Shanghai Hualian – a division of Shanghai Pharmaceutical Group and
the sole U. S. supplier of the abortion drug mifepristone is accused of
having manufactured contaminated leukemia drugs that have paralyzed or
otherwise harmed nearly 200 Chinese cancer patients, the New York Times
notes.
The case was presented last week in The Times in an article by Jake Hooker
and Walt Bogdanich. Contaminated leukemia drug methotrexate caused leg pain
and sometimes paralysis when injected into the spinal area. Cytarabin
hydrochloride, anothercancer drug manufactured in the same factory, also
began to show side affect.
In September 2007, the Chinese health and drug officials initiated an
investigation and found that both drugs had been contaminated during
production with vincristine sulfate, another cancer drug, which had been
stored in a refrigerator that also stored materials for use in creating
other drugs. The factory was closed and two company officials were detained,
including the head of the factory.
Danco Laboratories sell the abortion drug mifeprestone, also known as
RU-486, to women in the U. S. under the brand name Mifeprex. That pill is
made at a different factory that passed an F.D.A. inspection in May 2007 and
was inspected three times in recent months by Chinese drug regulators.
Zhou Qun, director of the Chinese FDA's drug safety control unit, said the
agency has inspected the factory that produces mifepristone three times in
recent months and found it in compliance. "It is natural to worry," Zhou
said, adding that "these two plants are in two different places and have
different quality-assurance people."
The U.S. FDA released a statement saying the agency “is not aware of any
evidence to suggest the issue that occurred at the
leukemia drug facility is linked in any way with the facility that
manufactures the mifepristone.”
On the other hand, Dr. Patrick Johnston, founder of the Association of
Pro-life Physicians, told Family News in Focus that
“RU-486, even if it is a clean drug, has significant side effects, and some
of them have been lethal, with hemorrhaging, incomplete abortion, et
cetera."
According to CitizenLink, RU-486 was fast-tracked through the Food and Drug
Administration in 2000, and since then, at least six American women and
thirteen women worldwide have died from complications related to the drug.