Thanks to Dave Lull and Justin Owings.
In a clinical trial of a new antipsychotic drug done at the University of Minnesota, a man named Dan Weiss was given a choice: be hospitalized in a psych ward or, shockingly, “take part in an industry-funded study of antipsychotic drugs”. The usual choice is between hospitalization or conventional treatment. Weiss chose to be in the clinical trial. During the trial he killed himself.
An FDA investigator named Sharon Matson decided that Weiss had not been coerced into participating! During a trial, Moira Keane, the head of the University of Minnesota Institutional Review Board, which of course is meant to protect human subjects, claimed the purpose of the board was not to protect human subjects. The purpose of the board, Keane said, was “to make sure that Olson and the trial sponsor had a plan to protect subjects.” This is false. IRBs sometimes measure compliance, not just plans.
After Weiss’s mom sued the University of Minnesota and lost,
The university filed a legal action against Mary, demanding that she pay the university $57,000 to cover its legal expenses. Gale Pearson, one of Mary’s attorneys, says that while such suits are technically permissible, she had never seen one filed in her previous 14 years of legal practice. The university agreed to drop the lawsuit against Mary only when she agreed not to appeal the judge’s decision.
The article by Carl Elliott about this case also contains excellent discussion of how drug companies shape clinical trials to get the results they want — and when that fails, hide the results. The effect is that new drugs are approved that are worse than the drugs they replace.
Thanks to James Andrewartha.
Duke University officials have known since 2009 that there were serious problems with Anil Potti’s research — serious enough to believe it is fraudulent. Here is how one researcher put it:
The Duke investigators said their data showed that expression of a particular gene, ERCC1, correlated with response to some agents. However, the commercial microarray chip the Duke investigators said they used in their experiments does not include that gene. “I admit this is one for which I do not have a simple, charitable explanation,†[said] Dr. Baggerly.
Potti, you may remember, lied about having a Rhodes Fellowship. Duke’s first investigation found him innocent.
Later events caused Duke officials to reconsider. They are still making up their minds. This is a horror story because a clinical trial based on Potti’s research is in progress. A hundred cancer patients are getting treated according to Potti’s research — that is, according to research that is probably fraudulent. Duke has done nothing to warn the patients or stop the trial.
The whole thing reminds me of UC Berkeley researchers taking weeks to tell a woman she had a large lump in her brain. As if their legal liability were more important than her life.
In November, UC Berkeley launched an investigation of Professor Peter Duesberg for misconduct associated with a paper of his retracted from Medical Hypotheses. According to the letter sent Duesberg informing him of the investigation, there were two allegations. One was that his paper had been withdrawn by the publisher due to “issues of credibility and false claims.” The other was that “you failed to declare a relevant conflict of interest with regard to the commercial interests of your co-authors.” Duesberg tried to learn more about what he was accused of, without success. Finally the university sent him the letters of complaint that led to the investigation. Here they are.
The first letter is incredibly vague. The “issues of credibility and false claims” aren’t spelled out and it is unclear why the University of California should care that “Bruce Rasnick failed to declare his conflict of interest.” The idea that publishing a dissenting paper about AIDS is an “attempt to discredit the academic community” is worthy of Orwell.
The second letter has several strange features. First, it contradicts itself. It says:
[Statement 1] Until recently, he [Rasnick] worked as a researcher for a company, the Dr Rath Health Foundation Canada [owned by Mattias Rath]
[Statement 2] [Rasnick's] former (and possibly current) employer, Mattias Rath.
Statement 1 says Rasnick no longer works for Rath. Statement 2 says he might still work for Rath.
Second, its logic is outside the way conflict of interest is normally understood. Because you used to work for someone that might benefit from your paper, you now have a conflict of interest? This makes no sense.
Finally, there is the weird idea that because something is “possible” — Mattias Rath is “possibly” Rasnick’s current employer — it deserves a misconduct investigation. It’s possible that a flying saucer will land on the White House lawn tomorrow.
In spite of all this, UC Berkeley administrators allowed themselves to be used to punish dissent.
Peter Duesberg, a professor at UC Berkeley, has been accused of misconduct for writing a paper espousing an unpopular idea (that HIV doesn’t cause AIDS) — and the university administration is taking this seriously! Here is the letter Duesberg received.
This is major-league harassment, similar to the human-subjects complaint against Michael Bailey. And it’s Berkeley’s second Academic Horror Story. Previously, Berkeley administrators carefully delayed an experimental subject from learning she had a big lump in her brain.
More “You can be as nasty as you like” (John Cleese on extremism, via Marginal Revolution).
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