When a test was developed three years ago to detect the
potentially deadly virus hepatitis C, researchers at the Food and
Drug Administration (FDA) made a disturbing discovery.
They found the genetic fingerprint of the virus in batches of a
blood-plasma product that has been used for decades to inoculate
U.S. soldiers and other Americans against hepatitis A and B before
they travel to Third World nations.
Officials at the FDA and the Centers for Disease Control and
Prevention (CDC) say that despite the finding, there is no need to
worry about the safety of those inoculations. Even if the virus got
into the inoculants, the officials contend, its genes were damaged
during the manufacturing process or otherwise neutralized.
Some scientists aren't so sure.
And FDA and CDC officials acknowledge that there has been no
definitive research on whether the inoculants could have
transmitted hepatitis C, a disease estimated to have infected 3.9
A number of public-health experts say more studies are needed to
prove that the inoculations were safe and didn't put soldiers and
travelers at risk of contracting the slow-moving, blood-borne virus
that is a leading cause of liver disease.
In a recent report, the General Accounting Office quoted an
anonymous FDA official as saying that although there are no known
instances in which the shots have transmitted the disease, "this is
a very scary situation."
Last year, after the FDA ordered that immune globulin inoculants
undergo testing for hepatitis C as a "fail-safe measure," all
private manufacturers pulled their products from the market. Some
of these companies, including Pennsylvania-based Centeon, which was
the military's principal supplier, said they soon will seek FDA
approval to add steps to their production processes that inactivate
the virus. The pharmaceutical industry also recently developed a
vaccine for hepatitis A that eliminates much of the need for the
But Sen. Richard Shelby, R-Ala., has asked the Pentagon to look
further into the possibility that the inoculants may have spread
In a letter to the Defense Department in May, Shelby said that
since the inoculants weren't virally inactivated, "it is possible
that military personnel sent to Somalia, Panama, Haiti, the Persian
Gulf and other theaters were exposed to hepatitis C through the . .
In a 1993 Army study, blood tests were taken on 513 soldiers
before and six months after they were inoculated with immune
globulin and deployed in Somalia. The study found that none was
infected by the shots, said coauthor James Writer, an
epidemiologist at the Walter Reed Army Institute of Research. But
Writer and other experts said the study's methodology wouldn't pass
scientific muster, in part because it wasn't known whether the
soldiers received tainted inoculants.
After a different immune globulin product was found to have
transmitted the disease in 1994, the CDC tested about 100 civilian
travelers who had received immune globulin shots from lots known to
contain hepatitis C genes. None was infected, said Jay Epstein, the
FDA's director of blood research and review, who vouches for the
Dr. John Penner, a Michigan State University hematologist who
sits on the FDA's Advisory Committee on Blood Safety and
Availability, said he cannot recall "any really good studies" on
whether immune globulin shots can transmit hepatitis C.
"It probably needs to be looked at . . . more carefully," he
said. However, if low amounts of the virus in the products infected
a small percentage of people, "we might have a hard time uncovering
it," he said.
Former Surgeon General C. Everett Koop said more research is
needed on all possible transmission routes for hepatitis C -
including immune globulin inoculations.
The inoculants have been considered a possible suspect in part
because most scientists view the virus' spread as somewhat of a
mystery. As many as 44 percent of its victims typically report no
risk factors - such as having had a blood transfusion, having
shared intravenous needles or having held a health-care job.
Also, until recently, it has been easy to contaminate immune
globulins. It takes 10,000 to 25,000 blood donations to produce one
dose, which can be tainted by a single infected donor. After tests
to detect hepatitis C were developed in 1990, manufacturers began
screening donors for the virus.
Federal health officials and spokesmen for makers of immune
globulin inoculants say that, despite these factors, the products
always have been safe because the manufacturing process kills the
"Intramuscular immune globulin is safe and has never transmitted
hepatitis C or any other infectious disease as licensed in the
United States," said Miriam Alter, the CDC's chief hepatitis
She said that although many victims reported having no risk
factors, follow-up interviews with a sample group established that
all but 1 percent of them had "high-risk drug and sexual
behaviors." Alter said her agency had "miscommunicated" by failing
to publicize that follow-up data, thus leaving the impression that
the disease spreads in unknown ways.
Other scientists, even federal officials who say that immune
globulins are safe, are skeptical of such sweeping conclusions.
Edward Tabor, director of the FDA's Division of
Transfusion-Transmitted Diseases, said he is "a little bothered" by
the deduction that anyone who has the virus and has used drugs got
it from an infected needle. In many cases, he said, "you're talking
about somebody who experimented with drugs once."
Centeon spokesman Jimmy Hendricks said that since 1992, 11
people have contended that the company's globulin gave them
hepatitis C and that FDA and company inquiries exonerated the
product in each case.
If immune globulin inoculants carried the hepatitis C virus in
the past, the military would be a good place to look for victims.
The Pentagon ordered 481,000 doses of the inoculants from 1992 to
1996; the number of those doses actually administered was
Capt. David Trump, an official of the Defense Department's
Office of Health Affairs, said that troops aren't routinely tested
for hepatitis C and that no statistics on the number of infected
soldiers exist. But, he said: "We really don't have any evidence
that the military population in general is different from the
civilian population when it comes to hepatitis C infection."
Army epidemiologist Writer said a 1992 study of random blood
samples from 15,124 active duty personnel found that 1.3 percent
tested positive for hepatitis C - below the national infection rate
of 1.5 percent. Rider didn't know how many of those tested had
received globulin shots.
Shelby, a member of the Senate defense appropriations
subcommittee, has inserted language in this year's appropriations
bill calling for the Defense Department to study the rate of
hepatitis C among personnel who received globulin inoculations.
At a warehouse in Rockville, Md., the department has stored
millions of frozen blood samples taken during physical examinations
of Army, Navy and Marine Corps personnel since the mid-1980s to
test troops for AIDS. Air Force blood samples were added
Former Surgeon General Koop said the military should begin
screening troops for hepatitis C. "You've got a demon on your
hands," he said. "You'd better find out where that's coming from if
Star Tribune intern Andrew Atkins contributed to this
report.; Copyright 1997 Star Tribune.; Greg Gordon; Staff Writer,
Did shots cause hepatitis C? Officials downplay concerns., Star
Tribune, 07-28-1997, pp 01A.
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