Shocking information has surfaced that once again reinforces Big Pharma’s greed and do-anything-to-sell approaches. After a review of pharma giant SmithKline Beecham’s (now GlaxoSmithKline) popular 2001 study that touted the adolescent antidepressant Paxil as effective, it was found that the drug wasn’t safe after all. Nevertheless, the greedy show must go on, right?
Here’s the deal.
The 2001 study, which was referred to as Study 329, was funded by GSK. Nothing like objectivity when funding your own research and providing findings to key journals and the people who will be taking your pill. Their information stated, “This study supports that paroxetine is beneficial in treating adolescents with major depression…” and the rest is history. Paxil, which is chemically known as paroxetine, was a must-have among depressed youngsters. Through the years, however, concern grew about the drug’s safety; people were becoming more depressed and exhibiting suicidal behaviors and violent tendencies, which was the complete opposite of what the drug was supposed to accomplish.
It’s no wonder a reanalysis of the initial study, which was recently published in the journal BMJ, found Study 329 to be riddled with flaws, including downplayed information and mislabeled details. In other words, Paxil was deemed unsafe and ineffective after all, providing an eye-opening dark side to something so many people were relying on to improve their mental health.
Reanalysis of initial Paxil study filled with flaws, involved use of public relations ghostwriters
The BMJ reanalysis stated that “…there were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group…” Its conclusion was as follows:
Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs. Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative. The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.
The mess goes on. It turns out that the folks at GSK thought it would be a grand idea to hire a public relations firm to ghostwrite Study 329. Why? They were well aware of the problems it posed for adolescents, so they scrambled to cleverly wordsmith the findings to make it appear safe for use. The report was then provided to doctors, spurring the off-label use of Paxil, which GSK was ultimately fined for.
Boston Globe‘s Ed Silverman explains the greed that keeps the industry going. “Beyond matters of constitutional law and governmental oversight,” he writes, “the pharmaceutical industry is clearly angling to boost prescription sales. Of course, this would fatten bottom lines, a good thing if you happen to be a shareholder.”
That’s just half of the story.
Yes, it gets worse.
It turns out that Paxil was not FDA-approved for use in adolescents. GSK glossed over that important detail and instead involved themselves in a massive marketing campaign geared towards doctors. Did it work? You bet. In fact, it was so convincing that in just 2002 alone, 2 million Paxil prescriptions were written. Between the well-worded Study 329 and the marketing efforts, many doctors were happy to be on board.
GSK: referring to original study as “misreported” is “wrong”
What does GSK have to say about all of this?
Like a bully who can’t admit to wrongdoing and must appear big and strong in the public eye while likely having sleepless nights, GSK has taken the defensive route. Along with other team members, Dr. Martin Keller of Brown University, who led the original research says, “In summary, to describe our trial as ‘misreported’ is pejorative and wrong.”
The shameful deceit that has gone on already and continues to this day by like-minded corporations must end. Are large bank accounts and prestige among shareholders really what life is all about? Wealth over health? Human lives are at stake here, and deliberately toying with the physical and mental health of others by engaging in fraudulent behavior is nothing to be proud of.