Beware Goat Serum
Agency warns patients, doctors after theft of experimental
September 15, 2003
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
"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
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.
Doctor Gary Davis was big on Hepatitis Therapy
years ago. If his Goat therapy works, he will
have to go farther than England to live because our
FDA does not like disease to be cured, just treated.
It is the modern medicine money machine and the FDA
is here to make sure it keeps running!