Eli Lilly and Company: Difference between revisions

* [[AdvaMed]] - Member.

* Canadian Rheumatology Association - Sponsor.

* Canadian Urological Association - Sponsor.

* [[Mood Disorders Association of Ontario]] (MDAO) - Donor.

* [[Centre for Addiction and Mental Health]] (CAMH) - Donor.

* [[Hospital for Sick Children (Toronto)|Hospital for Sick Children (SickKids)]] - Donor to the SickKids Foundation.

* [[Princess Margaret Cancer Centre]] (PMCC) - Conference sponsor, and donor to the Princess Margaret Cancer Foundation.

* [[Scarborough Health Network]] (SHN) - Donor to the SHN Foundation.

* [[Sinai Health System|Sinai Health Foundation]] - Donor. The foundation funds [[Mount Sinai Hospital (Toronto)|Mount Sinai Hospital]], [[Bridgepoint Active Healthcare]], and the [[Lunenfeld-Tanenbaum Research Institute]] in [[Toronto]], [[Ontario]].

* [[Sunnybrook Health Sciences Centre]] - Donor.

* [[Arthritis Australia]] - Sponsor.

* [[BioFIT]] - Sponsor. BioFIT holds events to connect academia, pharmaceutical companies, and investors in the field of [[life sciences]] and [[biotechnology]].

* Canadian Consortium on Neurodegeneration and Aging - Partner organization.

* Colorectal Cancer Canada - Sponsor.

* [[COVID-19 Therapeutics Accelerator]] - Collaborator.

* [[Diabetes Canada]] - Corporate partner.

* GIANT Health - Event sponsor.

* [[Juvenile Diabetes Research Foundation]] (JDRF) - Corporate partner.

* New Brunswick Health Research Foundation (NBHRF) - Sponsor.

* Pinnacle Research Group - Sponsor.

* Radcliffe Cardiology - Industry partner.

The company's most important products introduced prior to World War II included [[insulin]], which Lilly marketed as Iletin (Insulin, Lilly), Amytal, Merthiolate, [[ephedrine]], and liver extracts. Introduced in 1923, Iletin (Insulin, Lilly) was Lilly's first commercial insulin product.

During World War II Lilly produced penicillins and other antibiotics. In addition to penicillin, other wartime production included "antimalarials," blood plasma, encephalitis vaccine, typhus and influenza vaccine, [[gas gangrene]] antitoxin, Merthiolate, and Iletin (Insulin, Lilly).

Among the company's more recent pharmaceutical developments are [[cephalosporin]], [[erythromycin]], and [[Prozac]] (fluoxetine), a [[selective serotonin reuptake inhibitor]] (SSRI) for the treatment of [[clinical depression]]. Ceclor, introduced in the 1970s, was an oral cephalosporin antibiotic. Prozac, introduced in the 1980s, quickly became the company's best-selling product for treatment of depression, but Lilly lost its U.S. patent protection for this product in 2001. Among other distinctions, Lilly is the world's largest manufacturer and distributor of medications used in a broad range of [[psychiatry|psychiatric]] and [[mental health]]-related conditions, including [[clinical depression]], [[generalized anxiety disorder]], [[narcotic]] addiction, [[insomnia]], [[bipolar disorder]], [[schizophrenia]], and others.

In March 2023, Eli Lilly announced a $35 cap on the price of monthly [[insulin]] to be put in place immediately in order to be in line with the [[Inflation Reduction Act of 2022]].

{{further|Tadalafil}}

In 2003, Eli Lilly introduced [[Tadalafil|Cialis]] (tadalafil), a competitor to [[Pfizer]]'s blockbuster [[Viagra]] for [[erectile dysfunction]]. Cialis maintains an active period of 36 hours, causing it sometimes to be dubbed the "weekend pill". Cialis was developed in a partnership with [[biotechnology]] company Icos Corporation. On 18 December 2006, Lilly bought Icos in order to gain full control of the product.

{{further|Duloxetine}}

Another Lilly manufactured anti-depressant, [[Duloxetine|Cymbalta]], a [[serotonin-norepinephrine reuptake inhibitor]] used predominantly in the treatment of major depressive disorders and generalized anxiety disorder, ranks with Prozac as one of the most financially successful pharmaceuticals in industry history. It is also used in the treatment of [[fibromyalgia]], [[neuropathy]], [[chronic pain]] and [[osteoarthritis]].

{{further|Gemcitabine}}

In 1996, the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] approved [[gemcitabine|Gemzar]] for the treatment of [[pancreatic cancer]]. Gemzar is commonly used in the treatment of pancreatic cancer, usually in coordination with 5-FU [[chemotherapy]] and radiation therapy. Gemzar also is routinely used in the treatment of non-small cell [[lung cancer]].

{{further|Methadone}}

Eli Lilly was the first distributor of [[methadone]] in the United States, an [[analgesic]] used frequently in the treatment of [[heroin]], [[opium]] and other [[opioid]] and [[narcotic]] [[drug addiction]]s. Eli Lilly was able to acquire the right to produce the drug commercially for just $1 because the patent rights of the original patent holders, [[IG Farben]] and [[Farbwerke Hoechst]], were not protected after the [[Allies of World War II]] seized all German patents, research records and trade names. Eli Lilly introduced the drug to the United States in 1947, marketed under the trade name "Dolophine".

{{further|Fluoxetine}}

Prozac was one of the first therapies in its class to treat clinical depression by blocking the uptake of [[serotonin]] within the [[human brain]]. Prozac was approved by the U.S. FDA in 1987 for use in treating depression, with generic versions appearing after 2002.

{{further|Secobarbital}}

Eli Lilly has manufactured [[Secobarbital]], a [[barbiturate]] derivative with [[anaesthetic]], [[anticonvulsant]], [[sedative]] and [[hypnosis|hypnotic]] properties. Lilly marketed Secobarbital under the brand name Seconal. Secobarbital is indicated for the treatment of [[epilepsy]], temporary [[insomnia]] and as a pre-operative medication to produce anaesthesia and [[anxiolysis]] in short surgical, diagnostic, or therapeutic procedures which are minimally painful. With the onset of new therapies for the treatment of these conditions, Secobarbital has been less utilized, and Lilly ceased manufacturing it in 1999.

Secobarbital gained considerable attention during the 1970s, when it gained wide popularity as a [[Recreational drug use|recreational drug]]. On 18 September 1970, [[rock music|rock]] guitarist legend [[Jimi Hendrix]] died from a secobarbital overdose. On 22 June 1969, secobarbital overdose was the cause of death of actress [[Judy Garland]]. The drug was a central part of the plot of the hugely popular novel ''[[Valley of the Dolls (novel)|Valley of the Dolls]]'' (1966) by [[Jacqueline Susann]] in which three highly successful [[Hollywood, California|Hollywood]] women each fall victim, in various ways, to the drug. The novel was later released as a film by the same name.

{{further|Thiomersal}}

Eli Lilly has developed the [[vaccine]] preservative [[thiomersal]] (also called merthiolate and thimerosal). Thiomersal is effective by causing susceptible bacteria to [[Autolysis (biology)|autolyze]]. Launched in 1930, merthiolate was a mercury-based antiseptic and germicide that "had been formulated at the [[University of Maryland]] with support of a Lilly research fellowship." In November 2002, congressional Republicans inserted a provision into a domestic security bill that President [[George W. Bush]] signed into a law, protecting Eli Lilly from all suits in the federal courts, alleging that the drug, [[Thiomersal]] caused [[autism]] and other neurological disorders in children, such that all such matters be heard by a special master appointed for the purpose, rather than regular federal courts. Its toxicology was that it metabolized into [[ethylmercury]] (C2H5Hg+) and [[thiosalicylate]], in the body, which was immensely hazardous to developing countries like India.

 

Zyprexa ([[Olanzapine]]) (for [[schizophrenia]] and [[bipolar disorder]], as well as [[off-label]] uses) Released in 1996, (see [[#Illegal marketing of Zyprexa|Illegal marketing of Zyprexa]]) it was the company's best selling drug through 2010, when the [[patent]] expired.

[[File:President Trump Delivers Remarks on Protecting Seniors with Diabetes (49941277593) (cropped).jpg|thumb|David Ricks, Lilly CEO since 2016]]

[[Randall L. Tobias]], a vice chairman of [[AT&T Corporation]], was named chairman, president, and CEO in June 1993. Tobias, a Lilly board member since 1986, was recruited from outside the company's executive ranks first to replace Lilly's president and CEO, Vaughn Bryson, at Bryson's predecessor and then board chairman Richard Wood's urging and then, in short order, also Wood. Tobias later became the U.S. director of Foreign Assistance and administrator of the [[U.S. Agency for International Development]] (USAID), with the rank of ambassador.

[[Sidney Taurel]], former chief operating officer of Lilly, was named CEO in July 1998 to replace Tobias, who retired. Taurel became chairman of the board in January 1999. Taurel retired as CEO on 31 March 2008, but remained as chairman of the board until 31 December 2008. [[John C. Lechleiter]] was elected as Lilly's CEO and president, effective 1 April 2008. Lechleiter had served as Lilly's president and chief operating officer since October 2005.

The Lilly family as well as Eli Lilly and Company has a long history of community service. Around 1890 Col. Lilly turned over operation of the family business to his son, Josiah, who ran the company for the next several decades. Col. Lilly remained active in civic affairs and assisted a number of local organizations, including the Commercial Club of Indianapolis, which later became the Indianapolis Chamber of Commerce, and the [[Charity Organization Society]], a forerunner to the Family Services Association of Central Indiana, an organization supported by [[United Way of America|United Way]]. Josiah's sons, Eli and Joe, were also philanthropists who supported numerous cultural and educational organizations.

Josiah Sr. continued his father's civic mindedness and began the company tradition of sending aid to disaster victims. Following the [[1906 San Francisco earthquake]], the company sent much needed medicine to support recovery efforts and provided relief after the 1936 [[Johnstown Flood]].

{{main|Lilly Endowment}}

In 1937, Josiah K. Lilly Sr. and his two sons, Eli and Joe, founded the [[Lilly Endowment]], a private charitable foundation, with gifts of Lilly stock.Madison, ''Eli Lilly'', p. 205&ndash;6.</ref> The endowment still owns 11.3% of the company.

{{Further|Bovine somatotropin|label1=bovine growth hormone}}

In August 2008, Eli Lilly purchased the right to manufacture [[Bovine somatotropin|bovine growth hormone]], used to increase milk production in dairy cattle, from [[Monsanto]]. Use of the supplement has become controversial due to the [[animal ethics]] and [[Beef hormone controversy|human health concerns]].

{{Main|340B Drug Pricing Program}}

In 2021 Eli Lilly filed a court motion against in response to an advisory opinion of the [[United States Department of Health and Human Services|Department of Health and Human Services]] indicating that Eli Lilly and other drug manufacturers must continue to offer reduced pricing to covered outpatient drugs through pharmacies contracted to hospitals rather than only to the hospitals themselves.

{{Further|Standard Gravure shooting|Fluoxetine}}

On 14 September 1989, [[Standard Gravure shooting|Joseph T. Wesbecker]] killed eight people and injured twelve before committing suicide. His relatives and victims blamed his actions on the Prozac medication he had begun taking a month prior. The incident set off a chain of lawsuits and public outcries. Lawyers began using Prozac to justify the abnormal behaviors of their clients. Eli Lilly was accused of not doing enough to warn patients and doctors about the adverse effects, which it had described as [[Activation syndrome|"activation"]], years prior to the incident. The link between suicide and antidepressants remains a subject of public and academic dispute.

In October 2004, the FDA added a black box warning to all antidepressant drugs regarding use in children. In 2006, the FDA included adults aged 25 or younger. In February 2018, the [[Food and Drug Administration|FDA]] ordered an update to the warnings based on statistical evidence from twenty-four trials in which the risk of such events increased from two percent to four percent relative to the placebo trials.

{{See also|Olanzapine#Controversy, lawsuits and settlements|James Gottstein#Eli Lilly memos}}

Eli Lilly has faced many lawsuits from people who claimed they developed diabetes or other diseases after taking [[olanzapine]] (branded Zyprexa), an [[antipsychotic]] medication, as well as by various governmental entities, insurance companies, and others. Internal documents provided to [[The New York Times]] revealed that Lilly had downplayed the risks of Zyprexa. According to the documents, 16 percent of people taking Zyprexa gained more than 66 pounds in their first year, a much larger figure than Eli Lilly had shared with doctors.

In 2006, Lilly paid $700 million to settle around 8,000 of these lawsuits, and in early 2007, Lilly settled around 18,000 suits for $500 million, which brought the total Lilly had paid to settle suits related to the drug to $1.2 billion.

In March 2008, Lilly settled a suit with the state of Alaska, and in October 2008, Lilly agreed to pay $62 million to 32 states and the District of Columbia to settle suits brought under state [[consumer protection]] laws. In 2009, four sales representatives for Eli Lilly filed separate ''[[qui tam]]'' lawsuits against the company for illegally marketing Zyprexa for uses not approved by the [[Food and Drug Administration]].

Eli Lilly pleaded guilty to a US federal criminal [[misdemeanor]] charge of illegally marketing Zyprexa, actively promoting the drug for [[off-label]] uses, particularly for the treatment of dementia in the elderly. The $1.415 billion penalty included an $800 million civil settlement, a $515 million criminal fine, and forfeit assets of $100 million. The [[US Justice Department]] said the criminal fine of $515 million was the largest ever in a healthcare case and the largest criminal fine for an individual corporation ever imposed in a US criminal prosecution of any kind. "That was a blemish for us," [[John C. Lechleiter]], CEO of Lilly, said. "We don't ever want that to happen again. We put measures in place to assure that not only do we have the right intentions in integrity and compliance, but we have systems in place to support that." In an internal email, Lechleiter had stated "we must seize the opportunity to expand our work with [[Olanzapine|Zyprexa]] in this same child-adolescent population" for [[off-label]] use.

In January 2020, lawyer [[James Gottstein]] published a book titled ''The Zyprexa Papers'' summarizing the legal activities surrounding Zyprexa, and their impact on the political landscape of psychiatry and antipsychiatry in the US. The book details of how he obtained the Zyprexa papers, including how [[Will Hall (writer)|Will Hall]] and a small group of "psychiatric survivors" untraceably spread the Zyprexa Papers on the Internet and his battles on behalf of Bill Bigley, the psychiatric patient whose ordeal made possible the exposure of the Zyprexa Papers.

In September 2021, Eli Lilly and Company was accused in a [[Federal judiciary of the United States|federal court]] lawsuit of discriminating against older applicants for sales positions based on their implementation of hiring quotas for millennials.

In September 2013, Eli Lilly sued [[Canada]] for violating its obligations to foreign investors under the [[North American Free Trade Agreement]] by allowing its courts to invalidate patents for [[Atomoxetine|Strattera]] and [[Olanzapine|Zyprexa]]. Canadian courts found [[Atomoxetine|Strattera's]] seven-week long study of twenty-two patients, too short and too narrow in scope to qualify for the patent. The [[Olanzapine|Zyprexa]] patent was invalidated because it had not achieved its promised [[Utility in Canadian patent law|utility]]. The company sought damages in the amount of $500 million for lost profits. They ultimately lost the case in 2017.

{{See also|Raloxifene|label 1=Evista }}

[[Raloxifene|Evista]] is a medication typically used to prevent and treat [[osteoporosis]] in [[Menopause|postmenopausal]] women.

In December 2005, Eli Lilly and Company agreed to plead guilty and pay $36 million in connection with the illegal promotion of the drug. Sales representatives were trained to promote [[Raloxifene|Evista]] for breast cancer and cardiovascular disease, to prompt or bait questions by doctors, and to send them unsolicited letters promoting [[Raloxifene|Evista]] for unapproved use. The company distributed a videotape in which a sales representative declared that "Evista truly is the best drug for the prevention of all these diseases." Some sales representatives had also been instructed to conceal the disclosure page which stated that the effectiveness of the drug in reducing breast cancer risks had not yet been established.

In January 2019, lawmakers from the [[United States House of Representatives]] sent letters to Eli Lilly and other insulin manufacturers asking for explanations for their rapidly raising insulin prices. The annual cost of insulin for people with type 1 diabetes in the U.S. almost doubled from $2,900 to $5,700 over the period from 2012 to 2016.

Renewed attention was brought to Eli Lilly's pricing of insulin on November 10, 2022, after a [[Twitter verification|verified Twitter account]] impersonating Eli Lilly posted on Twitter that insulin would now be free. The following year, the company announced that it would be reducing the out-of-pocket price of insulin to $35 a month. The company also stated that it would lower the price of Humalog from $275 a month to $66 and that it would offer [[insulin glargine]] at a 78% discount compared to rival company [[Sanofi]]. Despite this, the reduced costs will not apply to Eli Lilly's newer brands of insulin, and the company's pricing is still significantly higher than it was several decades prior.