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According to the Time headline last week, a new study finds that the abortion pill RU-486 is “safe.” The only drug approved by the FDA that is designed to end human life, rather than improve it, “doesn’t increase risks” said the Chicago Tribune headline.

These headlines take deception in journalism to a whole new level. During the last Congress, I served as counsel to the House subcommittee on drug policy that investigated the FDA’s approval of RU-486. Anyone who seriously examines the highly irregular approval process and the serious adverse events associated with this drug can only conclude that it poses a deadly danger to women and should be removed from the market.

Following confirmation by the FDA in late 2005 that four women died from a rare bacterial infection after taking RU-486, Congressman Mark Souder, then-chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources, initiated a year-long investigation of how the FDA was handling RU-486 and addressing the adverse events associated with it. The subcommittee gathered thousands of documents from the FDA, conducted dozens of interviews, and held a congressional hearing, “RU-486: Demonstrating a Low Standard for Women’s Health?” Ultimately, the subcommittee published an extensive staff report on the drug, recommending its immediate removal from the market.

The report, “FDA and RU-486: Lowering the Standard for Women’s Health” summarizes a mountain of evidence about this drug’s serious and unpredictable danger to women, detailing the reasons that the drug should be immediately withdrawn from the market. Here are just some highlights: RU-486 was fraudulently approved; it has caused the deaths of at least eight women (that are known); and it is at least ten times deadlier than its surgical alternative.

RU-486 is actually a two-drug combination that first blocks nutrition from the developing embryo, which kills it, then causes the uterus to contract and expel the contents. It was approved in the waning days of the Clinton presidency under a highly unusual and specialized federal provision called Subpart H, which applies only to drugs that treat “serious or life-threatening illnesses and that provide a meaningful therapeutic benefit” over existing treatments.

RU-486 doesn’t even come close to meeting the Subpart H criteria: a normal pregnancy is not a serious or life-threatening illness (RU-486 is contraindicated for ectopic pregnancies); and surgical alternatives are safer for the mother. In short, FDA violated its own regulations to approve RU-486. (The advocacy group Judicial Watch has a detailed report on the Clinton administration’s drive to approve RU-48; and a Citizens Petition filed against the FDA on behalf of Concerned Women for America, the American Association of Pro-Life Obstetricians and Gynecologists, and Christian Medical Association offers a comprehensive account of the approval violations committed on behalf of RU-486 approval.)

RU-486 has caused a tremendously high rate of adverse events relative to the number of women who have taken the drug. As of last year, when the FDA provided information to the Subcommittee for its investigation, RU-486 had caused the deaths of at least eight women, nine life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. In total, we knew of more than 1070 adverse event cases associated with RU-486, out of only 575,000 prescriptions at most. This is even more alarming in light of the fact that adverse event reporting is notoriously low for any drug, much less a drug associated with abortion, for which reporting is expected to be even lower.

Finally, as explained in detail in The New England Journal of Medicine, RU-486 abortion (sometimes called “medical abortion”) is at least ten times more fatal than its surgical alternative. The figure, based on the most conservative numbers available, compares deaths from RU-486 abortion (a rate of 1 per 100,000) to surgical abortion before eight weeks (a rate of 0.1 per 100,000).

Now, just a few interesting facts about the business and manufacturing of this drug: Danco, the company that imports and distributes RU-486 (under the trade name of Mifeprex), is not a U.S. company, but is based in the Cayman Islands; RU-486 is its only product (making a voluntary withdrawal highly unlikely); and Danco imports RU-486 from that paragon of safe-product production, China.

So what are the options for actually withdrawing this drug from the market? There is a bill in the House that would suspend approval of RU-486 pending a Comptroller General review of the FDA’s initial approval. But approval could be reinstated after a favorable Comptroller General review. The FDA has authority, under a few provisions, for withdrawing a drug unilaterally, such as when a drug cannot be used safely despite restrictions, but it’s highly unlikely the FDA would pursue this course of action. The best current option for withdrawal of RU-486 rests with the Secretary of Health and Human Services, who has “Imminent Hazard” authority to remove a drug from the market under certain criteria (such as the unpredictability and severity of adverse events associated with a drug).

Returning to the mendacious headlines claiming RU-486 is “safe,” the careful reader will note that the study prompting this recent PR blitz lauding the abortion pill was not about the safety of RU-486 as a drug, or even as a form of abortion. The study was a comparison of subsequent pregnancy outcomes among women who had prior abortions, concluding that there was no difference between surgical or medical abortion on the impact on subsequent pregnancy.

However, abortion in general poses some risk to subsequent pregnancy; so to say there is no difference in long-term risk after having a medical versus surgical abortion is like saying there is no difference in long-term risk after getting into a traffic accident in a sedan versus a motorcycle. It ignores the fact that traffic accidents are dangerous, and motorcycle accidents are much more deadly.

2007-08-22 03:59:47 · 24 answers · asked by mission_viejo_california 2 in Politics & Government Politics

24 answers

The #1 cause of abortion, is, was, and always will be the stigma on unwed mothers from the conservative right.

After promising to outlaw abortiton, they were in power for 6 years, and never did.

Conservatives are liars who want abortion.

2007-08-22 04:04:33 · answer #1 · answered by Darth Vader 6 · 5 6

OK, I'm going to go out on a limb here and assume you did a copy/paste from some article instead of pounding all that out on your keyboard. Please provide the link(s) because it's impossible to determine whether or not some 'selective editing' took place, although I can smell an inherent bias.

Para#1 - I fail to see how Time and the Chicago Tribune reporting on a study saying the drug was "safe" correlates to the media being irresponsible, liberal, promiscous or promoting abortions. That's quite a leap, and far from objective on your part.

Para#2 - Your service on a committee, your opinion on the drug and your opinion of the overall approval process serve neither to validate nor refute journalistic quality. You appear to blame the media for using as their source a report with which you disagree.

Para#6 - Judicial Watch a "nonpartisan, public-interest law firm" that happens to "represent conservative interests." Judicial Watch’s Christopher Farrell called the FDA approval of RU-486 the "equivalent of a pro-abortion jihad" that "ultimately cost at least six women their lives and the lives of over 560,000 unborn children." Well, no biased agenda there, huh?
http://www.wilderness-cry.net/tcn/editorials/editorial7.html
http://lesforlife.blogspot.com/2006/05/has-abortion-pill-been-pushed-on.html
http://www.judicialwatch.org/archive/2006/jw-ru486-report.pdf
"Concerned Women for America, the American Association of Pro-Life Obstetricians and Gynecologists, and Christian Medical Association"
No agendas with these groups either??

Para #7 - The numbers don't seem to 'jive' because I came up with 553, not 1070, adverse event cases.

Para#11 - mendacious (habitually; dishonest; lying; untruthful) headlines... Again, your problem appears to be with the FDA approval process, yet you fault the media. Do you just hate Time and the Chicago Tribune?

I'll stop here because I believe I've made my point. Essentially, without providing any references to independently evaluate, your 'question' appears to be no more than a long-winded, agenda-driven rant.

2007-08-22 06:09:52 · answer #2 · answered by sagacious_ness 7 · 1 2

I think they have been using RU-486 in Europe for years. Why is it considered safe and effective there but not here?

Maybe it isn't the drug as a whole that should be vilified, just a particular company that makes it?

2007-08-22 04:11:38 · answer #3 · answered by Anonymous · 3 1

I cannot begin to address the fallacies of your argument; but if I were to write a couple of pages it wouldn't matter, you are not open to logic. So, all I will say is you have a constitutional right to believe whatever wacked out stuff you want to believe. Have a nice day.

2016-05-19 22:42:03 · answer #4 · answered by ? 3 · 0 0

Regarding complications from RU-486, you have to compare it to complications from a pregnancy carried to term, which are numerous.

And if you consider a zygote to be life, then you have some issues.

2007-08-22 04:08:47 · answer #5 · answered by Anonymous · 4 1

it has been a slow patient process..this is from 1963 part of the agenda and it has been working ..it was said that america would be defeated without firing a shot. .if you care to read the link you will find the other examples.

17. Get control of the schools. Use them as transmission belts for socialism and current Communist propaganda. Soften the curriculum. Get control of teachers' associations. Put the party line in textbooks.

18. Gain control of all student newspapers.

20. Infiltrate the press. Get control of book-review assignments, editorial writing, policymaking positions.

21. Gain control of key positions in radio, TV, and motion pictures.

2007-08-22 04:07:14 · answer #6 · answered by ? 7 · 0 3

For someone who claims to have worked as council for a subcommittee your use of the English language is sub par.

How many mistakes can we spot in the following sentence?

"Why does the Liberal media promotes promiscuity and abortions,?"

A comma before a question mark. Promotes? Come on, use the singular version. "Why does the 'Liberal Media' promote (with no s) ........"

2007-08-22 04:07:29 · answer #7 · answered by Anonymous · 2 2

Abortion is not safe, Ru-486 is not safe. Any procedure or pill that murders a human being is dangerous. Liberals are evil. God bless the innocent babies!

2007-08-22 04:06:24 · answer #8 · answered by Anonymous · 4 5

Now, for the record, I'm very anti abortion .....but holy crap that question is way too long.

2007-08-22 04:04:15 · answer #9 · answered by Dani 7 · 3 0

You've got lots of interesting facts here, but nothing that supports your question about promiscuity and abortion. You seem like the type who wouldn't jump to conclusions, so why such an inflammatory question?

2007-08-22 04:03:16 · answer #10 · answered by tabby90 5 · 5 3

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