Vivian was 22 years old, and died December 29, 2003, six days into the abortion process. She‘d been given the drugs on December 23 at the Costa Mesa Planned Parenthood facility. The autopsy showed that she died of sepsis.
Vivian‘s husband is suing the drug company, Planned Parenthood of Orange and San Bernadino Counties, and The Population Council Inc., in Orange County Superiour Court.
Planned Parenthood spokesperson Kimberlee Ward said that PP has "absolute confidence in this method of abortion".This, though they were dispensing the drugs in an unapproved manner. But since Vivian's fetus died, it seems that the abortion was, at least for Planned Parenthood, completely satisfactory.
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And what, pray, was "unorthodox" about the method?
ReplyDelete"Off label" uses of drugs are employed ALL THE TIME. It just means that the drug has multiple uses, others besides the use for which it was originally approved. Misoprostol was originally approved to treat ulcers, and methotrexate, for cancer and autoimmune diseases.
And medical abortion does not cause sepsis. The closeness of the abortion and the death is most likely coincidence.
And why is the husband suing the Population Council???
But you'd better have a good reason for doing it in an off label manner if you don't want to get your ass sued off. For example, some NSAIDS seem to prevent or slow the growth of certain cancers, so some oncologists will prescribe them to for that purpose in select patients.
ReplyDeleteBut what PP was doing was unmitigated laziness. They were NOT following the French protocol, but were instead having the woman use the prostaglandin without even examining her first to see if she needed it to expel the embryo (first screw up), and they were giving the prostaglandin as a suppository rather than orally despite the increased risk of infection with vaginal prostaglandin. So this was a shortcut routine that they were doing for all patients, and not a carefully-thought-out deviation for a particular patient based on her health needs.
As to why the husband is suing the Population Council, I believe it was due to their lobbying efforts to get RU-486 fast-track approval without first having studies done based on US practice rather than French practice.
Oho!--if that's why he's suing the PopCouncil, rots of ruck, laddybuck. Why not also sue the members of the FDA? Or go for the really deep pockets--sue Bill Clinton! In fact when FDA approved RU486 it had more than half a million well-documented uses abroad, many times more field-testing than most new occasional-use drugs get before going to market. That's why the FDA was willing to do some ahem unorthodox things (using Section H) to get it passed--everyone knew there was no problem. There were enough data available that should have justified its approval already under Bush/Quayle.
ReplyDeleteAnd you're wrong about off-label drug use being a litigation risk. As long as it's industry-standard use you're ok. Otherwise, there would be a big lobbying effort by docs to get the FDA to approve and reapprove everything for all possible uses. Waste of time and computer-space.
One other thing which may interest you: RU486 approval was very much less significant than people think. Medical abortion using methotrexate instead of RU486 was already well on the way to the mainstream. (I know because I helped it along in a very small way.) If RU486 had been further delayed it would have made zero difference, or near-zero, to medical abortion in USA. Some of your individual bad cases would have been prevented because methotrexate, unlike RU486, kills ectopic pregnancies. It's not entirely clear to me why anyone uses RU486 rather than methotrexate.
I didn't say the suit would fly. I just gave you what I think was his rationale.
ReplyDeleteActually if a medical abortion fails (especially the Misopristol or other prostaglandin) and the woman doesn't completely expell the pregnancy, it can lead to infection and sepsis as the pregnancy biodegrates. Actually, I believe having an incomplete abortion and needing a repeat abortion is one of the most common complaints made by women having medical abortions. Also consider that vaginitis is a documented side effect of Mifepristone and a bacterial vaginal infection can enter the uterus through the dilated cervix and introduce infection into the uterus. Seems more than an unlikely coincidence to me...
ReplyDeleteRachel C, that's all very rare. Not failed expulsion--that as you say is common, but infection of same is rare in medical abortion because there is no vector to bring outside bugs into the uterus.
ReplyDeleteYes vaginitis is a side effect of RU486 but it's a rare one.
But of course there's no way to tell for sure whether it was involved in this particular death. That's one of the reasons anecdotes don't prove anything.`
SoMG,
ReplyDeleteWhen a woman's baby dies in utero (spontaneous abortion) and it is not expelled within a few weeks, sometimes the body reabsorbs the "products of conception" but more frequently she is given a D&C, right? Isn't this to prevent an infection? Which you say should be "rare...because there is no vector to bring outside bugs into the uterus." From my understanding, a D&C is usually performed when a miscarriage does not complete itself naturally, because the dead fetus may rot in the woman's uterus causing infection. Why should a dead fetus from a medical abortion not rot and cause infection to the mother's uterus, while a dead fetus from a spontaneous abortion would?
Sure, you don't let dead meat stay in the patient's uterus indefinitely! If she's retaining after a month or so you do a D&C to kick-start her menstrual cycle as well as to get rid of the meat. You're not gonna just leave it there forever! But the IMMEDIATE risk is low, there's no urgency to it.
ReplyDeleteIn Vivian's case, she died six days after getting dosed. That's extremely unlikely to be from her medical abortion. I believe the number of post-RU486 sudden-sepsis deaths world wide is still less than twenty!--at least it was last time I googled it.
Besides, retained tissue would have been detected on autopsy. GG would have posted it.
You can get deadly sepsis from a tampon, too. Every few years I read about a case. That's the OTHER reason anecdotes are no good--you can find anecdotes about anything. People die of heart attacks sometimes during prayer, and I have anecdotes to prove it! So are you gonna stop praying? You need numbers. Otherwise you're, well, oogety-boogety.
dead meat
ReplyDeleteWhich means you don't see the unborn, or women, as worthy of protection.
Not after they're dead, no.
ReplyDeleteBesides, most of the meat is placenta.
ReplyDeleteI believe there are some cultures where they eat the placenta after birth.
Very tender, rich in iron, like other highly vascularized tissue such as liver.