Tuesday, September 14, 2010

Lawyers, Drugs, and Money

Is Medical Research

at the University of Minnesota


From City Pages:

In a damning new article in the latest issue of Mother Jones magazine, Dr. Carl Elliott, a professor at the University of Minnesota's Center for Bioethics, argues that the university's system of clinical research "has been so thoroughly co-opted by market forces that many studies have become little more than covert instruments for promoting drugs." Because of the large sums of money pharmaceutical companies are paying the university, Elliott writes, the institution is too often turning a blind eye to glaring conflicts of interest and serious ethical lapses. In one instance, Elliott contends it may even have lead to the death of a study's subject,

What's been the reaction of your peers to this article?

Well, outside the medical school, and outside the university as a whole: lots of support for me personally, and, as you'd expect, shock that this could happen here. Inside the medical school: silence.

One should perhaps no longer be surprised to find pharmaceutical companies suppressing unfavorable data and manipulating studies to get the results they desire, but to read in your piece that a respected medical institution like the university may be aiding that deception is stunning.

Why would the university risk its reputation?

Pharmaceutical industry funding is the norm for academic health centers, not the exception. In academic medicine, working for them is not seen as shameful; it is seen as a mark of status. For a lot of academic physicians, being chosen by a drug company to work as a paid consultant or speaker is like being admitted to an elite private club.

But when the head of your university's psychiatric department, for instance, is a well-paid consultant for a pharmaceutical company, and that company, in the interest of increasing profits, fudges results and hides unfavorable data, why wouldn't top officials at the U of M sound the alarm?

You could ask the same question about any of a number of scandals at the university. A couple of years ago, the Star Tribune discovered that Leo Furcht, the co-chair of an ethics task force at the U working on a new conflict-of-interest policy, had steered a $501,000 pharma grant into a firm he owned and which he later sold for $9.5 million in stock. When the Star Tribune asked Deborah Powell, the dean of the medical school, why she had appointed Furcht to chair the ethics task force, she said it was because of his "extensive experience" devising conflict-of-interest rules. Furcht remains chair of the Department of Laboratory Medicine and Pathology.

You point out that in one case, a 26-year-old man named Dan Markingson was used in a psychiatric drug study after being diagnosed as psychotic. He committed suicide during this study. His mother begged university researchers not to place her son in the study. She believes carelessness on their part led directly to his death.
Do you believe this?

I asked this question of my brother, a psychiatrist on the faculty at Wake Forest University. He said, "Look, if a mentally ill young man's mother keeps calling, begging you to take her son out of a study because she thinks he is going to commit suicide, you don't just ignore her. You call 911."

Did the drug given to Dan in the study cause the suicide?

That's impossible to say; you never know whether a suicide is linked to a drug or the underlying mental illness. Did Dan get poor treatment during the study? Yes. Were there financial incentives to enroll him in the study and keep him in? Yes. I asked Jerome Kassirer, the former editor of the New England Journal of Medicine, to comment on the case for my article, and here's what he said:

"The conflict of interest is disgusting, and it seems quite likely that the boy's death was an indirect consequence of the financial inducements of the study. At the very least, the university should have appointed an independent review board, dismissed all the hospital charges, and paid the boy's mother damages."

Do you have any support, inside the medical school, calling for some new approach to medical research?

There are a few people concerned about conflicts of interest, but most of them seem afraid to say much. They prefer to keep their thoughts to themselves. As my brother says, "Doctors fear drug companies like bookies fear the mob."

1 comment:

Anonymous said...

Kudos for Professors Gleason and Elliott for their outstanding commitment and determination for seeking the truth. The committee that researched and approved the new conflict-of-interest policy at the "U" obviously never attended a CME that was put on by the psychiatry department. It's like walking down the midway at the state fair. Pharma barkers at every booth and the center ring announcer the chair of the psychiatry department. The average citizen in this state has no clue what really happens at these psychiatric CME's. The egos at the head table are as large as the pharma check book. As for Carl Elliott's article regarding the CAFE study he did an amazing job. It's absolutely amazing to me that everyone suffering a first episode psychosis and enrolled into the CAFE study, that their physician had no clue on what drug to treat them with or at what dosage. How did we ever survive without all the great scientific knowledge gained from the CAFE study. It must be required reading now at the medical school for all psychiatric trainees; and if anyone doubts any of the Seroquel data all they have to do is check with the chair of the psychiatry department. For a nominal fee I'm sure he'll give them the most current data. After he does his analysis.