Eli Lilly controversies
Encyclopedia
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
.
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, was withdrawn from the market in 1982, just one month after gaining FDA approval.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.
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 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. 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, released to the New York Times by attorney Jim Gottstein (who was trying to prevent the forcible psychiatric drugging of his client), 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. The series of events around this "leak" are sometimes known as "The Zyprexa Papers" or "The Zyprexa Chronicles".
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.
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.
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.
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 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 plummeted; 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.
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 ten reports of psychotic episodes; two reports of completed suicide
s; 13 attempted suicides; four seizure
s—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. 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.
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.
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.
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 thiomersal was “biologically plausible.” 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. 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. 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 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.
, 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 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. 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 unit
s. 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. 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.
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
(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 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
.
fed to dairy cows to increase milk production.
for $2.1 billion, or $32 a share
. 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. 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. At a special meeting of shareholders, held on January 25, 2007, 77 percent of the shareholders voted in support of the acquisition. Closing of the transaction for Eli Lilly to acquire Icos for $2.3 billion occurred on January 29, 2007.
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. At the time of the acquisition, Icos was the largest biotechnology company in the Pacific Northwest
, employing approximately 700 people. 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.
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. 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.
Senior executives at Icos received cash payments worth a combined $67.8 million for selling the company to Eli Lilly. 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. 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).
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.
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. 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.
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. 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.
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.
(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, making George W. Bush
the top receiver of these contributions.
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.
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.
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.
(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." 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. 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.
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.
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
. 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.
Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States...
's global headquarters is located in Indianapolis
Indianapolis
Indianapolis is the capital of the U.S. state of Indiana, and the county seat of Marion County, Indiana. As of the 2010 United States Census, the city's population is 839,489. It is by far Indiana's largest city and, as of the 2010 U.S...
, Indiana
Indiana
Indiana is a US state, admitted to the United States as the 19th on December 11, 1816. It is located in the Midwestern United States and Great Lakes Region. With 6,483,802 residents, the state is ranked 15th in population and 16th in population density. Indiana is ranked 38th in land area and is...
, in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. The company was founded in 1876 by a pharmaceutical chemist
Chemist
A chemist is a scientist trained in the study of chemistry. Chemists study the composition of matter and its properties such as density and acidity. Chemists carefully describe the properties they study in terms of quantities, with detail on the level of molecules and their component atoms...
, Eli Lilly
Colonel Eli Lilly
Eli Lilly was an American soldier, pharmaceutical chemist, industrialist, entrepreneur, and founder of the Eli Lilly and Company pharmaceutical corporation...
, for which the company was ultimately named.
Eli Lilly and Company has been involved in numerous controversies, including those involving politics and medical ethics
Medical ethics
Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.-History:Historically,...
.
Medical ethics
While bringing many good pharmaceuticals to market, Eli Lilly has been found to push products to the marketplace with bad research, withhold research to the public and falsely advertise it's products.Lilly was cited in lawsuits filed against the manufacturers of diethylstilbestrol
Diethylstilbestrol
Diethylstilbestrol is a synthetic nonsteroidal estrogen that was first synthesized in 1938. Human exposure to DES occurred through diverse sources, such as dietary ingestion from supplemented cattle feed and medical treatment for certain conditions, including breast and prostate cancers...
(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
Benoxaprofen
Benoxaprofen is a non-steroidal anti-inflammatory drug. It was marketed by Eli Lilly and Company under the brand name Oraflex in the US and as Opren in Europe. Lilly suspended sales of Oraflex in 1982 after reports from the British government and the U.S. Food and Drug Administration of adverse...
, 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
Jaundice
Jaundice is a yellowish pigmentation of the skin, the conjunctival membranes over the sclerae , and other mucous membranes caused by hyperbilirubinemia . This hyperbilirubinemia subsequently causes increased levels of bilirubin in the extracellular fluid...
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.
Zyprexa
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 TorTor (anonymity network)
Tor is a system intended to enable online anonymity. Tor client software routes Internet traffic through a worldwide volunteer network of servers in order to conceal a user's location or usage from someone conducting network surveillance or traffic analysis...
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 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. 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, released to the New York Times by attorney Jim Gottstein (who was trying to prevent the forcible psychiatric drugging of his client), 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. The series of events around this "leak" are sometimes known as "The Zyprexa Papers" or "The Zyprexa Chronicles".
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
Dementia
Dementia is a serious loss of cognitive ability in a previously unimpaired person, beyond what might be expected from normal aging...
. 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
Mania
Mania, the presence of which is a criterion for certain psychiatric diagnoses, is a state of abnormally elevated or irritable mood, arousal, and/ or energy levels. In a sense, it is the opposite of depression...
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.
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.
Zyprexa was also the focus of the February 5, 2009 article by Ben Wallace-Wells in Rolling Stone
Rolling Stone
Rolling Stone is a US-based magazine devoted to music, liberal politics, and popular culture that is published every two weeks. Rolling Stone was founded in San Francisco in 1967 by Jann Wenner and music critic Ralph J...
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.
Legal
In one of the few three cases to ever go to trial for Prozac'sFluoxetine
Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor class. It is manufactured and marketed by Eli Lilly and Company...
possible role in inducing suicide
Suicide
Suicide is the act of intentionally causing one's own death. Suicide is often committed out of despair or attributed to some underlying mental disorder, such as depression, bipolar disorder, schizophrenia, alcoholism, or drug abuse...
, 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
Kentucky
The Commonwealth of Kentucky is a state located in the East Central United States of America. As classified by the United States Census Bureau, Kentucky is a Southern state, more specifically in the East South Central region. Kentucky is one of four U.S. states constituted as a commonwealth...
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
Federal Trade Commission
The Federal Trade Commission is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act...
(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
American Civil Liberties Union
The American Civil Liberties Union is a U.S. non-profit organization whose stated mission is "to defend and preserve the individual rights and liberties guaranteed to every person in this country by the Constitution and laws of the United States." It works through litigation, legislation, and...
(ACLU) requesting that the FTC investigate and take appropriate action to remedy the breach.
The company spent millions of dollars lobbying the United States Congress
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
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 plummeted; 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.
Medical/scientific
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. In May 1985, FDA’s (then) chief safety investigator, Dr. Richard Kapit, wrote: “Unlike traditional tricyclicTricyclic
Tricyclics are chemical compounds that contain three interconnected rings of atoms.Many compounds have a tricyclic structure, but in pharmacology, the term has traditionally been reserved to describe heterocyclic drugs...
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 ten reports of psychotic episodes; two reports of completed suicide
Suicide
Suicide is the act of intentionally causing one's own death. Suicide is often committed out of despair or attributed to some underlying mental disorder, such as depression, bipolar disorder, schizophrenia, alcoholism, or drug abuse...
s; 13 attempted suicides; four seizure
Seizure
An epileptic seizure, occasionally referred to as a fit, is defined as a transient symptom of "abnormal excessive or synchronous neuronal activity in the brain". The outward effect can be as dramatic as a wild thrashing movement or as mild as a brief loss of awareness...
s—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
Journal of the American Medical Association
The Journal of the American Medical Association is a weekly, peer-reviewed, medical journal, published by the American Medical Association. Beginning in July 2011, the editor in chief will be Howard C. Bauchner, vice chairman of pediatrics at Boston University’s School of Medicine, replacing ...
(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
National Institute of Mental Health
The National Institute of Mental Health is one of 27 institutes and centers that make up the National Institutes of 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." However, of the 11 authors of the study, six received funding from Eli Lilly, including the lead author, John March.
In 2005, an internal document purportedly from Eli Lilly, and originally published in the British Medical Journal
British Medical Journal
BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...
(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
CNN
Cable News Network is a U.S. cable news channel founded in 1980 by Ted Turner. Upon its launch, CNN was the first channel to provide 24-hour television news coverage, and the first all-news television channel in the United States...
by the office of U.S. Representative Maurice Hinchey
Maurice Hinchey
Maurice Dunlea Hinchey , is the U.S. Representative for , serving since 1993. He is a member of the Democratic Party...
(D-New York
New York
New York is a state in the Northeastern region of the United States. It is the nation's third most populous state. New York is bordered by New Jersey and Pennsylvania to the south, and by Connecticut, Massachusetts and Vermont to the east...
), 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.
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 EvistaRaloxifene
Raloxifene is an oral selective estrogen receptor modulator that has estrogenic actions on bone and anti-estrogenic actions on the uterus and breast...
osteoporosis drug for two unapproved uses.
The United States Department of Justice
United States Department of Justice
The United States Department of Justice , is the United States federal executive department responsible for the enforcement of the law and administration of justice, equivalent to the justice or interior ministries of other countries.The Department is led by the Attorney General, who is nominated...
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
ThiomersalThiomersal
Thiomersal , and commonly known in the US as thimerosal, is an organomercury compound. This compound is a well established antiseptic and antifungal agent....
is a preservative that contains mercury
Mercury (element)
Mercury is a chemical element with the symbol Hg and atomic number 80. It is also known as quicksilver or hydrargyrum...
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
Autism
Autism is a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior. These signs all begin before a child is three years old. Autism affects information processing in the brain by altering how nerve cells and their...
and thiomersal was “biologically plausible.” However, the Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
as well as the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
have subsequently concluded, on the grounds of extensive epidemiologic
Epidemiology
Epidemiology is the study of health-event, health-characteristic, or health-determinant patterns in a population. It is the cornerstone method of public health research, and helps inform policy decisions and evidence-based medicine by identifying risk factors for disease and targets for preventive...
data, that there is no evidence that thiomersal in vaccines is harmful. 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
Homeland Security Act
The Homeland Security Act of 2002, , 116 Stat. 2135 was introduced in the aftermath of the September 11 attacks and subsequent mailings of anthrax spores. The HSA was cosponsored by 118 members of Congress. It was signed into law by President George W...
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 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.
Xigris
In 2001, Eli Lilly's chairman, president and CEO, Sidney TaurelSidney Taurel
Sidney Taurel is chairman and a former chief executive officer for Eli Lilly and Company. He became chief executive officer in July 1998 and chairman of the board of directors on January 1, 1999. He was succeeded as chief executive officer by John C...
, told shareholders: "No medicine better symbolizes our mission than Xigris
Drotrecogin alfa
Drotrecogin alfa is a recombinant form of human activated protein C that has anti-thrombotic, anti-inflammatory, and profibrinolytic properties. Drotrecogin alpha belongs to the class of serine proteases. Drotrecogin alfa has not been found to improve outcomes in people with severe sepsis...
," calling it "one of our industry's genuine breakthroughs."
Xigris was designed to fight sepsis
Sepsis
Sepsis is a potentially deadly medical condition that is characterized by a whole-body inflammatory state and the presence of a known or suspected infection. The body may develop this inflammatory response by the immune system to microbes in the blood, urine, lungs, skin, or other tissues...
, 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 marketing campaign to promote Xigris. A report in the New England Journal of Medicine
New England Journal of Medicine
The New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It describes itself as the oldest continuously published medical journal in the world.-History:...
(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 unit
Intensive Care Unit
thumb|220px|ICU roomAn intensive-care unit , critical-care unit , intensive-therapy unit/intensive-treatment unit is a specialized department in a hospital that provides intensive-care medicine...
s. 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. 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.
Swedish research on Dextropropoxyphene(DXP)
Seven articles on DXP published 1998-2002 (pages 2–5 and 7-9 deal DXP) .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
Strattera and adult ADHD
In 2002, Lilly began marketing Strattera, the first non-stimulant medication approved for the treatment of attention-deficit hyperactivity disorderAttention-deficit hyperactivity disorder
Attention deficit hyperactivity disorder is a developmental disorder. It is primarily characterized by "the co-existence of attentional problems and hyperactivity, with each behavior occurring infrequently alone" and symptoms starting before seven years of age.ADHD is the most commonly studied and...
(ADHD). It was the first such medication to be specifically marketed to adults with this disorder.
Originally designed to be an antidepressant
Antidepressant
An antidepressant is a psychiatric medication used to alleviate mood disorders, such as major depression and dysthymia and anxiety disorders such as social anxiety disorder. According to Gelder, Mayou &*Geddes people with a depressive illness will experience a therapeutic effect to their mood;...
, 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 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
Marketing
Marketing is the process used to determine what products or services may be of interest to customers, and the strategy to use in sales, communications and business development. It generates the strategy that underlies sales techniques, business communication, and business developments...
.
Posilac
In late 2008, Eli Lilly bought over the rights to the controversial drug Posilac, a recombinant form of bovine somatotropinBovine somatotropin
Bovine somatotropin , or BGH, is a chain of amino acids produced by the cow's pituitary gland. Like other hormones, it is produced in small quantities and is used in regulating metabolic processes...
fed to dairy cows to increase milk production.
Icos
In October 2006, Eli Lilly announced that it had reached terms to acquire IcosICOS
Icos Corporation was the largest biotechnology company in the U.S. state of Washington before it was sold to Eli Lilly and Company in 2007. Co-founded in 1989 by George B. Rathmann, a pioneer in the industry and Chief Executive Officer and co-founder of Amgen, Icos focused on the development of...
for $2.1 billion, or $32 a share
Share (finance)
A joint stock company divides its capital into units of equal denomination. Each unit is called a share. These units are offered for sale to raise capital. This is termed as issuing shares. A person who buys share/shares of the company is called a shareholder, and by acquiring share or shares in...
. 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. 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. At a special meeting of shareholders, held on January 25, 2007, 77 percent of the shareholders voted in support of the acquisition. Closing of the transaction for Eli Lilly to acquire Icos for $2.3 billion occurred on January 29, 2007.
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
Biologics
A biologic is a medicinal product such as a vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, or living cells that are used as therapeutics to treat diseases...
facility. At the time of the acquisition, Icos was the largest biotechnology company in the Pacific Northwest
Pacific Northwest
The Pacific Northwest is a region in northwestern North America, bounded by the Pacific Ocean to the west and, loosely, by the Rocky Mountains on the east. Definitions of the region vary and there is no commonly agreed upon boundary, even among Pacific Northwesterners. A common concept of the...
, employing approximately 700 people. In December 2007, CMC Biopharmaceuticals A/S (CMC), a Copenhagen
Copenhagen
Copenhagen is the capital and largest city of Denmark, with an urban population of 1,199,224 and a metropolitan population of 1,930,260 . With the completion of the transnational Øresund Bridge in 2000, Copenhagen has become the centre of the increasingly integrating Øresund Region...
, Denmark
Denmark
Denmark is a Scandinavian country in Northern Europe. The countries of Denmark and Greenland, as well as the Faroe Islands, constitute the Kingdom of Denmark . It is the southernmost of the Nordic countries, southwest of Sweden and south of Norway, and bordered to the south by Germany. Denmark...
based provider of contract biomanufacturing services, bought the Bothell-based biologics facility and retained the existing 127 employees.
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. 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.
Senior executives at Icos received cash payments worth a combined $67.8 million for selling the company to Eli Lilly. Icos chairman, chief executive and president Paul Clark received a "golden parachute
Golden parachute
A golden parachute is an agreement between a company and an employee specifying that the employee will receive certain significant benefits if employment is terminated. Sometimes, certain conditions, typically a change in company ownership, must be met, but often the cause of termination is...
" worth $23.2 million in severance pay, cashed-out stock options, restricted stock awards and other bonuses for retention and closing the deal. Other management packages included Executive Vice President Gary Wilcox ($8.5 million); Chief Financial Officer
Chief financial officer
The chief financial officer or Chief financial and operating officer is a corporate officer primarily responsible for managing the financial risks of the corporation. This officer is also responsible for financial planning and record-keeping, as well as financial reporting to higher management...
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
Human resources
Human resources is a term used to describe the individuals who make up the workforce of an organization, although it is also applied in labor economics to, for example, business sectors or even whole nations...
($4 million); Clifford Stocks, Vice President, Business Development ($3.6 million), and Shing Chang, Senior Vice President, Drug Discovery ($1.4 million).
Political
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 RepublicansRepublican Party (United States)
The Republican Party is one of the two major contemporary political parties in the United States, along with the Democratic Party. Founded by anti-slavery expansion activists in 1854, it is often called the GOP . The party's platform generally reflects American conservatism in the U.S...
over Democrats
Democratic Party (United States)
The Democratic Party is one of two major contemporary political parties in the United States, along with the Republican Party. The party's socially liberal and progressive platform is largely considered center-left in the U.S. political spectrum. The party has the lengthiest record of continuous...
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.
- In 2000-2001, the American Diabetes AssociationAmerican Diabetes AssociationThe American Diabetes Association is a United States-based association working to fight the consequences of diabetes, and to help those affected by diabetes...
(ADA) did not disclose an unusual gift from Lilly: a lent executive, Emerson "Randy" Hall Jr., who moved into ADA's Alexandria, VirginiaAlexandria, VirginiaAlexandria is an independent city in the Commonwealth of Virginia. As of 2009, the city had a total population of 139,966. Located along the Western bank of the Potomac River, Alexandria is approximately six miles south of downtown Washington, D.C.Like the rest of northern Virginia, as well as...
headquarters and coached the organization on growth strategies, all paid by Lilly. A Philadelphia, PennsylvaniaPhiladelphia, PennsylvaniaPhiladelphia is the largest city in the Commonwealth of Pennsylvania and the county seat of Philadelphia County, with which it is coterminous. The city is located in the Northeastern United States along the Delaware and Schuylkill rivers. It is the fifth-most-populous city in the United States,...
native now retired and living in Princeton, New JerseyPrinceton, New JerseyPrinceton is a community located in Mercer County, New Jersey, United States. It is best known as the location of Princeton University, which has been sited in the community since 1756...
, 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 IllnessNational Alliance on Mental IllnessThe National Alliance on Mental Illness was founded in 1979 as the National Alliance for the Mentally Ill. NAMI is a nation-wide American advocacy group, representing families and people affected by mental illness as a non-profit grass roots organization and has affiliates in every American state...
(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 PennsylvaniaPennsylvaniaThe Commonwealth of Pennsylvania is a U.S. state that is located in the Northeastern and Mid-Atlantic regions of the United States. The state borders Delaware and Maryland to the south, West Virginia to the southwest, Ohio to the west, New York and Ontario, Canada, to the north, and New Jersey to...
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.
- In 2004 Charles Schalliol was made Director for the IndianaIndianaIndiana is a US state, admitted to the United States as the 19th on December 11, 1816. It is located in the Midwestern United States and Great Lakes Region. With 6,483,802 residents, the state is ranked 15th in population and 16th in population density. Indiana is ranked 38th in land area and is...
Office of Management and Budget. Schalliol was Governor Mitch Daniels'Mitch DanielsMitchell Elias "Mitch" Daniels, Jr. is the 49th and current Governor of the U.S. state of Indiana. A Republican, he began his first four-year term as governor on January 10, 2005, and was elected to his second term by an 18-point margin on November 4, 2008. Previously, he was the Director of the...
first appointment immediately following the 2004 election. 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 MedicaidMedicaidMedicaid is the United States health program for certain people and families with low incomes and resources. It is a means-tested program that is jointly funded by the state and federal governments, and is managed by the states. People served by Medicaid are U.S. citizens or legal permanent...
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 BuyerSteve BuyerStephen Earle Buyer is the former U.S. Representative for , and previously the , serving from 1993 until 2011. He is a member of the Republican Party. Buyer holds the rank of Colonel in the United States Army Reserve....
(R-Ind.), whose district flanks Lilly's Indianapolis headquarters, would largely exempt antipsychoticAntipsychoticAn antipsychotic is a tranquilizing psychiatric medication primarily used to manage psychosis , particularly in schizophrenia and bipolar disorder. A first generation of antipsychotics, known as typical antipsychotics, was discovered in the 1950s...
and antidepressantAntidepressantAn antidepressant is a psychiatric medication used to alleviate mood disorders, such as major depression and dysthymia and anxiety disorders such as social anxiety disorder. According to Gelder, Mayou &*Geddes people with a depressive illness will experience a therapeutic effect to their mood;...
medications from a larger measure designed to steer Medicaid patients to the least expensive treatment options. 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.
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. 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
Iraq
Iraq ; officially the Republic of Iraq is a country in Western Asia spanning most of the northwestern end of the Zagros mountain range, the eastern part of the Syrian Desert and the northern part of the Arabian Desert....
. They are accused of paying bribes to Saddam Hussein's
Saddam Hussein
Saddam Hussein Abd al-Majid al-Tikriti was the fifth President of Iraq, serving in this capacity from 16 July 1979 until 9 April 2003...
regime.
George H.W. Bush
After leaving the Central Intelligence AgencyCentral Intelligence Agency
The Central Intelligence Agency is a civilian intelligence agency of the United States government. It is an executive agency and reports directly to the Director of National Intelligence, responsible for providing national security intelligence assessment to senior United States policymakers...
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
Dan Quayle
James Danforth "Dan" Quayle served as the 44th Vice President of the United States, serving with President George H. W. Bush . He served as a U.S. Representative and U.S. Senator from the state of Indiana....
father, James C. Quayle
James C. Quayle
James Cline Quayle was an American newspaper publisher and businessman who owned several newspapers in the United States including the Huntington Herald-Press in Indiana and the Wickenburg Sun in Arizona. He was the father of Dan Quayle, the 44th Vice-President of the United States.Quayle was...
, owned controlling interest in the The Indianapolis Star
The Indianapolis Star
The Indianapolis Star is a morning daily newspaper that began publishing on June 6, 1903. It has won the Pulitzer Prize for investigative reporting twice, in 1975 and 1991. It is currently owned by the Gannett Company.-History:...
at that time.
Bush actively lobbied both within and without the Reagan Administration
Reagan Administration
The United States presidency of Ronald Reagan, also known as the Reagan administration, was a Republican administration headed by Ronald Reagan from January 20, 1981, to January 20, 1989....
as Vice President in 1981 to permit drug companies to sell obsolete or especially domestically-banned substances to Third World countries. While Vice President, Bush continued to act on behalf of pharmaceutical companies by personally going to the Internal Revenue Service
Internal Revenue Service
The Internal Revenue Service is the revenue service of the United States federal government. The agency is a bureau of the Department of the Treasury, and is under the immediate direction of the Commissioner of Internal Revenue...
for special tax breaks for certain drug companies, including Lilly, who were manufacturing in Puerto Rico
Puerto Rico
Puerto Rico , officially the Commonwealth of Puerto Rico , is an unincorporated territory of the United States, located in the northeastern Caribbean, east of the Dominican Republic and west of both the United States Virgin Islands and the British Virgin Islands.Puerto Rico comprises an...
.
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.
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.
George W. Bush
According to the Center for Responsive PoliticsCenter for Responsive Politics
The Center for Responsive Politics is a non-profit, nonpartisan research group based in Washington, D.C. that tracks money in politics and the effect of money and lobbying activity on elections and public policy and maintains a public online database of its information.Their database...
(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, making George W. Bush
George W. Bush
George Walker Bush is an American politician who served as the 43rd President of the United States, from 2001 to 2009. Before that, he was the 46th Governor of Texas, having served from 1995 to 2000....
the top receiver of these contributions.
Appointees with Eli Lilly interests
- President and CEO of Eli Lilly, Sidney TaurelSidney TaurelSidney Taurel is chairman and a former chief executive officer for Eli Lilly and Company. He became chief executive officer in July 1998 and chairman of the board of directors on January 1, 1999. He was succeeded as chief executive officer by John C...
, was named by U.S. President George W. Bush as a Homeland Security Advisory CouncilHomeland Security Advisory CouncilThe Homeland Security Advisory Council is part of the Executive Office of the President. It was created by an Executive Order on March 19, 2002.-Council Members:* William H. Webster , Partner, Milbank, Tweed, Hadley & McCloy, LLP...
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.
- Bush's former Secretary of Defense Donald RumsfeldDonald RumsfeldDonald Henry Rumsfeld is an American politician and businessman. Rumsfeld served as the 13th Secretary of Defense from 1975 to 1977 under President Gerald Ford, and as the 21st Secretary of Defense from 2001 to 2006 under President George W. Bush. He is both the youngest and the oldest person to...
has served on the boards of several companies including Eli Lilly partner Amylin Pharmaceuticals and Gilead SciencesGilead SciencesGilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two...
.
- Former White House Office of Management and Budget director and current IndianaIndianaIndiana is a US state, admitted to the United States as the 19th on December 11, 1816. It is located in the Midwestern United States and Great Lakes Region. With 6,483,802 residents, the state is ranked 15th in population and 16th in population density. Indiana is ranked 38th in land area and is...
Governor Mitch DanielsMitch DanielsMitchell Elias "Mitch" Daniels, Jr. is the 49th and current Governor of the U.S. state of Indiana. A Republican, he began his first four-year term as governor on January 10, 2005, and was elected to his second term by an 18-point margin on November 4, 2008. Previously, he was the Director of the...
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 CouncilUnited States National Security CouncilThe White House National Security Council in the United States is the principal forum used by the President of the United States for considering national security and foreign policy matters with his senior national security advisors and Cabinet officials and is part of the Executive Office of the...
and the Homeland Security CouncilHomeland Security CouncilThe Homeland Security Council is an entity within the White House Office tasked with advising the President on matters relating to Homeland Security...
.
- 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 DevelopmentUnited States Agency for International DevelopmentThe United States Agency for International Development is the United States federal government agency primarily responsible for administering civilian foreign aid. President John F. Kennedy created USAID in 1961 by executive order to implement development assistance programs in the areas...
(USAID), where he held the rank of Ambassador.
- Alex AzarAlex AzarAlexander M. Azar II was appointed by George W. Bush as the Deputy Secretary of the U.S. Department of Health and Human Services . Before this appointment, Mr. Azar served as General Counsel at HHS....
, 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 AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
, the National Institutes of HealthNational Institutes of HealthThe National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
, the Centers for Disease Control and PreventionCenters for Disease Control and PreventionThe Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
, and the Centers for Medicare and Medicaid ServicesCenters for Medicare and Medicaid ServicesThe Centers for Medicare & Medicaid Services , previously known as the Health Care Financing Administration , is a federal agency within the United States Department of Health and Human Services that administers the Medicare program and works in partnership with state governments to administer...
. In May 2007 Azar became senior vice president of corporate affairs and communication for Eli Lilly, reporting directly to Chief Executive Sidney Taurel.
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
White House Budget Director Mitch DanielsMitch Daniels
Mitchell Elias "Mitch" Daniels, Jr. is the 49th and current Governor of the U.S. state of Indiana. A Republican, he began his first four-year term as governor on January 10, 2005, and was elected to his second term by an 18-point margin on November 4, 2008. Previously, he was the Director of the...
is a former Lilly executive and oversaw the Medicare Prescription Drug, Improvement, and Modernization Act
Medicare Prescription Drug, Improvement, and Modernization Act
The Medicare Prescription Drug, Improvement, and Modernization Act is a federal law of the United States, enacted in 2003. It produced the largest overhaul of Medicare in the public health program's 38-year history.The MMA was signed by President George W...
of 2003.
On January 25, 2006, Democratic leader Nancy Pelosi
Nancy Pelosi
Nancy Patricia D'Alesandro Pelosi is the Minority Leader of the United States House of Representatives and served as the 60th Speaker of the United States House of Representatives from 2007 to 2011...
, Democratic Whip Steny H. Hoyer and Ranking Minority Member Henry A. Waxman asked J. Dennis Hastert, Speaker of the House of Representatives
United States House of Representatives
The United States House of Representatives is one of the two Houses of the United States Congress, the bicameral legislature which also includes the Senate.The composition and powers of the House are established in Article One of the Constitution...
at that time, for a congressional investigation into the role played by the Alexander Strategy Group
Alexander Strategy Group
Alexander Strategy Group was an American lobbying firm involved in the K Street Project, founded by Ed Buckham and his wife Wendy. Buckham is a former chief of staff of House Majority Leader Tom DeLay, and the firm openly promoted its access to DeLay. Its chief lobbyist was Paul Behrends.In...
, a lobbying firm closely linked to Tom DeLay
Tom DeLay
Thomas Dale "Tom" DeLay is a former member of the United States House of Representatives, representing Texas's 22nd congressional district from 1984 until 2006. He was Republican Party House Majority Leader from 2003 to 2005, when he resigned because of criminal money laundering charges in...
and Jack Abramoff
Jack Abramoff
Jack Abramoff is an American former lobbyist and businessman. Convicted in 2006 of mail fraud and conspiracy, he was at the heart of an extensive corruption investigation that led to the conviction of White House officials J. Steven Griles and David Safavian, U.S. Representative Bob Ney, and nine...
, in the passage of the Medicare Prescription Drug Act
Medicare Prescription Drug, Improvement, and Modernization Act
The Medicare Prescription Drug, Improvement, and Modernization Act is a federal law of the United States, enacted in 2003. It produced the largest overhaul of Medicare in the public health program's 38-year history.The MMA was signed by President George W...
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
Pharmaceutical Research and Manufacturers of America
Pharmaceutical Research and Manufacturers of America , founded in 1958, is a trade group representing the pharmaceutical research and biopharmaceutical companies in the United States. PhRMA's stated mission is advocacy for public policies that encourage the discovery of new medicines for patients...
(PhRMA) and Eli Lilly during consideration of the Medicare Prescription Drug Act. The person representing PhRMA and Lilly was Tony Rudy
Tony Rudy
Tony Charles Rudy , an American lobbyist and an associate of Jack Abramoff. After serving as a staffer in the office of U. S. Representative Tom DeLay from approximately 1995 to 2001, and rising to deputy chief of staff, Rudy joined "Team Abramoff" at Greenberg Traurig. Rudy was implicated in the...
, 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.
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.
Vaccine legislation protection
Early in 2002, U.S. Senator Bill FristBill Frist
William Harrison "Bill" Frist, Sr. is an American physician, businessman, and politician. He began his career as an heir and major stockholder to the for-profit hospital chain of Hospital Corporation of America. Frist later served two terms as a Republican United States Senator representing...
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
Thiomersal
Thiomersal , and commonly known in the US as thimerosal, is an organomercury compound. This compound is a well established antiseptic and antifungal agent....
, but this attempt was thwarted by U.S. Senator Edward Kennedy
Ted Kennedy
Edward Moore "Ted" Kennedy was a United States Senator from Massachusetts and a member of the Democratic Party. Serving almost 47 years, he was the second most senior member of the Senate when he died and is the fourth-longest-serving senator in United States history...
, 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
Political action committee
In the United States, a political action committee, or PAC, is the name commonly given to a private group, regardless of size, organized to elect political candidates or to advance the outcome of a political issue or legislation. Legally, what constitutes a "PAC" for purposes of regulation is a...
(PAC) had given Frist almost $10,000 in campaign contributions in 2004.
The White House
White House
The White House is the official residence and principal workplace of the president of the United States. Located at 1600 Pennsylvania Avenue NW in Washington, D.C., the house was designed by Irish-born James Hoban, and built between 1792 and 1800 of white-painted Aquia sandstone in the Neoclassical...
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.
President's Emergency Plan for AIDS Relief
The President's Emergency Plan For AIDS ReliefPresident's Emergency Plan For AIDS Relief
The President's Emergency Plan For AIDS Relief was a commitment of $15 billion over five years from United States President George W. Bush to fight the global HIV/AIDS pandemic...
(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
Randall L. Tobias
Randall L. Tobias is a former chief executive officer of Eli Lilly and Company who became the first United States Director of Foreign Assistance, and served concurrently as the Administrator of the U.S. Agency for International Development , with the rank of Ambassador...
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." 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
Mark R. Dybul
Ambassador Mark R. Dybul served as the United States Global AIDS Coordinator, leading the implementation of the President's Emergency Plan for AIDS Relief during the presidency of George W. Bush.-Biography:...
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. Tobias later become the Administrator of the United States Agency for International Development
United States Agency for International Development
The United States Agency for International Development is the United States federal government agency primarily responsible for administering civilian foreign aid. President John F. Kennedy created USAID in 1961 by executive order to implement development assistance programs in the areas...
(USAID), where he held the rank of Ambassador. Tobias, a proponent of abstinence
Abstinence
Abstinence is a voluntary restraint from indulging in bodily activities that are widely experienced as giving pleasure. Most frequently, the term refers to sexual abstinence, or abstention from alcohol or food. The practice can arise from religious prohibitions or practical...
as Global AIDS Coordinator, ironically resigned from USAID over a pay for sex scandal in April 2007.
New Freedom Initiative
A sweeping mental health initiative was unveiled by President George W. BushGeorge W. Bush
George Walker Bush is an American politician who served as the 43rd President of the United States, from 2001 to 2009. Before that, he was the 46th Governor of Texas, having served from 1995 to 2000....
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.
Bush established the New Freedom Commission on Mental Health
New Freedom Commission on Mental Health
The controversial New Freedom Commission on Mental Health was established by U.S. President George W. Bush in April 2002 to conduct a comprehensive study of the U.S. mental health service delivery system and make recommendations based on its findings...
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
Texas Medication Algorithm Project
The Texas Medication Algorithm Project is a decision-tree medical algorithm, the design of which was based on the expert opinions of mental health specialists. It has provided and rolled out a set of psychiatric management guidelines for doctors treating certain mental disorders within Texas'...
(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
Robert Wood Johnson Foundation
The Robert Wood Johnson Foundation is the United States' largest philanthropy devoted exclusively to health and health care; it is based in Princeton, New Jersey. The foundation's mission is to improve the health and health care of all Americans...
grant and by several drug companies.
Lilly's Olanzapine
Olanzapine
Olanzapine is an atypical antipsychotic, approved by the FDA for the treatment of schizophrenia and bipolar disorder...
(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
Medicaid
Medicaid is the United States health program for certain people and families with low incomes and resources. It is a means-tested program that is jointly funded by the state and federal governments, and is managed by the states. People served by Medicaid are U.S. citizens or legal permanent...
. 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.
See also
- Eli Lilly and CompanyEli Lilly and CompanyEli Lilly and Company is a global pharmaceutical company. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States...
- Hudson InstituteHudson InstituteThe Hudson Institute is an American think tank founded in 1961, in Croton-on-Hudson, New York, by futurist, military strategist, and systems theorist Herman Kahn and his colleagues at the RAND Corporation...
- New Freedom Commission on Mental HealthNew Freedom Commission on Mental HealthThe controversial New Freedom Commission on Mental Health was established by U.S. President George W. Bush in April 2002 to conduct a comprehensive study of the U.S. mental health service delivery system and make recommendations based on its findings...