By testing novel medications, treatments, and medical equipment to make sure they are safe and effective, volunteers have helped modern medicine achieve many of its most amazing triumphs.
However, hundreds of pages of documents obtained by the Bay Area News Group reveal that a large study by Kaiser Permanente of Northern California violated this trust by violating several rules intended to protect volunteers. The two researchers in charge attempted to conceal the violations by hiding important information from study participants and those in charge of them.
An internal audit by Kaiser’s Institutional Review Board, an independent committee mandated by law to ensure patient safety in clinical studies, found that Kaiser had halted the study and suspended two leading researchers from other projects for failing to conduct research in a way that is compliant, protects participants, and produces verifiable data. Kaiser’s supervision of the study was also criticized by a U.S. Food and Drug Administration probe.
An estimated 12% of clinical studies in the country are terminated prematurely, leaving a mess in their wake and wasting money, time, and resources. According to a National Library of Medicine and Johns Hopkins Bloomberg School of Public Health survey of ended clinical trials, situations like the Kaiser case, involving misconduct, seem to be extremely uncommon, even though there are frequently valid reasons to stop researching a treatment. These reasons could include the treatment being harmful or pointless, or a lack of volunteers.
According to Ken Taymor, a researcher and lecturer at the UC Berkeley School of Public Health who specializes in ethics and the governance of biomedical innovation, it’s critical that the general public has a greater understanding of the possible and inherent conflicts that arise in these medical settings.
According to the Kaiser audit, doctors took unprecedented disciplinary action against an older man who became unwell after they recruited him for a drug trial in adults at high risk for respiratory infections despite the fact that he had a known allergy that should have prevented him from participating.
He revealed his allergy and refused to participate, but after receiving a call from one of the researchers, he agreed, according to a complaint his daughter filed.
Additionally, the researchers tried to enlist other Kaiser members who were ineligible. According to the audit, some people were convinced to take part, while others were invited to enlist in spite of their poor English or cognitive issues.
The audit also discovered that the data and documentation were poorly maintained since the study was not carried out in accordance with certain guidelines.
Kaiser’s review board, which looked into the issues, wrote to the researchers that “your involvement in any human subjects research presents risks.” You frequently disregard the regulations pertaining to the protection of human subjects.
The two highly qualified researchers are in charge of Kaiser’s Division of Research’s extensive and well-established Clinical Trials Program, which carries out studies at over 260 clinics and 21 medical centers, many of which are in the Bay Area. The director is Dr. Alan Go, while the associate director is Dr. Andrew Ambrosy. Kaiser, located in Oakland, provides care for more than 9.4 million Californians. Emails asking for comment were not answered.
In December 2022, the 1,500-person research was halted. Their other eleven studies were put on hold.
According to Elyse Summers, president and CEO of the Association for Accreditation of Human Research Protection Programs, a Washington, D.C.-based organization that encourages high-quality research through its accreditation process, “this looks like a system that’s working as it should be because the problems were identified and the study was stopped.” The actions of Kaiser’s review board were consistent with clearly stated policies and procedures.
An FDA study also revealed shortcomings, stating that Kaiser’s research safety and ethics monitoring system lacked sufficient power for the Institutional Review Board. The IRB responded by saying that although it tried to fulfill its duties, doctors failed to supply the necessary information. An internal timeline reveals that Kaiser leadership postponed the IRB’s action.
According to an FDA inspection report based on eight inspections in August and September 2024, Kaiser’s Research Institute does not have a thorough Human Research Protection Program that oversees the institution’s whole human research process.
FDA inspectors noted in September 2024 that the institution’s continued assessment of research involving human subjects compromises its ability to protect human subjects and permits non-compliant research methods to continue without effective oversight or resolution.
After learning of the accusations, Kaiser spokesperson Kathleen Campini Chambers stated that the Go and Ambrosy study was halted and that the researchers’ further studies were put on hold. Plans for corrective action have been established, she said. She didn’t go into detail about the intentions for correction.
This enables us to examine the factors that contributed to the study’s issues and resolve any further concerns with Kaiser Permanente’s research oversight, she said. As one of the numerous methods we employ to guarantee the safety and integrity of our research, we consider this due diligence to be a best practice.
Clinical trials have demonstrated the effectiveness of life-saving antibiotics, protective vaccinations, and cancer treatments.
However, participants in these studies are extremely at risk. They might have early access to novel therapies. However, they also run the danger of unintended consequences and might have to have more testing, hospital stays, and surgeries.
The early 1970s disclosures of the Tuskegee Syphilis Study, in which impoverished Black men in a syphilis study were not informed about a penicillin cure, led to the development of policies protecting research participants.
Review boards must supervise research to guarantee that scientists adhere to stringent ethical standards and federal laws, such as informed consent and voluntary participation, without undue influence, in order to safeguard patient rights and safety. Promotional information that suggests the efficacy or safety of a therapy is prohibited. If a volunteer has a condition that could pose a risk, they must be excluded.
It’s a laborious but necessary process. The largest managed-care firm in California, Kaiser, with a 40% market share in health insurance and enrolls study volunteers.
A good inquiry prompted the launch of the problematic Kaiser trial in early 2021: Could Vascepa, a medication derived from fish oil, prevent or lessen respiratory illness consequences, such as COVID, in people with cardiovascular disease?
By lessening inflammation, the body’s reaction to the virus, researchers thought the medication would benefit patients. The goal of the study, which was sponsored by the pharmaceutical company Amarin Corp. and was named A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE), was to find heart disease participants over 50.
According to an internal IRB timetable, issues surfaced rapidly, but Kaiser’s Institutional Review Board failed to notice patient complaints because they were not communicated. The IRB claims that the researchers refused to give the board additional information when they requested it, citing privileged and secret reasons. This is against the board’s policies and procedures, which are crucial for guaranteeing that volunteers are treated ethically.
An email invitation to participate in the study was turned down by one Kaiser member, an unnamed elderly man who suffered a stroke in 2020. Ambrosy then called him and asked whether he would like to take part.
According to a complaint made by his daughter, who has not been identified publicly, he informed my father that the medication they wanted him to take was similar to fish oil and that it would help with blood pressure and heart health.
The patient informed Ambrosy that his severe shellfish allergy prevented him from taking the medication. He had been cautioned by another Kaiser physician that an allergic reaction may be lethal.
Records showed that Ambrosy pushed the patient to participate despite the allergies. After Dr. Ambrosy informed my father that the medication included minimal, if any, shellfish, he gave in, according to his daughter. Fish oil can causea very small, but potential riskof an allergic reaction.
According to his daughter, the man’s eyes became extremely sensitive to light in just three days. In addition, he had dizziness and a discomfort radiating down his neck from the back of his head. Because of his history of stroke, this was very concerning, she wrote to the two researchers and another Kaiser executive. The man’s identify is still unknown.
He was dismissed from the case. However, other patients were at risk in the interim.
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. 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, committee members said, and had the potential to put all research at Kaiser Permanente and the institution at risk.
–Lisa M. Krieger, The Mercury News
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