Pharma Gangsters & Cold War Double Agents

Organized crime masquerading as benevolence.

The death of Christine Cotton, which I wrote about in my post yesterday (Pfizer Whistleblower Christine Cotton Takes Her Life After Year of Excruciating Idiopathic Pain) reminded of Pfizer’s trovafloxacin scandal back in 1996, which was apparently the inspiration of John le Carré 2001 novel, The Constant Gardener.

I recently thought of le Carré while having lunch with a friend in London Savile Club, where le Carré was a member. This, in turn, reminded me of a chapter I wrote (with Dr. Peter McCullough) in our book, The Courage to Face COVID-19 about le Carré and his literary antecedent, Graham Greene, who both wrote stories about villains selling pharmaceuticals.

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CHAPTER 36: For the Love of Money

Long before COVID-19 arrived, I was a close observer of the pharmaceutical industry. My great grandparents believed that pharmaceutical labs were at the forefront of progress, relieving suffering and extending life, and for the most part they were right. My paternal great grandfather owned a large chain of drugstores and was a benefactor of UT Southwestern Medical School. At the time of my birth, my maternal great grandmother gave me a generous gift of Pfizer stock. She had been impressed by Pfizer’s key role in discovering how to mass produce penicillin during World War II (in which her son was killed in action). Eighteen years later her gift paid for my university education. And then, in 1998, Pfizer received FDA approval to sell Viagra.

Pfizer initially developed the drug to treat high blood pressure and angina pectoris. However, as Pfizer’s researchers discovered in clinical trials, the drug was better at inducing erections than managing angina. And so, the company repurposed the drug for erectile dysfunction and launched a massive, global PR and marketing campaign—including seeking moral approval from Pope John Paul II and contracting the war hero and 1996 presidential candidate Bob Dole to be the brand’s poster gentleman—that succeeded in making Viagra a blockbuster. Fortunately for me, I still owned a large chunk of Pfizer stock. The price spiked in late 1998 and reached an all-time high in April of 1999. I sold my entire remaining position, which financed my early years as a freelance author, before my first book was published.

So, I learned firsthand why pharmaceutical companies seek to develop blockbuster drugs with fanatical zeal. Formulating a safe and effective new medicine to address a large, unmet need is very difficult and expensive. Performing clinical trials and obtaining FDA-approval is an arduous process that normally takes several years. Thus, if an opportunity for a new blockbuster presents itself, a big drug company like Pfizer will go to extreme lengths to seize it.

Three years after the release of Viagra, I learned that Pfizer was not the entirely respectable company my great grandmother had believed it to be. I arrived at this realization through my interest in British spy novels. In 2001 I lived in Vienna, around the corner from the Burgkino (Burg Cinema) which still played the 1949 film noir classic The Third Man on its big screen every weekend. I spent many a dreary winter Sunday afternoon watching the film. Based on the novella and screenplay by Graham Greene, The Third Man is a crime story about Harry Lime—an American running a medical charity in Vienna, who makes a killing selling penicillin on the bombed out, impoverished city’s black market. To increase his profits, he cuts the drug with other substances, thereby destroying its efficacy and causing the patients (including children) to die horribly from their infections.

In the film’s most iconic scene, the good guy (played by Joseph Cotton) meets his old friend Harry Lime (played by Orson Welles) on the Giant Ferris wheel in the Vienna Prater amusement park and tries to appeal to his conscience. At the wheel’s apex, the charismatic Harry opens the door, points down to people walking on the ground below, and says:

Look down there. Would you really feel any pity if one of those dots stopped moving forever? If I offered you twenty thousand pounds for every dot that stopped, would you really, old man, tell me to keep my money, or would you calculate how many dots you could afford to spare? Free of income tax, old man. Free of income tax. ... Nobody thinks in terms of human beings. Governments don’t, why should we? They talk about the people and the proletariat; I talk about the suckers and the mugs. It’s the same thing. They have their five-year plans, and so have I.

I sensed that Graham Greene might have based the story on something he’d witnessed or heard about. Doing some research, I learned that Harry Lime was probably based on the British spy Harold “Kim” Philby, with whom Greene worked in British intelligence during World War II. Greene, it seems, discovered that Philby was a Soviet double agent long before he was exposed as such in 1963. Instead of ratting out his friend, he kept it to himself and left the intelligence service in 1944. Several pieces of evidence suggest that when he wrote The Third Man a few years later, he based it on his conflicted friendship with Philby.

John le Carré was also fascinated by Graham Greene and Kim Philby, and his thriller Tinker, Tailor, Soldier, Spy—one of my all-time favorites—was inspired by the Philby story. His novel The Constant Gardener was published in 2001, and I read it with great interest. The story wasn’t set in Cold War Europe, but in Kenya, where a British diplomat’s wife is brutally raped and murdered. Upon closer examination, the diplomat realizes that she was about to reveal a horrifying crime committed by a pharmaceutical company, which murdered her in order to prevent the exposure.

The novel’s plot was reminiscent of a controversial drug trial performed by Pfizer in Kano, Nigeria in 1996 during a meningococcal outbreak. For the trial of its new antibiotic, trovafloxacin, Pfizer gave 100 children this new drug. The control group of 100 other children received the standard anti-meningitis treatment at the time—a drug called ceftriaxone. However, for the control group, Pfizer administered a substantially lower dose of ceftriaxone than the drug’s FDA-approved standard.

When the reduced dosing in the control group was discovered, it raised the suspicion that Pfizer did this in order to skew the trial in favor of its new drug. Five of the children who received trovafloxacin died, while six who received the reduced dose of ceftriaxone died. Other children apparently suffered grave injuries from the administration of the experimental antibiotic without their informed consent. The investigation and litigation that ensued was the stuff of a thriller, involving private investigators, bribery, blackmail attempts, and disappearing records. Thirteen years later, in 2009, Pfizer settled out of court with the plaintiffs.

In his author’s note, le Carré claimed that nobody and no corporation in the novel was based on an actual person or corporation in the real world.

But I can tell you this. As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard.

In 2009, the same year that Pfizer settled with the trovafloxacin plaintiffs, the New York Times reported that a U.S. federal judge assessed Pfizer with the “largest health care fraud settlement and the largest criminal fine of any kind ever” for its illegal marketing of Bextra and three other drugs.200 The U.S. Department of Justice was unequivocal in characterizing Pfizer’s officers as guilty of grave criminal conduct at the expense of the American public.

Pfizer wasn’t alone. Between the years 2002 and 2012, the U.S. Department of Justice filed charges and reached settlements (ranging between $345 million and $3 billion) in 22 major cases of pharmaceutical company fraud, mostly under the U.S. False Claims Act. Violations included off-label promotion of drugs for uses not recognized by Medicare, failure to disclose safety data, paying kickbacks to treating physicians, and making false and misleading statements about safety.

Another notable case was Merck’s aggressive marketing of its painkiller Vioxx while knowing and concealing that high doses of the drug tripled the risk of heart attack. The FDA estimated it caused 27,785 heart attacks. Ultimately Merck settled the lawsuit for $4.85 billion and later paid a $950 million fine to the DOJ. After the civil settlement in 2005, Merck CEO Raymond Gilmartin took an early retirement and a job teaching a course titled “Building and Sustaining Successful Enterprises” at the Harvard Business School.

In the popular imagination, the criminal drug trade is synonymous with cartels and cocaine. And yet, under the cloak of scientific respectability, much organized crime has been conducted by certain American pharmaceutical companies.

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