15. "The Real Problem with the FDA"

The Food and Drug Administration (FDA) is a regulatory agency whose primary purpose is to establish and enforce standards for food and drug products produced and sold in this country. The regulatory agency, supported by the public's tax dollars, reputedly protects the public from unscrupulous manufacturers.

Yet, as Howie Kurtz pointed out in a Washington Monthly article in mid-1977, the FDA appears more concerned with protecting the manufacturers than the public.

An example documented by Kurtz deals with aspartame. In early 1974, the G.D. Searle Company was preparing to market an artificial sweetener called aspartame. A white, odorless, crystalline powder that is 180 times as sweet as sugar. Aspartame was to be used in breakfast cereals, chewing gum, beverages, puddings, whipped toppings, coffee, and tea, among other things. As required, Searle submitted test results to the FDA. They indicated that aspartame was safe and, in July, 1974, the FDA routinely approved it for general use.

It was not long, however, before independent scientists discovered disturbing evidence about aspartame. Dr. John Olney, of Washington University School of Medicine, in St. Louis, announced that mice fed aspartame developed brain lesions. "We found brain damage at the lowest effective dose we fed the mice," Olney said, "which is not a big amount if you're talking about a sweetener to be gobbled up by children and infants." A consumer group called LABEL cited studies that suggested aspartame could cause mental retardation in infants if consumed by pregnant women.

As the pressure and evidence mounted, the FDA agreed to take a second look at Searle's data, and created a special investigative task force to examine the company's testing procedures for aspartame. The investigators concluded that Searle had distorted and falsified some of its data on aspartame. For example, when test animals died in experiments, Searle substituted the blood of other animals for the dead ones, the investigators said. No slides were made of lesions found in some of the dead animals. And there were discrepancies between Searle's raw data and the summaries it gave the FDA. As a result, the FDA withdrew its approval of aspartame in December, 1975, before any had been sold.

The public's lack of knowledge about the lax controls of a regulatory agency, such as the FDA, and the agency's use of manufacturers' own test results, qualifies this story for nomination as one of the "best censored stories of 1977."

SOURCE:

"The Real Problem with the FDA" by Howie Kurtz, The Washington Monthly, July/August, 1977.