Evelyn Pringle February 2, 2007
The on-going legal battle over the disclosure of secret Eli Lilly documents that reveal the serious health risks associated with Zyprexa and the company's off-label promotion of the drug involves a matter of grave public concern.
But observers on the sidelines of this courtroom circus say the conduct of the judge in helping Lilly keep documents secret that give the specific details of an illegal marketing scheme that is literally killing people is almost as disturbing as the underlying acts.
The off-label prescribing of Zyprexa has created a public health crisis. According to the New York Times, the secret documents show a pattern of unlawful activities that may have left the 20 million individuals who have taken Zyprexa with incomplete information regarding the side effects of the drug.
Harvard trained psychiatrist, Dr Stefan Kruszewski, reports that Zyprexa increases the risk of obesity, diabetes, hypertension, cardiovascular complications, heart attacks and stroke.
Keeping in mind that the FDA says that only between 1% and 10% of adverse events are reported to the agency, a study conducted 5 years ago, in the July 2002, issue of Pharmacotherapy, reviewed the adverse event reports submitted on Zyprexa and found that of the 289 cases of diabetes reported, 225 of the patients were newly diagnosed.
The review also identified 100 Zyprexa patients who had developed ketosis, a serious complication of diabetes, 22 cases of pancreatitis, a life-threatening inflammation of the pancreas, and 23 deaths associated with the drug.
Zyprexa is an antipsychotic approved by the FDA to treat adults with schizophrenia and bipolar disorder only. But doctors are prescribing the drug for conditions, treatment durations, and patient populations for which it was never intended and worst of all it is being widely prescribed for children.
For instance, in February 2006, public health officials in Florida ordered an investigation into why the number of children who are prescribed antipsychotics billed to Medicaid in Florida had nearly doubled in five years, from 9,500 children to almost 18,000.
The lawsuits filed against Lilly to recover the money paid for Zyprexa by state Medicaid programs due to the company's off-label promotion say the drug is being sold for unapproved uses such as anxiety and other mood disorders, sleep disruption, autism, attention deficit disorders, hyperactivity, and dementia.
According to the attorney general of Mississippi, about 10% of Zyprexa patients on Medicaid in that state, have developed diabetes. In fact, the health problems associated with Zyprexa have become so prevalent, that one class action lawsuit is demanding money to cover the medical monitoring of all patients who took Zyprexa but have not yet been diagnosed with high blood sugar, diabetes, or pancreatitis.
Children on Zyprexa are developing life-long injuries. At the annual meeting of the American Academy of Child and Adolescent Psychiatry in Washington, DC, on October 20, 2004, researchers from the Johns Hopkins Children's Center reported that atypical antipsychotics were found to trigger insulin resistance in children. The researchers evaluated 11 children who gained significant amounts of weight while taking the drugs.
Weight gain is a known risk factor that contributes to insulin resistance. Insulin is produced by the pancreas to help cells absorb glucose and provide energy. When resistance occurs, the pancreas tries to keep up with the demand by producing more insulin until it eventually cannot keep up, and excess glucose builds up in the bloodstream which can increase the risk of type-2 diabetes, heart disease, and stroke.
All six children in the John Hopkins study who were on moderate or high doses of an antipsychotic developed symptoms of insulin resistance, and three of the 5 children on low doses did as well.
The study's lead author, Dr Mark Riddle, director of the division of child and adolescent psychiatry at the Center, said, "The insulin resistance seen in these children was greater than what would be expected from weight gain alone, suggesting there is a factor distinct from excess weight that directly induces insulin resistance."
Experts say Zyprexa is poison for some people. According to Dr Louis Caplan, Professor of Neurology at Harvard Medical School, there is overuse of antipsychotics in patients admitted to hospitals. "These drugs," he said, "are often given in high doses to very sick patients in intensive care units or on medical and surgical units," in the February 21, 2006, journal Neurology.
"They cause symptoms and neurological dysfunctions that are a common reason for neurological consultations in the hospital," Dr Caplan warns.
"Old sick people with abnormal brains do not tolerate these drugs well," he says. "In patients with Lewy-body disease and some Parkinsonian syndromes, their use is a disaster, setting patients back for weeks," he warns.
When the FDA approves a drug, it also approves the labeling which explains the manner in which the drug is to be prescribed. While doctors may prescribe drugs as they see fit, its illegal for drug companies to promote drugs for uses outside the labeling.
However, as vividly evidenced here, drug makers do it and get away with it all the time and the leaked Lilly documents prove that the US court system is aiding and abetting drug companies in hiding their illegal marketing schemes.
For instance, in one article, the Times quotes a sealed document that served as a script for a company meeting in 2001, where a Mr Bandick praised sales representatives for the number of new Zyprexa prescriptions they got doctors to write. According to the script, more than 100 representatives convinced doctors to write at least 16 extra prescriptions.
The legal battle over the documents began in December 2006, when Dr David Egilman, provided the documents to Alaskan attorney, Jim Gottstein, and Mr Gottstein turned them over to Alex Berenson, a reporter for the New York Times.
Dr Egilman first learned about Lilly's illegal conduct when he reviewed the documents a few years back as an expert witness in the Zyprexa litigation. However, when Lilly was successful in the settling the cases out of court, Dr Egilman was forcibly silenced because the court allowed Lilly to continue to keep the documents hidden with a protective order.
As soon as the articles began to appear in the New York Times, describing an off-label marketing scheme called, "Viva Zyprexa," Lilly got a judge to issue a mandatory temporary injunction on December 18, 2006, ordering Mr Gottstein to return the documents and list the names of everyone he disclosed them to or discussed them with.
After he supplied the list, Lilly got the court to issue a second temporary injunction on December 29, 2006, to prohibit the dissemination of the documents by Terrie Gottstein, Jerry Winchester, Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, Bruce Whittington, Dr Stefan Kruszewski, Laura Ziegler, Judy Chamberlin, Vera Sherav, Robert Whitaker, and Will Hall.
The above list reads like a Big Pharma hit list. It includes about every well-known expert on the side effects of psychiatric drugs in the US, as well as the journalists and authors who have investigated and written most extensively about the misconduct of drug companies when it comes to the off-label promotion of drugs, and specifically Zyprexa.
Conspicuously absent from the injunction is the New York Times and the reporter who actually used the documents when writing five articles on the matter. Most curious is the fact that Lilly has never even asked the court to issue an injunction for the Times.
On January 3, 2007, a hearing was held on a request by Lilly to extend the temporary injunction, and to force Mr Gottstein to appear in New York City for a deposition within 5 days, as a prelude to charging him with civil and criminal contempt of court for publicizing the documents.
As a result of that hearing, several more entities were added to the injunction list including Eric Whalen and his web site at www.joysoup.net; the MindFreedom web site at www.mindfreedom.org, and the Alliance for Human Research Protection (AHRP) web sites at www.ahrp.org and www.ahrp.blogspot.com.
Once again, the Times and Alex Berenson were not added, and in fact, during the hearing, Judge Jack Weinstein said he was not about to issue an injunction against the Times.
By its own estimate in the media, Lilly produced approximately 11 million documents in discovery for Zyprexa litigation thus far, and has designated them all confidential pursuant to Case Management Order 3, a protective order entered on August 9, 2004.
When issuing CMO-3, the court gave Lilly the right to designate documents confidential, as long as Lilly "in good faith" believed that they were. However legal experts say the secret documents at issue here never should have been covered by a protective order.
According to attorneys in the case, in entering CMO-3, the court did not articulate the reasons why a protective order was necessary or set forth any criteria to use when determining whether a document was actually confidential and deserving of protection.
Yet instead of keeping the focus on why the 11 million documents were ever permitted to remain hidden in the first place, Judge Weinstein is allowing Lilly to hammer away at the messengers who gave the documents to the press, after deciding that the information needed to be circulated before more people were injured and killed.
In a January 17, 2007, hearing, Mr Gottstein was asked: "In this particular case involving Zyprexa, at the time you subpoenaed Dr. Egilman, had you the impression that Eli Lilly had deliberately withheld from the public and from physicians adverse side effects of Zyprexa?"
He answered: "Absolutely."
Mr Gottstein was then asked whether it was his impression that there were thousands of cases of harm to people from Zyprexa, while Lilly was in the process of settling cases out of court, and he said yes and that was why he wanted the documents out there "to protect people from this drug."
He had nothing to gain personally by providing the documents the Times. Mr Gottstein testified that he does not represent clients who were injured by Zyprexa for money damages and that his sole interest was protecting patients.
On January 25, 2007, in response to a request for Dr Egilman to appear at a deposition in preparation for Lilly to file civil and criminal contempt of court charges against him, though his attorney, Dr Egilman informed Lilly's legal team that he will refuse to testify under the protection of the Fifth Amendment.
A number of persons restrained by the injunction have obtained attorneys to file briefs with First Amendment arguments including the public's right to know what is in the documents and some people appeared at the last court hearing.
Ms Sharav and Dr Cohen point out in their brief, that they are not ex-employees of Lilly who have stolen trade secrets. They are merely a public health advocate and a professor who seek to share Lilly's own words with the public and they view exposing the information that "Lilly wants so desperately to keep hidden" as their primary public role.
Ms Sharav testified at the January 17, 2007, hearing, and when asked why she was interested in the documents by a Lilly attorney, said because they document the fact that Lilly knew in 2000, that Zyprexa caused diabetes, "from a group of doctors that they hired who told them you have to come clean."
"And instead of warning doctors who are widely prescribing the drug," she testified, "Eli Lilly set about in an aggressive marketing campaign to primary doctors."
"Little children are being given this drug," she said, "Little children are being exposed to horrific diseases that end their lives shorter."
"Now, I consider that a major crime," she stated, "to continue to conceal these facts from the public is I think really not in the public interest. This is a safety issue."
Lilly's attorney asked the court to strike her comments from the record but the request was denied.
Attorney, Alan Milstein, appeared on behalf of Ms Sharav, the AHRP, and Dr Cohen, and toward the end of the hearing noted that in handling the underlying Zypexa litigation, the judge had had occasion to look at the documents in question or at least to read the Times articles and stated: "What is abundantly clear is that they are not trade secrets."
"Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo," Mr Milstein told Judge Weinstein.
"What Lilly wants to prevent," he said, "is the public at large, the consumers of its products, from seeing these documents and learning the truth about the product that Lilly produces and the way it markets it."
"Documents like that are not confidential and should not be marked confidential," he stated.
At the end of the hearing, the judge instructed the parties to file more briefs and another hearing is scheduled for February 7, 2007, for oral arguments.
In the latest turn of events, right out of the blue, Judge Weinstein issued an order this week with an "invitation" for Mr Berenson to appear in court to give testimony and be cross-examined on whether he participated in a conspiracy with Mr Gottstein and Dr Egilman to violate the original court order that sealed the documents.
In the meantime, while this circus plays out in the courts, every day thousands of doctors and patients are making uninformed decisions on whether to use Zyprexa. And the injury clock is ticking.
Allen Jones, a former fraud investigator in the Pennsylvania Office of Inspector General, states: "My best effort at correlating dollars spent with deaths suggests that people may be dying from side effects at the rate of at least one death for each one million dollars spent on the drug."
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