Evelyn Pringle January 16, 2007
The judge issuing injunctions in the Eli Lilly-Zyprexa-Documents case has decided that reporters at the New York Times enjoy the full protection of the First Amendment but that other reporters and media outlets do not.
The secret documents at the center of this hailstorm were provided to the New York Times, and several other journalists, by the same source. The Times took the lead and ran a series of articles quoting the documents, and an editorial calling for a Congressional investigation of Eli Lilly.
On December 29, 2006, Lilly obtained a temporary injunction ordering a list of people, including many authors and journalists, to return the documents and not disseminate them further, which included Terrie Gottstein, Jerry Winchester, Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, Bruce Whittington, Dr Stefan Kruszewski, Laura Ziegler, Judi Chamberlin, Vera Sherav, Robert Whitaker, and Will Hall.
At a January 3, 2007, even though he was not asked to, Judge Weinstein announced that he was not going to issue an injunction against the Times and specifically stated:
"The court takes no position on whether and how they can be used by others who received them from other sources. After all, the New York Times has disseminated them. This court is not going to issue an order telling the New York Times to return the documents. So everybody has access to them."
However, following a few weak arguments by Lilly attorneys during the hearing, the court extended the injunction, not to cover the Times, but to include the Wiki internet web site, Eric Whalen's web site, the Alliance for Human Research Protection web sites, and the MindFreedom web site.
The Times still has the documents which are now off-limits to other all the journalists, and notably, Lilly has not even bothered to ask the court to order the Times to return them or not disseminate them further.
For its part, when the Times first broke the story, and Lilly started publicly mouthing off about obtaining injunctions to get the documents back, the Times basically said that it would not return them.
"Our customary practice is to retain documents which we legitimately required during our news gathering process and which are likely to be relevant to future reporting," said Times attorney, George Freeman, in a Times article on December 20, 2006.
There are certainly no gripes against the Times itself because the information in the documents probably would have remained hidden forever had it not been for the Times. But a judge and a corporate giant can not decide that a reporter at the Times will be afforded more freedoms than any other reporter in this county.
The decision to allow one newspaper to publish important information and not others, should have all journalists enraged. Lilly's ability to get a court to issue an injunction against any journalist at the drop of a hat should be troubling to all members of the media.
Freedom of the press can not be based on the size of a publication or its readership, or in the case of the Times in this instance, the recognition of the power and availability of funds of a newspaper to rise up and fight against a violation of that right.
Last month, the Times reported that the documents show Lilly concealed the side effects of Zyprexa, specifically weight gain and diabetes, because the company knew the information would have a negative effect on sales, and also that Lilly directed its sales representatives to encourage doctors to prescribe Zyprexa off-label to patients who were not schizophrenic or bipolar.
The documents quoted by the Times were designated as confidential pursuant to Case Management Order 3, a Protective Order entered on August 9, 2004, which gave Lilly the right to designate documents confidential, so long as Lilly in good faith believed that they were. Legal experts now contend that the information quoted by the Times was never entitled to protection.
Several persons listed in the injunction have obtained attorneys to fight for the public's right to know what's in the documents. Attorneys representing interested parties include, Lilly attorney, Sean Fahey, of Pepper Hamilton LLP; Ted Chabasinski, on behalf of Judi Chamberlin and MindFreedom; John McKay, represents Jim and Terrie Gottstein; and Alan Milstein appears on behalf of Ms Sharav, the AHRP, and Dr Cohen.
On January 9, 2007, attorney, Fred von Lohmann, of the Electronic Frontier Foundation, jumped in the ring by filing a motion on behalf of John Doe, a citizen-journalist who contributes to the Wiki web site, to object to the injunction that names Wiki.
A January 8, 2007, brief filed by Lilly states: "The materials at issue here are subject to a valid protective order under Rule 26(c)(7) for trade secrets and other confidential information, and thus irreparable harm will result in the absence of an injunction."
The brief also cites a case that says, "It is well settled law that the harm caused by loss of trade secrets cannot be measured in monetary damages."
The conduct revealed by the Times could not possibly constitute protected trade secrets by any stretch of the imagination. Since when did teaching sales reps how to convince doctors to prescribe drugs off-label, for uses never intended, become a trade secret?
And since when is it a trade secret for a company to conceal the lethal side effects of a drug for 10 years, knowing full well that millions of people are at risk of being injured or killed?
What "irreparable harm" could come to Lilly that would justify allowing even one more person to take Zyprexa without full knowledge of the health risks linked to the drug?
Granted, the loss of what Lilly is trying to claim are "trade secrets" might lead to monetary damages, as it well knows. So far, to keep these "trade secrets" buried during the first 2 rounds of litigation, the company agreed to fork out more than $1 billion to Zyprexa victims who were willing to sign gag orders and remain silent, but thousands more are waiting in the wings for the start of round three.
When reviewing the court's broad injunctions, it is impossible to figure out what happened to Judge Weinstein since he wrote the book, Individual Justice in Mass Tort Litigation (2005), in which he could have been discussing the Lilly-Zyprexa-Document saga when he stated:
"A publicly maintained legal system ought not protect those who engage in misconduct, conceal the cause of injury from the victims, or render potential victims vulnerable. Moreover, such secrecy defeats the deterrent function of the justice system."
The doctors listed in the injunction have all authored books, studies, or papers in many different publications on issues related to the information revealed in the Lilly documents. The chilling effect of the court's orders is most obvious as it applies to these doctors.
In addition to their own journalistic writings, they have been quoted as experts by this author, and many others, in countless articles related to psychiatric drugs long before the new Lilly documents surfaced, yet they are now barred from discussing anything about the secret documents with this journalist or anyone else.
Dr Cohen is the author or co-author of over fifty articles in publications such as the American Journal of Psychiatry, Ethical Human Sciences and Services, and the Encyclopedia of Psychology, as well as twelve books and monographs.
Getting the court to muzzle Dr Kruszewski was a major victory for Lilly. He is on record telling this author early last year that Zyprexa increased the risk of obesity, diabetes type II, hypertension, heart attacks and stroke, "at the same time that it continues to cause neurological side-effects like the older antipsychotics."
And furthermore, he is quoted as saying Lilly knew about these health risks for years and failed to warn the public, in articles published months before the new documents emerged to validate his assertions.
Dr Jackson, author of, Rethinking Psychiatric Drugs, is definitely not on Lilly's Xmas card list either. In addition to the book and papers she has written, in 2003, she reviewed documents obtained under the FOIA, regarding to the FDA's approval of Zyprexa, and provided written and oral testimony under oath in a lawsuit about the statistical manipulation used by Lilly when obtaining FDA approval for the drug.
Ms Chamberlin has been an author, lecturer, and activist in the field of patients' rights for many years, and sits on the board of MindFreedom International, a coalition of about 100 advocacy groups in 13 countries that provides the public with information on all the latest safety issues and legal developments as they relate to psychiatric drugs.
Investigative journalist and author of, Mad in America, Robert Whitaker, likely holds the number one spot on Lilly's hit list of despised journalists. Lilly's legal team is probably still celebrating the victory of getting his name added to the injunction.
The lack of friendship between Bob and Lilly dates back to November 1998, when he wrote a series titled "Doing Harm: Research on the mentally ill," that was published on the front page of the Boston Globe, and reported that in pre-marketing clinical trials, Zyprexa was linked to life-threatening adverse effects in 22% of the adult patients tested.
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.