"Missing" Drug Company Documents Cause Alarm
Hear that sound? That's the sound of whistles blowing. Last November, an FDA insider made headlines when he told Congress that the FDA was lax in publicizing the dangers of Vioxx and several other high profile drugs. But as disturbing as that testimony was, it pales in comparison to a much more shocking revelation that shows just how callous and self-serving the drug industry can be when the dangers of a cash cow drug are covered up to protect profits. Paint this one a dark shade of greedy green.
You've got to love the pulp fiction sound of this: The British Medical Journal (BMJ) recently received some "missing" drug company documents. They were sent from an anonymous source. And no doubt they arrived on a dark and stormy night. According to reports from the BMJ, the documents indicate that more than 15 years ago, executives of Eli Lilly were fully aware that Prozac use increased the risk of suicide and violence. The fact that the information in these documents was not reported is bad enough. But that's only part of a larger story that includes a secret deal and some convenient rubber-stamping from an FDA panel.
Probably none of this would have come to light if it weren't for a 1989 tragedy in which a young Kentucky man named Joseph
Wesbecker killed eight of his co-workers, wounded a dozen, and then turned his gun on himself. He had been taking Prozac for a month prior to the shooting. The victims of the incident eventually brought a lawsuit against Eli Lilly, charging that the company had withheld clinical trial data from the FDA that found nearly 40 percent of patients who used Prozac reported new "activating" symptoms that include agitation, mania and hostility. Lilly actually won that case. Executives later crowed that Prozac had been proven to be safe and effective "in a court of law."
Case closed? Not quite. According to the BMJ, the judge who presided over the case smelled a rat. Years later, in 1997, he got Lilly execs to admit that they pulled an end run and brokered a secret settlement with the plaintiffs. The judge changed the verdict to read "settled with prejudice," and stated that Lilly had "sought to buy not just the verdict but the court's judgment as well." And if you're thinking, "Gee, how low can this go?" here's the answer: even lower.
Whoever sent those internal Lilly documents - "missing" from the Wesbecker case - to the BMJ was apparently aware that sending
them to the FDA would be like sending them from one oblivion to another. But wait - the FDA is supposed to be our drug safety
watchdog, right? Yeah, right.
The FDA granted the approval for Prozac in 1987, just two years after Germany refused to license the drug because of "suicidal
risk." Feeling some pressure a few years later, in 1991 the FDA appointed a scientific advisory panel to study the suicide risk
of Prozac. The panel's verdict:
No link to suicide. But some FDA insiders didn't agree with the results. And guess what? Several of the experts who served on
the panel has financial ties to - yep - Eli Lilly!
So here we are, 20 years after German scientists found a Prozac/suicide link, 16 years after young Wesbecker went on
a killing rampage, eight years after a judge took away Lilly's claim about Prozac being found safe in a court of law, and NOW
here's what an FDA spokesperson has to say to USA Today about that 1991 verdict from the advisory panel: "To date we
have not seen anything that would lead us to question the conclusions."
FDA officials are still reviewing the documents that were supplied to the BMJ. To say the least, it will be very interesting to see
how they react to this damaging information that's still a smoking gun, nearly two decades old. And in spite of sticking to their 1991
advisory panel conclusion, they can't really be too shocked. The agency has received many thousands of adverse reaction
reports concerning Prozac; more than any other drug in the agency's history.
Sources:
"Documents Missing From a 10 Year Old Murder Case Sent to the BMJ"Jeanne Lenzer, British Medical Journal, Vol. 329,
12/11/04,bmj.bmjjournals.com
"FDA to Review 'Missing' Drug Company Documents" Jeanne Lenzer, British Medical Journal, Vol. 330, 1/1/05
"Psychiatrist: Company Hid Prozac, Suicide Link" Marilyn Elias, USAToday, 1/5/05, usatoday.com |
