Attorney, Jim Gottstein, is calling for Eli Lilly to issue a Dr Doctor letter to warn prescribing physicians about the serious health risks associated with Zyprexa, which has become Lilly's top selling drug even though it is only approved to treat adults with schizophrenia or bipolar disorder.
In a letter to Lilly's attorneys, Mr Gottstein wrote, "it is formally requested that your client, Eli Lilly, issue what is sometimes referred to as a "Dear doctor" letter to all health care providers in the United States advising them Zyprexa should not be prescribed to anyone who is not already taking it."
Mr Gottstein explains that Zyprexa should not be withheld from current users because abrupt withdrawal can cause Neuroleptic Induced Discontinuation Syndrome.
"It is now clear," he wrote, "that Zyprexa has no benefits over other neuroleptics, while causing far more cases of diabetes than do other drugs in its class."
"This represents a massive health disaster including at least thousands of past and inevitable future deaths," the letter states.
Other experts agree that doctors and consumers alike need to be warned about the health risks of Zyprexa and its atypical cousins. "Millions of unsuspecting patients and their unsuspecting physicians are using and prescribing these brain-altering drugs without full information as to their safety, an issue that has serious medico-legal implications for the doctors who are being influenced by the Psycho-pharmaceutical Complex to prescribe them so widely, often for off-label uses," Dr Gary G Kohls, warns in the paper, "Significant Dissociation of Brain and Plasma Kinetics With Antipsychotics," Preventive Psychiatry E-Newsletter #93.
Mr Gottstein's request for a Dear doctor letter is based in part on internal company documents he obtained last month in litigation that show Lilly was aware that psychiatrists were reporting that many of their Zyprexa patients were developing high blood sugar or diabetes, but company officials decided not to reveal the information to consumers and doctors because they knew the disclosure would have a negative impact on Zyprexa sales.
The Lilly documents span from 1995 to 2004, and show that Lilly engaged its sales force in off-label marketing schemes, one called "Viva Zyprexa," to convince doctors to prescribe Zyprexa for conditions other than those approved resulting in many more injuries and deaths then would normally be expected if the drug was used only for its approved indications.
The information about Lilly's illegal conduct was actually discovered several years ago in litigation. However, Lilly has been successful in keeping it from public view by obtaining protective court orders to keep the documents under seal and silencing thousands of plaintiffs by requiring them to sign confidentiality agreements when settling their cases out of court.
Last month, when Mr Gottstein realized the magnitude of Lilly's off-label marketing of the drug, he took the information to the New York Times, which published several articles quoting the documents and setting off a coast-to-coast firestorm in the legal arena.
Mr Gottstein obtained the documents from a doctor who served as an expert witness in a previous Zyprexa case and learned about the concealment of risks and off-labeling marketing scheme when he reviewed the documents several years ago.
As soon as the articles began to appear in the Times, Lilly's legal team began pursing legal action against the doctor and Mr Gottstein for disclosing the company's misdeeds to the media giant, and has been frantically trying to get the incriminating information back under seal with court orders ever since.
In addition to injunctions against Mr Gottstein and the expert witness doctor, Lilly has thus far been successful in getting a court in New York to issue injunctions against specific advocacy groups, journalists, authors, doctors, and web sites on the internet, to bar them from disseminating or communicating any information contained in the Lilly documents .
The out of court settlement in the earlier litigation, in which Lilly was able to keep the documents sealed, cost Lilly just under $700 million to settle with roughly 8,000 Zyprexa victims In re: Zyprexa Products Liability litigation, MDL No 1596, United States District Court, Eastern District of New York (MDL 1596).
Lilly recently announced that it had reached out of court settlements with about 18,000 more Zyprexa plaintiffs for around $500 million, which will bring the total for settlements so far to approximately $1.2 billion.
The fact that this new settlement was underway is probably what led to Lilly's over-the-top proclamations of outrage last month when the secret documents became public. But then again, Lilly is also probably worried about the information's impact in future cases because the company's legal troubles are far from over. According to the Indy Star on January 5, 2007, about 1,200 claims remain unsettled, and Lilly also faces lawsuits from several states, including Alaska, Mississippi, Louisiana and West Virginia, to recoup money paid out by Medicaid.
Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect.
Not fair~Daniel Haszard
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Danny Haszard (1 articles, 0 quicklinks, 0 diaries, 50 comments)
on Sunday, January 14, 2007 at 10:37:47 AM
