and oil. The industry had lost its way. And I became even more determined to help overcome this prejudice with counter arguments and data.
On that day, I tried to express my sorrow to the distraught mother, but she abruptly turned and walked away. I learned a few years later from Dr. Abramson that this young girl was being treated for depression and, while on therapy, committed suicide. (I do not know which drug she was taking.) I cannot think of anything more tragic than losing a child. While it is uncertain that the drug was the cause of this suicide, her mother was persuaded. She was unable to accept my sympathy, nor consider my conviction – that the goal of pharmaceutical R&D is to alleviate pain and suffering, not cause it.
My advocacy began in 2006, when I was invited to give a lecture at the University of New Hampshire, which was open not just to the university community but also to the general public. The talk, “Pharmaceutical R&D: The World’s Hope for Tomorrow’s Cures,” was designed to help combat the broad criticism of the industry by answering a number of questions:
What value do new medicines bring to society?
Where do medicines come from?
What innovation does Big Pharma bring?
How are risks and benefits of medicines evaluated?
This 45‐minute talk began at 4 pm with an audience of a few hundred people. The ensuing question and answer period lasted another hour and a quarter and would have gone even longer if the organizers had allowed. The questions covered the entire spectrum of drug R&D.
People were more than curious. They had dozens of questions and wanted answers. They were stunned to hear how long and costly it is to discover and develop new drugs. People had little appreciation of the cutting‐edge science needed to be successful. They asked how scientists remain motivated when after spending years on a program, it suddenly dies. By the end of the session, people had a better understanding of the tremendous challenges involved in bringing forward new medicines. The audience began to see a major piece of the healthcare debate in a totally new light.
This experience led me to write Drug Truths: Dispelling the Myths of Pharma R&D. As a result of Drug Truths, I began to get invitations to speak, not just about pharmaceutical research, but also the industry itself. The call from The Dr. Oz Show invited me to debate some of the issues I addressed in my book: the safety of new drugs, the myth that the industry invents diseases, that people are overmedicated, etc. The opportunity to join this discussion appealed to me.
Looking back, I was incredibly naïve. The first time I saw that theme, “The Four Secrets that Drug Companies Don’t Want You To Know,” was when I walked on stage. Drs. Oz and Abramson were not buying my arguments and nor was the audience.
Confronted with the negative public perceptions of the pharmaceutical industry, I wrote Devalued and Distrusted: Can the Pharmaceutical Industry Restore Its Broken Image? It addressed a number of issues that pharma was facing at the time, including: improving its ability to measure not just the benefits but also the risks of new medicines; the need for greater transparency in the conduct as well as the outcomes of clinical trials; changing how drugs are marketed; changing how physicians are compensated for their work with pharmaceutical companies; etc.
Remarkably, the industry has made many changes to improve its accountability – albeit with some prodding from the government. For example, all clinical trials must be registered on the website: www.clinicaltrials.gov. In addition, the results of these studies – positive and negative – must be reported within 12 months of completion. Companies are also making public any payment in excess of $10 made to any physician resulting from collaboration with a company. With respect to payments to physicians, the Centers for Medicare and Medicaid Services (CMS) publishes all of these on its Open Payments website (www.CMS.gov/openpayments).
Despite this progress, there is still one reputational issue that dwarfs all others – the price of drugs. In fact, while our country is divided on almost every problem we face, drug pricing unifies political foes. It even brought together former President Donald Trump and his left‐leaning nemesis Senator Bernie Sanders. At a press conference in January 2017, President Trump said: “Our drug industry has been disastrous….And the other thing we have to do is create new bidding procedures for the drug industry, because they are getting away with murder [1].” Senator Sanders responded: “He’s right and I’ve been saying this for years. Pharma does get away with murder. Literally murder. People die because they can’t get the prescription drugs that they need [2].”
The pharmaceutical industry should not be surprised by the backlash. After all, stories about high drug prices appear almost daily. How can a single pill cost $1000? How can healthcare systems stay afloat when life‐saving gene therapies are priced at over $2 million per patient? Why is Senator Sanders taking busloads of Americans over the border to Canada to get insulin for their diabetes? How can Pfizer and Moderna justify billions of dollars in revenues for their mRNA vaccines? This book seeks to answer these and other questions. Is the drug industry filled with profiteers “getting away with murder” or is it an industry made up of companies that invest in a high‐risk business called “innovation” that makes reasonable returns on at‐risk capital? You decide.
REFERENCES
1 1. Karlin‐Smith, S. (2017). Trump says drug industry “getting away with murder” Politico, (11 January).
2 2. Carter, Zachary D. and Schumaker, Erin (2017). Bernie Sanders: Donald Trump is right about big pharma, HuffPost, (11 January).
CHAPTER 1 THE $1000 PILL: THE FISCAL CONSEQUENCES OF CURING HEPATITIS C
The company in this case” is asking for a blank check which if granted will blow up family budgets, will blow up state Medicaid budgets, will blow up employer benefit costs and wreak havoc on the federal debt.” This provocative comment was made by Ms. Karen Ignagni, former president and chief executive officer (CEO) of America’s Health Insurance Plans, the trade association of health insurance companies. The cause of Ms. Ignagni’s alarm was SovaldiTM, a breakthrough drug that cured the liver disease hepatitis C. Manufacturer, Gilead, priced its new medicine at $1000 a pill. Given that the standard course of treatment was once‐a‐day for 12 weeks, the cost of this cure was $84 000/patient. Ms. Ignagni’s concern was shared. Dr. Steven Miller, chief medical officer (CMO) of Express Scripts, a prescription management company, called this drug pricing unsustainable [1].
The World Health Organization (WHO) estimates that globally 71 million people have chronic hepatitis C with roughly 3 million of those in the United States. The most common modes of infection are through exposure to small quantities of blood. While largely asymptomatic, the hepatitis C virus (HCV) resides in the liver and can lead to devastating consequences such as liver scarring, cirrhosis, liver failure, and liver cancer. Many of these patients will ultimately require liver transplants to survive – a surgery that costs more than $300 000.
Older treatments were modestly effective. Cure rates ranged from 40 to 80%, depending on the severity of the disease. Patients were given a cocktail of drugs plus injections of interferon for 24–48 weeks. However, these medicines are poorly tolerated, particularly the interferon component that causes flu‐like symptoms in patients. As a result, many with hepatitis C often avoided treatment.
SovaldiTM provided new hope. The pill was found to cure hepatitis C in more than 90% of patients in just 12 weeks. Furthermore, it is safer and roughly 20% cheaper than the older treatments that cost over $100 000. One would think that the maker of such a
