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Overcoming Bias Commenter's avatar

It's absolutely appropriate to be astonished, not to mention outraged at this physician. I manage industry-sponsored drug studies for a living. I create value for biotech companies by providing clear data on the drug. If it doesn't work or it hurts people, we want to know that NOW, not years from now, which would be not only unethical but in purely pragmatic terms very financially painful. The perception that we pay people to say yes makes no sense, because without real data, you don't know if your product works, and you'll be throwing literally hundreds of millions of good dollars after bad.

Furthermore, when you do drug studies, you have people whose dedicated job it is to go out to the hospitals where the research is being done, and check in the doctors' records that every last i is dotted and t is crossed. One of the things they're trained to explicitly look for is fraud. Had I worked with this guy as an investigator, we would've found him out, period. I hope that it was someone from an industry sponsor directly monitoring his work who forced him out in the open by confronting him with whistle-blow-worthy evidence. It's entirely within the law to be sent to jail for these kinds of offenses.

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Overcoming Bias Commenter's avatar

Peer review relies on trusting the underlying data. People have obviously faked basic science experiments that get published in Science. It's hard to know they are faking until failure to replicate occurs. A more notorious example that comes to mind is for bone marrow transplant for breast cancer. A lot of phase II data (observational) supported the idea, and a south african randomized trial suggested it worked as well. It wasn't until 4 years later, when several american trials failed to show benefit, that the South African trial was audited, and found to be fraudulent.

Bone Marrow Transplant (BMT) is a very toxic treatment. Weak ineffective pain meds aren't going to kill anyone.

Anyway, I think what the BMT story indicates, which is probably also the case here, is that it was the investigator's status whoring that caused them to fake the data more so than financial ties. I don't recall any significant financial ties for the South African investigator.

Generally, when pharm companies fudge data -- its that they don't publish everything -- two recent examples that come to mind on this are size of anti-depressant effects (if you look at FDA data vs. published data, you get a much smaller effect size) and Rosiglitzone and cardiovascular mortality (again FDA data, shows a somewhat worrying picture, vs. published data).

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