Friday, October 9, 2015

For the Record: Dr. Mickey Nardo: "hardly a right" on clinical trials at University of Minnesota

Dr. Mickey Nardo, a psychiatrist with a conscience, writes on his outstanding blog:

1 Boring Old Man

hardly a right…

Posted on Thursday 8 October 2015

When Charles Schulz became Chairman of the Department of Psychiatry at the University of Minnesota Medical School in 1999, he came with a plan. I wrote about it in a series back in April if you’re not familiar with the story:

By that time, it was a plan following the lead of any number of Psychiatry Departments around the country. Build a Clinical Research Center and get the lucrative contracts for doing Clinical Trials for the Pharmaceutical Industry’s CNS drugs to support the Department’s overall funding. It was the heyday of psychopharmacology – and there were plenty of those studies available to propose or bid on. Such a plan requires some way of recruiting subjects for the studies, and that job fell to Stephen Olson who was apparently good at it.

They hit a glitch when a subject, Dan Markingson, killed himself while in a study in 2004. He had been recruited in an absurd way. He was declared incompetent, committed to treatment, but was offered a much less restrictive placement if he volunteered for a Clinical Trial. The paradox is obvious – declared incompetent? but volunteered? By my read of his records, Dan remained in a psychotic state throughout his stay in a halfway house until his suicide six months into the study. Ultimately, the legislature passed "Dan’s Law" in 2009 which prohibited the recruitment of committed patients for drug trials.

But like most states, in Minnesota, there’s a 72 hour holding period before a commitment hearing [for observation]. Is that a loophole? Comes now the case of Robert Huber:

By Carl Elliott
October 7, 2015
Thanks to a former Fairview Hospital patient with the courage to speak out about his mistreatment, the University of Minnesota is finally ending a controversial research practice. As of last month, the university will no longer test experimental drugs on mentally ill patients who have been involuntarily confined to a locked psychiatric unit under a 72-hour hold [“U halts recruiting of confined patients,” Sept. 26].
In July 2007, Robert Huber came to Fairview for help. He was hearing voices and feeling panicked. His treating psychiatrist, Dr. Stephen Olson, used a 72-hour emergency hold to confine Huber to a locked psychiatric unit. Then Olson asked Huber to sign up for a research study testing an experimental drug.
A pharmaceutical company was testing an unapproved antipsychotic drug called bifeprunox. Huber had never been prescribed any antipsychotic drug before, much less an experimental one, but he agreed to take part because he thought it was the only way to escape confinement. “I was so afraid they were going to lock me up,” Huber told the Star Tribune.
The study went very badly. The drug caused severe side-effects. Huber considered suicide. Only a few weeks after he was enrolled, the FDA rejected the drug for marketing approval, citing the death of a research subject in Europe. Yet nobody at the university told Huber — or for that matter, any of the other subjects enrolled in the U study — that the FDA had rejected the drug.
When Huber’s story was made public by KMSP-TV news in 2014, the university tried to smear him. A press statement prepared with the assistance of Brian Lucas, the senior communications director for the U’s Academic Health Center, read in part: “His medical record shows extreme anxiety and paranoia, a history of head injuries and lengthy battle with alcoholism. It is highly inappropriate for him to be put in the media spotlight as a spokesperson for clinical trial safety.”
In early 2013, Huber and I filed separate complaints to the university. It took over 14 months for the university to respond. The university hired an external consulting firm at a cost of $22,000, but neither the university nor the consulting firm ever bothered to interview Huber about what had happened to him. Finally, on May 6 of last year, the university sent Huber a letter informing him of its conclusion. The letter conceded minor problems but said, “You were not pressured or coerced to participate in this study.”

Recently, a commenter asked why I had spent so much time on a fourteen year old Clinical Trial. It was a long time ago, and nobody’s using that drug in kids anymore. Why not put it in the past and move on? One could equally say the same thing about Carl Elliott and the Markingson case, or the Huber case. It was a long time ago. Why not just move on? Here’s one part of the answer from Carl…

Huber deserves an apology from the university. He also deserves our gratitude, for having the courage to step forward and tell his story. There may well have been many other patients like him over the years. If the university is genuinely committed to research reform, it will find out how many other involuntarily committed patients have been recruited into research studies, and will apologize to them as well.
But sadly the evidence is that the university is «not» genuinely committed to research reform. And the authors of Paxil Study 329 are «not» genuinely committed to setting the record straight. If they were, these things wouldn’t have happened in the first place. Carl Elliott had to move heaven and earth [and the Minnesota State Legislature] to get them to finally act. It took Jon Jureidini twelve years to finally have his say about Study 329 and the original authors still remain mum or discounting. These stories come from a time when Clinical Trials in psychiatry had moved from the realm of a scientific enterprise aimed at defining the safety and efficacy of a new drug to becoming a hurdle to be negotiated on the way to commercial success, and a means for financial support for a psychiatry department.

In both of these Minnesota cases, recruitment and retention by any means necessary trumped clinical care, scientific observation, and the intent of the involuntary hospitalization procedures of the legal system. I question whether Charles Schulz stepping down is even close to enough. He apparently provided administrative support and brought in the studies, but left the actual conduct of the Clinical Trials in the hands of others [like Stephen Olson]. With the same people in charge, what’s to guarantee that the same forces won’t be at work in the future?

Running Clinical Trials is hardly a right. It’s a privilege…

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