“F” the FDA: How Planned Parenthood Policy Endangers Patients to Protect Profit

The moment that medical abortion (AKA RU486 or the “abortion pill”) was approved in the US in 2000, I mean immediately, Planned Parenthood ignored the FDA approved regimen and determined its own alternative. While off-label use of medicines is not illegal, Planned Parenthood’s ‘choice’ to flout the FDA protocol resulted in deaths and continues to mislead and endanger many patients.

Planned Parenthood’s deviations from the approved FDA regimen include 1) a lower dose of the first pill mifepristone (the really expensive one), 2) a higher dose of misoprostol (the really cheap pill), 3) allowing the misoprostol to be administered by the patient at home (Instead of by the physician on a 2nd visit,) and 4) allowing the regimen to be used through 9 weeks rather than 7 weeks as the FDA had approved. All of these are bad ‘choices’ for women.

Planned Parenthood used its standard rhetoric to justify the changes. “It’s more private” taking the second medicine at home, and “It’s more convenient” to not have to come back for a doctor to administer the second medicine or to never even see a doctor at all in the case of ‘telemedicine abortions’ (which PP is currently lobbying to federally approve.) These Planned Parenthood ‘choices’ threaten the safety and health of women. Very few women would choose a little convenience over safety and nobody would choose a little convenience over death.

The FDA study, based on a protocol used in France found that the regimen became significantly less effective with considerably more side effects after 7 weeks gestation. In fact, 1/5 of patients failed to abort between 8-9 weeks, requiring a followup surgical abortion. The Planned Parenthood regimen is based on one used by the poorest countries in the world, where patients couldn’t afford the $83 pill for Mifepristone, but could afford to increase the Misoprostol ($1 a pill.) Why did Planned Parenthood choose the Third World regimen for women in America? It charges up to $800 for a medical abortion, so one has to wonder!

Planned Parenthood also eliminated the second visit to the clinic for the physician to administer the misoprostol as prescribed by the FDA protocol, a cost saving measure for PP no doubt, disguised as caring about convenience for patients. PP initially instructed patients to take the misoprostol vaginally at home, but after 11 women using the vaginal regimen died, some clearly from bacterial sepsis (an overwhelming infection), PP changed the administration route to having patients place the misoprostol inside their cheeks to dissolve. PP also began to prescribe prophylactic antibiotics despite the FDA not having determined an appropriate antibiotic regimen or whether prophylactic antibiotics were even called for after PP abandoned its disastrous vaginal self-administration protocol. If you listen to the news, you know that prophylactic antibiotics can stimulate the growth of “superbugs” resistant to most antibiotics and their use must be carefully studied and recommended by the FDA, which is not the case here. Mifepristone is teratogenic, causing significant birth defects if the pregnancy is not terminated. Giving only 200 mg of it will cause significantly fewer successful abortions if the medication is not followed by the higher dose misoprostol, the medicine patients are entrusted with taking themselves. Since about 20% of patients were lost to follow up in Planned Parenthood’s study, one can only guess at how many actually took it, and also how many had severe consequences as a result of taking it.

Planned Parenthood misleads women in several ways regarding its version of medical abortion. It misleads patients as to what to expect with medical abortion. On several clinic sites and articles, it downplays and describes the medical abortion experience anywhere from like an early miscarriage to like a heavy period suggesting it will be over in a few hours though spotting might last for several weeks. The FDA study found women bled for an average of 16 days and I read that most women were much less satisfied with the medical abortion experience than a surgical abortion. PP suggests most would recommend medical abortion to a friend, but that is not how Abby Johnson who was a previous director of a Planned Parenthood clinic felt. You can read about her experience here-http://abortionpillrisks.org/real-stories/abby-johnsons-story/?doing_wp_cron=1444751517.4947569370269775390625.

In its “scientific” studies, investigating its own successes, Planned Parenthood first compared its vaginal administration of Misoprostol to its buccal admisinstration (neither FDA approved protocols) and claimed them equally effective, which resulted in ridiculous media acclaim. The same amount of medicine works if you administer it in a safer way than we originally chose….that’s not newsworthy unless you are the media’s favorite child.  PP has also lumped data to hide the worsening results later in pregnancy. It combines its data and eliminates the patients lost to follow-up from its analysis (dishonest research technique) then claims as high as a 97% success rate. Every one of those patients lost to followup could have wound up in an emergency room with a complication or in need of surgery. It does not tell its patients that medical abortion is less successful after 7 weeks. If it doesn’t work, PP simply does a surgical abortion to complete the process. Patients are required to agree to a surgical abortion in the “unlikely case” that the medical one fails. The $800 fee, almost double the price of an early surgical abortion, more than covers the cost of the PP version of a medical abortion (less than $100 for the medication) and a surgical ‘redo.”

PP prefers to do medical abortions because more of its clinics can do them, they have a better profit margin, and if PP wins its telemedicine battles, they can be done without the need for a physician on site. Every change PP made to the FDA approved regimen benefits Planned Parenthood’s bottom line. Every change PP made to the FDA approved regimen potentially endangers women. It is clear that the FDA protocol is safer and more effective. PP tries to claim its regimen is as safe and effective, but its study on this was done by PP itself and done poorly (omitting the large number of patients lost to followup). Here’s an example of the rhetoric you will see-“Other recent anti-choice legislation seized upon enforcing an outdated FDA-approved regimen for administering mifepristone, which requires patients make three or more office visits instead of only two. Under the evidence-based regimen, women can bring home the misoprostol they’re supposed to take two days after the mifepristone, while the FDA regimen requires an additional trip be made to take that misoprostol in front of a doctor…”Even for the most privileged of women, making four trips to a doctor’s office to terminate one pregnancy is a huge burden.” http://www.theverge.com/2015/8/25/9174769/abortion-pill-shot-surgery-medical-women-healthcare.

Just like with TRAP laws (see my last post), Planned Parenthood has used politics to rally people against laws, or in this case FDA approved regimens, which are intended to protect women. The FDA regimen recommends 3 (not 4 as exaggerated) visits to the clinic, while Planned Parenthood’s requires 2. The extra visit ensures the second medicine is taken correctly which is to the patient’s advantage. PP also has no good answer for changing to the cheaper (poorly tested) medical regimen or for allowing medical abortion through 9 weeks instead of 7 (even though less effective and with more side effects.)  These choices are not safe for women and Planned Parenthood clinics, particularly those in states which allow telemedicine abortions, should be avoided by any patient concerned about safety.