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Friday, November 05, 2010

Clinical Trial Fraud

MannKind's former senior director for regulatory affairs John Arditi is alleging that the company hid "scientific misconduct" from regulators. In a lawsuit filed Sept. 16, Arditi said he uncovered irregularities at Russian and Bulgarian trial sites, noting that patients at the Russian site were recorded as having the same blood pressure at several visits--something that is highly unlikely. In Bulgaria, patients were said to have been treated with the drug despite the fact that Afrezza packing slips indicate the drug had not yet been delivered to the site. Both issues points to the possibility of fake patients. The former exec further alleges that he was fired after bringing the issue to the company's attention.

Read more Clinical trial fraud accusations rock MannKind .

Mannkind is in for a fight Biotech companies never want to get into. Standard practice is to prepare a severance for the departing Cargo Cult Scientist with a clause that prevents him/her from exposing the Cargo Cult secrets. This one should be fun to watch.

Like Aubrey Blumnsohn, people with integrity and inside clinical trial information can be a real pain in the arse. The two cases differ in the kind of information that is meant to be hidden but they are the same in the struggle to tell the truth. You begin to question yourself, "does this matter"? Your superiors are saying that it does not and perhaps you are not smart enough to understand. You dig deep and try to prove yourself wrong. Your career is at stake. Does it matter? You can't prove yourself wrong. Not only do you think your concerns matter, but you think most rational people would agree.

In a sane world clinical trials be completely transparent. In the Cargo Cult you can still have fake patients. Once discovered you can't bring it to the attention of upper management without negative effects on your career. No one ever said leaving the Cargo Cult would be easy.

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