Monday, December 18, 2006

Psychiatric Drug Lies... by Eli Lilly

It really should come as no surprise that Eli Lilly has been accused of peddling their newer and most "profitable" drug Zyprexa to doctors for a use it is not approved.

Eli Lilly has a long and ugly history of foisting chemicals on the American market that have deadly consequences.

I wrote a paper in grad school about Lilly's seemingly strong disregard for humanity versus profits. I defended the paper in my Public Health Class during the height of the Prozac media on suicides. All of that controversy was supposedly to end when the FDA Psychiatric drug advisory committee decided to ignore the links Prozac has to suicide. Of course 15 years later those clowns had to reverse their decision. And now we have warnings about suicides and antidepressants. But how many died in between? Too many.

In my research, I found that Lilly and Co. was fined in the 1980's for selling a drug, Oraflex, in America while it knew it was going to be banned in what was then West Germany due to its relationship to heart related deaths. Eli Lilly & Co. still sought to make some cold, hard cash before paying a small fine to settle charges it mis-led the FDA about Oraflex's safety.

In September 2005 the FDA forced Lilly & Co. to label Strattera with the same black-box suicide warning as Prozac and the other antidepressants. But wait, Lilly doesn't sell Strattera for depression. No, Lilly got it approved for use on children since the pill failed to do anything for people labelled as depressed.

Prozac was invented by Eli Lillyas well as Seconol (http://en.wikipedia.org/wiki/Secobarbital) better known as "Reds" is a widely abused psychiatric drug made by Lilly & Co.

Dr. K

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http://www.nytimes.com/2006/12/18/business/18drug.html?em&ex=1166590800&en=28418dc86157c22c&ei=5087%0A
by Alex Berenson

Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug, in patients who did not have either condition, according to internal Lilly marketing materials. The marketing documents, given to The New York Times by a lawyer representing mentally ill patients, detail a multiyear promotional campaign that Lilly began in Orlando, Fla., in late 2000. In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia. A Lilly executive said that she could not comment on specific documents but that the company had never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the Food and Drug Administration, as required by law.

“We have extensive training for sales reps to assure that they provide information to the doctors that’s within the scope of the prescribing information approved by the F.D.A.,” Anne Nobles, Lilly’s vice president for corporate affairs, said in an interview yesterday. Zyprexa is not approved to treat dementia or dementia-related psychosis, and in fact carries a prominent warning from the F.D.A. that it increases the risk of death in older patients with dementia-related psychosis. Federal laws bar drug makers from promoting prescription drugs for conditions for which they have not been approved — a practice known as off-label prescription — although doctors can prescribe drugs to any patient they wish. Yet in 1999 and 2000 Lilly considered ways to convince primary care doctors that they should use Zyprexa on their patients. In one document, an unnamed Lilly marketing executive wrote that these doctors “do treat dementia” but “do not treat bipolar; schizophrenia is handled by psychiatrists.”

As a result, “dementia should be first message,” of a campaign to primary doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically. Later, the same document says that some primary care doctors “might prescribe outside of label.” Ms. Nobles said that the company had never promoted its drug for any conditions except schizophrenia and bipolar disorder. Older patients who seem to have dementia may actually have schizophrenia that has gone untreated, Ms. Nobles said. Several psychiatrists outside the company said yesterday that they strongly disagreed with Lilly’s claim. Schizophrenia is a severe disease that is almost always diagnosed when patients are in their teens or 20s. Its symptoms could not be confused with mild dementia, these doctors said. Zyprexa is by far Lilly’s best-selling product, with $4.2 billion in sales in 2005, 30 percent of its overall revenues. About two million people worldwide received it last year. Based in Indianapolis, Lilly is the sixth-largest American drug company. The issue of off-label marketing is controversial in the drug industry. Nearly every company is under either civil or criminal investigation for alleged efforts to expand the use of its drugs beyond the specific illness or condition for which they are approved. Lilly faces federal and state investigations over its marketing of Zyprexa. In its annual report for 2005, Lilly said that it faced an investigation by federal prosecutors in Pennsylvania and that the Florida attorney general’s office had subpoenaed the company “seeking production of documents relating to sales of Zyprexa and our marketing and promotional practices with respect to Zyprexa.”

Since Lilly introduced Zyprexa in 1996, about 20 million patients worldwide have received the drug, which helps control the hallucinations and delusions associated with schizophrenia and severe mania. But Zyprexa also causes weight gain in many patients, and the American Association found in 2004 that Zyprexa was more likely to cause diabetes than other widely used drugs for schizophrenia. Lilly says that no link between Zyprexa and diabetes has been proven.

As part of the “Viva Zyprexa” campaign, in packets for its sales representatives, Eli Lilly created the profiles of patients whom it said would be suitable candidates for Zyprexa. Representatives were told to discuss the patient profiles with doctors. One of the patients was a woman in her 20s who showed mild symptoms of schizophrenia, while another was a man in his 40s who appeared to have bipolar disorder.