Correspondence
A Sad Day for Science at the FDA
N Engl J Med 2005; 353:2619-2621December 15, 2005
- Article
To the Editor:
Much has been written about the trumping of science by political pressure, especially with regard to the emergency contraceptive Plan B.1,2 It is disturbing that we are still debating this question. I agree completely with Dr. Wood and colleagues (Sept. 22 issue)3 that Plan B is very effective, is incredibly safe, and when needed, should be dispensed without delay. My concern about the placing of age restrictions either by the manufacturer or by the Food and Drug Administration (FDA) is that the most vulnerable women may not be able to obtain Plan B in a timely enough fashion to realize its benefit. At times, the very people needed to grant permission may be involved in the abuse leading to the need for emergency contraception in the first place. I would urge unrestricted over-the-counter status for Plan B. There is no question that “Plan A” should consist of careful consideration of sexual behavior, protection against sexually transmitted diseases, and reliable contraception. When Plan A fails, there must be a Plan B.
3 ReferencesPaul D. Burstein, M.D.
University of Wisconsin Medical School, Milwaukee, WI 53211
pdburstein@aol.com 1
Burstein PD . The FDA, politics, and Plan B. N Engl J Med 2004;350:2413-2414
Full Text | Web of Science | Medline2
Steinbrook R . Waiting for Plan B -- the FDA and nonprescription use of emergency contraception. N Engl J Med 2004;350:2327-2329
Full Text | Web of Science | Medline3
Wood AJJ ,Drazen JM ,Greene MF . A sad day for science at the FDA. N Engl J Med 2005;353:1197-1199
Full Text | Web of Science | Medline
To the Editor:
I am somewhat surprised by the terms with which Dr. Wood and colleagues refer to the FDA decision that avoids making emergency contraception available without a medical prescription. Some studies show that this treatment is somewhat ineffective in terms of reducing the rate of abortion (5 pregnancies avoided per 10,000 users).1,2 The availability of emergency contraception may generate a false impression of safety,3 potentially increasing the prevalence of unprotected intercourse and unintended pregnancies.4 Furthermore, this method of contraception does not protect against sexually transmitted diseases. Considering that there are potential adverse effects associated with levonorgestrel treatment,5 this “nondecision,” as Wood et al. call it, may be interpreted as a cautious demand for more science on the part of the FDA and should not be regarded, exclusively, from a political point of view. On a personal note, I believe that the availability of emergency contraception without a prescription renders parental supervision ineffective. I wonder how many readers would like their teenage daughters to have unsupervised and uninformed access to such treatment. More evidence may turn this so-called sad day for the medical community into a safer tomorrow.
5 ReferencesJosé V. Fernández, M.D.
Clínica Universitaria de Navarra, 31008 Pamplona, Spain
jvfernandez@unav.es 1
Killick SR ,Irving G . A national study examining the effect of making emergency hormonal contraception available without prescription. Hum Reprod 2004;19:553-557
CrossRef | Web of Science | Medline2
Glasier A ,Fairhust K ,Wyke S , et al. Advanced provision of emergency contraception does not reduce abortion rates. Contraception 2004;69:361-366
CrossRef | Web of Science | Medline3
Jaccard J ,Dittus PJ . Adolescent perceptions of maternal approval of birth control and sexual risk behavior. Am J Public Health 2000;90:1426-1430
CrossRef | Web of Science | Medline4
Falk G ,Falk L ,Hanson U ,Milsom I . Young women requesting emergency contraception are, despite contraceptive counseling, a high risk group for new unintended pregnancies. Contraception 2001;64:23-27
CrossRef | Web of Science | Medline5
Rosendaal FR ,Van Hylckama Vlieg A ,Tanis BC ,Helmerhorst FM . Estrogens, progestogens and thrombosis. J Thromb Haemost 2003;1:1371-1380
CrossRef | Web of Science | Medline
To the Editor:
The postponement of a decision by the FDA to make emergency contraception available without prescription may be sensible. There are reasons for concern about the potentially carcinogenic, immunosuppressant, and vasoactive effects of high doses of levonorgestrel.
The use of progestin increases the risk of breast cancer more than does the use of estrogen.1 The number of breast cancers in young women with overexpression of cyclin D was doubled among those who used any oral contraceptives in the previous 20 years.2 Studies in animals suggest that a single large exposure to a carcinogen may induce tumors.3 In the United Kingdom, women who used hormonal emergency contraceptives on two or more occasions had a risk of muliple sclerosis that was almost three times as high as that among nonusers (odds ratio, 2.8; 95 percent confidence interval, 0.8 to 10.6).4 This finding warns of possible further increases in serious illnesses.
Resisting political meddling in the drug-approval process is laudable, but the large accumulation of scientific evidence of long-lasting harm to women from exposure to progestin should also be taken into account.
4 ReferencesEllen C. Grant, M.B., Ch.B.
20 Coombe Ridings, Kingston-upon-Thames KT2 7JU, United Kingdom
ellengrant@onetel.com 1
Beral V, Million Women Study Collaborators
CrossRef | Web of Science | Medline2
Terry MB ,Gammon MD ,Schoenberg JB ,Brinton LA ,Arber N ,Hibshoosh H . Oral contraceptive use and cyclin D1 overexpression in breast cancer among young women. Cancer Epidemiol Biomarkers Prev 2002;11:1100-1103
Web of Science | Medline3
Schoental R . The mode of action of carcinogens which can induce tumours with a single dose: a new hypothesis. Br J Cancer 1974;29:92-92
CrossRef | Web of Science | Medline4
Alonso A ,Jick SS ,Olek MJ ,Ascherio A ,Jick H ,Herman MA . Recent use of oral contraceptives and the risk of multiple sclerosis. Arch Neurol 2005;62:1362-1365
CrossRef | Web of Science | Medline
Author/Editor Response
Dr. Burstein shares the views of many who feel that the FDA decision-making process in the matter of Plan B has been disappointing. Dr. Fernández expresses a number of reservations about over-the-counter availability of emergency contraception with levonogestrel. First, he cites studies from England1 and Scotland2 that conclude that over-the-counter availability of emergency contraception has not reduced abortion rates in those regions. There is a huge gulf between making emergency contraception available over the counter and actually seeing a reduction in nationwide abortion rates. Bridging this gulf requires widespread knowledge of the availability of the product, reasonable pricing, ready access in pharmacies so that the product can be purchased and taken in a timely (efficacious) manner, and changes in human behavior. Over-the-counter availability of emergency contraception will reduce pregnancy rates and the need for abortion only among those who use it. Unfortunately, the same behavioral traits that lead to exposure to unplanned pregnancy are associated with a reduced likelihood that emergency contraception will be used even when it is readily available; this makes it critical to keep the barriers to emergency contraception as low as possible. Both cited studies did find that over-the-counter availability of emergency contraception resulted in more timely, and therefore efficacious, use when needed.
Dr. Fernández also repeats the common but unsupported concern that over-the-counter availability of emergency contraception will result in “increasing the prevalence of unprotected intercourse.” Many studies,3,4 including one cited by Dr. Fernández, show just the opposite to be true. Glasier et al.2 state that “women tended to move from less effective methods of contraception (mainly condoms) to more effective methods (hormonal) during the period of follow up.” Dr. Fernández also implies that there is a risk of thromboembolic complications from emergency contraception; however, this speculation is unsupported by data.
Dr. Grant expresses concern about carcinogenesis on the basis of data regarding chronic exposure to daily hormone-replacement therapy for years, with extrapolation to exposure to emergency contraception. A course of emergency contraception with levonorgestrel provides exposure for only 48 hours, and most women who use emergency contraception rarely use it more than once or twice. There are no data to support an enhanced risk of carcinogenesis from such short-term exposures. Similarly, Dr. Grant's reference to the increased risk of multiple sclerosis in the study by Alonso et al. is at odds with the authors' own interpretation of their data — that is, that exposure to emergency contraception was not significantly “associated with a higher risk” of multiple sclerosis. Emergency contraception is safe and effective; it should be available over the counter to all women who need it when they need it.
4 ReferencesMichael F. Greene, M.D.
Massachusetts General Hospital, Boston, MA 02114Jeffrey M. Drazen, M.D.
, Boston, MA 02115Alastair J.J. Wood, M.D.
Vanderbilt University, Nashville, TN 37232-66021
Killick SR ,Irving G . A national study examining the effect of making emergency hormonal contraception available without prescription. Hum Reprod 2004;19:553-557
CrossRef | Web of Science | Medline2
Glasier A ,Fairhust K ,Wyke S , et al. Advanced provision of emergency contraception does not reduce abortion rates. Contraception 2004;69:361-366
CrossRef | Web of Science | Medline3
Gold MA ,Wolford JE ,Smith KA ,Parker AM . The effects of advance provision of emergency contraception on adolescent women's sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004;17:87-96
CrossRef | Medline4
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;293:54-62
CrossRef | Web of Science | Medline
- Citing Articles (1)
Citing Articles
1
Andrea T. Borchers, Frank Hagie, Carl L. Keen, M. Eric Gershwin. (2007) The history and contemporary challenges of the US Food and Drug Administration. Clinical Therapeutics 29:1, 1-16
CrossRef
