Tuesday, January 16, 2007

The Latest On the Zyprexa Docs

From around the blogosphere, here’s what a few folks are saying about the latest Zyprexa developments. Below are quotes from various sites. Some may be reordered and I also provided only snippets. Go to the original posts for more. Any color highlighting is my addition, while italics are from the original authors.

Site: Measuring Up.

I thought I’d seen it all. But Judge Jack B. Weinstein, the presiding justice in the case against Eli Lilly and its hot selling antipsychotic drug, Zyprexa, showed me I hadn’t…

So how does he react? The judge tells this same lawyer that he needs to provide a list of every single recipient who received the “stolen” documents and collect all copies. On top of this, Judge Weinstein ordered that each of these 14 recipients communicate this injunction to everyone else who has since made copies, posted them to a web site or facilitated in the distribution of any information taken from the documents...

What planet is this judge from? It’s simply hilarious that this highly respected individual believes he can control the flow of this information after it has spread virally to thousands or points across the Internet. I’m not sure if he understands what the Internet is (or isn’t for that matter), but by executing this order, it has also made Eli Lilly look extremely foolish in the process. My guess is that most of the individuals who continue to distribute this information have absolutely nothing to do with Eli Lilly’s litigation and are probably passing on interesting fodder like this simply because of their interest in health related issues. Will he prosecute every ordinary citizen (including me) who has passed on the information at hand?

The genie is out of the bottle and no one can put him back. Legal issues aside, it’s time for Eli Lilly to focus on saving its reputation and come clean now.

Site: Health Care Renewal.

I cannot comment on the legal merits of the argument that the Eli Lilly memos about Zyprexa should not have been published.

It does seem to me that any effort to restrict discussion of the case by parties not involved in the case would be a serious general affront to free speech.

Furthermore, to make the best possible medical decisions for individual patients, the patients and their health care professionals need the best possible evidence about the benefits and harms of therapy. Thus, patients, health care professionals, and ultimately the public have a need to know about the benefits and harms of medications like Zyprexa, and about any attempts to suppress or manipulate such evidence by interested parties, particularly the medications' manufacturers.

Although I can appreciate Eli Lilly's interest in having a fair day in court, the company's attempts to corral documents that put its managers in an unflattering light do not enhance trust in how the company is run.

Site: More Health Care Renewal.

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. ] [BMJ quotes follow]

After the injunction was granted to Eli Lilly the documents rapidly disappeared from the internet. The company was given access to Dr Egilman's [a leaker of said documents] 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.' [end of BMJ quote]

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.

Site: Electronic Frontier Foundation. No quotes here. Contents from some of the legal docs are provided here. If you’re really serious about this case, this is a great resource. It’s the site from whence the above picture came.


Anonymous said...

Arthur Heller could no better than:

"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.'"

A judge can only require that individuals other than a company do not make a company's proprietary documents public. A company itself can make any and all of its internal memos public at any time. This is a idiotic as a battered wife claiming that a restraining order on her husband also means that she cannot approach within 300 yards of herself.

Some of the people at Lilly were once deemed to be pretty sharp. Either they need something like Zyprexa, or they're blowing deliberate nonsense at the BMJ about an issue that has already made it onto Page One of the Grey Lady.

Neither scenario makes Eli Lilly look all that good.

Anonymous said...

I am planning to testify. When I was a primary care rep, Lilly included pediatricians in our quota for Zyprexa - we raised hell and asked them to be pulled from our quota, as it was illegal to call on them for Zyprexa (no ped indication). It was 18 months before Lilly pulled out the peds - by not pulling them out of the quota, Lilly was forcing reps to sell off label to peds in order to meet Zyprexa quota. They knew exactly what they were doing.


This does not bode well for Lilly.