Dear Dr. Crawford:
On behalf of the members of Alabama Physicians For Life, Inc., I am again writing to ask you to raise the bar for medical safety by refusing to release emergency contraception (EC) over-the-counter (OTC), for the following reasons.
Sexual Predation/Promiscuity. Easy access to EC is a sexual predator’s dream come true. Pressure on young girls by older boys/men to use EC will be very strong.
Those already sexually active will learn to take EC prior to sexual activity; promiscuity will obviously increase.
STDs. Studies in Sweden [http://sti.bmjjournals.com/cgi/content/full/78/5/352] and Washington state [http://www.doh.wa.gov/cfh/STD/morbidity.htm] both showed increased Chlamydia rates with EC use.
In Sweden, following OTC availability of EC in the late 1990’s, there was a 30% increase in Chlamydia infections from l999 to 2001. In Washington state, in the five years following the start of the “pharmacist direct pilot project,” (l997-2002), there was a 23% increase in Chlamydia infection among teens. How can the FDA honestly suggest that EC-OTC is good national public health policy when, without physician oversight, these increased and undiagnosed STDs could result in infertility and cervical disease?
Ectopic Pregnancy. Studies by WHO, described by the British government, show a 6% ectopic pregnancy rate with EC. If EC were OTC, there would be a lack of physician oversight, which would endanger those women experiencing ectopic pregnancy. How can this be considered responsible national public health policy?
[http://www.dh.gov.uk/PublicationsAndStatistics/LettersAndCirculars/CMOUpdate/CMOUpdateArticle/fs/en?CONTENT_ID=4003844&chk=2uZJEX; CMO update #35, dated 4-2-03, content # 20]
Hormone Doses. How is it that women receiving low-dose oral contraceptives must have a physical exam and receive a prescription, for medical oversight purposes, while any woman/girl would be able to purchase high-dose EC, OTC, with no physical exam, no prescription, and no medical oversight? This would send a very clear message to women that our government really does not care about their long-term health and well-being.
Rape. We are very concerned that comments by EC proponents seem to be espousing the use of EC for rape victims. Mandatory physician oversight, including STD testing, pap smears, pregnancy tests, and a sense of overall concern for the well being of women who have experienced the trauma of rape is the only responsible protocol in this situation.
Unintended Pregnancy and Abortion. The main “reason” given for OTC status of EC is that a "50% decrease in elective abortion" would supposedly result in this country. However, there is no accurate, published, peer-reviewed study to support this claim.
In fact, a Swedish 5-year study that followed non-prescription EC availability resulted in a 31% increase in teen abortion [http://sti.bmjjournals.com/cgi/content/full/78/5/352: K Edgardh. Adolescent sexual health in Sweden. Sex Transm Inf 2002;78:352-356]
Even if this were the only study to show this relationship between EC and abortion rates, it seems that the FDA would require a long-term study of its own to verify or negate this Swedish study before approving EC – OTC.
However, it is not the only study. Abortion statistics in the United Kingdom have just been released for 2004. Since EC was released OTC in the UK in January, 2001, the abortion numbers have continued to increase each year since the release of EC (by 2.1% over 2003). How can this be, if the easy access to EC supposedly decreases abortion numbers?
Why would the FDA approve EC for OTC status if it can not even accomplish the only purpose for which it is being promoted?
And as you are aware, two other recent studies show that EC does not reduce unintended pregnancy rates, or abortion rates:
Study from University of San Francisco: Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs A Randomized Controlled Trial; Tina R. Raine, MD, MPH; Cynthia C. Harper, PhD; Corinne H. Rocca, MPH; Richard Fischer, MD; Nancy Padian, PhD; Jeffrey D. Klausner, MD, MPH; Philip D. Darney, MD, Msc; JAMA, 2005;293:54-62.
Study from Scotland: Contraception, Anna Glasier, Fairhurst, Wyke, Ziebland, Seaman, Walker, Lakha, Vol 69, Issue 5, May 2004, Pages 361-366. Original research article: Advanced provision of emergency contraception does not reduce abortion rates.
Health Safety. Barr Laboratories has not demonstrated the safety of their product with regard to the adverse health effects associated with OTC EC, and certainly, the research evidence is rapidly mounting which negates the safety of EC, as noted above.
You and the FDA are responsible for the medical protection of American women; women deserve this. Please, do not allow women to be exposed to such serious effects as increased ectopic pregnancy rates and increased STD rates, with no proof that pregnancy rates are even decreased.
We urge you to resist the political pressure to release EC over-the-counter. The long-term adverse effects on young women, both physically and emotionally, are much greater and more important than the political and financial concerns of those who are pressuring for EC-OTC.
We must consider the health and well-being of our young Americans, and demonstrate responsible medical care/physician oversight. We urge you to do – not what is expedient or politically correct – but what is right.
22 August 2005
Dr. Lester Crawford
Commiss
ioner
FDA CDER
5600 Fishers Lane
Rockville, MD 20852
(c) 2006 Alabama Physicians For Life, Inc.