United States pro-life representatives are crying foul after the drug they are calling “the human pesticide” moved to within a step of official approval south of the border.
The U.S Food and Drug Administration’s advisory committee on reproductive health drugs by a 6-0 vote (with two abstentions) decided July 19 that the benefits of the French-developed RU486 abortion pill, in combination with misoprostol, outweigh the risks and recommended that it be marketed.
All that remains now is for the full FDA commission to give its OK, which would happen as early as September or October, before RU 486 is available next year.
“Unfortunately, the committee, which was stacked with abortion supporters, brushed aside serious health concerns for women who take this drug,” observed Wanda Franz, a developmental psychologist and president of the National Right to Life Committee, the largest educational pro-life group in the U.S.
“The FDA approval process is moving at an unheard of pace to approve this deadly drug combination, leaving many concerns about safety unresolved,” she added.
“The drug is on a fast track,” said Olivia Gans, director of American Victims of Abortion. “The FDA is controlled by and large, by appointees of the Clinton administration, whose stated goal from the beginning was to get RU486 into the U.S. and into widespread usage before the next election.”
‘We feel (RU486) is going to be a very significant risk to women and their pre-born children, should they decide not to abort them,” said Bogomir Kuhar, executive director of Pharmacists for Life International. “Many studies have shown the (drug’s) deleterious effects.”
The advisory committee heard presentations from RU486 advocates of clinical data from two French trials involving 2,480 women and “preliminary” data from U.S. trials with 2,100 women. The French dada claimed RU486-misprostol has a 95 per cent success rate.
But the committee also heard about women who experienced painful contractions, nausea, vomiting, diarreah, pelvic pain and spasms and headaches. Other women were said to have completed their pregnancies and delivered deformed babies, while some found the procedure failed to produce and abortion.
The committee concluded that “a very small percentage” of the patients in the clinical trials required hospitalization, surgical treatment or blood transfusions.
Kuhar noted that RU486 by itself has a failure rate of 60 to 80 per cent and suggested the clinical trials may have painted a misleadingly rosy picture because the women used were only “ideal” subjects in top-notch health. “In real life, we’re going to see a much higher rate of side effects and failure,” he predicted.
Gans pointed out that drugs with life-or-death potential are normally studied for a minimum of 17 months before they are approved for use. The RU486-misoprostol combination, however, was studied for only eight months. “The trails themselves are not complete and yet they’re going ahead,” she said. “If that doesn’t smack of politics, I don’t know what does.”
“There’s no doubt that the side effects and potentially deadly effects of the drug are being underplayed by the Population Council (which holds the U.S. patent rights to RU486) and members of the FDA,” Gans added. “The press have in only small numbers made an effort to investigate the long-term complications.”
“The only issue here is the expansion of the number of individuals willing and able to do abortions,” she said. “The Population Council acknowledges there are a limited number of doctors now willing to do surgical abortions in the U.S. and the number shrinks every year.”
The July 27 edition of The Economist magazine acknowledged that surgical abortions are unavailable in 80 per cent of American states because doctors are unwilling to perform them and the procedure is becoming increasingly inaccessible thanks to mandatory waiting periods in many states.
The Vatican newspaper L’Osservatore Romano condemned RU486 as “the pill of Cain, the monster that cynically kills one’s brother.”
The advisory committee hea4rd from a self-professed pro-choice Iowa emergency room physician who testified that a participant in the RU486 trial who he treated lost more than half her blood and nearly died.
“I am concerned that all the true implications of RU 486 are not being reported to both the media and to the FDA,” said Dr. Mark Louviere.
Gans said it is unlikely the fast-tracking approval of RU486 can be derailed at this point, but with other U.S. pro-life representatives she vowed to continue this battle.
“at this stage of the game, the reality is our focus has to be on a massive educational campaign,” said Gans. “This is an incredibly dangerous situation based solely on the president’s radical pro-abortion agenda.”
“The expose of the for-profit activities of the Rockefeller-funded Population council will continue unabated and shall in fact, accelerate,” pledged Pharmacists for Life International president Lloyd DuPlantis Jr.
“The education of the profession and the public shall only increase as the new abortionists, the drug companies, continue on their erroneous course of developing and marketing chemicals intended to kill innocent, pre-born children”
RU486 was developed by French pharmaceutical company Rousell Uclaf, which in 1994 signed over U.S. rights to the Population Council, a New York-based organization dedicated to a slowing population growth.
During the first seven to nine weeks of pregnancy, the drug causes the uterine lining to break down and slough off. Misoprostol, which stimulates uterine contractions, is the administrated two days later.
Following the death of a woman who used the RU486-misoprostol combination, France’s health department used a series of restrictions on its use in 1990. The requirements stated that RU486 could not be given to diabetics, smokers, women with circulatory problems, high blood pressure, fibroids, anemia or gynaecological infections. Women 35 and over were also not permitted to use it.
RU486 has not been approved for use in Canada; however, moves are afoot to have it brought here.
B.C.’s provincial health minister, for example wrote a letter to the federal health minister recently urging its introduction.
The NDP government of B.C. offered to sponsor testing of RU486 in Canada, causing strong opposition from pro-life groups across the country. These groups are particularly distressed by moves to allow greater access to the drug. Some have described these chemicals as “genocide” against the innocent unborn.