Wednesday, September 06, 2006

Scientists and Medical Doctors Continue to Back-up Bloggers' Doubts about Plan B

Dear Dr. von Eschenbach,

In the 1960s, Dr. Frances Kelsey was a newly-hired physician with the FDA, and her first assignment was a presumably easy review of a "safe" sedative, thalidomide. However, she and other reviewers found deficiencies in methodology and in the completeness of data, especially that for chronic toxicity, in the experimental trials. She came under tremendous pressure from the Merrell company and from superiors who were badgered by the drug firm to approve the drug, but she refused to back down on her demands for better scientific evidence of safety.1
Fast forward four decades, to the FDA being pressured by a pharmaceutical company and political organizations to make Plan B available over-the-counter. The rationale offered for this change is that emergency contraception is safe and if it is more easily available it will reduce unwanted pregnancies and the abortion rate. However, the available scientific evidence does not support this rationale.

Emergency contraception use has been associated with concomitant sexually-transmitted infections and a higher incidence of ectopic pregnancies. Increased availability of emergency contraception has not resulted in a decline in pregnancy or abortion rates. Such evidence indicates that women using emergency contraception should be under the care of a physician to provide best care, including monitoring women for complications of the medication and sexually-transmitted infections. Women required to make a visit to their physician to obtain a prescription can be better evaluated and treated.

· Ectopic pregnancy--The British Government issued a warning to doctors to be especially aware of a potential complication of ectopic pregnancies following emergency contraception use. The post marketing surveillance experience in the United Kingdom, with specific reference to 201 emergency contraception failures, found 12 ectopic pregnancies, or a 6% rate‹triple the expected rate for both the UK and the US. (See: CMO update #35, dated 4-2-03, content # 20 at HERE)

· Sexually-transmitted infectionso In Sweden, following over-the-counter availability of emergency contraception in the late 1990¹s, there was a 30% increase in Chlamydia infections from l999 to 2001.2

o In Washington state, in the seven years following the start of the pharmacist direct pilot project for dispensing emergency contraception, chlamydia infection rates rose from 169.8 to 285.9 cases per 100,000, with teenage women showing a 36% increase (l997-2004) (see: HERE).
o A California study of women having different levels of access to emergency contraception found that 12 percent of all participants acquired a sexually-transmitted infection.3
o These data do not implicate a causal association between over-the counter emergency contraception and chlamdia or other sexually-transmitted infections, but show a need for physician supervision of any sexually active woman. Without physician oversight, these undiagnosed and untreated sexually transmitted infections may lead to infertility and cervical disease, which is surely not a good public health result for these women.

Easy access to emergency contraception does not necessarily produce intended results--Theoretically, the goal of enhanced availability of emergency contraception has been to reduce unintended pregnancies and abortion rates, but such results are lacking in actual research. In one study, advanced provision of emergency contraception did not decrease abortion rates.4 In Sweden, where emergency contraception is available without a prescription, increased induced abortion rates among teens have been found.2 A study in California compared three groups of women who had 1) pharmacy access to emergency contraception, 2) advance provision of emergency contraception, or 3) clinic access. Compared with controls, women in the pharmacy access groups and the advance provision groups did not have a significant reduction in pregnancy rates.3 While there was no reported significant differences between groups with respect to contraceptive or condom use or sexually transmitted infection rat! e or sexual behaviors, 12 percent of participants acquired a sexually-transmitted infection.3

A thalidomide catastrophe was prevented in the U.S. by one person, Dr. Kelsey, staunchly standing for good science in the face of tremendous pressure. Please stand firm in protecting the health of women and not make Plan B available without a prescription.
Thank you.
Sharon Quick, MD, FCP, FAAP
Washington State Coordinator, American Academy of Medical Ethics

1. Daemmrich A. A tale of two experts: thalidomide and political engagement in the United States and West Germany. Soc Hist Med. 2002 Apr;15(1):137-158.
2. Edgardh K. Adolescent sexual health in Sweden. Sex Transm Infect. 2002 Oct;78(5):352-356.
3. Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA. 2005 Jan 5;293(1):54-62.
4. Glasier A, Fairhurst K, Wyke S, et al. Advanced provision of emergency contraception does not reduce abortion rates. Contraception. 2004 May;69(5):361-366.

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