Neurontin might not be a drug for sexual problems, but this week's controversy surrounding it speaks volumes for the concerns I have about a number of the drug studies that I read in medical journals. These are journals I should be able to trust, but trust does not always run deep when so much of a journal's revenue comes from the big glossy ads that the drug companies place in them.
It's also difficult to feel trust when so many of the "unbiased" journal studies list authors who are employees of the drug companies. But even before the studies had to list the ringers from big pharm, I would often scratch my head thinking "Why did the authors ignore this?" or "Why did they create their own instrument to measure the results when others already exist?" I have often wondered if they didn't hire writers from Pravda to pen the discussion sections in some of these studies.
Of course there are risks in taking any medications--including the risk that the drug will not be effective. But why do we as consumers and healthcare providers have to base our decisions on studies that are as cosmetically enhanced as the breasts of the average porn star?
As for Neurontin, recent findings on how Pfizer fudged its studies in the New England Journal of Medicine point to just how deep the credibility gap runs for both the drug companies and the medical journals. The drug companies are starting to make Wall Street look a convent of nuns.
Perhaps the biggest hurdle of all is in finding scientists and independent labs which do not drink from the stream of funding that flows from the giant pharmaceuticals. Unfortunately, the FDA itself has not exactly been a beacon of light that inspires consumer trust.
This is the pickle we are in. From today's Pharmalot:
What Changes? Pfizer Fudged Neurontin Studies
A new analysis of a dozen studies in The New England Journal of Medicine examined possible new uses for the epilepsy drug and found the published results were often fudged, indicating the pill worked better than internal company documents showed. In essence, when the primary finding of a company-funded study wasn’t favorable, the study authors usually buried the result and found something else positive to highlight, without disclosing the change, the Associated Press notes.
The authors identified 20 trials for which internal documents were available from Pfizer and Parke-Davis, and of these trials, 12 were published. For eight of them, the primary outcome defined in the publication differed from what was described in the protocol. The primary outcome was changed in five of eight published trials for which statistically significant differences favoring Neurontin were reported. Of 21 primary outcomes described in the protocols of the published trials, six weren’t reported at all and four were reported as secondary outcomes. Of 28 primary outcomes described in the published reports, 12 were newly introduced (here is the abstract).
The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers, the AP notes. The lawyers claim Pfizer concealed evidence that Neurontin didn’t work for those unapproved uses, including nerve pain, migraines and bipolar disorder. One author, Kay Dickersin, is an expert witness for the plaintiffs, while another, Swaroop Vedule, has received fees from the lawyers.
Read more in Pharmalot.
