From the NovoPress Blog Archive
For pharmaceutical giant Eli Lilly, death and injury are just a cost of doing business. When Zyprexa, Lilly’s drug to treat schizophrenia and bipolar disorder, hit the marketplace in 1996, it was hailed as an “atypical” – a “safe, gentle psychotropic,” more effective than older drugs like Thorazine and Trilafon, without the dangerous side effects. Sales skyrocketed. The hype soon gave way to reality, as Lilly faced waves of lawsuits by patients suffering from diabetes, massive weight gain, pancreatitis and cardiac problems.
Lilly responded with the cozy arrangement that worked with Prozac, another blockbuster plagued with problems: quietly settle suits out of court, with proceedings sealed and secret under a gag order. Anything embarrassing – or illegal – that Lilly is doing behind closed doors would remain hidden from public view.
Even though the payout is enormous – more than a billion dollars in settlements to tens of thousands of plaintiffs – Lilly can afford it: atypicals sell for ten times more than older drugs, and Lilly’s marketing machine made Zyprexa its biggest profit maker, with more than 20 million customers worldwide and sales topping $4 billion annually. So Lilly writes a check, buys the silence of the people harmed by its products, and then turns around and passes the cost along to the consumer at inflated drugstore prices. All perfectly legal.
What Lilly didn’t count on was a whistleblower, a lawyer and hackers taking matters into their own hands. Just as Lilly’s legal muscle was lax during Christmas holidays, one of the expert witnesses in the Zyprexa litigation contacted human rights attorney Jim Gottstein, who used a combination of clever subpoena wizardry and fast action to get hundreds of secret documents out from under the court seal. Gottstein turned the memos over to The New York Times before Lilly could plug the leak.
The memos, emails and correspondence reveal how Lilly’s marketing strategy bent and broke the law, hid unfavorable risk studies and pushed Zyprexa for unapproved use on the elderly and children. The Times ran repeated front page stories, and Lilly’s stock took a nose dive.
Claiming “trade secrets” and proprietary “merchandising techniques,” Lilly lawyers swooped down on Gottstein, seizing emails and voice mail records. They convinced the court to order an injunction forbidding further distribution of the files, but Gottstein had already sent out disks loaded with scanned copies to a dozen activists and journalists around the country. Lilly tracked the disks down, trying to halt the escalating crisis.
And this is where the hackers come in. Someone – still not identified by Lilly – got a copy, but any distribution traced back to them could lead to contempt of court and serious legal consequences. So they turned to software called Tor, set up by the Electronic Frontier Foundation. Tor is an anonymous server privacy tool EFF created to help dissidents in totalitarian regimes like China slip past state censors. It was perfect to help the whistle-blowers evade Lilly’s surveillance. The file – zyprexakills.tar.gz – found its way into cyberspace, and the court finally ruled that Lilly couldn’t block websites from hosting the file once it was freely available online. The leak finally went public.
The Zyprexa documents are a disturbing glimpse into the marketing mind of one of the biggest companies in the world, a firm with close ties to the Bush Administration (Lilly CEO Sidney Taurel sits on the Homeland Security Council). When a study showed three times the risk of diabetes over other drugs, Lilly simply hid it from the Food and Drug Administration’s scrutiny. Lilly aimed sales to dementia patients – without approval – in a campaign called “Viva Zyprexa.” They instructed product representatives to downplay drug risks, and targeted children, who Zyprexa has never been tested on. Emails discussed the strategy of indemnifying doctors who prescribe Zyprexa against any legal action: “Our experience with Prozac,” the memo said, “confirms the impact and goodwill of such an initiative.” The memos reveal callous indifference to the diabetes risk Zyprexa causes, perhaps because Lilly’s other top selling drugs include – you guessed it – diabetes medications.
Lilly now faces a snowballing scandal. The Times compared Zyprexa to Vioxx, Merck’s painkiller withdrawn from the market after leaked documents showed the company hid heart attack risks. FDA scientist Dr. David Graham, who blew the whistle on Vioxx, testified to Congress that atypicals like Zyprexa kill some 62,000 people a year in unapproved uses. A study in the Archives of General Psychiatry concluded atypicals were no more effective than older, cheaper drugs, and five state governments, with enormous budgets for atypicals, initiated investigations. And last month, four-year-old Rebecca Riley died from drugs prescribed by a psychiatrist, including an atypical, raising concerns about the approximately 30,000 children under five who take these drugs, despite no study on drug safety for children.
Lilly objected to its secret memos going public because they might “cause unwarranted fear among patients that will cause them to stop taking their medication.” Yet this gets to the heart of Lilly’s corruption. Beyond hiding drug risks and marketing illegally, Big Pharma doesn’t trust its customers to make informed decisions about their health care. Growing numbers of people are turning off the TV pill ads and exploring other ways to deal with their suffering. A New York Times article last year broke the story of the many people with a schizophrenia diagnosis who do well with non-medication treatments. Maybe the solution isn’t to be found in a pill after all?
Now that would bring down Big Pharma faster than any scandal.
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