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Thin safeguards for public health

Is milk from cows that have been doused with antibiotics safe for humans to drink? How about meat from cattle "beefed up" on growth hormones? Most shoppers assume that food staples are safe by virtue of their availability on grocery store shelves. If pressed for the logic behind this assumption, they might say that federal agencies protect the market from unhealthy food and dangerous drugs.

Women considering silicone breast implants followed much the same reasoning. As consumers are beginning to understand, though, the federal government's cloak of safety is a makeshift, patchwork garment at best. The Food and Drug Administration (FDA) relies too heavily on industry-sponsored data, often taking the results of in-house clinical trials and product reviews at face value.

In other words, the only proof that some products are safe is that manufacturers say they are.

In the case of silicone breast implants, a major manufacturer, Dow Corning, suppressed warning signs from physicians, consumers and salesmen. As early as 1976, for instance, an in-house engineer complained that Dow Corning was sidestepping evidence of poor product quality. In 1978, a salesman let his supplier know that 15 percent of surgeons in his distribution area were reporting ruptured implants. In 1980, another salesman condemned the proposal to sell a batch of potentially defective implants. The decision, he wrote his superiors for the record, "has to rank right up there with the Pinto gas tank."

Breast implants have been marketed for three decades, yet the FDA waited until last year to ask Dow Corning for proof of product safety. Last month, with 800 pages of company documents in hand, the government agency called for a moratorium on silicone implant sales. This week, as the documents were released to the public, Dow moved to control the damage by replacing its top leadership.

The company also said it might consider a plan to help women who no longer wanted the implants but could not pay to have them removed. A more decent gesture would be to help anyone who wants to be free of Dow Corning's product. Why should these worried consumers be forced to pay twice?

Also this week, a federal oversight agency warned Congress that the FDA might be relying on "invalid, inaccurate or fraudulent data" in approving drugs for agricultural use. Once again, the data in question came from private laboratories, and some 60 percent of the safety tests were conducted abroad. Researchers from the General Accounting Office (GAO) found that only six out of 30 overseas laboratories had actually been inspected by U.S. officials.

According to the GAO report, "For the majority of safety studies, FDA relied solely on the assurances of drug sponsors that the foreign laboratories had complied with FDA requirements." No wonder the European Community has been reluctant to import American beef.

Assumptions based on assurances. Dinner, anyone?

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