Monday, January 15, 2007

Unringing the Zyprexa Memos Bell

We previously posted (here, here and here) about allegations in a New York Times series that Eli Lilly and Company 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, and then how the company tried to restrict publication of the internal memos on which these allegations were based.

The New York Times has continued its reporting on the subject,

It all began with Dr. David Egilman of Massachusetts, who was a consulting witness in ongoing litigation against Lilly. Dr. Egilman had in his possession a trove of internal Lilly documents — not all of them flattering to the company — sealed by the court as part of that litigation.

Comes James B. Gottstein, a lawyer from Alaska, who was pursuing unrelated litigation for mentally ill patients in his state. He somehow got wind (and precisely how is the subject of separate legal jujitsu) that Dr. Egilman had some interesting documents.

Mr. Gottstein sends Dr. Egilman a subpoena for copies. Hell begins breaking loose.

In a letter dated Dec. 6, Dr. Egilman informed Lilly’s lawyers, as was required by the order sealing the documents, that he had been subpoenaed. Lilly’s lawyers expressed their deep displeasure in a Dec. 14 letter to Mr. Gottstein, and politely told him to back off. In a response a day later, Mr. Gottstein informed them, among other things, that it was too late, and that some of the material had already been produced.

It seems Mr. Gottstein was also apparently in a sharing mood, which is how hundreds of pages ended up with a Times reporter, Alex Berenson — and about a dozen or so other individuals and organizations.

United States District Judge Jack B. Weinstein ordered Mr. Gottstein to provide a list of recipients to whom he had distributed the contraband pages, and to collect each copy back.

The Times, which politely declined to oblige, has since been left out of the legal wrangling, but on Dec. 29, the court temporarily enjoined an expansive list — 14 named individuals, two health advocacy groups (MindFreedom International and the Alliance for Human Research Protection), their Web sites, and a site devoted to the Zyprexa issue — not just from 'further disseminating these documents.' They were specifically ordered to communicate the injunction to anyone else who had copies, and enjoined from 'posting information to Web sites to facilitate dissemination of these documents.'

That’s right — it appeared that even writing on their Web sites something like, 'Hey, there’s a site in Brazil where you can get those Zyprexa documents,' would run afoul of the injunction.

The order was extended by Judge Weinstein on Jan. 4, and tomorrow the court will revisit the issue at length.

So now there are serious free speech issues (involving the First Amendment to the US Constitution) involved.

While surely painful for Lilly, the online proliferation began flirting with some bedrock principles of free speech and press, as well as some practical realities that looked a fair bit like toothpaste out of its tube.

As Mr. von Lohmann and the Electronic Frontier Foundation see it, the injunction is simply untenable. Whatever the legal merits of Lilly’s claims against Mr. Gottstein and Dr. Egilman for violating the seal, the court’s power to stifle the ever-growing chain of unrelated individuals and Web sites who, after one or two degrees of remove, had nothing to do with the Lilly litigation, cannot extend to infinity. Very quickly, Mr. von Lohmann argues, you are dealing with ordinary citizens who are merely trading in and discussing documents of interest to public health.

There is also a traditionally high bar set for placing prior restraint on the press — which, whether Judge Weinstein recognizes it or not, very much includes a colony of citizen journalists feeding a wiki.

For now, copies of the Lilly documents sit defiantly on servers in Sweden, and under a domain registered at Christmas Island, the Australian dot in the ocean 224 miles off the coast of Java. 'Proudly served from outside the United States,' the site declares. There are surely others.

On his TortsProf blog, William G. Childs, an assistant professor at Western New England School of Law in Springfield, Mass., put it this way in a headline: 'Judge Tries to Unring Bell Hanging Around Neck of Horse Already Out of Barn Being Carried on Ship That Has Sailed.'

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.

Hat tip (see this post) in the Clinical Psychology and Psychiatry blog.

1 comment:

Anonymous said...

Lilly is trying to control the information that physicians receive about its drug. A reasonable response on the part of physicians would be to decline to see to Lilly "detailers" or write Lilly scripts (when possible for patient care) until all the Zyprexa information is in the public domain. A script for Viagra instead of a script for Cialis, for example, will meet patients' needs while sending a message to Lilly that physicians need full information on all these drugs if we are to prescribe them.