By Adam Marcus
HealthScout Reporter

WEDNESDAY, Dec. 27 (HealthScout)-- Drug regulators are warning patients and health-care providers to beware of an experimental AIDS treatment made from goat serum that was allegedly stolen from a North Carolina storage facility.
The U.S. Food and Drug Administration (FDA) says Dr. Gary Davis, the doctor who invented the therapy, notified the agency about the theft earlier this month. In a letter to the FDA, Davis said the goat drug has "the potential to be extremely dangerous" and warned that people may be trying to sell the product to patients.

"FDA urges that patients and health-care providers exercise caution and be aware that there is no assurance of the safety of products which are not studied or produced in compliance with FDA regulations designed to protect patients," the agency says.

In 1996, Davis, who was living in Tulsa, Okla. and now lives in England, applied to the FDA for permission to investigate the serum's powers, but the FDA has put a "clinical hold" on the treatment. That prevents it from being tested on people until more information on its safety is available.

The latest episode isn't the first time Davis has claimed his goat serum fell into the wrong hands. In 1998, a Maryland woman took her daughter to his Tulsa office. The doctor has said she lifted a vial of the drug from a freezer and administered it to her HIV-infected daughter. The girl miraculously recovered, and the case garnered national attention.

The concept of using goat serum to defeat a virus isn't entirely farfetched. Goats don't get HIV, but they can generate proteins, called antibodies, against the infection that might be used to help patients neutralize the organism.

Pauline Jolly, a virus specialist at the University of Alabama in Birmingham, tested Davis' goat serum on human cells in a lab dish in the mid-1990s, and says the drug was modestly effective.

"It had some effect at preventing the virus from infecting cells," Jolly says. "Human serum from infected people may have the same effect."

However, Jolly notes, her experiments say nothing about how well the treatment might work in patients.  "The bottom line is, this serum is just a serum that's not been purified. It would have to be tested a lot more before anyone could determine an effect in human beings."

What To Do

Dr. Pablo Tebas, who runs clinical AIDS trials at Washington University in St. Louis, says patients should be very wary of untested treatments: "I definitely would not inject myself with anything from animals that has not gone through a very severe quality control."

Although alternative therapies aren't necessarily dangerous -- indeed, many of the drugs now used against AIDS were at one time alternative -- they could cause serious harm. For example, the FDA recently warned that St. John's Wort, the popular herbal treatment, could weaken indinavir -- a drug that prevents HIV from replicating in the body.

To learn more about HIV and AIDS therapies, visit the HIV/AIDS Treatment Information Service or Project Inform.

You can also try The Body.

For more stories on AIDS treatments, visit HealthScout.

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