Talk:Eli Lilly and Company

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[edit] Absolutely

Merge. Lilly must be presented as they are in toto, IN ONE PLACE. Those who seek INFORMATION must be readily apprised of the complete picture; separating the bad from well, whatever else is there, is not serving the interests of accuracy.

Cisum.ili.dilm 17:31, 10 November 2007 (UTC)

[edit] Bush family

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.

[edit] Subjective

There is text in the article that is purly subjective and not backed up by a referrence:

[edit] Global reputation

Along with General Electric and IBM, Eli Lilly has developed a global reputation for attracting some of the brightest corporate managerial talent.

Can this be substantiated with a link ref?

[edit] BIASED Criticism: check this out!

Unless the Eli Lilly Corporation is pure evil -- which, hey, they may be -- the 'criticism' section is far too long. Now, look what I’ve discovered:

Prior to December 25, 2006, there was no criticism section at all. None. Then comes user 67.82.232.151, who single-handedly wrote the vast majority (possibly all) of its current content. Check out this guy's revision history: aside from minor grammatical corrections, almost 100% of his edits are designed to defame the Eli Lilly Corporation.

Now, that’s fine, so long as he does so in a non-POV manner. He doesn’t. The guy writes with obvious bias, and often (though not always) his statements are unsourced. Most that are sourced aren’t internet-accessible, and therefore cannot be easily verified.

Since this one guy with a grudge has had such a huge effect on this page, I’m adding a POV tag. I know nothing about the industry myself, so until someone can verify this user's rant, we should let people know what’s what.

Here are some of his edits to the Eli Lilly page:

Eli Lilly has been known to engage in withholding internal information on medications, including Prozac, Thimerosal and Zyprexa in order to downplay side effects and adverse reactions in order to boost profits. [1]

Consequently, many critics claim that the FDA approval of duloxetine for Major Depressive Disorder (MDD) and diabetic neuropathy is irresponsible and intellectually dishonest, and is a case illustration of the agency's failure to prevent harmful drugs from being marketed in the name of big profits. [2]

In one of the only three cases to ever go to trial for SSRI indication in 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. [3]

Over the last decade, the company spent millions of dollars lobbying Congress in hopes of extending its patent on Prozac and some lawmakers even attempted to insert last-minute provisions to omnibus spending bills to grant the company’s wish. Generic drugmakers prevailed, handing Eli Lilly one of its few legislative losses in recent memory. The company, which favors Republicans over Democrats with its contributions… [4]


This same user also started the ‘Controversy’ statement on the Duloxetine page, containing the following outsourced and obviously biased statements:

In the 1980s, [Eli] Lilly waged a successful campaign to get fluoxetine, brand name Prozac, through the FDA even though not a single study submitted to the agency showed the drug to be effective for depression when taken alone. …not only targets serotonin, it also impacts another important neurochemical, norepinephrine. This flatly contradicts the ‘serotonin/good, norepinephrine/bad’ story that launched the SSRI revolution that [Eli] Lilly started with fluoxetine. [5]

He started a ‘Legal’ section on the Olanzapine page with this:

…documents given to The Times by a lawyer representing mentally ill patients, show that [Eli] Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes. [6]

He adds this unsourced statement to the SSRI Discontinuation Syndrome page:

Data obtained from 9 clinical trials assessing the efficacy and safety of duloxetine in the treatment of major depressive disorder (MDD) by Lilly Research found that patients with discontinuation-emergent adverse events (DEAEs) were reported by 44.3% of duloxetine patients… No follow up was published by [Eli] Lilly stating the duration of DEAE's longer than one week ultimately persisted for. [7]

--70.17.209.58 09:02, 22 March 2007 (UTC)

This article is a collaborative effort. The controversy section is important to this article and if their are problems with it, it should be fixed, not removed. Neitherday 12:49, 22 March 2007 (UTC)
Gosh, guess I shouldn't have removed it then. Oh wait, I didn't, and never suggested doing so. --70.17.209.58 20:23, 22 March 2007 (UTC)
That should be directed to the person who did. Sorry it came across wrong, and that is my fault. I should not have indented so as to indicate a direct reply. Neitherday 21:06, 22 March 2007 (UTC)
Nevertheless you're right! Also there is a link on the main page to a "El Lilly Controversy" article (in the controversy section). This is content forking and does not follow Wikipedia guidelines ... Content forking. I am also considering putting in Neutrality templates and Dispute templates but am not jumping yet as I do not fully understand the procedure. If a more experienced editor want's to jump ahead of me then fine :) DJ Barney 16:10, 4 June 2007 (UTC) Can't get the links to work for some reason... http://en.wikipedia.org/wiki/Wikipedia:Neutrality_templates http://en.wikipedia.org/wiki/Wikipedia:Dispute_templates DJ Barney 16:13, 4 June 2007 (UTC)

[edit] One of the largest corporations?

It's not even one of the largest Pharma corporations!

<img src="http://www.economist.com/images/20050618/CSU885.gif">

http://www.economist.com/images/20050618/CSU885.gif

Pfizer, Glaxo, Sanofi all are far larger pharma companies.

Eli Lilly is 229th largest company in the world. And in the top 40 in the USA [8]. Not bad considering there are over two million corporation worldwide. Charles Edward 00:20, 29 May 2008 (UTC)

[edit] Zyprexa

Zyprexa (Olanzapine) is Lilly's largest seller. It used to be the first-place atypical antipsychotic in the U.S. but has dropped to third. This is probably because doctors and patients have learned, through the NIH CATIE study and through thousands of lawsuits, that it has the most dangerous side effects of all the drugs in its class. It causes diabetes, hyperglycemia, and death. 8000 plaintiffs settled with Lilly in 2005 and are still waiting for payment. Many states have sued Lilly for alleged fraud, for not revealing its side effects, and for compensation to their state's Medicaid programs for the costs of the drug as well as the costs involved in caring for people who got such conditions as diabetes from the drug. Lilly has also been charged with alleged fraud in off-label marketing of the drug for children. Many individual lawsuits remain outstanding and will begin to be heard once the 8000 plaintiff suit has been finalized. Lilly states that it will "vigously defend" itself against these individual lawsuits, but a number of them are for death allegedly caused by this drug.

Should this be included? Frank 16:17, 17 December 2006 (UTC)

I briefly had a contribution up with a typo in it. My profound apologies to all.--Mumbler7 15:41, 18 January 2007 (UTC)

Lilly Zyprexa Lawsuit 8 State Countdown May 25 2007

Zyprexa targeted by AG's for Fraud

Utah Latest state to sue Eli Lilly in developing "Viva Zyprexa" Scandal.

Side effects to Zyprexa can include high blood sugar levels, acute weight gain and pancreatitis, according to the lawsuit.

"Utah has paid millions of dollars for inappropriate and medically unnecessary doses of Zyprexa. As a result, Lilly has been illegally enriched at the expense of the State," the lawsuit said.

The state is seeking civil damages and penalties, including $5,000-$10,000 for each prescription that was "not medically necessary."

Lilly also faces lawsuits filed by attorneys general of Alaska, Louisiana, Mississippi, New Mexico and West Virginia alleging that it marketed Zyprexa for unapproved uses or hid the risks of weight gain and diabetes.

Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect.

Not fair!

Daniel Haszard Bangor Maine 4 year Zyprexa user who now has diabetes http://www.zyprexa-victims.com

[edit] What about Lilly's impact on the mass production of Insulin?

[edit] Re: Prozac

It does not stimulate release of serotonin; it keeps the serotonin that's been released from being reuptaken: reuptake inhibitor. Aleta 01:12, 15 November 2006 (UTC)Aleta


[edit] Controversy and medical ethics

These sections below have good potential, but really need more and better citations. RXPhd 23:30, 31 March 2007 (UTC)

[edit] Strattera and adult ADHD

 This article does not cite any references or sources. (March 2007)
Please help improve this article by adding citations to reliable sources. Unverifiable material may be challenged and removed.

In 2002, Lilly began marketing Strattera®, the first non-stimulant medication approved for the treatment of Attention-deficit hyperactivity disorder. It was the first such medication to be specifically marketed to adults with this disorder.

Strattera has been used by more than two million patients. In 2004, Strattera grossed $632 million, or roughly 25 percent, of the $2.6 billion U.S. ADHD pharmaceutical market, and was the fastest growing medication in this market.

Strattera carries a Food and Drug Administration (FDA) black box warning, the highest level of warning a drug can receive, as a result of studies showing a possible link between use of the drug and suicidal thoughts in children, as well as possible liver damage in adults.[citation needed] Lilly acknowledges that the medication has several other side effects, including pain during urination and orgasm, urinary retention, a tightening of the scrotum, mood swings, and dry mouth.

Strattera, a Selective norepinephrine reuptake inhibitor, was originally developed as an anti-depressant, but never received FDA approval for this use. The drug instead was approved by the FDA for use in the treatment of adult ADHD, which has become its more common use.

Lilly owns the domain adultadd.com, which allows visitors to take a test to see if they have the condition, and the company has run advertising campaigns, which have been designed to raise awareness of the condition. This effort has been controversial because there are some medical professionals[who?] who believe that ADHD is overdiagnosed and that companies like Lilly have perpetuated this with extensive television and other marketing.

[edit] Controversy

 The neutrality of this section is disputed.
Please see the discussion on the talk page.(December 2007)
Please do not remove this message until the dispute is resolved.

Eli Lilly is one of the nation’s leading pharmaceutical companies. While the company has played a role in developing a number of progressive drugs and treatments for all kinds of ailments, its most famous product is Prozac, the world’s best known antidepressant. The company spent millions of dollars lobbying the United States Congress in hopes of extending its patent on Prozac. The patent on Prozac was declared invalid on February 2, 2001, in connection with a lawsuit against a generic competitor. The early loss of patent exclusivity allowed generic companies to sell Prozac and Lilly sales plumeted; the corporation is still recovering from this major financial setback. Eli Lilly subsequently released Prozac Weekly and Cymbalta. The company has joined others in the drug industry in continuing to fight for extended patent laws that would protect their exclusive rights to market their pharmaceutical products.

Eli Lilly is also one of many drug companies that give soft money to advocacy groups and political action committees (PACs) to help influence lawmakers and regulators. Historically Eli Lilly favors pro-business Republicans over Democrats with its political contributions (75% to 25% in the last nine US election cycles).[1]

Though the contributions of Lilly and similar large pharmaceutical companies typically are aimed at influencing policies and laws, it is difficult to argue that these contributions are aimed at approving specific new molecules. Approval is handled via the FDA, not congress or any other lawmaker. The FDA's primary source of funding is "user fees" paid by the industry to ensure there are adequate resources available to review and approve these drugs. Many have argued these user fees represent a conflict of interest. It is worth noting that the current system was put in place c. 1990 in response to allegations that drugs were not being approved efficiently; this movement stemmed from gay-rights activists unhappy with the slow progress of HIV treatments.

Other donations sometimes come through the Lilly Endowment, which maintains nearly $11 billion in assets and owns 13% of the company's stock. The grants are portrayed by the company's and nonprofits as "giving back" to patients. The funding usually comes from the company's marketing or sales divisions, not charity offices. Grants often rise with promotional spending as a drug hits the market and fall when sales ebb.

In 2000-2001, the American Diabetes Association (ADA) did not disclose an unusual gift from Lilly: a lent executive, Emerson "Randy" Hall Jr., who moved into ADA's Alexandria, Virginia headquarters and coached the organization on growth strategies, all paid by Lilly.

A Philadelphia, Pennsylvania native now retired and living in Princeton, New Jersey, Hall said he never tried to influence the group and merely helped it market itself, including writing its slogan: "Cure. Care. Commitment." Hall estimated that his work, including diabetes patient research he subsequently shared with Lilly, would have cost "hundreds of thousands" from a contractor. Asked why it did not cite Hall on its tax returns or annual report, ADA spokeswoman Diane Tuncer said: "There is not a requirement to do so."

Another non-profit group, the National Alliance on Mental Illness (NAMI), did not disclose that Lilly marketing manager Gerald Radke briefly ran its entire operation. Radke began in 1999 as a Lilly-paid "management consultant," then left Lilly and served as NAMI's paid "interim executive director" until mid-2001. The group acknowledged this only after being shown Radke's resume listing the job. After NAMI, he ran the Pennsylvania Office of Mental Health and Substance Abuse, and now serves in the Pennsylvania Health Department.

Lilly, which donated at least $2.5 million to the ADA and $3 million to NAMI between 2003 and 2005, called its executive loans mutually beneficial. "The primary goal is to assist that organization in developing a needed capacity or function, but it also often serves to assist in the career development of the employee," a Lilly spokesman, Edward G. Sagebiel, said.[2]

In 2005, as part of a U.S. House of Representatives budget bill that reduces spending on Medicaid prescription drugs, Eli Lilly and other businesses secured a provision ensuring that their mental health drugs continue to fetch top price at a cost of hundreds of millions of dollars to the states.

The provision, inserted by Rep. Steve Buyer (R-Ind.), whose district flanks Lilly's Indianapolis headquarters, would largely exempt antipsychotic and antidepressant medications from a larger measure designed to steer Medicaid patients to the least expensive treatment options. To opponents, Buyer's measure underscores the excessive power that corporate interests wield on Capitol Hill. Critics say the measure also violates the purpose of the budget-cutting bill, which was drafted to give state governments the flexibility to cut program costs in ways that minimize the harm done to beneficiaries. The Congressional Budget Office has estimated that the provision will raise federal drug spending by $125 million over five years, while state officials say they are likely to face far higher costs.[3]

On January 25, 2006, Democratic leader Nancy Pelosi, Democratic Whip Steny H. Hoyer and Ranking Minority Member Henry A. Waxman asked J. Dennis Hastert, Speaker of the House of Representatives at that time, for a congressional investigation into the role played by the Alexander Strategy Group, a lobbying firm closely linked to Tom DeLay and Jack Abramoff, in the passage of the Medicare Prescription Drug Act which was passed on December 8, 2003. With the indictments of DeLay and Abramoff, new questions arose about the role of the Alexander Strategy Group in the passing of the bill. Lobby disclosure forms showed that the largest single client of the Alexander Strategy Group was the pharmaceutical industry, which paid the small firm over $2.5 million, including nearly $1 million in 2003 when the prescription drug law was being written.

The lobby disclosure forms also revealed that the primary clients represented by the Alexander Strategy Group were Pharmaceutical Research and Manufacturers of America (PhRMA) and Eli Lilly during consideration of the Medicare Prescription Drug Act. The person representing PhRMA and Lilly was Tony Rudy, a former deputy chief of staff for DeLay who worked for Abramoff from 2001 to 2002. On January 9, 2006, the Alexander Strategy Group announced that it was shutting down its lobbying operations.[4]

Senior Vice President and General Counsel for Eli Lilly, Robert A. Armitage, is the past chair of the Patent Committee of PhRMA.

In February 2007, the Serious Fraud Office in the UK launched an investigation into allegations of Eli Lilly being involved in the discredited oil-for-food sanctions regime in Iraq. They are accused of paying bribes to Saddam Hussein's regime.[5]

[edit] Medical ethics

 The neutrality of this section is disputed.
Please see the discussion on the talk page.(December 2007)
Please do not remove this message until the dispute is resolved.

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.

[edit] Zyprexa

According to a New York Times article published on December 17, 2006,[6] 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,[7] 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.[8] 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.[9]

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.[10]

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.[11]

[edit] PRIME

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).[12] 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.[13]

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.

[edit] Prozac

[edit] Legal

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".[14]

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.

[edit] Medical/Scientific

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.[15] 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.”[16]

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.

[edit] Evista

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.

[edit] Thiomerosal

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.[17] 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.

[edit] Xigris

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."[18]

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.[19] 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.[20]. 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.[21]

[edit] Neutrality

The article has has become heavily biased towards the company. There is a section of accolades (of which there are many) but not a section of critisisms (of which there are many). I beleive someone has unbalanced the article in Eli Lilly's favour due to the recent New York Times articles. I'm rather new to wikipedia editing and don't know the process myself, but could someone more fluent please help with this issue? —The preceding unsigned comment was added by 69.76.170.199 (talk) 04:39, 23 April 2007 (UTC).

There should be a brief overview of some of the controversy surrounding Eli Lilly in this article, though the details should stay in the controversy article. Neitherday 16:11, 25 May 2007 (UTC)
A seperate article is not within Wikipedia guidelines ( Content forking ). The articles should be recombined. I am seeking advice from experienced editors. DJ Barney 13:56, 5 June 2007 (UTC)
Actually, (in jan08 at least) the Content forking page says:There is no consensus whether a "Criticism of .... " article is always a POV fork. At least the "Criticism of ... " article should contain rebuttals if available, and the original article should contain a summary of the "Criticism of ... " article.Mujinga (talk) 17:12, 19 January 2008 (UTC)
This article is a war zone by the look of it! I am putting an Unreferenced tag on the page as it has none. If it is removed then I will face the music. But it looks like this article could go into arbitration (and should?), I must admit I'm not sure of the procedure. DJ Barney 15:41, 4 June 2007 (UTC)