Trusting Sponsored Medical Research
The comments on a recent post raised the question of how much we can trust drug studies sponsored by the very companies that manufacture the drugs in question. On that point, a recent New York Times article may be relevant:
In what may be among the longest-running and widest-ranging cases of academic fraud, one of the most prolific researchers in anesthesiology has admitted that he fabricated much of the data underlying his research, said a spokeswoman for the hospital where he works.
The researcher, Dr. Scott S. Reuben, an anesthesiologist in Springfield, Mass., who practiced at Baystate Medical Center, never conducted the clinical trials that he wrote about in 21 journal articles dating from at least 1996, said Jane Albert, a spokeswoman for Baystate Health. . . .
The drug giant Pfizer underwrote much of Dr. Reuben’s research from 2002 to 2007. Many of his trials found that Celebrex and Lyrica, Pfizer drugs, were effective against postoperative pain. . . .
“When researchers are beholden to companies for much of their income, there is an incredible tendency to get results that are favorable to the company,” said Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and the author of a book about conflicts of interest.
Is it naive to be astonished that it took this long for someone to notice that 21 scholarly articles had been published about clinical trials that had never occurred?
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.
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).