Firm to pay Utah $24 million in settlement
Nov. 11, 2009
By Geoff Liesik
Pharmaceutical giant Eli Lilly and Co. has agreed to pay $24 million to settle a lawsuit filed by the Utah Attorney General's Office.
Attorney General Mark Shurtleff sued the company after a nearly four-year investigation revealed that Lilly concealed its knowledge of significant weight gain and obesity associated with the anti-psychotic medication Zyprexa. Investigators also showed that Lilly's sales representatives illegally promoted the drug for uses not approved by the U.S. Food and Drug Administration.
"We're not just asking them for money. We want their bad conduct to stop," Shurtleff said Wednesday while announcing the settlement.
"As part of the settlement agreement, there are corporate integrity responsibilities and remedial provisions that will continue to be monitored by the court to stop (Lilly's) harmful behavior."
Zyprexa is approved for the treatment of schizophrenia and certain types of bipolar disorder in adults. But authorities say that in 1999, Lilly's marketing arm that focuses on doctors who treat the elderly began encouraging physicians to prescribe the drug for dementia, Alzheimer's disease, agitation, aggression, hostility, depression and generalized sleep disorder without prior FDA approval. Lilly also trained its sales teams to avoid discussions with health-care professionals about the weight gain side effect, investigators said.
Shurtleff said his office's investigation, conducted in conjunction with the Utah Department of Health, showed there were 1,769 Medicaid patients in Utah over the age of 65 who took Zyprexa but never had a diagnosis of either schizophrenia or bipolar disorder.
Dr. David Sundwall, executive director of the state Health Department, said when he was presented with those numbers he knew they were inflated and agreed to lend his agency's support to the case. He said the timing of the settlement "couldn't be better."
"Due to our recent economic decline, we've had the highest increase ever in enrollment in Medicaid," Sundwall said. "We need funds to keep up with demand."
He added that Wednesday's announcement shouldn't be viewed as an indictment of drug companies.
"We do not intend to demonize the pharmaceutical industry," Sundwall said. "As a clinician, and even as a patient, I appreciate the research and development done by pharmaceutical companies in our nation. Because of newer and better drugs we prevent disease; we treat illness and sometimes cure it; we prevent unnecessary hospitalizations and surgeries."
Joe Steele, a private attorney who aided the state in its case, described the lawsuit as "righteous litigation."
"They did what we accused them of doing," he said, referring to Lilly. "Bringing the money back into the state to take care of the children who so badly need it and the people who so badly need the medical care that Medicaid provides is, I think, one of the most important things we can do."
The settlement is the largest in Utah's effort to hold drug companies accountable for illegal practices, according to Shurtleff.
The state is expected to receive approximately $20 million once contingency fees are paid to private attorneys who aided in the litigation. That money will be placed in the state's general fund for allocation by the Legislature.
There are dozens of organizations that are objecting to provisions in the U.S. health care reform bills. As the primary mental health watchdog organization, CCHR has been hard at work identifying the specific mental health provisions in these bills so we can inform the public of the very real risks of various aspects of these bills that clearly are designed to benefit the psycho/pharmaceutical industry, not the general public. To read CCHR's analysis of the House Bill and two Senate Health Care Reform bills (which will soon be merged into one Senate bill), and to find out where all of this is heading before a final bill/vote is completed, click here.
Charles Nemeroff, an Atlanta psychiatrist who was the subject of a Senate investigation concerning huge sums he received from drug companies, has been named chairman of the psychiatry department at the University of Miami.
Last year Nemeroff, as the top psychiatrist at Emory University, was the focus of an investigation by Sen. Charles Grassley, R-Iowa, who said he was concerned about the millions the psychiatrist received from drug companies while conducting supposedly unbiased research for the National Institutes of Health on drugs made by the companies he was receiving money from.
On Thursday, Pascal Goldschmidt, dean of UM medical school, called Nemeroff ``an exceptional psychiatrist and an exceptional scientist who has one issue in which he recognizes he made a mistake,'' in not telling Emory how much he was getting from drug makers.
Goldschmidt said he had read investigative reports from Emory about Nemeroff's activities and Emory found nothing to indicate that payments the psychiatrist received had in any way influenced his research results.
Elsewhere, opinions are divided.
The former head of psychiatry at Duke University told The Miami Herald Thursday that Nemeroff was ``economical with the truth'' and his work can't be trusted, while the leader of the Columbia University psychiatry program said Nemeroff was a top-flight scientist and he had never seen any bias in his work.
For his own part, Nemeroff, 60, said he was excited to be coming to Miami. ``I think it's going to be a top-10 school.''
Nemeroff's appointment comes at a time when healthcare reform bills in both the House and Senate have sections requiring healthcare providers to publicly reveal their payments to doctors.
In October 2008, the psychiatrist's activities made the front page of The New York Times after Grassley investigators found that Nemeroff -- ``one of the nation's most influential psychiatrists,'' according to The Times -- had received $2.8 million in consulting deals with drug makers over seven years and failed to report at least $1.2 million of that to Emory.
Based on Grassley's complaints, Nemeroff's work on a mayor NIH grant was suspended and Emery asked him to step down as chair of psychiatry while it studied his conduct.
The Atlanta Journal-Constitution reported that the Office of the Inspector General of the Department of Health and Human Services had launched an investigation into Nemeroff's activities. An OIG spokesman said it never confirms nor denies investigations. Nemeroff said he knew nothing about OIG looking at him.
According to published reports, the psychiatrist received between $800,000 to $1.2 million from GlaxoSmithKline while leading a major study into mood disorder drugs, including ones made by GSK.
Nemeroff said Thursday that the news reports had not made clear that his talks were on GSK drugs now on the market, while his research funded by NIH involved basic lab studies of GSK chemical compounds that were years away from market. That work did not promote GSK products, he told The Herald.
But Bernard Carroll, former head of psychiatry at Duke University and once Nemeroff's boss, said parts of Nemeroff's work involved Paxil, a GSK antidepressant. ``Basically, he was doing basic science pimping for Paxil to produce talking points,'' Carroll told The Herald in an e-mail Thursday. ``All he ever produced was speculation but that was enough to satisfy Glaxo marketing. . . . I have been exposing his shenanigans for some years.''
Jeffrey Lieberman, head of psychiatry at Columbia University, praised Nemeroff as a leading expert in ``basic neuroscience,'' studying underlying pathologies and proteins in the brain that cause mental illness. He said he had never detected ``any undue influence or bias'' in Nemeroff's research.
However, all the academics interviewed Thursday acknowledged that large payments to researchers were a concern. ``Of course, it creates problems,'' Carroll said.
At UM, Goldschmidt said it was important for researchers and pharmaceutical companies to work together to develop better drugs. He said limits of how much researchers should be allowed to receive are still being debated.
In June, the Pew Prescription Project gave UM a ``B'' on a scorecard designed to measure ethical policies on professors' relationship with the pharmaceutical industry.
UM is now in the process of strengthening its reporting requirements, said Goldschmidt, so that all outside professional work must be reported -- and the results will eventually be posted online for the public to see.
Those requirements will apply to Nemeroff, who starts at UM on Dec. 1, and all other medical school staffers.
In the past, Goldschmidt said, there was debate whether professors needed to report fees from drug makers for giving continuing medical education (CME) talks, which are supposed to be non-promotional. That became an issue in Nemeroff's case in Atlanta.
In an interview Thursday, Nemeroff said in retrospect he should have declared the CME payments he received from drug makers, but he viewed Emory standards as not requiring such revelations.
LETTER OF SUPPORT
In a letter to Grassley last December, Emory officials wrote: ``We do not believe that Dr. Nemeroff's participation in the compensated speaking arrangements with GSK in any way biased the research conducted under the grant.''
The letter said Nemeroff's talks on behalf of GSK were ``focused on medical education and were not product specific or promotional. . . . As you alleged, Dr. Nemeroff did not disclose substantial speaking fees from pharmaceutical companies to Emory. Under federal regulations and Emory's policies, we believe he should have done so, although both the regulations and our policies could have been clearer.''
Grassley responded in a letter that his staff's research found that Nemeroff's talks were promoting GSK products -- not educational -- and should have been reported.
Tom Johnson, former president of the CNN network and former publisher of The Los Angeles Times, said Thursday he was part of an Emory advisory board that examined Nemeroff's behavior and the university's ethics policies. The policies were ``confusing,'' Johnson told The Herald. They have since been modified.
The Wall Street Journal released a new study published in the Journal of the American Medical Association today, which noted that antipsychotic drugs, widely used in children, actually caused them to gain as much as 19 pounds on average after just 11 weeks on the medications.
And while weight gain can sometimes be seen as a relatively minor side effect – especially when compared to increased and even murderous aggression or the often reported suicidal tendency these exact drugs bring to adults and youth alike, the report noted the drugs propensity to cause the type of significant weight gain that could lead to diabetes and cardiovascular (heart) disease.
Known as the atypical antipsychotics, the direct correlation to significant weight gain adds to growing concerns about giving the medicines to patients under 18 years of age. The study's authors urged child psychiatrists to exercise more caution before deciding to prescribe, and recommends close monitoring of patients who do wind up taking these “wonder” drugs.
These powerful drugs are used to treat schizophrenia and bipolar disorder, but have faced growing scrutiny, not only because of proven side effect risks, but also because of the aggressive and often illegal re-marketing tactics by their makers that have helped make them the highest-selling class of drugs in the U.S.
The study results were fortuitously released in advance of Food and Drug Administration’s likely official authorization of these drugs for even younger patients. Atypical antipsychotics already have limited approval for youths, but doctors have been “free to prescribe them as they see fit” without any FDA authorization to do so and unfortunately they often give them to children and adolescents, say analysts and psychiatrists
Psychiatrists turned to the new drugs after they began going on sale in the 1990s because they didn't cause involuntary facial tics and other visually obvious cosmetic type problems that an earlier generation of these types of medicines did. Last year, the drugs collectively generated $14.6 billion in sales in the U.S., but a growing number of studies confirm that these new drugs have their own set of significant, yet often ignored, side effects.
"The weight gain is much larger than we thought," said Christoph Correll, the study's lead author, who is a psychiatrist and a scientist at the Feinstein Institute for Medical Research in Manhasset, N.Y. "It's massive, and it's the medication" that caused it, he said.
The JAMA study, conducted in 272 youths ages 4 to 19 years, is the largest and most definitive to date to establish a link between the drugs and weight gain, the authors said. Unlike earlier studies, it looked only at patients who hadn't previously taken the medicines.
The drugs examined were four top-selling atypical antipsychotics: Abilify, sold by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co.; Risperdal from Johnson & Johnson; Seroquel from AstraZeneca PLC; and Zyprexa from Eli Lilly & Co.
Interestingly, the study found that, of the drugs studied, Zyprexa caused the most weight gain. Over 11 weeks of use, children on Zyprexa gained the most weight on average, nearly 19 pounds, or a 15% increase. The Zyprexa drug was also found to significantly raise levels of blood sugar, cholesterol, insulin and triglycerides, which can lead to diabetes and heart problems.
Patients taking the other three drugs gained from 10 to 13 pounds on average, according to the study and the negative impact on users' blood sugar and other metabolic levels varied, depending on the drug.
In January, Lilly agreed to pay $1.42 billion to settle a federal probe into alleged improper re-marketing of Zyprexa. Other pharmaceutical companies have also come under fire for allegedly promoting off-label uses of atypical antipsychotics and playing down or withholding information on their adverse side effects.
Fortunately, as concerns about the side effects have mounted, prescriptions for children have slowed down. Dr. Correll encouraged child psychiatrists to be even more careful about giving the drugs to youths and, when they do, to encourage a healthy diet and to check weight and metabolic levels every three months.
The FDA will soon decide whether to approve younger patients' use of Seroquel, Zyprexa and Geodon, another atypical antipsychotic. (note: Geodon wasn't part of the study because, until now it's not often used in new patients and too few users were even enrolled in the trials according to Dr. Corell).
You can call the FDA and let them know your thoughts about whether they should authorize any of these antipsychotic products to be remarketed to children in light of recent revelations. You can also suggest more in-depth trials be conducted to determine additional side effect risks.
Call 1-888-463-6332) Press 2, followed by 1 for information, then select #3 for drug products in order to log your complaint and/or suggestions.
You can also write to the Wall Street Journal reported who wrote this story to thank him for releasing this information in advance of any FDA approval to remarket these powerful drugs to children. We do not recommend promotion of any kind however, you can suggest related issues and possible follow up stories. The reporter is Jonathan Rockoff and he can be reached by email at Jonathan.Rockoff@wsj.com