Friday, January 12, 2007

Eli Lilly Threatens Zyprexa Whistle-Blowers with "Very Severe" Sanctions

We previously posted (here and here) about allegations in a New York Times series that Eli Lilly had used questionable marketing tactics to promote its atypical anti-psychotic drug Zyprexa (olanzapine), and especially that the company had suppressed information suggesting that the drug had more adverse effects than previously reported.

The latest issue of the British Medical Journal featured a news article by Jeanne Lenzer about how Lilly has tried to suppress publication of the internal memos on which the Times based its series. [Lenzer J. Drug company tries to suppress internal memos. Brit Med J 2007; 334: 59. ]Lenzer wrote,


The drug maker Eli Lilly instigated legal action against a number of doctors, lawyers, journalists, and activists over hundreds of internal corporate documents and emails said to have been obtained by them regarding the antipsychotic drug olanzapine (Zyprexa). Eli Lilly obtained a court injunction on 29 December ordering 16 individuals and organisations to stop publishing the documents and to remove any copies posted on the internet.

The documents created a furore after they were leaked to the New York Times, which reported that they showed that Eli Lilly "engaged in a decade-long effort to play down the health risks of Zyprexa" (www.nytimes.com/2006/12/17/business/17drug.html).

Eli Lilly disclosed the internal documents to the attorneys for the plaintiffs in a pending class action suit in the US District Court for the Eastern District of New York, but they remained confidential. However, Jim Gottstein, a lawyer representing a client in a separate court case in Alaska complaining about the coercive use of antipsychotic drugs, subpoenaed the documents from David Egilman, a prominent occupational health expert and an expert witness in the New York class action suit.

Alex Reinert, attorney for Dr Egilman, said that his client did not violate the law in releasing the documents under subpoena to Mr Gottstein. Mr Gottstein, who acknowledges giving the documents to the New York Times, said that he didn't violate the law as he was not a party to the confidentiality agreement issued in the New York class action suit.

After the injunction was granted to Eli Lilly the documents rapidly disappeared from the internet. The company was given access to Dr Egilman's computers for three days for 'forensic examination'; and Mr Reinert said that Eli Lilly has indicated that it wants to seek 'all possible sanctions' against Dr Egilman. The consequences, Mr Reinert said, 'could be very severe' and could conceivably extend to compensatory damages and time in jail.

Mr Gottstein said that Eli Lilly has also warned him of possible 'disciplinary action at the bar.'

Eli Lilly, in email messages to the BMJ, states that it is pursuing action because 'these individuals have violated a federal court order by leaking the documents' and that it has not released its internal documents publicly because the company 'has no intention of violating that order by releasing documents ourselves.'

It added, 'We intend to try the remaining cases in court—not in the news media.'

Eli Lilly also states that 'documents that have been illegally leaked to the New York Times are a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process. They do not accurately portray Lilly's conduct.'

The leaked documents, says the company, were "only a few hundred of the 11 million pages" and had been "carefully selected by the ‘leakers' to tell a story that the ‘leakers' want them to tell."

Eli Lilly's statement to the BMJ continued: 'These documents do not in any way represent an accurate view of Lilly company strategy or activities. What these individuals are not likely to show you is the millions of other pages of documents demonstrating how Lilly and its employees have worked to improve the lives of people with schizophrenia and bipolar disorder.'


This is a chilling development. It seems to me that patients, physicians, and the public ought to know whether Lilly marketed Zyprexa honestly, or whether it sought to deceive, and particularly whether it sought to suppress or manipulate data from trials on patients who thought that the information about them was to be used for the advancement of science, not commercial marketing purposes.

Lilly, of course, has a right to explain its actions, and defend itself from any allegations about its conduct.

But for a drug company to threaten whistle-blowers with "very severe" sanctions, including jail time, in a case like this does not exactly inspire confidence in their commitment to transparency, or to putting the welfare of patients, particularly patients in drug trials, ahead of marketing concerns.

3 comments:

Anonymous said...

The ability to bury someone in legal fees and threats is an old tried and true means of assuring compliance. We should all be concerned when this is the corporate policy of any company who has a stake in our health and welfare.

We learn in an AP story published Jan. 12, 2007 that an anesthetized dog was used in a sales demonstration of a medical device to treat a brain aneurysm. While the Cleveland Clinic condemned this action, and is investigating, one has to question the integrity of any institution where this could occur. This is not the first question raised about this institution and it's profit making endeavors.

The callous destruction of this animal shows there are no limits in selling a new product. Without protection, how will those who know of such atrocities be able to speak freely?

Steve Lucas

DanielHaszard said...

At a glance,zyprexa was promoted 'off label' to uses that weren't FDA approved.This opens up a can of worms for patients like myself took it for PTSD for which it was ineffective and moreover gave me diabetes.

True,leaked documents don't convey the 'whole picture' but what is compelling is that zyprexa is the 7th some say 5th largest drug sell in the world and Eli Lilly's #1 drug sale by their own admission.
This is for a drug that won't get you "high" cost $2.50 a pill and only indicated for less than 1% of the population.

Hello! Somebody in Lilly land is pushing zyprexa hard-Daniel Haszard

Ted P said...

The suggestion that Lilly cannot disclose the documents itself because of the confidentiality order is absurd. Under the order, Lilly can designate or un-designate as confidential any of its own documents at any time. It shows how much Lilly has to hide.