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