In 2005 the bird or avian flu was no joke. Charles Hensley, however, has been arrested for pushing medications in 2005 and marketing the illegal drug Vira 38, not approved by the FDA or in Hong Kong for that matter, which was supposedly able to prevent symptoms of the deadly outbreak that gripped the globe. Hensley has pleaded not guilty. His trial is set to begin in late July, and could face up to 20 years in prison.
Millions of birds had been culled to prevent the spread of the disease, but by the middle of 2005, some 50 people had died from bird flu. Given fears that the virus would mutate to a more contagious form, experts continued to warn of the potential for a full-blown pandemic, much like the 1918 flu epidemic. It seems this is when Hensley saw an opportunity.
In November 2005, the U.S. Food and Drug Administration (FDA) issued warning letters recently to nine companies marketing bogus flu products behind claims that their products could be effective against preventing the avian flu or other forms of influenza. FDA was, and still is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu and the agency was concerned that the use of these products could harm consumers or interfere with conventional treatments.
Andrew von Eschenbach, MD explained in 2005:
“There are initiatives in place to deter counterfeiters and those who sell fraudulent or phony products to prevent or treat avian flu. The use of unproven flu cures and treatments increases the risk of catching and spreading the flu rather than lessening it because people assume they are protected and safe and they aren’t. I consider it a public health hazard when people are lured into using bogus treatments based on deceptive or fraudulent medical claims.”
Eight of the products purported to be dietary supplements. Examples of the unproven claims cited in the Warning Letters include: “prevents avian flu,” “a natural virus shield,” “kills the virus,” and “treats the avian flu.” These alternative therapies are promoted as “natural” or “safer” treatments that can be used in place of an approved treatment or preventative medical product.
In the Warning Letters, FDA advised the firms that it considers their products to be drugs because they claim to treat or prevent disease. The Warning Letters further stated that FDA considers these products to be “new drugs” that require FDA approval before marketing. The letters also noted that the claims regarding avian flu are false and misleading because there are no scientific basis for concluding that the products are effective to treat or prevent avian flu.
Charles B. Hensley was arrested on charges that he sold the drug Vira 38 as a “prevention and treatment” of influenza and bird flu without Food and Drug Administration approval, said Assistant U.S. Atty. Pio Kim.
Kim adds:
“His problem was claiming that this treats disease. You can’t just decide to take it upon yourself to say this treats a serious disease, particularly something like bird flu.”
Kim further explained that the indictment alleges that Hensley shipped 26 bottles of the drug from Hong Kong to customers in the United States. Vira 38 was marketed on the website for Hensley’s company, PRB Pharmaceuticals, which was based in Cypress.
Hensley had initially attempted to sell the drug in Hong Kong, Kim said. When authorities there would not approve it, Hensley started marketing it on the Internet.
Another Hensley venture, Zicam, had issues of its own about a decade ago. The FDA ordered Zicam’s manufacturer, Matrixx Initiatives of Scottsdale, Ariz., to stop selling the product because it damages users’ sense of smell. Matrixx still sells lozenges, syrups and sprays under the Zicam name.
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Written by Sy Kraft