Yes, it appears the makers of Paxil may have been a bit disingenuous in their publication of the risks of suicide associated with their medication back in the early 1990s. The U.S. Senate has made available an in-depth report (4 MB PDF) written by Joseph Glenmullen, a Harvard psychiatry professor, who examined the drug company’s data on Paxil. There apparently were some serious discrepancies in the original researchers’ data analysis.
One of those discrepancies was a pretty big one — that Paxil resulted in a suicide rate 8 times greater than a sugar pill. That’s a huge, major difference.
The researchers were clever in their cover-up. They included 2 people who apparently committed suicide before the study even began and attributed their suicides to the placebo control group. Nobody, of course, would’ve ever discovered this creative data interpretation if it weren’t for a lawsuit filed against GlaxoSmithKline (the makers of Paxil) in California.
There isn’t much dispute about whether the original researchers’ data analysis was proper in any form, manner or universe — it wasn’t. It was a crass manipulation of the data in order to gain market approval for the drug (which was later accepted by the FDA as a part of the drug’s safety and efficacy new drug application).
The report also noted that suicides during these kinds of research trials should be fairly rare anyways, because the researchers specifically stack the cards:
During the wash-out period [a period of 1 to 2 weeks before the study begins where subjects are removed from all existing medications], all patients are given daily placebo pills. Hence, another name for this pre-study period is the “placebo wash-out phase.” Patients whose depressions quickly improve during this time are labeled “placebo responders” and excluded from the actual study. Administering a placebo during the wash-out phase is also a technique used by pharmaceutical companies to wee out patients who would respond quickly to a placebo in the official study. This weakens the performance of the placebo by removing quick placebo responders, thereby making the performance of the antidepressants look better.
Pharmaceutical companies use this technique because the placebo effect accounts for such a high percentage of an antidepressant’s effect. According to the FDA, the placebo effect accounts for about 80% of the effect of antidepressants. […] If the pharmaceutical companies did not use the placebo wash-out procedure, the difference between placebo and antidepressants would be even smaller. Thus, the placebo wash-out phase accomplishes two tasks: washing out patients’ old drugs and weeding out placebo responders.
In other words, some pharmaceutical companies go to great lengths to “stack the deck” to ensure that when the study begins, they get the best results possible.
Keep in mind, too, that anyone who is seriously suicidal or depressed is actually excluded from participating in these kinds of studies. This only reinforces the importance of these findings — these are people who were not actively or seriously suicidal before taking Paxil.
Many psychiatrists and doctors consider Paxil a good “go-to” antidepressant for folks with depression and a little anxiety. It tends to be more calming than some other SSRI antidepressants, and therefore was very widely prescribed in the 1990s and even now. Undoubtedly such prescriptions have helped millions of Americans over the past two decades in grappling with their depression.
But it likely has also caused more harm than doctors or patients were aware of, because of these kinds of data manipulations that understated the risk of suicide.
I sincerely hope pharmaceutical companies are learning from these mistakes — all research data will eventually become public knowledge. So ensure you don’t cut any corners to get your drug approval, or else the chickens will come home to roost one day.