How To Beat The FDA | Eastern North Carolina Now

    Publisher's note: This article appeared on John Hood's daily column in the Carolina Journal, which, because of Author / Publisher Hood, is linked to the John Locke Foundation.

    RALEIGH     As recent controversies in North Carolina and elsewhere have established, political debate is only partially about facts, principles, and logic. Effective politicians also think carefully about the words they use and the stories they tell with them.

    Some of my favorite examples come from the political career of former North Carolina Gov. Jim Martin, whose biography I wrote. Consider his successful fight as a congressman in the 1970s to defend the artificial sweetener saccharin from being outlawed by the Food and Drug Administration.

    The problem originated with an FDA policy called the Delaney Clause, which prohibited the use in food of any product shown to increase the risk of cancer in humans or laboratory animals. During the 1960s and early 1970s, regulators began applying the Delaney "zero-risk" standard to substances that had in the past been generally recognized as safe. Initial toxicological studies found elevated instances of bladder cancer among rats consuming high levels of saccharin. The FDA responded on March 9, 1977 by recommending a ban on saccharin as a food additive.

    As a chemist, Martin had long disliked the Delaney Clause. When it was first enacted, substances were often tested in parts per thousand. As the technology improved, they were detected in parts per million and then parts per billion. Zero-risk standards grew increasingly absurd. Regulators were citing animal studies employing very high concentrations of tested chemicals as a justification for banning even trace amounts.

    In the saccharin studies, for example, the rats were force-fed such high dosages that a person would have to drink 800 cans of diet soda a day to get the same exposure. "Fifty cans of pure water each day would kill most of us," then-Congressman Martin observed, as one would drown.

    Shortly after the FDA's announcement, Martin filed a bill to deny the FDA the authority to ban saccharin. It attracted more than 200 co-sponsors. Martin became one of the leaders of a coalition of House and Senate members who sought to, in his words, "bomb the ban" while reforming the Delaney Rule itself.

    A few weeks later, on May 17, the FDA convened a high-profile set of hearings. By this time, Martin and other opponents had developed a strategy not just for winning the scientific debate but also for illustrating the real hardship a saccharin ban would impose. The pharmaceutical industry testified that saccharin was an essential ingredient in more than 600 medicines. Because sugar often couldn't be used to disguise what would otherwise be bitter-tasting drugs, a saccharin ban could lead to many patients not complying with their medical treatments. The coalition also included a large and sympathetic constituency: diabetics. Representing them at the FDA hearing were Chicago Cubs third-baseman Ron Santo and other professional athletes with juvenile-onset diabetes, as well as several dozen diabetics who arrived from Atlanta on a train they dubbed the "Sweet Georgia Brown Saccharin Special."

    Martin was the first witness to testify at the May 17 hearing. The audience laughed with delight when he argued that government should never ban something "at the drop of a rat." He may not have originated the phrase - no one quite recalls who used it first - but Martin certainly popularized it. The FDA hearings were front-page news across the country, and his "at the drop of a rat" quote appeared hundreds of times in newspaper articles and news broadcasts. NBC News even described Martin as "leading the congressional drive" to change the Delaney Clause.

    Of course, Martin was still a Republican in a Democratic Congress. The cause needed a high-profile Democratic champion. It got one in Teddy Kennedy, who chaired the Senate Subcommittee on Health and Scientific Research. He filed a new version of Martin's bill in June. President Jimmy Carter signed Kennedy and Martin's legislation into law on November 23, 1977.

    Over the course of time, Martin's position was fully vindicated by scientific research. But I'll bet what most readers will remember from this story is that he said government shouldn't ban anything "at the drop of a rat." Which is my point.
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