Zyprexa Cat Out Of The Bag

December 19, 2006, 12:00AM. By Evelyn Pringle

Washington DCDocuments acquired by the New York Times from attorney Jim Gottstein show that Eli Lilly ran a "Viva Zyprexa" marketing campaign to convince doctors to prescribe Zyprexa off-label and between 1999 and 2002, its sales doubled from $1.5 billion to $3 billion.

Although most people would recognize that the Zyprexa cat cannot be stuffed back in the bag, Lilly nonetheless, got a judge to issue an order on December 15, 2006, in attempt to get the documents returned which states in relevant part:

James Gottstein, Esquire, is in possession of documents produced by Eli Lilly and Company in the above-captioned action in violation of CMO-3, and has been so notified by counsel for Eli Lilly and Company without response by Mr. Gottstein.

Mr. Gottstein has further disseminated these documents to additional third parties in violation of CMO-3.

Mr. Gottstein shall immediately return any and all such documents (including all copies of any electronic documents, hard copy documents and CDs/DVD).

In addition, although Lilly does not mention how hard it is working behind the scenes in the courts to get the Zyprexa documents back in the bag, in a December 18, 2006, press release, the drug maker denied all wrongdoing and states that Lilly "vigorously objects to the characterization of company practices in a New York Times article based upon selective documents illegally leaked by plaintiffs' lawyers."

Market Watch even says that Lilly denies it "vehemently."

To that I says, "So what's new?"

A drug company gets busted red-handed illegally promoting a dangerous and useless drug for uses not approved as safe and effective by the FDA, and its always denial, even in cases such as this where the documents are indisputable.

Its difficult to believe that the person who wrote this press release did it with a straight face. It also leads the mind to wonder how much Big Pharma pays a person to write an out and out fraudulent press release these days.

Here! Here! Lilly also says it "deplores the illegal release of select confidential documents," in its statement.

To that I say, "I'll bet."

"This illegal and selective disclosure of incomplete information," the company writes, "will cause unwarranted concern among patients that may cause them to stop taking their medication without consulting a physician."

To that I say, "we can only hope."

"The Times," Lilly whines, "failed to mention that these leaked documents are a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process."

This statement begs the question of how would reading 11 million other documents change what is said in the documents quoted by the Times?

Picturing somebody trying to read eleven million documents simply tells me that Lilly tried to send the plaintiffs' legal team on a wild goose chase to find a few needles in a haystack and apparently some diligent attorneys were up to the task because they caught the goose and found the needles.

But there must be a lot more needles to find because Lilly is showing signs of outright paranoia and desperation in wanting those documents out of the public domain. In fact, on December 19, 2006, Lilly got the court to issue an Order for Mandatory Injunction directed at Mr Gottstein which states in relevant part:

Mr. Gottstein shall immediately, upon receipt of this Order, provide to Special Master Woodin and the parties a listing of all persons, organizations or entities to whom any documents covered by this Order, or any subset thereof, were provided.

Mr. Gottstein shall, within 24 hours of this Order, identify to Special Master Woodin and the parties, by specific dates stamp, those the particular documents to any person, organization or entity noted above, which shall also include the date and location such documents were disseminated.

Mr. Gottstein shall immediately take steps to retrieve any documents subject to this Order, regardless of their current location, and return all such documents to Special Master Woodin. This shall include the removal of any such documents posted at any website.

Mr. Gottstein shall take immediate steps to preserve, until further Order of the Court, all documents, voice mails, emails, materials, and information, including, but not limited to all communications, that refer to, relate to or concern Dr. Egilman or any other efforts to obtain documents produced by Eli Lilly and Company.

For his part, Mr Gottstein is not an attorney in the lawsuit in which Lilly got the judge to allow the company to hide the documents in the first place. He obtained them in another case and therefore, he surely would not be covered by any protective order.

Mr Gottstein is an advocate for patient rights and sits at the helm of, "The Law Project for Psychiatric Rights (PsychRights)," a public interest law firm that has mounted a legal campaign against forced psychiatric drugging all around the country.

His only interest in disclosing the documents appears to be a noble one; to alert unwitting doctors and Zyprexa patients about the high risk of injuries and death associated with the drug that Lilly has been successfully concealing for a decade. However, it now looks like Lilly has not been acting alone, but rather with a few accomplices embedded in the US court system.

Mr Gottstein legal pursuits do not involve chasing the almighty dollar; his organization helps people who ordinarily have little or no money. For instance, earlier this year Mr Gottstein won a landmark case before the Alaskan Supreme Court that found Alaska's forced drugging regime to be unconstitutional, in Myers v Alaska Psychiatric Institute, 138 P3d 238 (Alaska 2006).

Mr Gottstein says he took on this case because he was concerned about the rights of those people who find the drugs like Zyprexa both unhelpful and intolerable. "No other field of medicine allows this sort of forced treatment," he points out.

"For people who want to try non-drug approaches," he explains, "the research is very clear that many will have much better long-term outcomes, including complete recovery after being diagnosed with serious mental illness."

He says the massive forced drugging is turning many patients into drooling zombies and preventing them from going on to live the full lives they could otherwise enjoy.

On appeal, Mr Gottstein argued that the provisions governing authorization of treatment with psychotropic medications violate the Alaska Constitution's guarantees of liberty and privacy and the Supreme Court agreed.

"In our view," the Court wrote, "before a state may administer psychotropic drugs to a non-consenting mentally ill patient in a non-emergency setting, an independent judicial best interests determination is constitutionally necessary to ensure that the proposed treatment is actually the least intrusive means of protecting the patient."

In its decision, the Court addressed the class of drugs known as psychotropic medications. "Because psychotropic medication can have profound and lasting negative effects on a patient's mind and body," the Court stated, "Alaska's statutory provisions permitting nonconsensual treatment with psychotropic medications implicate fundamental liberty and privacy interests."

In addition to a compilation of published studies, the PsychRights' website has a wealth of information about psychiatric medications. However, in light of the above injunction, who knows how long it will be permitted to provide information about the dangers of Zyprexa.

The internal Lilly documents that Mr Gottstein provided to the Times cover the period 1995 to 2004, and clearly show that Lilly tried to hide information about Zyprexa's link to drastic weight gain even after it knew that 30% of patients on Zyprexa (olanzapine) for more than a year gained 22 pounds, and some as much as 100, a factor known to cause type-2 diabetes.

As far back as November 1999, emails show that Lilly was worried that if the risks became know it would hurt sales. "Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule," Dr Alan Breier wrote to Lilly employees that announced the formation of an "executive steering committee for olanzapine-associated weight changes and hyperglycemia."

In 2000, a group of diabetes doctors retained by Lilly to consider a possible link between diabetes and Zyprexa warned Lilly that "unless we come clean on this, it could get much more serious than we might anticipate," in an email from one Lilly manager to another, quoted in the Times.

In March 2002, a document shows that Lilly dismissed a plan to give psychiatrists information about how to treat diabetes, worrying that it would remind them of the risk. "Although M.D.'s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa," a Lilly manager wrote in an email quoted in the Times.

In 1999 and 2000, Lilly considered ways to convince primary care doctors who did not see patients with schizophrenia or manic depression, to prescribe Zyprexa. 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, the Times said.

It also noted that some primary care doctors "might prescribe outside of label."

If an epidemic of adult schizophrenia and manic-depression occurred since Zyprexa came on the market in 1996, I find it amazing that I somehow missed it.

But I must have because the Times describes a 2001 company meeting with Zyprexa sales representatives, where a Mr Bandick praised 16 sales reps for the number of prescriptions they had convinced doctors to write, according to a script prepared in advance of the meeting.

The Times states: "More than 100 other representatives had convinced doctors to write at least 16 extra prescriptions and thus "maxed out on a pretty sweet incentive," Mr Bandick said.

So the question here is, how could 100 sales reps get doctors to write prescriptions for a drug only approved for schizophrenia or manic depression for 16 more people if they were not promoting the drug for other uses?

Lilly apparently expects us to be stupid enough to believe that all these doctors in every state in the US, many of whom were general practitioners, came up with the idea to prescribe Zyprexa to every Tom, Dick and Mary for every indication under the sun right out of the blue.