Executive Summary

Eli Lilly and Company, Inc. (Lilly) is a global pharmaceutical manufacturer founded in 1876 by the company’s eponymous founder, Eli Lilly, an Indiana cotton farmer turned pharmacy entrepreneur.  Today, Lilly is a Fortune 500 company netting over $20 billion dollars a year from pharmaceutical and over-the-counter drug sales.  Through its global research and supply network, Lilly products are sold in over 120 countries around the world.  Its most widely prescribed and consumed products are Prozac (despression and anxiety), Zyprexa (schizophrenia and bipolar disorder), Byetta (type 2 diabetes) and Cialis (erectile dysfunction).

History of Lilly

So the story goes,  Colonel Eli Lilly, a veteran of the Civil War and the founder of the global pharmaceutical giant, started his humble drug company due to his alleged dissatisfaction with the quality of contemporary medicine in his day.  One of the first drugs that Colonel Lilly produced was quinine, a drug for the treatment of malaria.  Lilly was also known as an innovator for first coating pills and capsules with gelatin.  Over the years, Lilly grew considerably and established a landmark manufacturing facility in its present-day headquarters in Indianapolis, Indiana.  In the 1970s, Lilly hit $1 billion in sales for the first time.  Today, Lilly employs over 40,000 people worldwide.

Lilly, Prozac and the Market for Psychiatric Medication:

Lilly is perhaps best known for production of the psychiatric drug Prozac (fluoxetine) the first Selective Serotonin Reuptake Inhibitor (SSRI) to arrive on the market in 1988.  It is hard to overstate what a huge impact Prozac was both for Lilly and the booming market for psychiatric drugs.  Soon after its introduction, Prozac was netting close to $1 billion a year in sales for Lilly.  Suffice to say, Prozac went on to embed itself in popular culture and has come to be one of the most recognized drug names for the treatment of depression today.

Lilly and Issues with Dangerous Drugs:

As remarkable as Lilly’s history, growth and success over the past 150 years have proven, the company’s business and reputation have suffered in recent years from a string of issues arising from dangerous drugs pushed into the market.  Some of the more notable cases to make headlines have arisen from:

Axiron

Marketed in 2011 as an underarm testosterone replacement gel for men, Axiron was billed by Lilly as an easy and effective method for treatment of low-testosterone levels.  Due to a rash of studies in recent years, which have indicated that low testosterone may be responsible for a number of common ailments in older men – notably fatigue and loss of sexual ability, treatments to boost testosterone have become remarkably popular.  Unfortunately, they also tend to be overprescribed and aggressively marketed at men who may not actually be suffering from low testosterone levels.  Many men who began testosterone treatments, some under the most specious of circumstances, later began suffering increased risk from heart attacks, strokes and sudden death at a much greater rate than normal.  Consequently, Lilly has been embroiled in lawsuits resulting from these complications and Axiron has been withdrawn from the market.

Actos

Approved by the U.S. Food and Drug Administration (FDA) in 1999, Actos (pioglitazone hydrochloride) was a drug jointly-marketed by Lilly and pharmaceutical giant, Takeda Pharmaceutical Co. for the treatment of type 2 diabetes mellitus.  The FDA issued a black-box warning for Actos in 2007 due to concerns over increased risk for heart failure associated with the drug.  In 2011, the American Diabetes Association reported its findings that Actos could also be associated with increased risk for bladder cancer.  Litigation against both Takeda and Lilly ensued culminating with verdicts against both companies totalling $9 billion for masking cancer risks associated with Actos.

Zyprexa

One of the more popular medications for treatment of schizophrenia and bipolar mania upon its introduction to the market, Zyprexa (olanzapine) was also frequently prescribed alongside of Prozac as “Symbyax”.  In 2005, the FDA mandated that both drugs receive black box warnings for the risk of death from heart failure and various infections for elderly patients who were prescribed the drugs for the treatment of dementia (an off-label use, for which the FDA did not expressly approve the drug).  Additionally, Lilly modified the label for Zyprexa in 2007 due to concerns about increased suicidal thoughts and ideation in children who were prescribed the medication.  It should be noted that Zyprexa was never approved for use in patients under the age of 18 (another off-label use).  In 2009, Lilly plead guilty and admitted that it illegally marketed Zyprexa as appropriate for elderly dementia patients and children despite not being approved for such use on its label by the FDA.

Tradjenta

A medication for type 2 diabetes, Tradjenta (linagliptin) is part of a larger family of drugs known as dipeptidyl peptidase-4 (DDP-4) inhibitors.  This family also includes other diabetic medications such as Januvia, Byetta and Victoza.  Also known as mimetics, these drugs have been cited by the FDA for their increased risk of pancreatitis and related pre-cancerous cell changes.  In 2013, the agency announced that it would be investigating the unpublished findings of several academic researchers who examined post-mortem tissue samples from patients for further evidence of the pancreatic linkage.

 

Sources Cited:

1) “About Lilly” https://www.lilly.com/who-we-are/about-lilly

2) “Novartis Takes Aim at Eli Lilly with Cosentyx FDA Nod in Spondyloarthritis” https://www.fiercepharma.com/pharma/novartis-takes-aim-at-eli-lilly-fda-nod-for-cosentyx-spondyloarthritis

3) “Eli Lilly pharmaceutical company starts Phase 3 coronavirus trial with drug used to treat arthritis” https://www.foxnews.com/health/lilly-starts-phase-3-coronavirus-trial-for-baricitinib-arthritis-drug

4) “Eli Lilly (LLY) Stock Sinks As Market Gains: What You Should Know” https://www.yahoo.com/news/eli-lilly-lly-stock-sinks-214509929.html

5) Eli Lilly and Company SEC Filings http://www.getfilings.com/sec-filings/160219/LILLY-ELI-and-CO_10-K/lly-20151231x10kexhibit21.htm

6) “25 Years After Prozac” https://www.pharmacist.com/25-years-after-prozac

7) “Selling Prozac at the Life-Enhancing Cure for Mental Woes” https://www.nytimes.com/2014/09/22/us/selling-prozac-as-the-life-enhancing-cure-for-mental-woes.html

8) “Testosterone Treatment: Fountain of Youth or Heart Attack Risk?” https://www.indystar.com/story/money/2014/11/21/testosterone-treatment-fountain-youth-heart-attack-risk/70041122/

9) “Lilly Adds Strong Warning Label to Zyprexa, a Schizophrenia Drug” https://www.nytimes.com/2007/10/06/business/06zyprexa.html

10) “The Trouble with Zyprexa” https://pro.psychcentral.com/the-trouble-with-zyprexa/

11) “FDA Warns About Using Antipsychotic Drugs for Dementia” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC556368/

12) “Zyprexa Medication Guide” https://www.fda.gov/files/drugs/published/Zyprexa-Medication-Guide.pdf