After the Second World War, Pfizer circumvented the traditional drug distribution networks and began marketing its products directly to hospitals and physicians. Pfizer became the leading advertiser in the Journal of the American Medical Association (JAMA). It ran ads for antibiotics that displayed the names of doctors who endorsed its products — the doctors were fictitious. Its aggressive sales tactics through various promotions and teams of detail men came to be known as the “Pfizer Blitz.”
Politcal cartoonist Bill Mauldin, best known for his weary GI Everyman characters Willie and Joe during World War II, published this take on Big Pharma's tactics on Feb. 3, 1959. In a 1961 book of reprinted cartoons, Mauldin offered this additional comment: "The drug industry admitted peddling itself into profits of several thousand percent."
In 1958, the Federal Trade Commission found that Pfizer had made false and misleading statements to the U.S. Patent Office to obtain a patent on Tetracycline, which, in dollar volume, was the world’s leading broad-spectrum antibiotic. In addition to misrepresentations made to the patent examiner, the Pfizer scientists who conducted the tests rigged them to produce the desired outcomes. Patents in hand, Pfizer then conspired to fix prices.
In 1961 the Justice Department indicted Pfizer, American Cyanamid and Bristol-Myers, along with the top executives of the three companies, John E. McKeen of Pfizer, Wilbur G. Malcolm of American Cyanamid, and Frederic N. Schwartz of Bristol Meyers. A federal court dismissed the cases against the individual defendants, ruling that their Fifth Amendment rights against self-incrimination had been violated. On civil liberties grounds the ruling was laudable; courts ought to uphold the civil liberties of individuals more rigorously than they do, but the behavior at issue is a window into Pfizer’s criminal culture.
A federal jury found the three companies guilty on various criminal conspiracy counts. But appeals ended up with retrials and an ultimate dismissal by a judge sitting without a jury. Pfizer and the other companies settled lawsuits brought by state and local governments for about $150 million.
Putting aside the fraudulently obtained patents and the conspiracy to fix prices, the huge sums Pfizer and other drug companies spent on advertising in medical journals sought to persuade doctors to prescribe drugs by brand names rather than much cheaper generics. They also made the publications reluctant to challenge the extravagant claims made for the efficacy of the drugs. These purposes were self-evident. Today’s media display the same tendencies, which is a story for another day. But the obvious purposes of the millions of dollars spent on advertising in medical journals were overshadowed by a hidden, more sinister one.
A Regulator with a Blatant Conflict of Interest
Henry Welch headed the Antibiotic Division of the Food and Drug Administration in the 1950s. Welch was the key regulator in securing government approval for new antibiotics. At the same time, Welch had a financial interest in several medical journals whose profits were tied to the sale of advertising and the purchase of reprints.
Tennessee Senator Estes Kefauver figures into this story. A New Deal, pro-labor, liberal Democrat in a conservative state, he is best remembered, especially by older Americans, for the trademark coonskin cap that he wore whenever he ran for office. It’s an amusing little story so we’ll just pause here to tell it.
Kefauver was a congressman when he first ran for the Senate. He was much too liberal and independent for Tennessee’s Democratic Party boss, E.H. Crump, who was backing another candidate. Crump railed against him as a “fellow traveler working for the pinkos and communists with the stealth of a raccoon.” Kefauver put on a coonskin cap and proclaimed, “I may be a pet coon, but I’m not Boss Crump’s pet coon.” Most Tennesseans didn’t agree with his politics but they liked his integrity and elected him to the U.S. Senate.
In 1950, just as Americans were buying their first television sets, Kefauver became famous when he headed a Senate committee investigating organized crime. Mob bosses and politicians were subpoenaed and forced to take the Fifth Amendment in front of the television cameras. Many Americans were introduced for the first time to the idea of a criminal organization known as the Mafia. The televised hearings became known as the Kefauver hearings.
Somewhat lesser known but more important was his chairmanship of the Senate Anti-Trust and Monopoly Subcommittee, which delved deeply into the concentration of wealth and power in many sectors of the economy. One of them was the pharmaceutical industry. It was those hearings that exposed the corrupt bargains between Pfizer and other drug companies, some doctors, medical journals, and at least one important regulator.
The executives of some small companies testified that unless they advertised in the medical journals, they had “a very difficult time getting their product approved by the Antibiotics Division.” Welch, the federal regulator, was editor-in-chief of two journals: Antibiotics Chemotherapy and Antibiotic Medicine Clinical Therapy and jointly owned Medical Encyclopedia, Inc. publisher of the Antibiotic Annual.
Pfizer, a heavy advertiser, had no problems getting its drugs approved. Pfizer bought hundreds of thousands of reprints that carried favorable comments by Welch about its drugs. The company sent the reprints to doctors who assumed that Pfizer was legitimately calling attention to the endorsements of a prominent, disinterested regulator. They prescribed the drugs to their patients even though much cheaper genetics were available.
Welch even submitted his speeches on antibiotics to Pfizer employees, who edited them to synchronize the remarks of the FDA’s chief antibiotics regulator with the precise phrasing used in their promotional campaigns.
Welch was forced out of the FDA in 1960 but neither he nor Pfizer’s top executives were ever disciplined, let alone prosecuted.
Those hearings led to the enactment of the Kefauver-Harris Drug Act of 1962. Before that legislation was passed, the Food and Drug Administration (FDA) had little authority to require a showing of a drug’s efficacy or to force disclosure of its risks. Much like today’s Republicans, regulation — even of drug safety — was decried as hamstringing legitimate business, putting government bureaucrats between patients and doctors, curbing free enterprise, etc. Kefauver was portrayed as the lead villain in the plot to destroy our freedoms.
His legislation, giving the FDA authority to compel drug companies to provide efficacy and safety data before they could market their product, was going nowhere. Then, a young FDA medical review officer, Frances Kelsey, questioned the adequacy of data submitted by a drug company that was seeking approval to sell a sleeping aid. It was also promoting the same drug to pregnant women for morning sickness. At about the same time, the British Medical Journal had published a report associating the drug with persistent neuropathic symptoms. Kelsey declined to approve the drug, in those days a rare occurrence at the FDA.
Meanwhile, in Europe large numbers of babies were being born with severe birth defects, their hands or feet emerging directly from their torsos. Nobody knew the reason. Eventually, though the compound was being marketed all over the world under more than 60 different trade names, the deformities were traced to thalidomide. Even after the discovery, because it was marketed under so many different names, it continued to be sold in many countries until the end of 1961. But not before many thousands of “Thalidomide babies” had been born.
Frances Kelsey had saved countless babies because that drug company never did get to sell thalidomide in the United Sates.
It took the thalidomide story to make the case for the government’s right, let alone its obligation, to require manufacturers to provide adequate data about risks and benefits before they can market a prescription drug. Today, in what Gore Vidal has called the United States of Amnesia, the Republican Party and its deregulation advocates, cleverly calling themselves “Freedom Caucus,” would like us to forget this history. Forget about the dangers of deregulating food and drugs and workplace safety and forget about of the consequences of strangling regulatory agencies by cutting off their funding. Instead, they urge us to have “faith” in “Free Markets” and “Free Enterprise.” Hocus-pocus; it’s all where you focus.
The Kefauver-Harris Drug Act, once going nowhere, became law of the land, giving the FDA more authority to regulate the pharmaceutical industry. But as we know, more authority is only the beginning of the story.
Written for Fedupnewyorkers.org
Cartoon copyright 1959, The State Historical Society of Missouri, SHSOFMO.org, reprinted by permission.
For more on Pfizer, See "Pfizer, Inc.'s Executives Get Pass on Proseccution"