Archive for the ‘RU486’ Category
California Woman Dies After Taking RU-486
Eighteen-year-old Holly Marie Patterson died in September from complications that resulted after she took RU-486 to induce an abortion. Patterson obtained the drug from a Planned Parenthood clinic.
Patterson apparently followed the directions given to her by Planned Parenthood but died a week after taking the pill. Patterson’s father, Monty Patterson, told news organizations that an attending physician said that fragment of the fetus lodged in her uterus where they caused an infection that killed Holly.
According to the U.S. Food and Drug Administration, this was the third death linked to RU-486 since the drug’s approval two years ago. In about 5 percent of cases, bleeding following taking the drug is so severe that surgery is required.
Anti-abortion groups were quick to seize on Patterson’s death as proof that RU-486 is not safe, while pro-abortion groups noted that more people die from using aspirin every year than from RU-486.
Monty Patterson told the Associated Press that he did not blame RU-486 for his daughter’s death, but was not convinced that she and her boyfriend received enough information about the drug and its possible complications,
What’s disturbing is these young couples, they are relying upon what they think is good, solid info, and relying on what they think is a supportive network telling them everything is OK. I would have said, ‘You know what, they don’t know everything. Let’s get more information.
The most disturbing part of Holly Patterson’s death is that her boyfriend took her to a hospital three days after she took RU-486. Holly reported bleeding and cramps so severe she could not walk, but she was simply given painkillers and sent home.
Sources:
Teen Dies After Taking Abortion Pill. Associated Press, September 22, 2003.
Abortion Foes Are Winning
Being pro-abortion, I do not want to see the right of a woman to obtain an abortion disappear. It is clear, however, that this is what is slowly happening and the road map is clear — conservatives are finally embracing the paternalistic, Big Brother solutions of their liberal counterparts. A case in point is the nomination of Tommy Thompson to head Health and Human Services.
Thompson is anti-abortion and was asked what, if anything, he would do about RU-486, the so-called abortion pill. RU-486 suppresses a hormone required to continue a pregnancy in the early stages.
Rather than wax on about unborn children and abortion as potentially being a murderous act, Thompson had a ready made answer. He would review the drug to make sure it was “safe.” According to Thompson,
I do not intend to roll back anything unless they are proven to be unsafe. It’s a new drug. It’s contentious. It’s controversial. And the safety concerns, as I understand it, are something that’s in question. And I think it’s my role to review the safety concerns for women in the United States on that drug (and) all drugs.
This is a clever repackaging of traditional anti-abortion views. Having lost the debate over whether or not it is moral to ever abort a pregnancy, anti-abortion activists will emphasize safety and health concerns and gradually chip away at support for legalized abortion. The beauty is that liberals, who otherwise support abortion, have laid the groundwork for this assault on abortion rights.
Liberals have established a very amorphous standard of “safety,” for example, and proclaimed that the state has a moral duty to intervene to afford citizens such safety, even when they don’t want such protection. Conservatives are preparing to deftly turn the regulatory state against abortion rights, and when the dust is cleared they will probably succeed in establishing a good deal of onerous restrictions on the procedure.
Source:
Bush Cabinet Nominee Says to Review Abortion Pill. Adam Entous, Reuters, January 19, 2001
Some Universities Announce They Won’t Carry RU-486
In several weeks, the abortion-inducing drug RU-486 drug will hit pharmacy shelves — but not at the pharmacies of health centers at many colleges and universities. Already, Emory University, The University of Georgia, Boston University, and the entire Florida public university system have announced that their health centers will offer RU-486.
There are several reasons for these decisions, perhaps the biggest begin the ridiculous restrictions that the U.S. Food and Drug Administration slapped onto the drug. Health facilities that are very close to hospitals might be able to meet the strict requirements, but most university health systems simply don’t have the sort of facilities to meet the FDA’s requirements.
An option not mentioned, but certainly on the minds of universities must also be the possibilities of lawsuits. RU-486 has a number of occasionally severe side effects and university systems might be afraid of becoming the deep pocket victims of lawsuits.
And, of course, some colleges and universities simply want to avoid getting caught up in the abortion controversy. You can bet that many state legislatures will consider bills in the coming years to withhold funds for state-sponsored universities and colleges that offer RU-486, along with heightened abortion-related protests at institutions regardless of what decision they make (with the pro-lifers being outraged if they offer it, and the pro-abortion contingent outraged if it’s not offered).
Source:
Many Campuses Won’t Offer Abortion Pill. Kris Osborn, Fox News, October 24, 2000.
As If RU-486 Needed Any Additional Controversy…
When the U.S. Food and Drug Administration finally approved RU-486, it would not release the name or location of the company that would manufacture the drug for the U.S. market citing safety and security reasons. In fact it looks like it wanted to avoid a public relations problem that it’s going to have to deal with anyway — Hua Lian Pharmaceutical Company in Shanghai, China, will produce the drug.
Clearly the FDA was less concerned about safety concerns than getting attacked by anti-abortion activists for awarding the contract to China with its repressive dictatorial regime and history of extreme population control measures.
National Right to Life’s Douglas Johnson quickly attacked the FDA after the Washington Post revealed where the drug would be manufactured, telling the Associated Press,
They said they wanted to protect the company from violence or protests, but it’s ludicrous to say that it is an issue in China, where demonstrations aren’t permitted. It’s a public relations problem they want to avoid — they don’t want the association with Chinese coercive abortion practices.
This is just going to increase the level of controversy surrounding the drug and create a public relations nightmare for anti-abortion groups to latch on to. This FDA decision is likely to prove a disaster, and the FDA should seriously try to find a manufacturer in a more democratic nation to produce RU-486.
Source:
China plant to make U.S. abortion pill. The Associated Press, October 12, 2000.
RU-486 Becomes A Hot Political Issue
The recent FDA approval of the abortion inducing RU-486 became a hot political issue this week as Republican presidential candidate George W. Bush tried to dodge statements he made back in January that if he were president he would have serious reservations about the FDA approving the drug, while several politicians chimed in to say they would do all in their power to reverse the FDA’s decision.
Reform Party presidential candidate Pat Buchanan reaching deep into his rhetorical bag referred to RU-486 as “a human pesticide,” adding that if he should be elected, “I would use all the power of my office, including appointments at the FDA, to prevent its being put on the market.”
Unlike Buchanan, who has no real chance of winning in November, Sen. Tim Hutchinson, R-Arkansas, does hold elective office. Hutchinson told ABC’s “This Week” that there “a lot of questions” about whether or not the drug is safe and hinted that Congress might try to put additional restrictions on the drug. Rep. Tom Coburn, R-Okalhoma, said he would introduce legislation that would do just that. Given all of the burdensome restrictions that are already placed on the drug’s use, it’s hard to know what else they want to do.
For a variety of reasons, the Republican position on abortion is not the dominant view of the American people (neither is the pro-choice view, however — most Americans seem to be somewhere in between, wanting abortion to remain legal, but sometimes approving of limited restrictions on its use). Using backdoors like this to try to get their way is a bit unseemly.
On the other hand, if they succeed they’re just beating the feminists at their own game. After all there are any number of feminist tracts likening the birth control to the poisoning of women by patriarchal power brokers (the difference being when Mary Daly attacks birth control, feminists hail her as a genius, whereas were some Republican Senator to do so, he’s immediately pounced upon by feminists).
RU-486 is certainly safe, and since it leads to abortion very early in the first trimester (and by manipulating hormone levels rather than through a surgical procedure), it also meets the objections of a lot of Americans with concerns about late 2nd and even early 3rd trimester abortions. The FDA placed too many restrictions on its use, but overall it did a good thing by finally bringing this drug to market.
Source:
Abortion opponents question safety of new pill. The Associated Press, October 1, 2000.
Tags: George W. Bush
FDA Approves RU486 — With Restrictions
The U.S. Food and Drug Administration today finally approved the abortion-inducing drug RU-486 after more than 12 years of battles between pro- and anti-abortion forces. Unfortunately while they approved it, the FDA attached ridiculous restrictions to the drug that will make obtaining the drug more of a hassle for women.
The drug, originally developed in France, blocks a hormone, progesterone, which in turn causes the lining of the uterine wall to thin resulting in a spontaneous abortion. The drug is more than 90 percent effect in causing an abortion if taken within 49 days of the beginning of a woman’s last menstrual period.
In a bizarre, though not unexpected, move, the FDA placed numerous restrictions on RU486 approving it only for distribution by doctors who, as the Associated Press described it, “can operate in case a surgical abortion is needed to finish the job or in cases of severe bleeding — or to doctors who have made advance arrangements for a surgeon to provide such care to their patients.”
This is ridiculous. This would be like saying that only surgeons able to preform back surgery should be able to dispense medication for back pain. Millions of people see non-surgeons for heart and other ailments which might later call for surgery without having to find a doctor who himself is a surgeon.
The Associated Press story on the approval speculates RU486 might become an issue of debate in upcoming presidential election, but oddly claimed that
Republican candidate George W. Bush opposes abortion; his father’s administration banned RU-486 from this country in 1989. The pro-choice Clinton-Gore administration worked for seven years to bring mifepristone here.
No, actually, Clinton-Gore did absolutely nothing for the past 7 years while the FDA stood around and dragged its feet on a drug approval that should have been extraordinarily routine, and apparently did nothing to try to dissuade the FDA of the ridiculous conditions they attached to the drug.
Source:
FDA approves abortion pill. The Associated Press, September 28, 2000.
Tags: Bill Clinton, George W. Bush
FDA’s Patronizes Women with RU486 Restrictions
A couple months ago, I wrote about the U.S. Food and Drug Administration dragging its feet in approving the abortion pill RU-486 (|FDA vs. Women’s Health, Again|.) When he was running for president and needed women’s votes, Bill Clinton promised swift approval of RU-486 if he were elected. Of course once in office, Clinton forgot about his promise and, if anything, the Clinton FDA approach to RU-486 was far worse than the Reagan administration approach (at least the Reagan administration was frank enough to admit its ideological opposition to RU-486).
Now word comes from on high that the FDA is finally ready to approve RU-486. Unfortunately it is going to attach a set of unprecedented conditions that may make illegally smuggling the drug into the U.S. more viable than getting the drug via prescription.
First, the FDA wants all physicians who prescribe RU-486 to be part of a national registry of abortion pill providers. What genius at FDA thought this would be a good idea? Is it possible they’ve been so busy finding excuses not to approve the drug that they’ve missed the wave of anti-abortion violence directed against clinics and doctors over the past 20 years? The creation of a national registry is an open invitation for violent anti-abortion extremists.
Second, the FDA wants to limit the doctors who can prescribe RU-486 to just those doctors who are also qualified to perform surgical abortions. In addition the doctors would be required to hold admitting privileges to a hospital within one hour’s drive of their office. According to the FDA, the justification for this rule is that if RU-486 should not cause an abortion, the woman’s physician will be able to perform a surgical abortion. This is downright bizarre. My wife has chronic back pain and went to her physician for a pain killing prescription. Under the FDA’s logic, however, only a physician qualified to do back surgery should be allowed to write prescriptions for back pain. Women are clearly resourceful enough in this day and age to find a physician to perform a surgical abortion if RU-486 fails.
Finally, the FDA unbelievably wants to create some sort of system to track women who take RU-486, which it says is necessary to track any possible side effects from the drug.
The reality is that, again, the FDA seems more likely to be interested in presidential politics, not wanting to inject the RU-486 issue as an issue in the upcoming election. This is a drug that has been used safely and successfully in Europe for decades now — the requirements to limit and track who can prescribe the pill are completely unwarranted, as is the tracking of patients, considering the drug’s track record in Europe. As Dr. Michael Creinin of the University of Pittsburgh told CNN, “The FDA is creating a whole new standard with these restrictions” (FDA approval of abortion pill linked to stringent conditions).
The FDA should stop its shameful delaying tactics and approve RU-486 with all possible haste. Leave it to the Clinton administration to play politics with women’s health and reproductive choices.
Tags: Bill Clinton
FDA vs. Women’s Health, Again
Feminists in the United States
waged a decade-long battle against right wing activists to bring an important
medical technology to the United States only to experience years of foot
dragging from the Clinton administration which recently announced it still
won’t allow women access to a drug that has been available in Europe for
12 years.
The drug, of course, is RU-486
and induces an abortion 95.5 percent of the time when taken within the
first 49 days of pregnancy. Originally developed by Hoechst AG, the drug
first went on sale in France in 1988.
Unfortunately anti-abortion
activists actively campaigned to keep the drug from being available in
the United States. Promising to retaliate against Hoechst AG if the drug
were sold in the United States, the drug company refused to allow Roussel
Uclaf — which held RU-486’s marketing rights for the United States –
to market the drug here.
The anti-abortion groups were
aided by Congress and the Bush administration. In 1989 the U.S. Food and
Drug Administration banned the import of RU-486 for personal use. U.S.
Customs seized a prescription of RU-486 from an American citizen brought
to the United States after a trip to Europe and the Supreme Court refused
to hear the pregnant woman’s appeal of the seizure, allowing the FDA ban
to stand.
But feminists thought that
would all change with the election of Bill Clinton in 1992. In an effort
to court feminist voters, candidate Clinton pledged his support for bringing
RU-486 to this country and after the election the FDA announced that it
could review and approve RU-486 in as little as six months. FDA Commissioner
David Kessler wrote to Roussel Uclaf and encouraged the company to submit
the drug for approval.
Unfortunately Hoechst AG and
Roussel Uclaf still were resistant to selling the drug in the United States,
but agreed to transfer the marketing rights to the nonprofit Population
Council. Finally, on May 16, 1994 the Population Council was granted the
U.S. patent rights to RU-486 and clinical trials began in October 1994.
And almost six years later the drug is still not available in the
United States (so much for that six month speedy approval the Clinton
FDA promised.)
All of the studies conducted
so far indicate the drug is safe and effective, yet the FDA still refuses
to grant it final approval. Just last week, the FDA announced that it
still is not ready to approve the drug, saying that it had concerns about
the manufacturing and labeling of the drug, which is pretty much the same
thing the FDA said in a 1996 letter.
Planned Parenthood spokeswoman
hit the nail on the head when she said, “We think it’s appalling that
for 10 years the world’s most industrialized nation has not had access
to this drug that would benefit women.”
This is a classic example of
the idiocy of the FDA. Although in the 1950s or 1960s, U.S. drug approval
processes might have been said to be superior to Europe’s, today the techniques
for distinguishing between safe and unsafe medications are well known
and practiced by all Western industrial nations. A much better policy
would be to allow any drug approved for sale in Europe to be sold in the
United States with a warning that the drug has been reviewed by European
regulatory agencies but not the U.S. FDA.
Why not let women choose for
themselves what to do with their bodies? Or are we to assume that the
same woman able to decide whether or not to abort a fetus is simply incapable
of making a decision about whether or not to take a drug that has been
approved an in use in Europe for more than a decade?
References:
French
abortion pill falls short of FDA requirements. Fox News, February
21, 2000.
The Fight To
Make RU-486 Available To U.S. Women. From The Feminist Majority Foundation.