AEGiS-GMHC: SPV-30 Promos Nixed by FDA

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

SPV-30 Promos Nixed by FDA

Treatment Issues, Vol 11, No 4/5; April 1997
Dave Gilden

It's banned -- no, it's just warned -- wait a minute, the crisis is over. This spring was a controversial one for SPV-30, an extract of the European boxwood tree made by the French company Arkopharma. SPV-30, which reputedly has anti-HIV properties, is sold here by some AIDS buyers clubs and a few pharmacies. For a time it also was available in America through a large "informal" trial protocol.

On March 5, the FDA's New York office sent a warning letter to The Health Connection, SPV-30's Long Island-based U.S. distributor. The letter stated that because of specific disease claims made in the product's labeling (which the FDA defines to include advertising and promotional literature), SPV-30 is now considered a drug rather than a dietary supplement. It cannot be distributed without an FDA-approved New Drug Application, the letter said.

On the advice of its lawyer, The Health Connection then suspended all sales of SPV-30 until the matter was cleared up. This decision triggered assertions that "the U.S. Food and Drug Administration has shut down the distribution of SPV-30," as stated in a nationally circulated letter from two AIDS buyers clubs (the Boston Buyer's Club and Direct AIDS Alternative Information Resources in New York). Although the media were quick to repeat this statement, FDA spokesperson Richard Kline observed, "The labeling is the problem. It talks about CD4 cells and viral load. All the company has to do is to change the labeling and make it a dietary supplement . . . The FDA did not block sales, though everybody said it did."

Ben Cohen, head of The Health Connection, says that his offer to revise his company's literature was initially rebuffed by the FDA. In any event, an April 21 meeting between Ben Cohen, buyers club representatives and FDA officials, resulted in the FDA promising not to further hinder distribution of SPV-30 if The Health Connection refrains from making specific medical claims.

"It was clear from the beginning that they [the FDA representatives] were scolding the New York office for being so quick to react, without consulting the community. They apologized," said David Stokes, director of the Boston Buyer's Club, which with other buyers clubs can continue to distribute literature about SPV-30 with little restriction.

Still, it is in the public interest not to overplay the available data. Last year's increasingly bold SPV-30 ads made poorly supported claims. David Stokes, who organized the "informal" trial in which people received free SPV-30 in exchange for their lab test results, likewise has made many public presentations lauding the "encouraging" data. Yet his study recorded no appreciable changes in the 400 participants' blood work. CD4 counts dropped slightly on average over six months, and HIV levels were virtually unchanged among the 84 people who sent in viral load data.

Release of the results from a blinded, controlled French trial is expected this summer. This 18-month trial enrolled 145 people with CD4 counts between 250 and 500. If objectively and disinterestedly analyzed, its data will provide a more definitive word on SPV-30's activity.

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Copyright © 1997 - Treatment Issues. Reproduced with permission. Treatment Issues is published twelve times yearly by GMHC, Inc. All rights reserved. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. GMHC Treatment Issues, The Tisch Building, 119 West 24th Street, New York, NY 10011 fredg@gmhc.org http://www.gmhc.org

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