Mr Gottstein contends that the information sought from Eli Lilly, AstraZeneca and Johnson & Johnson will show that the side effects of the drugs were well-established by the drug makers' own clinical trials and therefore, his client should not be forced to take such medications against his will.
According to Mr Gottstein, various off-label combinations of Risperdal, Seroquel, Zyprexa and the anti-seizure drug Depakote have been administered to his client in the past, over his objections, which have not been FDA approved as safe or effective for use in any patient.
The subpoena issued to Sidney Taurel, Chairman and CEO of Eli Lilly calls for the production of the same documents requested by Congressman Henry Waxman (D-Cal), as chairman of the House Oversight and Government Reform Committee, on March 1, 2007.
On March 1, 2007, Rep Waxman sent letters to both Lilly and AstraZeneca, requesting extensive information about their marketing practices. The letter to Lilly states in part, "Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa," and requests information relevant to these allegations.
The letter asks for a list of all Zyprexa trials, studies, or reports; all presentations given to employees who promoted Zyprexa; information shown to physicians; presentations related to prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.
The letter to Astra basically asks for the same documents except that Rep Waxman asks for more information related to the physicians and authors involved in company sponsored studies on Seroquel and writing the reports.
However, Rep Waxman also asked Lilly to turn over a batch of documents that were kept under seal for years with a court order issued by a federal court in New York, but were provided to him by Attorney Gottstein in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.
Mr Gottstein originally obtained the documents by subpoenaing Dr David Egilman, who served as a plaintiffs expert witness in the Zyprexa Products Liability litigation, pending in the United States District Court in the Eastern District of New York (MDL 1596), for a case unrelated to the Products Liability case.
The MDL 1596 litigation involved tens of thousands of lawsuits filed by Zyprexa victims who alleged that Lilly illegally marketed the drug for off-label uses and concealed the serious side effects known to be associated with Zyprexa for a decade.
As soon as Mr Gottstein received the documents he provided copies to reporter, Alex Berenson, at the New York Times, and to a number of other journalists, patient rights activists and advocacy groups and several leading experts on psychotropic drugs.
Once a medication is approved to treat one condition, doctors may prescribe it off-label for other indications if they think it will be effective, but drug makers are barred by law from encouraging physicians to prescribe a drug for uses other than those listed on the FDA approved label. But in recent years, its a well-known fact that off-label promotion has become the industries primary marketing tool when it comes to psychiatric drugs.
"Off-label" use also includes treating an approved condition for a longer duration of time, or in combination with other drugs, or at a different dosage, or with a different patient population such children or the elderly, than are listed on the label.
Zyprexa (Lilly), Risperdal (J&J) and Seroquel (AstraZeneca) belong to a class of drugs known as "atypical" antipsychotics. The other atypical drug include Abilify (Bristol Meyers Squibb), Geodon (Pfizer) and Clozril (Novartis).
The drugs were FDA approved only to treat schizophrenia and the manic phase of bipolar disorder in adults and have never been approved for use in combination with each other.
The many lawsuits filed against Lilly allege that the company's off-label marketing campaigns included influencing doctors to prescribe the drug to millions of patients ranging from toddlers to the elderly for an exhaustive list of unapproved uses such as anxiety, sleep disruption, mood swings, post-partum depression, autism, attention deficit hyperactivity and dementia.
According to Harrisburg Pennsylvania psychiatrist, Dr Stefan Kruszewski, the atypical drugs can increase the risk of drastic weight gain, diabetes, pancreatitis, hypertension, heart attacks and stroke.
"The drugs can cause both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," he explains, "at the same time that they cause the neurological side effects as the older antipsychotics such as akathesis, a severe restlessness and tardive dyskinesia an often irreversible movement disorder."
As an expert witness in the case, Dr Egilman reviewed the Lilly documents kept under seal by the court order and learned that Lilly had indeed engaged in a massive off-label marketing scheme to increase profits by encouraging doctors to prescribe the drug for unapproved uses and had concealed the drug's serious side effects.
As a physician, after learning what was in the documents and knowing the harm that was sure to come to patients who continued to take Zyprexa, Dr Egilman was clearly facing a major ethical dilemma.
At the time, Lilly had already managed to keep the documents hidden by settling out of court with about 8,000 Zyprexa victims in 2005 by paying close to $700 million, after only five plaintiffs had provided depositions and before any substantive depositions could be taken from any of the Lilly defendants.
And the first batch out of court settlements did nothing to deter the off-label sales of Zyprexa. According to Lilly's SEC filings, sales in the second quarter of 2006 totaled $1.12 billion, or a 2% increase over the second quarter of 2005.
In addition, Dr Egilman was aware that the company was getting ready to settle with about 18,000 more Zyprexa victims, and that the second round of settlements would guarantee that the secret documents would remain sealed.
And as a condition of settlement, the 28,000 plaintiffs had to sign agreements promising never to discuss the charges made against the company related to Zyprexa.
According to several plaintiffs who settled out of court, they we were not aware that there were documents that showed in many instances that Lilly knew full well that the injuries suffered could occur and had intentionally concealed the information from doctors and patients because it would have had a negative impact on Zyprexa sales.
In fact, these plaintiffs said they were never told that these secret documents even existed much less that by signing settlement agreements they would be allowing more patients to be injured or killed because the documents would remain sealed.
They also said that they were completely surprised to learn that their attorneys had access to documents that could have been presented to a jury to prove that the allegations in their lawsuits were true when the media began reporting the story in December 2006.
For instance, a November 12, 1999, letter from a Dr Albert Marrero, to Lilly's medical director, described the blood sugar problems occurring in patients. "We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars," he stated.
Dr Marrero also told Lilly: "Two patients had to be hospitalized due to out of control diabetes....We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent," he wrote.
A November 1999 report showed that after examining 70 clinical trials, Lilly found that 16% of patients on Zyprexa for a year had gained over 66 pounds but instead of informing doctors of this information, the company used data from a smaller group of trials to say about 30% of patients gained only 22 pounds.
Another document showed that in 2000, after a group of diabetes doctors retained by Lilly substantiated the diabetes risk, a Lilly manager stated in an email, "unless we come clean on this, it could get much more serious than we might anticipate."
A email dated two years later in March 2002, shows that Lilly shot down a plan to provide doctors with information about diabetes, because it would draw too much attention the risk. "Although M.D.'s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa," the email stated.
Although the documents clearly show that Lilly had knowledge of these life-threatening health risks in 1999, it did not add a warning about blood sugar levels and diabetes to the Zyprexa label until the FDA forced it to in the fall of 2003. In fact, Japan and the UK issued warnings about the increased risk of diabetes in 2002.
According to Ellen Liversridge, whose son took Zyprexa and gained 100 pounds before he fell into a coma and died of profound hyperglycemia in 2002, "both the FDA and Lilly fought putting a warning on the label, until articles on the front pages of the New York Times, Baltimore Sun, and Wall Street Journal so embarrassed the FDA that they finally gave in to adding the warnings."
But even then she says, the FDA required the same warning on the labels of all atypical drugs, "when Zyprexa was associated with a 37% higher increase in the risk of diabetes when compared to other medications."
However, the secret documents show that Lilly was hard at work behind the scenes to make sure that the new warnings would have minimal effects on Zyprexa sales. A July 7, 2003, memo titled, "Diabetes Update," described a plan to protect doctors who were afraid of being sued for prescribing Zyprexa after the news of the diabetes risk became public that would indemnify doctors who continued to prescribe drug
"We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase)," the Update said,
"solely on the basis of personal fear (of being sued)."
"Indemnification represents the most meaningful demonstration of confidence in Zyprexa--both with our customers and with our employees," it stated.
The memo also discussed a plan to pay millions of dollars to the National Alliance on Mental Illness, the most notorious industry backed front group in the nation, to help downplay the news about the diabetes risk.
The public health crisis created by patients who developed diabetes as a result of using Zyprexa is real. A Medicaid fraud lawsuit filed against Lilly by the attorney general of Mississippi in July 2006, alleges that about 10% of patients who used Zyprexa in that state have developed insulin-dependent diabetes and some are children, the complaint says.
When forced to make a decision on whether to warn the public about Zyprexa or abide by a court order that could result in the death and injury of thousands upon thousands of more people, Dr Egilman obviously followed the natural instinct of any decent human being and gave up the documents.
Whether or not he actually realized what consequences he might face is anyone's guess, but he no doubt recognizes the consequences of crossing the drug giant today.
On September 7, 2007, Lilly issued a press release with the headline: "Egilman Admits Wrongdoing in Illegally Releasing Documents to New York Times and Resolves Case to Avoid Possible Civil and Criminal Sanctions".
The release said that Dr Egilman will pay $100,000, and in return, the company "agreed to forego seeking criminal and civil penalties against Dr. Egilman for his illegal activities."
Although it will be interesting to see how many "Good Samaritans" will stick their neck out for the common good after hearing about Dr Egilman's fate, it is apparently still easy to find doctors willing to prescribe Zyprexa off-label because SEC filings show Lilly earned $4.36 billion from the drug in 2006
With all that said, on September 6, 2007, it was certainly a Deja Vue moment when the judge in Mr Gottstein's latest case against forced drugging in Alaska, issued an order to have the court hearing and file closed, even though the client had elected to have it open.