Word: fda
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...story by relying solely on its in-house critic in the field, Michael Hansen, rather than a panel review. "Nobody has the credibility to handle a wide range of issues," Bauman says. He adds that he found a Hansen report on bst "replete with mistakes" and that the fda sent Hansen a letter listing all the errors. "I don't think this helps the magazine's credibility," Bauman observes...
...political profit. In the last Congress Gingrich introduced three bills to suspend duties on drug ingredients imported by Solvay Pharmaceuticals, a subsidiary of a large Belgian company based in his Georgia district. In January 1994 Solvay contributed $30,000 to the foundation. In mid-1994, Gingrich pressed the FDA to speed the approval of a drug manufactured by Solvay. Last September Gingrich lobbied the White House and the FDA on behalf of Direct Access Diagnostics, a Johnson & Johnson subsidiary that was seeking approval for a home test kit to detect the AIDS virus. Soon after, Direct Access contributed an estimated...
...case of the drug companies, there is no linkage between the favors Gingrich did for them and the money they gave the foundation, says Jeffrey Eisenach, founder and president of the foundation. Indeed, Gingrich had been railing against the inefficiencies at the FDA long before he asked the foundation to provide him with a plan for revamping the agency and before it even started collecting donations. There is also no evidence that Gingrich knew of these donations or that the foundation promised influence when seeking financial support...
...chance to prove he has one more medical miracle up the sleeve of his lab coat. Last week an expert advisory panel to the Food and Drug Administration recommended that the agency allow Salk to test his AIDS vaccine on 5,000 volunteers. If the FDA agrees, Salk's preparation would be the first AIDS vaccine to undergo a large-scale trial...
Then why did the FDA panel vote for wider testing? Clearly, Salk himself was a big selling point. "He has a reputation among some scientists as a god," says one top AIDS researcher. "He's a powerful advocate, and they find it very hard to turn him down." The committee may also have had a hard time saying no to the AIDS patients who participated in the early pilot programs. They fear that if the FDA does not expand the trial, they will no longer receive the shots. And many are convinced that the treatments are helping. Mike Slattery...