Lilly Fights Release Of Zyprexa Documents In Alaska
6 CommentsBy Ed Silverman // September 4th, 2008 // 7:20 am
In the latest twist in the complicated Zyprexa litigation, Lilly is asking an Alaska court to deny a request by Jim Gottstein, an attorney who was one of three people named as conspirators in the Zyprexa document scandal last year, to unseal some of the same documents that a federal court in New York ordered remain under seal.
The move came after Gottstein recently renewed his fight against a federal-court injunction. You may recall the lawyer, who runs The Law Project for Psychiatric Rights, a non-profit against forced drugging; David Egilman, who was an expert witness for plaintiffs’ lawyers suing Lilly, and a New York Times reporter were accused by US District Court Judge Jack Weinstein of violating a court order by scheming to publish sealed Zyprexa documents.
Since then, Lilly and Alaska settled a lawsuit for $15 million in which the drugmaker was accused of failing to properly warn the state’s Medicaid program and healthcare providers that its Zyprexa antipsychotic could result in weight gain, high blood sugar and diabetes. More recently, Bloomberg News succeeded in convincing an Alaska court to unseal various documents, which Gottstein posted on his web site.
Now, though, Lilly is trying to prevent still more documents from being unsealed, even though these have been circulating on the Internet for more than a year (look at Furious Seasons for a peek). Why? Lilly is arguing that since Gottstein was already sanctioned for “illegally” leaking these documents by a federal judge, then the state court in Alaska shouldn’t honor his request for the documents.
“Granting this application would have the unintended - but nevertheless real - effect of nullifying, in part, Judge Weinstein’s efforts to enforce his orders, and would allow Mr. Gottstein to effectively modify an injunction entered as a result of his willful violation of another court’s order,” according to Lilly’s lawyers. “…This Court should not accept Mr. Gottstein’s thinly veiled invitation to enter the MDL proceedings, and provide him with a convenient bootstrap argument or free pass to evade the injunction against him.” Here is the Lilly brief.
Hat tip to Furious Seasons
Salmon
Very interesting. However the dates on the titles are mid 1998 and 1999.
If you look at the 1998 and 1999 PDRs there was already some mention of this and Lilly had already been paying for ads for diabetes educaton right at the end of the labeling for Zyprexa. Even their positioning in the PDR is arranged by the drug company.
It looks like Lilly was concerned even premarketing and was trying to use it to increase sales of their other products, otherwise why have an ad placement for diabetes where primarily psychiatrists are looking. This tends to be confirmed by the 1999 discussion of animal data and effects relative to clozapine and other antipsychotics. These studies would likely have been done premarketing.
Having looked at the original review documents on FDA’s website (drugs@fda) I think there are much more serious problems with Zyprexa and Symbyax (Zyprexa and Prozac) than the diabetes, and Lilly and the FDA know about it and are covering it up. I will be communicating with state attorney generals in the near future.
Salmon
Daniel Haszard
Zyprexa has generated a lot of bad press for Eli Lilly and they still have unresolved Zyprexa settlement claims.
Eli Lilly is ‘reaping the whirlwind’ for aggressive marketing of Zyprexa that has caused suffering and deaths.
Zyprexa is being avoided by doctors they aren’t prescribing it for new patients at all anymore.
–
Daniel Haszard Zyprexa patient who got diabetes from it.
Jenny
Throw the corporate bums out!
The now notorious Zyprexa diabetes connection is elaborated at thousands of pages on line.
My own local clinic and clinics everywhere have stopped dispensing Zyprexa except as a PRN for acute cases.
Eli Lilly’s zyprexa gravy train will stall soon enough.
Melody
Daniel–
Welcome to the club called “diabetes.” Those same good folks who brought you Zyprexa are the American “manufacturer” (more or less) of the rDNA insulin you may be using to “manage” your diabetes. Too bad that you never had the opportunity to try natural animal insulins . . . which were “unpopular” (read that as–not nearly as profitable as rDNA synthetic insulin). You may want to visit a site like http://www.alliesvoice.com/ to get a flavor of how diabetes treatment (as presented by the current insulin cartel) is not necessarily the be-all, end-all.
Many of us have recognized how fortuitous it is for Lilly that they can promote Zyprexa; if a patient then develops diabetes, they are johnny-on-the-spot to provide diabetes medications. (Incidentally, they are also big on offering Prozac–since ALL diabetics apparently experience depression.) What a company–it just keeps on giving.
Meg
Thanks for your work, Salmon. You might add that Japan and the UK, in the Spring of 2002, required Lilly to place black box warnings for diabetes, hyperglycemia, and death while the FDA did its usual nothing. Also, there is an early article on AHRP archives zyprexa 3-03 from the Baltimore Sun showing the FDA’s obfuscation as well as Lilly’s.
Salmon
Daniel this is not the first time that Lilly has rushed to promote a drug that had serious repercussions.
In 1981 or 82 Lilly instituted the very first direct to consumer (DTC) advertising campaign for the nonsteroidal antiinflammatory drug benoaprofen (Oraflex) what happened was a lot of rapid use (especially in the elderly) and a number of deaths in the elderly, in particular patients who had both decreased renal and hepatic function. This resulted in withdrawal of Oraflex from the market.
Just prior to this in the 1970’s Lilly had an almost 10 year headache over their use of prisoner’s testing drugs in phase I studies with the question of was this true informed consent. Since Indianapolis has a large black population these prisoner’s were mainly black and this occurred a few years after the public became aware of the Tuskegee syphillis experiments. This is how Senator Ted Kennedy originally made his name and they are referred to as the Kennedy hearings.
Just a year or 2 ago Bob Temple the Director for Medical Policy gave an interview in an FDA Newletter News Along the Pike(available via FOI) where he said that the current scandals would blow over just like the Kennedy Hearings did and nothing ever came of them which he agreed with. His statement is misleading as Lilly stopped using prisoners on their own around 1980 due to the bad publicity, and although the hearings stopped HHS policies on the ethics of using prisoners in drug trials were issued.
I personally find it repugnant that the FDA’s Director of Medical Policy indicates that he personally doesn’t believe in the policies that he’s supposed to be in charge of enforcing. Especially such basic medical ethics such as not using prisoners which was established as a consequence of the Nuremberg trials and as a requirement of all international good clinical practice standards including the World Health Organization standards that the US and FDA is a signatory to.
I believe there have also been other large public instances of major ethical problems with Lilly over the decades but the examples escape me right now.
Salmon