** And he hasn't even been sworn in yet!
During the campaign GW Bush said many times that he opposed the distribution of RU 486 in the US. When the FDA approved the "kill pill," GW said that his administration would look for new evidence to make the FDA revisit that decision. Now that he has secured enough pro-life votes to get into the White House he has withdrawn all plans to oppose RU 486.
Look for this to be just the first of many slaps at the conservatives that took to the polls and then to the streets to make him president. - TCN
** Pill Is Not Only Dangerous But Morally Reprehensible
** George W. Bush Says He Won't Take Action When He Becomes President
(Washington, DC) Today, Judicial Watch, the nonpartisan, public-interest law firm which fights government abuse and corruption, declared "war" against the RU-486 abortion pill by filing suit against the Food and Drug Administration (FDA). When Judicial Watch filed a Freedom of Information Act request seeking all documents concerning the FDA's grant of a New Drug Application - on the basis of the pill being "safe and effective" - typically the Clinton-Gore Administration stonewalled and failed even to respond. The suit therefore proved necessary.
During the Presidential debates, President-elect George W. Bush was asked what he would do about the RU-486 pill. He claimed he would be powerless to act since he would not "control" the FDA.
"At last glance, the President sits atop the executive branch, and the FDA is an executive branch agency. Bush clearly will have the power to order a review of the 'safety and effectiveness' of the RU-486 pill, but has decided apparently to do nothing," stated Judicial Watch President Tom Fitton.
"George W. Bush won't take action, but we will," stated Judicial Watch Chairman and General Counsel Larry Klayman.
"In the last few days, Bush's spokespersons have said he would 'govern from the middle.' Judicial Watch will, however, continue to represent conservative interests, and the RU-486 abortion pill is one of our highest priorities, in addition to bringing the Clinton-Gore Administration to justice, among other matters," added Judicial Watch President Tom Fitton.
"The Constitution stipulates that "No person shall...be deprived of life...without due process of law". Every one of us is a living, human person, endowed by Almighty God with an immortal soul, from the moment of fertilization until death. That is why we vigorously oppose euthanasia as well as abortion. We will end government-approved abortion and stop subsidies to organizations which promote abortion. We will do this because it is required by the laws of God and the Constitution of the United States." - Howard Phillips, Constitution Party
Washington, DC -- A prominent former abortionist warns that RU-486, the abortion drug recently approved by the federal government, has potentially harmful side effects for women who use it.
In 1969, Dr. Bernard Nathanson was co-founder of National Association for the Repeal of Abortion Laws, later renamed National Abortion Rights Action League. He was also the director of what was then the largest abortion facility in the world New York Citys Center for Reproductive and Sexual Health.
Presiding over 60,000 abortions during his career and helping to make abortion legal in the United States, Nathanson later renounced his profession and became a pro-life advocate, a conversion that made headlines.
During a recent interview, Nathanson revealed dangers that the FDA doesnt want to reveal to the American public about RU-486 and its companion drug, misoprostol, or cytotec. He commented that the approval of RU-486, or mifepristone, had less to do with public health and more to do with the politics of the Food and Drug Administration.
According to Nathanson, one potentially harmful side effect of RU-486 is the possibility that disorders could be passed down to surviving offspring of women who have taken the drug.
"RU-486 is the drug which acts on the female reproductive system, and anything that does that we have to be keenly aware of what are called transgenerational effects," said Nathanson.
One such drug acting on the female reproductive system was given to women during the 1940s and 1950s to stop excessive bleeding and to prevent miscarriages. Although the drug proved to be ineffective, it had an unintended side effect. Many female children of the women who had taken the drug suffered from a transgenerational effect and developed vaginal cancer, which led to numerous mutilating operations and death.
Another concern Nathanson has regarding RU-486 is that a woman who starts taking the pill may decide to carry the baby to term. The result, Nathanson said, can be serious skull deformities for the newborn.
Although RU-486s harmful side effects may apply only to the children of women who have taken the drug, its companion drug, cytotec, may have health-altering consequences for the women, too, the doctor warns.
"RU-486 in itself is not potentially dangerous to women, but [cytotec] is, and you have to give them together," Nathanson said. Nathanson explained that the drug has a potential to cause asthma, or exacerbations of asthma, and "things of that sort."
The drug also can cause excessive bleeding, Nathanson said, because at the early stages of a pregnancy, the drug cytotec, which expels the dead baby from the womb, often isnt completely successful on its own. The pregnancy tends to detach itself partially but not enough to be expelled, causing the bleeding.
"Many of these women bleed for hours at home, having terrible cramps, and end up in emergency rooms," Nathanson said.
Besides physical harm, Nathanson said, there are other potential problems that could spring up because of the dangerous abortion drug. One problem would be that already overcrowded emergency rooms would be even more overcrowded with young women who are experiencing excessive bleeding.
But even if the woman completes the abortion at home, she must still show the remains of her unborn child to the abortion practitioner.
"Many states have laws which require that the physician examine the fetal remains whatever is passed," Nathanson said. "Now the question is how is a young girl of 17 going to go plowing through a toilet bowl full of blood clots and other nasty things to try to find this tiny little fetus and bring it to the doctor?
Perhaps an even more complex problem, which could involve international drug enforcement agencies, could be that the drug will find its place in the dark world of organized crime. "Theres no doubt a black market will spring up with these pills in respect to smuggling into Central and South America, or places where they dont approve of abortion," Nathanson said.
A woman wanting to have an abortion using the pill would now have to pay a hefty fee $600 for the three pills of RU-486 and two pills of cytotec. Nathanson calls this price-gouging but believes the price will eventually come down and be easily affordable.
Right now, Nathanson explained, a woman could walk into an abortion facility and pay just $150. However, even if an abortion practitioner sells a set of the pills at the exorbitant rate Nathanson said pharmacists would probably not sell the pill; abortion facilities will sell them directly he believes this poses a conflict of interest.
Once the price of the pills comes down, Nathanson said, the pills would in all probability show up in the clinics of the nations public schools.
"Theyll pass this out [in school] too, and many kids, probably, will be using this for contraception and adults too," said Nathanson. "Theyll be taking it every month at the end of the month just to be sure."
Although Nathanson made it clear during the interview he was speaking more as an ob-gyn and less as a pro-life advocate and bioethicist, he concluded his discussion over the pill by saying, "It really trivializes life, so there are ethical and moral issues."
[ NewsMax ]
By Charmaine Crouse Yoest
How many times will women be used as guinea pigs? We should have learned some lessons from the Dalkon Shield. DES and maybe even breast implants. But last week, the president announced that RU-486. the French abortion drug, well be coming to America. Thanks to back-door negotiations between the Clinton administration and Roussel-Uclaf, the patent-holder of RU-486, the patent will be donated to the Population Council, a liberal abortion-advocacy group.
Abortion advocates keep telling American women that this drug is `safe and effective'--and both foes and supporters of abortion argue that the abortion procedure is `easy.' Yet all these claims are open to serious question.
Just how safe is the RU-486 abortion? It has killed at least one woman in France. In that case, the young woman was dead within an hour after receiving the prostaglandin injection that is the final stage of the four-step RU-486 regime. Abortion advocates keep claiming that RU-486 itself didn't kill her: it was the prostaglandin in the fourth step. That may be true, but it's not particularly relevant. RU-486 abortions without prostaglandin just don't happen.
As a result of that death, smokers and women over age 34 may not take RU-486 in France. Additionally, women are advised not to take the drug if they have any of the following very common conditions: high blood pressure, anemia, gynecologic infections and fibroids.
However, we don't really know just how dangerous RU-486 is. In one of the major studies of women using the drug, published in the New England Journal of Medicine, 75 of the 2.115 women in the study were not followed after receiving the final injection. Did any of them suffer severe, or fatal, complications? We simply don't know.
The record does show that RU-486 has also been responsible for two nonfatal heart attacks. And according to Roussel's own data, out of 950 women studied, 270 required narcotics for intense pain. Seven required blood transfusions.
Janice Raymond, associate director of the MIT-based Institute on Women and Technology--and a bona-fide abortion supporter--is opposing the drug after a thorough review of the scientific literature on RU-486.
So, at best, the jury is still out on `safe.' Is the RU-486 regime `effective'? To a degree. But in the one out of 20 times that the unborn child is not killed, its deformities are so severe that Roussel-Uclaf, fearing litigation, requires women to sign an agreement to a surgical abortion. What if a woman changes her mind after taking the first dose of RU-486? Will she be forced, Chinese-style, into a surgical abortion?
The RU-486/prostaglandin regime effectively completes an abortion through inducing the contractions and hemorrhage that expel the unborn child. Supporters of the drug rhapsodize about the increased `privacy' of `taking the pill at home.' But they are glossing over the reality that women are administered the drug in a clinic and then sent home to wait as the bleeding begins. The president of Roussel-Uclaf, Edouard Sakiz, says it is `an appalling psychological ordeal.' In Europe there are support groups for women who have endured the procedure.
This raises the issue of informed consent. Having advocates like the Population Council bring this drug into the country presents a clear conflict of interest. When a woman comes to participate in the field trials, having heard in the media that RU-486 is easy, will she be told about the side effects and that MIT's Ms. Raymond has questiond the impact of RU-486 on her health? Will she know what she is getting into before it is too late?
It is very troubling that the groups that will be administering an experimental abortion drug with serious potential side effects are the same ones that have demonstrated their opposition to a woman's right to know all the information about surgical abortion. Pro-abortion groups have fought informed consent laws all the way to the Supreme Court.
And what about parental consent? Will 14-year-old girls be given RU-486 and sent home to hemorrhage without their parents' knowing anything about it? All too often, parents are not informed of their daughters' surgical abortions.
Surgical abortion is legal and accessible in the U.S. And, contrary to the hyperbolic pro-abortion rhetoric, RU-486--with its mandatory four doctor visits--is not easier and more private than surgical abortion. It's odd that the same people who say that a 24-hour wait to see a doctor for a surgical abortion is absolutely unacceptable would be promoting chemical abortion, which in its current state is a much more drawn out procedure. Shouldn't we be asking why this questionable drug is so important to them? And to the president?
Quick. Name something the president has done to address breast cancer, a disease that attacks one out of nine women. Name just one other drug for which the president has personally lobbied. What's going on here? Is it women's rights and women's health the president is concerned about--or just abortion at any cost?
[ Wall Street Journal ]
Washington, DC -- The Chinese company producing the dangerous abortion pill RU-486 for the U.S. market has been cited by federal regulators for bringing mislabeled and impure drugs into the United States, according to congressional investigators.
This and other information, turned up by the House Commerce Committee staff, suggest that the long battle over bringing RU-486 to American women may not have ended last month when the Food and Drug Administration approved the abortion drug for distribution. Critics of the abortion pill quickly cited the new information as evidence that the FDA did not conduct an adequate review and that Congress should force the agency to reconsider.
The maker of the drug defended the Chinese company that manufactures it. "As part of the approval process, the FDA had to review the manufacturing process and the manufacturer met the specifications of the FDA," said Heather O'Neill, a spokeswoman for Danco Laboratories, the New York firm marketing the drug in the United States.
Danco conducted a worldwide search for a manufacturer after large pharmaceutical companies said that they did not want to produce the drug, fearing lawsuits and boycotts from pro-life groups. After a deal with a Hungarian plant fell through, Danco signed a contract with the state-owned Shanghai Hua Lian Pharmaceutical Co. Ltd., according to people familiar with events.
According to FDA records cited by the House investigators, a drug produced by Hua Lian was detained earlier this year by agency officials in Cincinnati because of false or misleading labeling. That drug, betamethasone sodium phosphate, is sometimes used in skin creams and asthma drugs.
Samples of another product, an herbal remedy called composite tegafuri capsules, were found to be tainted in a 1998 study by the California Department of Health Services. That study found high contamination in hundreds of similar products made at the same plant.
The tegafuri was made by the Shanghai No. 12 Pharmacy Factory, which is cited as the previous name for the Hua Lian factory on the company's Web site. The product was found to be contaminated with fluorouracil, which in some forms is a chemotherapy drug.
Pro-life Rep. Thomas J. Bliley (R-VA), chairman of the House Commerce Committee, wrote to the FDA on Wednesday asking whether the agency knew that the Chinese plant had previously run afoul of U.S. regulators and whether that information was considered during the approval process for the abortion pill.
In his letter, Bliley also cited the report of an FDA official who inspected the Shanghai plant in October 1999 in connection with the agency's review of the pill. In that report, the FDA inspector said that the plant copied data from another application in filling out required paperwork, rather than using data from its own laboratory tests.
The plant passed a later FDA inspection in July. But in his letter to the FDA, Bliley asked whether the "discrepancies" during the first inspection suggested a wider "data integrity problem" at the plant.
The information turned up by Bliley's inspectors could become crucial for pro-life lawmakers who want to create hurdles for the abortion pill in Congress. Moreover, Texas Gov. George W. Bush, the Republican presidential nominee, has said that he opposes distribution of the abortion pill and, as president, might look for any new evidence that the FDA should revisit its decision on use of the drug. Vice President Al Gore, the Democratic nominee, supports distribution of the danerous abortion drug.
Douglas Johnson, legislative director of National Right to Life, called it "appalling" that the FDA approved production of the drug "by a Chinese plant that has been cited for producing both contaminated and mislabeled drugs . . . and that falsified FDA documents."
"We conclude that the Clinton-Gore administration is willing to place American women in jeopardy in order to win short-term political points from pro-abortion special interest groups," Johnson said.
[Los Angeles Times ]
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