In September 1984, Food and Drug Administration Commissioner Frank E. Young formed a new health fraud branch to focus the FDA's efforts against "quack" drugs that endanger or dupe consumers.
After more than a year and a half, there is little to suggest that the FDA is moving more speedily or aggressively to get fraudulent drugs off the market.
Of the FDA's $400 million annual budget, the share devoted to health fraud has remained constant at 0.5 percent. The total of seizures and injunctions against such products has not increased since the fraud branch's creation, and the most recent criminal prosecution sought by the agency -- against General Nutrition Inc. for marketing oil of evening primrose for arthritis, high blood pressure and other serious conditions -- was filed in late 1984 and has not come to court.
Fraudulent drugs include a variety of products offered without FDA approval to treat ills from life-threatening diseases such as acquired immune deficiency syndrome (AIDS) or cancer to problems such as pain, obesity, baldness or impotence. The FDA divides such products into three categories: direct health hazards, those that are harmless in themselves but prevent a consumer from getting more effective treatment, and those that are merely a waste of money.
Ninety percent of fraudulent health products are in the last category, said FDA spokesman Bruce Brown. Yet an internal guidance manual issued last January states that because of limited resources, FDA action against economic frauds "will usually be limited to support of . . . public education activities."
Young, who last year included health fraud among his top 10 targets for action, said the FDA is concentrating more on educating consumers than on enforcement efforts because he believes that "vaccinating" the public against phony treatments works better than trying to drum quacks out of business. He likened health-fraud merchants to gophers: Chase them down one hole and they pop up another.
Consumer advocates, while applauding Young's educational campaign, argue that the agency should wield its legal authority more aggressively against the $25 billion health-fraud industry. "Education can't protect gullible people and it can't protect desperate people. Only enforcement can," said Dr. Stephen Barrett, a board member of the National Council Against Health Fraud.
The FDA has the strongest legal mandate of any federal agency to control quack products, but has done less than the U.S. Postal Service or the Federal Trade Commission, which regulate mail-order fraud and dishonest advertising claims, according to Kathleen Gardner, staff director of the House Select Committee on Aging's subcommittee on health and long-term care.
Young maintained that the FDA has intensified its pursuit of quack drugs during his tenure, but said most actions take the form of regulatory letters rather than legal remedies such as seizures of goods, injunctions against manufacturers or criminal prosecutions. A regulatory letter warns a company to change aspects of a product's manufacture, labeling or promotion or risk legal action by the government.
Young said such a letter usually suffices to stop marketing of a fraudulent remedy, but acknowledged that critics, including some FDA employes, feel that criminal prosecutions would be a much stronger deterrent.
FDA spokesman Brown said the low priority on economic fraud causes discouragement in the agency. "We do have a reasonable track record where threat to life and health are involved," he said, "but that leaves an awfully big industry out there."
He said the FDA's efforts against health fraud compete for resources with its responsibilities to regulate legitimate drugs and deal with emergencies such as product tampering and food contamination. Local FDA inspectors often are further frustrated by the length of time federal officials take to approve a recommendation for legal action against a fraudulent product.
Daniel Michels, director of compliance in FDA's Center for Drugs, said that although the agency can act within days in an emergency, it routinely takes several weeks for his office to review a local recommendation for a regulatory letter or product seizure. If a seizure or injunction request is approved, it must next be forwarded to the FDA's general counsel and then to a U.S. attorney or the Justice Department.
Months or years may pass before local authorities get the go-ahead to act. In the meantime, Brown said, any change a manufacturer makes in the name, labeling or even the color of a fraudulent product can send the investigation back to square one.
In one case, FDA officials in California issued a regulatory letter in June 1982 to Herbalife, a California manufacturer of weight-loss products and nutritional supplements. In September 1983, the chief compliance officer on the case recommended seizure of Herbalife products that were falsely claimed to relieve menstrual disorders, treat high blood pressure and "liquefy fatty tissue."
In May 1985, Young was called to testify before the Senate Governmental Affairs permanent subcommittee on investigations about why the agency had not yet acted. He blamed the delay on internal disagreement over whether the products were foods or drugs.
In an interview, Young said he could not explain the delay. "It went back and forth for about four years," he said. After the 1982 regulatory letter, "we didn't do what we usually do, of going back to the firm . . . . We were silent . . . . I'm not sure what the 'because of' was."
Young, a pathologist, said he personally reviewed autopsy records in five deaths alleged to have been linked to Herbalife products and concluded that no cause-and-effect relationship could be proved. He said the FDA has since resolved its differences with Herbalife by persuading the firm to change its promotional claims.
Brown said the health fraud branch had succeeded on some fronts. It acted against "oral chelators," vitamin-mineral pills claimed to dissolve plaques in diseased arteries, and against DHEA and CCK, two hormones marketed to promote weight loss. In Oregon, the agency won an injunction last February in U.S. District Court against KC Laboratories and Manna International, manufacturers and distributors of products made from blue-green algae and promoted to treat Alzheimer's disease, herpes, arthritis, diabetes and other diseases. Last year it seized more than $1 million in products from Robertson Taylor, a Florida-based nationwide distributor of weight-loss products.
Young's educational campaign against health fraud, which included a national conference in Washington last September and a series of regional conferences this year, is partly designed to raise the consciousness of local law enforcement officials and encourage them to take a bigger role in regulating quackery. But he said cutbacks in FDA travel allowances as a result of the Gramm-Rudman-Hollings deficit-reduction law will prevent Washington officials from attending the regional conferences this year. Budget cuts also have forced the agency to cancel planned broadcast and print ads.
More state and local action is required against health fraud because the problem is too big for the FDA, said William Jarvis, chairman of the National Council Against Health Fraud. "You've got a line of quacks 3,000 deep, and taking them one at a time, some of them are going to die of old age before the FDA gets to their cases," he said.