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The "Most Hated CEO" in America: Michael D. Jones, University of Cincinnati
The "Most Hated CEO" in America: Michael D. Jones, University of Cincinnati
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On September 22, 2015, Martin Shkreli, the CEO of Turing Pharmaceuticals, appeared
on Bloomberg News to defend his recent decision to increase the price of a
pharmaceutical drug by several thousand percent by saying that it was “still underpriced
relative to its peers.”1 The drug, Daraprim, was used to treat HIV patients and others
with suppressed immune systems who were suffering from a toxoplasmosis infection.
Turing Pharmaceuticals acquired the marketing rights to Daraprim one month earlier
in August and immediately raised the price of a 100 pill bottle from $1,700 to $75,000.
While the marginal cost to manufacture the 100 pill bottle was estimated at $100,2
Shkreli partly justified the price hike by arguing that much of the company’s profit
would go towards research of new drugs.3
Daraprim was released into the market in 1953 after the US Food and Drug
Administration (FDA) approved the drug for sale. Although the chemical formulation
was no longer under patent protection, Turing Pharmaceuticals purchased the
marketing rights for $55 million from Impax Laboratories on August 10, 2015. Before
entering the market as a potential competitor, any generic drug would still be required
to undergo an extensive and lengthy FDA approval process. As a result, Turing
Pharmaceuticals would operate as the sole US manufacturer of the drug for a
substantial period of time. In an email obtained by the US Congressional Committee
on Oversight and Government Reform, Martin Shkreli said:
“We raised the price from $1,700 per bottle to $75,000 … So 5,000 paying
bottles4 at the new price is $375,000,000—almost all of it is profit and I think
we will get 3 years of that or more. Should be a very handsome investment
for all of us.”5
The media and government attention that resulted from Daraprim’s price hike was
intense. On the same day of his interview with Bloomberg News to defend the price
increase, the Democratic presidential candidate, Hillary Clinton, called for US
regulators to investigate the company’s actions.6 One day later on September 23, 2015,
the British Broadcasting Corporation released an article with the title “Who is Martin
Shkreli – the most hated man in America?”7 On that day, Shkreli also met with
representatives from ABC News. During the interview he said “we have heard the
public’s demands. We have decided to lower the price of Daraprim. We have yet to
-----------------------------
Copyright © 2017 by the Case Research Journal and by Michael D. Jones. The author wishes to thank
John J. Lawrence and the anonymous CRJ reviewers for their feedback. An earlier version of the
case was presented at the 2016 Annual Meeting of the North American Case Research Association
in Las Vegas, Nevada, United States.
decide what that price will be…but after reviewing all of our costs, we will decide to
lower the price to a point where the company makes a small and marginal profit on the
product.”8 In early November, doctors, patients, and advocacy groups grew restless
and sent a letter on behalf of more than 150 organizations to Turing Pharmaceuticals
to demand a price reduction.9 Finding himself in the media spotlight once again,
Martin Shkreli needed to decide if, and by how much, he would lower the price of
Daraprim.10
MARTIN SHKRELI
On the New York morning radio show, Breakfast Club, Martin Shkreli was asked by
one of the interviewers if he was privileged and entitled.11 Shkreli responded that he
was born as the son of an immigrant couple, both of whom were employed as janitors.
Born in 1983, Shkreli spent his childhood in Brooklyn, sharing a bedroom with one of
his siblings. He attended Hunter College High School, an elite public school that only
accepted the top quarter of one percent of New York City students. At the school,
Shkreli described himself as a “trouble-making kid from the hood” who did not fit in.
While in summer school, he developed a love for rap music and later in life purchased
the sole copy of the Wu Tang Clan’s album “Once Upon a Time in Shaolin” for two
million dollars.12
While still a teenager at Hunter College High School, Shkreli secured an internship
with a hedge fund owned by Jim Cramer, who would later produce the TV show Mad
Money. Shkreli graduated from Baruch College and worked in the financial industry for
several years before starting his own hedge fund, Elea Capital Management. The fund
failed in 2007 and he moved back in with his parents. A few years later, Shkreli was
able to convince investors to start another fund, MSMB Capital. At MSMB Capital,
he generated profits by selling short, or betting against, biotech companies. However,
in 2012 his fund changed strategies and acquired a drug company, Retrophin.
Retrophin focused on developing drugs for rare diseases. After being fired as CEO by
Retrophin’s Board of Directors, Shkreli launched Turing Pharmaceuticals in February,
2015. Shkreli said “we saw it as an opportunity to make money for our shareholders,
but also be a platform for rare and infectious diseases.”13
recouped along with a reasonable profit. Without this pricing power, a manufacturer
may not have the financial incentive to develop new drugs. In a 2014 report, the Tufts
Center for the Study of Drug Development estimated that the costs to develop a new
drug, including opportunity costs and the cost of drug failures, had increased to nearly
$2.6 billion dollars.15 While some skeptics expressed disagreement with the
methodology and calculations used to determine this estimate, there was strong
evidence that the cost to develop a new drug was at least in the range of hundreds of
millions of dollars.
Before a new drug can be approved by the FDA, the manufacturer must submit
an application detailing the drug’s chemical composition, manufacturing process, and
plans to test the drug in humans (Exhibit 2). In phase 1 of clinical trials, less than 100
volunteers are typically used to evaluate the safety and side effects of the drug. In
phase 2, hundreds of volunteers are used to test the effectiveness of the new drug. In
this phase, patient volunteers are typically randomized and some volunteers
unknowingly receive a placebo while others receive the actual drug. If the drug
successfully passes phase 2, thousands of patients are evaluated in phase 3 to collect
additional data on dosages, drug interactions, and different patient populations. Once
the FDA receives an Investigational New Drug Application (NDA), the likelihood of
successfully moving through the clinical trials and having the new drug application
approved is less than 10 percent.16 Compounding the costs to developing a drug is the
time required to successfully move through each of the FDA approval phases. Once
the time required to develop a new drug is included, it takes approximately ten years
on average to launch a drug in the marketplace.17
Because of low success rates and the long time in development, pharmaceutical
companies relied on “blockbuster” drugs to generate profits. For example, Lipitor,
manufactured by Pfizer, was the highest grossing pharmaceutical drug of all-time with
approximately $130 billion in sales between 2000 and 2013. Exhibit 3 displays the
revenues and profit margins of the ten largest pharmaceutical firms in the world.
The drug is for use for a serious condition for which effective treatment
is not available in the United States;
There is no commercialization or promotion of the drug to U.S. residents;
The drug is considered not to be risky;
The individual importing the drug verifies in writing that it is for his or
her own use, and provides contact information for the doctor providing
treatment or shows the product is for the continuation of treatment begun
in a foreign country; and
Generally, not more than a 3-month supply of the drug is imported.
The FDA maintained some level of enforcement discretion. The Director of
Knowledge Ecology International, James P. Love, cited an email in 2011 in which the
FDA suggested to the National Institute of Health that the FDA could use its
enforcement discretion to permit the importation the drug, Fabrazyme, which was
facing a shortage at the time.24 Importing Daraprim from overseas would not have
been cost prohibitive as it was available from international pharmacies for as little as
$6 a pill.
GENERIC PHARMACEUTICALS
In order to encourage the release of generic pharmaceuticals in the market while
maintaining the incentive for pharmaceutical companies to manufacturer new drugs,
Congress passed the Hatch-Waxman Act in 1984. Under this legislation, generic drug
manufacturers could submit an abbreviated new drug application (ANDA) to the FDA
for approval. Under an ANDA, manufacturers are not required to undertake the same
time-consuming and expensive clinical trials as a New Drug Application (NDA).
Instead, the manufacturer only has to prove that the generic drug is bioequivalent to
the brand name drug. Generic drugs must have “the same active ingredient, strength,
dosage form, and route of administration as the brand name product.”25 The passage
of the Hatch-Waxman Act led to generics being filled for 8 out of 10 prescriptions by
2015. Generics are typically priced 80 – 85 percent lower than the brand name drug
and consumers saved $158 billion dollars in 2010 by using generic drugs instead of
brand name drugs. While a generic drug could take considerably less time than a brand
name drug to be approved, the FDA commissioner estimated that the median review
time from ANDA receipt to drug approval was 42 months.26
The Hatch-Waxman Act also protected the R&D investment of brand name
manufacturers by extending the patent term length of a new drug. Because a drug is
often patented well before FDA approval, the effective life of a 20-year patent can be
significantly shortened. The Hatch-Waxman Act allowed for a patent to be extended
due to lengthy delays in the approval process. The balancing act between protecting
innovation and encouraging generic entrants into the market was noted by the Chief
Counsel of the FDA, Daniel Troy, when he said “the FDA has tried to maintain a
balance between protecting innovation in drug development and in expediting the
approval of lower-cost generic drugs.”27
ORPHAN DRUGS
While the Hatch-Waxman Act encouraged drug innovation by protecting
manufacturers from competition through patent extensions, the market must be large
enough in the first place in order for a firm to recoup all of its development costs. For
diseases that afflict only a small number of individuals, the R&D and FDA approval
costs may be too large to justify new drug development. To promote drug
development for these rare diseases, Congress passed the Orphan Drug Act of 1983.
The Act specified three possible incentives: 1) marketing exclusivity of 7 years 2) 50
percent tax credit on human clinical trials, and 3) federal research grants.28 In 1997,
Congress also waived the FDA application fees. A rare disease, or orphan disease, is
one defined as afflicting less than 200,000 individuals in the US. Prior to 1983, only a
few drugs were approved by the FDA to treat orphan diseases. Since that time, more
than 200 drugs have been approved.
Despite these successes, drug companies have been accused of gaming the orphan
drug system. After a drug has been FDA approved as treatment for an orphan drug,
physicians can prescribe the medication “off-label” for other uses. Rituxan, approved
initially to treat non-Hodgkin’s lymphoma, generated nearly $4 billion in sales in 2014.29
Rituxan has been used off-label to treat multiple sclerosis, for example.30 Companies
can also narrow the population targeted for treatment, or classify a disease into smaller
sub-diseases, in order to gain designation as an orphan drug. This process is known as
“salami-slicing.”
Despite being a drug that treats an orphan disease, Daraprim would not have
benefited from the Orphan Drug Act as it has been on the market since the 1950s.
The drug is designed to treat toxoplasmosis, a condition caused by a parasite that
particularly affects those with HIV and weakened immune systems.31 According to
industry research from IMS Health, only 8,821 prescriptions were written for Daraprim
in 2014.32 As a result, there was not a sufficient market size to justify a large number
of Daraprim manufacturers.
of the report could shed light on the public relations struggle revealed in internal emails
that were turned over to the government. In addition, a sizable portion of Daraprim
was used by the HIV community, and Turing faced a backlash by making the drug
unaffordable to that community. Officials from the Human Rights Campaign, one of
the 150-plus organizations that signed the open letter to Turing Pharmaceuticals on
November 3, had been asking its 1.5 million members to be active in social media with
the hashtag #rollitback.35
While Turing Pharmaceuticals’ strategy was focused on insurance companies’
paying the increased price, patients were liable for copays that went as high as $16,000.
The Director of Specialty Pharmacy Development at Walgreens wrote to Turing to ask
for relief for a patient who had a co-pay of $16,830.36 If these patients became
particular vocal in the media with their stories, Turing would face even further scrutiny
or public challenge from legislators. Patients were not the only ones struggling with
the price increase. Massachusetts General Hospital, one of the most well-known
hospitals in the country, wrote to a Turing sales account manager that they were
switching their patients to an alternative to Daraprim, Bactrim. Jackson Memorial
Hospital was also switching its patients to Bactrim.37 While Bactrim was not the same
chemical formulation as Daraprim, it was seen as an imperfect substitute for Daraprim.
In September, 2015, the Head of Investor Relations at Turing, Ed Painter, emailed
the Director of Business Development, Patrick Crutcher, to ask if there was a
possibility for an annual price reduction. He wrote “is there an annual price reduction
commitment that would discourage generics from entering the market? What if we
headlined …Turing Pharmaceuticals commits to an out of pocket cost to individuals
of less than $20 for treatment of Toxoplasmosis with Daraprim and an annual
reduction in price to institutions of at least X%?” Crutcher responded to Ed by saying
that the “only thing to PR is the Patient Assistance Program (PAP) and R&D.”38
In a September 21, 2015 tweet, Martin Shkreli wrote “no doubt i am a capitalist
who plays to win. but unlike other companies with this strategy, we do R&D.” In
another tweet, Shkreli wrote “PhRMA member companies invest on average 20% of
total revenue on R&D. Turing spends over 50% of its revenue on R&D.” Despite
these communication strategies, the pressure did not relent. It was early November,
weeks after Turing Pharmaceuticals committed to lowering the price of Daraprim, but
patients, politicians, and the media were still waiting on the announcement of the new
price from Martin Shkreli.
Source: “New Drug Application (NDA).” (2016, March 29). US Food and Drug
Administration. Retrieved from
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelop
edandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm
Profit
Revenue R&D Marketing Profit
Company Margin
($ billion) ($ billion) ($ billion) ($ billion)
(%)
Johnson & Johnson 71.3 8.2 17.5 13.8 19
Novartis 58.8 9.9 14.6 9.2 16
Pfizer 51.6 6.6 11.4 22 43
Hoffmann-La Roche 50.3 9.3 9 12 24
Sanofi 44.4 6.3 9.1 8.5 11
Merck 44 7.5 9.5 4.4 10
GSK 41.4 5.3 9.9 8.5 21
AstraZeneca 25.7 4.3 7.3 2.6 10
Eli Lilly 23.1 5.5 5.7 4.7 20
AbbVie 18.8 2.9 4.3 4.1 22
10 Company Average 42.9 6.6 9.8 9.0 21
NOTES
1 “Drug Goes from $13.50 to $750 Overnight.” (2015, September 21). Bloomberg.com.
Retrieved from https://www.bloomberg.com/news/videos/2015-09-21/why-turing-
increased-price-of-daraprim-over-500-
2 Wheeling, K. “Biotech Company Marks Up Drug Cost by 5,000 Percent, Because It
Retrieved from
http://democrats.oversight.house.gov/sites/democrats.oversight.house.gov/files/doc
uments/Memo%20on%20Turing%20Documents.pdf
6 Lifesaving Drug Price Increase Reversed After Consumer Outcry. (2015, September
11 “An Interview with Martin Shkreli.” Breakfast Club (2016, February 3). Retrieved from
https://www.youtube.com/watch?v=JTNOWSKMS10
12 Conti, A. “Why is Martin Shkreli Still Talking?” (2016, January 27). Vice Magazine.
http://www.fdareview.org/03_drug_development.php
17 “Biopharmaceutical Research and Development.” PhRMA. http://phrma-
docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf
18 “Import Program - Importations of Drugs.” (1998, April 3). Retrieved from
http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm
19 “FDA Basics - Is It Legal for Me to Personally Import Drugs?” (2016, March 4).
Retrieved from
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194904.htm
20 Mangan, D. “When Staying Healthy Forces You to Break the Law.” (2014, May 23).
Retrieved from
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194904.htm
24 Love, J. “FDA Enforcement Discretion to Allow Unregistered Generic Daraprim to be
Imported and Sold at Lower Prices.” (2015, October 8). Knowledge Ecology
International. Retrieved from http://keionline.org/node/2332
25 “Facts about Generic Drugs.” (2015, June 19). Retrieved from
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSaf
ely/UnderstandingGenericDrugs/ucm167991.htm
26 “Justification of Estimates for Appropriations Committees.” (2016). Food and Drug
27 Troy, D. “Testimony - FTC Study: Generic Drug Entry Prior to Patent Expiration.”
(2003, June 17). Retrieved from
http://www.fda.gov/NewsEvents/Testimony/ucm161034.htm
28 “The Orphan Drug Act: Implementation and Impact.” (2001, May). Office of
from http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=114
35 Halloran, L. “Fourteen Days Since Turing Pharmaceuticals CEO Promised to Roll