Nearly seven years ago, 26-year-old Dan Markingson killed himself while participating in a clinical trial at the University of Minnesota, where researchers were studying the Seroquel antipsychotic. And the circumstances surrounding his participation and subsequent death led to widely publicized allegations that the university put its own interests ahead of the patient.
How so? One reason - an academic researcher also consulted for AstraZeneca, which markets the pill and sponsored the study. And the researchers were allegedly under pressure to bolster enrollment. These details emerged following a lawsuit filed by Markingson's mother, who objected to her son's participation because he was already mentally ill and possibly incompetent, but was enrolled anyway (background here).
Her lawsuit went nowhere, as did a complaint to the state medical board about one researcher, Charles Schulz, who has denied any wrongdoing (more detail here). Yet a group of eight university bioethicists recently wrote the university's Board of Regents to complain that the school failed to properly monitor the situation and to demand that an independent board should probe the episode.
Now, the school has exonerated itself. In a letter sent by the Regents to the bioethicists, the school determined there was no "improper or inappropriate" care provided to the patient and there was no evidence of misconduct or that any laws or regulations were violated (read the letter). And the Regents noted the FDA, the Minnesota Attorney General and the Minnesota Board of Medical Practice had previously conducted investigations and reached the same conclusion.
A central issue was the extent to which Markingson's participation contributed to his suicide. The researchers and the university maintained he had actually begun to improve prior to his death. "Not withstanding (his mother's) belief, there is simply no evidence that Mr. Markingon's death was causally connected to his participation" in the study, wrote university general counsel Mark Rotenberg, in a separate letter to the same bioethicists. His office conducted the university probe.
The circumstances in which Markingson wound up in the study were central to the controversy. Back in 2003, he suddenly exhibited troubling behavior and threatened his mother before he was briefly committed involuntarily to a mental institution. To avoid remaining there, he was placed in the university trial, although just before that occurred, a physician connected to the trial reportedly indicated in a court petition that he was dangerous and mentally incapable of consenting to taking antipsychotics.
As his mother, Mary Weiss, wondered: How could her son suddenly be capable of consenting to a participation in a research study while he was in a state mental institution? A report written in Mother Jones by Carl Elliott, one of the university bioethicists, suggested the researchers were under pressure to bolster enrollment in the trial.
This same report also noted that patients experiencing their first psychotic episode are at higher risk of killing themselves or other people. "For this reason, most studies of antipsychotic drugs specifically bar researchers from recruiting patients at risk of violence or suicide, for fear that they might kill themselves or someone else during the study,” he wrote at the time.
thanks to mary weiss for the photo
11 Comments
I missed if his parents attempted a coercion case. Release from involuntary commitment to participate seems a sure thing.
What the university bioethicists had asked for was an independent investigation which was unbiased. What the university regents have delivered is paramount to doing nothing but rubber stamping a prior tainted report.
By the University Regents PR statement "exonerated itself" they have shown once again a shameful misuse of power to cover-up the truth from ever coming to light and those culpable (AKA Schulz) being held accountable for their actions.
I gather the institutional corruption runs so deep that Big Pharma money trumps scholastic integrity even @ the highest levels of our university system in these times.
Well then, it appears the FDA is worthless in patient care safety!
Once we all face the fact that AstraZeneca deems itself "not too big to fail" and above all laws placing patents before patients, and profit before laws and patient safety, then we can all sleep at night--just like David Brennan and the rest of the scandoulous group that lied to get the drug on the market, and maybe paid off some FDA officials to keep getting it approved again and again for other uses!
ALSO, don't forget the UMN is currently trialing Seroquel XR with Dr Charles Schulz for use for Borderline Personality Disorder and the IRB is governing that trial too!
These crimes will continue to happen again and again until doctors and CEOs do PRISON TIME FOR WHAT THEY HAVE DONE. Otherwise, the DOJ fines, the slaps on the wrist, the news articles, will fall on deaf ears, AstraZeneca, Schulz the UMN will continue to do 'business as usual' while innocent people die and are injured by Seroquel!
Just my opinion.
Most competent psychiatrists know that when psychotic or depressed patients begin to improve, this is actually the most vulnerable window for likelihood of committing suicide. The reason is that the patient is now more able to appreciate the depth of his/her mental illness, and has the physical energy to now do something about it, such as taking his/her own life. This is why any competent psychiatrist knows to follow the patient even more closely during the inital phase of improvement than while the patient is in the throes of active psychosis or depression. The exception is when the psychotic patient is having command type hallucinations ordering him or her to commit suicide, which the doctor should obviously be aware of and take appropriate precautions therewith.
If a potential study subject is not fully competent, then they cannot sign an informed consent form. The investigator or coordinator should never have entered such a subject. Ethical processes don't seem to have been followed here and the IRB was not protecting the rights of the patient. That much is clear as day.
@industry insider - what a total crock of shit. The suicide rate of schizophrenics has at least doubled and some people even estimate an increase of up to 20-fold since neuroleptics. Way to go, psychiatry, you bunch of incompetent, murderous quacks
I'm sorry, Kim. I checked the boards and I didn't see you state your medical credentials. Mine are an MD and a PhD. What are your? Where did you do your psychiatric residency or get your fellowship in psychopharmacology?
BTW, if anyone wonders why we in Big Pharma research don't do many clinical drug trials in universities anymore, this case is a good example. As long as we use an independent, duly constituted outside IRB when contracting trials privately, we don't have to deal with university "bioethicists", who can endlessly debate how many angels can dance on the head of a pin and slow things to a crawl.
On the side - as we had discussed whether participating in clinical trials should be considered employment...
Did anyone else catch the guy on American Idol who, when asked what he did for a living, said he participated in drug trials for a pharmaceutical company? He didn't make it to the next round, btw.
So how do you recruit mentally ill patients for these studies, if severe mental illness disqualifies them from consenting? Limit the studies to patents already being adequately treated by other drugs, or those so young or so ill that someone else has guardianship over them?