Friday, August 26, 2005

FDA "Stumped" Over Plan B; Fetal Pain Article Prompts Hate Mail

[Cross-posted on AmbivaBlog]

(Listening to ABC World News Tonight:) They've determined that Plan B is safe for girls over 17, and could be sold to them over the counter; but how to prevent girls younger than 17 from using it? Under pressure to make a decision, and afraid or unable to make one, the FDA has taken the unprecedented step of throwing the matter open for 60 days of public discussion and comment. (The FDA calls this "taking action.")

So let the comments fly, folks! But how? Where? A look around the FDA website reveals a "Submit Electronic Comments" link, but no "open docket" on Plan B on which to comment -- at least not yet.

Opponents are still saying easier availability of Plan B "would embolden young people to engage in more risky behavior," even though a study of over 2,000 California women ages 15 to 24, conducted by the Center for Reproductive Health Research and Policy at UC San Francisco, showed no such effect. The study found that easy availability of Plan B made young women likely to do only one thing more often: use Plan B.

Plan B can prevent ovulation, fertilization, and (possibly) implantation of a zygote, or fertilized egg, according to these guidelines from The McKinley Health Center of the University of Illinois:

HOW DOES PLAN B WORK?
Plan B works through delaying or preventing ovulation, by interfering with fertilization (inhibiting the movement of the egg or the sperm through the fallopian tube), and may inhibit implantation by altering the lining of the uterus. It is not effective if the process of implantation has begun. Plan B will NOT cause a miscarriage. . . . Pregnancies occurring despite treatment do not have an increased risk of adverse outcome.

Plan B should be taken as soon as possible after unprotected intercourse.
HOW EFFECTIVE IS IT?
Plan B may reduce the risk of pregnancy by 95% when taken within the first 24 hours after unprotected intercourse and by 61% when taken between 48-72 hours. Recent research indicates that taking Plan B between 96 and 120 hours after unprotected intercourse continues to provide some protection against unwanted pregnancy. Plan B is not as effective as using consistent contraception with each act of intercourse and should not be considered a routine contraceptive method. Plan B is effective only for this particular act of intercourse . . . and will not provide any contraceptive protection during the remainder of this menstrual cycle. It is very important to use a consistent method of birth control for the remainder of this cycle.
WHO SHOULD NOT TAKE PLAN B?
Plan B should not be used if a woman is pregnant or suspects that she may already be pregnant.
If you believe, as I do, that actual life (not potential life) begins with implantation (I'll have more to say about this in Part III of the AmbivAbortion Rant, coming soon), then Plan B should be an important piece of a problem pregnancy and abortion prevention strategy, along with abstinence, responsible use of contraception, and encouragement of adoption.

MEANWHILE, MORE NEWS ON THE ABORTION FRONT: The editor-in-chief of the Journal of the American Medical Association defended her decision to publish the UCSF "fetuses probably feel no pain" study "despite receiving criticism for not disclosing the abortion-related work of two of the authors." According to Daily Reports from kaisernetwork.org:
[T]he article does not mention that study co-author Eleanor Drey, a UCSF OB/GYN, is the medical director of the abortion clinic at San Francisco General Hospital . . . The review also does not mention that study lead author Susan Lee -- a medical student and a lawyer -- worked in the legal department of NARAL Pro-Choice America for eight months in 1999 and 2000. . . .

DeAngelis -- a Roman Catholic who opposes abortion -- said she has received dozens of "horrible, vindictive" e-mails condemning her for publishing the review. She said she will publish properly submitted comments on the review in an upcoming JAMA issue but added that there is "nothing wrong" with the review. DeAngelis said the review was based on data from dozens of medical articles by other researchers, adding, "If there weren't four other authors and this wasn't a peer-reviewed journal, I'd worry ... but I don't" . . . . DeAngelis also said Drey did not have to reveal her scope of practice as an OB/GYN, but added that she will find out more information about Lee's work with NARAL Pro-Choice America and give the authors "the opportunity to explain why they didn't reveal it."

Critics of the review have said the affiliations of the authors are important when considering its results, the Chicago Tribune reports. "These are people with years of professional and ideological investment in the pro-abortion cause, not some neutral team of medical professionals," Douglas Johnson, legislative director of the National Right to Life Committee, said. Marcia Angell, a senior lecturer in social medicine at Harvard Medical School and a former editor of the New England Journal of Medicine, said, "Suppose there were an article that said that (fetuses) do feel pain and it was written by people who were involved in the right-to-life movement. Would I want to know that? I think I would". . . . [Another scientist asked for comment said] "The standard for disclosure in medical and scientific journals is not your politics . . . There's no obligation to tell people what your mind-set is ... as long as the data is sound and gathered objectively".
Go to the Kaiser article for sources and links.

What do you think? Should the "abortion connection" have been disclosed, and do you think it necessarily affects either the selection or the interpretation of the data? (Remember that this article was a broad review of previously published studies, not a new study.)

The rather callow Terry Moran ended his ABC News report by saying that the JAMA editor had stated she still had complete faith in the study's . . . pregnant pause, attempt at significant eye-roll . . . "integrity." Moran tried to infuse that last word with, I don't know, heavy irony? sarcasm? ambiguity? It was such a strange, awkward signal -- ABC News trying to display its lack of liberal bias? Moran doing his own editorializing? But the editorial was unreadable. It was as if he was trying simultaneously to channel both Peter Jekyll and Sean Hyde.

4 Comments:

At 11:23 PM, Anonymous kenb said...

Should the "abortion connection" have been disclosed

Yes -- it's hard to believe that the co-author could have really thought that that information was of no consequence. It would have been much preferable to reveal it up-front.

and do you think it necessarily affects either the selection or the interpretation of the data?

Nope, not necessarily at all, and given that only one of the authors has that connection, it's certainly no reason to dismiss the report out of hand, as the right-to-life folks are trying to do.

 
At 7:29 AM, Anonymous SwissKnife said...

National Right to Life has published an interesting memo, summarizing its objections to the paper and to the manner in which many main stream media outlets have reported on it ("gullibly"). The memo contains a bunch of links to documents, including a number from sources not associated with the right-to-life movement, such as a report submitted to a federal judge by internationally recognized pediatric pain researcher Dr. Kanwaljeet S. Anand.

 
At 5:13 PM, Blogger demdiva said...

Dr. Anand, though well-recognized, has been associated with the anti-choice movement. He testified in the court cases surrounding the federal abortion ban. Furthermore, he has admitted that he alone among researchers in asserting that fetal perception could begin as early as 20 weeks. While he is certainly not as compromised as other doctors and researchers who are clearly ideologically motivated, one man's conclusions do not scientific proof make.

The survey reaches a conclusion similar to the British commission which reviewed all available data on fetal perception.

 
At 11:20 AM, Blogger amba said...

For a possibly more objective assessment of whether and when a fetus might feel pain (and of what we don't and can't know about this), look at this article in the British Journal of Obstetrics and Gynaecology (pdf format), which is also referenced in the NRLC memo.

 

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