Heart supplement targets black audience
A dietary supplement recommended as an alternative treatment for cardiovascular disease is being marketed to an African American audience via a full-page ad in the Dec. 12 issue of Jet magazine.
In the ad, Perfusia-SR, made by Thorne Research Inc., is billed as a “natural, nonprescription, inexpensive” treatment “without the side effects of drugs.”
The ad in Jet, a magazine targeted to a black audience, stops short of comparing Perfusia to BiDil, a drug approved earlier this year by the Food and Drug Administration for the treatment of heart failure in African Americans. But an article published in the Electronic Urban Report -- an urban/black entertainment newsletter distributed via e-mail and on the Web -- lauds the supplement as an alternative to the heart failure drug.
The comparison between the drug and the supplement concerns some cardiologists, who say there is no evidence that Perfusia is an effective alternative to such potentially life-saving medications as BiDil and other treatments.
Perfusia is a time-release version of L-arginine, a protein amino acid present in all life forms, according to the Physician’s Desk Reference (PDR).
Test tube experiments have found that L-arginine has effects “that could be expected to inhibit cardiovascular disease,” according to the PDR. “Inferences have been drawn from these studies suggesting that L-arginine, through its nitric oxide activity,” inhibits a number of bodily activities that promote cardiovascular disease.
The supplement’s promotion has caught the attention of the FDA. Thorne Research received a letter from the agency in September 2004, stating that the company had promoted Perfusia and 12 other products “for conditions that cause these products to be drugs” under the Federal Food, Drug and Cosmetic Act.
“The therapeutic claims on your Web site establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of diseases,” the FDA letter said.
The letter advises Al Czap, president of Thorne Research, that it is the responsibility of the company to “ensure that all products marketed by your firm comply with the Act and its implementing regulations.”
Czap said his company, which makes the supplement, made changes to comply with FDA regulations. FDA spokeswoman Kimberly Rawlings said last week that the agency was “considering what action, if any, may be warranted” against Thorne Research “in terms of enforcement.”
Perfusia’s bottle label states it is “patent pending for use in numerous cardiovascular and blood flow indications,” but -- like many dietary supplements on the market -- adds the disclaimer, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Still, some cardiologists are skeptical. “To market this as an alternative to BiDil is, frankly speaking, ridiculous,” said Mandeep Mehra, head of cardiology at the University of Maryland School of Medicine.
