Unanswered questions in light of FDA changing its RU-486 protocol

By Dave Andrusko

fdabldgThere was so much coverage yesterday of Donald Trump’s comment about “punishing” women who have aborted (a position he later reversed) that perhaps not enough attention was paid to the gift the FDA gave to the Abortion Industry in general, Planned Parenthood in particular.

Both Dr. Randall K. O’Bannon, Ph.D., NRL Director of Education & Research, O’Bannon and myself wrote about the decision, which came at the behest of Danco, the U.S. distributor. Reuters paraphrased Abby Long, a spokeswoman for Danco, as saying

The FDA update reflects data from 22 studies including almost 31,000 women that showed the existing information is out of date.

Dr. O’Bannon succinctly summarized the alteration in the two-drug abortion technique known as RU-486.

The FDA, responding to a request by the U.S. distributor of the drug, has modified dosages [more of the cheaper misoprostol , less of the more expensive mifepristone ], changed the administration, reduced the number of visits, expanded the prescriber pool, and extended the time frame where the drugs may be used. Though applauded by the abortion industry, the documentation demonstrating the impact on women’s safety has not been made publicly available.

Let’s think about this for a while.

Obviously the Abortion Industry is ecstatic. It can make more money off the altered dosages and attract women who may be wary about a surgical abortion (not knowing how bloody and excruciating painful these chemical abortions are). More to the point the FDA gave its after-the-fact support for what abortionists had decided to do on their own going back years and years.

But what don’t we know? Here are just a few items.

Danco spokeswoman Long told Reuters it has been “has been used by more than 2.75 million women in the United States since it was approved in 2000,” but (interestingly) “declined to provide sales data for the pill.” We don’t know how many women have died after taking RU-486 or suffered “adverse events.”

Or, more specifically, we don’t know anything more than what we learned five years ago! At that juncture, the FDA reported that the deaths of 14 women were associated with the use of RU-486 and that there had been 2,209 “Adverse Events.” Adverse events is a blanket term that covers everything from the need for blood transfusions to endometritis, pelvic inflammatory disease, and pelvic infections with sepsis (“a serious systemic infection that has spread beyond the reproductive organs,” according to the FDA).

We don’t know how many abortion clinics have women vaginally self-administer the pills rather than take them buccally (placing the pills between the gums and the cheek) or orally. Neither in its original 2000 protocol or the one announced yesterday did the FDA recommend vaginal self-administration.

We know the FDA on Wednesday signed off on the Abortion Industry’s unilateral decision to eliminate the second visit to the abortionist altogether. We know that the Abortion Industry on its own decided to administer the two-drug technique through the 10th week LMP, and the FDA capitulated yesterday.

But what we don’t know is if having succeeded in moving the outer limit from 7 weeks to 10 weeks, the Abortion Industry will stop there. Based on their past brazen behavior, there is every reason to believe they will not–and then expect retroactive FDA approval.

We don’t know what studies the FDA looked out, who conducted those studies, who at the FDA looked at those studies (if the review committee met, what their credential are, what ties they have to the abortion industry), and so forth.

We don’t know whether or not “effectiveness” (a dead baby completely expelled) dropped off with the new protocol, or when/whether side effects were reduced, what methods and dosages were used associated with reduced side effects, or what impact the reduced side effects had on overall effectiveness, patient safety.

Finally, we don’t know how many women have died overseas, having taken mifepristone/ misoprostol. Does the FDA? If not, why not? And if they do, what is the number? And what is the number of “Adverse events”?

And those are just a few of the unanswered questions.

More tomorrow.