Popular Zyprexa linked to illnesses
Schizophrenia drug at center of lawsuit
Saturday, March 17, 2007
Harlan SpectorPlain Dealer Reporter
The Ohio Medicaid program has spent hundreds of millions of dollars on the schizophrenia drug Zyprexa, at the same time Ohio and other states pursue its maker in court because of adverse medical problems caused by the drug.
For several years, the schizophrenia drug introduced in 1996 has been linked to extreme weight gain and elevated blood sugar that causes diabetes. Its maker, Eli Lilly and Co., has settled more than 28,000 cases for more than $1 billion and faces still more lawsuits and investigations.
Several states are investigating whether Lilly improperly marketed the drug and concealed its risks. Some are suing to recover Medicaid money spent caring for Zyprexa users.
Lilly said in a statement that it is cooperating with state attorneys general but can't comment further. Ohio has not sued directly but has attached claims - for $7.5 million so far - to lawsuits involving 1,100 Ohio Medicaid beneficiaries.
Despite all that, Zyprexa remains Lilly's best seller and has been among the most expensive pharmaceuticals in state Medicaid programs, including Ohio's.
Last year, Ohio doctors prescribed Zyprexa 165,000 times to Medicaid patients, which doesn't include those enrolled in Medicaid managed-care plans. The state doesn't keep figures for prescriptions dispensed in managed-care plans, which last year covered about half of the state's 1.7 million Medicaid beneficiaries, officials said.
Of the prescriptions the state does track, more than 13,000 for Zyprexa were written for children under 19, who researchers say may be particularly vulnerable to weight gain and the diabetes effect.
"Awareness of cardiovascular and metabolic risks has yet to cool clinicians' enthusiasm" for Zyprexa and other new antipsychotics, said a December 2006 editorial in the American Journal of Psychiatry.
Medicaid officials say they have no choice but to pay for the drug because doctors are free to prescribe as they see fit.
Asked why Zyprexa remains a drug of choice, doctors chalk it up to this: There are simply no great treatments for the estimated 2.4 million American adults with schizophrenia. Doctors say they need Zyprexa in the arsenal of drugs because for some patients it works best at blunting delusions and other symptoms.
"There are still patients who benefit," said Dr. Cristinel Coconcea, medical director of inpatient psychiatry at University Hospitals Case Medical Center.
The Food and Drug Administration in 2003 ordered warning labels that Zyprexa and other new antipsychotics may cause high blood sugar. Doctors say they then stepped up blood sugar control and steered patients at risk for diabetes to other drugs.
"I personally have some patients who have been on [Zyprexa] a while and they like it," Coconcea said.
over drug's uses
The marketing of Zyprexa also may have fueled its popularity. The medication is approved for schizophrenia and bipolar disorder. But internal documents leaked to the New York Times show Lilly urged doctors to prescribe the drug for dementia, the newspaper reported in December.
While doctors are allowed to prescribe drugs "off label," drugmakers are not allowed to promote them that way. A Lilly spokeswoman said in an e-mail Friday that the company promotes drugs only for FDA-approved uses.
The company also encouraged primary care doctors to prescribe it for schizophrenia and bipolar, the Times reported, though primary physicians generally do not treat these illnesses.
The company responded that primary care doctors provide about half the medical care for serious mental illnesses.
"We believe that it is absolutely appropriate to discuss Zyprexa and its indicated uses with primary care physicians in the interest of meeting a critical medical need," spokeswoman Marni Lemons said in an e-mail.
Drug's side effects
at heart of dispute
The Indianapolis company also said research has not proven that Zyprexa causes diabetes.
The safety question is at the center of the federal case in New York involving 18,000 plaintiffs. The case was settled recently after the Times published stories about the internal documents, including disclosures that Lilly as early as 1999 played down concerns about side effects.
Lilly denies the allegation, saying doctors have always been informed of the potential risks of weight gain and diabetes. The company said Friday that the "handful" of leaked documents are among 15 million pages of confidential papers that Lilly provided in the case and that they do not represent an accurate view.
The judge ruled the documents were confidential and ordered the Times to surrender them. Patient legal advocates argued that the court was withholding important information from the public.
Richard Zitrin, a lawyer who founded the Center for Applied Legal Ethics at the University of San Francisco, said in an interview that such secrecy is not good for doctors, patients or state Medicaid programs.
"If the states are spending hundreds of millions on the drug, it may be they don't know what harm has been shown in the New York case," Zitrin said. "The states are being victimized by lack of knowledge."
The Ohio Medicaid program spent $391 million on Zyprexa from 2002 to 2006, which again does not count prescription costs for an increasing number of Medicaid patients enrolled in managed care plans. A 2004 report prepared for the Ohio Commission to Reform Medicaid said Zyprexa was the costliest drug in the publicly funded program.
Research leaves open to debate whether Zyprexa and other new antipsychotics are better or safer than older -- and far cheaper -- drugs. Lilly said Zyprexa's cost to public programs is offset by money it saves by decreasing hospitalizations.
In Ohio's state-run psychiatric hospitals, the use of Zyprexa has tailed off because of risks, state mental health officials said. The department spent $1.6 million on Zyprexa in 2006, compared with $2.6 million in 2002.
"It's not just that these patients are gaining weight or having modest gains in blood sugar. There is really a significant lifespan cost to all that," said Dr. Max McGee, an assistant medical director at the Ohio Department of Mental Health.
Zyprexa is still needed, though, McGee said. "Because these illnesses are so severe and so debilitating, all treatment options have to be available," he said. "The bottom line is none of these drugs work as well as we'd like them to. We need new medications."
Linda Johnson, 49, of suburban Columbus, is among the thousands of people who have sued Lilly. Johnson said she gained more than 60 pounds in 18 months that she took Zyprexa. She was later diagnosed with diabetes. The disease caused damage to the nerve endings of her stomach, she said, making digestion difficult.
"It's a very serious condition. I could lose my stomach over it," Johnson said in a telephone interview arranged by a Virginia law firm representing her and 650 other plaintiffs against Lilly.
"I would have never taken it [Zyprexa] if I had known," she said.
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