January 6

Lilly -Zyprexa Casualties-$1.2 Billion Settlements-More Casualties_NYT_WSJ

The latest Eli Lilly- Zyprexa settlement for another massive lawsuit brought by 18,000 people who claimed they developed diabetes or other diseases after taking Lilly’s antipsychotic drug is for $500 million. Another 1,200 plaintiffs are not part of the settlement.
Lilly is less concerned about settlements—having settled a Zyprexa lawsuit involving 8,000 plaintiffs for $690 million. Lilly’s greatest concern is public disclosure of the evidence contained in its own documents which are the basis for these settlements. The content of those documents was partly disclosed by The New York Times in four articles and an editorial calling for Congressional hearings: http://ahrp.blogspot.com/2006/12/eli-lilly-lies-about-zyprexa-nyt-calls.html

The two front page reports in the Times (Dec. 17 and 18): http://ahrp.blogspot.com/2006/12/eli-lilly-documents-show-risks-of.html  http://ahrp.blogspot.com/2006/12/eli-lilly-documents-show-lilly.html
Since the Times reports, Lilly’s brigade of lawyers have embarked on a campaign of intimidation against patient advocacy organizations and individuals—including AHRP—who received copies of the same documents as those reported about by NYT. http://ahrp.blogspot.com/2006/12/zyprexa-injunction-news-flash.html 

Lilly is tracking the internet in an effort to to suppress the evidence of Zyprexa's lethal effects from reaching public view.  As long as the evidence remains concealed in Lilly’s files the public is at risk–including children for whom the drug is being prescribed irresponsibly by physicians who have been deceived by Lilly’s sales reps. http://ahrp.blogspot.com/2007/01/continuing-legal-efforts-to-suppress.html

See: Zyprexa Drug Rep posted on YouTube video, by Pharmed Out, a group of physicians. Check for link at: http://ahrp.blogspot.com/2007/01/zyprexa-sales-rep-video-must-see.html  

Lilly obtained temporary court injunctions to prevent the documents from reaching consumers–some of who are being forced to take the drug. Lilly’s demand for secrecy has nothing to do with proprietary information. The information in the documents can save lives but cut sales.  What is the rationale for allowing Lilly to conceal life-threatening drug effects from those who are at risk of being prescribed Zyprexa on the basis of false claims about its safety and efficacy?

Antipsychotics which are marketed as “saving lives” have never been shown to save lives. The risks associated with Zyprexa far outweigh any benefits. The New York Times profiled a 41-year old patient, John Eric Kauffman, who, like countless of others became a Zyprexa casualty.
The Times reports that Kauffman gained 80 pounds while taking Zyprexa and died of heart disease in March 2006.  The company’s “internal documents show that Lilly’s own clinical trials found that 16 percent of people taking Zyprexa gained more than 66 pounds after a year on the drug, a far higher figure than the company disclosed to doctors.”

Like the thousands of plaintiffs whose suits Lilly just settled, Kauffman's case encapsulates the consequences of current toxic treatments prescribed for people with mental illnesses.   Indeed, studies show that since the use of antipsychotics, life expectancy for mental patients in the public system has decreased by 25 years.  https://ahrp.org/risks/antipsychotic/joukamaa2006.pdf  and http://www.cdc.gov/pcd/issues/2006/apr/05_0180.htm  [1, 2]

Thus, it might be more accurate to describe Zyprexa as a drug that shortens lives.

The Times reported that the documents show Lilly executives accelerated the Zyprexa marketing campaign to primary care physicians who were encouraged to prescribe the drugs for unapproved, off-label uses AFTER the diabetes risk was confirmed by a group of diabetes specialists hired by Lilly.

FDC reports that Lilly criticized the Times profile of John Kauffman because "Lilly is concerned that this tragic story about a single patient could unnecessarily frighten people with schizophrenia and bipolar disorder and cause them to discontinue their medication without first consulting a physician." 

Frightening?  Frightening to Lilly’s marketing division, no doubt.
The fact is, accurate drug safety information saves lives—drugs such as Zyprexa induce debilitating diseases that shorten lives.

The Wall Street Journal reports that attorneys in the settlement note that “the current settlement enables Lilly to postpone the disclosure of marketing information that shows its off-label promotion."  State probes, however, are intensifying. 

Connecticut Attorney General Richard Blumenthal, in concert with counterparts in other states, has expanded an investigation into Zyprexa's marketing practices and in an interview referred to a "potentially huge claim" alleging that the company promoted the drug to Medicaid and non-Medicaid patients for unapproved uses.  Similar investigations are under way in California and Florida.

Advocates are calling for criminal indictments against Lilly on the basis of the evidence contained in the secret documents. Documents that provided plaintiffs' attorneys with the persuasive evidence that led Lilly to settle for close to $1.2 billion.  ($500 million + $690 million)

What do you think—would Lilly or any pharmaceutical company shell out that amount on sealed settlements– if there was nothing to hide?

Furthermore, if Lilly has nothing to hide, why is Lilly harassing outspoken advocates who have nothing to do with its litigation?  The case underscores the enormous disservice to consumers when lawyers for plaintiffs and lawyers for Big Phara agree to sealed settlements in cases involving drugs that pose life-threatening risks.

  1. See: MATTI JOUKAMAA, MARKKU HELIOVAARA, PAUL KNEKT, HELIO« VAARA, ARPO AROMAA, RAIMO RAITASALO and VILLE LEHTINEN Schizophrenia, neuroleptic medication and mortality, BRITISH JOURNAL OF PSYCHIATRY (2006), 188, 122-127. https://ahrp.org/risks/antipsychotic/joukamaa2006.pdf

  2. See: Colton CW, Manderscheid RW. Congruencies in increased mortality rates, years of potential life lost, and causes of death among public mental health clients in eight states. Prev Chronic Dis 2006 Apr. Available from: http://www.cdc.gov/pcd/issues/2006/apr/05_0180.htm.

Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org
Lilly to Pay Up to $500 Million to Settle Claims
Eli Lilly agreed today to pay up to $500 million to settle 18,000 lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa, Lilly’s drug for schizophrenia and bipolar disorder. Including earlier settlements over Zyprexa, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who claim they were injured by the drug. At least 1,200 suits are still pending, the company said. About 20 million people worldwide have taken Zyprexa since its introduction in 1996.
The settlement covers cases filed in state and federal courts by 14 plaintiffs’ law firms or groups of firms, Lilly said. The federal suits have been overseen by a judge in Brooklyn, Jack B. Weinstein of the Eastern District of New York.
The settlement will not affect civil or criminal investigations pending over Zyprexa from state attorneys general and federal prosecutors, which are continuing.
Both Lilly and lawyers for plaintiffs said they were pleased with the agreement. With sales of $4.2 billion last year, Zyprexa is Lilly’s largest-selling drug and a major contributor to the company’s profits. Lilly shares were little changed after the settlement announcement.

Zyprexa is the brand name for olanzapine, a potent chemical that binds to receptors in the brain to reduce psychotic hallucinations and delusions. Clinical trials show Zyprexa also causes severe weight gain and increases in cholesterol and blood sugar in many patients.

Documents provided to The New York Times last month by a lawyer who represents mentally ill patients show that Lilly played down the risks of Zyprexa to doctors as the drug’s sales soared after its introduction in 1996. The internal documents show that Lilly’s own clinical trials found that 16 percent of people taking Zyprexa gained more than 66 pounds after a year on the drug, a far higher figure than the company disclosed to doctors.

The documents also show that Lilly marketed the drug as appropriate for patients who do not meet accepted diagnoses of schizophrenia or bipolar disorder, Zyprexa’s only approved uses. By law, drugmakers may only promote their drugs for diseases in which the Food and Drug Administration  has found the medicines to be safe and effective, although doctors may prescribe drugs in any way they see fit.
In response to questions about the information in the documents, Lilly has denied any wrongdoing and said it provided all relevant information to doctors and the F.D.A. Lilly has also said it did not promote Zyprexa for conditions other than schizophrenia or bipolar disorder.
In 2004, a panel of the American Diabetes Association found that Zyprexa caused diabetes more than other widely used antipsychotic drugs in part because it tends to cause much more weight gain. But the F.D.A. has never made a similar finding. Instead, the F.D.A. added a warning in 2003 to the label of Zyprexa and other new antipsychotic drugs about their tendency to cause high blood sugar.
The settlement follows an additional $700 million agreement in 2005 covering 8,000 patients, as well as 2,500 individual settlements whose total value has not been disclosed, Lilly said. The 2005 settlement valued each claim at nearly $90,000 per plaintiff, while today’s agreement values claims at more than $27,000 per plaintiff.
The lower value for the new claims comes in part because of the F.D.A. label change, which has allowed Lilly to contend that it adequately warned doctors of Zyprexa’s risks after 2003. The label change may also help to protect Lilly from other lawsuits going forward, drug industry analysts and lawyers say.
In its statement, Lilly said the settlement did not change its views that Zyprexa is a safe and effective treatment for mental illness. "We wanted to reduce significant uncertainties involved in litigating such complex cases," Sidney Taurel, Lilly’s chief executive, said in the statement.
Richard Meadow, one of the lead lawyers for plaintiffs, said the deal was fair to both sides. "Prolonging this litigation further is in no one’s best interest," he said.
Copyright 2007  The New York Times Company <http://www.nytco.com/


<strong>THE NEW YORK TIMES<br /> January 4, 2007 <br />Mother Wonders if Psychosis Drug Helped Kill Son <br />By ALEX BERENSON </strong>

At first, the psychiatric drug Zyprexa may have saved John Eric Kauffman’s life, rescuing him from his hallucinations and other symptoms of acute psychosis. But while taking Zyprexa for five years, Mr. Kauffman, who had been a soccer player in high school and had maintained a normal weight into his mid-30s, gained about 80 pounds. He was found dead on March 27 at his apartment in Decatur, Ga., just outside Atlanta.

An autopsy showed that the 41-year-old Mr. Kauffman, who was 5 feet 10 inches, weighed 259 pounds when he died. His mother believes that the weight he gained while on Zyprexa contributed to the heart disease that killed him.

Eli Lilly, which makes Zyprexa, said in a statement that Mr. Kauffman had other medical conditions that could have led to his death and that “Zyprexa is a lifesaving drug.” The company said it was saddened by Mr. Kauffman’s death.

No one would say Mr. Kauffman had an easy life. Like millions of other Americans, he suffered from bipolar disorder, a mental illness characterized by periods of depression and mania that can end with psychotic hallucinations and delusions. After his final breakdown, in 2000, a hospital in Georgia put Mr. Kauffman on Zyprexa, a powerful antipsychotic drug. Like other medicines Mr. Kauffman had taken, the Zyprexa stabilized his moods. For the next five and a half years, his illness remained relatively controlled. But his weight ballooned — a common side effect of Zyprexa.

His mother, Millie Beik, provided information about Mr. Kauffman, including medical records, to The New York Times.

For many patients, the side effects of Zyprexa are severe. Connecting them to specific deaths can be difficult, because people with mental illness develop diabetes and heart disease more frequently than other adults. But in 2002, a statistical analysis conducted for Eli Lilly found that compared with an older antipsychotic drug, Haldol, patients taking Zyprexa would be significantly more likely to develop heart disease, based on the results of a clinical trial comparing the two drugs. Exactly how many people have died as a result of Zyprexa’s side effects, and whether Lilly adequately disclosed those risks, are central issues in the thousands of product-liability lawsuits pending against the company, and in state and federal investigations.

Because Mr. Kauffman also smoked heavily for much of his life, and led a sedentary existence in his last years, no one can be sure that the weight he gained while on Zyprexa caused his heart attack.

Zyprexa, taken by about two million people worldwide last year, is approved to treat schizophrenia and bipolar disorder. Besides causing severe weight gain, it increases blood sugar and cholesterol in many people who take it, all risk factors for heart disease. <br />In a statement responding to questions for this article, Lilly said it had reported the death of Mr. Kauffman to federal regulators, as it is legally required to do. The company said it could not comment on the specific causes of his death but noted that the report it submitted to regulators showed that he had “a complicated medical history that may have led to this unfortunate outcome.”<br />“Zyprexa,” Lilly’s statement said, “is a lifesaving drug and it has helped millions of people worldwide with schizophrenia and bipolar disorder regain control of their lives.”

Documents provided to The Times by a lawyer who represents mentally ill patients show that Eli Lilly, which makes Zyprexa, has sought for a decade to play down those side effects — even though its own clinical trials show the drug causes 16 percent of the patients who take Zyprexa to gain more than 66 pounds after a year.

Eli Lilly now faces federal and state investigations about the way it marketed Zyprexa. <br />Last week — after articles in The Times about the Zyprexa documents — Australian drug regulators ordered Lilly to provide more information about what it knew, and when, about Zyprexa’s side effects.

Lilly says side effects from Zyprexa must be measured against the potentially devastating consequences of uncontrolled mental illness. But some leading psychiatrists say that because of its physical side effects Zyprexa should be used only by patients who are acutely psychotic and that patients should take other medicines for long-term treatment. “Lilly always downplayed the side effects,” said Dr. S. Nassir Ghaemi, a specialist on bipolar disorder at Emory University in Atlanta. “They’ve tended to admit weight gain, but in various ways they’ve minimized its relevance.”

Dr. Ghaemi said Lilly had also encouraged an overly positive view of its studies on the effectiveness of Zyprexa as a long-term treatment for bipolar disorder. There is more data to support the use of older and far cheaper drugs like lithium, he said.<br />Last year, Lilly paid $700 million to settle 8,000 lawsuits from people who said they had developed diabetes or other diseases after taking Zyprexa. Thousands more suits are still pending.

But Ms. Beik is not suing Lilly. She simply wants her son’s case to be known, she said, because she considers it a cautionary tale about Zyprexa’s tendency to cause severe weight gain. “I don’t think that price should be paid,” she said.

Mr. Kauffman’s story, like that of many people with severe mental illness, is one of a slow and steady decline.  Growing up in DeKalb, Ill., west of Chicago, he acted in school plays and was a goalie on the soccer team. A photograph taken at his prom in 1982 shows a handsome young man with a messy mop of dark brown hair.

But in 1984, in his freshman year at Beloit College in Wisconsin, Mr. Kauffman suffered a breakdown and was found to have the most severe form of bipolar disorder. He returned home and, after medication stabilized his condition, enrolled in Northern Illinois University. He graduated from there in 1989 with a degree in political science.

For the next year, he worked as a bus driver ferrying senior citizens around DeKalb. In a short local newspaper profile of him in 1990, he listed his favorite book as “Catch-22,” his favorite musician as Elvis Costello, and his favorite moment in life as a soccer game in which he had made 47 saves. A few months later, he followed his mother and stepfather to Atlanta and enrolled in Georgia State University, hoping to earn a master’s degree in political science. “He wanted so much to become a political science professor,” Ms. Beik said.  But trying to work while attending school proved to be more stress than Mr. Kauffman could handle, Ms. Beik said. In 1992, he suffered his most severe psychotic breakdown. He traveled around the country, telling his parents he intended to work on a political campaign. Instead, he spent much of the year homeless, and his medical records show that he was repeatedly admitted to hospitals.

Mr. Kauffman returned home at the end of 1992, but he never completely recovered, Ms. Beik said. He never worked again, and he rarely dated.  In 1994, the Social Security Administration deemed him permanently disabled and he began to receive disability payments. He filed for bankruptcy that year. According to the filing, he had $110 in assets — $50 in cash, a $10 radio and $50 in clothes — and about $10,000 in debts.

From 1992 to 2000, Mr. Kauffman did not suffer any psychotic breakdowns, according to his mother. During that period, he took lithium, a mood stabilizer commonly prescribed for people with bipolar disorder, and Stelazine, an older antipsychotic drug. With the help of his parents, he moved to an apartment complex that offered subsidized housing. But in late 1999, a psychiatrist switched him from lithium, which can cause kidney damage, to Depakote, another mood stabilizer. In early 2000, Mr. Kauffman stopped taking the Depakote, according to his mother.

As the year went on, he began to give away his possessions, as he had in previous manic episodes, and became paranoid. During 2000, he was repeatedly hospitalized, once after throwing cans of food out of the window of his sixth-floor apartment.  In August, he was institutionalized for a month at a public hospital in Georgia. There he was put on 20 milligrams a day of Zyprexa, a relatively high dose.

The Zyprexa, along with the Depakote, which he was still taking, stabilized his illness. But the drugs also left him severely sedated, hardly able to talk, his mother said. “He was so tired and he slept so much,” Ms. Beik said. “He loved Shakespeare, and he was an avid reader in high school. At the end of his life, it was so sad, he couldn’t read a page.”

In addition, his health and hygiene deteriorated. In the 1990 newspaper profile, Mr. Kauffman had called himself extremely well-organized. But after 2000, he became slovenly, his mother said. He spent most days in his apartment smoking. A therapist who treated Mr. Kauffman while he was taking Zyprexa recalls him as seeming shy and sad. “He was intelligent enough to have the sense that his life hadn’t panned out in a normal fashion,” the therapist said in an interview. “He always reminded me of a person standing outside a house with a party going on, looking at it.” The therapist spoke on the condition that her name not be used because of rules covering the confidentiality of discussions with psychiatric patients.

As late as 2004, Mr. Kauffman prepared a simple one-page résumé of his spotty work history — evidence that he perhaps hoped to re-enter the work force. He never did. As Mr. Kauffman’s weight increased from 2000 to 2006, he began to suffer from other health problems, including high blood pressure. In December 2005, a doctor ordered him to stop smoking, and he did. But in early 2006, he began to tell his parents that he was having halluci nations of people appearing in his apartment.

On March 16, a psychiatrist increased his dose of Zyprexa to 30 milligrams, a very high level. That decision may have been a mistake, doctors say. Ending smoking causes the body to metabolize Zyprexa more slowly, and so Mr. Kauffman might have actually needed a lower rather than higher dose.  A few days later, Mr. Kauffman spoke to his mother for the last time. By March 26, they had been out of contact for several days. That was unusual, and she feared he might be in trouble. She drove to his apartment building in Decatur the next day and convinced the building’s manager to check Mr. Kauffman’s apartment. He was dead, his body already beginning to decompose.<br />An autopsy paid for by his mother and conducted by a private forensic pathologist showed he had died of an irregular heartbeat — probably, the report said, as the result of an enlarged heart caused by his history of high blood pressure.

Ms. Beik acknowledged she cannot be certain that Zyprexa caused her son’s death. But the weight gain it produced was most likely a contributing factor, she said. And she is angry that Eli Lilly played down the risks of Zyprexa. The company should have been more honest with doctors, as well as the millions of people who take Zyprexa, she said. Instead Lilly has marketed Zyprexa as safer and more effective than older drugs, despite scant evidence, psychiatrists say.

Ms. Beik notes that Stelazine — an older drug that is no longer widely used even though a federally financed clinical trial showed it works about as well as Zyprexa — stabilized Mr. Kauffman’s illness for eight years without causing him to gain weight. “He was on other drugs that worked,” she said.<br />~~~~~~~~~~~~~~~~~~~

The Wall Street Journal

Lilly Settles 18,000 Zyprexa Claims, but More Loom
January 5, 2007; Page A4

Eli Lilly & Co. moved to settle some 18,000 claims, most of which allege that it failed to adequately warn patients that its blockbuster antipsychotic Zyprexa can cause diabetes. But the drug maker must contend with some 1,200 holdouts and additional suits brought by insurers and state governments.
Lilly said it reached settlement agreements with 14 groups of law firms. The Indianapolis company said it would take a charge of under $500 million in the fourth quarter to settle the product-liability claims. In 2005, Lilly paid $700 million to compensate 10,500 claimants.
The company said the cases — settled or not — were without merit. John Lechleiter, Lilly's president and chief operating officer, said the firm decided to settle because "it's in the best interest of Lilly, and physicians and patients."

The chairman of the plaintiffs' steering committee, Melvyn Weiss, said the settlement "reflects the judgment of some of the most outstanding tort lawyers in America that these are very difficult cases to try and that it was better to settle." He added, "Zyprexa is taken by people who are seriously ill with complicating diseases and trying these cases can be a daunting task, but I am confident there are cases that are triable."

Nonetheless, the legal troubles aren't over for Lilly and Zyprexa, still its bestseller in 2005 with $4.2 billion in revenue. The company faces suits brought by third-party payers contending, in large part, that they wouldn't have paid a premium for Zyprexa over other medicines if they had been adequately warned of its risks. And some lawyers say the remaining 1,200 personal-injury cases could still be a threat to the company.

State probes are intensifying. Connecticut Attorney General Richard Blumenthal, in concert with counterparts in other states, has expanded an investigation into Zyprexa's marketing practices and in an interview referred to a "potentially huge claim" alleging that the company promoted the drug to Medicaid and non-Medicaid patients for unapproved uses. California's attorney general mounted an investigation in September into the company's marketing of Zyprexa. Some attorneys general have filed suits seeking damages.

"What's left is a significant number of seriously injured plaintiffs' cases pending in state and federal court, and you have a half-dozen or more attorney-general cases and you have third-party payer class-action cases," said William Audet, the founding partner of Audet & Partners, a San Francisco firm representing more than 300 plaintiffs whose cases aren't part of the latest settlement.

Still, Lilly appears to be paying less to settle more cases in this round of legal agreements. The difference may be that Lilly changed Zyprexa's labeling in 2003 to reflect the increased diabetes risk, weakening later cases. Also, some lawyers said that second-round settlements tend to be smaller than the initial ones, since plaintiffs' lawyers tend to bring their strongest cases forward first.
"The current settlement enables Lilly to postpone the disclosure of marketing information that shows its off-label promotion," said Thomas M. Sobol, a lawyer with the Cambridge, Mass., firm Hagens, Berman, Sobol & Shapiro, which brought suit on behalf of insurers.

A Lilly spokeswoman said the company will continue to try cases and that its rationale for settling wasn't to keep damaging information under seal.
— Peter Loftus and Heather Won Tesoriero contributed to this article.

Write to Avery Johnson at avery.johnson@WSJ.com1

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