Saturday, April 22, 2006

Holly's Law and the Rapture Rupture...From Reality, That Is

We have a partial answer in the case of the two most recent deaths in women who underwent medical abortions using a RU-486 (Mifeprex)/misoprostol regimen:

WASHINGTON (Reuters) - One of two recent deaths of women taking the abortion pill RU-486 was unrelated to an abortion or use of the drug, but the second case is still under investigation, U.S. regulators said on Monday.

The woman in the second case showed symptoms of infection, the U.S. Food and Drug Administration said. Both cases were reported in March, making a total of 6 deaths in women after use of the drug.

...

"Of the two most recent deaths ... one has been determined to be unrelated to an abortion or to the use of Mifeprex and misoprostol and the other, with symptoms of infection, continues to be under investigation," the FDA said in a statement.

Four other previously reported deaths in women who took the abortion pill were linked to complications from infection, but the FDA has not attributed them to the drug. In those cases, the women were given misoprostol vaginally -- an unapproved method -- rather than orally.


Although we mustn't lose hope that one of these days the press will report information accurately, I have to point out that Reuters still manages to make a mistake about the off label regimen--the women were given a different dosage of RU-486 orally, and a different dosage of misoprostol vaginally. And so does the AP. From the AP article on the same story:

Neither of the two women followed FDA-approved instructions for the pill, which require swallowing three tablets of one drug, followed by two of another drug two days later.

Instead of swallowing the final two tablets, the second course of pills was inserted vaginally in the four women, an "off-label" use that studies have shown effective and that has been recommended by a majority of the nation's abortion clinics. That use does not have federal approval, though studies have indicated it produces fewer side effects.


No, no, no, and no! The off label regimen does NOT consist of swallowing 3 tablets of RU-486, followed by vaginal insertion (pv) of 2 tablets of misoprostol. There are several off label regimens in use, and none of them consist of 3 tabs of RU-486 po, followed by 2 tabs of misoprostol pv.

According to the FDA, the off label regimen used in the cases under discussion was 1 tablet of RU-486 (200 mg) orally, followed by 4 tablets of misoprostol (800 mcg) pv.

Compare this off label regimen, with the FDA-approved regimen (which the AP does report correctly)--3 tablets of RU-486 (600 mg) orally, followed by 2 tablets of misoprostol (400 mcg) orally.

Not that I've been successful so far in my efforts (despite emailing everybody involved, the NIH still has the wrong information on emergency contraception on their site), but I will try to contact Reuters and AP and at least make them aware of their continuing misreporting of medical abortion regimens.

And speaking of emailing people, here are some people in urgent, and serious need of being contacted and quizzed on their grasp of reality:

Separately, nearly 50 members of Congress are expected to ask for a U.S. House of Representatives vote on a bill calling for RU-486's withdrawal and an investigation by the Government Accountability Office.

Lisa Lyons Wright, spokeswoman for Maryland Republican Rep. Roscoe Bartlett (news, bio, voting record), said on Monday 45 Republicans and two Democrats are expected to sign the letter to House Majority Leader John Boehner, an Ohio Republican. It should be sent Tuesday, she added.

Even if a Boehner plans a vote on the bill, called Holly's Law, House lawmakers are not expected to return from a two-week recess until April 25.


Feel free to come up with your own questions for these esteemed leaders, but here's one to get you started: Why call for an withdrawal of mifepristone instead of misoprostol? [Bonus points for any politician who recognizes the drug names and is aware of the difference between them without consulting a reference.] All the deaths occurred in patients who used double the misoprostol dose administered pv, but only used 1/3 of the FDA-approved RU-486 dose po. So RU-486 should be withdrawn because, why?

I was going to end my post with the paragraph above, but, just for completeness, I took a quick look at this Holly's Law (H.R. 1079). I so shouldn't have done that!

SEC. 2. FINDING.

The Congress finds that the use of the drug mifepristone (marketed as Mifeprex, and commonly known as RU-486) in conjunction with the off-label use of misoprostol to chemically induce abortion has caused a significant number of deaths, near deaths, and adverse reactions.


Either members of Congress are incompetent, or, and there's just no diplomatic way of saying this, they are actually lying.

First of all, there have been no reported deaths in women using the FDA-approved mifepristone and misoprostol regimen. All the deaths occurred when women used *both* mifepristone and misoprostol off label.

Second, and most importantly, there exists no scientific finding whatsoever--not by the FDA, by ACOG, or by any random clinician, scientist or study--that the use of the drug mifepristone (marketed as Mifeprex, and commonly known as RU-486) in conjunction with the off-label use of misoprostol to chemically induce abortion has caused a significant number of deaths. The government's own FDA spells it out (emphasis mine):

Of the two most recent deaths (reported to FDA in March 2006) one has been determined to be unrelated to an abortion or to the use of Mifeprex and misoprostol and the other, with symptoms of infection, continues to be under investigation.

As previously reported by the agency four women in the United States died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with Mifeprex and misoprostol....We do not know whether using Mifeprex or misoprostol caused these deaths.


Have we reached the point where it's acceptable for Congress members to make up facts and then legislate the fantasy? Are there no minimal standards of reality for introducing legislation in the United States Congress? And what about the press? I couldn't find one article that even remotely mentions the fact that Holly's Law has no factual basis. Shouldn't the public be informed when our beloved leaders lose touch with reality?

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