Mother-Infant Trial Suspended Due to Liability Issue; Year's Delay Expected

By Nancy Solomon

Abbott Laboratories is refusing to provide HIV Hyperimmune
Globulin (HIVIG), a blood product containing antibodies to
HIV, for a clinical trial to stop pregnant women from passing
HIV to their babies, according to the medical officer for the
study.

The decision by Abbott is expected to delay the AIDS Clinical
Trials Group (ACTG) 185 for another year; it had already been
delayed since April due to contract negotiations with the
pharmaceutical company.

Abbott spokeswoman Cathy Babington said the company would
still like to provide HIVIG for the trial, but only if the
National Institutes for Health agree to waive any product
liability. She said negotiations are continuing.

"It's a business decision of Abbott Labs," Babington said.
"We had sought assurances that the NIH would waive product
liability."

The delay has angered activists. "They"re a profiteering
company and they don"t want it to affect the bottom line,"
said Vince Maloney of ACT UP/Golden Gate. But Abbott's delay
could pose a public relations nightmare because the company
is the largest producer of infant formula in the United
States. "They"re selling formula for infants but they won"t
do anything to save infant lives," Maloney said.

The activists' anger appears to be supported by doctors
associated with the trial who want to see the therapy tested
as soon as possible. The trial would provide a combination of
AZT and HIVIG to pregnant women with HIV and then the
combination therapy would be given to the babies for six
months after birth.

"It's a sad statement that promising therapies will be held
up because of monetary concerns," said Lynn Mofenson, M. D.,
the medical director of ACTG 185. "Abbott is insisting the
NIH provide 100 percent indemnification but none of the other
companies have that."

The phase III trial is designed to enroll 400 HIV-positive
pregnant women at 12 ACTG sites around the country. All the
women would be given AZT while half receive HIVIG and the
other half receive Intravenous Immune Globulin (IVIG), a
blood product similar to HIVIG but without any HIV
antibodies.

HIVIG is produced by concentrating several liters of blood
plasma taken from asymptomatic people with HIV. The blood
donors are selected because they have shown a strong immune
response to HIV, meaning they are unusually healthy and have
a high amount of antibodies. When the concentrated plasma is
injected into patients it is expected to boost the immune
response against HIV. The plasma is screened for HIV so it is
safe and unable to infect healthy cells, according to the
research protocol.

[Note: As we went to press, ACT UP/Golden Gate announced a
demonstration against Abbott Laboratories, Wednesday, July 8,
at noon, at the Pacific Stock Exchange, 301 Pine Street (near
Sansome), in San Francisco. The demand is that people should
sell stock in Abbott. For more information, call Vince
Maloney, 415/922-5480.]