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FDA Considers Lowering Acceptable “Failure” Rate on Approved Contraceptive Pills

Chilean President Signs Decree to Permit Hand-Out of Morning After Pill to Young Girls

Emergency Contraception: Two Recent Articles in the Green Journal  

New Study Shows Natural Family Planning Technique More “Effective” Than Contraception

Contraceptive Patch Found to Raise Blood Clot Risk…

FDA CONSIDERS LOWERING ACCEPTABLE “FAILURE” RATE ON APPROVED CONTRACEPTIVE PILLS. The US Food and Drug Administration is reconsidering contraceptives, but only to make sure they are more effective at preventing – or ending – a pregnancy.

The FDA has asked an expert panel whether it ought to ensure higher standards of “effectiveness” of new hormonal contraceptive/abortifacient drugs before approval for the market. The 14 member panel of outside experts met this week to advise the agency on future guidelines for drug manufacturers seeking approval.

The pills approved by the FDA in 1960 contained much higher doses of hormones than modern pills and had a lower “failure” rate, approximately 1 in 100 “woman-years” of use. That is, one woman in one hundred using the drug for a year became pregnant. The dangerous side effects of the high dose drug prompted the development of lower dose versions.

In recent years, the FDA has approved lower doses of the pill, though studies have shown that they allow more pregnancies to occur and also still have serious side effects.

The agency has approved pills allowing more than two pregnancies for every 100 woman-years of use. According to a 2005 study by Planned Parenthood’s Guttmacher Institute, 11.6 million US women use hormonal birth control pills. Possible side effects of low-dose pills, apart from the possible death of already-conceived children, include blood clots and cardiovascular problems. One recent study showed that woman have a 100 per cent increase in risk of heart attack and stroke with the low-dose pill. Read related coverage:
Parents Sue After 14-Year-Old Daughter Died with Birth Control Patch
[By Hilary White WASHINGTON, January 24, 2007]


CHILEAN PRESIDENT SIGNS DECREE TO PERMIT HAND-OUT OF MORNING AFTER PILL TO YOUNG GIRLS. Following through on her threat earlier this month, Chile’s President Michelle Bachelet signed a decree Monday authorizing the distribution of abortifacient emergency contraception to girls as young as 14 without their parents’ consent, the latest move in a drawn-out battle over efforts to legalize EC in Chile. Distribution of the drug was halted earlier this month when the Constitutional Court ruled that the Health Minister did not have the power to authorize handing out the drug to minors, after 32 legislators petitioned the court to rule on the issue. The lawmakers argued that the drug violates the country’s anti-abortion laws by causing early abortions when taken after fertilization of the egg has occurred. They also argued that giving the drug to minor girls without their parents knowledge was a violation of parental rights.
Jorge Reyes, attorney for the legislators opposing the drug, said a presidential decree would not end the matter, at the time of the Court ruling earlier this month, saying if a decree was issued, “We will go back to the court to object to other aspects of the program that we consider unconstitutional.” [31Jan07, G. Schultz, Santiago,]




#1. “Impact of Increased Access to EC”; Raymond, et al, Ob & Gyn, Vol 108, No. 5, Nov 2006.  Objective: To assess how strategy to maximize access to EC pills would affect rates of pregnancy and STI's. Methods: sexually active 14-24 y.o. women, randomly assigned, one group had FREE ADVANCED provision, unlimited supply; the other group had OTC access, but had to pay for and procure as needed. Participants were followed for 1 year.

Conclusion: this intensive strategy to enhance access to EC pills [jdc -remember, FREE ADVANCED ACCESS] substantially increased the use of the method, and had no adverse impact on STI risk. However, it did not show benefit in decreasing pregnancy rates.

[AAPLOG note: You will notice that this is the same result as the Scotland and the San Francisco studies…You will also note that while STI risk may be the same in both groups, the OTC women will often have a much lower or much delayed rate of diagnosis and  treatment—but the authors make no mention of that. ACOG has never seriously addressed this problem, as far as we are aware.]

“Population Effect of Increased Access to Emergency Contraceptive Pills”; Raymond, Trussel, Polis, Ob & Gyn, Vol 109, No. 1, Jan 2007. Objective: We systematically reviewed data on effects of increased access to EC pills on pregnancy rates and use of the pills. Tabulation, integration, and results: The authors selected for review 23 of 717 articles that met their criteria. In all but one study, increased access to EC pills was associated with greater use. However, no study found an effect on pregnancy or abortion rates. [djc – Most of us naive folk thought that is the reason this medicine is being pushed so hard—to prevent 89% of expected pregnancies!]

Conclusion: Increased access to emergency contraceptive pills enhances use but has not been shown to reduce unintended pregnancy rates. Further research is needed to explain this finding and to define the best ways to use EC to produce public health benefit. [Our AAPLOG note: what can be better than FREE unlimited advance access and personalized counseling???!!!

All this has been common knowledge for a couple years now. This knowledge, however, did not blunt the exuberance of the "ASK ME" button campaign that was such a p

art of the ACOG ACM last May. Nor was the FDA able to discern that "no effect on pregnancy rates" actually meant that EC was not effective as advertised. Or, if they actually did discern the truth, it simply didn't matter to them.

After all, everyone knows that Emergency Contraception is 100% effective for 27 days of each month (since there are just 3 fertile days per month). This is why the overall effectiveness can be quoted as 89%. This is a kind of deception in advertising that shouldn't happen, but has. Big time. And women, including teenagers, will not benefit from the misinformation. AAPLOG 6Jan07]

Jan 9, 07
Three days ago we email you material from 2 recent articles in the Green Journal (Nov 06 and Jan 07) showing total ineffectiveness of EC to decrease abortion rates, even when given to women FREE, with ADVANCED PROVISION, and professional counseling on when to swallow. This letter reviews statements of the previous opinions of James Trussell and Elizabeth Raymond, and commends these doctors for honestly looking at the literature. Would that
ACOG could be as candid.


The preceeding 2 articles by Trussell and Raymond (in our letter of 1-6-07) represent a remarkable about-face in opinion.

This turnabout comes, conveniently for OTC EC advocates, AFTER EC has been granted OTC status. Earlier, the same two authors offered radically different advice to the FDA and American women. In l998, James Trussell, a widely respected Population Council expert, was quoted in a CNN Special: "We decided about six years ago that making emergency contraception widely available was the most important step we could take in the United States to reduce the incidence of unintended pregnancies," said Dr. James Trussell of Princeton University. (From the CNN program: Specials, 1998 Year in Review/Health/ Emergency contraception kit wins FDA approval).

Dr Elizabeth Raymond, writing with Dr. David Grimes in 2002, proclaimed: Easier access to and wider use of emergency contraception could dramatically lower the high rates of unintended pregnancy and induced abortion in the United States. (Family Health International, David A. Grimes, MD, and Elizabeth G. Raymond, MD, MPH, 6 August 2002 | Volume 137 Issue 3 | Pages 180-189.) This article was cited in 5 major journals, including Neurology, Academic Emergency Medicine, Pediatrics, Annals of Int Med, and the NEJM.
(AAPLOG wonders how many journals will cite the author's new opinion that , "it did not show benefit in decreasing pregnancy rates." Our guess: NONE will. We hope we are wrong.

Still on the record is the outstandingly inaccurate (and some might even say irresponsible) testimony by ACOG Pres-Elect Dr. Vivian Dickerson to the 2003 FDA hearings considering OTC approval. Dr. Dickerson proclaimed:
"Overall it is estimated that widespread use of EC pills has the potential to decrease by at least 50% the current incidence of unintended pregnancies and subsequent abortions…" (aaplog note: that would be 700,000 less abortions!!!) "…and recent data show that it may even work for up to five days after unprotected intercourse" (aaplog note: in our opinion, this was less than defensible statement, given existing literature).

Drs. Trussell and Raymond, much to their credit, have gone on record recognizing the error of their previous opinion. This was brave of them, as they will undoubtedly pay a professional price for their recent article.

The question "before the House" is, will ACOG follow suit? We hope so. (But we are not holding our breath.) (Just a suggestion: how about ACOG mailing an "ASK ME IF EC MAKES ANY DIFFERENCE" button to all members.) aaplog



New Study Shows Natural Family Planning Technique More “Effective” Than Contraception
A new study by German researchers shows that a method of natural family planning is statistically as effective as the contraceptive pill in delaying pregnancy.
Researchers from the University of Heidelberg studied the statistical effectiveness of the symptothermal method (STM) to avoid achieving pregnancy. Unlike contraceptives that either suppress a woman's natural fertility cycle or act as a barrier to conception, STM helps a woman to understand the natural signs of her fertility in order to achieve or temporarily delay pregnancy.
The study involving 900 women was published in the journal, Human Reproduction, and found that the correct use of STM to delay pregnancy led to a rate of 0.4 pregnancies per 100 women per year. The lowest pregnancy rate was found among women who abstained from sex during their most fertile period identified through STM.
In contrast, women who used a barrier method, such as a condom, had a pregnancy rate of .6 pregnancies per 100 women per year. Women who had sex (without contraception) during the fertile period had a pregnancy rate of only 7.5 pregnancies per 100 women per year, however researchers noted that this was a quarter of the rate one would usually expect.
According to Lead researcher Dr Petra Frank-Herrmann: "The effectiveness of STM is comparable to the effectiveness of modern contraceptive methods such as oral contraceptives, and is an effective and acceptable method of family planning."
However, Vicki Braun, the assistant director for education at Couple to Couple League, an organisation teaching NFP techniques to married and engaged couples since 1971, said that STM should not be regarded as a kind of "natural contraception", a headline billed in many news reports.
"'Natural' and 'contraception' [against conception] are at totally opposite ends of the spectrum," Braun said. "Natural family planning is really fertility awareness" explaining that STM by itself does nothing, but gives couples data on the natural signs of a woman's fertility. The couple then discerns how they use the data of STM, whether to increase their chances of conceiving or to delay temporarily the conception of a child.
NFP methods are recognized to increase communication between a couple if used responsibly. The divorce rate of couples using NFP is dramatically below the norm and is a mere 5%.
 The Difference between Artificial Contraception and Natural Family Planning
[By Peter J. Smith, HEIDELBERG, Germany, February 21, 2007]



Contraceptive Patch Found to Raise Blood Clot Risk: Women who use a contraceptive patch appear to be more than twice as likely to develop a dangerous blood clot in their veins as those who use an oral contraceptive, new research shows.
Dr. Alexander M. Walker and colleagues

, from i3 Drug Safety in Auburndale, Massachusetts, note that it was not known if users of the patch system ran the same risk of stroke, heart attack and venous blood clots as users of oral contraceptives.
They point out that the FDA changed the labeling for the patch contraceptive system in 2005 to warn of a possible increased risk of so-called "thrombotic events," because of a higher average circulating estrogen levels with the product.
The investigators' study, reported in the journal Obstetrics and Gynecology, involved 49,000 women using the Ortho Evra patch and 202,000 who used oral contraceptive pills between April 2002 and December 2004.
The researchers found that the occurrence of blood clots or "venous thromboembolism" in patch users was 2.2-times higher than in pill users: 40.8 vs. 18.3 cases per 100,000 women per year.
Because heart attacks and strokes were so rare, the researchers could not tell from their data if the risk of these outcomes was any different, statistically speaking, between the pill and the patch users.
[Obstetrics and Gynecology, February 2007; 19Feb07 NEW YORK Reuters Health, ]