Eli Lilly and Company: Difference between revisions

{{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.