In October 1962, Congress passed a law saying that within two years the government "shall" halt sales of any prescription drug not shown by substantial evidence to live up to the claims made for it by the manufacture.
More than 16 years and one court order later, 482 prescription products for which such evidence hasn't been provided remain on sale. In 1977, the public spent $191 million for just four of them.
Yesterday U.S. District Court Judge William B. Bryant was asked once more to crack down on the government to make it rid the market of medicines that haven't been proved to be effective.
The plea came from the American Public Health Association and the National Council of Senior Citizens, which in June 1970 sued to compel the commissioner of the Food and Drug Aministration and his boss, the secretary of health, education, and welfare, to enforce the so-called Kefauver-Harris amendments to the drug law.
More than two years later, Judge Bryant told the FDA to start to enforce the law rigorously. "It could not be clearer that the secretary must begin the procedures to withdraw a drug when he concludes that there is no substantial evidence of efficacy," he said.
Bryant issued an order establishing a four-year schedule for compliance with the law, requiring the agency to file semiannual reports with the court, and retaining jurisdiction over the case indefinitely.
Yesterday in a motion to restore the case to the docket, attorneys William B. Schultz and Diane B. Cohn urged Bryant "to reactivate the case because defendants are in violation of the deadlines established by the court..."
The 482 less-than-effective prescription products still being sold amount to 25.3 percent of the drugs covered by the order and show that HEW and FDA have "blatantly violated" it, the lawyers charged. They are members of the Public Litigation Group, which is financed by Ralph Nader's Public Citizen, Inc.
An FDA spokesman told a reporter that the agency "has already removed from the market about 7,000 drug products, including all of those believed to raise serious safety questions. This means the program is substantially completed."
Citing limited staff, the spokesman said, "FDA is moving as quickly as resources permit to resolve the status of the few remaining drugs whose effectiveness has been questioned.
"Some of these drugs are the subject of industry-requested administrative hearings, which require hearing examiners, lawyers, and witnesses," the spokesman continued. "Others are undergoing further testing."
Dr. Sidney M. Wolfe, director of the Health Research Group, another Public Citizen affiliate, estimated that the public is spending $1 billion a year for the medicines that haven't been demonstrated to be effective. "If HEW is really serious about controlling health costs, it would have removed these drugs long ago," he told the reporter.
As examples, Wolfe listed two multi-ingredient products that were found to be ineffective as combinations in that they haven't been proved to be more effective than their components used separately:
Combid, a Smith Kline & French product for gastrointestinal conditions for which doctors in 1977 wrote 3.2 million prescriptions with a retail value of $31 million.
Butazolidin Alka, a Geigy Corp. anti-arthritis product: 6.6 million prescriptions, $40 million.
Wolfe also listed two other combinations that are being sold freely under a supposedly narrow, limited exemption.
One is a family of four Phenergan expectorants, made by Wyeth Laboratories. Although rated ineffective, 1977 prescriptions numbered 11.6 million; retail sales were $50 million.
The second, rated "possibly" effective, is Librax, a Roche Laboratories mixture for digestive disorders. Prescriptions totaled 7.1 million and sales $70 million.
Most of the drugs rated ineffective or possible effective have only one active ingredient. The efficacy ratings were made for the FDA, under a 1966 contract, by the National Academy of Sciences-National Research Council.