May 11, 2008

Eli Lilly Zyprexa diabetes cases

Eli Lilly Settles Zyprexa/Diabetes Cases for $690 Million

On June 15, 2005, Eli Lilly & Co., the manufacturer of the antipsychotic drug Zyprexa, settled an estimated 8,000 lawsuits pending in the United States concerning its alleged failure to warn about the risk of Zyprexa causing diabetes. The company agreed to pay $690 million but denied any wrongdoing.

Although Eli Lilly claims it has done nothing wrong, under the rules of the settlement agreement the company will be allowed to seal all of the critical documents, making them unavailable to other attorneys, health professionals, or the public. If Eli Lilly wants to demonstrate its innocence, it should make public all of its internal documents relating to how much it knew, or didn’t know, and how much it continues to know, about Zyprexa causing diabetes and pancreatitis.

Dr. Peter Breggin was one of the medical experts who evaluated cases on behalf of the plaintiffs, including cases in which individuals died of acute diabetic coma or pancreatitis while being treated with Zyprexa.  With 8,000 cases involved, Dr. Breggin made a relatively small overall contribution by reviewing a few cases.  However, in all the other 70 or more cases described on the Home Page under Legal Cases and on the Legal Page, Dr. Breggin was the key psychiatric expert and sometimes the only expert, and performed as a consultant to the attorneys.

Dr. Breggin has been involved as a scientific expert for the plaintiffs in many lawsuits against Eli Lilly in regard to both Prozac and Zyprexa. The Prozac cases have involved the drug’s capacity to cause severe mental and behavioral abnormalities, including mania, suicidality, and violence. The Zyprexa suits have mainly concerned the production of life-threatening diabetes and pancreatitis, as well as tardive dyskinesia (permanent drug-induced abnormal movements).

Recently another Eli Lilly drug has come under scrutiny concerning its potential for causing suicide. Cymbalta (duloxetine), a new Eli Lilly antidepressant, is currently under FDA investigation in regard to possible drug-induced suicidality. The drug was approved by the FDA despite a controversial, highly publicized suicide that occurred during the controlled clinical trials used for FDA approval.

Earlier this year, news reporter Jeannie Lenzer of the British Medical Journal released documents concerning unpublished in-house Eli Lilly data indicating that Prozac (compared to placebo and to an older antidepressant) caused an increased suicide rate in controlled clinical trials. [An Examination of Eli Lilly and Co’s Contention that the BMJ Prozac Documents were Never Missing and Have No Significance (PDF)]

Dr. Breggin has written extensively about Eli Lilly and especially Prozac in Talking Back to Prozac (1994), Brain-Disabling Treatments in Psychiatry (1997, updated and revised 2008) and the Antidepressant Fact Book (2001). Especially in Brain-Disabling Treatments, Dr. Breggin has discussed how Eli Lilly has suppressed data about the risk of Prozac-induced mania, violence, and suicide — allegations that the drug company continues to deny, usually without actually addressing Dr. Breggin’s data.