Thursday, August 29, 2013

Don’t count on federal officials to protect research subjects

If there is anything I have learned from the past four years, it is that we can’t count on the federal government to protect subjects of medical research -- even when subjects have been killed or injured, and even when it is obvious that the research in question was abusive, exploitative and dangerous.  In fact, in the case of Dan Markingson, not only did federal offices fail to fix obvious dangers; they made the problems worse.

Exhibit A, of course, is the incompetent investigation conducted by a local FDA inspector named Sharon Matson in 2005.  If the FDA had not issued this astonishingly flawed report, the University of Minnesota would not have had a leg to stand on when it was forced to defend its actions later on. 
After I wrote an article about Dan’s death for Mother Jones in 2010, I contacted the federal Office of Human Research Protection (OHRP) – which, by virtue of its name, one might think would have an interest in human research protection.  But I was told that OHRP would not investigate, because the CAFÉ study was funded by a pharmaceutical company, not by federal sources. OHRP sent the matter along to a bioethicist at the FDA -- and of course, that went nowhere.

In the spring and summer of 2012 I prepared a 300 page dossier of evidence.  On October 12, 2012, I sent it to the Health and Human Services Office of the Inspector General (HHS OIG), asking for an investigation. No acknowledgement. After two months of repeated emails, letters and phone calls, I was finally given a response on December 7, 2012.  The letter said that HHS OIG would not be investigating and that it had forwarded my complaint to the Office of Human Research Protection – the very office that had refused to investigate the matter two years earlier. Later, I was informed once again by OHRP that it would not be looking into the case.

There was one small glimmer of hope in the letter from HHS OIG, however.  It said that my concerns about possible HIPAA violations had been forwarded to the HHS Office of Civil Rights.  I was instructed to contact Ms. Susan McAndrew, the Director of the Health Information Privacy Division.  On March 9, 2013, after new information emerged regarding possible HIPAA violations, I filed an additional complaint with Ms. McAndrew. But Ms. McAndrew has never responded to my correspondence or even acknowledged receipt of my complaint.

Next up: the Office of Research Integrity at the National Institutes of Health.  I thought the fact that Dr. Stephen Olson and the recently sanctioned Jean Kenney had worked on the NIH-funded CATIE study might persuade them to have a look.  Unlike every other federal office, the NIH Office of Research Integrity actually responded to my correspondence promptly. But after a relatively short period they declined to investigate as well.

When new evidence emerged suggesting irregularities with “evaluation to consent” forms (or competency evaluation forms) for the CAFÉ and CATIE studies, I decided to try the FDA again.  This time, however, I filed a complaint with a different office – the Office of Compliance in the Division of Scientific Investigations.  My contact was Ms. Dana Walters.  I sent my complaint on March 9, 2013.  Two months later, on May 20, after repeated emails and phone calls, Ms. Walters acknowledged receipt of my complaint.  She informed me that the matter was “under review.”  It has been over three months since that email, and since that time she has not responded to any of my emails or phone calls asking for status reports.

I don’t suppose any of this is surprising.  The response (or lack thereof) to these complaints isn’t all that different from the responses to the complaints filed with other bodies – professional boards, university offices, state regulators, and so on.  The federal government is slower, less responsive, and more infuriating to deal with, but in the end, the results are the same: nothing.

Yet I think the federal government bears more blame. The FDA knew about this case in 2005; they botched the investigation spectacularly; and eight years later, that botched investigation has been used repeatedly to bolster the university’s claims of innocence.  It has been used as a PR weapon, a legal defense, and an excuse for inaction by countless other parties who might have been in a position to help.  It is hard to avoid the suspicion that this botched FDA investigation might also be behind the inertia, evasiveness and non-responsiveness of other federal agencies that have been contacted.

And of course, the real question is this: in the eight years since the FDA conducted that incompetent investigation, how many other subjects have been injured, killed or mistreated in the University of Minnesota’s Department of Psychiatry?


  1. The question you ask is one that needs be answered---and not only for UMN. The fact that all of the regulatory authorities have utterly failed, in effect and in fact it is individuals who are "public servants" and medical professionals abdicated the ethical duty each of them owed to Dan Markingson with impunity. It is more than apparent to me that they act with impunity because of the stigma of the diagnosis itself, after all people labeled with schizophrenia do not have even basic Human Rights--they are deprived of them upon diagnosis "for their own good." The APA is as always silent about obviously unethical conduct of it's members and the negative effects of a DSM diagnosis on the people who are without recourse or escape once stigmatized by psychiatry.

  2. And people ask me why I gave up pursuing justice in the prenatal dex case via the Feds. The Fed agencies that are supposed to protect human subjects of medical experimentation are playing a big game of "Go ask your mother," "Go ask your father."

    You turn to them, and all you get is a "go away" letter that the crooks use to tell the press you have no case.

    I sometimes think that the biggest threat to medical research in this country is not the GOP; it's the federal government under the Obama administration turning a blind eye to the poor, uninsured, ill, and people of color who are disproportionately used as lab fodder to produce data for the privileged.

    My report on last week's HHS meeting, in which remarkably little time was spent on the question of justice:

    I want my OHRP back. I want my FDA back.