Mr Whitatker has been investigating and reporting on Lilly and Zyprexa more persistently than any other journalist. In 2005, he used the FOIA to obtain FDA data and reported that Zyprexa's adverse effects included cardiac abnormalities and hypotension; Parkinson-like motor impairment; unbearable restlessness (akathisia); and acute weight gain (50%) that increased the risk of diabetes, or basically the same information revealed in the leaked documents.
Vera Sharav, president of the Alliance for Human Research Protection, and Lilly are not the best of buddies either. She has reported extensively on all issues related to Lilly and Zyprexa as they have developed over the past several years.
In fact, the AHRP sends out daily Infomails on the internet that provide all the up-to-date information on drug safety and legal issues to advocacy groups, members of the scientific community, public officials, the media, medical journal editors, and attorneys.
In addition, Ms Sharav has authored articles appearing in Ethical Human Psychology and Psychiatry, Journal of Disability Policy Studies, and American Journal of Bioethics.
And last but not least, there is Dr Breggin, the author of countless books on psychiatric drugs, who represents a nightmare in broad daylight to every corrupt pharmaceutical company on earth. Dr Breggin makes a habit of exposing drug makers that conceal dangerous side effects of psychiatric drugs which in Lilly's case, not only includes Zyprexa but Prozac as well.
Its not too difficult to figure out why Lilly does not want these incriminating secret documents to be added to the collection that this group of authors has managed to gather on its own over the years, whether it be through litigation or by use of the FOIA.
There is a full hearing set for 2:00 pm on January 16, 2007, for all the attorneys to argue for and against the injunction. Hopefully, one of the attorneys will bring up the fact that allowing Lilly to keep these documents secret for all these years, while the company agreed to pay out over a billion dollars in out-of-court settlements, has done nothing to curb the off-label marketing of Zyprexa.
As a vivid example of Lilly's off-label promotion efforts revealed in the documents, in one article last month the Times quoted an August 2001, email from a doctor that was sent to both Lilly and the FDA, complaining about an off-label presentation made by a Lilly sales representative.
The doctor said the sales rep "presented an elderly female patient who was presented to her physician by her family complaining of insomnia, agitation, slight confusion, and had no physical finding to explain her state."
The doctor said the sales rep then suggested that Zyprexa might be prescribed for this patient and he went on to describe his interaction with the sales rep in the email stating:
"I inquired what Zyprexa was indicated for she then indicated that many physicians might prescribe an antipsychotic for this patient. I then asked for her package insert and read to her that her product was indicated for schizophrenia and bipolar mania - neither of which the presented patient had been diagnosed with."
The truth is, the off-label marketing schemes discussed in the documents have been so successful that a medication, approved only for an extremely limited population of adults with two types of mental illness, has magically transformed into a best selling blockbuster.
If Lilly had stopped promoting the off-label use of Zyprexa, by now declining sales figures would be showing up in the company's earnings reports, because there has been no epidemic of mental illness to account for the massive number of prescriptions still being written.
But there has been no decline in sales. In fact, according to SEC filings, for the third quarter of 2006, Zyprexa sales overall totaled $1.085 billion, a 5% increase over the same quarter in 2005. In the US, the filings state, sales increased 3%, to $519 million, and prescription volume held steady during the first nine months of 2006.
Evelyn Pringle evelyn-pringle@sbcglobal.net
(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)
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