Eli Lilly controversies

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Eli Lilly and Company

Type	Public
Industry	Pharmaceuticals, Healthcare
Founded	1876
Headquarters	Indianapolis, Indiana, USA
Key people	Sidney Taurel, Chairman John C. Lechleiter, President & CEO Derica Rice, CFO Eli Lilly, Founder
Products	Prozac, Humalog, Cialis, Strattera, Darvocet
Revenue	$18.633 billion USD (2007)
Employees	40,600 (2007)
Website	www.lilly.com

Eli Lilly and Company is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. The company was founded in 1876 by a pharmaceutical chemist, Eli Lilly, for which the company was ultimately named.

Eli Lilly and Company has been involved in numerous controversies, including those involving politics and medical ethics.

Contents 1 Medical ethics 1.1 Zyprexa 1.2 Prozac 1.2.1 Legal 1.2.2 Medical/scientific 1.3 Evista 1.4 Thiomersal 1.5 Xigris 1.6 Swedish research on Dextropropoxyphene(DXP) 1.7 Strattera and adult ADHD 2 Acquisitions 2.1 Posilac 2.2 Icos 3 Political 4 Eli Lilly and the Bush Family 4.1 George H.W. Bush 4.2 George W. Bush 4.2.1 Appointees with Eli Lilly interests 4.2.2 Medicare Prescription Drug, Improvement, and Modernization Act of 2003 4.2.3 Vaccine legislation protection 4.2.4 President's Emergency Plan for AIDS Relief 4.2.5 New Freedom Initiative 5 See also 6 References 7 External links

[edit] Medical ethics

While bringing many good pharmaceuticals to market, Eli Lilly has sometimes been accused of pushing products to the marketplace with bad research, withholding of research to the public or false advertising.

Lilly was 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.

Oraflex, the American version of Benoxaprofen, was withdrawn from the market in 1982, just one month after gaining FDA approval.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.

[edit] Zyprexa

According to a New York Times article published on December 17, 2006,^[1] 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,^[2] 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 4, 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.^[3] 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.^[4]

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.^[5]

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.^[6]

In order to make up for shrinking sales figures for Zyprexa in the U.S.A. the company increased the prices for this medication in Germany in May 2007 by 18 percent.^[7][8]

Zyprexa was also the focus of the February 5, 2009 article by Ben Wallace-Wells in Rolling Stone magazine titled Bitter Pill. The article outlines the creation, marketing, and subsequent legal and ethical issues brought forth by Lilly's actions to quickly put out a new anti-psychotic drug as the patent for Prozac neared expiration.^[9]

[edit] Prozac

[edit] Legal

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In one of the few 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".^[10]

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.^{[citation needed]} 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.^{[citation needed]}

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.^{[citation needed]}

The company spent millions of dollars lobbying the United States Congress in hopes of extending its patent on Prozac.^{[citation needed]} 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 plummeted; the corporation is still recovering from this major financial setback.^{[citation needed]} 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.^{[citation needed]}

[edit] Medical/scientific

This section needs additional citations for verification. Please help improve this article by adding reliable references. Unsourced material may be challenged and removed. (February 2009)

The signs of violence and suicidality were there since Prozac was tested in premarketing trials. In May 1984, Germany’s regulatory agency (Bundesgesundheitsamt, BGA) 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.^[11] 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.”^[12]

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 ten reports of psychotic episodes; two reports of completed suicides; 13 attempted suicides; four seizures—including a healthy volunteer; and four 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.^[13] 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." However, of the 11 authors of the study, six received funding from Eli Lilly, including the lead author, John March.^[14]

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.^{[citation needed]} 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.^[15] 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.^[16]

[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 United States 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] Thiomersal

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.^{[citation needed]} In 2001 the Institute of Medicine concluded that the link between autism and thiomersal was “biologically plausible.”^{[citation needed]} However, the Institute of Medicine as well as the World Health Organization have subsequently concluded, on the grounds of extensive epidemiologic data, that there is no evidence that thiomersal in vaccines is harmful.^[17][18] Nonetheless, by 2002, thiomersal 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.^[19] Known as the "Eli Lilly Protection Act",^[20] 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 thiomersal poisoned their children, causing autism and other neurological ailments, but the rider was subsequently repealed when the next session of Congress convened in 2003.^{[citation needed]}

[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."^[21]

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.^{[citation needed]} 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.^{[citation needed]}

Eli Lilly used the Belsito & Company public relations firm in a marketing campaign to promote Xigris. 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.^[22] 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.

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 in 2002.^[23] 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.^[24]

[edit] Swedish research on Dextropropoxyphene(DXP)

Seven articles on DXP published 1998-2002 (pages 2–5 and 7-9 deal DXP) .^[25]

Two dissertations were written:

1). Studies on Dextropropoxyphene with Special Reference to Dependency Among Chronic Pain Patients, Classification of the Manner of Death in Fatal Poisoning, and Characteristics of the Fatal Poisoning Victims, of Birgitta Jonasson. Uppsala University 2000.

2.) Studies of the practice of dextropropoxifen from a public health perspective. The impact of a regulatory framework. by Ulf Jonasson. Nordic Hälsovårdshögskolan, 2001.

The two main findings - which were presented in the articles and theses - were that 200 people poisoned to death by DXP during the investigated period 1992-1999. Results nr two was that 956 (54%) of the 1782 deaths in the years 1992-1996 - with DXP in the blood - were assessed as poisoning. Of the 956 deaths were judged 49 cases (5%) as emergency relief, in 542 cases (57%) as suicide and 365 cases (38%) as unclear fatality which dissect the doctors were not entirely clear on whether it was an accident or suicide.

In order to get the results outside the academic world published a popular book on DXP-research. "Death by use and abuse of analgesics" by Ulf and Birgitta Jonasson, in cooperation with Rättsmedicinalverket. (RMV report 1999:1). The year 2001 was given an English translation of the report. "Fatalities due to use or misuse of pain-killers" (RMV-report 2001:1)

In the year 2003, the DXP-issue was raised in Europe, Parliament of Marit Paulsen, who represented the Liberal Party. European Parliament: The dangers of Dextropropoxyphene: March 23 2003 Committee on the Environment, Public Health and Consumerpolicy, Oral Question no.10/03 by Marit Paulsen http://www.europarl.europa.eu/meetdocs/committees/envi/20030521 / 488535EN.pdf

A follow-up study - on behalf of Rättsmedicinalverket, the Medical Products Agency and in cooperation with the National Social Insurance Board and the Emergency telephone - was published in 2004. Restrictions on the prescription of dextropropoxifen (DXP) - effects on sales and poisoning: (2004-06-15) http://www.lakemedelsverket.se/Tpl/NewsPage____505.aspx

The report is also available in English: Restrictions on the prescribing of dextropropoxyphene ( DXP) - effect on sales and cases of fatal poisoning http://www.rmv.se/pdf/dxp-report.pdf Preface in English: http://www.rmv.se/pdf/dxp-preface.pdf Summary of the report: http://www.rmv.se/pdf/dxp-summary.pdf

On two occasions restrictions introduced in Sweden in which DXP would be prescribed. The first time was in June 2001, when the prescribing doctor had to use a special form, which must also be used when classified as narcotics medicines printed. Distalgesic was banned in 2005 - that has been on the Swedish market for about 40 years - and Paraflex Comp was also removed from the market. In the 1990s, there were seven different DXP-preparations, today left two on the Swedish market, both are so-called Dextropropoxifennapsylat and contains only substance DXP. Nicotine preparations are Dexofen (AstraZenca) and Doloxene (MEDA). Sales have over the same period dropped by around 70-80% and the number of fatal poisonings with about as much.

The English Agency MHRA decided on 31 January 2005 to "phase out the analgesic drug Co-Proxamol" - that is matched by, among other things, Darvon and Distalgesic - until the end of December 2007. http://www.dh.gov.uk/en/Publicationsandstatistics/Pressreleases/DH_4102347

The study, which mainly was behind the MHRA's decision was: Co-Proxamol and suicide; preventing the continuing of overdose deaths, QJM 2005 98 (3) :159-170. (See, among other things, reffs; 21-26) http://qjmed.oxfordjournals.org/cgi/content/full/98/3/159

On 28 February 2006 the American Consumers Public Citizen sent a petition to the U.S. Agency FDA (Food and Drug Administration): Petition to the FDA Thursday ban all propoxyphene (Darvon) products; prescribing painkiller causes many fatalities (HRG Publication # 1762),http://www.citizen.org/publications/release.cfm?ID=7420

In a so-called docket-site with the FDA to publish comments from, among others, individuals on the petition send : Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products http://www.fda.gov/ohrms/dockets/dockets/06p0090/06p0090.htm

A summary of the petition can be found here: Public Citizen Petitions FDA Thursday Ban Darvon Products, Prescription painkiller Many Causes Fatalities Filed today with the FDA. http://www.citizen.org/pressroom/release.cfm?ID=2145

A letter to the director of the FDA - Dr. von Eschenbach - written by the Swedish research vouple Jonasson - are reported on page http://www.fda.gov/ohrms/dockets/DOCKETS/06p0090/06P-0090-EC13-Attach-1.pdf

In the autumn of 2007 the following report from the Medical Products Agency was presented: Dextropropoxyphene - the follow-up report over the security 2000-2006. http://www.lakemedelsverket.se/Tpl/NewsPage____6275.aspx

The following picture shows the "Death - DXP of forensic material" http://www.lakemedelsverket.se/upload/nyheter/2007/figur1_dextropropoxifen_dödsfall.gif

Sales from Svedis: http://www.lakemedelsverket.se/upload/nyheter/2007/figur3_dextropropoxifen_försäljningsdata.gif

On 28 November 2007 a video was introduced on YouTube: Darvon, Distalgesic, Co-Proxamol. "The worst drugs ever." http://www.youtube.com/watch?v=vw5O4tgErsg

On June 19 2008 Public Citizen sued FDA Public Citizen Sues FDA for Failure to Act on Dangerous Drug Propoxyphene (Darvon) Has Hazardous Side Effects And Is No http://www.citizen.org/pressroom/release.cfm?ID=2677

[edit] Strattera and adult ADHD

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

Originally designed to be an antidepressant, 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. 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.

Lilly owns the domain www.adultadd.com^[26] 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 believe that ADHD is overdiagnosed and that companies like Lilly have perpetuated this with extensive television and other marketing.

[edit] Acquisitions

[edit] Posilac

In late 2008, Eli Lilly bought over the rights to the controversial drug Posilac, a recombinant form of bovine somatotropin fed to dairy cows to increase milk production. ^[27]

[edit] Icos

In October 2006, Eli Lilly announced that it had reached terms to acquire Icos for $2.1 billion, or $32 a share.^[28] After receiving pressure from large institutional shareholders, as well as proxy advisory firm Institutional Shareholder Services (ISS), Lilly increased its offer to $34 per share, a 6 percent increase.^[29] Resistance to the new offer was voiced again by some large shareholders, and ISS again advised shareholders against accepting the offer, which it deemed as insufficient.^[30] At a special meeting of shareholders, held on January 25, 2007, 77 percent of the shareholders voted in support of the acquisition.^[31] Closing of the transaction for Eli Lilly to acquire Icos for $2.3 billion occurred on January 29, 2007.^[32]

As a result of the acquisition, Eli Lilly gained complete ownership of Cialis and promptly shut down Icos operations and employment of Icos personnel, except for 127 employees working at the biologics facility.^[33][34] At the time of the acquisition, Icos was the largest biotechnology company in the Pacific Northwest, employing approximately 700 people.^[34][35] In December 2007, CMC Biopharmaceuticals A/S (CMC), a Copenhagen, Denmark based provider of contract biomanufacturing services, bought the Bothell-based biologics facility and retained the existing 127 employees.^[34]

In addition to the termination of Icos employees, other aspects of the acquisition were similarly legal but controversial, such the assertions that Icos was being sold too cheaply and that conflicts of interests existed.^[36] The latter related to Icos senior executives, who - despite poor stock performance in part from failed clinical development programs and an inability to successfully license drugs over the preceding years - advocated for and were to be massively compensated upon a successful acquisition.^[28]

Senior executives at Icos received cash payments worth a combined $67.8 million for selling the company to Eli Lilly.^[37] Icos chairman, chief executive and president Paul Clark received a "golden parachute" worth $23.2 million in severance pay, cashed-out stock options, restricted stock awards and other bonuses for retention and closing the deal.^[37] Other management packages included Executive Vice President Gary Wilcox ($8.5 million); Chief Financial Officer Michael Stein ($7.1 million); Chief Medical Officer David Goodkin ($5.9 million); Thomas St. John, Vice President, Therapeutic Development ($5.2 million); Leonard Blum, Senior Vice President, Sales & Marketing ($4.9 million); John Kliewer, Vice President, General Counsel ($4 million); Michelle Yetman, Vice President, Human Resources ($4 million); Clifford Stocks, Vice President, Business Development ($3.6 million), and Shing Chang, Senior Vice President, Drug Discovery ($1.4 million).^[37]

[edit] Political

This article contains weasel words, vague phrasing that often accompanies biased or unverifiable information. Such statements should be clarified or removed. (February 2009)

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 has favored Republicans over Democrats with its political contributions when Republicans have held the majority in Congress, but provided more support to Democrats than Republicans in 2008 and 2010 when Democrats had the majority.^[38]

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.^[who?] 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.^[who?]

• 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.^{[citation needed]} 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.^{[citation needed]} 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."^{[citation needed]}

• 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.^[39]

• In 2004 Charles Schalliol was made Director for the Indiana Office of Management and Budget. Schalliol was Governor Mitch Daniels' first appointment immediately following the 2004 election.^[40] Daniels is also a former Eli Lilly executive and was the head of Office of Management and Budget for President George W. Bush before becoming Governor of Indiana. Prior to joining Governor Daniels administration Schalliol held a variety of executive positions at Eli Lilly and Company, principally in strategic planning, investment banking and business development. Schalliol led the purchase and sale of companies for Lilly including the formation of Guidant Corporation.

• 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.^{[citation needed]} 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.^[who?] 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.^[who?] 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.^[41]

In response to allegations about funding, Eli Lilly has stated it will now become the first major pharmaceutical company to voluntarily post online all information regarding educational grant funding and other contributions provided to US organizations.^[42] The gifts do not include the Lilly Foundation, which acts as a charitable organization separate from the company.

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.^[43][44]

[edit] Eli Lilly and the Bush Family

[edit] George H.W. Bush

After leaving the Central Intelligence Agency in 1977, George H.W. Bush joined the board of directors of Eli Lilly for two years (1977-1979). Future Vice President to Bush Dan Quayle's father, James C. Quayle, owned controlling interest in the The Indianapolis Star at that time.

Bush actively lobbied both within and without the Reagan Administration as Vice President in 1981 to permit drug companies to sell obsolete or especially domestically-banned substances to Third World countries.^{[clarification needed]} While Vice President, Bush continued to act on behalf of pharmaceutical companies by personally going to the Internal Revenue Service for special tax breaks for certain drug companies, including Lilly, who were manufacturing in Puerto Rico.

In 1982, Bush intervened with the U.S. Department of Treasury in connection with proposed rules that would have forced pharmaceutical companies to pay significantly more taxes. Bush was personally ordered to stop lobbying the IRS on behalf of the drug companies by the U.S. Supreme Court.^[45]

Bush stopped lobbying, but pharmaceutical interests still received a 23% additional tax break for their companies in Puerto Rico, who made these obsolete or banned American drugs for sale to Third World countries. Lilly's Puerto Rico-based affiliate now employs approximately 1,100 workers at three plants in Carolina and Mayagüez and 220 additional employees in its sales and marketing offices in San Juan.

[edit] George W. Bush

George W. Bush is the clear front runner when it comes to drug company contributions and patronage. According to the Center for Responsive Politics (CRP), manufacturers of drugs and health products had contributed $764,274 to the 2004 Bush campaign through their political action committees and employees by April 26 of the election year 2004.

[edit] Appointees with Eli Lilly interests

• President and CEO of Eli Lilly, Sidney Taurel, was named by U.S. President George W. Bush as a Homeland Security Advisory Council member in 2002. In 2003 Bush named Taurel a member of the President's Export Council. Bush named Taurel to the Advisory Committee for Trade Policy and Negotiations (ACTPN) in April 2007 for a four year term.^[46]

• Bush's former Secretary of Defense Donald Rumsfeld has served on the boards of several companies including Eli Lilly partner Amylin Pharmaceuticals and Gilead Sciences.

• Former White House Office of Management and Budget director and current Indiana Governor Mitch Daniels is a former Lilly executive. Daniels served as Director of the Office of Management and Budget from January 2001 through June 2003. In this role he was also a member of the National Security Council and the Homeland Security Council.

• Former Eli Lilly CEO Randall Tobias was named by Bush as Global AIDS Coordinator in 2003. Tobias later become the Administrator of the United States Agency for International Development (USAID), where he held the rank of Ambassador.

• Alex Azar, was deputy secretary of Health and Human Services under George W. Bush, serving as chief operating officer for two years. In that role, he oversaw such agencies as the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services. In May 2007 Azar became senior vice president of corporate affairs and communication for Eli Lilly, reporting directly to Chief Executive Sidney Taurel.^[47]

[edit] Medicare Prescription Drug, Improvement, and Modernization Act of 2003

White House Budget Director Mitch Daniels is a former Lilly executive and oversaw the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

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.^[48]

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

[edit] Vaccine legislation protection

Early in 2002, U.S. Senator Bill Frist tried to obtain protection for Eli Lilly from suits attached to legislation that would increase the availability of vaccines to average Americans, and regulate lawsuits against Eli Lilly involving thiomersal, but this attempt was thwarted by U.S. Senator Edward Kennedy, who opposed the measure. Despite Kennedy's effort, however, identical legal protections found their way into Homeland Security legislation (H.R. 5005). After the bill passed, no one in Washington, D.C. was willing to take responsibility for having written or inserting the Lilly legal protections. The rider was later annulled by Congress in 2003. Eli Lilly's Political action committee (PAC) had given Frist almost $10,000 in campaign contributions in 2004.

The White House denied any knowledge of the author/sponsor of the Lilly amendment. Many argue this stretches belief, considering the ties the Bush administration has to the pharmaceutical giant.

[edit] President's Emergency Plan for AIDS Relief

The President's Emergency Plan For AIDS Relief (PEPFAR/Emergency Plan) is President Bush's pledge of $15 billion over five years (2003–2008) to fight the HIV/AIDS pandemic.

On July 2, 2003, President George W. Bush selected former Eli Lilly chief executive Randall L. Tobias as the Global AIDS Coordinator for a $15 billion program to slow the spread of global AIDS and to treat it in Africa and the Caribbean. Bush signed into law a measure to direct the money to 14 countries, most of them in Africa. Tobias retired from Lilly in 1998.

"This decision is another deeply disturbing sign that the president may not be prepared to fulfill his pledge to take emergency action on AIDS," noted Paul Zeitz, executive director of the Global AIDS Alliance. "It raises serious questions of conflict of interest and the priorities of the White House."^[49] Several said they feared that Tobias would be "the fox in charge of the henhouse," as Kate Krauss of the AIDS Policy Project put it. Ambassador Mark Dybul replaced Tobias as U.S. Global AIDS Coordinator on October 10, 2006.

Bush's AIDS project under Tobias has been called "extremely flawed" by critics.^[50] Tobias later become the Administrator of the United States Agency for International Development (USAID), where he held the rank of Ambassador. Tobias, a proponent of abstinence as Global AIDS Coordinator, ironically resigned from USAID over a pay for sex scandal in April 2007.^[51]

[edit] New Freedom Initiative

A sweeping mental health initiative was unveiled by President George W. Bush in July 2004. The plan promises to integrate mentally ill patients fully into the community by providing "services in the community, rather than institutions," according to a March 2004 progress report entitled New Freedom Initiative.^[52][53]

Bush established the New Freedom Commission on Mental Health in April 2002 to conduct a "comprehensive study of the United States mental health service delivery system." The commission issued its recommendations in July 2003.

The President's commission found that "despite their prevalence, mental disorders often go undiagnosed" and recommended comprehensive mental health screening for "consumers of all ages," including pre-school children. According to the commission: "Each year, young children are expelled from preschools and childcare facilities for severely disruptive behaviours and emotional disorders." Schools, wrote the commission, are in a "key position" to screen the 52 million students and 6 million adults who work at the schools.

The commission also recommended "Linkage [of screening] with treatment and supports" including "state-of-the-art treatments" using "specific medications for specific conditions." The commission commended the Texas Medication Algorithm Project (TMAP), a similar program Bush started as Governor of Texas, as a "model" medication treatment plan that "illustrates an evidence-based practice that results in better consumer outcomes."

The Texas project started in 1995 as an alliance of individuals from the pharmaceutical industry, the University of Texas, and the mental health and corrections systems of Texas. The project was funded by a Robert Wood Johnson grant and by several drug companies.

Lilly's Olanzapine (trade name Zyprexa) is one of the atypical antipsychotic drugs recommended as a first line drug in the Texas scheme. A 2003 New York Times article reported that 70% of Olanzapine sales are paid for by government programs, such as Medicare and Medicaid.^[54] All together Lilly reportedly contributed $103,000 to support TMAP. Heather Lusk, an Eli Lilly representative, said contributions to TMAP were "educational" grants made by a company grants office.

[edit] See also

• Eli Lilly and Company
• Hudson Institute
• New Freedom Commission on Mental Health

[edit] References

[edit] External links

• Eli Lilly and Company Official Web Site.