Last week the New York Times and LA Times reported violations of FDA mandated dosage levels in the chemicals used in clinical PET (positron emission tomography) studies at a major lab, the Kreitchman PET Center, at the Columbia University Medical Center.
Most people who participate in experimental studies of drug treatments are vulnerable–either via poverty, mental illness, other disability, race–and while they consent to participate. That consent carries with it an acknowledgment of a higher risk, but it’s also based on the basic trust that the studies are at least in accord with federal and other regulations (e.g., university research ethics boards approvals, when done in university environments).
The practice of chasing “willing subjects” to all corners of the globe became widespread as these approvals onshore became harder to gain for domestic populations, a story told in The Constant Gardener that had at least one kind of less-than-fully-evil outcome, as reported last year by The Independent.
So what is going on at Columbia University? (apart from damage control by their administration) Below the fold is the LA Times article; here’s the link to the original article, and here’s a h/t link to the AHRP blog post by Vera on this story.
Safety violations at N.Y. brain lab may have bigger fallout
Some research is suspended at a Columbia University center, but experts fear the case could deter people from participating in crucial brain-imaging studies.
The suspension of some research at a prominent Columbia University brain-imaging lab because of sloppy practices could have repercussions beyond that laboratory, potentially affecting brain-imaging studies nationwide and raising questions about the safety of participants, research experts said Saturday.
The Kreitchman PET Center in Manhattan, part of Columbia University, halted brain-imaging studies after federal authorities reportedly found safety violations that could endanger patients and invalidate research findings. The center has admitted to poor manufacturing processes of radioactive compounds injected in patients and to sub-par record-keeping.
Columbia authorities reported the findings of its own internal investigation in a July 6 letter to the Food and Drug Administration. Lab personnel are alleged to have used chemicals that had failed required purity tests when conducting brain scans of people with mental disorders. The scans, called PET scans, produce images of the brain and various neurological processes.
The chemicals used at the Columbia center were found to have contained impurities at levels well above what is permitted under FDA protocols. The center has halted research using those locally manufactured chemicals; the lab itself remains open, is still conducting other types of research and continues to see patients.
Experts disagree on whether the Columbia incident is an anomaly or if such slip-ups are widespread in research labs. But the documented lapses highlight apparent disregard for patient safety that rarely comes to light at major research institutions.
No patients were harmed, according to a statement from Columbia University released Saturday. But the practices also include failure to report use of the substandard chemicals and even efforts to hide the shoddy work, according to a New York Times account. That article, in Saturday’s newspaper, first detailed the investigation and the resulting replacement of lab managers.
“We acknowledge serious shortcomings of quality control in the manufacturing process and record-keeping in this lab,” Dr. David Hirsh, Columbia’s executive vice president for research, said in the university’s statement.
Experts familiar with such research say the suspension could damage public perception of clinical trials across the nation, deterring some people from enrolling in crucial studies and perhaps limiting — at least for a while — the potential advances gleaned from brain-imaging research.
“It undermines the trust implicit between research participants and investigators,” said Dr. E. Ray Dorsey, an assistant professor of neurology at the University of Rochester Medical Center in New York, who has studied clinical trial participation.
Imaging studies have been key to helping brain researchers understand the biological basis for mental disorders, addiction and dementia — all while drug companies search for treatments for brain-based conditions.
“This area of research is one that is making great progress,” Dorsey said. “And there is greater demand and fewer centers that do this type of research.”
It’s particularly troubling that the violations at the Columbia lab occurred during research on people with serious mental illnesses, such as schizophrenia, said Vera Sharav, president of the Alliance for Human Research Protection, an organization in New York that works to ensure safe and ethical medical research practices.
The organization has complained repeatedly to Columbia University officials about protection of research participants in psychiatric studies, Sharav said.
“Columbia is one of the major institutions as far as psych research and in terms of volume and money,” she said. “But these patients are exploited. They are voiceless.”
Mentally ill patients may be particularly vulnerable. Federal guidelines designed to protect clinical trial participants include special instructions for groups such as pregnant women, prisoners and children, but there is no specific mention of people with mental illness, said Maureen Moran, an assistant professor of preventive medicine at Northwestern University, who teaches research ethics and serves on the board that oversees the school’s human subject research.
That’s not to say the abuses at the Columbia center were malicious. They probably were not, Moran said.
“The motivation is not so much ‘We don’t care about these people,’ as ‘Let’s just get this done,’ ” she said.
Still, any slipshod work involving volunteers in clinical trials sends a shudder through the field, said Dr. Gary Small, a professor of psychiatry and biobehavioral sciences at UCLA who does brain-imaging research focusing on Alzheimer’s diagnosis.
“This is a problem because it’s very difficult to get people to volunteer for research,” he said. “We are so grateful to those who do. Anything like this sort of incident makes it more difficult.”
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