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Even as the FDA was easing its rules, AIDS sufferers were still searching for a cure on the black market for unapproved drugs. It was revealed last week that an underground network of doctors in four cities has been conducting a clandestine trial of a drug known as Compound Q. In test tubes, it can destroy cells infected with the AIDS virus, but it has not yet been proved to be safe and effective in humans. In the unofficial trial, 42 patients have received Compound Q, which is derived from a Chinese cucumber-like plant. Among those taking the drug...
...AIDS drugs. Now that doctors have medications that work, they need to find what works best. But for the past several years, experimental drugs have first been available on the AIDS black market, through which patients who felt they had little to lose began their own treatment programs. The FDA, responding to intense public pressure to demonstrate both compassion and efficiency, has established a "fast track" for the approval of AIDS drugs. However, that streamlining may have permanently distorted the traditional protections afforded by careful drug studies. Some scientists are demanding a stop to self-experimentation...
...dimensions of the inspection effort are daunting, and have been made even more so by the budget slashes of the Reagan era. The FDA, for example, can assign only 910 staff members -- in contrast to 1,105 in 1977 -- to monitor food, including imports. Some foreign growers easily circumvent the process; produce from Mexico is often trundled across the border at Nogales, Ariz., on the inspector's day off. And the USDA last year fielded only 7,000 inspectors -- down from 10,000 eight years ago -- to examine the carcasses of nearly 120 million cows, pigs and horses...
...heptachlor case highlights another flaw in the system. USDA and FDA investigators have been unable to trace the source of the tainted seed because it changed hands -- from farmer to grain-elevator operator to feed broker to poultry producer -- so many times. Closer monitoring is necessary at every step along the food-supply chain. Federal agencies also need more flexible enforcement powers. The USDA, for example, cannot levy fines on processing plants. It can close a plant down, but that is a drastic action that is not readily employed...
Though there is no reason for fish to be inspected any less strenuously than meat or poultry, the FDA manages to examine just 1% of domestic seafood and 3% of imports (two-thirds of the fish Americans eat comes from abroad). Inspectors get to about a third of the nation's 4,000 seafood-processing plants a year and to some facilities once in three years...