Questions are being raised about a medical study by manufacturers on the safety of ephedra diet pills, a report said Wednesday.
Documents released Tuesday by a House subcommittee show a panel of scientists has found flaws and shortcomings in the data. Some government officials said those problems could undercut its safety findings at a time when federal regulators are trying to decide if they should ban ephedra, an herbal stimulant, or restrict its sales, the New York Times reported.
For several years, the industry had refused to give the regulators all the data from the study, which was conducted at medical centers in New York and Boston in the late 1990s.
But last February, the Food and Drug Administration made an unusual deal to gain access to the data, officials say.
The agency had to make the deal because drug companies are required to prove the safety of their products and must turn over safety data and consumer complaints to the FDA. The agency, under a 1994 law, has no such authority over the makers of dietary supplements like ephedra.