The Race to Market

Heart Supplement Targets Blacks, Echoing Race-Based Drug

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 (FDA) 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 text of the article was pulled nearly verbatim from a press release submitted by a representative of Thorne Research, according to Lee Bailey, who runs Rabercom Enterprises, distributor of The Electronic Urban Report.

Headlined "Free Alternative Cardiovascular Medication for African Americans: Perfusia-SR is all-natural alternative to controversial 'Race-Based' BiDil," the article calls Perfusia an "inexpensive nutritional supplement [that] may provide an effective natural alternative to a controversial prescription medication that is now being specifically targeted to African Americans either at risk or suffering from cardiovascular disorders."

The supplement is "especially noteworthy given the recent controversy regarding the pharmaceutical drug BiDil earlier this summer," the article states. The approval of BiDil specifically for blacks was controversial in the medical community because it is the first so-called race-based therapy.

That 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. Makers of prescription drugs must submit rigorous scientific studies to qualify for approval, a standard that dietary supplements like Perfusia are not required to meet.

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.

Still, some cardiologists are skeptical. "I think that the harm from this may not exist from the formulation [of the supplement], but the harm may exist from offering it as an alternative" to other cardiovascular treatments, said Mandeep Mehra, head of cardiology at the University of Maryland School of Medicine. "To market this as an alternative to BiDil is, frankly speaking, ridiculous."

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 Inc., 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."

At the time, Thorne's Web site named several conditions for which "inadequate nitric oxide production and the resultant endothelial dysfunction" appeared to be a problem, including heart disease, hypertension, erectile dysfunction, diabetes, peripheral vascular disease, Alzheimer's disease and vascular dementias, according to the FDA letter.

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 is "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."

The Jet ad offers free samples of Perfusia to the first 20,000 respondents. But it's the cost of a one-month supply of the supplement -- $32.95 plus shipping and handling -- that concerns some doctors. Generic versions of several commonly prescribed heart failure medications can be purchased together for up to, or less than, that amount, Mehra said -- including the two components of BiDil, an ACE inhibitor and other drugs.

Researchers believe BiDil, the drug approved for use in African Americans, works because it raises the level of nitric oxide in the body, said Mehra, who has no financial ties to the manufacturer of BiDil. "But that is a theory -- not proven," he said.

Perfusia, Czap said, when taken as three capsules twice a day, is also believed to help increase the production of nitric oxide in the body. Czap said studies show L-arginine is a "good alternative [for] improved endothelial function."

And despite the race-specific messages in Jet and The Electronic Urban Report, Perfusia is an effective alternative for anyone concerned about cardiovascular disease, Czap said, not just African Americans.

"Anyone can benefit from it. My personal opinion is virtually anyone over 40 should consider some sort of supplementation like this."

Some test tube L-arginine findings have been confirmed in animal and human studies, including a recent study in humans that found that the supplement, when given for six months, resulted in improved coronary small-vessel endothelial function. Other positive findings of L-arginine supplementation, according to the PDR, include improved sperm count and erectile response in men and improved healing after burn or wasting injuries.

Paul Underwood, president of the Association of Black Cardiologists (ABC) and the author of an article about cardiovascular disease that appears in Jet opposite the Perfusia ad, said The Electronic Urban Report article was "cleverly written." The ABC is an active supporter of BiDil and has received some funding from NitroMed, the maker of the drug.

"It's not that I disbelieve" what The Electronic Urban Report article says, Underwood said, "but to then mix that in with some of the development of a product like BiDil and where it sits in the marketplace and say that it [Perfusia] would be comparable, I think that it is a very large stretch."

While many patients take supplements to complement their medical treatment, he said, "we would prefer that the individuals be on medications that have been shown to prolong their lives."

Comments: paynej@washpost.com.