Jun 14

The documents also revealed Lilly officials wrote medical journal studies about Zyprexa and then asked doctors to put their names on the articles, a practice called “ghostwriting.”

Lilly employees compiled a guide to hiring scientists to write favorable articles, complained to journal editors when publication was delayed and submitted rejected articles to other outlets, according to the documents.


The drug has never been approved for use with dementia patients, according to the FDA’s Web site.

A file photograph of Eli Lilly & Co.’s schizophrenia medication, Zyprexa, in Cambridge, Massachusetts. Photographer: JB Reed/Bloomberg News

June 12 (Bloomberg) — Eli Lilly & Co. urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the medicine didn’t work for such patients, according to unsealed internal company documents.

In 1999, four years after Lilly sent study results to the U.S. Food and Drug Administration showing Zyprexa didn’t alleviate dementia symptoms in older patients, it began marketing the drug to those very people, according to documents unsealed in insurer suits against the company for overpayment.

Regulators required Lilly and other antipsychotic drug- makers in April 2005 to warn that the products posed an increased risk to elderly patients with dementia. The documents show the health dangers in marketing a drug for an unapproved use, called off-label promotion, said Sidney Wolfe, head of the health research group at Public Citizen in Washington.

“By definition, off-label means there is no clear evidence that the benefits of a drug outweigh the risks,” Wolfe said. “The reason why off-label promotion is illegal is that you can greatly magnify the number of people who will be harmed.”

In 1999, when Lilly began its marketing push, Zyprexa’s only approved use was for patients suffering from schizophrenia, according to the FDA. In 2008, Zyprexa was Lilly’s best-selling drug, with $4.7 billion in sales, while antipsychotics as a group topped U.S. drug sales last year, with $14.6 billion.

Seven Studies

In a request for a December 2003 meeting over a proposed label change, Lilly told the FDA that data from seven studies showed Zyprexa didn’t alleviate symptoms of Alzheimer’s or other dementia.

The studies found death rates among older dementia patients taking Zyprexa were “significantly greater” than those who didn’t get the medicine, the company said, according to the unsealed documents.

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Apr 09

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug. Continue reading »

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