Eli Lilly

Trump makes a lame attempt on drug prices by requiring wholesale prices (?) in TV ads, sued by merck,Lilly and Amgen on 1st amend .

320

https://theintercept.com/2020/02/29/cronyism-and-conflicts-of-interest-in-trumps-coronavirus-task-force/

alex AZAR, the secretary of health and human services, admitted Wednesday that a vaccine for a new coronavirus might not be affordable for all Americans. “We can’t control that price,” Azar told Rep. Jan Schakowsky, D-Ill., during a congressional hearing about the novel strain, which has been spreading throughout the world and is widely expected to become a serious public health issue in the United States.

After a wave of criticism from Democrats, Azar walked the comment back the next day, saying that he would ensure public access to a vaccine for Covid-19, the disease caused by the virus, if one should be developed.But Azar, who served as the top lobbyist for Eli Lilly before becoming president of the drug company’s U.S. operations in 2012 and the secretary of health and human Services in 2018, knows of what he unthinkingly speaks. Exorbitant drug pricing often leaves life-saving treatment out of reach for the poorest Americans. And to the extent that Azar and the other businessmen who make up the majority of the president’s coronavirus task force have any experience with pharmaceuticals, one of the most profitable sectors of the economy, it’s been making money off the system that keeps them out of reach.

In the case of Azar, who earned nearly $2 million during his last year at Lilly, that profit came at the expense of the people who needed the drugs, according to a lawsuit filed in 2017. While Azar was leading the pharmaceutical giant, the cost of its drugs went up significantly. In particular, insulin sold by the company more than doubled in price. According to the suit, which also names Novo Nordisk and Sanofi, Eli Lilly engaged in a scheme to artificially inflate the price of its drug, leaving some diabetic people unable to pay the cost and forced to use expired insulin or none at all. Eli Lilly did not immediately respond to a request for comment, but the company has told other publications that the suit has no merit and that it follows the “highest ethical standards.”

For another task force member, the profits could come from the coronavirus itself. Joseph Grogan was a lobbyist for the pharmaceutical giant Gilead Sciences before he joined the Trump administration as director of the Domestic Policy Council and led the Drug Pricing and Innovation Work Group. On Wednesday, after Gilead announced that it would be starting two clinical trials of an antiviral drug that could be used to treat Covid-19, the company’s stock price surged.

As a former lobbyist for a company that stands to gain big from a possible treatment for the respiratory disease, Grogan’s participation on the task force poses a host of ethical problems, according to Robert Klitzman, professor of psychiatry and director of the bioethics master’s program at Columbia University. “Does he have a conflict of interest? Yes!” said Klitzman, who points out that the government is likely to spend money on both the research and purchase of treatments for the virus. “Gilead could help shape a government request for proposals so that they could have an unfair advantage.”

While Grogan appears to have sold his Gilead stock and, according to the Office of Management and Budget, has severed all financial relationships and taken “the Trump pledge,” the situation is still problematic, according to Klitzman. “When he gets out of office, they could give him a gift for doing a good job or just hire him again. And what about his buddies? I’m sure he is still close to people who work for Gilead who will benefit. These are all major ethical concerns.”

Although Grogan and his friends may have a lot to gain from his participation on the task force, it is not clear what expertise he and most of the others serving on the group bring to it. Of the task force’s 16 members — 17, if you include Vice President Mike Pence, who is heading the effort — only four have any training in science or medicine. The others mostly hail from the business world, including Treasury Secretary Steven Mnuchin, an investment banker who was sued for asset stripping; Ken Cuccinelli, a lawyer and self-described “opponent of homosexuality” now serving as acting deputy secretary of homeland security; and Christopher Liddell, a former executive at Microsoft and General Motors, who worked with Trump’s son-in-law Jared Kushner on the modernization of federal IT systems before directing the country’s response to what may be the biggest public health crisis in over a century.

Pence also named Larry Kudlow to the task force on Thursday. Kudlow, a top economic adviser to Trump who used to work for Bear Stearns, went on Fox Business to reassure the American public that reports of increasing coronavirus infections around the world don’t necessarily mean “that this thing is going to skyrocket in North America.” Kudlow then encouraged everyone to keep investing, saying, “Stocks look pretty cheap to me.”

Trump has fired many of the people who actually know how to coordinate government responses to epidemics. As Laurie Garrett reported in January, the president shut down the National Security Council’s global health security unit and cut $15 billion in national health spending, including funding for the management of infectious global diseases at the Centers for Disease Control and Prevention, Department of Homeland Security, and HHS. At the CDC, the funding cuts to the global health section were so severe, Garrett wrote, that “the number of countries it was working in was reduced from 49 to merely 10.”

While four doctors are on the task force, it’s not clear how much they will be allowed to direct the response to the virus. The White House reportedly told Anthony Fauci, an immunologist who directs the National Institute of Allergy and Infectious Disease and has extensive experience combating infectious diseases, not to speak publicly without clearance after he said at a meeting that the virus “has adapted extremely well to human species.”

On Thursday, Deborah Birx, a physician who has served as the U.S. Global AIDS Coordinator since 2014, was named as the White House coronavirus response coordinator, and Surgeon General Jerome Adams was added to the task force. Their appointments came after Sen. Bernie Sanders slammed Trump for putting “political cronies, not scientists” in charge of the government response to the virus.

===

https://www.washingtonpost.com/national/health-science/senate-finance-committee-advances-alex-azars-nomination-to-head-hhs/2018/01/17/db4928c8-fb96-11e7-ad8c-ecbb62019393_story.html?utm_term=.7d898d47f471

The Senate Finance Committee approved Alex Azar as the next health and human services secretary on Wednesday, voting 15-12 to send his nomination to the Senate floor.

The vote followed party lines, with the exception of Democratic Sen. Thomas R. Carper (Del.), who supported the nomination.

If approved by the full Senate, Azar, a former executive for the Eli Lilly pharmaceutical company, would succeed President Trump’s first HHS secretary, Tom Price. The former congressman from Georgia resigned under pressure in September during an investigation of his use of private charter planes at taxpayer expense to attend official events.

“Mr. Azar is well-credentialed to lead such a critical department at a time America’s health care system is facing difficult challenges,” Committee Chairman Orrin G. Hatch (R-Utah)said in a written statement.

“He continues to demonstrate that he has what it takes to help alleviate problems caused by Obamacare, all while bolstering and improving Medicare and Medicaid.”

Azar told Finance members during the Jan. 9 hearing on his nomination that prescription drug prices cost too much but that he was not in favor of broad government action to curb prices. His other priorities, he said, would be making health care more affordable, rewarding Medicare providers for promoting good health and combating the opioid epidemic.

The committee’s top Democrat, Sen. Ron Wyden (Ore.), again criticized Azar Wednesday for his “documented history of raising drug prices” while he worked at Lilly. He said that Azar didn’t offer “a single example” of the company lowering prices during Azar’s tenure, which included five years as president of its largest affiliate, Lilly USA.

Carper explained his vote in a statement late Wednesday afternoon. “I am still evaluating Mr. Azar’s nomination,” he said, “and, while I am concerned about his perspective on Medicaid, the Affordable Care Act and his knowledge on women’s health issues, I believe he is qualified for consideration by the full Senate.”

Azar served in the agency during George W. Bush’s administration as both the department’s general counsel and deputy secretary.

He left Lilly in early 2017 and formed a consulting firm. He told a different Senate committee in late November that he no longer owned Lilly stock.

Trump picks Alex Azar to lead Health and Human Services

Pharm, under attack for drug prices, started an industry war

pharma mkt blog john mack

Tuesday, June 28, 2005

WLF Watches FDA Watching Drug Ads

The Washington Legal Foundation (WLF), a conservative watchdog group funded by businesses (including drug companies), last week launched the "FDA/DDMAC Watch" program to "scrutinize" FDA advertising regulations. DDMAC is the FDA's Division of Drug Marketing, Advertising, and Communications, which oversees drug ads.:{

DDMAC Watch's first actionchallenged an FDA warning letter regarding a TV ad for Eli Lilly& Co.'s adult ADD therapy, Strattera (see "}:Watchdog Group Blasts FDA").

According to the WLF, the FDA is acting “"outside its legal authority"” when its writes such letters, and shows "“disregard for the First Amendmentby alleging that materials are misleading with no evidence of how consumers understand them." ” (See the WLF Letter to DDMAC).

In short, the Washington Legal Foundation claims, the FDA "“invented" much of its power to police drug advertising. ("Watchdog Group Blasts FDA").

:{WLF is to the first amendment what the NRA is to the second amendment. That is, every argument by WLF begins and ends with the first amendment as it applies to a special interest group -- i.e., businesses like the pharmaceutical industry.:{

The House(s) That Troy Built}:}:

What's really interesting, however, are the ties that bind WLF, FDA, and the Pharma industry.

One of the main ties is Daniel E. Troy, former chief counsel to the FDA who joined WLF's board of directors just 4 days before the DDMAC Watch letter.}: According to the WLF Web site, Troy was "the first appointee to the Food and Drug Administration made by President George W. Bush."

"Troy managed to restrict FDA's ability to use its statutes creatively, and this in turn deterred mid-level managers from advocating new approaches to emerging scientific issues, leaving the agency looking - and feeling - weak." (See "FDAers Think Troy Weakened Them, Worry About Masoudi").

Before his stint at the FDA, Troy repeatedly sued the FDA.He argued that the FDA had only limited ability to regulate drug companies. Troy filed those suits through --- you guessed it -- the WLF! He also did legal work for Pfizer. Oh well, just another case of "What goes around, comes around."

What About Those Warning Letters?}:

The WLF criticism of the Strattera warning letter, which I will get to in a moment, comes at a time when the FDA is sharply increasing the number of warning letters sent to pharmaceutical companies.

The FDA issues two types of letters: untitled letters or Notices of Violation and warning letters. The warning letter goes to the CEO and essentially says "we think you have really screwed up and in a way that we think is important to the public health and we expect you to put out some kind of additional information to correct the misinformation you sent." (I quote here John Kamp, Executive Director, Coalition for Healthcare Communication. Kamp was speaking at a CME conference in Princeton, NJ.)

An untitled letter is sent to the head of marketing and says "we think you have a problem, let's sit down and work something out." This type of letter is much less serious and effective than a warning letter. In fact, I've heard it said that untitled letters are considered rites of passage by pharma product managers, who frame them and hang them on their office walls. That's what I've heard some people say.

:{:{According to the Philadelphia Inquirer ("Deluge of drug ads has FDA struggling to stop the hype"):}:

In January 2002, the Office of the FDA Chief Legal Counsel, Daniel Troy, began reviewing the evidence behind all proposed enforcement letters with an eye toward scuttling any that might not hold up in court. Claude Allen, the deputy secretary of the Health and Human Services Department, the FDA's parent agency, ordered the change in policy.

:{Troy effectively hobbled the issuance of warning letters by the FDA.

An October 2002 study by the General Accounting Office, the investigative arm of Congress, said that, before Troy's reviews began, FDA notices went out within days after a problem ad was spotted.Under the new policy, clearing the letters took 13 to 78 days, the report said. "Some regulatory letters may not be issued until after the advertising campaign has run its course," the GAO found. (Phila Inquirer)

:{While the number of total enforcement letters sent by the FDA has hovered around 23-25 in the last three years, the number of warning letters increased dramatically in 2004 (before Troy left the FDA but during the VIOXX debacle). In that year the FDA issued 12 warning letters compared to 5 in 2003 and 1 in 2002. 2005 promises to be a record year -- already nine warning letters have been issued.

The FDA may be getting the impression that the drug industry is not listening. According to Kamp, "DDMAC is saying the same things over and over again [in warning letters], but the industry is just not getting it. FDA is turning up the heat. How much higher, might I add, does it have to get before we start paying attention?"

If the WLF represents the pharma industry -- and with Troy involved it's hard to dispute that it does -- then the industry is paying attention, but responding by criticizing the FDA. There has been some more positive response as well. Recent DTC policy changes by J&J and BMS come to mind (see "DTC Straight Talk" and "New DTC Principles Emerging").:{

So What's the Beef With the Strattera TV Ad?}:}:

The FDA had asked Lilly on June 14 to pull its Strattera TV ad on the grounds that the flashy graphics made the warnings on side effects too difficult for consumers to comprehend (see warning letter and "Watchdog Group Blasts FDA").

WLF had this to say:

:{"DDMAC cites no evidence demonstrating that consumers cannot process the information presented in the advertisement. In fact, theTV advertisement conveys its message regardingattention deficit disorder so many times that it is incomprehensible that consumers would miss it.The sole source of authority for DDMAC's allegations against Lilly is the individual judgment of the DDMAC reviewer who signed the letter."

}:

:{I don't recall seeing the ad myself, but the FDA presented promotional material, submitted by Lilly, which included screen shots from the ad. It looks distracting to me. I don't think you have to do a scientific study to tell whether or not an ad is effectively presenting labeling information. To suggest that "evidence" be produced is merely a ploy to delay the process so the ad can run it's course.

The problem is that the review by the FDA happens after the ad is already produced and running. It would be better, as proposed by BMS, that DTC ads be submitted to the FDA for approval BEFORE they run (see "New DTC Principles Emerging").

Guidance Needed

There is at least one point made by the WLF that I can agree with. It has to do witrh guidance from the FDA regarding TV DTC ads for Rx drugs:

:{"DDMAC should start providing concrete guidance to industry to help them fulfill this objective and stop playing 'gotcha' with drug companies," said WLF Chief Counsel Richard Samp.

}:

Maybe Samp has a point. While the FDA has issued guidance regarding print DTC ads (see "Future of Drug Print Ads"), it hasn't done the same for TV DTC ads. Perhaps that will come sooner than Samp would like.

brulle 2013:

donor trust 14%

scaife 7%, bradley 5 plus 1% ed, koch 5, howard charatible fdn 4, john w pope 4, searle 4, templeton 4%, dunn's fdn for the adv of rt thinking 2, smith richardson 2, vanguard 2, ...annenbeg kohler 2, Lilly 2%

RECIPIENTS

aei 16%, heritage 14, hoover 8% 45 mil$, Manh 6%, cato 5, hudson 5, atlas 4, afp 4, locke 3, heartl 3, reason 3, mrc 3, mercatus 3, ncpa 3, cei 2, spn2, pacif res 2, iwf 1, landmark 1, freedomwork 1 5.3m$

b2? protected lily from vaccine suit 186

From SourceWatch

Lilly and Company is apharmaceutical company based in Indianapolis, Indiana. It is the 149th largest corporation in the United States. It is best known for the anti-depressant Prozac. Other top drugs include Zyprexa (schizophrenia and bipolar disorder), Cymbalta (depression), Gemzar, Alimta (cancer), Humalog insulin and the osteoporosis medication Evista. The company also manufactures cardiovascular and anti-infective pharmaceuticals as well as animal health products. Eli Lillymarkets its products in 135 countries and is publicly traded on the New York Stock Exchange.^{[1]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-0)

In the fiscal year ending in December of 2009, the company recorded sales of approximately $21.84 billion dollars and had 40,360 employees. ^{[2]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-1)

Contents[hide]

Animal testing

Eli Lilly does animal testing.

Animals by species, numbers & location (United States)

Eli Lilly, Indianapolis, Indiana ^{[3]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-2)

Numbers of primates being used & held (United States)

Eli Lilly, Indianapolis, Indiana ^{[4]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-3)

Facility information, progress & USDA-APHIS reports

This facility performed animal experiments involving pain or distress but no analgesics, anesthetics or pain relievers were administered. For copies of this facility's U.S. Department of Agriculture-Animal Plant Health Inspection (APHIS) reports, other information and links, see also Facility Reports & Information, Eli Lilly. ^{[5]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-4)

Contract testing

Eli Lilly contract tests out toSNBL, ^{[6]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-5) an international contract research organization (CRO). Firms hire CROs to conduct toxicity animal testing for agrochemicals, petrochemicals, household products, pharmaceuticals and toxins. SNBL has a history of gross animal welfare violations. See also SNBL.

Monsanto sells U.S. Posilac (rBGH) division to Eli Lilly

In August 2008, Monsanto sold their Posilac division to Eli Lilly and Company for $300 million (who exclusively sold Posilac outside the US for 10 years before the acquisition.) ^{[7]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-6), ^{[8]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-7)Posilac creates additional Growth Factor One (IGF-1) in milk (a growth hormone which is identical in cows and humans). IGF-1 is considered to be a fuel cell for cancer growth and has been identified in the rapid growth cancer. The Food and Drug Administration (FDA) insists that IGF-1 is destroyed in the stomach. ^{[9]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-8) However, if that were true, the FDA has proven that breast feeding cannot work.^{[10]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-9) It is worth noting that rBGH is banned in every industrialized country in the world except for the U.S., Mexico and Brazil. According to Dr. Michael Hanson of the Consumers Union of the U.S., there is strong scientific evidence to support potential health hazards of rBGH and a case for labeling dairy products that contain rBGH. ^{[11]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-10) The FDA approved the use of bovine growth hormone (rbGH) for cows on February 4th, 1994. Both Europe and Canada turned down Monsanto's application for approval. ^{[12]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-11) See also FDA.

Disclosure initiatives

In September 2008, Eli Lilly announced that it will begin reporting its payments to doctors in late 2009, using an online database. But the disclosure is limited to payments of more than $500 made for giving talks or advice to the company; payments for other services or gifts will not be included. Payments made before 2009 will also not be disclosed. Eli Lilly president and CEO John Lechleiter explained the move by stating, "We've learned that letting people see for themselves what we're doing is the best way to build trust." ^{[13]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-12), ^{[14]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-13)

Lilly announced its new registry of payments to doctors comes as Congress considered thePhysician Payments Sunshine Act of 2007. The bill would require disclosure of any drug company payment to doctors of more than $25, whether the payment was for food, travel, entertainment, gifts, consulting fees or any other purpose. ^{[15]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-14)

In May 2007, as the U.S. Senate Committee on Finance was investigating drug company grants to patient groups, Eli Lillybegan disclosing its grants to U.S. nonprofit groups and educational institutions. ^{[16]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-15)

Unethical drug studies, programs & partnerships

In 1994, the FDA chastised Lilly for using alcoholics in a drug study. ^{[17]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-16)

Drug issues

Zyprexa

1.4 billion dollar charge in Zyprexa probe

In October of 2008, the company settled an 18-month federalZyprexa probe spanning 32 states. According to a company statement from Robert Armitage, senior vp and general counsel:

"The government’s investigation ...has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues."

The investigation was initiated by the U.S. Attorney in Philadelphia in 2004. In November of 2007, Eli Lilly received a grand jury subpoena. The State Medicaid Fraud Control Units of over states coordinated its investigation with federal authorities into the Medicaid-related claims concerning Zyprexa marketing. 11 other states; Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, West Virginia, Connecticut, Arkansas and Idaho have filed lawsuits over Zyprexa but did not participate in the coordinated probe. ^{[18]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-17)

According to an October of 2005 article in the San Francisco Chronicle, Medicaid programs purchase an estimated 60 to 75% of antipsychotic drugs, nationwide. In California, Zyprexa was the highest expenditure at close to $250 million. On November 28, 2005, the Indianapolis Business Journal listed Zyprexa as the most costly antipsychotic covered by South Carolina's Medicaid program. According to Bloomberg News in September of 2005:

"The 40-year-old drug perphenazine costs less than $1.50 a day, while the newer medicines can cost 10 times as much."

Eli Lilly has even found ways to convince the Veterans Administration to prescribe Zyprexa. Dr Robert Rosenheck, a Director with the VA, calculated that the VA spent more than $208 million on antipsychotics that year, with over $106 million, or more than half, spent on Zyprexa.

Diabetes lawsuits

According to the New York Times, the company documents reveal that Eli Lilly was fully aware of Zyprexa's link with diabetes and weight gain. Using fraud, kickback and antitrust statutes, state attorneys general all over the country have filed lawsuits against Eli Lilly to recover the money paid for Zyprexa as well as medical costs for patients harmed by Zyprexa, whose health care is covered by public programs. In February of 2006, West Virginia and Alaska filed lawsuits against the company. They alleged that Eli Lilly marketed Zyprexa for unapproved uses in their states. The result cost the states millions of dollars in patient care for diabetes and other diseases related to the drug use. West Virginia seems reimbursement for payment for all medical costs, in addition to the over $70 million paid for the drug.

According to the lawsuit, studies have linked Zyprexa to diabetes since 1998. Sales representatives misled doctors about the safety and the efficacy of Zyprexa. Company advertisements deceptively understated risks and overstated its benefits. It also alleges that Lilly promoted "off label" prescriptions for a host of conditions, these included including anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia:

"Lilly benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs."

In July of 2006, the attorney general of Mississippi filed a lawsuit against Eli Lilly to recoup the ill-gotten gains from the promotion of off-label use of Zyprexa. The suit alleges that the company knew Zyprexa increased the risk of diabetes. In April of 2002, almost a year and a half before the company first issued warnings in the U.S., the labels in the United Kingdom and Japan were changed to include warnings of diabetes related injuries. Tim Balducci, Mississippi special assistant attorney general, asserted that the company targeted Mississippi because their Medicaid program does not signal when a doctor prescribes off label drugs.^{[19]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-18)

Drugging children

According to Attorney General Hood, 10% of Zyprexa patients have developed diabetes, some of whom are children, even though Zyprexa "has never been approved for, nor found to be effective, in the treatment of children."

Eli Lilly has doctors prescribing Zyprexa off-label to children and billing state Medicaid programs all over the country. In an August of 2004, the Archives of Pediatric Adolescent Medicine found the number of Tennessee children covered by TennCare being antipsychotics, nearly doubled in six years. In Texas, a review of prescription records for July and August of 2004, found that over 19,400 teenagers were prescribed antipsychotics billed to a publicly funded program. According to ACS-Heritage, a medical consulting firm hired by the state to investigate psychotropic drug use in children, almost 98% of the teens were prescribed off-label antipsychotics. In over half the cases, the dosage appeared to be inappropriately high.

Almost half the children did not appear to half a valid diagnosis warranted the use the drugs at all. One third were on two or more drugs.Almost half of the children did not appear to have a valid diagnosis warranting the use of the drugs, and one-third were on 2 or more drugs.

The March/April 2006 Journal of Ambulatory Pediatrics, led by Dr William Cooper at Vanderbilt University, analyzed data drawn from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey. The survey found nearly 6 million outpatient visits to providers by children between the ages of 2 and 18, during which an antipsychotics were prescribed, between between 1995 and 2002. Nearly 80% occurred in physician]s offices; 14% in outpatient clinics and 9% in emergency rooms. According to the survey, there has been no increase in mental health disorders which could possible account for such increases in administering these medications. Side effects of Zyprexa are more common and severe in children than in adults. The Children's Hospital of Philadelphia recently reported that 19% of children newly diagnosed with Type 2 diabetes, were being treated with new antipsychotics. The study pointed out that the Food and Drug Administration (FDA) "has not approved any antipsychotic drugs for treating childhood schizophrenia; yet, clinicians routinely use medications for this disorder."^{[20]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-19)

2002 FDA reports prior to warning in 2003

Eli Lilly was well aware of serious health risks long before it issued U.S. warning labels for Zyprexa in 2003. According to a Duke University study published in the July 2002, FDA adverse event reports submitted on Zyprexa reported 289 cases of diabetes, with 225 patients reported as newly diagnosed. It also reported that 100 patients developed ketosis, a serious complication of diabetes. 22 people developed pancreatitis, a life threatening inflamation of the pancreas. The review identified 23 deaths, including a 15-year-old who died of necrotizing pancreatitis.^{[21]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-20)

Promoting Zyprexia for dementia

In December of 2007, the New York Times that company representatives were promoting Zyprexa with primary care physicians specifically for the off-label treatment of dementia.^{[22]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-21)

Xigris

In 2006, a whistleblower reported in the New England Journal of Medicine that the company of initiated false reports of a shortage of the drug, Xigris. Thepublic relations firm Belsito and Company was used to create the message that doctors were being forced to ration Xigris due to its high cost. ^{[23]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-22)

Tobacco issues

In 1989, Eli Lilly started marketing an anti-depressant drug called fluoxetine (Prozac) that, in addition to elevating mood, was noted to help smokers quit. ^{[24]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-23), ^{[25]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-24)

Political contributions

Eli Lilly gave $2,254,487 to federal candidates in the 2008 election cycle through its political action committee (PAC) - 50% toDemocrats, 50% to Republicans.^{[26]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-25)

Lobbying

The company spent $$11,215,000 for lobbying in 2009. $2,520,000 of this total went to 13 outside firms, with the remaining amount spent on in-house lobbying. ^{[27]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-26)

Lobbyists

Kathryn Dickey Karol is Assistant Vice President of Global Government Affairs^{[28]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-27)

Executives & board

Key executives

John Lechleiter - Chairman, President & CEO
Derica Rice - SVP * CFO
Michael Heim - VP Information Technology, CIO^{[29]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-28)

Board members

John C. Lechleiter, Ph.D. - Chairman
Ralph Alvarez - Ret President & COO,McDonald's
Sir Winfried Bischoff - Chairman - Lloyds Banking Group plc
Michael L. Eskew - Former Chairman & CEO - United Parcel Service, Inc.
Martin S. Feldstein, Ph.D. - George F. Baker Professor of Economics - Harvard University
J. Erik Fyrwald - Chairman, President & CEO - Nalco Company
R. David Hoover - Chairman & CEO - Ball Corporation
Karen N. Horn, Ph.D. - Retired President, Private Client Services; Managing Director, Marsh, Inc.
Ellen R. Marram - President, The Barnegat Group LLC
Douglas R. Oberhelman - Vice Chairman & CEO Officer-Elect, Caterpillar, Inc.
Franklyn G. Prendergast, M.D., Ph.D. - Director,Mayo Clinic Center for Individualized Medicine
Kathi P. Seifert - Retired Executive Vice President -Kimberly-ClarkCorporation^{[30]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-29)

Executive Compensation

According to Fierce Pharma, Eli Lilly's CEO, Sidney Taurel, was the ninth top wage earner in 2007 among pharmaceutical CEOs.

Total Compensation: $13M
2007 Revenue: $15.7B
2006 Revenue: $18.6B
Change: -15%

"Taurel earned $1.7 million in base salary in 2007, up from $1.6 million in 2006. However, his overall pay was down, from $15.2 million in 2006 to $13 million last year. He pulled in $7.04 million in stock and options, $4 million in incentives, and $215.044 in other compensation, which included $107,105 for use of the company's aircraft."^{[31]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-30)

Key executives and 2006 pay: ^{[32]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-31)		Options exercised
Sidney Taurel - Chairman & CEO	$1,650,000	$3,190,000
John C. Lechleiter - COO	$1,110,000	$269,000
Derica W. Rice - CFO	$615,000	$57,000
Steven M. Paul - Executive VP, Science and Technology	$916,000	$59,000

Contact

Lilly Corporate Center

Indianapolis, Indiana 46285

USA

Phone: 317-276-2000begin_of_the_skype_highlighting 317-276-2000 end_of_the_skype_highlighting

Fax: 317-276-4878

Web address:http://www.lilly.com

Articles & sources

SourceWatch articles

Eli Lilly and Company is a pharmaceutical company based in Indianapolis, Indiana. It is the 149th largest corporation in the United States. It is best known for the anti-depressant Prozac. Other top drugs include Zyprexa (schizophrenia and bipolar disorder), Cymbalta (depression), Gemzar, Alimta (cancer), Humalog insulin and the osteoporosis medication Evista. The company also manufactures cardiovascular and anti-infective pharmaceuticals as well as animal health products. Eli Lillymarkets its products in 135 countries and is publicly traded on the New York Stock Exchange.^{[1]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-0)

Contents[hide]

Animal testing

Eli Lilly does animal testing.

Animals by species, numbers & location (United States)

Eli Lilly, Indianapolis, Indiana ^{[3]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-2)

Numbers of primates being used & held (United States)

Eli Lilly, Indianapolis, Indiana ^{[4]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-3)

Facility information, progress & USDA-APHIS reports

Contract testing

Eli Lilly contract tests out to SNBL, ^{[6]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-5) an international contract research organization (CRO). Firms hire CROs to conduct toxicity animal testing for agrochemicals, petrochemicals, household products, pharmaceuticals and toxins. SNBL has a history of gross animal welfare violations. See also SNBL.

Monsanto sells U.S. Posilac (rBGH) division to Eli Lilly

In August 2008, Monsanto sold their Posilac division to Eli Lilly and Company for $300 million (who exclusively sold Posilac outside the US for 10 years before the acquisition.) ^{[7]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-6), ^{[8]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-7) Posilac creates additional Growth Factor One (IGF-1) in milk (a growth hormone which is identical in cows and humans). IGF-1 is considered to be a fuel cell for cancer growth and has been identified in the rapid growth cancer. The Food and Drug Administration (FDA) insists that IGF-1 is destroyed in the stomach. ^{[9]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-8) However, if that were true, the FDA has proven that breast feeding cannot work. ^{[10]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-9) It is worth noting that rBGH is banned in every industrialized country in the world except for the U.S., Mexico and Brazil. According to Dr. Michael Hanson of the Consumers Union of the U.S., there is strong scientific evidence to support potential health hazards of rBGH and a case for labeling dairy products that contain rBGH. ^{[11]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-10) The FDA approved the use of bovine growth hormone (rbGH) for cows on February 4th, 1994. Both Europe and Canada turned down Monsanto's application for approval. ^{[12]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-11) See also FDA.

Disclosure initiatives

Lilly announced its new registry of payments to doctors comes as Congress considered the Physician Payments Sunshine Act of 2007. The bill would require disclosure of any drug company payment to doctors of more than $25, whether the payment was for food, travel, entertainment, gifts, consulting fees or any other purpose. ^{[15]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-14)

In May 2007, as the U.S. Senate Committee on Finance was investigating drug company grants to patient groups, Eli Lilly began disclosing its grants to U.S. nonprofit groups and educational institutions. ^{[16]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-15)

Unethical drug studies, programs & partnerships

In 1994, the FDA chastised Lilly for using alcoholics in a drug study. ^{[17]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-16)

Drug issues

Zyprexa

1.4 billion dollar charge in Zyprexa probe

In October of 2008, the company settled an 18-month federal Zyprexa probe spanning 32 states. According to a company statement from Robert Armitage, senior vp and general counsel:

"The government’s investigation ...has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues."

"The 40-year-old drug perphenazine costs less than $1.50 a day, while the newer medicines can cost 10 times as much."

Diabetes lawsuits

"Lilly benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs."

Drugging children

2002 FDA reports prior to warning in 2003

Promoting Zyprexia for dementia

Xigris

In 2006, a whistleblower reported in the New England Journal of Medicine that the company of initiated false reports of a shortage of the drug, Xigris. The public relations firm Belsito and Company was used to create the message that doctors were being forced to ration Xigris due to its high cost. ^{[23]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-22)

Tobacco issues

Political contributions

Eli Lilly gave $2,254,487 to federal candidates in the 2008 election cycle through its political action committee (PAC) - 50% to Democrats, 50% to Republicans. ^{[26]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-25)

Lobbying

Lobbyists

Kathryn Dickey Karol is Assistant Vice President of Global Government Affairs ^{[28]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-27)

Executives & board

Key executives

John Lechleiter - Chairman, President & CEO
Derica Rice - SVP * CFO
Michael Heim - VP Information Technology, CIO^{[29]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-28)

Board members

John C. Lechleiter, Ph.D. - Chairman
Ralph Alvarez - Ret President & COO, McDonald's
Sir Winfried Bischoff - Chairman - Lloyds Banking Group plc
Michael L. Eskew - Former Chairman & CEO - United Parcel Service, Inc.
Martin S. Feldstein, Ph.D. - George F. Baker Professor of Economics - Harvard University
J. Erik Fyrwald - Chairman, President & CEO - Nalco Company
R. David Hoover - Chairman & CEO - Ball Corporation
Karen N. Horn, Ph.D. - Retired President, Private Client Services; Managing Director, Marsh, Inc.
Ellen R. Marram - President, The Barnegat Group LLC
Douglas R. Oberhelman - Vice Chairman & CEO Officer-Elect, Caterpillar, Inc.
Franklyn G. Prendergast, M.D., Ph.D. - Director, Mayo Clinic Center for Individualized Medicine
Kathi P. Seifert - Retired Executive Vice President - Kimberly-Clark Corporation^{[30]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-29)

Executive Compensation

According to Fierce Pharma, Eli Lilly's CEO, Sidney Taurel, was the ninth top wage earner in 2007 among pharmaceutical CEOs.

Total Compensation: $13M
2007 Revenue: $15.7B
2006 Revenue: $18.6B
Change: -15%

Key executives and 2006 pay: ^{[32]^}(http://www.sourcewatch.org/index.php?title=Eli_Lilly#cite_note-31)		Options exercised
Sidney Taurel - Chairman & CEO	$1,650,000	$3,190,000
John C. Lechleiter - COO	$1,110,000	$269,000
Derica W. Rice - CFO	$615,000	$57,000
Steven M. Paul - Executive VP, Science and Technology	$916,000	$59,000