When a study shows that a popular anti-depressant doesn’t work, those results are routinely suppressed, claims an article in a respected medical journal. According to the New England Journal of Medicine, all of the positive studies are published, but those that show negative or questionable results are often not published at all.
The article posed the question whether doctors and patients could make informed decisions about the use of anti-depressants such as Effoxor, Zoloft, Wellbutrin, Paxil, Remeron and Prozac.
The report examined 74 studies of anti-depressants and found that 38 studies showed positive results and 36 showed negative or questionable results. That means that nearly half of the studies showed unfavorable results. In many cases, patients taking a placebo experienced the same benefits. In some studies, the placebo actually worked better!
Since many of the studies were funded by drug companies producing the anti-depressants, very few of those unfavorable results ever saw the light of day. According to the article, only 14 unfavorable studies were ever published and, in 11 of them, the results were mischaracterized. So, only three studies were published showing unfavorable results. What doctors and patients saw were 38 studies showing favorable results from anti-depressants and only three studies showing unfavorable results, even though the real ratio was almost 50:50.
The drug companies dispute the findings. They claim that all of the results are reported – reported somewhere that is.
Whether or not they were easy to find is another matter.
Anti-depressants are extremely popular. Many people are being helped by them. But shouldn’t the average person or doctor who is considering them be able to see a complete picture of all results of testing to make an informed decision about the risks and benefits, without having to lift up every rock to try to find the bad results?
The drug companies claim that new procedures are being put in place to make the information more accessible. Let’s hope so.
What about a company that intentionally suppresses bad test results when applying for FDA approval of the drug? There is at least one creative and effective means for citizens to fight back. Drug companies are liable for fraud if, at the time they apply for FDA approval, they lie or conceal important facts.
That means the public has a potent weapon in its arsenal. If an insider or former employee of a drug company knows that the application to the FDA for a drug contained material omissions or outright lies that resulted in the drug being approved, then every sale of the drug would be a violation of the law.
If such an insider steps forward to report the fraud, as a whistleblower, he or she would receive up to 25 percent of what the Department of Justice recovers from the drug company for its fraud. The DOJ must prove two things. First, that the drug company knew it was submitting false or misleading information. Second, that the FDA would not have approved the drug if it had known the truth.
Although this is a high standard, if you can prove fraud, the amount of a reward for something like one of these blockbuster anti-depressant drugs could conceivably exceed a billion dollars. You could easily afford to retire and buy an exotic island!
If you have first-hand knowledge of fraud in gaining FDA approval for a drug, reporting it not only may earn you a reward, but it is simply the right thing to do.
