U.S.
Food and Drug Administration
FDA Consumer magazine
May-June 2002
Table
of Contents
By Michelle Meadows
They claimed their products could bolster the immune system and treat several serious diseases, including AIDS and cancer. But Allen J. Hoffman of Finksburg, Md., and a Virginia physician are now serving prison terms for fraudulently peddling an intravenous mixture containing aloe vera to treat autoimmune and other conditions.
Through businesses called T-Up Inc. of Baltimore and Astec Biologics of Hanover, Pa., Hoffman and Donald MacNay, M.D., an orthopedic surgeon in Manassas, Va., billed up to $18,000 for a two-week treatment of intravenous aloe vera. Some patients traveled from the United States to the Bahamas and Mexico to receive the injections. Hoffman, who called his products T-UP, also sold bottled combinations of aloe vera and other unapproved drugs to treat autoimmune diseases.
Aloe vera is a member of a large family of succulent plants called Liliaceae, found in Africa and elsewhere. Also called Aloe barbadensis, aloe vera contains a juice that contains barbaloin, a substance that prompts emptying of the bowels.
In December 2001 the U.S. District Court of Maryland in Baltimore sentenced Hoffman to about four years in prison and ordered him to pay $222,506 in restitution to people taken in by the scam. He was also ordered to stop marketing and selling aloe vera and to stop engaging in any activities related to treating patients.
By introducing an unapproved drug into interstate commerce with intent to defraud, Hoffman violated the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FD&C Act, it is illegal to market a drug for treatment of specific illnesses if it is not approved by the FDA.
From September 1996 through November 1997, Hoffman sold aloe vera treatments to people in several states with MacNay's help. In 2000, MacNay pleaded guilty to fraud and conspiracy charges and was sentenced to three years in prison. Another codefendant in the case, Odus Hennessee, who supplied the aloe vera through Cosmetic Specialty Labs in Lawton, Okla., was acquitted of all charges.
Hoffman used mass mailings, radio broadcasts, audiotapes, videotapes, telephone solicitation, and the Internet to promote aloe vera as a treatment for several diseases. Promotional materials included an audiotape titled "There is Hope: You Do Not Have to Die!" and a brochure titled "Boost Your Immune System."
FDA special agents say Hoffman lied and told consumers that his T-UP products were drugs approved by the FDA, even though no new drug application was ever submitted to the FDA for review and approval. Approval by the agency would have required a sponsor to collect and submit extensive scientific data, including data from clinical studies regarding the products' safety and effectiveness.
Hoffman assured customers that the bogus aloe vera treatments wouldn't have side effects. He failed to tell them that cesium chloride, which he used in aloe vera mixtures, can cause an irregular heartbeat and deplete the body's potassium levels. The infusion of aloe vera can cause swelling and diarrhea.
More than 3,000 people purchased products from Hoffman. It's difficult for the FDA's special agents to quantify the extent of the harm caused by Hoffman and MacNay. But it is clear that some people were misled and defrauded into trying dangerous, unapproved and ineffective alternative treatments, while possibly forgoing approved medical options. "We know there are risks with these treatments and that they could have caused some patients' symptoms to worsen," says Kim Rice, assistant special agent in charge in the FDA's Office of Criminal Investigations (OCI) in the Washington, D.C., area. "There is no question that Hoffman took advantage of people by giving them false hope."
Hoffman also misled consumers about his educational background and medical qualifications. He called himself "doctor," and falsely claimed to have earned a Ph.D. in biology. Hoffman admitted during trial testimony that he paid $500 for a phony Ph.D. from Heidelberg University in Germany. He stated that he was contacted by someone at the university who said he qualified for a Ph.D., and that the $500 was a processing fee.
The only legitimate documentation Hoffman produced was a transcript from a community college in Baltimore showing enough credits for an associate's degree, though there was no proof that the degree was ever awarded.
Hoffman also made false and misleading statements about his medical background to FDA special agents and other law enforcement officers, misrepresenting the way he promoted, sold, and distributed aloe vera. He claimed to have sold his products only as a nutritional supplement, not as a cure for disease.
Law enforcement officials learned about Hoffman's and MacNay's activities in 1997 after family members reported that a Texas man died following an alternative medicine procedure carried out by MacNay. The Virginia state police searched MacNay's clinic, and notified the FDA's OCI about the matter. OCI worked on the case with the FDA's Baltimore district office, the Internal Revenue Service, the United States Postal Inspection Service, and the Maryland State Attorney General's Office of Consumer Protection.
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