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MindFreedom’s office is in Eugene, Oregon, and the local daily newspaper has provided coverage about the Zyprexa files controversy.

Injunction snares mental health activist

Date Published:

Feb 15, 2007 03:00 AM

Author: Susan Palmer

Source: The Register-Guard; Eugene, Oregon, USA

A New York judge severely scolded those involved in leaking sealed documents about side effects of an anti-psychotic drug, but in a Tuesday ruling acknowledged that he could no longer keep the information from public view.

The complicated decision allows some people and Web sites to continue to make the documents available while blocking others from the same activities. In one instance, local mental health activist David Oaks remains under the injunction, but the Web site of his nonprofit agency, MindFreedom, apparently may freely publish it.

The case came about after stories published in December by the New York Times suggested that drug manufacturer Eli Lilly withheld information about Zyprexa’s tendency to cause weight gain and lead to diabetes in patients who took it to control schizophrenia and bipolar disorder. The stories also suggested that Eli Lilly promoted the drug for uses that had not been approved by the Food and Drug Administration.

New York Times reporter Alex Berenson based the stories on documents that had been provided to lawyers representing thousands of patients who blamed Zyprexa for severe health problems and had filed class action suits against Eli Lilly. The company has paid $1.2 billion to settle those suits and, as part of the settlement, required that the documents be kept secret.

After the stories ran, Eli Lilly requested an injunction against the two men who had provided the information to the New York Times, demanding the return of hundreds of pages that included inside research, e-mails and marketing ideas. The injunction expanded as the documents leaked out onto the Internet, eventually including people who merely posted links on Web sites telling others where online versions could be downloaded.

That’s how Eugene activist Oaks got swept up in the case. Oaks said he never received copies of the documents and that the MindFreedom Web site never posted them, although it did alert people to their presence on the Internet.

U.S. District Judge Jack Weinstein, in his 78-page ruling, had harsh words not only for the men who provided the information to the New York Times but the process the reporter used to get it.

A witness in the class action lawsuits had the Eli Lilly files and, according to court documents, was approached by reporter Berenson, who suggested that he get in touch with an Alaska lawyer working on mental health cases. The Alaska lawyer subpoenaed the documents from the witness then sent them to Berenson and several other people who began posting electronic versions online.

Referring to the three as co-conspirators, the judge rebuked them for breaking the law when they “conspired to obtain and publish documents in knowing violation of a court order not to do so.”

While Eli Lilly did not name Berenson among those it sought to limit under the injunction, the judge called his actions reprehensible.

The New York Times did not respond to a message left after hours for comment.

Those believed to have directly received copies of the documents remain under the injunction and the judge demanded that the documents be returned. Those who secondarily found them online and copied them or posted links to them were released from the injunction.

“It is limited to individuals who participated in the conspiracy or aided the conspirators,” Weinstein wrote.

Oaks said he remains under the injunction because the judge mistakenly believes he has copies of the documents.

“We’ve never had them,” he said. “We’ve never disseminated them.”

Oaks called the decision a mixed blessing, with the information now widely available for people who have concerns about the drug. That drug companies can keep such records secret is still a problem, he said.

The judge stayed his ruling for 10 days to allow to appeal. A spokeswoman for the company said no decision had yet been made on whether to file an appeal.

But the company will go after the two men who originally leaked the documents, seeking court sanctions that could include contempt of court charges, and civil or criminal penalties, spokeswoman Marni Lemons said.

Lemons said the documents represent just a fraction of the 11 million pages submitted in the previous cases and that they were carefully selected to make the company look bad.

She said the Zyprexa label always has noted weight gain, increased blood sugar and diabetes as possible side effects, and that there are thousands taking the drug who are able to control the weight gain.

“We just really hope that as a result of this, vulnerable patients won’t be deterred from taking this life-saving medication,” she said.