Information from the documents related to Lilly's antipsychotic drug, Zyprexa, was highlighted two days in a row in front-page articles in the Times
The documents reveal the illegal marketing schemes used by Lilly to make Zyprexa its best-seller, which the company has managed to keep hidden for years by entering into out of court settlements in civil lawsuits which included confidentiality clauses and by getting judges to place the documents under protective orders to shield them from public view.
For instance, the documents under seal here are from a case where Lilly entered into an out-of-court settlement in June 2005, and agreed to pay $690 million to cover claims by about 8,000 Zyprexa victims. But in order to get paid, the plaintiffs were required to sign a confidentiality clause and basically keep their mouths shut about Zyprexa from then on.
It's really comical the way Lilly keeps acting all indignant over the disclosure of these documents as if they contain brand new charges, when the company has been under federal and state investigations related to its off-label marketing of Zyprexa for several years already. The company is also facing Medicaid fraud charges in lawsuits all over the county.
In 1996, Zyprexa was approved for the treatment of adults with schizophrenia, and a few years later, it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.
Yet despite these extremely limited approved uses, Zyprexa went on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly's best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.
The documents provided to Times, span a decade and clearly show that the company promoted off-label the sale of Zyprexa for uses not approved by the FDA as being safe and effective. They also reveal that Lilly knew about Zyprexa's link to drastic weight gain and diabetes for years but failed to inform prescribing doctors and consumers.
In fact according to the Times, Lilly knowingly distributed false information to doctors about the risks as late as 2001. On December 21, 2006, the Times reported that the information provided to doctors about the blood-sugar risks of Zyprexa did not match data circulated inside the company after a review of Lilly's clinical trials.
The Times quotes a Lilly report from November, 1999, that shows that after examining 70 clinical trials, Lilly found that 16% of patients taking Zyprexa for a year had gained over 66 pounds. But instead of making these findings public, the company used data from a smaller group of trials that showed roughly 30% of Zypexa patients gained 22 pounds.
Mr Gottstein is not involved in the case in which the judge issued a protective order In re: Zyprexa Products Liability litigation, MDL No. 1596, United States District Court, Eastern District of New York (MDL 1596), "in any manner whatsoever," he says.
He is the leader of, "The Law Project for Psychiatric Rights" (PsychRights), a public interest law firm devoted to the defense of people facing forced psychiatric drugging against their will.
Currently, Mr Gottstein represents an Alaskan patient and says the injunction will prevent him from using the Lilly documents to show that the side effects of Zyprexa are well-established by the company's own clinical trials and therefore, his client should not be forced to take such drugs against his will.
In Myers v Alaska Psychiatric Institute, 138 P.3d 238 (Alaska 2006), a case argued by Mr Gottstein last summer, the Alaska Supreme Court ruled that Alaska's forced drugging procedures were unconstitutional because they did not require the court to find such drugging to be in the person's best interests, and that there were no less restrictive
In order to present the evidence in the case he is handling now, Mr Gottstein is looking to the Alaskan courts to issue a ruling that says his client's right to avoid forced drugging outweighs Lilly's right to keep the information about risks hidden.
He says the documents are highly relevant to a court inquiry, now required in Alaska, before a court can make an informed decision about whether to order forced drugging for his client.
In a December 17, 2006, letter to the court in the New York case, Mr Gottstein stated: "In large part, this state of affairs has been created by the lies told by the manufacturers of psychiatric drugs."
"My impression is," he wrote, "that Eli Lilly's lies about Zyprexa form the basis of the plaintiffs' claims in MDL 1596, but that is not PsychRights' focus."
"PsychRights' focus," he explained, "is helping people avoid being forcibly drugged pursuant to court orders, where the courts have been, in my view, duped by Eli Lilly and other pharmaceutical company prevarications."
"In my view," Mr Gottstein concluded, "the proper disposition of the question would be in favor of my client's right to inform the court of the extreme harm caused by Zyprexa, which Eli Lilly has successfully hidden for so long, while making its billions off the pill."
A court hearing was held in Brooklyn, New York, on a December 18, 2006, on a motion by Lilly, asking the court to order Mr Gottstein to return the documents to the court, and to bar him from disseminating them any further.
According to the transcript, Lilly also asked the court to require Mr Gottstein to "preserve all emails and all correspondence of any kind, whether it's voice mail, written letters, emails, so that we can pursue a contempt proceeding against both he and Dr Egilman."
Even though the Lilly documents prove that the company knew that Zyprexa was causing diabetes, and kept pushing the drug anyways, potentially harming millions more patients, the judges gave Mr Gottstein hell and threatened to find him in contempt for doing nothing more than warning the public about the side effects of Zyprexa after Lilly concealed the information for a decade.
There is not one single word in the transcripts about Lilly knowingly injuring and killing people with Zyprexa or illegally pushing the drug to unwitting victims for off-label use.
Instead, Judge Brian Cogan, granted Lilly's motion, and told Mr Gottstein's attorney that his client, "deliberately aided and abetted Dr Egilman in getting these documents released from the restriction that they were under, under the protective order. He knew what he was doing, and he did it deliberately."
Judge Cogan went on to tell the attorney, "your client should be on notice that of this moment, he is under a mandatory injunction to return those documents ... to take them down from any websites that he may have posted them on, and to take any reasonable effort to recover them from any sites or persons to which he has delivered them."
On December 18, 2006, at an earlier telephone conference in Brooklyn, Judge Roane Mann also did not utter one word about Lilly's illegal conduct, but instead admonished Mr Gottstein for not playing fair with poor Eli Lilly in making the information about Zyprexa public, stating:
"I personally am not in a position to order you to return the documents. I can't make you return them but I can make you wish you had because I think this is highly improper not only to have obtained the documents on short notice without Lilly being advised of the amendment but then to disseminate them publicly before it could be litigated. It certainly smacks as bad faith."These judges apparently believe that an expert, such as Dr David Egilman, who is hired to review documents in a case and subsequently learns that people are being seriously injured and killed, should be forced to keep that knowledge a secret if a judge issues a protective order.
There is something very wrong with this picture. It begs the question of how can an ethical doctor not speak if he knows that patients are being harmed.
The reason always cited for the need to keep documents under seal is the claim that the information contains trade secrets. However, just as Lilly has done here, drug companies have for too long been abusing the process by using protective orders to hide illegal conduct by concealing documents that show the company is illegally promoting the off-label use of a drug or that a drug can cause serious injuries or that a drug does not work.
In a case like this, if a court truly does not have a choice and is required to seal documents even when they show blatant illegal conduct on the part of a drug company, then Congress had better get busy and pass a law to stop the use the US court system to protect what could very easily be described as corporate murder.
In response to an earlier article on this issue, reader Larry Bone wrote and asked this author, "Is the corruption on this so widespread that no one would dare prosecute?"
"It is criminal behavior," he points out, "on a huge scale that is being virtually totally ignored by the authorities responsible for the public safety."
"I just feel," Mr Bone wrote, "that there has to be an attorney or someone in a judicial or ethical capacity who would have the guts, and persistence to prosecute Lilly."
"It seems incredibly ridiculous," he states, "let alone obscene, that such blatant wrongdoing seemingly continues to be ignored by the legal authorities with jurisdiction over these sorts of cases."
"If these companies believe they have done nothing wrong," he says, "then let them prove their innocence in court."
Ellen Liversridge also wants a criminal investigation of Lilly. She lost her 30-year-old son, Rob, to the adverse effects of the drug. "He gained almost 100 pounds while taking Zyprexa," Ellen says.
"Rob lapsed into a coma," she recalls, "and died of profound hyperglycemia four days later on October 5, 2002."
"I believe that the people who did this should have a criminal trial," Ellen says. "Enron executives went to prison for wiping out people's life savings," she points out.
"Lilly executives should go to prison," she says, "for knowingly being responsible for people's deaths, shattered families; ruined and grieving families."
Ellen has nothing but praise for the New York Times and its source. "I am grateful to Jim Gottstein for making available this awful truth and hope it results in justice being done."
"If there can ever be justice for a crime as heinous as this," she adds.
Daniel Haszard, of Bangor Maine, feels the same way. In 1996, he was prescribed Zyprexa off-label to supposedly treat Post Traumatic Stress Disorder, and he remained on the drug for 4 years.
Although he paid $250 a month for the drug, Mr Haszard says the drug did not relieve his symptoms of PTSD at all and in early 2000, he was diagnosed with diabetes.
He was shocked to hear the diagnosis, he said, because there was no history of diabetes in his family. Just as thousands of other Zyprexa victims, Mr Haszard did not make the connection between his diabetes and the drug until he saw a commercial for a law firm in December 2005.
Zyprexa causes diabetes, he says, and public health programs are left to pick up the tab for the medial expenses. According to Mr Haszard, "there are now 7 states going after Lilly for fraud and restitution," related to the promotion of Zyprexa for off-label use and the concealment of its risks.
Dr Stefan Kruszewski, MD, a Harvard trained, certified psychiatrist in adult, adolescent, and geriatric psychiatry, from Harrisburg, Pennsylvania, also finds Lilly's conduct appalling.
"Neither health professionals nor consumers," he states, "can accurately provide information about the risk and benefits of a drug like Zyprexa - or any drug for any condition - without a comprehensive awareness of the risks and benefits."
"If the clinical research data regarding effectiveness, efficacy or safety is sequestered or misrepresented from observation studies, randomized drug trials or meta-analyses," he says, "then it is not possible for any provider to give any patient what he or she needs to make an informed consent."
"At that point," Dr Kruszewski says, "individuals receive drugs that may or may not help them, but always at their own peril."
"Zyprexa causes both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," Dr Kruszewski advises, "at the same time that it continues to cause neurological side-effects like the older antipsychotics."
"Zyprexa and its antipsychotics cousins," he explains, "were marketed to be safer and easier to tolerate because the pharmaceutical companies said that the newer drugs caused fewer neurological injuries, like restlessness or 'akathesia,' and tardive dyskinesia."
Those assertions are false he says, and "what we have now is a drug whose massive revenues and promotion are based upon faulty disclosures by Eli Lilly."