Archive for the ‘Birth Control’ Category
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
Hating the Pill
A couple weeks ago marked the 40th anniversary of the birth control pill — and in those 40 years it rivals (and probably beats) the computer as the single most important technological innovation of the last four decades. I was born well after the introduction of the Pill, and to me cheap, reliable contraceptives seem as natural and commonplace as long distance phone calls or routine air travel, which were revolutionary in their own right.
The funny thing about the Pill, though, is that ideologues throughout the political spectrum tend to hate it. The conservative version of the Pill is pretty straightforward — the Pill severed the link between sex and procreation and caused massive, largely negative, social upheaval. Writing for Frontpage.Com, for example, Chris Weinkopf (A Bitter Pill) laments that,
By effectively thwarting women’s reproductive systems, the Pill and the revolution it enabled granted sexual partners the confidence that one-night stands would not become lifetime obligations. Not surprisingly, women now complain that most men think of them as little more than sexual objects, and are unwilling to “commit.”
…by completely divorcing sex from the possibility of procreation, the Pill degraded the marital act from an expression of unconditional love, rooted in an openness to new life, to an exercise in physical and emotional gratification. This devaluation has no doubt contributed to the national rise in adultery — which experts estimates now affects at least half of all marriages — and the national divorce rate, which has more than doubled since 1960.
Weinkopf also blames the Pill for contributing to the problem of many children growing up fatherless, and complains that not only has the Pill not made a dent in the abortion rate, but that the Pill in fact is abortion. Some oral contraceptives work by inhibiting the ability of fertilized eggs from implanting on the wall of the uterus — and Weinkopf and others think interfering even with a fertilized egg at all is tantamount to murder (even though fertilized eggs often fail to implant due to any number of reasons without the Pill). Weinkopf posits some sort of active effort by “feminists [who have] succeeded for four decades in concealing from the American public … that it can cause abortions.” Perhaps there are some women who don’t know how the Pill works, though they could just read the package insert that comes with every prescription, but more likely even people concerned about the ethics of abortion don’t necessarily consider a handful of un-implanted cells to be a person.
Don’t think it’s just conservatives, though, who dislike the Pill. Radical feminists such as Mary Daly argue that the Pill is literally a poison designed by male scientists to benefit the patriarchy and make it easier to control women. In fact there is a strain of radical feminism that sees pretty much all scientific research into reproduction as a patriarchal attempt to further seize control of women.
One of the things Daly and others cite is the debate over whether or not the Pill contributes to an increased risk of some form of cancers and other side effects. While most of these risks are overblown by a media interested in hyping tales of disaster, no technology is risk free (witness the small number of men who have died because they ignored the warnings accompanying Viagra, which also causes a number of well-documented problems in certain men).
The fear of lawsuits, however, is one of the reasons that there have been so few new contraceptive drugs in the intervening years. In fact, one of the few new products that was put on the market — Norplant — immediately became the subject of a large number of lawsuits which have yet to be resolved.
It is not surprising that the Pill should have so many detractors — the Pill increased the amount of freedom that women and men had in sexual matters. As in any other area of life, freedom carries with it a great deal of responsibility and inevitably some people act irresponsibly. Yes, to some extent people have chosen to trivialize their marriage vows (though others have left bad marriages for good reasons) and too many men don’t take their responsibilities seriously.
On the other hand, the Pill also allows married couples to easily defer having children until they are older, wiser and better off financially. It allows people from turning one reckless night into a lifelong mistake.
Weinkopf, and I imagine many conservatives, finds it hard to believe Gloria Feldt’s claim that “the Pill has enabled women to take charge of … their lives,” but his real problem is that he doesn’t approve of how women (and men) have freely chosen to live their lives in the post-Pill era. In this view, he’s not all that different from the radical feminists.
Tags: Mary Daly
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.