Comments: The Zyprexa Chronicles: Begging Questions
I'm surprised the story hasn't gotten much traction in the UK, since their regulatory agency also expressed concerns to Lilly about Zyprexa in 2002.
I'd be suprised if Jeanne Lezner didn't have an article in the BMJ by this summer. That may spark a new fire under the media's lethargic ass.
Posted by zipzip at February 21, 2007 01:14 PM
Philip--
I've mentioned before that the Lilly's Zyprexa troubles have roots in the rDNA insulin "non-problem." You ask: "Where the hell was the FDA."
Back then (rDNA insulin) approval was garnered in an unbelievably short timeframe for a product that was supposedly aimed to benefit only a few (those diabetics exhibiting allergic responses to natural insulins.) There was controversy about this FIRST genetically-engineered product, and, my understanding is that it gained approval when a second-tier decision-maker flouted his authority while the big boss was away. Subsequently, there have not been post-marketing studies, and the FDA's adverse-event-reporting system is such a farce as to be meaningless. Aggressive marketing turned this marginally-needed product into the "GOLD STANDARD" with the aid of the medical profession.
The "business model" designed around rDNA insulin blazed the trail for Lilly's subsequent offerings. Whether you speak of a lapdog FDA, a gullible and/or complicit medical profession, pseudoscientific educators, or uneducated/uninformed patients--the results are still quite predictable. The M.O is always to blame the disease, blame the patient . . . and if you get caught--settle, with an iron-clad nondisclosure agreement. Unfortunately, while Lilly has had some wrist slaps with their Oraflex, Prozac and now Zyprexa, no one ever spoke for insulin-dependent diabetics.
Posted by Melody at February 21, 2007 01:51 PM
BS"D
From these documents, would you agree or disagree with MindFreedom's attorney Ted Chabasinski that Lilly officials engaged in criminal behavior that is prosecutable by state Attorneys General or the Justice Department (not that the Bush Administration would ever go after a corporation with which it has close ties to and is a big GOP contributor)? There is a letter-writing campaign on to get some of these AGs to file criminal homicide charges against Lilly officials based on the content of these documents.
Zyprexa Kills
Lilly Lies
Lilly Profit$
More People Die
Posted by Stephen Mendelsohn at February 21, 2007 02:02 PM
In 1886, corporations obtained the rights of personhood through a Supreme Court decision.
In 1886, . . . in the case of Santa Clara County v. Southern Pacific Railroad Company, the U.S. Supreme Court decided that a private corporation is a person and entitled to the legal rights and protections the Constitutions affords to any person. Because the Constitution makes no mention of corporations, it is a fairly clear case of the Court's taking it upon itself to rewrite the Constitution.
Far more remarkable, however, is that the doctrine of corporate personhood, which subsequently became a cornerstone of corporate law, was introduced into this 1886 decision without argument.
If corporations have the rights of "persons" they should have the same responsibilities and the same accountability. It will be argued that a corporation is a conglomeration of shareholders and employees. BUT very few of those shareholders and employees make the decisions that ultimately harm others. Those who make the decisions should stand proxy for the corporation. If the behavior is criminal (willingly and knowingly harming others for profit), the punishment should fit the deed. Another alternative would be a "death sentence" for a corporation--no restructuring, no reincorporating under another name . . . just pink slips for all, employees and shareholders alike.
Posted by Melody at February 21, 2007 04:38 PM
I completely agree that the media is asleep at the wheel. I have a full-time job and blog on the side, yet I have reported more on the Zyprexa issue than ABC, NBC, CBS, Fox, and CNN combined. Not to mention all the print media except for the New York Times. I'm not saying that I've done a fantastic job on my site, though I AM saying that Philip has done a GREAT job here. This story has legs. Read the documents, read Philip's posts, read my posts, and ask yourself why there is not more reporting on this issue. Anna Nicole Smith? Seriously...
Posted by CL Psy at February 21, 2007 04:55 PM
Actually it's a little ironic you mention Anna Nicole Smith because, guess what? -- she almost certainly died of accidental psych drug poisoning -- serotonin syndrome -- exactly like her son and that really is not unrelated to the Zyprexa story. And, once again, the media doesn't put two and two together. Some day, hopefully, this will move from a couple of wonderful blogs to more mainstream media reporting. Maybe we should try and get Jon Stewart (sp?) to tackle the subject.
Posted by Sara at February 21, 2007 10:21 PM
Being that 'scandal' means "public outrage"; in my opinion, there is no other word to use.
Now, if only the public knew to be outraged; is another question.
Posted by Stephany at February 21, 2007 11:07 PM
I would respectfully disagree with your belief that the Zyprexa disgrace (scandal is too weak a word) is worse than the Prozac disgrace.
First of all, I would rather be an obese diabetic than dead.
When Prozac broke, Lilly offered the first plaintiffs to go to trial financial inducements to present a weak case, and then claimed that to have been vindicated. Depression and suicide tragically go hand in hand, and Lilly was able to harp on this connection and the FDA's reports to create reasonable doubt in the minds of juries. To my (somewhat informed) mind, the case against Prozac is much stronger than that against Zyprexa.
Juries, on the other hand, will not believe that gaining 100 lbs and becoming diabetic can be caused by an "episode." There is no reasonable doubt.
Back in the mid 80s, there were no blogs, no social networks and not even much talk radio; corporations controlled the flow of information. To my mind, NAMI is completely morally bankrupt. Depression also carried a much huger stigma than it does today.
I don't think Lilly would even dream about launching Prozac in today's environment; with Zyprexa on the other hand, they knew they were sailing into choppy waters, and did so never the less. Just look how Merck didn't even try to get the Texas legislature to sign off on their HPV vaccine, tried (desperately and futilely) to get it mandated by an executive order, and then ran away, with its tail between its legs with all hell broke loose.
20 years ago, industry would have hired its MD PhD cheerleaders, done a little cheering, and quietly moved it through the regulatory process.
I think the biggest question all this begs is "Are the United States a banana republic?"
Posted by lurker at February 22, 2007 04:21 AM
my point isn't that zyprexa is a worse scandal, simply that lilly has settled more cases for more money.
my point about the term 'scandal' is that the media often applies it to things that hardly rise to the level of 'news' much less scandal.
yes, i think the internet can make a real difference in all of this. we shall see.
Posted by Dawdy at February 22, 2007 08:46 AM