Lilly Updates Zyprexa Warning Label
10 CommentsBy Ed Silverman // October 5th, 2007 // 9:04 am
Interesting timing. The drugmaker will include new warnings for weight gain, elevated cholesterol and hyperglycemia. This comes just as Lilly is seeking FDA approval to market the antipsychotic to teens. Then there are those mounting lawsuits filed by various states that accuse the drugmaker of improperly marketing Zyprexa because side effects - weight gain and diabetes - allegedy weren’t disclosed properly.
There’s also ongoing litigation in federal court in New York, where consumers are suing over those same side effects. In fact, Lilly is trying to convince a federal judge in California to delay a whistleblower suit filed by a former employee, who charges the drugmaker marketed Zyprexa for off-label uses. Lilly wants the whistleblower suit combined with the New York litigation and there’s a Nov. 9 hearing. Lilly already settled thousands of claims with individual consumers for nearly $1.2 billion, by the way.
In a statement today, Lilly says the updates “reflect recently completed pooled analyses of Lilly’s clinical trial data in adults and adolescents, information from two large non-Lilly studies of atypical antipsychotics (CATIE and CAFE) and discussions with the FDA.” The new labeling data, which will also be made to the Symbyax bipolar disorder treatment, would specifically include info on the risk of higher blood sugar levels with the drugs compared with other antipsychotics.
“Today’s communication is part of Lilly’s historical and ongoing commitment to inform doctors and patients about updated prescribing information,” says Sara Corya, Lilly’s global medical director. And in fact, Lilly argues it has reported higher blood sugar levels, cholesterol levels and weight gain as side effects since Zyprexa was approved in 1996. Well, not everyone agrees with this. Perhaps, the litigation will illuminate the public’s understanding of just how much side-effect info was known and thoroughly disclosed.
HG
This may well be the perfect example of why we need both civil liability and FDA reguation as a _dual_ system of consumer protection, which is still the case in every state except Michigan.
In other words, it is one of the best cases recently that argues against “FDA preemption.”
Ask yourselves how long it might have been before Lilly changed Zyprexa warnings if there were no lawsuits whatsoever, and we were entirely dependent on waiting for action by the FDA . How long would that have taken?
I don’t think a reasonable person could answer other than, “till Kingdom come.”
Casual Observer
I think you make a good point, HG, but at the same time, as we take greater feats in regulation and civil lawsuits, big pharma companies like Lilly have fewer incentives to push much-needed drugs through the pipeline. I’m not by any means advocating that they falsely advertise, but the truth of the matter is, punishing a company for bringing a drug like Zyprexa to the market does consumers more harm than good.
Hank
Appreciate the thought, CO. Of course, no one is punishing Lilly for creating Zyprexa. Despite rumors of “jackpot justice,” it is extremely difficult to win a “failure-to-warn” or “fraud” case - as the Vioxx saga so far tells us. .
Companies that play by the rules have very little to fear. Consumers have a great deal to fear from companies that do not.
The history of both regulation and civil liability (as I read it) suggests that consumers’ confidence in those safeguards (and disincentives for delinquency) has been very good for companies’ bottom lines. Preemption, on the other hand, is a DTC ad that says “We can’t be trusted.”
Re: the industry as a whole, I don’t agree with that conclusion. But I think that’s how it plays.
An Updated Zyprexa Warning Label - World of Psychology
[...] including weight gain, higher blood sugar, metabolic problems and higher cholesterol. You can read Pharmalot’s take on the announcement, as well as the New York Time’s news article: Internal Lilly documents [...]
Laurie
“Companies that play by the rules have very little to fear.”
This is the bottom line. With Zyprexa, the side effects have been known for years, but Lilly’s all out effort to block that information from being made public is a huge problem. Trust of drug companies is at an all time low. The ball is in their court to correct that image, which can only be done with complete disclosure of risks.
Lauren
I don’t understand why there are not criminal cases against Eli Lilly considering the number of people who are dead or permanently chronically ill with diabetes. In fact, I don’t ever recall a Pharma going to jail. In the case of Zyprexa, the internal documents are there for all to see, with names included. Why isn’t this happening? In the Enron case, all that was involved was money. In this case, we are talking about loved ones who died due to the drug. And will continue to die.
Hank
Lauren - Your question happens to be something I’ve looked into.
As you suggest, criminal cases against pharma companies as companies (as opposed to individual employees) have been extremely rare over the years. Most that have occurred have been triggered by whistleblowers; most notably, the Neurontin off-label case of a few years ago, in which Pfizer (which had acquired Warner-Lambert) ended up paying $430 million in civil and criminal penalties. Ironically or not, Neurontin sales only continued to grow after the convictions, so from a “cost of doing business” perspective, it was probably a wash (at worse).
As far as “failure to warn” convictions, there are virtually none in the past twenty-five years. The most egregious probably go back to the 80s and concern the drugs Oraflex and Selacryn. The Justice Dept. decided not to pursue “intent,” and so there were very small fines for misdemeanor rather than felony fraud in both cases. From the perspective of many of those involved, there was little question that the unreporting of fatalities in pre-approval trials was no “accident.”
This issue ties to the question of FDA preemption since those who argue for it often say that companies that commit fraud or the like will still be accountable to the FDA/Justice Dept. even if not to civil action. That leads to the obvious question of how often, in fact, have companies ever been so held accountable.
Answer: Almost never.
Simon Passanante - Finally, the Zyprexa warning label is updated
[...] Pharmalot reports that Eli Lilly is updating the Zyprexa label to include warnings for weight gain, elevated cholesterol and hyperglycemia. [...]
Kellen’s Corner » Blog Archive » The Dangers of Mood Stabilizers
[...] simultaneously applying for permission to market the drug for teens, according to this article in Pharmalot. I cannot fathom why. I can only hope that patients and the parents of patients look up the [...]
ErnestR
Maybe severe weight gain and diabetes aren’t the worst Zyprexa has to offer. Has anybody noticed an increase in suicidal or homicidal ideation associated with taking Zyprexa? I am seeing more and more stories of teens and young adults on anti-psychotics for bipolar, autism and Asperger’s turning violent and attacking or killing their parents and/or friends and neighbors. This never used to be common. These are not just suicides but multiple murders followed by suicide or attempted suicide much like what is happening with these school shooters on anti-depressants.