Talk:Eli Lilly and Company
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The connection to the Bush family section is unnecessarily spurious. Shorten it up, give just relevant facts, stay on the topic at-hand, which is Eli Lilly & Co. It looks as if it was largely included to more make the Bush family look "evil" rather than to give info to anyone searching for data on Eli Lilly.
The Bush section is too long and off-topic. It deserves its own page.
Can this be substantiated with a link ref?
||The neutrality of this section is disputed. (December 2007)|
Oraflex, the American version of Benoxaprofen, was withdrawn from the market in 1982, just one month after gaining FDA approval. A British medical journal found five cases of death due to jaundice in patients taking the drug and the FDA accused Lilly of suppressing unfavorable research findings. In 1985, the U.S. Justice Department filed criminal charges against the company and Dr. William Ian H. Shedden. Lilly pleaded guilty to 25 criminal counts and paid a $25,000 fine.
Lilly was also cited in lawsuits filed against the manufacturers of diethylstilbestrol (DES), a drug prescribed to women in the 1940s and 1950s to prevent miscarriages. The company was ordered to pay $400,000 in damages from DES even though the complications that developed were not known at the time.
According to a New York Times article published on December 17, 2006, Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers. These documents and e-mail messages were soon made publicly available as a location hidden Tor service, and then made available on the public Internet. Eli Lilly sought and obtained a "Temporary Restraining Order" from a U.S. District Court on January 4th, 2007 to stop the dissemination or downloading of Eli Lilly documents about Zyprexa, and this allowed them to get a few U.S.-based websites to remove them. The documents can now only be downloaded from public Internet sites outside the U.S. These health risks include an increased risk for diabetes through Zyprexa's links to obesity and its tendency to raise blood sugar. Zyprexa is Lilly’s top-selling drug, with sales of $4.2 billion last year.
The documents, given to the New York Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar, two known risk factors for diabetes.
Lilly’s own published data, which it told its sales representatives to play down in conversations with physicians, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004. In 2006, Lilly paid $700 million to settle 8,000 lawsuits from people who said they had developed diabetes or other diseases after taking Zyprexa. But thousands of additional lawsuits are still pending.
Lilly also instructed its sales representatives to suggest that physicians prescribe Zyprexa to older patients with symptoms of dementia. One document states "dementia should be first message" for primary care doctors, since they "do not treat bipolar" or schizophrenia, but "do treat dementia." Three months after its launch, Lilly's Zyprexa campaign, called 'Viva Zyprexa', led to 49,000 new prescriptions. In 2002, the company changed the name of the primary care campaign to 'Zyprexa Limitless' and began to focus on people with mild bipolar disorder who had previously been diagnosed as depressed, despite the fact that Zyprexa has been approved only for the treatment of mania in bipolar disorder, not depression.
In 2002, British and Japanese regulatory agencies warned that Zyprexa may be linked to diabetes. But even after the FDA issued a similar warning in 2003, Lilly did not publicly disclose their own findings.
Eli Lilly agreed on January 4, 2007 to pay up to $500 million to settle 18,000 lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa. 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.
A controversial experiment, Prevention through Risk Identification, Management, and Education (PRIME), was initiated by Dr. Thomas McGlashan of Yale University, and director of the National Institute for Mental Health (NIMH), with funding from Eli Lilly and the NIMH. PRIME investigators tested a speculative schizophrenia prevention theory by exposing healthy youngsters for one year to Lilly’s toxic blockbuster drug, the neuroleptic, Zyprexa (olanzapine). From 1997 to 2003, sixty previously healthy youngsters were enrolled in the experiment: of whom half were exposed to Zyprexa (olanzapine), a drug so toxic it is now costing Eli Lilly over a billion dollars in lawsuit settlements.
None of the youngsters in PRIME met the diagnostic criteria of either condition for which the drug was approved. Absent a diagnosable condition, and absent any evidence to support the assumption that a drug can prevent schizophrenia, these healthy youngsters were exposed to a toxic drug on the basis of speculations. The authors now acknowledge in their published report that the experiment had failed and that Zyprexa did not prevent schizophrenia.
Alan Breier, Vice President and Medical and Chief Medical Officer for Eli Lilly was involved in the PRIME project and was one of the chief medical authors of the clinical trials. Prior to joining Lilly, Breier completed a three-year research fellowship at NIMH.
In one of the only three cases to ever go to trial for Prozac's possible role in inducing suicide, Eli Lilly was caught corrupting the judicial process by making a deal with the plaintiff's attorney to throw the case, in part by not disclosing damaging evidence to the jury.
The case, known as the Fentress Case involved a Kentucky man, Joseph Wesbecker, who was on Prozac and went to his workplace, opening fire with an assault rifle killing eight people (including Fentress), and injuring 12 others before killing himself. The jury returned a 9-to-3 verdict in favor of Lilly. But the judge, in the end, referred the matter to the Kentucky Supreme Court, which later found that "there was a serious lack of candor with the trial court and there may have been deception, bad faith conduct, abuse of judicial process and, perhaps even fraud." The judge later revoked the verdict and instead, recorded the case as settled. The value of the secret settlement deal has never been disclosed, but was reportedly "tremendous".
In 2001 Eli Lilly and Company (Lilly) agreed to settle Federal Trade Commission (FTC) charges regarding the unauthorized disclosure of sensitive personal information collected from consumers through its Prozac.com Web site. The company disclosed E-mail addresses of 669 Subscribers to its Prozac Reminder Service. On June 27, 2001, a Lilly employee created a new computer program to access Medi-messenger subscribers' e-mail addresses and sent them an e-mail message announcing the termination of the Medi-messenger service. The June 27 e-mail message included all of the recipients' e-mail addresses within the "To:" line of the message, thereby unintentionally disclosing to each individual subscriber the e-mail addresses of all 669 Medi-messenger subscribers.
As part of the settlement, Lilly said it would take appropriate security measures to protect consumers' privacy. Lilly's security breach was the subject of a July 2001 petition from the American Civil Liberties Union (ACLU) requesting that the FTC investigate and take appropriate action to remedy the breach.
The signs of violence and suicidality were there since Prozac was tested in premarketing trials. In May 1984, Germany’s regulatory agency (GBA) rejected Prozac as “totally unsuitable for treating depression.” In July 1985, Eli Lilly’s own data analysis—from a pool of 1,427 patients—showed high incidence of adverse drug effects and evidence of drug-induced violence in some patients. In May 1985, FDA’s (then) chief safety investigator, Dr. Richard Kapit, wrote: “Unlike traditional tricyclic antidepressants fluoxetine’s profile of adverse side effects more closely resembles that of a stimulant drug than one that causes sedation.” He warned: “It is fluoxetine’s particular profile of adverse side-effects which may perhaps, in the future give rise to the greatest clinical liabilities in the use of this medication to treat depression.”
Dr. Kapit’s safety review described the clinical trial data from 46 trials with a total of 1,427 patients. He noted under the section, “Catastrophic and Serious Events,” 52 cases of “egregiously abnormal laboratory reports which were the reason for early termination,” and “additional adverse event reports not reported by the company [which] were revealed on microfiche.” Dr. Kapit reported: “In most cases, these adverse events involved the onset of an unreported psychotic episode.” There were 10 reports of psychotic episodes; 2 reports of completed suicides; 13 attempted suicides; 4 seizures—including a healthy volunteer; and 4 reports of movement disorders.
In 1985 Dr. Kapit recommended “labeling warning [for] the physician that such signs and symptoms of depression may be exacerbated by this drug". No such warning was issued until 2004.
On August 18, 2004, a study in the Journal of the American Medical Association (JAMA) showed Prozac and cognitive behavior therapy, in combination, to be the most effective treatment of depression in adolescents. The research, conducted over three years at 12 medical centers, was funded and coordinated by the National Institute of Mental Health (NIMH) at a cost to US taxpayers of $17 million. A total of 439 adolescents aged 12-17 were given Prozac, Prozac plus cognitive behavior therapy (CBT), placebo plus CBT, or placebo alone. After 12 weeks, 71% of those treated with Prozac and CBT showed improvement (defined by the therapists and the subjects' responses to questionnaires). Improvement was reported by 60% of those taking Prozac without CBT, 43% getting CBT alone, and 35% taking placebo alone.
NIMH Director Thomas Insel told the media it was a "landmark study" because "it's the largest publicly funded study and the only study this size that doesn't have pharmaceutical funding", but lead investigator John March of Duke University Medical Center was on the Eli Lilly payroll.
Data to which March et al did not draw attention showed a higher incidence of harmful behavior among teens taking Prozac (11.9%) compared to those on placebo (5.4%) and CBT alone (4.5%). Few stories mentioned that teenagers to whom suicidal thoughts had occurred had been excluded from the study before it began. According to FDA documents posted on the FDA website on September 25, 2003, at least 2 of 48 children treated with Prozac in the NIMH-sponsored trial attempted suicide. NIMH's role in funding a study with taxpayer money was subsequently used by Eli Lilly as court evidence to extend its Prozac patent exclusivity and to obtain FDA approval for treating depression in children.
In 2005 an internal document purportedly from Eli Lilly, and originally published in the British Medical Journal (BMJ) showed that the drug maker had data more than 15 years old showing that patients on its antidepressant Prozac were far more likely to attempt suicide and show hostility than were patients on other antidepressants and that the company attempted to minimize public awareness of the side effects. The 1988 document indicated that 3.7 percent of patients attempted suicide while on the blockbuster drug, a rate more than 12 times that cited for any of four other commonly used antidepressants. The document, which cited clinical trials of 14,198 patients on fluoxetine also stated that 2.3 percent of users suffered psychotic depression while on the drug, more than double the next-highest rate of patients using another antidepressant.
The document was provided to CNN by the office of U.S. Representative Maurice Hinchey (D-New York), who called for tightening FDA regulations on drug safety. "The case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks," Rep. Hinchey said. The BMJ said the documents disappeared in 1994, during the Fentress Case. Each of the four pages of the paper obtained by CNN is stamped "Confidential" and "Fentress," the name of one of Wesbecker's victims.
In 2005 Eli Lilly and Co. agreed to plead guilty to a federal misdemeanor and pay $36 million to settle charges that it illegally marketed and promoted its Evista osteoporosis drug for two unapproved uses.
The Department of Justice said an investigation that began in July 2002 found that some Lilly sales representatives promoted Evista in 1998 as useful for preventing and reducing the risk of breast cancer and for reducing the risk of heart disease. The FDA had approved neither use.
Thiomersal is a preservative that contains mercury and is used by Eli Lilly and others in vaccines. In 1999 the American Academy of Pediatrics and the Public Health Service urged vaccine makers to stop using mercury-based preservatives. In 2001 the Institute of Medicine concluded that the link between autism and thimerosal was “biologically plausible.” By 2002, thimerosal lawsuits against Eli Lilly were progressing through the courts.
Political analysts and the parents of autistic children were baffled when it was revealed, shortly after the passage of the Homeland Security Act in 2002, that a rider to the bill had been added just prior to passage, that would shield Eli Lilly and the pharmaceutical industry from billions of dollars in anticipated lawsuits over vaccines. Known as the "Eli Lilly Protection Act", the provision was designed to force lawsuits over the preservative thiomersal, calling the suits into a special 'vaccine court'. The provision could have resulted in the dismissal of thousands of cases filed by parents, who contend mercury in thimerosal poisoned their children, causing autism and other neurological ailments, but the rider was subsequently repealed when the next session of Congress convened in 2003.
In 2001, Eli Lilly's chairman, president and CEO, Sidney Taurel, told shareholders: "No medicine better symbolizes our mission than Xigris," calling it "one of our industry's genuine breakthroughs."
Xigris was designed to fight sepsis, a condition that kills more than 200,000 Americans annually. Xigris is the only approved drug for sepsis, and it costs $8,000 to treat a single patient. Lilly hoped Xigris would be a blockbuster, with sales of at least a billion dollars a year. But after five years on the market, sales are only $200 million.
Eli Lilly used the Belsito & Company public relations firm in a deceptive marketing campaign to promote Xigris, its drug for treatment of sepsis. A report in the New England Journal of Medicine (NEJM) accused Lilly of initiating false reports of a shortage of the drug to boost sales. Belsito and Company spread the word that the drug was being "rationed" and physicians were being 'systematically forced' to decide who would live and who would die. As part of this effort, Lilly provided a group of physicians and bioethicists with a $1.8 million grant to form the Values, Ethics, and Rationing in Critical Care (VERICC) Task Force, purportedly to address ethical issues raised by rationing of the drug in hospital intensive care units. Finally, the Surviving Sepsis Campaign was established, in theory to raise awareness of severe sepsis and generate momentum toward the development of treatment guidelines.
This marketing campaign is especially troublesome because Xigris has been linked to increased risk of serious bleeding in patients who use it as well as other concerns. "Controversy surrounds both the drug study itself and the FDA approval," wrote NEJM editor-at-large Richard P. Wenzel, MD in 2002.. The FDA approved the drug despite the advisory committee's split vote (10 to 10) due to concerns about the validity of the claimed efficacy and safety findings on the basis of a single trial.
Eli Lilly spokeswoman Judy Kay Moore insists that the company did not mastermind the ethics task force or steer the guideline-writing process. It was only a coincidence, Moore says, that the ethics task force and the Surviving Sepsis Campaign used the same public relations firm, Belsito and Company.
This section didn't have many citations, more are needed, especially for more recent products.
- The New York Times Dec 17 2006
- The Zyprexa Memos (Requires Tor)
- ZyprexaKills: Download the documents and memos
-  Mother Wonders if Psychosis Drug Helped Kill Son, New York Times January 4, 2007
-  New York Times, Dec 18, 2006
-  Lilly to Pay Up to $500 Million to Settle Claims. The New York Times, January 4th, 2007
- 1. McGlashan TH, Zipursky RB, Perkins D, Addington J, Miller TJ, Woods SW, Hawkins KA, Hoffman R, Lindborg S, Tohen M, Breier A: The PRIME North America randomized double-blind clinical trial of olanzapine versus placebo in patients at risk of being prodromally symptomatic for psychosis, I: study rationale and design. Schizophr Res 2003; 61:7–18
- Thomas H. McGlashan, M.D. Robert B. Zipursky, M.D. Diana Perkins, M.D. Jean Addington, Ph.D. Tandy Miller, Ph.D. Scott W. Woods, M.D. Keith A. Hawkins, Psy.D. Ralph E. Hoffman, M.D. Adrian Preda, M.D. Irvin Epstein, M.D., F.R.C.P.C. Donald Addington, M.D. Stacy Lindborg, Ph.D. Quynh Trzaskoma, M.S. Mauricio Tohen, M.D., Dr.P.H. Alan Breier, M.D. Randomized, Double-Blind Trial of Olanzapine Versus Placebo in Patients Prodromally Symptomatic for Psychosis, American Journal of Psychiatry, May 2006, vol 163:790-799.
-  from Richard Zitrin & Carol M. Langford. "Hide and Secrets in Louisville" from "The Moral Compass of the American Lawyer". Ballantine Books, 1999
- Eli Lilly internal analysis submitted to the Joachim Wernicke (July 2, 1985), PZ 2441 2000. Document uncovered during Fentress litigation.
- Kapit R. FDA Safety Review NDA 18-963, March 23, 1985.
- CBSNEWS Dec 12 2002
- Eli Lilly Annual Report, 2001
-  Peter Q. Eichacker, Charles Natanson, Robert L. Danner, "Surviving Sepsis — Practice Guidelines, Marketing Campaigns, and Eli Lilly". NEJM Volume 355:1640-1642. (10 2006)
-  Laurie Barclay, MD. "Controversy Brews Over Xigris' Role in Treating Sepsis". Medscape Medical News. Oct 1, 2002
- National Public Radio October 18, 2006