In deciding whether to allow Eli Lilly to continue to use court orders to hide documents that show the company illegally marketed Zyprexa for unapproved uses and failed to warn the public about the serious health risks associated with the drug for a decade, the court needs to consider the harm done to the public by Lilly's conduct.
The public has a right to know everything about the drugging for profit scheme revealed in the documents since the majority of profits made off Zyprexa came from the public trough. The court needs to recognize the harm done to tax payers in billing public health care programs like Medicaid for the massive off-label sale of the drug. According to the October 23, 2005, San Francisco Chronicle, nationwide, Medicaid programs purchase an estimated 60 to 75% of antipsychotic drugs.
In California for instance, in the year ending June 2005, Zyprexa was the highest expenditure at close to $250 million. On November 28, 2005, the Indianapolis Business Journal listed Zyprexa as the most costly antipsychotic covered by South Carolina's Medicaid program with a month's supply of 20-milligram tablets costing South Carolina $700.52 at the time.
On September 29, 2005, Bloomberg News stated that Medicaid could reduce the "$5.5 billion it spends annually on schizophrenia drugs for the poor" because a study found the cheaper generic, perphenazine, about as effective as new drugs, including Zyprexa.
"The 40-year-old drug perphenazine costs less than $1.50 a day," Bloomberg wrote, "while the newer medicines can cost 10 times as much."
When buying a 3-month supply, at drugstore,com, the retail price for Zyprexa in September, 2005 was $1,500, and a 3-month supply of perphenazine, was only $135.
Lilly has even found ways to convince doctors within the Veteran Administration's hospital system to prescribe Zyprexa rather than the older, cheaper and equally effective drugs. Dr Robert Rosenheck, a Director with the Department of Veterans Affairs, reviewed the prescribing records for schizophrenic patients in the VA system for 2003 and found that more than 80% were on the new antipsychotics. He calculated that the VA spent more than $208 million on antipsychotics that year, with over $106 million, or more than half, spent on Zyprexa.
According to the New York Times, the company documents at issue show that Lilly knew full well about Zyprexa's association with diabetes and weight gain that often leads to diabetes. The public's right to know about this charge can not be easily dismissed considering the costs to the public of paying for the care of the tens of thousands of Zyprexa victims who developed diabetes.
By using fraud, kickback and antitrust statutes, state attorneys general all over the US are filed lawsuits against Lilly to recover the money paid for Zyprexa, and the medical costs for patients harmed by Zyprexa, whose health care is covered by public programs.
In February 2006, West Virginia and Alaska filed lawsuits against Lilly alleging the company marketed Zyprexa for unapproved uses in those states and as a result it has cost millions of dollars to care for patients who developed diabetes and other diseases.
West Virginia is seeking payment for all medical costs related to Zyprexa, in addition to the more than $70 million the state paid for the drug. The lawsuit says studies have linked Zyprexa to diabetes since 1998, and that sales representatives misled doctors about the safety and the efficacy of Zyprexa and that Lilly's advertisements deceptively understated its risks and overstated its benefits.
The complaint alleges that Lilly promoted "off label" prescriptions for a host of conditions including anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia. "Lilly benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs," the complaint states.
A lawsuit was filed by the attorney general of Mississippi, JimHood, in July 2006, to recoup the ill-gotten gains that Lilly enjoyed by promoting the off-label use of Zyprexa in that state, and alleges that Lilly knew Zyprexa increased the risk of diabetes, because in April, 2002, nearly a year and a half before Lilly first warned doctors and consumers in the US, the company changed Zyprexa's labeling in the UK and Japan to include warnings about the drug's association with diabetes related injuries.
Tim Balducci, Mississippi special assistant attorney general, says Lilly targeted Mississippi because the state's Medicaid program is not set up to signal when a doctor prescribes a drug off-label.
According to Mr Hood, about 10% of Zyprexa patients have developed diabetes, some of whom are children, even though Zyprexa "has never been approved for, nor found to be effective, in the treatment of children."
The fact is, Lilly has doctors prescribing Zyprexa off-label to children and billing state Medicaid programs all over the country. For instance, a study in the August 3, 2004, Archives of Pediatric Adolescent Medicine, found the number of Tennessee children covered by TennCare, who were prescribed antipsychotics nearly doubled in six years. The largest increases were among children aged 13 to 18 at 116%, followed by a 93% increase in children aged 6 to 12, and a 61% increase in use with preschool children.
