http://www.freedom-center.org/pdf/1-22-07GazetteEditorialLillysBitterMedicine.pdf

Hampshire Gazette: Activist Gagged For Dug Fact Leak In Lilly Case

Hampshire Daily Gazette
In Our Opinion: Eli Lilly's bitter medicine

1/22/2007

A Northampton resident's experience with drug giant Eli Lilly illustrates why so many Americans suspect the pharmaceutical industry is not looking out for the best interests of consumers. Will Hall, who co-founded a local mental health advocacy group known as the Freedom Center, has been the target of Lilly's legal efforts to squelch information about potential side effects from its best-selling medication, Zyprexa.

The medicine, used to treat schizophrenia, has been taken by 20 million people worldwide; it generates $4.5 billion a year for Lilly. The drug has been on the market since 1996 and, over the years, doctors have voiced suspicions that it may cause diabetes in some patients by encouraging weight gain and high blood sugar.

While Lilly has consistently tried to play down any risks associated with Zyprexa, it agreed in 2005 to pay $700 million to settle 8,000 claims filed by people who said they developed diabetes after taking the medication.

A lawyer involved in that litigation obtained Lilly's internal documents on Zyprexa and distributed them to a number of mental health advocates, including Hall.

Lilly has fought in court to have a gag order placed on Hall and 12 other activists to prevent them from speaking publicly about the documents. A judge granted the first request, and then agreed to renew the gag order.

Information from the Lilly documents has been released nonetheless through a number of media outlets. The documents demonstrate that Lilly was aware that Zyprexa could cause diabetes, but withheld the information from the public because it could hurt sales of the medication.

One document shows that Lilly had been advised that 30 percent of the people who take the medication gained at least 22 pounds after the first year; some gained as much as 100 pounds. Six years ago, a panel of diabetes doctors warned Lilly that "unless we come clean on this, it could get much more serious than we might anticipate."

Yet, Lilly continues to insist the documents were taken out of context and don't paint an accurate picture of Zyprexa. Last month, the company issued a statement saying "there is no scientific evidence establishing that Zyprexa causes diabetes."

All of this is reminiscent of a similar controversy a few years ago involving another drug maker, Merck, and its painkilling medication Vioxx. In response to lawsuits filed by people who said they developed heart disease after taking Vioxx, Merck released documents showing the company had been aware of a link to cardiovascular disease but played down the risks to protect its profits; Vioxx has since been pulled from the market.

Pharmaceutical companies spend billions of dollars a year on television commercials to advertise their newest drugs, yet they can't level with the public about possible side effects.

They also spread millions of dollars more in campaign contributions among politicians in an effort to obtain favorable legislation. Meanwhile, drug prices continue to soar, placing an enormous burden on the nation's health system and making some medications unaffordable for many Americans, especially senior citizens.

It's understandable if the pharmaceutical industry is wary of litigation; The industry does make a great investment, and take financial risks, to develop new medications and is sometimes the target of frivolous lawsuits.

When the pharmaceutical industry seeks gag orders against people like Will Hall, though, it only reinforces the suspicion that it has something to hide. Hall and others like him are simply doing what drug makers have failed to do: tell the truth about the possible side effects of medications.

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http://snipurl.com/vadvocatezyprexa

Leaking the Truth

Pharmaceutical giant Eli Lilly slaps an injunction on a local mental health activist to suppress information about its "Wonder Drug," Zyprexa.

By Kendra Thurlow

January 18 2007

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.”•