Leaking the Truth
Source: Valley Advocate; Easthampton, Massachusetts, USA
Pharmaceutical giant Eli Lilly slaps an injunction on a local mental health activist to suppress information about its “Wonder Drug,” Zyprexa.
Over 2 million people worldwide took Zyprexa last year. The drug’s FDA-approved use is for the treatment of schizophrenia and bipolar disorder, but many doctors prescribed the drug for other ailments, including milder mental illnesses.
This off-label prescription usage is due in large part to a multi-year promotional campaign orchestrated by Eli Lilly and Co., for whom Zyprexa is a best-selling product, producing roughly 30 percent of Lilly’s revenue. The campaign encouraged Lilly salespeople to approach primary care physicians, who, Lilly’s internal studies showed, were less likely than specialists to be aware of Zyprexa’s damaging side effects and would prescribe the drug, billed as a “safe, gentle psychotropic,” for older people with dementia.
James B. Gottstein, a lawyer who represents mentally ill patients in court actions against Lilly, subpoenaed internal Lilly documents concerning Zyprexa and then provided them to the New York Times . The documents, which include internal memos and emails as well as undisclosed medical trial results, detail a years-long coverup of the link between Zyprexa and ailments such as high blood sugar and serious weight gain (up to 100 pounds), both factors in developing diabetes. The documents also show that Eli Lilly marketed Zyprexa for off-label use. (While physicians can legally prescribe drugs for uses other than their FDA-approved ones, drug companies are not allowed to market drugs for other uses without FDA approval.)
Lilly says it warned physicians after 2003 that users might experience weight gain and diabetes-related disorders, and that its sales materials were always shown to the FDA.
Shortly after two front-page articles appeared in the Times , the internal documents were linked to the Internet by a citizen journalist, an action which was soon mimicked by others. Claiming the distribution of the internal records was illegal, Eli Lilly asked a Brooklyn court to order Gottstein to return the documents and cease from disseminating them. Judge Brian Cogan complied with Lilly’s request and then some, issuing an injunction against 12 people, ordering them to remove and retrieve all copies of the documents thus far distributed and to refrain from further distribution.
One of the 12 individuals named is Will Hall, a prominent member of the Freedom Center, a Northampton-based mental health advocacy group that educates patients about how to make accurate, informed choices about taking psychiatric medications.
“This is a freedom of information issue,” says Hall in a statement on the Freedom Center website. “People need to know what Eli Lilly is doing behind closed doors. For years Lilly has covered up the dangers of its drugs. Hundreds of people in Northampton are at risk for diabetes and other dangerous effects from the Zyprexa they take.” To date, Eli Lilly has agreed to pay a total of $1.2 billion to 28,500 people, including $500 million, awarded on Jan. 4 in 18,000 lawsuits, to individuals who developed diabetes or other illnesses after taking Zyprexa.
Lilly’s alleged marketing behavior is not atypical of the pharmaceutical industry; many drug companies are under investigation for promoting off-label use. The apparent falsification of medical trial data and coverup of harmful side effects has prompted the New York Times to call for congressional hearings on the matter.
“I don’t think the New York Times ’ call for congressional hearings in this scandal goes far enough,” says Hall. “We need to realize that it’s a disaster to entrust our health and well-being to private corporations, who at the end of the day can only care about stockholder profit.”