It’s called “Study 329.”
And as far as Sara Bostock is concerned, it killed her daughter.
Cecily Bostock had only been taking the antidepressant Paxil for a couple weeks when she plunged a knife into her own chest.
Like millions of other children and young adults, Cecily had been prescribed Paxil based on GlaxoSmithKline’s Study 329 — a clinical trial that supposedly proved the drug was safe and effective for younger patients.
But a new analysis is proving that this study was based on fraud, deception and outright lies.
It was part of a plot to make GSK billions — no matter how many young lives were lost in the process.
The RIAT actResearchers are now calling Study 329 one of the worst cases of drug company misconduct in medical history.
And if you ask me, that’s putting it lightly. Because this “misconduct” has put millions in harm’s way over the past decade and a half.
You see, when Study 329 was published in 2001, it was designed to prove that Paxil could be safely taken by kids and younger adults. But the drug didn’t work any better than a placebo, and even the FDA called it a “failed trial.”
And that’s when the GSK spin machine kicked into high gear. The company launched a massive campaign of lies — right under the FDA’s nose — claiming Study 329 proved Paxil was effective for younger patients.
The claims were so outrageous that the company even had to pay $3 billion in penalties after the New York State Attorney General’s Office hauled GSK to court.
But by then the damage was done. Doctors all across the country had drunk the GSK Kool-Aid and were prescribing Paxil to millions of adolescents.
And it turns out that, in some cases, docs were handing these young patients a death sentence.
Through a unique program called RIAT — which was started a few years ago by leading medical journals and stands for “restoring invisible and abandoned trials — researchers have begun analyzing 77,000 pages of raw data on Study 329.
And they’ve found damning evidence that GSK may have tried to cover up evidence of suicides and other risks for young patients who took Paxil.
Talk about blind greed!
The data revealed that adolescents in the trial who attempted suicide (such as one who took 80 Tylenol tablets) were deliberately misclassified using strange coding methods or filtered from the results completely.
Adverse events were even lumped together so they appeared less obvious. And in many cases, reactions to the drug were never even added to the trial’s records.
And here’s the kicker — it turns out that Study 329 wasn’t even authored by the 22 prestigious doctors whose names appear on it. It was written by a PR firm hired by GSK.
It’s clear that GSK was hellbent on making a fortune off of Paxil — even if it had to hide the deadly risks from doctors and patients. Risks that may have cost Cecily Bostock and other patients their lives.
We saw just this week how the owner of a peanut butter company was sentenced to 28 years in prison for knowingly causing a salmonella outbreak. And if you ask me, someone from GSK ought to end up in handcuffs over Study 329.
And scientists are now demanding that Study 329 be permanently retracted and that GSK admit it was bogus from the start. Well, good luck with that.
As a BMJ editor noted, “no correction, no retraction, no apology, no comment” have been offered by either GSK or the academics involved.
No surprise there, right?
And while GSK and the Feds might not be doing a thing to keep Paxil away from children and young adults, there’s plenty you can do.
If there’s a young person in your life who has been prescribed this killer — and many are still getting the drug and its generic version paroxetine every single year — schedule a doctor’s appointment right away.
And in the meantime, always be on the lookout for sudden behavioral changes. Because this fraud has already claimed enough victims, and you don’t want someone you love to be next.
“The human cost of a misleading drug-safety study” David Dobbs, September 18, 2015, The Atlantic, theatlantic.com