georgia, meanwhile, paid $17,831 in 2023, up from $16,313 in 2022. Some surgeons in Catoosa County paid $65,616 in 2023, up from $60,032 in 2022. Inflation could be one factor behind higher liability premium rates. Claim severity is a key driver of higher premium rates, Mr. White added.
“We have not seen stability in claims severity,” he said. “It is continuing to go up and, in all likelihood, it will drive [premium] rates up further from this point.”
A version of this article appeared on Medscape.com.
US Board Discloses Cheating, Grads Say Problem Is Rampant
The United States Medical Licensing Examination (USMLE) program is invalidating scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal.
In a January 31 announcement, the USMLE program said that officials are in the process of notifying examinees with results in question and that the examinees will be required to take validation exams. The program did not offer further details about its investigation or how the questionable performance was identified.
“The USMLE program regularly monitors and analyzes examinees’ test performances for unusual score patterns or variations, and other information that could raise questions about the validity of an examinee’s results,” the program said in a statement. “Highly irregular patterns can be indicative of prior unauthorized access to secure exam content.”
Some medical graduates say the action against students cheating on the USMLE is long overdue.
, particularly by groups within the international medical graduate (IMG) community, according to multiple IMGs who shared their concerns with this news organization. Sellers operate under pseudonyms across social media platforms and charge anywhere from $300 to $2000 for questions, Medscape research shows.
Facebook posts often advertise questions for sale, said Saqib Gul, MD, an IMG from Pakistan who has voiced concerns about the practice on social media.
“People make up fake profiles and tell others to [direct message] them for recalls,” he told this news organization. “There was a dedicated Facebook page that was doing this. In other cases, a couple of friends that took the exam remember a certain number of questions and write them down after the test.”
Ahmad Ozair, MD, an IMG from Lucknow, Uttar Pradesh, India, said that he has come across many groups online sharing or selling USMLE recalls. He first became suspicious when he saw several students, all from a few medical schools in Nepal, posting on social media about scoring in the 270 and 280-plus range.
“The statistical probability that you would have three or more candidates in the same year, scoring in the 99th percentile worldwide, belonging to a small geographical area is extremely low.”
Dr. Ozair, who now is studying public health at Johns Hopkins University in Baltimore, said that the issue is important for “all stakeholders” who care about patient safety: “Would you want a doctor who has cheated on the medical licensing exam to take care of you?”
In an interview, USMLE program spokesman Joe Knickrehm said that the program relies on multiple processes to detect and respond to claims that exam integrity is being compromised. The process includes monitoring performance data, an anonymous tip line for reporting suspicious behavior, and a thorough investigative process.
“The USMLE program regularly monitors social media channels for comments relating to exam security and irregular behavior and will initiate an investigation if warranted,” Mr. Knickrehm told this news organization. “ The covert nature of this activity does not lend itself to a definitive statement regarding whether the problem has increased or decreased in recent years.”
Mr. Knickrehm said that the program’s STOPit app allows people to report suspicious behavior electronically to the USMLE program. Since its launch in 2021, the program has received more than 80 tips per year through the app, according to Mr. Knickrehm. Security violations are investigated by USMLE staff and reviewed by the USMLE Committee for Individualized Review (CIR). Anyone found to have engaged in irregular behavior by the CIR for activities undermining exam integrity are typically barred from access to the USMLE for multiple years.
How Easy Is It to Buy Recalls?
Two years ago, Dr B was approached by a former study partner who had just completed Step 2 of the USMLE. She asked whether Dr B wanted to buy recalled questions to help her pass.
“She paid this guy almost $2000 for recalls and told me if I pay this money, he’ll give me the recalls,” said Dr B, who asked to remain anonymous for fear of being associated with students cheating on the USMLE. “I told her I was not interested, and she said the guy would lower the price. I broke contact with her.”
Dr B, an IMG from Pakistan, was appalled. But she said that the episode was not the first time she has come across groups selling USMLE recalls or heard peers brag about having access to exam content.
“I am baffled at how many [groups] post on social media and brazenly advertise their ‘services,’” she told this news organization. “No one arrests them, their customers go on to score abnormally high on the boards, making it unachievable for people who take the honest route, plus giving IMGs a bad rep.”
Groups offering recalls are easily findable on sites such as Telegram and Signal. Telegram is a cloud-based messaging app that focuses on security, and Signal is an encrypted messaging service.
The website recallmastery.com purports to offer a range of USMLE recall packages, from a free, unsorted version to Step 1 and Step 2 packages that include “fresh updates,” and sections with “mostly repeated topics. Prices range from the free version to the $799 VIP package.
Another site called MedPox.com boasts 2024 Step 2 recalls, advertising “ actual exam questions to get HIGH scores.” The website’s owner states that the recalls were collected “by my friends,” and to message the them to be added to the “recalls group.”
A reporter was able to easily download a free version of alleged USMLE questions and answers from recallmastery.com. The document was a combination of typed and handwritten notes about medical questions, with red circles around recalled answers.
J. Bryan Carmody, MD, who blogs about medical education, reviewed a copy of the document. He said that the content appeared “credible” and was in fact recalled USMLE questions. However, the extent of which the question stem was recalled was incomplete at best, and there was little production value to the document, said Dr. Carmody, a nephrologist and associate professor of pediatrics at the Eastern Virgina Medical School in Norfolk.
The person selling the recall packages states on the website that the free version is not organized or sorted, but it allows viewers to “see how this works before paying for premium recalls.”
Mr. Knickrehm said that the program could not comment on the document, but that “whenever the USMLE program receives or locates information about a potential security violation, we investigate and take necessary action.”
When asked about the specific websites noted above, Knickrehm said that the program routinely monitors a wide array of websites, message boards, and chat rooms for USMLE-related materials. Though many sites advertise having USMLE recalls for sale, it’s more likely they are selling non-USMLE content, he said.
Using past content to cheat on medical exams is an old problem. In 2010, for example, the American Board of Internal Medicine suspended 139 physicians after they were caught cheating on the board exams. The scandal involved a vast cheating ring that included physicians memorizing questions and reproducing them after the tests. The board later sued a gastroenterologist for her part in the scandal.
In 2012, a CNN investigation exposed doctors who were memorizing test questions and creating sophisticated recall banks to cheat on radiology boards. The Association of American Medical Colleges sued a medical student in 2017 for attempting to secretly record content on the MCAT using spyglasses.
In recent years, Dr. Carmody said that he has received multiple messages and screenshots from concerned students and residents who were offered or encountered recalls.
“One thing that’s unclear is how legitimate the claims are,” he said. “Many of these recalls may be faulty or outdated. It could be someone who took the exam yesterday and has a photographic memory or it could be some sparsely recalled or mis-recalled information. Unless you’re willing to pay these people, you can’t inspect the quality, or even if you did, you wouldn’t know if the information was current or not.”
‘As an IMG, There Is So Much at Stake’
Whether recall sellers — and those buying them — are more frequently IMGs has fostered heated debate on social media.
On a Reddit thread devoted to IMG issues, posters expressed frustration about being bombarded with recall advertisements and unwanted messages about buying USMLE questions while trying to find study materials. One poster called the practices a “huge slap to all those IMGs who are struggling day and night, just to get a good score.”
In an X thread about the same subject, however, some self-described IMGs took offense to claims that IMGs might score higher because they have access to recalls. The allegations are “incendiary” and “malign hardworking IMGs,” posters wrote.
When Dr. Gul spoke out online about the “biopsy” culture, he received multiple private messages from fellow IMGs telling him to remove his comments, he said.
“I received a lot of backlash on social media,” he told this news organization. “Some IMGs asked me to take down my posts because they thought I was making IMGs look bad, and it might prompt authorities to take action or shut down international examination centers for IMGs.”
Most of the IMGs who spoke to this news organization were afraid to be publicly identified. Several IMG advocates and IMG associations contacted for the story did not respond. One medical education expert said that his institution advised him to “steer clear” of commenting because the issue was “controversial.”
“As an IMG, there is so much at stake,” Dr B said. “Any association with shady operations like these is an absolute suicide. I’m personally afraid of any repercussions of the sort.”
USMLE officials declined to comment on whether the buying or selling of recalls appears to be more prevalent among the IMG community, saying it is “difficult to generalize this behavior as ‘prevalent’ simply due to the clandestine nature of this activity.”
Cheat-Proofing the USMLE
The USMLE program has taken several steps intended to prevent cheating, but more needs to be done, medical education advocates say.
For example, Dr. Carmody called the recent change in the attempt limit for taking USMLE exams from six to four times a good move.
“The reality is, if you’re taking a USMLE exam five-plus times, you’re far more likely to be memorizing questions and selling them for shady test prep operations than you are to be legitimately pursuing U.S. residency training or licensure,” he wrote on X.
The 2022 move to make USMLE Step 1 pass or fail is another positive change, said Dr. Gul, who added that US programs should also put less weight on test scores and focus more on clinical experience.
“Many programs in the US prioritize scores rather than clinical experiences in home countries,” he said. “If program directors would remove these criteria, probably the cheating practices would stop. Clinical practice matters. When a doctor gets matched, they have to be good at seeing and treating patients, not just good at sitting in front of a screen and taking an exam.”
Turning over questions more rapidly would help curb the practices, Dr. Carmody said. Another strategy is using math techniques to identify unusual deviations that suggest cheating, he said.
A blueprint for the strategy was created after a cheating scandal involving Canada’s Medical Council of Canada Qualifying Examination (MCCQE) in 2004. After learning which questions were circulated, MCCQE administrators evaluated exams by comparing answers of compromised questions with the answers of noncompromised questions.
“For a person who was not cheating, the error of performance should be pretty similar on those two groups of questions,” Dr. Carmody said. “But if you were given the questions in advance, you might have very poor performance on questions that had not been compromised, and very high performance on those that had been compromised. That disparity is very unlikely to occur just by chance alone.”
Based on his research, Dr. Ozair is working on an academic review paper about cheating on the USMLE and on the Medical Council of Canada Qualification Examination. He said that he hopes the paper will raise more awareness about the problem and drive more action.
He and others interviewed for this story shared that the websites they’ve reported to the USMLE program are still active and offering recalls to buyers.
“Even if they are not actually offering something tangible or true, appearance matters,” Dr. Ozair said. “I think it’s worth the USMLE sending cease and desist letters and getting these websites taken down. This would restore faith in the process and underscore that this issue is being taken seriously.”
A version of this article appeared on Medscape.com.
The United States Medical Licensing Examination (USMLE) program is invalidating scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal.
In a January 31 announcement, the USMLE program said that officials are in the process of notifying examinees with results in question and that the examinees will be required to take validation exams. The program did not offer further details about its investigation or how the questionable performance was identified.
“The USMLE program regularly monitors and analyzes examinees’ test performances for unusual score patterns or variations, and other information that could raise questions about the validity of an examinee’s results,” the program said in a statement. “Highly irregular patterns can be indicative of prior unauthorized access to secure exam content.”
Some medical graduates say the action against students cheating on the USMLE is long overdue.
, particularly by groups within the international medical graduate (IMG) community, according to multiple IMGs who shared their concerns with this news organization. Sellers operate under pseudonyms across social media platforms and charge anywhere from $300 to $2000 for questions, Medscape research shows.
Facebook posts often advertise questions for sale, said Saqib Gul, MD, an IMG from Pakistan who has voiced concerns about the practice on social media.
“People make up fake profiles and tell others to [direct message] them for recalls,” he told this news organization. “There was a dedicated Facebook page that was doing this. In other cases, a couple of friends that took the exam remember a certain number of questions and write them down after the test.”
Ahmad Ozair, MD, an IMG from Lucknow, Uttar Pradesh, India, said that he has come across many groups online sharing or selling USMLE recalls. He first became suspicious when he saw several students, all from a few medical schools in Nepal, posting on social media about scoring in the 270 and 280-plus range.
“The statistical probability that you would have three or more candidates in the same year, scoring in the 99th percentile worldwide, belonging to a small geographical area is extremely low.”
Dr. Ozair, who now is studying public health at Johns Hopkins University in Baltimore, said that the issue is important for “all stakeholders” who care about patient safety: “Would you want a doctor who has cheated on the medical licensing exam to take care of you?”
In an interview, USMLE program spokesman Joe Knickrehm said that the program relies on multiple processes to detect and respond to claims that exam integrity is being compromised. The process includes monitoring performance data, an anonymous tip line for reporting suspicious behavior, and a thorough investigative process.
“The USMLE program regularly monitors social media channels for comments relating to exam security and irregular behavior and will initiate an investigation if warranted,” Mr. Knickrehm told this news organization. “ The covert nature of this activity does not lend itself to a definitive statement regarding whether the problem has increased or decreased in recent years.”
Mr. Knickrehm said that the program’s STOPit app allows people to report suspicious behavior electronically to the USMLE program. Since its launch in 2021, the program has received more than 80 tips per year through the app, according to Mr. Knickrehm. Security violations are investigated by USMLE staff and reviewed by the USMLE Committee for Individualized Review (CIR). Anyone found to have engaged in irregular behavior by the CIR for activities undermining exam integrity are typically barred from access to the USMLE for multiple years.
How Easy Is It to Buy Recalls?
Two years ago, Dr B was approached by a former study partner who had just completed Step 2 of the USMLE. She asked whether Dr B wanted to buy recalled questions to help her pass.
“She paid this guy almost $2000 for recalls and told me if I pay this money, he’ll give me the recalls,” said Dr B, who asked to remain anonymous for fear of being associated with students cheating on the USMLE. “I told her I was not interested, and she said the guy would lower the price. I broke contact with her.”
Dr B, an IMG from Pakistan, was appalled. But she said that the episode was not the first time she has come across groups selling USMLE recalls or heard peers brag about having access to exam content.
“I am baffled at how many [groups] post on social media and brazenly advertise their ‘services,’” she told this news organization. “No one arrests them, their customers go on to score abnormally high on the boards, making it unachievable for people who take the honest route, plus giving IMGs a bad rep.”
Groups offering recalls are easily findable on sites such as Telegram and Signal. Telegram is a cloud-based messaging app that focuses on security, and Signal is an encrypted messaging service.
The website recallmastery.com purports to offer a range of USMLE recall packages, from a free, unsorted version to Step 1 and Step 2 packages that include “fresh updates,” and sections with “mostly repeated topics. Prices range from the free version to the $799 VIP package.
Another site called MedPox.com boasts 2024 Step 2 recalls, advertising “ actual exam questions to get HIGH scores.” The website’s owner states that the recalls were collected “by my friends,” and to message the them to be added to the “recalls group.”
A reporter was able to easily download a free version of alleged USMLE questions and answers from recallmastery.com. The document was a combination of typed and handwritten notes about medical questions, with red circles around recalled answers.
J. Bryan Carmody, MD, who blogs about medical education, reviewed a copy of the document. He said that the content appeared “credible” and was in fact recalled USMLE questions. However, the extent of which the question stem was recalled was incomplete at best, and there was little production value to the document, said Dr. Carmody, a nephrologist and associate professor of pediatrics at the Eastern Virgina Medical School in Norfolk.
The person selling the recall packages states on the website that the free version is not organized or sorted, but it allows viewers to “see how this works before paying for premium recalls.”
Mr. Knickrehm said that the program could not comment on the document, but that “whenever the USMLE program receives or locates information about a potential security violation, we investigate and take necessary action.”
When asked about the specific websites noted above, Knickrehm said that the program routinely monitors a wide array of websites, message boards, and chat rooms for USMLE-related materials. Though many sites advertise having USMLE recalls for sale, it’s more likely they are selling non-USMLE content, he said.
Using past content to cheat on medical exams is an old problem. In 2010, for example, the American Board of Internal Medicine suspended 139 physicians after they were caught cheating on the board exams. The scandal involved a vast cheating ring that included physicians memorizing questions and reproducing them after the tests. The board later sued a gastroenterologist for her part in the scandal.
In 2012, a CNN investigation exposed doctors who were memorizing test questions and creating sophisticated recall banks to cheat on radiology boards. The Association of American Medical Colleges sued a medical student in 2017 for attempting to secretly record content on the MCAT using spyglasses.
In recent years, Dr. Carmody said that he has received multiple messages and screenshots from concerned students and residents who were offered or encountered recalls.
“One thing that’s unclear is how legitimate the claims are,” he said. “Many of these recalls may be faulty or outdated. It could be someone who took the exam yesterday and has a photographic memory or it could be some sparsely recalled or mis-recalled information. Unless you’re willing to pay these people, you can’t inspect the quality, or even if you did, you wouldn’t know if the information was current or not.”
‘As an IMG, There Is So Much at Stake’
Whether recall sellers — and those buying them — are more frequently IMGs has fostered heated debate on social media.
On a Reddit thread devoted to IMG issues, posters expressed frustration about being bombarded with recall advertisements and unwanted messages about buying USMLE questions while trying to find study materials. One poster called the practices a “huge slap to all those IMGs who are struggling day and night, just to get a good score.”
In an X thread about the same subject, however, some self-described IMGs took offense to claims that IMGs might score higher because they have access to recalls. The allegations are “incendiary” and “malign hardworking IMGs,” posters wrote.
When Dr. Gul spoke out online about the “biopsy” culture, he received multiple private messages from fellow IMGs telling him to remove his comments, he said.
“I received a lot of backlash on social media,” he told this news organization. “Some IMGs asked me to take down my posts because they thought I was making IMGs look bad, and it might prompt authorities to take action or shut down international examination centers for IMGs.”
Most of the IMGs who spoke to this news organization were afraid to be publicly identified. Several IMG advocates and IMG associations contacted for the story did not respond. One medical education expert said that his institution advised him to “steer clear” of commenting because the issue was “controversial.”
“As an IMG, there is so much at stake,” Dr B said. “Any association with shady operations like these is an absolute suicide. I’m personally afraid of any repercussions of the sort.”
USMLE officials declined to comment on whether the buying or selling of recalls appears to be more prevalent among the IMG community, saying it is “difficult to generalize this behavior as ‘prevalent’ simply due to the clandestine nature of this activity.”
Cheat-Proofing the USMLE
The USMLE program has taken several steps intended to prevent cheating, but more needs to be done, medical education advocates say.
For example, Dr. Carmody called the recent change in the attempt limit for taking USMLE exams from six to four times a good move.
“The reality is, if you’re taking a USMLE exam five-plus times, you’re far more likely to be memorizing questions and selling them for shady test prep operations than you are to be legitimately pursuing U.S. residency training or licensure,” he wrote on X.
The 2022 move to make USMLE Step 1 pass or fail is another positive change, said Dr. Gul, who added that US programs should also put less weight on test scores and focus more on clinical experience.
“Many programs in the US prioritize scores rather than clinical experiences in home countries,” he said. “If program directors would remove these criteria, probably the cheating practices would stop. Clinical practice matters. When a doctor gets matched, they have to be good at seeing and treating patients, not just good at sitting in front of a screen and taking an exam.”
Turning over questions more rapidly would help curb the practices, Dr. Carmody said. Another strategy is using math techniques to identify unusual deviations that suggest cheating, he said.
A blueprint for the strategy was created after a cheating scandal involving Canada’s Medical Council of Canada Qualifying Examination (MCCQE) in 2004. After learning which questions were circulated, MCCQE administrators evaluated exams by comparing answers of compromised questions with the answers of noncompromised questions.
“For a person who was not cheating, the error of performance should be pretty similar on those two groups of questions,” Dr. Carmody said. “But if you were given the questions in advance, you might have very poor performance on questions that had not been compromised, and very high performance on those that had been compromised. That disparity is very unlikely to occur just by chance alone.”
Based on his research, Dr. Ozair is working on an academic review paper about cheating on the USMLE and on the Medical Council of Canada Qualification Examination. He said that he hopes the paper will raise more awareness about the problem and drive more action.
He and others interviewed for this story shared that the websites they’ve reported to the USMLE program are still active and offering recalls to buyers.
“Even if they are not actually offering something tangible or true, appearance matters,” Dr. Ozair said. “I think it’s worth the USMLE sending cease and desist letters and getting these websites taken down. This would restore faith in the process and underscore that this issue is being taken seriously.”
A version of this article appeared on Medscape.com.
The United States Medical Licensing Examination (USMLE) program is invalidating scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal.
In a January 31 announcement, the USMLE program said that officials are in the process of notifying examinees with results in question and that the examinees will be required to take validation exams. The program did not offer further details about its investigation or how the questionable performance was identified.
“The USMLE program regularly monitors and analyzes examinees’ test performances for unusual score patterns or variations, and other information that could raise questions about the validity of an examinee’s results,” the program said in a statement. “Highly irregular patterns can be indicative of prior unauthorized access to secure exam content.”
Some medical graduates say the action against students cheating on the USMLE is long overdue.
, particularly by groups within the international medical graduate (IMG) community, according to multiple IMGs who shared their concerns with this news organization. Sellers operate under pseudonyms across social media platforms and charge anywhere from $300 to $2000 for questions, Medscape research shows.
Facebook posts often advertise questions for sale, said Saqib Gul, MD, an IMG from Pakistan who has voiced concerns about the practice on social media.
“People make up fake profiles and tell others to [direct message] them for recalls,” he told this news organization. “There was a dedicated Facebook page that was doing this. In other cases, a couple of friends that took the exam remember a certain number of questions and write them down after the test.”
Ahmad Ozair, MD, an IMG from Lucknow, Uttar Pradesh, India, said that he has come across many groups online sharing or selling USMLE recalls. He first became suspicious when he saw several students, all from a few medical schools in Nepal, posting on social media about scoring in the 270 and 280-plus range.
“The statistical probability that you would have three or more candidates in the same year, scoring in the 99th percentile worldwide, belonging to a small geographical area is extremely low.”
Dr. Ozair, who now is studying public health at Johns Hopkins University in Baltimore, said that the issue is important for “all stakeholders” who care about patient safety: “Would you want a doctor who has cheated on the medical licensing exam to take care of you?”
In an interview, USMLE program spokesman Joe Knickrehm said that the program relies on multiple processes to detect and respond to claims that exam integrity is being compromised. The process includes monitoring performance data, an anonymous tip line for reporting suspicious behavior, and a thorough investigative process.
“The USMLE program regularly monitors social media channels for comments relating to exam security and irregular behavior and will initiate an investigation if warranted,” Mr. Knickrehm told this news organization. “ The covert nature of this activity does not lend itself to a definitive statement regarding whether the problem has increased or decreased in recent years.”
Mr. Knickrehm said that the program’s STOPit app allows people to report suspicious behavior electronically to the USMLE program. Since its launch in 2021, the program has received more than 80 tips per year through the app, according to Mr. Knickrehm. Security violations are investigated by USMLE staff and reviewed by the USMLE Committee for Individualized Review (CIR). Anyone found to have engaged in irregular behavior by the CIR for activities undermining exam integrity are typically barred from access to the USMLE for multiple years.
How Easy Is It to Buy Recalls?
Two years ago, Dr B was approached by a former study partner who had just completed Step 2 of the USMLE. She asked whether Dr B wanted to buy recalled questions to help her pass.
“She paid this guy almost $2000 for recalls and told me if I pay this money, he’ll give me the recalls,” said Dr B, who asked to remain anonymous for fear of being associated with students cheating on the USMLE. “I told her I was not interested, and she said the guy would lower the price. I broke contact with her.”
Dr B, an IMG from Pakistan, was appalled. But she said that the episode was not the first time she has come across groups selling USMLE recalls or heard peers brag about having access to exam content.
“I am baffled at how many [groups] post on social media and brazenly advertise their ‘services,’” she told this news organization. “No one arrests them, their customers go on to score abnormally high on the boards, making it unachievable for people who take the honest route, plus giving IMGs a bad rep.”
Groups offering recalls are easily findable on sites such as Telegram and Signal. Telegram is a cloud-based messaging app that focuses on security, and Signal is an encrypted messaging service.
The website recallmastery.com purports to offer a range of USMLE recall packages, from a free, unsorted version to Step 1 and Step 2 packages that include “fresh updates,” and sections with “mostly repeated topics. Prices range from the free version to the $799 VIP package.
Another site called MedPox.com boasts 2024 Step 2 recalls, advertising “ actual exam questions to get HIGH scores.” The website’s owner states that the recalls were collected “by my friends,” and to message the them to be added to the “recalls group.”
A reporter was able to easily download a free version of alleged USMLE questions and answers from recallmastery.com. The document was a combination of typed and handwritten notes about medical questions, with red circles around recalled answers.
J. Bryan Carmody, MD, who blogs about medical education, reviewed a copy of the document. He said that the content appeared “credible” and was in fact recalled USMLE questions. However, the extent of which the question stem was recalled was incomplete at best, and there was little production value to the document, said Dr. Carmody, a nephrologist and associate professor of pediatrics at the Eastern Virgina Medical School in Norfolk.
The person selling the recall packages states on the website that the free version is not organized or sorted, but it allows viewers to “see how this works before paying for premium recalls.”
Mr. Knickrehm said that the program could not comment on the document, but that “whenever the USMLE program receives or locates information about a potential security violation, we investigate and take necessary action.”
When asked about the specific websites noted above, Knickrehm said that the program routinely monitors a wide array of websites, message boards, and chat rooms for USMLE-related materials. Though many sites advertise having USMLE recalls for sale, it’s more likely they are selling non-USMLE content, he said.
Using past content to cheat on medical exams is an old problem. In 2010, for example, the American Board of Internal Medicine suspended 139 physicians after they were caught cheating on the board exams. The scandal involved a vast cheating ring that included physicians memorizing questions and reproducing them after the tests. The board later sued a gastroenterologist for her part in the scandal.
In 2012, a CNN investigation exposed doctors who were memorizing test questions and creating sophisticated recall banks to cheat on radiology boards. The Association of American Medical Colleges sued a medical student in 2017 for attempting to secretly record content on the MCAT using spyglasses.
In recent years, Dr. Carmody said that he has received multiple messages and screenshots from concerned students and residents who were offered or encountered recalls.
“One thing that’s unclear is how legitimate the claims are,” he said. “Many of these recalls may be faulty or outdated. It could be someone who took the exam yesterday and has a photographic memory or it could be some sparsely recalled or mis-recalled information. Unless you’re willing to pay these people, you can’t inspect the quality, or even if you did, you wouldn’t know if the information was current or not.”
‘As an IMG, There Is So Much at Stake’
Whether recall sellers — and those buying them — are more frequently IMGs has fostered heated debate on social media.
On a Reddit thread devoted to IMG issues, posters expressed frustration about being bombarded with recall advertisements and unwanted messages about buying USMLE questions while trying to find study materials. One poster called the practices a “huge slap to all those IMGs who are struggling day and night, just to get a good score.”
In an X thread about the same subject, however, some self-described IMGs took offense to claims that IMGs might score higher because they have access to recalls. The allegations are “incendiary” and “malign hardworking IMGs,” posters wrote.
When Dr. Gul spoke out online about the “biopsy” culture, he received multiple private messages from fellow IMGs telling him to remove his comments, he said.
“I received a lot of backlash on social media,” he told this news organization. “Some IMGs asked me to take down my posts because they thought I was making IMGs look bad, and it might prompt authorities to take action or shut down international examination centers for IMGs.”
Most of the IMGs who spoke to this news organization were afraid to be publicly identified. Several IMG advocates and IMG associations contacted for the story did not respond. One medical education expert said that his institution advised him to “steer clear” of commenting because the issue was “controversial.”
“As an IMG, there is so much at stake,” Dr B said. “Any association with shady operations like these is an absolute suicide. I’m personally afraid of any repercussions of the sort.”
USMLE officials declined to comment on whether the buying or selling of recalls appears to be more prevalent among the IMG community, saying it is “difficult to generalize this behavior as ‘prevalent’ simply due to the clandestine nature of this activity.”
Cheat-Proofing the USMLE
The USMLE program has taken several steps intended to prevent cheating, but more needs to be done, medical education advocates say.
For example, Dr. Carmody called the recent change in the attempt limit for taking USMLE exams from six to four times a good move.
“The reality is, if you’re taking a USMLE exam five-plus times, you’re far more likely to be memorizing questions and selling them for shady test prep operations than you are to be legitimately pursuing U.S. residency training or licensure,” he wrote on X.
The 2022 move to make USMLE Step 1 pass or fail is another positive change, said Dr. Gul, who added that US programs should also put less weight on test scores and focus more on clinical experience.
“Many programs in the US prioritize scores rather than clinical experiences in home countries,” he said. “If program directors would remove these criteria, probably the cheating practices would stop. Clinical practice matters. When a doctor gets matched, they have to be good at seeing and treating patients, not just good at sitting in front of a screen and taking an exam.”
Turning over questions more rapidly would help curb the practices, Dr. Carmody said. Another strategy is using math techniques to identify unusual deviations that suggest cheating, he said.
A blueprint for the strategy was created after a cheating scandal involving Canada’s Medical Council of Canada Qualifying Examination (MCCQE) in 2004. After learning which questions were circulated, MCCQE administrators evaluated exams by comparing answers of compromised questions with the answers of noncompromised questions.
“For a person who was not cheating, the error of performance should be pretty similar on those two groups of questions,” Dr. Carmody said. “But if you were given the questions in advance, you might have very poor performance on questions that had not been compromised, and very high performance on those that had been compromised. That disparity is very unlikely to occur just by chance alone.”
Based on his research, Dr. Ozair is working on an academic review paper about cheating on the USMLE and on the Medical Council of Canada Qualification Examination. He said that he hopes the paper will raise more awareness about the problem and drive more action.
He and others interviewed for this story shared that the websites they’ve reported to the USMLE program are still active and offering recalls to buyers.
“Even if they are not actually offering something tangible or true, appearance matters,” Dr. Ozair said. “I think it’s worth the USMLE sending cease and desist letters and getting these websites taken down. This would restore faith in the process and underscore that this issue is being taken seriously.”
A version of this article appeared on Medscape.com.
Cardiorespiratory Fitness May Cut Prostate Cancer Risk
Men with cardiorespiratory fitness (CRF) who increased their CRF by more than 3% had a significantly lower risk of prostate cancer incidence, a large Swedish study found.
The prospective analysis, published in the British Journal of Sports Medicine, done in a cohort of nearly 58,000, was conducted by Kate A. Bolam, PhD, a clinical exercise physiologist at the Swedish School of Sport and Health Sciences in Stockholm.
“The findings suggest that physicians could work toward supporting patients to understand what types of activities could improve their fitness and ways they can incorporate these activities into their lives in an enjoyable way, or at the very least refer patients on to an exercise specialist,” Dr. Bolam said in an interview.
Grouped by baseline CRF, the association between change in absolute CRF and prostate cancer incidence was significant only for participants with a moderate baseline CRF. Moreover, changes in both absolute and relative CRF were not associated with prostate cancer mortality.
The lack of mortality significance may be due to the relatively few deaths from prostate cancer in the cohort, Dr. Bolam said. “It may be we weren’t powered to detect anything with such low numbers. And it’s not likely men will die from prostate cancer but more likely from more common chronic diseases such as heart disease.” The authors noted that unlike the case with other common cancers, there are relatively few preventable risk factors with strong evidence for reducing overall prostate cancer risk. “Aside from developmental factors, being diagnosed with overweight or obesity are the main risk factors for developing advanced prostate cancer, but insufficient evidence exists to extend this conclusion to non-advanced prostate cancer,” they wrote.
There is evidence, however, that exercise reduces all-cause mortality risk across many cancer types, including prostate.
Study details
The cohort was drawn from Swedish national health-profile database figures from 1982 to 2019. Participants completed an occupational health profile assessment including at least two valid CRF tests on a cycle ergometer. During a mean follow-up of 6.7 years, 592 (1%) of 57,652 men (mean age 41.3 years, standard deviation 10.55) were diagnosed with prostate cancer, and in 46 (.08%) prostate cancer was the primary cause of death.
An increase in absolute CRF (as a percentage of liters per minute of cardiac output) was associated with a reduced incidence risk, with a hazard ratio of 0.98 (95% CI, 0.96-0.99). Grouping participants as having increased (+3%), stable (±3%), or decreased (−3%) CRF, the investigators found increased fitness was associated with an HR for prostate cancer incidence of 0.65 (95% CI, 0.49-0.86), vs decreased fitness.
According to the authors, this and similar investigations of mechanisms behind physical activity benefits will lead to more targeted prevention recommendations. The results highlight the importance of encouraging the general public to increase CRF or reach moderate fitness levels, Dr. Bolam’s group wrote. The group is planning a similar study in breast cancer.
This study was funded by the Swedish Cancer Society. The authors declared no competing interests.
Men with cardiorespiratory fitness (CRF) who increased their CRF by more than 3% had a significantly lower risk of prostate cancer incidence, a large Swedish study found.
The prospective analysis, published in the British Journal of Sports Medicine, done in a cohort of nearly 58,000, was conducted by Kate A. Bolam, PhD, a clinical exercise physiologist at the Swedish School of Sport and Health Sciences in Stockholm.
“The findings suggest that physicians could work toward supporting patients to understand what types of activities could improve their fitness and ways they can incorporate these activities into their lives in an enjoyable way, or at the very least refer patients on to an exercise specialist,” Dr. Bolam said in an interview.
Grouped by baseline CRF, the association between change in absolute CRF and prostate cancer incidence was significant only for participants with a moderate baseline CRF. Moreover, changes in both absolute and relative CRF were not associated with prostate cancer mortality.
The lack of mortality significance may be due to the relatively few deaths from prostate cancer in the cohort, Dr. Bolam said. “It may be we weren’t powered to detect anything with such low numbers. And it’s not likely men will die from prostate cancer but more likely from more common chronic diseases such as heart disease.” The authors noted that unlike the case with other common cancers, there are relatively few preventable risk factors with strong evidence for reducing overall prostate cancer risk. “Aside from developmental factors, being diagnosed with overweight or obesity are the main risk factors for developing advanced prostate cancer, but insufficient evidence exists to extend this conclusion to non-advanced prostate cancer,” they wrote.
There is evidence, however, that exercise reduces all-cause mortality risk across many cancer types, including prostate.
Study details
The cohort was drawn from Swedish national health-profile database figures from 1982 to 2019. Participants completed an occupational health profile assessment including at least two valid CRF tests on a cycle ergometer. During a mean follow-up of 6.7 years, 592 (1%) of 57,652 men (mean age 41.3 years, standard deviation 10.55) were diagnosed with prostate cancer, and in 46 (.08%) prostate cancer was the primary cause of death.
An increase in absolute CRF (as a percentage of liters per minute of cardiac output) was associated with a reduced incidence risk, with a hazard ratio of 0.98 (95% CI, 0.96-0.99). Grouping participants as having increased (+3%), stable (±3%), or decreased (−3%) CRF, the investigators found increased fitness was associated with an HR for prostate cancer incidence of 0.65 (95% CI, 0.49-0.86), vs decreased fitness.
According to the authors, this and similar investigations of mechanisms behind physical activity benefits will lead to more targeted prevention recommendations. The results highlight the importance of encouraging the general public to increase CRF or reach moderate fitness levels, Dr. Bolam’s group wrote. The group is planning a similar study in breast cancer.
This study was funded by the Swedish Cancer Society. The authors declared no competing interests.
Men with cardiorespiratory fitness (CRF) who increased their CRF by more than 3% had a significantly lower risk of prostate cancer incidence, a large Swedish study found.
The prospective analysis, published in the British Journal of Sports Medicine, done in a cohort of nearly 58,000, was conducted by Kate A. Bolam, PhD, a clinical exercise physiologist at the Swedish School of Sport and Health Sciences in Stockholm.
“The findings suggest that physicians could work toward supporting patients to understand what types of activities could improve their fitness and ways they can incorporate these activities into their lives in an enjoyable way, or at the very least refer patients on to an exercise specialist,” Dr. Bolam said in an interview.
Grouped by baseline CRF, the association between change in absolute CRF and prostate cancer incidence was significant only for participants with a moderate baseline CRF. Moreover, changes in both absolute and relative CRF were not associated with prostate cancer mortality.
The lack of mortality significance may be due to the relatively few deaths from prostate cancer in the cohort, Dr. Bolam said. “It may be we weren’t powered to detect anything with such low numbers. And it’s not likely men will die from prostate cancer but more likely from more common chronic diseases such as heart disease.” The authors noted that unlike the case with other common cancers, there are relatively few preventable risk factors with strong evidence for reducing overall prostate cancer risk. “Aside from developmental factors, being diagnosed with overweight or obesity are the main risk factors for developing advanced prostate cancer, but insufficient evidence exists to extend this conclusion to non-advanced prostate cancer,” they wrote.
There is evidence, however, that exercise reduces all-cause mortality risk across many cancer types, including prostate.
Study details
The cohort was drawn from Swedish national health-profile database figures from 1982 to 2019. Participants completed an occupational health profile assessment including at least two valid CRF tests on a cycle ergometer. During a mean follow-up of 6.7 years, 592 (1%) of 57,652 men (mean age 41.3 years, standard deviation 10.55) were diagnosed with prostate cancer, and in 46 (.08%) prostate cancer was the primary cause of death.
An increase in absolute CRF (as a percentage of liters per minute of cardiac output) was associated with a reduced incidence risk, with a hazard ratio of 0.98 (95% CI, 0.96-0.99). Grouping participants as having increased (+3%), stable (±3%), or decreased (−3%) CRF, the investigators found increased fitness was associated with an HR for prostate cancer incidence of 0.65 (95% CI, 0.49-0.86), vs decreased fitness.
According to the authors, this and similar investigations of mechanisms behind physical activity benefits will lead to more targeted prevention recommendations. The results highlight the importance of encouraging the general public to increase CRF or reach moderate fitness levels, Dr. Bolam’s group wrote. The group is planning a similar study in breast cancer.
This study was funded by the Swedish Cancer Society. The authors declared no competing interests.
FROM BRITISH JOURNAL OF SPORTS MEDICINE
Small PFS gain in metastatic prostate cancer with TKI and ICI
The combination of the tyrosine kinase inhibitor (TKI), cabozantinib (Cabometyx), and the immune checkpoint inhibitor (ICI), atezolizumab (Tecentriq), was associated with a median PFS of 6.3 months vs 4.2 months for patients assigned to second hormonal therapy with either abiraterone (Zytiga) and prednisone, or enzalutamide (Xtandi) in the CONTACT-02 trial, Neeraj Agarwal, MD, reported at the ASCO Genitourinary Cancers Symposium.
“CONTACT 2 is the first phase 3 trial of the TKI/ICI combination to show statistically significant improvement in PFS in patients with mCRPC,” said Dr. Agarwal, of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.
The data support the combination of cabozantinib and atezolizumab as a potential new treatment option for patients with mCRPC that has progressed on novel hormonal therapy, he said.
Study Design Questioned
That opinion, however, was not shared by Kim N. Chi, MD, of the University of British Columbia in Vancouver, BC, Canada, the invited discussant.
Dr. Chi acknowledged that the study results as presented were positive, but also pointed to several limitations, including the small difference between the treatment groups in radiographic progression-free survival (rPFS).
“I would say the rPFS benefit is modest, and in the absence of other improvements the difference in the median rPFS is equivalent from one scan to the next in the scanning cycle. I would argue about the clinical significance of that,” he said.
He also noted that there was no improvement in the investigational arm in patient-reported outcomes, and that pain progression and quality-of-life deterioration occurred within 2 to 4 months, which is “quite quick.”
Additionally, he questioned the choice of an androgen receptor pathway inhibitor (ARPI) switch as the control arm of the study.
“I’d also argue that ARPI switch is not the best standard of care for this patient population with measurable disease and 40% visceral metastases; there are better options,” he said.
For example, in phase 3 trials, docetaxel and cabazitaxel (Jevtana) have consistently demonstrated radiographic PFS of 8 to 9 months. In addition, lutetium-177–PSMA-617, a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells and the tumor microenvironment, has also been shown to have PFS and overall survival benefits, he said.
“Irrespective of regulatory decisions, I personally could not recommend this at this time, given the data that we’ve seen and the better options that are available for this patient population,” Dr. Chi said.
Real-World Practice
“Kim Chi offered a pretty fair critique and summary of the control arm, but in real world practice, ARPI switch, from abi [abiraterone] to enza [enzalutamide] or enza to abi continues to be used in routine clinical practice for various reasons,” Xin Gao, MD, a genitourinary oncologist at Mass General Cancer Center in Boston, said in an interview.
“There are patients who can’t tolerate chemotherapy or don’t want chemotherapy, and we do know also that there are patients who can benefit from an ARPI switch, especially some patients with more indolent disease,” said Dr. Gao, who attended the presentation but was not involved in the study.
He noted that some patients being switched from abiraterone to enzalutamide have clinical responses, and that the ARPIs are generally more tolerable than chemotherapy.
In addition, CONTACT-02 is one of a series of trials in which ARPI switch was used as the control arm, and many of these trials were initiated before there were data confirming the superior efficacy of some newer therapeutic options, Dr. Gao noted.
He agreed, however that there is growing evidence to show that ARPI switch may not be the optimal choice for patients with more measurable disease, especially visceral metastases, and other more aggressive forms of mCRPC.
CONTACT-02 Details
Investigators in the phase 3 study screened 866 men with mCRPC and after stratification by liver metastases, prior docetaxel use for castration-sensitive prostate cancer, and disease stage for which the first novel hormonal therapy was given. About 500 patients (507) were randomized to receive either oral cabozantinib 40 mg daily plus intravenous atezolizumab 1200 mg every 3 weeks or second hormonal therapy with either abiraterone 1000 mg with oral prednisone 5 mg twice daily, or oral enzalutamide 160 mg daily.
After a median follow-up of 14.3 months in the PFS intention-to-treat population, the median PFS by blinded central review was 6.3 months with cabozantinib/atezolizumab and 4.2 months with second hormonal therapy. This translated into a hazard ratio of 0.64 (P = .0002). The results were similar for a PFS analysis according to Prostate Cancer Working Group 3 criteria.
The combination was also associated with modest improvements in PFS in prespecified subgroups, including patients who had liver or bone metastases and those who had previously received docetaxel.
There were no significant differences in overall survival at the time of data cutoff. Overall survival data were not mature and will be reported at a later date.
Disease control rates, a composite of complete and partial responses and stable disease, were 73% with the combination and 55% with second hormonal therapy (P value not shown).
Safety Data
The safety analysis indicated that patients found the ARPI switch easier to tolerate than the combination.
Adverse events leading to dose reductions occurred in 40% of patients on the combination, vs 3% of patients on second hormonal therapy, and treatment-related adverse events leading to discontinuation occurred in 13% and 2%, respectively.
Grade 3 or 4 adverse events occurred in 48% of patients assigned to the combination vs. 23% of patients assigned to the ARPI switch.
In all, 8% of patients on the combination and 12% on second hormonal therapy died on study, but none of the deaths were deemed to be treatment related.
CONTACT-02 was sponsored by Exelixis in partnerships with Ipsen and Takeda.
Dr. Agarwal disclosed institutional research funding from Exelixis, Roche, Takeda, and others, and travel expenses from Pfizer. Dr. Chi disclosed honoraria, a consulting/advisory role and institutional research funding with Roche and others. Dr. Gao has served as a consultant or advisor to several companies, not including the sponsors of the study, and has served as principal investigator at his institution, which has received research funding from Exelixis, Takeda, and others.
The combination of the tyrosine kinase inhibitor (TKI), cabozantinib (Cabometyx), and the immune checkpoint inhibitor (ICI), atezolizumab (Tecentriq), was associated with a median PFS of 6.3 months vs 4.2 months for patients assigned to second hormonal therapy with either abiraterone (Zytiga) and prednisone, or enzalutamide (Xtandi) in the CONTACT-02 trial, Neeraj Agarwal, MD, reported at the ASCO Genitourinary Cancers Symposium.
“CONTACT 2 is the first phase 3 trial of the TKI/ICI combination to show statistically significant improvement in PFS in patients with mCRPC,” said Dr. Agarwal, of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.
The data support the combination of cabozantinib and atezolizumab as a potential new treatment option for patients with mCRPC that has progressed on novel hormonal therapy, he said.
Study Design Questioned
That opinion, however, was not shared by Kim N. Chi, MD, of the University of British Columbia in Vancouver, BC, Canada, the invited discussant.
Dr. Chi acknowledged that the study results as presented were positive, but also pointed to several limitations, including the small difference between the treatment groups in radiographic progression-free survival (rPFS).
“I would say the rPFS benefit is modest, and in the absence of other improvements the difference in the median rPFS is equivalent from one scan to the next in the scanning cycle. I would argue about the clinical significance of that,” he said.
He also noted that there was no improvement in the investigational arm in patient-reported outcomes, and that pain progression and quality-of-life deterioration occurred within 2 to 4 months, which is “quite quick.”
Additionally, he questioned the choice of an androgen receptor pathway inhibitor (ARPI) switch as the control arm of the study.
“I’d also argue that ARPI switch is not the best standard of care for this patient population with measurable disease and 40% visceral metastases; there are better options,” he said.
For example, in phase 3 trials, docetaxel and cabazitaxel (Jevtana) have consistently demonstrated radiographic PFS of 8 to 9 months. In addition, lutetium-177–PSMA-617, a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells and the tumor microenvironment, has also been shown to have PFS and overall survival benefits, he said.
“Irrespective of regulatory decisions, I personally could not recommend this at this time, given the data that we’ve seen and the better options that are available for this patient population,” Dr. Chi said.
Real-World Practice
“Kim Chi offered a pretty fair critique and summary of the control arm, but in real world practice, ARPI switch, from abi [abiraterone] to enza [enzalutamide] or enza to abi continues to be used in routine clinical practice for various reasons,” Xin Gao, MD, a genitourinary oncologist at Mass General Cancer Center in Boston, said in an interview.
“There are patients who can’t tolerate chemotherapy or don’t want chemotherapy, and we do know also that there are patients who can benefit from an ARPI switch, especially some patients with more indolent disease,” said Dr. Gao, who attended the presentation but was not involved in the study.
He noted that some patients being switched from abiraterone to enzalutamide have clinical responses, and that the ARPIs are generally more tolerable than chemotherapy.
In addition, CONTACT-02 is one of a series of trials in which ARPI switch was used as the control arm, and many of these trials were initiated before there were data confirming the superior efficacy of some newer therapeutic options, Dr. Gao noted.
He agreed, however that there is growing evidence to show that ARPI switch may not be the optimal choice for patients with more measurable disease, especially visceral metastases, and other more aggressive forms of mCRPC.
CONTACT-02 Details
Investigators in the phase 3 study screened 866 men with mCRPC and after stratification by liver metastases, prior docetaxel use for castration-sensitive prostate cancer, and disease stage for which the first novel hormonal therapy was given. About 500 patients (507) were randomized to receive either oral cabozantinib 40 mg daily plus intravenous atezolizumab 1200 mg every 3 weeks or second hormonal therapy with either abiraterone 1000 mg with oral prednisone 5 mg twice daily, or oral enzalutamide 160 mg daily.
After a median follow-up of 14.3 months in the PFS intention-to-treat population, the median PFS by blinded central review was 6.3 months with cabozantinib/atezolizumab and 4.2 months with second hormonal therapy. This translated into a hazard ratio of 0.64 (P = .0002). The results were similar for a PFS analysis according to Prostate Cancer Working Group 3 criteria.
The combination was also associated with modest improvements in PFS in prespecified subgroups, including patients who had liver or bone metastases and those who had previously received docetaxel.
There were no significant differences in overall survival at the time of data cutoff. Overall survival data were not mature and will be reported at a later date.
Disease control rates, a composite of complete and partial responses and stable disease, were 73% with the combination and 55% with second hormonal therapy (P value not shown).
Safety Data
The safety analysis indicated that patients found the ARPI switch easier to tolerate than the combination.
Adverse events leading to dose reductions occurred in 40% of patients on the combination, vs 3% of patients on second hormonal therapy, and treatment-related adverse events leading to discontinuation occurred in 13% and 2%, respectively.
Grade 3 or 4 adverse events occurred in 48% of patients assigned to the combination vs. 23% of patients assigned to the ARPI switch.
In all, 8% of patients on the combination and 12% on second hormonal therapy died on study, but none of the deaths were deemed to be treatment related.
CONTACT-02 was sponsored by Exelixis in partnerships with Ipsen and Takeda.
Dr. Agarwal disclosed institutional research funding from Exelixis, Roche, Takeda, and others, and travel expenses from Pfizer. Dr. Chi disclosed honoraria, a consulting/advisory role and institutional research funding with Roche and others. Dr. Gao has served as a consultant or advisor to several companies, not including the sponsors of the study, and has served as principal investigator at his institution, which has received research funding from Exelixis, Takeda, and others.
The combination of the tyrosine kinase inhibitor (TKI), cabozantinib (Cabometyx), and the immune checkpoint inhibitor (ICI), atezolizumab (Tecentriq), was associated with a median PFS of 6.3 months vs 4.2 months for patients assigned to second hormonal therapy with either abiraterone (Zytiga) and prednisone, or enzalutamide (Xtandi) in the CONTACT-02 trial, Neeraj Agarwal, MD, reported at the ASCO Genitourinary Cancers Symposium.
“CONTACT 2 is the first phase 3 trial of the TKI/ICI combination to show statistically significant improvement in PFS in patients with mCRPC,” said Dr. Agarwal, of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.
The data support the combination of cabozantinib and atezolizumab as a potential new treatment option for patients with mCRPC that has progressed on novel hormonal therapy, he said.
Study Design Questioned
That opinion, however, was not shared by Kim N. Chi, MD, of the University of British Columbia in Vancouver, BC, Canada, the invited discussant.
Dr. Chi acknowledged that the study results as presented were positive, but also pointed to several limitations, including the small difference between the treatment groups in radiographic progression-free survival (rPFS).
“I would say the rPFS benefit is modest, and in the absence of other improvements the difference in the median rPFS is equivalent from one scan to the next in the scanning cycle. I would argue about the clinical significance of that,” he said.
He also noted that there was no improvement in the investigational arm in patient-reported outcomes, and that pain progression and quality-of-life deterioration occurred within 2 to 4 months, which is “quite quick.”
Additionally, he questioned the choice of an androgen receptor pathway inhibitor (ARPI) switch as the control arm of the study.
“I’d also argue that ARPI switch is not the best standard of care for this patient population with measurable disease and 40% visceral metastases; there are better options,” he said.
For example, in phase 3 trials, docetaxel and cabazitaxel (Jevtana) have consistently demonstrated radiographic PFS of 8 to 9 months. In addition, lutetium-177–PSMA-617, a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells and the tumor microenvironment, has also been shown to have PFS and overall survival benefits, he said.
“Irrespective of regulatory decisions, I personally could not recommend this at this time, given the data that we’ve seen and the better options that are available for this patient population,” Dr. Chi said.
Real-World Practice
“Kim Chi offered a pretty fair critique and summary of the control arm, but in real world practice, ARPI switch, from abi [abiraterone] to enza [enzalutamide] or enza to abi continues to be used in routine clinical practice for various reasons,” Xin Gao, MD, a genitourinary oncologist at Mass General Cancer Center in Boston, said in an interview.
“There are patients who can’t tolerate chemotherapy or don’t want chemotherapy, and we do know also that there are patients who can benefit from an ARPI switch, especially some patients with more indolent disease,” said Dr. Gao, who attended the presentation but was not involved in the study.
He noted that some patients being switched from abiraterone to enzalutamide have clinical responses, and that the ARPIs are generally more tolerable than chemotherapy.
In addition, CONTACT-02 is one of a series of trials in which ARPI switch was used as the control arm, and many of these trials were initiated before there were data confirming the superior efficacy of some newer therapeutic options, Dr. Gao noted.
He agreed, however that there is growing evidence to show that ARPI switch may not be the optimal choice for patients with more measurable disease, especially visceral metastases, and other more aggressive forms of mCRPC.
CONTACT-02 Details
Investigators in the phase 3 study screened 866 men with mCRPC and after stratification by liver metastases, prior docetaxel use for castration-sensitive prostate cancer, and disease stage for which the first novel hormonal therapy was given. About 500 patients (507) were randomized to receive either oral cabozantinib 40 mg daily plus intravenous atezolizumab 1200 mg every 3 weeks or second hormonal therapy with either abiraterone 1000 mg with oral prednisone 5 mg twice daily, or oral enzalutamide 160 mg daily.
After a median follow-up of 14.3 months in the PFS intention-to-treat population, the median PFS by blinded central review was 6.3 months with cabozantinib/atezolizumab and 4.2 months with second hormonal therapy. This translated into a hazard ratio of 0.64 (P = .0002). The results were similar for a PFS analysis according to Prostate Cancer Working Group 3 criteria.
The combination was also associated with modest improvements in PFS in prespecified subgroups, including patients who had liver or bone metastases and those who had previously received docetaxel.
There were no significant differences in overall survival at the time of data cutoff. Overall survival data were not mature and will be reported at a later date.
Disease control rates, a composite of complete and partial responses and stable disease, were 73% with the combination and 55% with second hormonal therapy (P value not shown).
Safety Data
The safety analysis indicated that patients found the ARPI switch easier to tolerate than the combination.
Adverse events leading to dose reductions occurred in 40% of patients on the combination, vs 3% of patients on second hormonal therapy, and treatment-related adverse events leading to discontinuation occurred in 13% and 2%, respectively.
Grade 3 or 4 adverse events occurred in 48% of patients assigned to the combination vs. 23% of patients assigned to the ARPI switch.
In all, 8% of patients on the combination and 12% on second hormonal therapy died on study, but none of the deaths were deemed to be treatment related.
CONTACT-02 was sponsored by Exelixis in partnerships with Ipsen and Takeda.
Dr. Agarwal disclosed institutional research funding from Exelixis, Roche, Takeda, and others, and travel expenses from Pfizer. Dr. Chi disclosed honoraria, a consulting/advisory role and institutional research funding with Roche and others. Dr. Gao has served as a consultant or advisor to several companies, not including the sponsors of the study, and has served as principal investigator at his institution, which has received research funding from Exelixis, Takeda, and others.
FROM ASCO GU 2024
Respiratory Virus Surge: Diagnosing COVID-19 vs RSV, Flu
Amid the current wave of winter respiratory virus cases, influenza (types A and B) leads the way with the highest number of emergency room visits, followed closely by COVID-19, thanks to the JN.1 variant, and respiratory syncytial virus (RSV). With various similarities and differences in disease presentations, how challenging is it for physician’s to distinguish between, diagnose, and treat COVID-19 vs RSV and influenza?
While these three respiratory viruses often have similar presentations, you may often find that patients with COVID-19 experience more fever, dry cough, and labored breathing, according to Cyrus Munguti, MD, assistant professor of medicine at KU Medical Center and hospitalist at Wesley Medical Center, Wichita, Kansas.
“COVID-19 patients tend to have trouble breathing because the alveoli are affected and get inflammation and fluid accumulating in the lungs, and they end up having little to no oxygen,” said Dr. Munguti. “When we check their vital signs, patients with COVID tend to have hypoxemia [meaning saturations are less than 88% or 90% depending on the guidelines you follow].”
Patients with RSV and influenza tend to have more upper respiratory symptoms, like runny nose, sternutation — which later can progress to a cough in the upper airways, Dr. Munguti said. Unlike with COVID-19, patients with RSV and influenza — generally until they are very sick — often do not experience hypoxemia.
Inflammation in the airways can form as a result of all three viruses. Furthermore, bacteria that live in these airways could lead to a secondary bacterial infection in the upper respiratory and lower respiratory tracts — which could then cause pneumonia, Dr. Munguti said.
Another note: , according to Panagis Galiatsatos, MD, pulmonologist and associate professor at Johns Hopkins Medicine. “The Alpha through Delta variants really were a lot more lung tissue invading,” Dr. Galiatsatos said. “With the COVID-19 Omicron family — its capabilities are similar to what flu and RSV have done over the years. It’s more airway-invading.”
It’s critical to understand that diagnosing these diseases based on symptoms alone can be quite fickle, according to Dr. Galiatsatos. Objective tests, either at home or in a laboratory, are preferred. This is largely because disease presentation can depend on the host factor that the virus enters into, said Dr. Galiatsatos. For example, virus symptoms may look different for a patient with asthma and for someone with heart disease.
With children being among the most vulnerable for severe respiratory illness, testing and treatment are paramount and can be quite accurate in seasons where respiratory viruses thrive, according to Stan Spinner, MD, chief medical officer at Texas Children’s Pediatrics and Urgent Care. “When individuals are tested for either of these conditions when the prevalence in the community is low, we tend to see false positive results.”
Texas Children’s Pediatrics and Urgent Care’s 12 sites offer COVID-19 and influenza antigen tests that have results ready in around 10 minutes. RSV testing, on the other hand, is limited to around half of the Texas Children’s Pediatrics and none of the urgent care locations, as the test can only be administered through a nasal swab conducted by a physician. As there is no specific treatment or therapy for RSV, the benefits of RSV testing can actually be quite low — often leading to frustrated parents regarding next steps after diagnosis.
“There are a number of respiratory viruses that may present with similar symptoms as RSV, and some of these viruses may even lead to much of the same adverse outcomes as the RSV virus,” Dr. Galiatsatos said. “Consequently, our physicians need to help parents understand this and give them guidance as to when to seek medical attention for worsening symptoms.”
There are two new RSV immunizations to treat certain demographics of patients, Dr. Spinner added. One is an RSV vaccine for infants under 8 months old, though there is limited supply. There is also an RSV vaccine available for pregnant women (between 32 and 36 weeks gestation) that has proved to be effective in fending off RSV infections in newborns up to 6 months old.
Physicians should remain diligent in stressing to patients that vaccinations against COVID-19 and influenza play a key role in keeping their families safe during seasons of staggering respiratory infections.
“These vaccines are extremely safe, and while they may not always prevent infection, these vaccines are extremely effective in preventing more serious consequences, such as hospitalization or death,” Dr. Galiatsatos said.
A version of this article appeared on Medscape.com.
Amid the current wave of winter respiratory virus cases, influenza (types A and B) leads the way with the highest number of emergency room visits, followed closely by COVID-19, thanks to the JN.1 variant, and respiratory syncytial virus (RSV). With various similarities and differences in disease presentations, how challenging is it for physician’s to distinguish between, diagnose, and treat COVID-19 vs RSV and influenza?
While these three respiratory viruses often have similar presentations, you may often find that patients with COVID-19 experience more fever, dry cough, and labored breathing, according to Cyrus Munguti, MD, assistant professor of medicine at KU Medical Center and hospitalist at Wesley Medical Center, Wichita, Kansas.
“COVID-19 patients tend to have trouble breathing because the alveoli are affected and get inflammation and fluid accumulating in the lungs, and they end up having little to no oxygen,” said Dr. Munguti. “When we check their vital signs, patients with COVID tend to have hypoxemia [meaning saturations are less than 88% or 90% depending on the guidelines you follow].”
Patients with RSV and influenza tend to have more upper respiratory symptoms, like runny nose, sternutation — which later can progress to a cough in the upper airways, Dr. Munguti said. Unlike with COVID-19, patients with RSV and influenza — generally until they are very sick — often do not experience hypoxemia.
Inflammation in the airways can form as a result of all three viruses. Furthermore, bacteria that live in these airways could lead to a secondary bacterial infection in the upper respiratory and lower respiratory tracts — which could then cause pneumonia, Dr. Munguti said.
Another note: , according to Panagis Galiatsatos, MD, pulmonologist and associate professor at Johns Hopkins Medicine. “The Alpha through Delta variants really were a lot more lung tissue invading,” Dr. Galiatsatos said. “With the COVID-19 Omicron family — its capabilities are similar to what flu and RSV have done over the years. It’s more airway-invading.”
It’s critical to understand that diagnosing these diseases based on symptoms alone can be quite fickle, according to Dr. Galiatsatos. Objective tests, either at home or in a laboratory, are preferred. This is largely because disease presentation can depend on the host factor that the virus enters into, said Dr. Galiatsatos. For example, virus symptoms may look different for a patient with asthma and for someone with heart disease.
With children being among the most vulnerable for severe respiratory illness, testing and treatment are paramount and can be quite accurate in seasons where respiratory viruses thrive, according to Stan Spinner, MD, chief medical officer at Texas Children’s Pediatrics and Urgent Care. “When individuals are tested for either of these conditions when the prevalence in the community is low, we tend to see false positive results.”
Texas Children’s Pediatrics and Urgent Care’s 12 sites offer COVID-19 and influenza antigen tests that have results ready in around 10 minutes. RSV testing, on the other hand, is limited to around half of the Texas Children’s Pediatrics and none of the urgent care locations, as the test can only be administered through a nasal swab conducted by a physician. As there is no specific treatment or therapy for RSV, the benefits of RSV testing can actually be quite low — often leading to frustrated parents regarding next steps after diagnosis.
“There are a number of respiratory viruses that may present with similar symptoms as RSV, and some of these viruses may even lead to much of the same adverse outcomes as the RSV virus,” Dr. Galiatsatos said. “Consequently, our physicians need to help parents understand this and give them guidance as to when to seek medical attention for worsening symptoms.”
There are two new RSV immunizations to treat certain demographics of patients, Dr. Spinner added. One is an RSV vaccine for infants under 8 months old, though there is limited supply. There is also an RSV vaccine available for pregnant women (between 32 and 36 weeks gestation) that has proved to be effective in fending off RSV infections in newborns up to 6 months old.
Physicians should remain diligent in stressing to patients that vaccinations against COVID-19 and influenza play a key role in keeping their families safe during seasons of staggering respiratory infections.
“These vaccines are extremely safe, and while they may not always prevent infection, these vaccines are extremely effective in preventing more serious consequences, such as hospitalization or death,” Dr. Galiatsatos said.
A version of this article appeared on Medscape.com.
Amid the current wave of winter respiratory virus cases, influenza (types A and B) leads the way with the highest number of emergency room visits, followed closely by COVID-19, thanks to the JN.1 variant, and respiratory syncytial virus (RSV). With various similarities and differences in disease presentations, how challenging is it for physician’s to distinguish between, diagnose, and treat COVID-19 vs RSV and influenza?
While these three respiratory viruses often have similar presentations, you may often find that patients with COVID-19 experience more fever, dry cough, and labored breathing, according to Cyrus Munguti, MD, assistant professor of medicine at KU Medical Center and hospitalist at Wesley Medical Center, Wichita, Kansas.
“COVID-19 patients tend to have trouble breathing because the alveoli are affected and get inflammation and fluid accumulating in the lungs, and they end up having little to no oxygen,” said Dr. Munguti. “When we check their vital signs, patients with COVID tend to have hypoxemia [meaning saturations are less than 88% or 90% depending on the guidelines you follow].”
Patients with RSV and influenza tend to have more upper respiratory symptoms, like runny nose, sternutation — which later can progress to a cough in the upper airways, Dr. Munguti said. Unlike with COVID-19, patients with RSV and influenza — generally until they are very sick — often do not experience hypoxemia.
Inflammation in the airways can form as a result of all three viruses. Furthermore, bacteria that live in these airways could lead to a secondary bacterial infection in the upper respiratory and lower respiratory tracts — which could then cause pneumonia, Dr. Munguti said.
Another note: , according to Panagis Galiatsatos, MD, pulmonologist and associate professor at Johns Hopkins Medicine. “The Alpha through Delta variants really were a lot more lung tissue invading,” Dr. Galiatsatos said. “With the COVID-19 Omicron family — its capabilities are similar to what flu and RSV have done over the years. It’s more airway-invading.”
It’s critical to understand that diagnosing these diseases based on symptoms alone can be quite fickle, according to Dr. Galiatsatos. Objective tests, either at home or in a laboratory, are preferred. This is largely because disease presentation can depend on the host factor that the virus enters into, said Dr. Galiatsatos. For example, virus symptoms may look different for a patient with asthma and for someone with heart disease.
With children being among the most vulnerable for severe respiratory illness, testing and treatment are paramount and can be quite accurate in seasons where respiratory viruses thrive, according to Stan Spinner, MD, chief medical officer at Texas Children’s Pediatrics and Urgent Care. “When individuals are tested for either of these conditions when the prevalence in the community is low, we tend to see false positive results.”
Texas Children’s Pediatrics and Urgent Care’s 12 sites offer COVID-19 and influenza antigen tests that have results ready in around 10 minutes. RSV testing, on the other hand, is limited to around half of the Texas Children’s Pediatrics and none of the urgent care locations, as the test can only be administered through a nasal swab conducted by a physician. As there is no specific treatment or therapy for RSV, the benefits of RSV testing can actually be quite low — often leading to frustrated parents regarding next steps after diagnosis.
“There are a number of respiratory viruses that may present with similar symptoms as RSV, and some of these viruses may even lead to much of the same adverse outcomes as the RSV virus,” Dr. Galiatsatos said. “Consequently, our physicians need to help parents understand this and give them guidance as to when to seek medical attention for worsening symptoms.”
There are two new RSV immunizations to treat certain demographics of patients, Dr. Spinner added. One is an RSV vaccine for infants under 8 months old, though there is limited supply. There is also an RSV vaccine available for pregnant women (between 32 and 36 weeks gestation) that has proved to be effective in fending off RSV infections in newborns up to 6 months old.
Physicians should remain diligent in stressing to patients that vaccinations against COVID-19 and influenza play a key role in keeping their families safe during seasons of staggering respiratory infections.
“These vaccines are extremely safe, and while they may not always prevent infection, these vaccines are extremely effective in preventing more serious consequences, such as hospitalization or death,” Dr. Galiatsatos said.
A version of this article appeared on Medscape.com.
Combo Tx Best in Metastatic Prostate Cancer with HRR Mutations
That’s the conclusion of investigators in the phase 2 BRCAAway trial, which compared a combination of abiraterone (Zytiga) and prednisone plus olaparib (Lynparza) against sequential therapy with the same agents.
At the time of data cutoff, median progression-free survival (PFS), the primary endpoint, was 39 months for patients randomized to the combination, compared with 8.4 months for those assigned to abiraterone/prednisone, and 14 months for those assigned to olaparib monotherapy, reported Maha Hussain, MD, of the Robert H. Lurie Comprehensive Cancer Center in Chicago.
“In patients with metastatic castration-resistant prostate cancer [mCRPC] and BRCA1/2 or ATM alterations, abiraterone and prednisone plus olaparib was well tolerated and resulted in better progression-free survival and response rates vs. single-agent olaparib or abiraterone/prednisone,” she said in an oral abstract presentation at the ASCO Genitourinary Cancers Symposium.
Although the study allowed crossover between the single-agent arms at the time of progression, only a few patients made the switch. Nonetheless, in these patients the PFS with the frontline combination was superior to that of sequential therapy, she noted.
Study Rationale and Design
Germline or somatic mutations in genes encoding for homologous recombination-repair occur in about 20% of men with mCRPC. Olaparib, a PARP1 (poly-adp ribose polymerase-1) inhibitor, interacts with androgen signaling, and preclinical studies have shown that castration-resistant prostate tumor cells have increased PARP1 activity. In addition, PARP1 has been shown preclinically to synergize with androgen receptor pathway inhibitors (ARPIs) such as abiraterone, Dr. Hussain explained.
The BRCAAway trial was designed to test whether co-targeting the androgen receptor and PARP1 could result in higher and more durable responses than current frontline therapies in patients with mCRPC with DNA-damage response mutations.
Patients with mCRPC with no prior exposure to either a PARP1 inhibitor, androgen receptor inhibitor, or mCRPC-directed chemotherapy underwent next-generation sequencing and germline testing of tumor tissues, and those patients found to have inactivating BRCA1/2 and/or ATM alterations were randomized on a 1:1:1 basis to either abiraterone 1000 mg daily plus prednisone 5 mg twice daily (19 patients); olaparib 300 mg twice daily (21 patients); or to the combination (21 patients).
The primary endpoint was radiographic PFS according to RECIST 1.1 criteria, Prostate Cancer Working Group 3 criteria, clinical assessment, or death.
As noted, the median PFS was 8.4 months with abiraterone/prednisone, 14 months with olaparib, and 39 months with the combination.
Secondary endpoints also favored the combination therapy arm, with objective response rates of 22%, 14%, and 33%, respectively; PSA response rates of 61%, 67% and 95%; and undetectable PSA response rates of 17%, 14%, and 33%.
A total of 8 of 19 patients on abiraterone were crossed over to olaparib, and 8 of 21 initially assigned to olaparib were crossed over to abiraterone. In these patients the median PFS from crossover was 8.3 and 7.2 months, respectively. In each crossover group the median PFS from the time of randomization was 16 months.
There were no grade 4 adverse events or treatment-related deaths reported in any of the study arms, and “essentially when you look at the adverse events, they pretty much are consistent with what you would expect to see with these particular agents,” Dr. Hussain said.
“Overall the patients were tolerating the treatment well,” she added.
Practice Changing with Caveats
Kim N. Chi, MD, FRCPC, of the University of British Columbia in Vancouver, BC, Canada, the invited discussant, said that the strengths of the study included an olaparib monotherapy arm — something that was missing from phase 3 trials — that provides insights into how PARP inhibitors perform in this population. He also applauded the inclusion of clinical assessment as a primary endpoint, noting that “this is what we do in routine practice, and therefore, the generalizability of the trial becomes more evident.”
The crossover design provides important information about whether an upfront combination or a sequential therapy approach is more effective, as well, he added.
He pointed out, however, that the trial was limited by small sample size and by its “horse race” design rather than as a comparison trial.
“So how does the BRCAAway trial change our practice? Despite the limitations, I think it does support an upfront PARP inhibitor-ARPI combination as firstline therapy for HRR gene-mutated metastatic CRPC. These data suggest synergy, and most importantly, there is no loss of opportunity [for more effective therapies]. However, the limitations of the trial will not end this debate today,” he said.
The trial was funded by AstraZeneca. Both Dr. Hussain and Dr. Chi disclosed honoraria, consulting/advising, and institutional research funding from AstraZeneca and others.
That’s the conclusion of investigators in the phase 2 BRCAAway trial, which compared a combination of abiraterone (Zytiga) and prednisone plus olaparib (Lynparza) against sequential therapy with the same agents.
At the time of data cutoff, median progression-free survival (PFS), the primary endpoint, was 39 months for patients randomized to the combination, compared with 8.4 months for those assigned to abiraterone/prednisone, and 14 months for those assigned to olaparib monotherapy, reported Maha Hussain, MD, of the Robert H. Lurie Comprehensive Cancer Center in Chicago.
“In patients with metastatic castration-resistant prostate cancer [mCRPC] and BRCA1/2 or ATM alterations, abiraterone and prednisone plus olaparib was well tolerated and resulted in better progression-free survival and response rates vs. single-agent olaparib or abiraterone/prednisone,” she said in an oral abstract presentation at the ASCO Genitourinary Cancers Symposium.
Although the study allowed crossover between the single-agent arms at the time of progression, only a few patients made the switch. Nonetheless, in these patients the PFS with the frontline combination was superior to that of sequential therapy, she noted.
Study Rationale and Design
Germline or somatic mutations in genes encoding for homologous recombination-repair occur in about 20% of men with mCRPC. Olaparib, a PARP1 (poly-adp ribose polymerase-1) inhibitor, interacts with androgen signaling, and preclinical studies have shown that castration-resistant prostate tumor cells have increased PARP1 activity. In addition, PARP1 has been shown preclinically to synergize with androgen receptor pathway inhibitors (ARPIs) such as abiraterone, Dr. Hussain explained.
The BRCAAway trial was designed to test whether co-targeting the androgen receptor and PARP1 could result in higher and more durable responses than current frontline therapies in patients with mCRPC with DNA-damage response mutations.
Patients with mCRPC with no prior exposure to either a PARP1 inhibitor, androgen receptor inhibitor, or mCRPC-directed chemotherapy underwent next-generation sequencing and germline testing of tumor tissues, and those patients found to have inactivating BRCA1/2 and/or ATM alterations were randomized on a 1:1:1 basis to either abiraterone 1000 mg daily plus prednisone 5 mg twice daily (19 patients); olaparib 300 mg twice daily (21 patients); or to the combination (21 patients).
The primary endpoint was radiographic PFS according to RECIST 1.1 criteria, Prostate Cancer Working Group 3 criteria, clinical assessment, or death.
As noted, the median PFS was 8.4 months with abiraterone/prednisone, 14 months with olaparib, and 39 months with the combination.
Secondary endpoints also favored the combination therapy arm, with objective response rates of 22%, 14%, and 33%, respectively; PSA response rates of 61%, 67% and 95%; and undetectable PSA response rates of 17%, 14%, and 33%.
A total of 8 of 19 patients on abiraterone were crossed over to olaparib, and 8 of 21 initially assigned to olaparib were crossed over to abiraterone. In these patients the median PFS from crossover was 8.3 and 7.2 months, respectively. In each crossover group the median PFS from the time of randomization was 16 months.
There were no grade 4 adverse events or treatment-related deaths reported in any of the study arms, and “essentially when you look at the adverse events, they pretty much are consistent with what you would expect to see with these particular agents,” Dr. Hussain said.
“Overall the patients were tolerating the treatment well,” she added.
Practice Changing with Caveats
Kim N. Chi, MD, FRCPC, of the University of British Columbia in Vancouver, BC, Canada, the invited discussant, said that the strengths of the study included an olaparib monotherapy arm — something that was missing from phase 3 trials — that provides insights into how PARP inhibitors perform in this population. He also applauded the inclusion of clinical assessment as a primary endpoint, noting that “this is what we do in routine practice, and therefore, the generalizability of the trial becomes more evident.”
The crossover design provides important information about whether an upfront combination or a sequential therapy approach is more effective, as well, he added.
He pointed out, however, that the trial was limited by small sample size and by its “horse race” design rather than as a comparison trial.
“So how does the BRCAAway trial change our practice? Despite the limitations, I think it does support an upfront PARP inhibitor-ARPI combination as firstline therapy for HRR gene-mutated metastatic CRPC. These data suggest synergy, and most importantly, there is no loss of opportunity [for more effective therapies]. However, the limitations of the trial will not end this debate today,” he said.
The trial was funded by AstraZeneca. Both Dr. Hussain and Dr. Chi disclosed honoraria, consulting/advising, and institutional research funding from AstraZeneca and others.
That’s the conclusion of investigators in the phase 2 BRCAAway trial, which compared a combination of abiraterone (Zytiga) and prednisone plus olaparib (Lynparza) against sequential therapy with the same agents.
At the time of data cutoff, median progression-free survival (PFS), the primary endpoint, was 39 months for patients randomized to the combination, compared with 8.4 months for those assigned to abiraterone/prednisone, and 14 months for those assigned to olaparib monotherapy, reported Maha Hussain, MD, of the Robert H. Lurie Comprehensive Cancer Center in Chicago.
“In patients with metastatic castration-resistant prostate cancer [mCRPC] and BRCA1/2 or ATM alterations, abiraterone and prednisone plus olaparib was well tolerated and resulted in better progression-free survival and response rates vs. single-agent olaparib or abiraterone/prednisone,” she said in an oral abstract presentation at the ASCO Genitourinary Cancers Symposium.
Although the study allowed crossover between the single-agent arms at the time of progression, only a few patients made the switch. Nonetheless, in these patients the PFS with the frontline combination was superior to that of sequential therapy, she noted.
Study Rationale and Design
Germline or somatic mutations in genes encoding for homologous recombination-repair occur in about 20% of men with mCRPC. Olaparib, a PARP1 (poly-adp ribose polymerase-1) inhibitor, interacts with androgen signaling, and preclinical studies have shown that castration-resistant prostate tumor cells have increased PARP1 activity. In addition, PARP1 has been shown preclinically to synergize with androgen receptor pathway inhibitors (ARPIs) such as abiraterone, Dr. Hussain explained.
The BRCAAway trial was designed to test whether co-targeting the androgen receptor and PARP1 could result in higher and more durable responses than current frontline therapies in patients with mCRPC with DNA-damage response mutations.
Patients with mCRPC with no prior exposure to either a PARP1 inhibitor, androgen receptor inhibitor, or mCRPC-directed chemotherapy underwent next-generation sequencing and germline testing of tumor tissues, and those patients found to have inactivating BRCA1/2 and/or ATM alterations were randomized on a 1:1:1 basis to either abiraterone 1000 mg daily plus prednisone 5 mg twice daily (19 patients); olaparib 300 mg twice daily (21 patients); or to the combination (21 patients).
The primary endpoint was radiographic PFS according to RECIST 1.1 criteria, Prostate Cancer Working Group 3 criteria, clinical assessment, or death.
As noted, the median PFS was 8.4 months with abiraterone/prednisone, 14 months with olaparib, and 39 months with the combination.
Secondary endpoints also favored the combination therapy arm, with objective response rates of 22%, 14%, and 33%, respectively; PSA response rates of 61%, 67% and 95%; and undetectable PSA response rates of 17%, 14%, and 33%.
A total of 8 of 19 patients on abiraterone were crossed over to olaparib, and 8 of 21 initially assigned to olaparib were crossed over to abiraterone. In these patients the median PFS from crossover was 8.3 and 7.2 months, respectively. In each crossover group the median PFS from the time of randomization was 16 months.
There were no grade 4 adverse events or treatment-related deaths reported in any of the study arms, and “essentially when you look at the adverse events, they pretty much are consistent with what you would expect to see with these particular agents,” Dr. Hussain said.
“Overall the patients were tolerating the treatment well,” she added.
Practice Changing with Caveats
Kim N. Chi, MD, FRCPC, of the University of British Columbia in Vancouver, BC, Canada, the invited discussant, said that the strengths of the study included an olaparib monotherapy arm — something that was missing from phase 3 trials — that provides insights into how PARP inhibitors perform in this population. He also applauded the inclusion of clinical assessment as a primary endpoint, noting that “this is what we do in routine practice, and therefore, the generalizability of the trial becomes more evident.”
The crossover design provides important information about whether an upfront combination or a sequential therapy approach is more effective, as well, he added.
He pointed out, however, that the trial was limited by small sample size and by its “horse race” design rather than as a comparison trial.
“So how does the BRCAAway trial change our practice? Despite the limitations, I think it does support an upfront PARP inhibitor-ARPI combination as firstline therapy for HRR gene-mutated metastatic CRPC. These data suggest synergy, and most importantly, there is no loss of opportunity [for more effective therapies]. However, the limitations of the trial will not end this debate today,” he said.
The trial was funded by AstraZeneca. Both Dr. Hussain and Dr. Chi disclosed honoraria, consulting/advising, and institutional research funding from AstraZeneca and others.
FROM ASCO GU 2024
More Side Effects With Local Therapies for Prostate Cancer
These were the findings of a retrospective cohort study in JAMA Network Open.
The standard treatment of advanced prostate cancer is androgen deprivation therapy (ADT). “The role of local therapy has been debated for several years. Studies have shown that radiation therapy or radical prostatectomy can improve patient survival under certain conditions,” said Hubert Kübler, MD, director of the Clinic and Polyclinic for Urology and Pediatric Urology at the University Hospital Würzburg in Germany. “At academic centers, a local therapy is pursued for oligometastatic patients if they are fit enough.”
The hope is to spare patients the side effects of ADT over an extended period and thus improve their quality of life. “But what impact does local therapy itself have on the men’s quality of life, especially considering that the survival advantage gained may be relatively small?” wrote study author Saira Khan, PhD, MPH, assistant professor of surgery at Washington University School of Medicine in St. Louis, Missouri, and her colleagues.
Examining Side Effects
This question has not been thoroughly examined yet. “To our knowledge, this is one of the first studies investigating the side effects of local therapy in men with advanced prostate cancer for up to 5 years after treatment,” wrote the authors.
The cohort study included 5500 US veterans who were diagnosed with advanced prostate cancer between January 1999 and December 2013. The tumors were in stage T4 (tumor is fixed or has spread to adjacent structures), with regional lymph node metastases (N1), and partially detectable distant metastases (M1).
The average age was 68.7 years, and 31% received local therapy (eg, radiation therapy, radical prostatectomy, or both), and 69% received systemic therapy (eg, hormone therapy, chemotherapy, or both).
Types of Local Therapy
Combining radiation therapy and radical prostatectomy “diminishes the meaningfulness of the study results,” according to Dr. Kübler. “The issue should have been analyzed in much finer detail. Studies clearly show, for example, that radiation therapy consistently performs slightly worse than prostatectomy in terms of gastrointestinal complaints.”
In their paper, the researchers reported that the prevalence of side effects was high, regardless of the therapy. Overall, 916 men (75.2%) with initial local therapy and 897 men (67.1%) with initial systemic therapy reported experiencing at least one side effect lasting more than 2 years and up to 5 years.
In the first year after the initial therapy, men who underwent local therapy, compared with those who underwent systemic therapy, experienced more of the following symptoms:
- Gastrointestinal issues (odds ratio [OR], 4.08)
- Pain (OR, 1.57)
- Sexual dysfunction (OR, 2.96)
- Urinary problems, predominantly incontinence (OR, 2.25)
Lasting Side Effects
Even up to year 5 after the initial therapy, men with local therapy reported more gastrointestinal and sexual issues, as well as more frequent incontinence, than those with systemic therapy. Only the frequency of pain equalized between the two groups in the second year.
“Our results are consistent with the known side effect profile [of local therapy] in patients with clinically localized prostate cancer receiving surgery or radiation therapy instead of active surveillance,” wrote the authors.
The comparison in advanced prostate cancer, however, is not with active surveillance but with ADT. “As the study confirmed, ADT is associated with various side effects,” said Dr. Kübler. Nevertheless, it was associated with fewer side effects than local therapy in this study. The concept behind local therapy (improving prognosis while avoiding local problems) is challenging to reconcile with these results.
Contradictory Data
The results also contradict findings from other studies. Dr. Kübler pointed to the recently presented PEACE-1 study, where “local complications and issues were reduced through local therapy in high-volume and high-risk patients.”
The study did not consider subsequent interventions, such as how many patients needed transurethral manipulation in the later course of the disease to address local problems. “There are older data showing that a radical prostatectomy can reduce the need for further resections,” Dr. Kübler added.
“I find it difficult to reconcile these data with other data and with my personal experience,” said Dr. Kübler. However, he agreed with the study authors’ conclusion, emphasizing the importance of informing patients about expected side effects of local therapy in the context of potentially marginal improvements in survival.
Different Situation in Germany
“As practitioners, we sometimes underestimate the side effects we subject our patients to. We need to talk to our patients about the prognosis improvement that comes with side effects,” said Dr. Kübler. He added that a similar study in Germany might yield different results. “Dr. Khan and her colleagues examined a very specific patient population: Namely, veterans. This patient clientele often faces many social difficulties, and the treatment structure in US veterans’ care differs significantly from ours.”
This article was translated from the Medscape German edition. A version of this article appeared on Medscape.com.
These were the findings of a retrospective cohort study in JAMA Network Open.
The standard treatment of advanced prostate cancer is androgen deprivation therapy (ADT). “The role of local therapy has been debated for several years. Studies have shown that radiation therapy or radical prostatectomy can improve patient survival under certain conditions,” said Hubert Kübler, MD, director of the Clinic and Polyclinic for Urology and Pediatric Urology at the University Hospital Würzburg in Germany. “At academic centers, a local therapy is pursued for oligometastatic patients if they are fit enough.”
The hope is to spare patients the side effects of ADT over an extended period and thus improve their quality of life. “But what impact does local therapy itself have on the men’s quality of life, especially considering that the survival advantage gained may be relatively small?” wrote study author Saira Khan, PhD, MPH, assistant professor of surgery at Washington University School of Medicine in St. Louis, Missouri, and her colleagues.
Examining Side Effects
This question has not been thoroughly examined yet. “To our knowledge, this is one of the first studies investigating the side effects of local therapy in men with advanced prostate cancer for up to 5 years after treatment,” wrote the authors.
The cohort study included 5500 US veterans who were diagnosed with advanced prostate cancer between January 1999 and December 2013. The tumors were in stage T4 (tumor is fixed or has spread to adjacent structures), with regional lymph node metastases (N1), and partially detectable distant metastases (M1).
The average age was 68.7 years, and 31% received local therapy (eg, radiation therapy, radical prostatectomy, or both), and 69% received systemic therapy (eg, hormone therapy, chemotherapy, or both).
Types of Local Therapy
Combining radiation therapy and radical prostatectomy “diminishes the meaningfulness of the study results,” according to Dr. Kübler. “The issue should have been analyzed in much finer detail. Studies clearly show, for example, that radiation therapy consistently performs slightly worse than prostatectomy in terms of gastrointestinal complaints.”
In their paper, the researchers reported that the prevalence of side effects was high, regardless of the therapy. Overall, 916 men (75.2%) with initial local therapy and 897 men (67.1%) with initial systemic therapy reported experiencing at least one side effect lasting more than 2 years and up to 5 years.
In the first year after the initial therapy, men who underwent local therapy, compared with those who underwent systemic therapy, experienced more of the following symptoms:
- Gastrointestinal issues (odds ratio [OR], 4.08)
- Pain (OR, 1.57)
- Sexual dysfunction (OR, 2.96)
- Urinary problems, predominantly incontinence (OR, 2.25)
Lasting Side Effects
Even up to year 5 after the initial therapy, men with local therapy reported more gastrointestinal and sexual issues, as well as more frequent incontinence, than those with systemic therapy. Only the frequency of pain equalized between the two groups in the second year.
“Our results are consistent with the known side effect profile [of local therapy] in patients with clinically localized prostate cancer receiving surgery or radiation therapy instead of active surveillance,” wrote the authors.
The comparison in advanced prostate cancer, however, is not with active surveillance but with ADT. “As the study confirmed, ADT is associated with various side effects,” said Dr. Kübler. Nevertheless, it was associated with fewer side effects than local therapy in this study. The concept behind local therapy (improving prognosis while avoiding local problems) is challenging to reconcile with these results.
Contradictory Data
The results also contradict findings from other studies. Dr. Kübler pointed to the recently presented PEACE-1 study, where “local complications and issues were reduced through local therapy in high-volume and high-risk patients.”
The study did not consider subsequent interventions, such as how many patients needed transurethral manipulation in the later course of the disease to address local problems. “There are older data showing that a radical prostatectomy can reduce the need for further resections,” Dr. Kübler added.
“I find it difficult to reconcile these data with other data and with my personal experience,” said Dr. Kübler. However, he agreed with the study authors’ conclusion, emphasizing the importance of informing patients about expected side effects of local therapy in the context of potentially marginal improvements in survival.
Different Situation in Germany
“As practitioners, we sometimes underestimate the side effects we subject our patients to. We need to talk to our patients about the prognosis improvement that comes with side effects,” said Dr. Kübler. He added that a similar study in Germany might yield different results. “Dr. Khan and her colleagues examined a very specific patient population: Namely, veterans. This patient clientele often faces many social difficulties, and the treatment structure in US veterans’ care differs significantly from ours.”
This article was translated from the Medscape German edition. A version of this article appeared on Medscape.com.
These were the findings of a retrospective cohort study in JAMA Network Open.
The standard treatment of advanced prostate cancer is androgen deprivation therapy (ADT). “The role of local therapy has been debated for several years. Studies have shown that radiation therapy or radical prostatectomy can improve patient survival under certain conditions,” said Hubert Kübler, MD, director of the Clinic and Polyclinic for Urology and Pediatric Urology at the University Hospital Würzburg in Germany. “At academic centers, a local therapy is pursued for oligometastatic patients if they are fit enough.”
The hope is to spare patients the side effects of ADT over an extended period and thus improve their quality of life. “But what impact does local therapy itself have on the men’s quality of life, especially considering that the survival advantage gained may be relatively small?” wrote study author Saira Khan, PhD, MPH, assistant professor of surgery at Washington University School of Medicine in St. Louis, Missouri, and her colleagues.
Examining Side Effects
This question has not been thoroughly examined yet. “To our knowledge, this is one of the first studies investigating the side effects of local therapy in men with advanced prostate cancer for up to 5 years after treatment,” wrote the authors.
The cohort study included 5500 US veterans who were diagnosed with advanced prostate cancer between January 1999 and December 2013. The tumors were in stage T4 (tumor is fixed or has spread to adjacent structures), with regional lymph node metastases (N1), and partially detectable distant metastases (M1).
The average age was 68.7 years, and 31% received local therapy (eg, radiation therapy, radical prostatectomy, or both), and 69% received systemic therapy (eg, hormone therapy, chemotherapy, or both).
Types of Local Therapy
Combining radiation therapy and radical prostatectomy “diminishes the meaningfulness of the study results,” according to Dr. Kübler. “The issue should have been analyzed in much finer detail. Studies clearly show, for example, that radiation therapy consistently performs slightly worse than prostatectomy in terms of gastrointestinal complaints.”
In their paper, the researchers reported that the prevalence of side effects was high, regardless of the therapy. Overall, 916 men (75.2%) with initial local therapy and 897 men (67.1%) with initial systemic therapy reported experiencing at least one side effect lasting more than 2 years and up to 5 years.
In the first year after the initial therapy, men who underwent local therapy, compared with those who underwent systemic therapy, experienced more of the following symptoms:
- Gastrointestinal issues (odds ratio [OR], 4.08)
- Pain (OR, 1.57)
- Sexual dysfunction (OR, 2.96)
- Urinary problems, predominantly incontinence (OR, 2.25)
Lasting Side Effects
Even up to year 5 after the initial therapy, men with local therapy reported more gastrointestinal and sexual issues, as well as more frequent incontinence, than those with systemic therapy. Only the frequency of pain equalized between the two groups in the second year.
“Our results are consistent with the known side effect profile [of local therapy] in patients with clinically localized prostate cancer receiving surgery or radiation therapy instead of active surveillance,” wrote the authors.
The comparison in advanced prostate cancer, however, is not with active surveillance but with ADT. “As the study confirmed, ADT is associated with various side effects,” said Dr. Kübler. Nevertheless, it was associated with fewer side effects than local therapy in this study. The concept behind local therapy (improving prognosis while avoiding local problems) is challenging to reconcile with these results.
Contradictory Data
The results also contradict findings from other studies. Dr. Kübler pointed to the recently presented PEACE-1 study, where “local complications and issues were reduced through local therapy in high-volume and high-risk patients.”
The study did not consider subsequent interventions, such as how many patients needed transurethral manipulation in the later course of the disease to address local problems. “There are older data showing that a radical prostatectomy can reduce the need for further resections,” Dr. Kübler added.
“I find it difficult to reconcile these data with other data and with my personal experience,” said Dr. Kübler. However, he agreed with the study authors’ conclusion, emphasizing the importance of informing patients about expected side effects of local therapy in the context of potentially marginal improvements in survival.
Different Situation in Germany
“As practitioners, we sometimes underestimate the side effects we subject our patients to. We need to talk to our patients about the prognosis improvement that comes with side effects,” said Dr. Kübler. He added that a similar study in Germany might yield different results. “Dr. Khan and her colleagues examined a very specific patient population: Namely, veterans. This patient clientele often faces many social difficulties, and the treatment structure in US veterans’ care differs significantly from ours.”
This article was translated from the Medscape German edition. A version of this article appeared on Medscape.com.
FROM JAMA NETWORK OPEN