More Eli Lilly Pud Sucking

Yesterday I worked a 12 hour shift with a head cold, went home and crashed for the night before I had a chance to even throw any scotch down my throat. This is good news. By definition, an alcoholic cannot function without regular infusions of booze, and the fact I was able to go a good 48 hours without any should put any doubt concerning alcoholism and me to rest for a good month or two.

The bad news is, when you pause to sleep you are at serious risk of missing the latest revelations of Big Pharma's pursuit of any and all dollars at the expense of public health. Last night, while I lay dreaming of things like Whitney Houston and The MC5, The New York Times zapped a story to my e-mail box I almost deleted the next morning in a Nyquil induced haze. Fortunately for you I didn't, and when the nighttime, sniffling, sneezing, coughing, aching, fever, so you can rest medicine wore off, this is what I saw.

Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.

A little background for those of you not in the profession. While it is perfectly legal for a doctor to prescribe any drug for any condition they see fit, it is illegal for a drug manufacturer to advertise or market a med for any use other than it's official indications. Zyprexa has two official indications; schizophrenia and bipolar disorder. Remember this.

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.”

Boy that sucks for Lilly. If they could only find some way to get those dementia-treating primary care doctors to write prescriptions for Zyprexa. One way would be to prove that Zyprexa actually can benefit people with dementia. Another would be to break the law and market to those primary care docs for an unapproved indication. Do you really need me to tell you which way Lilly chose?

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.

The third patient was “Martha,” a widow with adult children “who lives independently and has been your patient for some time.” Martha was described as being agitated and having disturbed sleep, but without the symptoms of paranoia or mania that typically marked a person with schizophrenia or bipolar disorder.

Write your own joke here about a marketing campaign dreamed up by middle aged white guys named "Viva Zyprexa"

A Lilly spokesperson wasn't joking though when they said:

Lilly had actually intended Martha’s profile to represent a patient with schizophrenia. But psychiatrists outside the company said this claim defied credibility, especially given Martha’s age. Instead, she appeared to have mild dementia, they said.

“It’d be very unusual for this to be a schizophrenic patient,” said Dr. John March, chief of child and adolescent psychiatry at Duke University medical center. “Schizophrenia is a disease of teenagers and young adults.”

So, we're expected to believe that Lilly, a company full of scientists from top to bottom, scientists who spend their entire lives studying diseases of the human body, diseases like schizophrenia, put out a profile of what was supposed to be a patient with schizophrenia with symptoms that do not match schizophrenia?

And OJ is looking for the real killer as you read this.

"So what" I can hear Republicans and other bitches of the drug industry saying. "It's a pointless rule anyway."

Is it? This is the first thing you see when you open a Zyprexa package insert these days. When studies finally were done on elderly patients with dimentia, years after Lilly was marketing "Martha" to those primary care docs, this is what they found. Read it and tell me how pointless it is to make sure drug companies have the science to back up their advertising claims:

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with atypical anti psychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. ZYPREXA (olanzapine) is not approved for the treatment of elderly patients with dementia-related psychosis.