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The Truth About ella

Yesterday, an article was published on Slate, “Is Ella Birth Control or Abortion? The new morning-after pill.”

 This response will address some points made in the Slate article that may be misleading about the newly-approved drug.

Studies have found [ella] to last longer and be twice as effective as Plan B, the version currently on the market, which is only effective for up to 72 hours after intercourse.” And “Pro-life supporters… are worried about the effect of ella on an embryo before it implants and raised similar concerns following the approval of Plan B in 1999.”

While both ella and Plan B are touted as “emergency contraception,” the drugs have dissimilar chemical make-ups and work differently.  The drug ella is deadlier than Plan B and is not simply a newer “version.”   

As the article admits, the chemical make-up of ella is similar to the abortion drug RU-486.  Both are selective progesterone receptor modulators (SPRMs).  By blocking progesterone, an SPRM can either prevent a developing human embryo from implanting in the uterus, or it can kill an implanted embryo by starving it to death.

When the Food and Drug Administration (FDA) approved Plan B (which is a progestin-based drug, as opposed to a progesterone blocker like ella and RU-486)  it acknowledged that the drug not only prevented fertilization but “may also work by…preventing attachment to the uterus (i.e. implantation) …”  

However, in approving ella, the FDA has chosen even broader language to describe how it may work: ella “may affect implantation.” This acknowledges that ella does more than “prevent” implantation – ella can disrupt implantation, killing the implanted embryo.

Furthermore, while the FDA made specific assurances that Plan B would not affect an embryo after implantation, just the opposite is true for ella.  The FDA advises that ella should not be taken if there is  a “known or suspected” pregnancy. 

Critics, however, warn that it’s a potentially dangerous drug that was inadequately studied.”

It’s not just ella’s critics who warn that the drug was inadequately studied.  The FDA’s prescribing instructions note among the things that have not been studied are:

–       The safety and efficacy of repeated use of ella

–       How ella may interact with hormonal contraceptives

–       The effects of ella on minors

–       The risks to a fetus when ella is administered to a pregnant woman

–       The risks to an infant when ella is taken by a nursing mother

In addition, since ella’s chemical make-up and mode of action are very similar to RU-486, serious concerns exist about ella’s risk to women’s health.  RU-486 is known to cause serious adverse health risks such as severe bleeding, ruptured tubal pregnancies, serious infections, and even death.  Further study is necessary to ensure ella is safe for women, particularly if it is used off-label.

“[T]here’s no evidence that ella can interrupt an existing pregnancy or prevent implantation, and other experts point to the drug’s 2 percent failure rate as proof.”

The failure rate of ella cannot be offered as proof that the drug does not cause abortions.  The other FDA-approved abortion drug, RU-486, also “fails.”  In U.S. clinical trials, the failure rate for RU-486 abortions was 8% when taken 49 days or less from the last menstrual period (LMP) and jumped to 17% at 50-56 days LMP, and to 23% at 57-63 days LMP.[1]

In fact, ella’s extremely low “failure” rate is an indication that it does cause abortions.  At the FDA advisory panel meeting in June, Dr. Scott Emerson, a professor of Biostatistics at the University of Washington and panelist, repeatedly raised the point that the low pregnancy rate for women taking Ella four or five days after intercourse suggests that the drug must have an “abortifacient” quality.  Even if ella’s primary mechanism of action is to delay ovulation, it cannot be so successful at “preventing” pregnancy four to five days after intercourse unless it also works to interfere with (or kill) a developing embryo, as conception will have already occurred in a more significant number of women that many days after intercourse.  The study results regarding ella’s effectiveness, presented by its manufacturer HRA Pharma, clearly do not make sense otherwise.

Moreover, it is false to claim there is “no evidence” that ella can interrupt an existing pregnancy or prevent implantation.  As already explained, the FDA’s prescribing instructions note that ella may affect implantation, and it cites animal studies demonstrating high embryofetal loss. 

 “[Dr. Trussell] adds that a woman would have to take ‘many, many, many times’ the amount of the drug to induce an abortion. ‘And where is someone going to get it?’”

Advocates of ella hide behind the lack of research to claim that low doses of ella will not harm a pregnancy.  First, it is bad science to say that because you have not done the study, and therefore do not have any results to disprove your point, you must be correct.  Second, numerous studies show that ella causes abortions in animals, including rats, rabbits, guinea pigs and macaques (similar to monkeys).  Moreover, the European Medicines Agency (EMEA), the EU equivalent of the FDA, indicated that ella “is embryotoxic at low doses, when given to rats and rabbits.” 

Even assuming for the sake of argument that it would take an off-label use of ella to cause an abortion, we know that Planned Parenthood, an expected major provider of ella, is no stranger to misusing drugs.  At the FDA advisory panel meeting on ella  in June, Planned Parenthood’s Dr. Vanessa Cullins boasted about the organization’s off-label use of Plan B, giving us every reason to expect they will do the same with ella.  Planned Parenthood’s dangerous off-label use of RU-486 in a variety of ways is also well known. We can expect that Planned Parenthood will similarly push off-label use of ella

An unfortunate pattern seems to be developing with the FDA and abortion-causing drugs.  The approval of ella is yet another example of the agency’s willingness to let politics trump its obligation to ensure the safety and proper marketing of the drugs it approves.

[1] Irving Spitz et al., “Early pregnancy termination with mifepristone and misoprostol in the United States,” New England Journal of Medicine 1998, 338:1241-47.