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Additional Dangers to Women under Lax Standards Set by FDA

 

Failure to diagnose an ectopic pregnancy can result in maternal death. (Wu, op cit., 198-199) "Some recent adverse events resulting from undiagnosed ectopic pregnancies have led providers to pay more attention to ultrasound examination. One study found that 84% of providers in Beijing used ultrasound routinely..." (Id. at 197). The FDA has dropped the reported requirement that prescribers be certified in the use of ultrasound.

Congressman Tom Coburn, M.D., a practicing ob-gyn, has proposed legislation that would, in effect, re-instate the safeguards previously considered by the FDA, but abandoned in the final approval. The American College of Obstetricians and Gynecologists ("ACOG"), a group whose leadership consistently supports abortion, objects to stricter precautions. On October 16, Dr. Coburn wrote ACOG's Executive Vice President to respond to that organization's opposition to his bill. Concerning the failure to require ultrasound use, Dr. Coburn writes:

"Given the risks associated with the administration of mifepristone later than seven weeks LMP or in the case of an ectopic pregnancy, it is critically important to the safety of the patient to make sure that the diagnosis is accurate. We have a wonderful diagnostic tool in ultrasound. It is reliable in answering both of these key questions. The only alternative is patient self-diagnosis–a perfectly acceptable diagnostic guide to traditional obstetrics, but potentially fatal in the administration of RU 486. Why in the world would ACOG object to requiring physicians prescribing mifepristone to be able to read an ultrasound? It would seem irresponsible on its face for any physician to prescribe a drug without an ultrasound diagnosis. Yet, thanks in part to your objection to this standard, the FDA now requires physicians to be able to diagnose these conditions in any manner, without specification. In practice, this means that patient self-diagnosis is an acceptable standard. If the patient errs by two weeks in recalling the date of her last period, or dismisses the pain that might suggest an ectopic pregnancy, that is just her tough luck; she should have been more observant. That is an utterly unacceptable standard of patient care. Failure to use ultrasound to get an accurate diagnosis is negligence. Advocacy of such negligence is nothing less than a willful disregard of patient safety" (Letter to Ralph W. Hale, M.D., Executive Vice President, ACOG, Oct. 16, 2000).

The nature of abortion practice in the United States is that nine out of ten abortions take place in free-standing abortion clinics or in doctors' offices (Alan Guttmacher Institute, Facts in Brief, 1997) with minimal government supervision.

There are no guarantees that doctors prescribing mifepristone and misoprostol to U.S. women will adequately screen for medical conditions that make use of these drugs dangerous, among which are: adrenal insufficiency; coagulation disorders; use of steroid medications; known allergies to the drugs; liver, respiratory, renal or cardiovascular disease; thrombo-embolism; hypertension; anemia; and insulin-dependent diabetes mellitus. (Source: MPI and NEJM, op. cit.)

Women in the U.S. often do not return to abortion clinics for the required follow-up appointment. Suzanne Poppema, a Seattle abortion provider, has said they are "lucky if 30-40% of patients" return. In PC's U.S. trials, despite stringent counseling standards, 5% of women failed to return for the day 14 checkup. Not only do women with incomplete abortions or hemorrhaging risk death, but those with ongoing pregnancies are also at risk. Eight malformations to children were reported in 71 cases of continuing pregnancy in France, Sweden and the United Kingdom between 1987 and 1998. (Von Hertzen, op. cit. at 136).

One hopes that Congress will act quickly to block the entry of mifepristone into the U.S. until these many serious concerns are addressed. 



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