I’ve often wondered, in idle moments, how a drug such as Seroxat was ever granted a licence in the first place.
From 1980-1991, approximately 5000 patients were tested on Paxil during SKB’s clinical trials. 83 different Paxil trials were conducted. Various time periods were involved in the individual trials. Many patients were tested for only a month or 6 weeks. Some were tested longer, including approximately 400 who were in trials longer than a year. SKB (Glaxo) pulled out all the stops to ensure the trials were successful. Only two positive trials are required for FDA market approval. By any reasonable person’s perspective, Paxil’s track record in the clinical trials was poor. After a decade of juggling data in the 83 different trials, SKB was finally able to cite 4 “positive” trials and three 3 “supportive” trials to justify Paxil’s approval. Dropouts in most trials were rampant. Most of the dropouts occurred because Paxil caused adverse experiences, and the victims wanted nothing more to do with the drug.
Paxil’s clinical trials were a statistical sham. Rather than deal with real numbers, SKB created a fraudulent measuring standard called “patient years” (or “patient exposure years”). The need for “patient years” became obvious in the 1980s. It was obvious in the late 1980s and into the 1990s that Paxil clinical patients were attempting suicide and suffering “adverse experiences” at an alarmingly high rate. Moreover, as indicated above, hundreds of Paxil volunteers dropped out because they could not tolerate the drug. The dropout rate was 20%. 58 patients alone attempted suicide after they were given Paxil. Hundreds of additional Paxil patients suffered adverse experiences caused by the drug. In 1991, SKB “ran the numbers” and discovered the absolutely horrible Paxil record. The 58 attempted suicides out of the patient base constituted a suicide rate of 0.77% in real numbers. Under clinical standards, a rate of 1% is considered a “frequent” occurrence.On those numbers, Paxil patients approached a “frequent” suicide rate. This was a far greater suicide rate than “placebo” or the other active drug being tested on the patient population. To avoid a company disaster on the Paxil project, SKB had to change the rules, and shift to the “patient years” sham.
It works like this. Assume 366 patients are selected at random to test Paxil. 365 patients take Paxil and suffer horribly the first day–immediately quitting the test. These patients are called, not surprisingly, “losers”. The 366th patient, however, tolerates Paxil quite well, and even improves on the drug, staying in one or more trials for a full year. This patient is a “winner” by SKB standards. Like a champion race horse, this “winner” is entered in all the sweepstake trials for Paxil–and these trials are intentionally programmed to be long. Knowing they have a champion race horse, SKB racks up “points.” By anyone’s common sense standards, 365 failures out of 366 attempts would render the drug a dismal failure. But not so under “patient years”. Under patient years, the one Paxil patient who tolerated the drug for one year counts the same as the 365 patients who couldn’t tolerate the drug and dropped out the first day. The “score” in this example is “one patient year” for each side. Not surprisingly, the mathematicians who go along with this voodoo math are subordinate to the physicians and clinicians in the corporate chain of command, and the physicians at the top of the FDA chain of command.