http://www.freedom-center.org/pdf/01-29-07RepublicanAntipsychoticDrugSparksBattle.pdf
http://www.masslive.com/news/topstories/index.ssf?/base/news-1/1170061031282200.xml&coll=1&thispage=1
http://www.freedom-center.org/pdf/1-16-07ActivistGaggedLillyWillHallGazetteSCANNED.pdf

Anti-psychotic drug sparks battle
Monday, January 29, 2007
By PATRICIA NORRIS
Springfield Republican

A Northampton man is among several mental health advocates involved in a controversial legal battle over the antipsychotic drug Zyprexa.

Wilton E. Hall, co-founder of the Freedom Center, a Northampton advocacy group that promotes alternative treatments to mental illness other than pharmaceuticals, was one of 13 activists named in an injunction issued by a New York federal court recently.

The order seeks to stop Hall and others from disseminating damaging internal Eli Lilly documents about Zyprexa that were given to him and others by an Alaskan mental health lawyer. Hall was named in the injunction simply because he received the material.

Eli Lilly manufactures Zyprexa. The drug has been on the market since 1996.

Hall and others contend Eli Lilly suppressed information regarding serious side effects of the widely used drug, which is prescribed to reduce hallucinations and delusions among people who are schizophrenic or bipolar.

The internal documents, which were also leaked to the New York Times, show side effects such as weight gain, high blood sugar, and diabetes that were downplayed by the company. The Times reports that the company also promoted the drug for dementia patients, a use not approved by the government. Several states, including Vermont, are now investigating Lilly's Zyprexa marketing tactics.

The documents came to Hall, The New York Times and others by way of Alaskan human-rights lawyer James Gottstein. Gottstein had retrieved them after a subpoena was issued in another lawsuit involving the drug. Hall, a friend of Gottstein who was diagnosed with schizophrenia in 1992 but no longer "accepts that label," said he took no part in disseminating the documents and is complying with the court order. Hall has had Western Massachusetts friends who have been forced to take the drug despite the side effects, he said.

"The horse is out of the barn," said Hall. "... The regulatory oversight system has failed and people need information about the danger of these psychiatric drugs and how Eli Lilly is covering them up."

A lawyer for the Electronic Frontier Foundation has taken the case pro bono on behalf of the 13 named in the injunction, according to Hall. The foundation contends that the Jan. 4 order forbidding them to disseminate the information is a violation of the First Amendment as it prevents "citizen journalists" from posting links to the documents that were put on the Internet.

In an e-mail response to The Republican, Eli Lilly spokeswoman Carole W. Puls wrote: "The documents that have been illegally leaked 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 - only a few hundred of the 11 million pages, so far as we can determine - have been carefully selected by the 'leakers' to tell a story that the 'leakers' want them to tell. 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 or bipolar disorder."

The company contends that the release of the documents was illegal because they were "confidential documents" in a court procedure.

Activists like Hall are not the only ones disappointed by the documents' purported revelations, however.

Dr. Benjamin Lipzin, chairman of the department of psychiatry at Baystate Medical Center in Springfield, said clinicians and patients had been telling Eli Lilly for years that there were extreme side effects with the drug, which is also highly effective in reducing hallucinations and delusions.

"It was pretty clear that they were trying to combat the experiences that psychiatrists and others had with the drug," Lipzin said. He said he believes the competitive marketplace may have prompted the company to downplay weight gain and other problems because other antipsychotics on the market do not have the same effects.

"They would tell us, oh, that is not really true," Lipzin said.

But Puls said adverse reactions, such as weight gain and diabetes, "were disclosed on the prescribing label since the day the drug was approved." She urged consumers to go to zyprexafacts.com and www.lillytrials.com for more information.

In his own practice, Lipzin had patients who gained 50 to 75 pounds on the drug, which increases food cravings in some patients.

"It causes a metabolic syndrome," said Lipzin.

Still, Lipzin will prescribe the drug in some cases because it is very effective, he said.

"There was a major clinical trial funded by the National Institute of Mental Health, not the drug companies, that showed Zyprexa was at least as good and maybe better than others in terms of how long someone stayed on it," he said. "It is not a terrible drug or an ineffective drug."

Moderate weight gain - 8 to 10 pounds - is usually expected with the drug, he said.

"All medications have risks and benefits. There is a risk in being psychotic and taking your own life or hurting someone because God is telling you to kill someone. That is no way to live either," Lipzin said.