lizzy241
32 분 전
Halted research, disciplined doctors: internal audit finds Kaiser ignored patient protections in Northern California study
TRIBUNE CONTENT AGENCY 4:45 PM ET 1/29/2025
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AMRN 0.565up -0.0277 (-4.6735%)
QUOTES AS OF 04:00:00 PM ET 01/29/2025
Many of modern medicine’s most remarkable achievements have been accomplished through the trust of volunteers, who test new drugs, procedures and medical devices to determine if they are safe and effective.
A major study by Kaiser Permanente of Northern California, however, violated this trust by breaking multiple rules designed to protect volunteers, and the two researchers in charge tried to cover up the lapses by withholding critical information from study participants and those who oversee them, according to hundreds of pages of documents obtained by the Bay Area News Group.
Kaiser stopped the study and suspended two top researchers from other projects after they “failed to conduct research in a manner that is compliant, protects participants and produces verifiable data,” according to an internal audit by Kaiser’s Institutional Review Board (IRB), an independent committee required by law to ensure patient safety in clinical studies. A U.S. Food and Drug Administration investigation was also critical of Kaiser’s oversight of the research.
An estimated 12% of the nation’s clinical trials are stopped early and they typically leave a mess behind them, squandering human, physical, and financial resources. While there are often good reasons to stop studying a treatment – it may be futile or harmful, or not enough people volunteer — instances like the Kaiser case, involving misconduct, appear to be very rare, according to a survey of terminated clinical trials by the National Library of Medicine and Johns Hopkins Bloomberg School of Public Health.
“It’s important for the public to better understand the potential and inherent conflicts that occur in these medical settings,” said Ken Taymor, a researcher and lecturer at the UC Berkeley School of Public Health specializing in ethics and regulation of biomedical innovation.
The unusual disciplinary steps were taken at Kaiser after one elderly man was sickened when doctors recruited him for a study of a drug in adults at high risk for respiratory illnesses, despite a known allergy that should have excluded him, the Kaiser audit shows.
According to a complaint filed by his daughter, he disclosed his allergy and declined to participate but relented after a phone call from one of the researchers.
The researchers also attempted to recruit other ineligible Kaiser members. Some were persuaded to participate; others were invited to enroll despite limited English proficiency, or cognitive problems, the audit found.
Additionally, the audit found the study wasn’t conducted according to specific protocols, so documentation and data were not well maintained.
“Your involvement in any human subjects research presents risks,” stated a letter to the researchers by Kaiser’s review board, which investigated the problems. “You have a pattern of inattention to human subjects protection requirements.”
The two disciplined researchers lead the institution’s large and long-respected Clinical Trials Program in Kaiser’s Division of Research, which conducts studies across 21 medical centers and more than 260 clinics, many in the Bay Area. Dr. Alan Go is director, and Dr. Andrew Ambrosy is associate director. Oakland-based Kaiser cares for over 9.4 million Californians. They did not respond to emails requesting comment.
The scientists’ 1,500-member study was stopped in December 2022. Eleven of their other studies were suspended.
Because the problems were identified and the study was stopped, “this looks like a system that’s working as it should be,” said Elyse Summers, president and CEO of the Washington D.C.-based Association for Accreditation of Human Research Protection Programs, which promotes high-quality research through its accreditation process. Kaiser’s review board “acted in accordance with well-articulated policies and procedures.”
An FDA investigation also found fault, saying Kaiser’s system for monitoring research safety and ethics did not provide the Institutional Review Board with adequate authority. In response, the IRB reported that it sought to do its job, but that doctors didn’t provide needed information. Kaiser leadership delayed the IRB from taking action, according to an internal timeline.
An FDA inspection report based on eight visits in August and September 2024 found Kaiser’s Research Institute lacks a comprehensive Human Research Protection Program responsible for monitoring the entire human research process within an institution.
“Despite this, the institution continues to review human subject research, compromising its ability to adequately protect human subjects and allowing non-compliant research practices to continue without proper oversight or resolution,” FDA inspectors wrote in September 2024.
Kaiser spokesperson Kathleen Campini Chambers confirmed the study by Go and Ambrosy was terminated and that the researchers’ additional studies were suspended after it “learned of complaints.” Corrective action plans have been put in place, she said. She did not elaborate on the corrective plans.
“This allows us to analyze what led to the problems with the study and address any additional areas of concern for oversight of research at Kaiser Permanente,” she said. “We believe this due diligence is a best practice and one of the many ways we work to ensure the integrity and safety of our research.”
The discovery of life-saving antibiotics, the development of protective vaccines, curative cancer treatments – all were proven by clinical trials.
But volunteers in these experiments are very vulnerable. They may get early access to new treatments. Yet they also risk unforeseen effects, and may undergo additional tests, hospitalizations and procedures.
Policies protecting research participants grew out of revelations in the early 1970s about the Tuskegee Syphilis Study, in which poor African American men in a syphilis study were not told about a penicillin cure.
That’s why, to protect patient rights and safety, review boards must oversee studies to ensure scientists follow strict ethical principles and federal regulations, such as informed consent and voluntary participation, without undue influence. Information cannot be promotional, implying that a therapy is safe or effective. Volunteers must be excluded if they have conditions that create potential risk.
It’s a painstaking process but an essential one. Kaiser, California’s largest managed-care organization, holds a 40% share of the state’s health insurance market — and its research volunteers are its enrollees.
Related Articles
Researchers hoped the drug could help patients by reducing inflammation, a bodily response to the virus. The trial — called A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) by its sponsor, drug manufacturer Amarin Corp.(AMRN) — sought to recruit volunteers over the age of 50 who have heart disease.
Problems quickly emerged, but patients’ complaints went undetected by Kaiser’s Institutional Review Board, because it wasn’t told, according to an internal IRB timeline. When the board asked for more information, the researchers declined to provide it, according to the IRB, saying it was privileged and confidential. This is contrary to the board’s policy and procedures, which are essential to ensure the ethical treatment of volunteers.
One Kaiser member, an unidentified elderly man who had a stroke in 2020, had declined an email request to participate in the study. Then he got a phone call from Ambrosy, asking if he would participate.
“He told my father that the medicine that they would like him to take is something like fish oil and that it would be beneficial for heart health and blood pressure,” according to a complaint filed by his daughter, who has not been publicly named.
The patient told Ambrosy that he didn’t want to take the drug because he was dangerously allergic to shellfish. Another Kaiser doctor had warned him that an allergic reaction could be fatal.
Documents indicated Ambrosy disregarded the allergy and pressured the patient to participate. He relented after “Dr. Ambrosy told my father that the medicine ‘contained little, if any, shellfish,” wrote his daughter. Fish oil can cause a very small, but potential risk,of an allergic reaction.
Within three days, the man’s eyes became very sensitive to light, according to his daughter. He also felt light-headed, and he had a pain from the back of his head going down his neck. Because of his history of stroke, “this was very concerning,” she wrote to the two researchers and another Kaiser executive. The man’s identity has not been revealed.
He was dropped from the trial. But meanwhile, other patients were exposed to potential risk.
The audit found 17 subjects with fish or shellfish allergies who should have been excluded from the study. People with allergies to a component of a tested substance are typically not included in medical studies. One subject had a history of an asthma attack after eating shrimp scampi; another reported that his throat closed when eating shellfish and his hands itched when cracking crab.
Others were enrolled despite other medical problems, which are traditionally grounds for exclusion. One suffered from kidney failure and was on dialysis. Two, diagnosed with cancer, were receiving chemotherapy.
People from vulnerable populations are typically excluded from research studies. But the trial enrolled five people who had little or no English proficiency. Six were cognitively impaired so could not consent on their own. One person was blind.
Dozens of other volunteers appear to have been unduly influenced, another violation. According to internal records obtained during the audit, 38 enrollees were told that the drug offered benefits, such as helping their hearts. Many were persistently flagged for “reapproach,” despite their reluctance.
“Not interested. Could be swayed by nurse,” according to one report by study staffers and reviewed by the IRB. Another said: “Really nice guy and was really polite, telling me he’s not interested. Try to reapproach patient.”
“Patient didn’t want because of heart irregularities. Informed him of low probability,” wrote one staffer.
In nine cases, staff minimized the side effects of the study, the audit found.
At least 12 patients who had difficulty swallowing the large capsules wanted to stop. But they were instead directed to open the capsules and put them in food or drink, an unauthorized change to the FDA-approved protocol.
That study wasn’t the only one where problems were discovered. In a closer look at other studies conducted by Go and Ambrosy, the IRB found issues related to documentation, protocol adherence, data management and administrative and procedural practices. All of the two researchers’ studies were suspended by the review board in 2023; this broad suspension was later limited to 11 studies by Kaiser leadership.
The researchers confirmed the accuracy of the audit in a memo to investigators, but said there were instances where the study was misunderstood or misinterpreted. They appealed Kaiser’s decision to end the study; this appeal was denied.
Meanwhile, they are required to follow specific corrective and preventive action plans to prevent future problems.
Kaiser’s reputation is at stake, according to the IRB. Drs. Go and Ambrosy were institutional leaders, but weren’t competent to conduct safe research, worried committee members said at a September 2023 meeting. Kaiser did not respond to a request for information about whether the doctors are still conducting research.
“Allowing Drs. Go and Ambrosy to continue conducting research was putting participants at risk,” they said, “and had the potential to put all research at Kaiser Permanente and the institution at risk.”
Whalatane
6 시간 전
Dr Bhatt was very involved with the trial design . AMRN almost certainly knew why the trial disappeared ...they just wanted the news to come from Kaiser.
https://pmc.ncbi.nlm.nih.gov/articles/PMC7843090/
Rationale and design of the pragmatic randomized trial of icosapent ethyl for high cardiovascular risk adults (MITIGATE)
Andrew P Ambrosy a,b,?, Umar I Malik a, Rachel C Thomas b, Rishi V Parikh b, Thida C Tan b, Choon H Goh a, Van N Selby a, Matthew D Solomon b,c, Harshith R Avula d, Jesse K Fitzpatrick a, Jacek Skarbinski b,e, Sephy Philip f, Craig Granowitz f, Deepak L Bhatt g, Alan S Go b,h,i,j
There was a cardiovascular risk reduction as secondary endpoint IIRC that Dr Bhatt was instrumental in having added to the MITIGATE trial design ....if positive benefit shown, would have supported R-IT US data
Kiwi
lizzy241
8 시간 전
Yikes.....
Kaiser bad.
Halted research, disciplined doctors: internal audit finds Kaiser ignored patient protections in Northern California study
TRIBUNE CONTENT AGENCY 9:17 AM ET 1/29/2025
Symbol Last Price Change
AMRN 0.5927down 0 (0%)
QUOTES AS OF 04:00:00 PM ET 01/28/2025
Many of modern medicine’s most remarkable achievements have been accomplished through the trust of volunteers, who test new drugs, procedures and medical devices to determine if they are safe and effective.
A major study by Kaiser Permanente of Northern California, however, violated this trust by breaking multiple rules designed to protect volunteers, and the two researchers in charge tried to cover up the lapses by withholding critical information from study participants and those who oversee them, according to hundreds of pages of documents obtained by the Bay Area News Group.
Kaiser stopped the study and suspended two top researchers from other projects after they “failed to conduct research in a manner that is compliant, protects participants and produces verifiable data,” according to an internal audit by Kaiser’s Institutional Review Board (IRB), an independent committee required by law to ensure patient safety in clinical studies. A U.S. Food and Drug Administration investigation was also critical of Kaiser’s oversight of the research.
An estimated 12% of the nation’s clinical trials are stopped early and they typically leave a mess behind them, squandering human, physical, and financial resources. While there are often good reasons to stop studying a treatment – it may be futile or harmful, or not enough people volunteer — instances like the Kaiser case, involving misconduct, appear to be very rare, according to a survey of terminated clinical trials by the National Library of Medicine and Johns Hopkins Bloomberg School of Public Health.
“It’s important for the public to better understand the potential and inherent conflicts that occur in these medical settings,” said Ken Taymor, a researcher and lecturer at the UC Berkeley School of Public Health specializing in ethics and regulation of biomedical innovation.
The unusual disciplinary steps were taken at Kaiser after one elderly man was sickened when doctors recruited him for a study of a drug in adults at high risk for respiratory illnesses, despite a known allergy that should have excluded him, the Kaiser audit shows.
According to a complaint filed by his daughter, he disclosed his allergy and declined to participate but relented after a phone call from one of the researchers.
The researchers also attempted to recruit other ineligible Kaiser members. Some were persuaded to participate; others were invited to enroll despite limited English proficiency, or cognitive problems, the audit found.
Additionally, the audit found the study wasn’t conducted according to specific protocols, so documentation and data were not well maintained.
“Your involvement in any human subjects research presents risks,” stated a letter to the researchers by Kaiser’s review board, which investigated the problems. “You have a pattern of inattention to human subjects protection requirements.”
The two disciplined researchers lead the institution’s large and long-respected Clinical Trials Program in Kaiser’s Division of Research, which conducts studies across 21 medical centers and more than 260 clinics, many in the Bay Area. Dr. Alan Go is director, and Dr. Andrew Ambrosy is associate director. Oakland-based Kaiser cares for over 9.4 million Californians. They did not respond to emails requesting comment.
The scientists’ 1,500-member study was stopped in December 2022. Eleven of their other studies were suspended.
Because the problems were identified and the study was stopped, “this looks like a system that’s working as it should be,” said Elyse Summers, president and CEO of the Washington D.C.-based Association for Accreditation of Human Research Protection Programs, which promotes high-quality research through its accreditation process. Kaiser’s review board “acted in accordance with well-articulated policies and procedures.”
An FDA investigation also found fault, saying Kaiser’s system for monitoring research safety and ethics did not provide the Institutional Review Board with adequate authority. In response, the IRB reported that it sought to do its job, but that doctors didn’t provide needed information. Kaiser leadership delayed the IRB from taking action, according to an internal timeline.
An FDA inspection report based on eight visits in August and September 2024 found Kaiser’s Research Institute lacks a comprehensive Human Research Protection Program responsible for monitoring the entire human research process within an institution.
“Despite this, the institution continues to review human subject research, compromising its ability to adequately protect human subjects and allowing non-compliant research practices to continue without proper oversight or resolution,” FDA inspectors wrote in September 2024.
Kaiser spokesperson Kathleen Campini Chambers confirmed the study by Go and Ambrosy was terminated and that the researchers’ additional studies were suspended after it “learned of complaints.” Corrective action plans have been put in place, she said. She did not elaborate on the corrective plans.
Related Articles
The discovery of life-saving antibiotics, the development of protective vaccines, curative cancer treatments – all were proven by clinical trials.
But volunteers in these experiments are very vulnerable. They may get early access to new treatments. Yet they also risk unforeseen effects, and may undergo additional tests, hospitalizations and procedures.
Policies protecting research participants grew out of revelations in the early 1970s about the Tuskegee Syphilis Study, in which poor African American men in a syphilis study were not told about a penicillin cure.
That’s why, to protect patient rights and safety, review boards must oversee studies to ensure scientists follow strict ethical principles and federal regulations, such as informed consent and voluntary participation, without undue influence. Information cannot be promotional, implying that a therapy is safe or effective. Volunteers must be excluded if they have conditions that create potential risk.
It’s a painstaking process but an essential one. Kaiser, California’s largest managed-care organization, holds a 40% share of the state’s health insurance market — and its research volunteers are its enrollees.
Related Articles
Researchers hoped the drug could help patients by reducing inflammation, a bodily response to the virus. The trial — called A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) by its sponsor, drug manufacturer Amarin Corp.(AMRN) — sought to recruit volunteers over the age of 50 who have heart disease.
Problems quickly emerged, but patients’ complaints went undetected by Kaiser’s Institutional Review Board, because it wasn’t told, according to an internal IRB timeline. When the board asked for more information, the researchers declined to provide it, according to the IRB, saying it was privileged and confidential. This is contrary to the board’s policy and procedures, which are essential to ensure the ethical treatment of volunteers.
One Kaiser member, an unidentified elderly man who had a stroke in 2020, had declined an email request to participate in the study. Then he got a phone call from Ambrosy, asking if he would participate.
“He told my father that the medicine that they would like him to take is something like fish oil and that it would be beneficial for heart health and blood pressure,” according to a complaint filed by his daughter, who has not been publicly named.
The patient told Ambrosy that he didn’t want to take the drug because he was dangerously allergic to shellfish. Another Kaiser doctor had warned him that an allergic reaction could be fatal.
Documents indicated Ambrosy disregarded the allergy and pressured the patient to participate. He relented after “Dr. Ambrosy told my father that the medicine ‘contained little, if any, shellfish,” wrote his daughter. Fish oil can cause a very small, but potential risk,of an allergic reaction.
Within three days, the man’s eyes became very sensitive to light, according to his daughter. He also felt light-headed, and he had a pain from the back of his head going down his neck. Because of his history of stroke, “this was very concerning,” she wrote to the two researchers and another Kaiser executive. The man’s identity has not been revealed.
He was dropped from the trial. But meanwhile, other patients were exposed to potential risk.
The audit found 17 subjects with fish or shellfish allergies who should have been excluded from the study. People with allergies to a component of a tested substance are typically not included in medical studies. One subject had a history of an asthma attack after eating shrimp scampi; another reported that his throat closed when eating shellfish and his hands itched when cracking crab.
Others were enrolled despite other medical problems, which are traditionally grounds for exclusion. One suffered from kidney failure and was on dialysis. Two, diagnosed with cancer, were receiving chemotherapy.
People from vulnerable populations are typically excluded from research studies. But the trial enrolled five people who had little or no English proficiency. Six were cognitively impaired so could not consent on their own. One person was blind.
Dozens of other volunteers appear to have been unduly influenced, another violation. According to internal records obtained during the audit, 38 enrollees were told that the drug offered benefits, such as helping their hearts. Many were persistently flagged for “reapproach,” despite their reluctance.
“Not interested. Could be swayed by nurse,” according to one report by study staffers and reviewed by the IRB. Another said: “Really nice guy and was really polite, telling me he’s not interested. Try to reapproach patient.”
“Patient didn’t want because of heart irregularities. Informed him of low probability,” wrote one staffer.
In nine cases, staff minimized the side effects of the study, the audit found.
At least 12 patients who had difficulty swallowing the large capsules wanted to stop. But they were instead directed to open the capsules and put them in food or drink, an unauthorized change to the FDA-approved protocol.
That study wasn’t the only one where problems were discovered. In a closer look at other studies conducted by Go and Ambrosy, the IRB found issues related to documentation, protocol adherence, data management and administrative and procedural practices. All of the two researchers’ studies were suspended by the review board in 2023; this broad suspension was later limited to 11 studies by Kaiser leadership.
The researchers confirmed the accuracy of the audit in a memo to investigators, but said there were instances where the study was misunderstood or misinterpreted. They appealed Kaiser’s decision to end the study; this appeal was denied.
Meanwhile, they are required to follow specific corrective and preventive action plans to prevent future problems.
Kaiser’s reputation is at stake, according to the IRB. Drs. Go and Ambrosy were institutional leaders, but weren’t competent to conduct safe research, worried committee members said at a September 2023 meeting. Kaiser did not respond to a request for information about whether the doctors are still conducting research.
“Allowing Drs. Go and Ambrosy to continue conducting research was putting participants at risk,” they said, “and had the potential to put all research at Kaiser Permanente and the institution at risk.”
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