No Minnesota Nice For Dan Markingson

By Michael D. Shaw, Contributing Columnist - This originally appeared here in the HealthNewsDigest.com- Jan 5, 2015

In the wake of the one-year-delayed Employer Mandate kicking in on January 1st, it should be emphasized that getting everyone insured is not the biggest problem facing American health care. Far from it. If by magic, every person in the US suddenly had platinum level health insurance, they would still have to embrace a system which has the distinction of spending much more than any other country for at best mediocre outcomes.

There are many reasons for this, with Medicare heading the list. Today, though, let's examine what can go wrong in our miserable and massively corrupted clinical trials jungle. Here, then, is the sad tale of patient Dan Markingson, under the "care" of the University of Minnesota's Department of Psychiatry. Please note that this story is far from unique.

Markingson, who apparently came up with that last name as he descended into paranoid schizophrenia, was unfortunate enough to be forced into a clinical trial called CAFE (Comparison of Atypicals in First-Episode Schizophrenia). The work was sponsored by AstraZeneca, the manufacturer of Seroquel, and managed by Quintiles, a contract research organization. The study compared the effectiveness of three different atypical antipsychotic drugs: Zyprexa, Risperdal, and Seroquel. The University of Minnesota was one of 26 sites chosen for the year-long effort.

According to a meta-analysis published in February, 2006 in the American Journal of Psychiatry, in 90% of cases whereby atypical antipsychotics are compared, whichever drug company sponsors the study, its product comes out on top. As such, most reasonable people would question the value of such studies, unless of course you were the institution getting bucks for running them.

Besides, as a patient on public assistance, Markingson's treatment was no moneymaker, but under its arrangement with AstraZeneca, the psychiatry department earned $15,648 for each subject who completed the CAFE study. Alas, he only made it about six months, before offing himself quite horrifically, with a box cutter to the throat, on May 8, 2004. He was 27.

Dozens of articles have been written about this case, and the hosting psych ward--described by physician/bioethicist Carl Elliott as a cross between One Flew Over the Cuckoo's Nest and Fargo. Outspoken as can be, Elliott leads the army of critics and reformers decrying what happened to Markingson. Ironically, Elliott is with the University of Minnesota. Good thing he has tenure. You betcha!

Elliott cites a few other disturbing incidents within the department, that occurred before the Markingson suicide. In a trial involving Gamma-Hydroxybutyrate (GHB), a central nervous system depressant commonly used as a date rape drug, one of the docs recruited unwitting Hmong opium addicts. Another psychiatrist in the department was sentenced to federal prison for research fraud--following a four-year cover-up by the University. It seems that this doc signed an agreement with the Dean of the Med School to keep his mouth shut.

And, how about former prof in the department Dr. Faruk Abuzzahab, found by the state board to be responsible for the deaths and injuries of an astonishing 46 patients? Many of these poor souls were involved in drug studies, including one who left the ward on a day pass and jumped off the bridge into the Mississippi River. Shades of Josef Mengele.

As to the Markingson matter, here are a few points made by the naysayers..

• Markingson was coerced into the CAFE study by the threat of involuntary commitment.
• Markingson was incompetent to consent to the study.
• The CAFE study improperly enrolled psychotic subjects at risk of homicide or violence.
• University of Minnesota investigators illegally released private health information to CAFE study sponsors.
• The CAFE study consent form failed to disclose serious risks to subjects.
• The CAFE study targeted vulnerable subjects for recruitment.
• AstraZeneca and a University of Minnesota investigator manipulated research results to promote Seroquel.
• University of Minnesota investigators failed to disclose important financial conflicts of interest to subjects.
• The CAFE study coordinator was given responsibility for medical duties for which she was unqualified, and routinely forged the medical charts, using the initials of a physician.
• University of Minnesota officials have repeatedly refused to conduct an impartial investigation into the conduct of the CAFE study and other questionable studies in the Department of Psychiatry.

More than that, Markingson's mother, Mary Weiss, begged to get him off the trial, and repeatedly warned the doctors in charge that he was suicidal. I guess she was right. Upon his death, the University stonewalled to the max, going so far as to try to collect $57,000 in their legal fees from her, and barring her and a friend from hand-delivering a letter to the University president.

Markingson notwithstanding, serious concerns have emerged regarding these "atypicals." Despite marketing hype, they do not have fewer side effects than the much cheaper older drugs, and some studies even question their effectiveness versus a placebo. As it is, in April 2010, AstraZeneca agreed to pay $520 million to settle two federal investigations and two whistle-blower lawsuits alleging that it had marketed Seroquel for unapproved uses and did not divulge health risks. The company still faces more than 25,000 civil suits.

The good news is that the circle-the-wagons strategy of University of Minnesota might be backfiring, as this ten-year-old case refuses to go away. We hope that it will continue to shine a bright light on the pernicious, wasteful mess that comprises so much of academic science research--to say nothing of big time academia in general.