The Enduring Success of a Healthcare Radical

12/4/12

I’ve spent some time over the past few months reading about an American political figure’s transformative role in our health care system. His crusade began when his staff surveyed drug prices in 77 countries and found “of these, 28 allowed product patents and the prices of drugs in those countries were 18 to 255 times higher than in non-patent countries, with both American made and European made drugs costing far less in Europe than in U.S.” Outraged by these high prices, he initiated legislation that was primarily intended to control drug costs. Not everyone, however, appreciated his reforming efforts. He was branded a “socialist hell-bent on ruining healthcare” for his work. His opponents accused him of “trying to unnecessarily expand the power of government, threatening the viability of the pharmaceutical industry, and inserting Washington bureaucrats between patients and their doctors”. His labors were strongly opposed by the powerful pharmaceutical industry, of which he said, “These drug fellows pay for a lobby that make the steel boys look like popcorn vendors.

Who was this remarkable individual who tried (and succeeded) in his heroic efforts to reform serious problems in the US healthcare system?

If you thought the quotes above were referring to Barack Obama, you were wrong. Maybe I was describing Bill Clinton? Good guess, but again you’re mistaken. Actually, the healthcare radical I’m referring to was Senator Estes Kefauver (D-Tennessee), the driving force behind the Kefauver-Harris Drug Control Act of 1962. This year marks the 50th anniversary of one of the most significant events in American medical history. Very few Americans have ever heard of this law, even though it impacts virtually all of us. What did this revolutionary legislation accomplish?

In brief, it amended the Federal Food, Drug, and Cosmetic Act of 1938 in a way that at the time seemed quite extreme, but now looks simply like common sense. The most important changes enacted by passage of this legislation were:

1) Medicines needed to actually demonstrate proof of efficacy before they could be sold on the U.S. market.

2) Drug advertising needed to disclose accurate information in terms of efficacy and expected side effects.

3) Inexpensive generic drugs could not be re-branded under new trade names and then marketed (at a much higher cost) as “breakthrough” medications.

4) It increased government inspection of drug manufacturing plants.

5) The act called for the removal of drugs that were “an immediate hazard to the public health.”

6) Patients taking part in clinical trials needed to give informed consent.

7) Doctors and pharmaceutical companies were required to report adverse drug reactions to the FDA.

The passage of this landmark legislation is nicely recounted in Joseph Bruce Gorman’s 1971 book Kefauver: A Political Biography. Kefauver, the chair of the U.S. Senate Antitrust and Monopoly Subcommittee, held hearings from1959-1963 on the workings of the pharmaceutical industry. He felt that the industry was earning excessive profits at the expense of U.S. consumers. As such, his primary aim in drafting this legislation was an economic one. His initial goal was to reduce the length of drug patents, which at the time ran 17 years (they now last for 20 years). He wanted to replace these patents with a system in which drug sellers would be forced to license their medicines to competitors after only three years of exclusive selling. In exchange for this they would get a royalty that was calculated based on how much it cost to produce the drug. The path to getting this legislation passed turned out to be anything but straightforward, as both the drug lobby and the American Medical Association opposed his efforts. There was public support for the general idea that drugs should be both safe and effective, but there was disagreement then, as now, as to the role the federal government should play in this process.

 

[Illustration courtesy of Josh Lyman]

The patent provisions were stripped out of his bill through a series of backstabbing legislative maneuvers. The Kennedy administration then bypassed Kefauver’s work and submitted its own bill that was put together after a secret meeting (of which Kefauver was unaware) of administration officials, several Senators, the drug industry, and representatives of the Department of Health, Education, and Welfare (now known as the Department of Health and Human Services). Kefauver found out that the Administration officials had removed not only the patent pricing stipulations, but they had also gutted the safety and efficacy provisions in the bill. His anger boiled over and he railed against the “drug manufacturing industry and its acolytes” in a speech on the Senate floor.

Kefauver worked hard to restore some measure of meaningful reform to his bill. It was fortuitous timing that the public was just becoming aware of the thalidomide drug disaster. Reports were flooding in from Europe of babies born with truncated or missing limbs to mothers who had taken this medicine when pregnant. The U.S. Food and Drug Administration never allowed the drug to be sold in the U.S. as a treatment for morning sickness, arguing that it hadn’t yet been established as safe. But as people learned about the serious birth defects associated with this drug, and the potential for drugs like that to cause harm to U.S. patients, public support and eventually political backing rallied to Kefauver’s version of the bill, which required manufacturers to demonstrate both safety and efficacy before a new drug could be sold. The Kennedy administration reversed its position and championed a strengthened version of the legislation. With cooperation building in all quarters, it was signed into law in October of 1962.

Sadly, Estes Kefauver died suddenly in 1963 of a ruptured aortic aneurysm, just 10 months after President Kennedy signed his landmark legislation into law. His Drug Control Act legislation is considered the high point of his legislative career, and he was justifiably proud of the consumer protections he helped guide into place. Kefauver clearly put his career and political reputation on the line in order to do what he felt was right for the American drug consumer.

As 2012 comes to an end, I have a suggestion for honoring Senator Kefauver’s courageous consumer protection efforts. Share this story whenever someone whines about efforts to reform our broken healthcare system (which was ranked 37th in the world by the World Health Organization in 2000). Imagine what our medical system would be like today without the reforms introduced by his “radical” legislation that was opposed by many groups back in 1962. Let’s hope that future efforts to ensure that our drugs are safe and effective, as well as widely affordable, will be as successful as his were.

(Note: Quotes in the first paragraph were excerpted from David Healy’s 2012 book Pharmageddon except where indicated).

Stewart Lyman is Owner and Manager of Lyman BioPharma Consulting LLC in Seattle. He provides strategic advice to clients on their research programs, collaboration management issues, as well as preclinical data reviews. Follow @

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