In 2007, patients were suing the pharmaceutical company Eli Lilly, claiming that its antipsychotic drug olanzapine (trade name Zyprexa) had caused dramatic weight gain and diabetes. As an expert witness for the plaintiffs, David Egilman, now Clinical Professor of Family Medicine at Brown University, when reviewing company documents found emails implying that Eli Lilly knew of the danger but had tried to play it down. He called Jim Gottstein, the author of this book, because Alex Berenson, a reporter for The New York Times had suggested to Egilman that Gottstein might be willing to subpoena Egilman so that Egilman could legally send the secret company documents to Gottstein to forward to Berenson. Gottstein had previously been involved in litigation concerning Zyprexa in which a client of his was resisting efforts to drug her with Zyprexa against her will.

Gottstein, an Alaska lawyer, is President and CEO of the Law Project for Psychiatric Rights (PsychRights), a public interest law firm whose mission is to mount a strategic litigation campaign against forced psychiatric drugging and electroshock. He was detained in psychiatric hospital himself aged 29 for a psychotic illness and had a short hospitalization a few years later, but has recovered and the only psychotropic medication he now takes is very occasional night sedation. 

As the Zyprexa papers were subject to a secrecy order and Eli Lilly were said not to have been given sufficiently reasonable opportunity to object, the Court regarded both Egilman and Gottstein has having illegally conspired to release the papers. They both feared criminal charges and Egilman came to a financial settlement with Eli Lilly for contempt. Gottstein says in the book that he is pretty sure the agreement included Egilman not being able to communicate with him, as Gottstein has never since received replies to telephone calls or occasional emails. 

Meanwhile The New York Times had already published articles that included indications that Eli Lilly had told its sales representatives to play down its own data linking Zyprexa to obesity and increased blood sugar levels in conversations with doctors; provided information to doctors about the blood-sugar risks of Zyprexa that did not match data from its review of its first clinical trial results; and promoted Zyprexa for unapproved off-label uses, such as dementia. Eli Lilly continued to deny that Zyprexa caused diabetes even though Zyprexa-associated weight gain is a major risk factor for diabetes. The Zyprexa papers suggested that Eli Lilly was aware of Zyprexa’s links to obesity and high blood sugar at least since 1999. In fact, olanzapine causes more weight gain than all other second-generation antipsychotics except clozapine. Eli Lilly only admitted in 2007 that olanzapine causes more weight gain than other atypical antipsychotics. The average weight gain after 6-8 weeks taking olanzapine is 5-6 kg, which is significantly higher than the average weight gained, for example, while taking risperidone (4 kg) or haloperidol (3 kg). The Japanese government had required Eli Lilly to issue a warning about Zyprexa causing diabetes in 2002, which caused a 75% drop in new patients, but US doctors were not given a similar warning at that time.

Publication of the Zyprexa papers led to the Food and Drug Administration (FDA) investigating why it may not have been provided with necessary safety information by Eli Lilly. In 2003, the FDA had warned that second-generation antipsychotic drugs could cause high blood sugar, but didn’t specifically mention Zyprexa. A label warning was added in 2004 regarding an increased risk of diabetes. 

The papers also reinforced the claims of illegal marketing in federal courts against Eli Lilly for fraud. As far as off-label prescribing is concerned, the momentum created by the Zyprexa papers eventually led to a $1.4 billion settlement of criminal and civil charges against Eli Lilly to the federal government and over $290 million to state governments, one of the largest ever off-label prosecutions against any drug company. The evidence is that these settlements have not in fact reduced off-label prescribing of olanzapine. Eli Lilly only pleaded guilty to one misdemeanour of illegal marketing for dementia, but the Zyprexa papers also provide evidence of marketing for subsyndromal bipolar disorder. 

Eli Lilly never admitted to civil allegations and arguably has not been sufficiently punished for failing to properly inform people about the risks of weight gain with olanzapine. This is despite payouts amounting to $billions to tens of thousands of people. Zyprexa’s global sales have been many $billions more than this.

Secrecy agreements are commonly part of settlements of claims against drug companies but should be in the public interest. Secrecy orders shouldn’t also be used to hide illegal marketing. Association with such illegality must raise concern about the ethics of psychiatric and medical practice in general. This corruption influences academic debate about diagnosis and treatment. It’s all very well for psychiatrists to blame the pharmaceutical companies but they do need to acknowledge their own institutional corruption.

This book also describes details of the case of Bill Bigley that Gottstein used to subpoena Egilman. Gottstein gives a very honest portrayal of all the convoluted legal shenanigans in relation to the disclosure of the Zyprexa papers. He says that one of the aims of writing the book was to show the truth, from his point of view, that locking people up and drugging them against their will is harmful. The book is dedicated to Bigley.

I found the detail of the book rather overinclusive, making what could be an interesting account in fact quite boring. Nonetheless, Gottstein clearly should be praised for his bravery in standing up to Eli Lilly. He may overestimate the clinical harm caused by olanzapine, although weight gain is a serious side-effect and doctors should properly warn patients of the risk. I’m not convinced they do, even now. Nonetheless, helping to reveal the over and illegal marketing of Eli Lilly is a worthy end that justified the means, despite any unfairness in how Gottstein was treated by the legal system and the significant costs for him personally. This book deserves to be more widely known.

© 2020 Duncan Double

Duncan Double is a retired consultant psychiatrist. He blogs on critical psychiatry at http://criticalpsychiatry.blogspot.com.

Categories: Medications, Psychiatry

Keywords: zyprexa, medication, ethics