In turning the secret Eli Lilly documents over to the press, Mr Gottstein's goal was the same as Dr David Egilman's, to alert the public about Lilly's off-label marketing schemes aimed at getting doctors to prescribe Zyprexa to more patients who were unaware of the serious health risks associated with the drug.
Zyprexa was approved only for the treatment of adults with schizophrenia in 1996, and it wasn't until several years later, that it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.
In a February 13, 2007, interview with the Anchorage Daily News, Mr Gottstein explained that the secret document showed the rate at which Zyprexa caused diabetes, massive weight gain and other metabolic problems and how Lilly trained sales staff to mislead doctors about the drug's association with diabetes and illegally promoted Zyprexa for off-label use with children and the elderly.
As the playing field stands today, the average American alone would be lucky to find any law firm financially strong enough to take a drug giant like Lilly with its billions of dollars of power and a well that will never run dry in large part because the illegal off-label marketing of Zyprexa is ongoing and continues to earn billions of dollars each year.
However, a small group of patient advocates that included some of the most well-known psychiatric drug experts, journalists, and attorneys in the US went head to head with Lilly in the public battle in a US District Court in New York that dragged out over 2 months to lift an injunction that barred the public disclosure of information about the serious adverse effects of Zyprexa that Lilly had successfully kept hidden under a court order until the documents were leaked to the press in December 2006.
Lilly filed the motion for the injunction in attempt to get the documents back under seal and succeeded in muzzling just about every expert in the US involved in the fight to dismantle the mass-drugging schemes put in place by the pharmaceutical industry over the past 10 years including Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, and Dr Stefan Kruszewski, as well as the award winning journalist, Robert Whitaker, who wrote "Mad in America," and revealed all the negative information that showed up in the clinical trials conducted on Zyprexa and the other atypicals.
The score looked bad for the home team early on when Lilly won the second round by getting the court to add the names of two of the world's most powerful patient advocacy groups to the injunction, along with their internet web sites and leaders, including Vera Sharav, director of the Alliance for Human Research Protection, and Judy Chamberlin and David Oaks from the international organization MindFreedom, a coalition of about 100 advocacy groups in 13 different countries.
At the time, Mr Oaks said, "This appears to be about Eli Lilly using its billions of dollars to try to intimidate grassroots critics."
The New York legal battle turned into an all out war when Ms Sharav and Dr Cohen brought in the high profile attorney, Alan Milstein, to file their own motion asking the judge to unseal the documents because they should have never been designated confidential to begin with.
"What is abundantly clear," Mr Milstein told the judge in a hearing, "is that they are not trade secrets."
"Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo," he said.
"What Lilly wants to prevent, 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," Mr Milstein said in the hearing.
Alaskan Attorney, John McKay, stepped in to represent Mr Gottstien and his wife Terrie, and then attorney, Fred von Lohmann of the Electronic Frontier Foundation, widened the battlefield by filing a brief on behalf of John Doe, described as a citizen-journalist who wanted to publish the secret documents on web sites because they were "plainly related to a matter of overriding public concern."
California attorney, Ted Chabasinski, jumped in the ring on behalf of Robert Whitaker, Judi Chamberlin, and David Oaks. "While the injunction purports to be an attempt to recover the documents," he wrote in a letter to the judge, "it is clear that its real purpose is to intimidate Lilly's critics, and the court should refuse to cooperate with this."
Mr Chabasinski told the court that criminal charges should be filed against Lilly executives for illegally marketing Zyprexa for unapproved uses, with full knowledge that thousands of patients were being injured and killed. "If executives can go to prison for stealing their companies' money," he told the judge in a letter, "surely those who steal people's lives deserve at least the same fate."
Mr Chabasinski informed the court that the secret documents were evidence of Lilly executives' "criminal behavior" and their "willingness to kill people for profit." He also made it known that he was encouraging members of the public to contact state attorney generals and was directing private citizens to a list of current contact information for each state posted on the Mindfreedom web site.
And some citizens did just that. Richard Bleecker, whose nephew died unexpectedly of hyperglycemia due to Zyprexa, wrote to the New Jersey attorney general and stated: "In your capacity as New Jersey's Attorney General, I ask that you launch an investigation into Eli Lilly's violation of the public interest by its concealment of the risks of Zyprexa."
"Despite the FDA restrictions on use and warning labels," he wrote, "the drug continues to be vigorously promoted by Lilly and prescribed for patients in record numbers, including children."
He pointed that the state itself had an interest in the matter "since government programs like Medicare and Medicaid purchase over 70% of the Zyprexa sold in the USA, taxpayers in our State as well as across the nation are footing most of the bill."
"I appeal to you, to investigate Eli Lilly's willingness to see patients suffer and die to enhance its profits," Mr Bleeker wrote.
Over 10 states have now sued Lilly for Medicaid fraud over the off-label marketing of Zyprexa. And for good reason according to a report in the March 23, 2007, New York Times, that said Zyprexa costs more than $300 a month and is the single biggest drug expense for state Medicaid programs with spending of more than $1.3 billion in 2005.
During court hearings, several people restrained by the injunction testified about why the documents should be made public which resulted in media reports about what was in them before the legal battle even ended.
For instance, at a January 17, 2007, hearing, Mr Gottstein was asked, "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?"
And he answered: "Absolutely."
He was then asked whether he feared there would be thousands more cases of harm to people from Zyprexa, while Lilly was settling cases out of court, and Mr Gottstein said yes, and that he wanted the documents released "to protect people from this drug."
Mr Milstein told the judge that the documents were critically important to saving human lives and said, "this Court should in no way assist Lilly in keeping them from the public."
At the same hearing, Lilly attorneys asked Ms Sharav why she was interested in the documents and she said because they documented 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, Eli Lilly set about in an aggressive marketing campaign to primary doctors," she testified.
Ms Sharav told the court, "This is a safety issue," and "to continue to conceal these facts" from the public "is not in the public interest."
She said, "this is about the worst that I have seen."
"It borders on indifference to human life," she told the judge. "Eli Lilly knew that Zyprexa causes hypoglycemia, diabetes, cardiovascular damage and they set about both to market it unlawfully for off label uses to primary care physicians."
She said Lilly taught primary care doctors to diagnose patients as bipolar if they experienced mania after taking antidepressants. "That is absolutely outrageous and that is one of the reasons that I felt that this should involve the Attorney General," she testified.
Mr Sharav also objected to the off-label sale of Zyprexa to kids. "Little children are being exposed to horrific diseases that end their lives shorter," she testified.
She said, "the reason the drug became a four and a half billion dollar seller in the United States is because they encouraged the prescription for children, for the elderly, for all sorts of reasons."
"I consider that a major crime," she told the judge and said she asked Mr Gottstein for 2 copies of the documents so that she could deliver one copy to the New York attorney general.
By the time of that hearing, Ms Sharav no doubt was aware that the crime was ongoing because in January 2006, USA Today reported that although the atypicals are not approved for any use with children, the prescription rate for children "is growing dramatically faster than the rate for adults," quoting Robert Epstein, chief medical officer for Medco Health Solutions, pharmacy benefit managers.
In addition, an assessment by Christoph Correll, of the Child and Adolescent Psychiatric Clinics of North America, showed Zyprexa to be the worst of the atypicals for kids and listed the side effects of diabetes and weight gain with the drug as "severe."
Technically, on February 13, 2007, Lilly scored a knock-out punch when the judge issued a permanent injunction prohibiting Mr Gottstein and Dr Egilman from further disseminating the documents and allowed Lilly to keep them sealed under a court order.
However, the judge also acknowledged in his written ruling that there was no way he could not enjoin the world by extending the injunction to the internet and by that time the worldwide web was flooded with all the damning information.
And Lilly would soon learn that the push to make the information public extended far beyond the courtroom. On February 23, 2007, a grass roots advocacy group issued a press release to rally support for Mr Gottstein for providing the documents to the media and to announce the "The Just Say "Know" to Prescription Drugs Campaign," with a goal of getting one million people reevaluate the prescription drugs they were taking.
"If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it," said Dr Greg Tefft, co-founder of the Campaign.
"We're talking 20 million people potentially at risk and more being added daily," he added.
The group set out to educate the public about off-label prescribing and what consumers must do to protect themselves against Zyprexa, or other drugs, when they are prescribed without warnings about side effects or unapproved uses.
"We are convinced that the way to solve this problem is to work the demand side of the market," Dr Tefft said. "We are going directly to consumers and encouraging them to know what they are taking."
Chairman of the Campaign, Dr Dominick Riccio, hosted a Zyprexa radio series and Dr Laurence Simon provided information to consumers about the drug and they set up an official web site for the Campaign is http://justsayknow.kpncradio.com
A month and a half later, on April 4, 2007, the ranking Republican on the Senate Committee on Finance, Senator Charles Grassley (R-Iowa), was knocking on Lilly's door with a letter to the CEO saying, "I have an obligation to ensure that the public's money is properly spent to provide safe and effective treatments to the vulnerable populations that are beneficiaries of the Medicare and Medicaid programs."
"I am aware of several pending products liability actions regarding Zyprexa," he said, "and questions have been raised regarding safety information and marketing practices relating to that drug."
Senator Grassley also wrote, "I understand that Eli Lilly produced certain documents in the course of these litigations that shed light on issues of interest to the Committee," referring to leaked documents and said, "please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available ... pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig."
And in the end, it could be said that injunction or no injunction, the small group of warriors led by Mr Gottstein and Dr Egilman, who bravely banded together against the billion dollar giant helped make Lilly's worst nightmare come true by fighting against the injunction and keeping the spotlight on the documents that the company fought so hard to keep hidden, not so much from the public, but from the stockholders.
According to legal experts, Lilly's desperate filing for the injunction had nothing to do with the lawsuits filed by private plaintiffs because that litigation was the least of its worries being the company was settling the cases for peanuts with plaintiffs signing confidentiality agreements that would shut them up for life.
However, following the public disclosure of proof that Lilly had engaged in a 10-year illegal off-label marketing scheme while concealing the adverse effects of Zyprexa, the company was hit with the big Kahoona, when 4 class action lawsuits were filed in April 2007 on behalf of shareholders, alleging the fraud by Lilly and its top executives had cost them more than $30 billion, and the evidenced cited to support the allegations was the information from the secret documents that resulted in the battle over the injunction.
It remains to be seen whether these shareholder lawsuits will do anything to stop the drugging of kids in the US because as it stands right now the mass drugging campaign appears to be unstoppable. On September 5, 2007, Rob Waters reported that the number of antipsychotic prescriptions for children doubled to 4.4 million between 2003 and 2006, citing data provided to Bloomberg News by Wolters Kluwer NV, a drug-tracking firm.
Mr Waters also reported that the growth was most dramatic in the youngest children with 20,280 prescriptions written for kids aged 4 and younger, a five-fold increase over 2003, and with 5- to 9-year-olds, prescriptions increased almost six-fold to 710,937 in 2006.