A Clinical Trial, A Suicide And Patient Safety
6 CommentsBy Ed Silverman // August 24th, 2010 // 8:58 am
What happens when a university is bound up in the outcome of an industry clinical trial? What does it say when university researchers are actively recruiting patients for a trial while also accepting consulting or speaking fees from the same drugmaker sponsoring the study? Is the research furthering commercial needs more so than scientific needs? And how are patients protected in such situations?
These are among the questions explored in a sobering piece in Mother Jones magazine by University of Minnesota bioethicist Carl Elliott. He focuses on the sorry plight of Mary Weiss, who lost her 26-year-old son, Dan, while he was enrolled - over her strenuous objections - in a trial at the University of Minnesota (yes, the same school) to compare AstraZeneca’s Seroquel antipsychotic with rival brands.
The circumstances in which Dan was placed in the study go to the heart of the matter. Back in 2003, he suddenly exhibited increasingly troubling behavior and threatened his mother before he was briefly committed involuntarily to a mental institution. Later, he was transferred to a halfway house before being released. But along the way, he was enrolled in the trial by a University of Minnesota psychiatry professor, who was also doing work for AstraZeneca, as was another researcher in the department.
Yet just before that occurred, this same physician indicated in a court petition that Dan was dangerous and mentally incapable of consenting to taking antipsychotics. As his mother 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? Elliott goes on to explain the university researchers were under pressure to bolster enrollment in the trial, which was run by Quintiles, the contract research company.
As Elliott notes, the study contained a loophole. “Like other patients with schizophrenia, 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 writes. “Conveniently, however, the study only prohibited patients at risk of suicide, not homocide. This meant that Dan - who had threatened to slit his mother’s throat, but had not threatened to harm himself - was a legitimate target for recruitment.”
The tale goes on to recount previous ethical lapses at the university, the interlocking interests among academic researchers and drugmakers, and oversight issues raised by the growing number of for-profit institutional review boards. At the end of the day, studies are supposed yield info to improve medical conditions - a Machiavellian prospect, perhaps, for those who say shareholder interests predominate.
But as Elliott posits after combing through product-liability litigation: “The documents…suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to generate commercially attractive messages?”
Condor
Nice recap, here, Ed.
I think these are complicated questions — as we are also looking at (as a general rule) severely ill mental patients, here. Balanced against these desperate patients, is the fact that, in every study conducted by big pharma, there is at least a “mixed motive” (almost none are done purely for the science any longer) — an interest in a specific outcome.
Ans so, as I noted over the weekend, we face an unprecedented conflict between the oath of Hippocrates, and the financial interests of both the universities, and the PIs (or principal investigators). [and as I said -- I do think Dr. Elliott's writing on Dan Markingson's suicide is Pulitzer-worthy, here.]
This morning, the NYT has added to this now-swirling topic, by outlining the failure of Lilly’s latest Alzheimer’s drug candidate trial — it asks:
“What should the nation’s doctors tell their patients (both inside the Lilly study, and not — those trying other, similar drug candidates, in competing studies) about that failed Lilly study?”
A great question.
One with no clear answers, I’m afraid.
Namaste, to all.
Bill Gleason
Ironically, when I called Dean Frank Cerra of the University of Minnesota to task for foot dragging on conflict of interest more than a year ago he responded: “And remember we’re not violating a legal statute.”
Don’t believe me? I’ve got it on tape:
http://ptable.blogspot.com/2009/07/were-not-violating-legal-statute-i.html
Bernard Carroll
… a study whose principal aim is to generate commercially attractive messages?”
Some years ago I came up with the term experimercial to describe such disguised marketing studies.
The academics who fronted for this scientifically worthless experimercial called CAFE are the same ones who ran the acclaimed CATIE project with NIH funding. CATIE changed peoples’ minds about the relative efficacy and safety of the so-called atypical antipsychotic drugs. So why are these distinguished academic investigators putting patients at risk for AstraZeneca’s marketing goals, without including a comparator drug of the early antipsychotic class, like they did in CATIE? Go figure.
Stephany
Dr.Schulz is the Principal Investigator of Seroquel XR for Borderline currently recruiting at University of Minnesota, sponsored by AstraZeneca.
What a twisted return to the scene of the crime and in my opinion it’s proof this is all about profit and data baking to profit perfection for AstraZeneca.
http://tinyurl.com/2bre7bu
Does this disturb anyone else? why is AZ’s hand in the cookie jar for COI and why is Schulz still doing this?
Who speaks for U of Minnesota? The potential trial participants should be completely skeptical of the ethics and reasons this trial is being conducted–$$$$$ patent extension!
Stephany
Condor–people are forcibly injected with antipsychotics against their will if in a locked psych ward the first 14 days, that’s not an alarmist comment I make it is based on fact. I;ve witnessed it for a decade, behind the scenes in several hospitals.
Dan was enrolled (coersion)w/out an advocate present, and convinced to remain in the trial, it’s all unethical.
It is NOT always about severe cases, I have witnessed ppl in locked psych wards, involuntarily committed, be walking zombies within 24 hrs. and lose capability of thinking straight or making any decision due to the drugging.
This is how it always plays out in the media…the horrors of patients dying or suffering always blamed on the “severe illness”…no one questions the DRUGS inducing these behaviors and delusions. I HAVE witnessed people going straight up psychotic ON MEDS, after meds are given!
God Bless that mother, our voices are small but we have seen more than pharma and the rest want to know!
Stephany
“The state ombudsman raised concerns after Markingson’s suicide, including the method of ensuring that patients were taking their pills and the ethics of one doctor both recruiting and treating a patient. The report also questioned whether Markingson was truly eligible for the study, because he wasn’t diagnosed with schizophrenia until several weeks after he had enrolled.”
This is why it is wrong, in my opinion, to state “severe cases” of MI.
This raises the ethics standard bar higher…especially due to the fact, that the U of MN and Schulz are re-trialing Seroquel right now, in a trial vs. sugar pill–for Borderline Personality Disorder.
A personality disorder being trialed w the same drug for severe MI cases? the XR version to boot.
Is this business as usual for the drug industry? Is this all citizens have to depend on for care? research like this?
What about the FDA? consumer safety?
Maybe someone here can tell me why this trial is happening at the U of MN and why there is not a larger uprising to shut it down.
Does Conflict of Interest truly mean nothing? AstraZeneca has taken charge of the health industry, in fact they snub the CIA’s and the DOJ regularly, bake their data to sell Seroquel, get caught and are allowed to keep on selling and trialing that drug.
This is, in my opinion a crime against humanity of horrific magnitude, the drug is being trialed in 10 yr olds for Bipolar Depression…when will the assault on the American public by AZ be stopped?