Studies of most medications sold over the counter show that their active ingredients have not been shown to be safe and/or effective in 69 percent of the specific uses or medical conditions for which manufacturers promote them, Public Citizen Inc. said yesterday.
The nonprofit, Washington-based group, founded by Ralph Nader, used the Freedom of Information Act to obtain a 9-month-old summary of the studies, which were done as much as seven years ago by panels of expert outside advisers to the Food and Drug Administration.
They found that of the 1,249 re-commended specific uses, substantial evidence of safety and effectiveness was shown for 393, or 31 percent. For 401 uses (32 percent), they found evidence of safety to be lacking, and, in some cases, affirmative evidence of a hazard.
Public Citizen President Dr. Sidney M. Wolfe cited the data in a letter to FDA Commissioner Arthur Hull Hayes about a lawsuit intended "to force FDA to expedite the process of stopping the marketing" of non-prescription preparations with ingredients of unproved safety, usefulness, or both.
An agency spokesman said, "We're moving as fast as we can" while according "everybody a fair hearing.
Last year, manufacturers' revenues from all over-the-counter (OTC) products totaled an estimated $5.4 billion, "meaning that consumers probably paid over $9 billion," Wolfe wrote. His letter listed five examples of OTC products with combined 1980 sales of $211.5 million that had one or more ingredients questioned by the panels:
* Neosporin: external antiseptic; 1980 sales, $25.9 million; questioned ingredients, polymyxin B sulfate and neomycin sulfate, each on grounds of safety and effectiveness, and bacitracin, effectiveness.
* Absorbine Jr.: external painkiller; 1980 sales, $16.6 million; thymol, effectiveness.
* Dristan: cold medicine; 1980 sales, $51 million; caffeine, effectiveness.
* Robitussin: cough syrup; 1980 sales, $106 million; guaifenesin, effectiveness.
* Nupercainal: hemorrhoidal products; 1980 sales, $12 million; dibucanine (in ointment and suppository), safety and effectiveness, and bismuth subgallate (in suppository only), effectiveness.
The FDA has estimated the number of non-prescription products at 300,000. Yet the different ingredients they contain, many of which have multiple uses, number fewer than 1,000.
The lawsuit was filed in U.S. District Court here by two individuals, Mimi Cutler of Bethesda and Stephen D. Annand of Alexandria, and the National Council of Senior Citizens, all represented by Public Citizen. The suit seeks enforcement of the drug-effectiveness requirements of a 19-year-old law. The named defendants are FDA Commissioner Hayes and his boss, Richard S. Schweiker, secretary of health and human services.