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 This is how Senator Ted Kennedy originally made his name and they are referred to as the Kennedy hearings.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

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.

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.

–
Daniel Haszard Zyprexa patient who got diabetes from it.

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