By Dave Andrusko
Once upon a time, the FDA had a very strict medical protocol about how the two-drug RU-486 abortion technique could be employed. Requirements about dosage, number of visits, how late in pregnancy the drugs (Mifepristone and Misoprostol] could be used, and the like.
For primarily for two reasons—lack of willpower and the utter unwillingness of the abortion industry to follow the “protocol”—all have fallen by the wayside.
And as winter follows fall, a commentary appearing in Wednesday’s New England Journal of Medicine [NEJM] calls for the remaining safety requirements to be abandoned.
“Mifeprex, for instance, cannot be purchased with a doctor’s prescription at a drug store, or ordered online,” according to the Los Angeles Times’ Melissa Healy. “It can be dispensed only by a specially certified prescriber in a clinic, medical office or hospital. To get it, a patient must attest that she has been briefed on its proper use.”
But if, as the Philadelphia Inquirer reports, the group (which calls itself the “Mifeprex REMS Study Group”) has its way,
“We’d like to see Mifeprex be available in pharmacies like other drugs with a similar safety profile,” said Princeton University public health researcher Kelly Cleland, who joined nine co-authors from academic medical centers and advocacy organizations.
If an ultrasound is needed to confirm that the patient is no more than 10 weeks pregnant, she could get the scan in a nearby radiology center, without an in-person visit to the mifepristone prescriber, Cleland said.
“We trust women and providers to make safe decisions for themselves,” she said.
If, as all the data says is happening, there has been a huge increase in the number of chemical abortions [somewhere in the 30% range], why the need to make abortifacients as easy to purchase as hair coloring? According to Marie McCullough
However, mifepristone has done little to make abortion more accessible or part of private medical practices. Only about 7 percent of sales in 2014 were to private physicians, according to Danco, the manufacture.
The commentary’s argument is that chemical abortions are safe, safe, safe. One piece of new news, however, is an updated figure on deaths associated with RU-486.
Nearly six years ago, 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.
According to McCullough, “The [NEJM] commentary says that in the 16 years since mifepristone was approved, 19 deaths have been reported to the FDA.” There was no update on other “adverse events.”
All this comes less than a year after the FDA radically changed its protocol. At the time, Dr. Randall K. O’Bannon. NRLC director of education and research, told NRL News Today
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.
Editor’s note. For a much more in-depth examination, please read “Activist Abortion Academics Want RU-486 Sold at Your Local Pharmacy,” by Dr. Randall K. O’Bannon, NRLC’s director of education and research.