By Randall K. O’Bannon, Ph.D. NRL Director of Education & Research
Editor’s note. The issues raised here in this series are part of a larger more detailed defense and analysis of the FDA’s regulations on mifepristone offered in National Right to Life’s “Special Report” found here.
Efforts to get the U.S. Food and Drug Administration (FDA) to drop its special Risk Evaluation and Mitigation Strategy (REMS) regulations are only the latest salvo in a long campaign to get government authorization forDo-It-Yourself (DIY) chemical abortions. Abortion pill advocates have been angling for “at home” self-managed abortions for years.
In the beginning, they simply tried to get the FDA to reduce the number of office visits. They told the FDA women didn’t need to return to be administered the second drug misoprostol, which stimulates contractions to force the dead baby out.
Then they tried pushing a version of telemedicine where the pills could be released at a remote location connected by a webcam. That was replaced by an effort to have the pills delivered by mail to the home. Now, most recently, they have been arguing that women can order the pills from the internet and manage the abortions themselves without the need for any testing at all.
At each point, advocates conducted and published studies alleging that each of these modifications to the protocol was safe, that the pills were still sufficiently effective to be used in this increasing less controlled manner.
Studies that claim to prove that women can safely abort with telemedicine or mail order pills, that argue women can do without Rh testing, can screen themselves for ectopic pregnancy and other contraindications, date their pregnancies, recognize signs of dangerous complications, etc., are plagued by serious practical and methodological problems.
In particular, those studies are characterized by an inability to track the pills they send out and by high numbers of lost patients. This leads to potentially inflated success rates and an overly enthusiastic interpretation of the results, thus minimizing or ignoring the seriousness of the risk of failure or complications for women for whom the pills do not work as expected.
Real patient outcomes are unknown because of high numbers lost to follow up.
For example, a recent five-state study of abortion by telemedicine by some of the nation’s top abortion researchers claimed a “success” rate of 94%, leading authors to claim that their method was “safe, effective, efficient, and satisfactory.” But only 177 of the original 248, or just 71% of those who were mailed the drugs were actually known to have “successfully” aborted with the pills. Some of these ended up having surgical abortions, a couple more continued their pregnancies, but the outcome for the other 23% of patients is unknown.
Even if the failure rate were only 6%, this would still represent a significant number of women having to seek medical help to surgically or chemically complete the abortion or find emergency assistance to deal with the bleeding, or to address other complications that arose. Even at that rate, this would represent more than 20,000 women if projected for all “medication abortion” patients in the country.
But if large numbers of patients are lost to follow-up, even that high failure rate is a minimal projection.This study and many similar others, show it is a serious mistake to assume failure and complication rates for missing telemedicine patients to be similar to those returning to the clinic or for whom the outcome is otherwise known.
Women supposedly choose telemedicine because a visit to the clinic is not desirable or convenient. If and when they have problems, it may seem easier and more secure for a woman to visit her regular local doctor or an emergency room where physicians are trained to deal with trauma rather than to visit a clinic which is far away. The prescribing clinic may lack the needed surgical capacity and likely ti have a doctor and staff with whom the woman has little personal relationship.
If so, researchers relying on clinic datawould never hear of those incomplete abortions or complications unless the patient or doctor re-contacted the prescriber.
The situation is made worse by the explicit advice some advocates of self-managed abortions give to patients contradicting advice given by the FDA. They tell women that emergency room physicians cannot tell if a woman is having a miscarriage or a chemical abortion and suggesting that they do need not tell these doctors of the attempted abortion.The FDA says it is important that women inform ER doctors that they have taken the abortion pills.
Under the circumstances, assurances of the safety of telemedical abortion patients, particularly with high numbers lost to follow up, are difficult to take at face value.
If pills are mailed, there is no way to be sure the right person receives and uses them.
Inherent in the internet and mail order scheme is an inability to guarantee that the person ordering and taking the pills is the right age, the right gestation, has no disqualifying conditions, and will use them as directed.
Or to even ensure that the person is real!
FDA requirements that pills be distributed only to certified prescribers who are personally responsible for ensuring that the patient they have screened is actually the one that takes the pill and initiates the chemical abortion process. This helps to avoid those pills getting lost or getting into the wrong hands.
Anyone can order the pills and say that they are 18, that they are 9 weeks pregnant, that they are not allergic to the pills, etc., and simply have them sent to the address they give, so long as they have functioning credit card. Once receiving them, they can take them, save them, sell them, or dispose of them however they wish.
Even if the supplier of the pills gives the buyer the appropriate screening and warnings, there is no assurance this information will be passed on to the ultimate recipient of the pills. And, as demonstrated above, those pills can prove dangerous.
Allowing the purchase of abortion drugs over the internet further expands the potential for abuse. Men may order and give the drugs to unsuspecting partners to abort children the fathers do not want or do not want to support, attempting to have the women abort without her knowledge or consent. This has already happened with abortion pills bought illegally; it will certainly be worse if the FDA decides to allow these sales.
REMS limits are essential to the safety of mifepristone patients.
Some women, perhaps even most, may be able to endure a DIY, self-managed, “no-test” or telemedical abortion without any immediate or obvious long lasting physical damage. But drugs or protocols like chemical (or “medication”) abortion that pose demonstrated risks to a significant number of potential users require special management and monitoring, if not outright removal from the market.
Because the pills pose special risks to certain populations, women need to be professionally screened for blood conditions, drug allergies, molar or ectopic pregnancy and other conditions.
Testing for Rh antibodies needs to be done so as not to force a woman to sacrifice her reproductive future.
Her pregnancy needs to be dated by a medical professional trained to do so or with access to ultrasound equipment in order to ensure that the drugs not be prescribed at gestations where both failure and more serious side effects are more likely.
Being counseled in person about the risks and the warning signs by the health care professional conducting the examination and prescribing the pills will surely make a stronger impression than the talking head of a stranger on a webcam. This information could prove critical to the woman’s health and safety.
If she does have excessive bleeding or some other complication, she has somewhere she can go where there are medical professionals familiar with her case and how the drugs workand can hopefully provide her the immediate sort of help she needs.
With every protocol out there, these drugs fail a certain percentage of the time. Though in some cases it is easy to tell whether or not they have worked, women may sometimes bleed and cramp and pass clots and believe they have aborted only to find out later that they did not. The surest and quickest way to find out is to be checked out or tested by a specially trained medical professional.
Distribution of these drugs must continue to be managed to ensure drug purity and safe use.
Pills should not be sent by mail from uninspected, unaccountable foreign pharmaceutical makers offering poorly packaged drugs of questionable dose or purity and missing due warnings or even basic instructions.
Mifepristone and misoprostol should not be available from over-the-counter pharmacies selling the pills to women who have not met with and been screened and counseled by trained and certified prescribers.
The tracking of patient outcomes and safety is hard enough already with patients who come into the clinics and receive the drugs and take the mifepristone on site; knowing with any reasonable certainty who ultimately receives these pills and how they fare will be difficult if not impossible when patient and prescriber never physically meet.
The FDA’s current REMS regulations, if followed, offer women some safeguards, helping mitigate these demonstrated risks.
The promoters of these drugs may be willing to live with a certain amount of risk, to accept a number of failures and complications, but the FDA must consider the health and safety of all the women who may use these drugs.
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