Big Pharma: It's just the sales

At a "5 Star" care center on the Gulf Coast in SW Florida the policy seems to over dose the elderly people there with a poly-pharmaceutical regimen that often contains Zyprexa. In the evaluation I had done by an FDA research pharmacist I know through my work in natural mental health it showed an excessive overload of psychotropic drugs.

This issue is important to me because it is my mother, with no voice, who is the recipient of a mix of drugs "that would drop a 30 year old", according to my colleague.

Neither the prescribers, director of nursing, nurse practitioner or consulting pharmacist picked up on the serious drug interaction based on the profile I completed. As the DON said, "You know how these people are after they suffer a head injury."

Even my younger brother, a yuppie insurance agent ensconced in his defensive attitude about his Power of Attorney, responded to this third party evaluation. He hasn't seen that she has a neurological consult or speech therapy for the expressive aphasia she endures as a result of a closed head injury after a fall.

So I guess I'll never know how my mother might have been had she been not receiving Zyprexa or receiving proper care, including speech therapy.

And perhaps, in a less drugged state she might not have fallen or had serious side effects from the drugs that caused her to try to jump out of a window.

To find this out all you have to do is to read the side effects, warnings and contraindications in the PDR.

Thanks to these writers for their article.

Lilly Trained Sales Force to Ignore Drug's Risks (Update2)
By Margaret Cronin Fisk and Elizabeth Lopatto
July 31 2008
(Bloomberg) -- Eli Lilly & Co. trained its sales force to downplay risks for Zyprexa and encourage doctors to prescribe the drug beyond approved uses for schizophrenia and bipolar disorder, according to court documents.

Lilly's research showed some patients on Zyprexa gained as much as 80 pounds and that the incidence of high blood sugar at diabetes levels was 3.5 times higher than for placebos, according to documents filed in a lawsuit brought by the state of Alaska. Before those findings, doctors already saw a ``logical link between weight gain and diabetes,'' an instruction sheet advised the sales force in 2002.

``We believe it is essential to weaken this link to neutralize the diabetes/hyperglycemia issue,'' the company said in the sales document, which was provided for the Alaska case. ``Neutralizing any concern from our customers will be essential to the future growth of Zyprexa in the marketplace.''

Zyprexa became the company's top-selling drug, with $4.76 billion in sales last year -- about a quarter of Lilly's revenue. Company sales representatives disputed or ignored the risks and pursued primary-care and nursing-home doctors as well as psychiatrists, according to documents in the Alaska case that were released July 29 after Bloomberg News filed a motion to unseal them.

Lilly agreed to pay $15 million to settle the Alaska suit in March. The company has paid about $1.2 billion to resolve claims brought by more than 31,000 patients who said they weren't adequately warned Zyprexa could cause weight gain, diabetes or inflammation of the pancreas, Lilly spokeswoman Marni Lemons said July 8.

Failure to Warn

Lilly faces suits by nine other states alleging failure to warn and improper marketing, separate consumer-protection investigations in about 30 other states and an investigation of off-label marketing by the U.S. Attorney in Philadelphia, the company said May 6 in a regulatory filing.

Lilly doesn't engage in improper marketing and hasn't downplayed the risks, spokeswoman Tarra Ryker said in an e-mailed statement. The lawsuit documents ``are a tiny fraction of the more than 20 million pages'' provided by Lilly, Ryker said. ``They do not accurately portray our company strategy or our overall conduct.''

Lilly closed down 30 cents at $47.11 in New York Stock Exchange composite trading after falling about 1 percent in the initial minutes after U.S. markets opened.

Pushed Sales

Lilly pushed Zyprexa sales to primary care physicians and doctors in nursing homes for patients who weren't diagnosed with schizophrenia or bipolar disorder, according to complaints filed by Montana and Mississippi.

Most documents and depositions were acquired by plaintiffs' lawyers in consolidated Zyprexa litigation before U.S. District Judge Jack Weinstein in New York. Alaska's lawyers, who were provided the material, acquired additional evidence before trial.

The unsealed documents showed that about 550 sales representatives were greeted at an October 2000 meeting with a ``Viva Zyprexa'' version of the Elvis Presley song, ``Viva Las Vegas,'' touting the ``many wonderful indications'' for the drug.

There were only two indications for the drug at the time, Mike Bandick, director of marketplace management for the Zyprexa product team, testified in a June 2006 deposition. This didn't mean the team was pushing sales beyond the approved uses, he said. ``I assume this had more to do with getting the right number of syllables into that line,'' referring to song's lyrics.

Zyprexa's ``attributes line up so beautifully in the elderly,'' Alan Breier, then-team manager for the drug, told the group. ``The need for better treatment in Alzheimer's and other elderly conditions is so paramount and so key,'' Breier said, according to a recording provided for the Alaska lawsuit.

CEO Questioned

Zyprexa wasn't approved for use with Alzheimer's or for elderly conditions, Sidney Taurel, the current chairman of Lilly's board and then-chief executive officer, said under questioning by Alaska's lawyers in September. Breier wasn't encouraging improper sales, Taurel said.

``He's talking about the characteristics of the molecule which might make it a good agent for Alzheimer's,'' Taurel testified. ``He was not giving them instructions as to what to do the next day in the field.''

Sales representatives were advised to focus on symptoms, not diagnoses, when dealing with primary care physicians or PCPs, according to the Alaska documents.

``The doctor's thinking that he does not see a schizophrenic or bipolar patient,'' Bandick said in a December 2000 internal e- mail to the marketing department. ``But he probably does see patients with symptoms of behavior, mood and thought disturbances,'' he wrote. ``Even if the doctor does not have diagnosis, he should treat anyway.''

Not Approved

Zyprexa wasn't approved for such indications at the time, Bandick said in his June 2006 deposition. ``I did not intend for the sales force to promote under mood, thought and behavioral disturbances,'' he testified.

Lilly's sales representatives encouraged doctors to prescribe for such uses, according to call notes produced in the Alaska suit. In a July 2002 note, sales representative Thea Jung described her meeting with a doctor in Anchorage this way: ``Dr. B said she misunderstood and thought Z was just for bipolar or schizophrenia and was really excited to hear that it was applicable to her practice for `complicated mood.'''

Talking to patients about symptoms ``is an important and necessary piece of the dialogue between physicians and sales representatives,'' Lilly's Ryker said.

Added Warning

Lilly added a warning to its packaging in October 2007 saying that more than half of patients in 13 studies gained an average of 12 pounds after taking the drug for less than a year. It said Zyprexa was more associated with higher blood sugar levels, a risk factor for diabetes, than similar medications.

Before the October 2007 label change, Lilly didn't instruct its sales force to say Zyprexa's diabetes rates were higher, former marketing director David Noesges said in a January deposition.

``We will NOT proactively address the diabetes concern,'' the Zyprexa sales force was advised in 2002, the documents show. ``The competition wins if we are distracted into talking about diabetes.''

The case is Alaska v. Eli Lilly and Co., 3AN-06-05630 CI, Alaska Superior Court, Anchorage District.

To contact the reporters on this story: Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net; Elizabeth Lopatto in New York at elopatto@bloomberg.net.