Evelyn Pringle January 15, 2007
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.
And more states could still sue, H Blair Hahn, an attorney who has been involved in the Zyprexa cases, told the Star. "That litigation is many times larger than what Lilly has dealt with to date," Mr Hahn said. "Their liability could be in billions in those cases."
Mr Gottstein is not alone in his attempts to stop the Zyprexa drugging for profit schemes. Other people who have been injured by the drug, or their family members, have been writing letters to law enforcement officials calling for a criminal investigation of Lilly for concealing the adverse effects of the drug and marketing it for unintended uses.
Richard Bleecker, whose nephew died unexpectedly at age 39 of hyperglycemia, wrote to the attorney general in his state and said in part:
"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."
"I appeal to you," Mr Bleeker wrote, "to investigate Eli Lilly's willingness to see patients suffer and die to enhance its profits."
He informed the AG that New Jersey itself has an interest in this 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."
"Despite the FDA restrictions on use and warning labels," he told the AG, "the drug continues to be vigorously promoted by Lilly and prescribed for patients in record numbers, including children."
According to a Medicaid fraud lawsuit filed in West Virginia, Lilly illegally promoted the sale of Zyprexa in that state to patients of all ages for the off-label treatment of dementia, anxiety, sleep disruption, mood swings, and attention deficit hyperactivity.
On July 24, 2006, Mississippi filed a lawsuit alleging that Lilly engaged in a calculated marketing plan to defraud the state Medicaid program out of millions of dollars for off-label uses of Zyprexa and "Mississippi is spending millions of dollars on Zyprexa® for patients who are not indicated for the drug; and further, who are being harmed by it."
Even though the drug is not approved for any use with children, Lilly's off-label marketing efforts have led doctors to prescribe Zyprexa to many children including infants and toddlers. On April 25, 2005, the Columbus Dispatch reported a review of Ohio Medicaid records that found 18 newborn to 3 years-old babies had been prescribed antipsychotic drugs in the month of July 2004.
A study directed by Oregon Health & Science University professor David Pollack, found 246 preschool children covered by the Oregon Health Plan receiving antipsychotic or antidepressant drugs, with 41% prescribed for attention deficit disorder.
In February 2006, Florida's public health officials ordered an independent investigation into why the number of children on Medicaid in that state taking antipsychotics has nearly doubled over the past five years from 9,500 to almost 18,000.
This off-label prescribing is killing children. A USA Today report on May 1, 2006, based on an analysis of FDA data, determined that at least 45 children had died with an atypical listed as the "primary suspect," between 2000 and 2004.
Zyprexa is also being fed to elderly patients with grave consequences. In April 2005, the FDA warned that the new antipsychotics had been linked to deaths from heart failure and pneumonia in elderly dementia patients and instructed drug makers to revise their drug labels to include strong warnings about the increased risk of death.
Any Zyprexa death count would have to include suicides because investigative journalist, Robert Whitaker, reports that "researchers in Ireland reported in 2003 that since the introduction of the atypical antipsychotics, the death rate among people with schizophrenia has doubled."
In addition, according to the June 12, 2006, New York Times, more mentally ill patients are dying from diabetes and complications like heart disease. "Uncontrolled diabetes can ruin a person's life as much as uncontrolled schizophrenia," Dr Newcomer, a professor of psychiatry at Washington University in St Louis, told the Times.
A 2003 survey by the City's health department, found that about 17% of adults who reported symptoms of a mental illness, or about 52,000, also had diabetes and the cost of atypical-induced conditions is taking a toll on public programs. "Mental illness is itself a money sponge," the Times notes, "an expense borne largely by tax dollars."
"But that cost may be dwarfed," the Times points out, "by the bill to manage the heart attacks and amputations that diabetes bestows."
Probably because its impossible to estimate how much Zyprexa injuries will end up costing tax payers in the future, a class actions filed in New York, on February 28, 2006, requested payment for monitoring all people who have taken Zyprexa but have not yet been diagnosed with pancreatitis, diabetes or high blood sugar.
There is no telling how many people have actually died while Lilly concealed the risks and raked in billions of dollars each year. Former federal fraud investigator turned whistleblower, Allen Jones states that correlating dollars spent with deaths from side effects suggests that people may be dying at the rate of at least one death for each one million dollars spent.