Friday, February 13, 2015

RU-486 - myth #4 - more on safety and remote areas

I've condensed this last blog post on RU-486.

The main points in it, were that the two doctors interviewed, Dr. Shelia Dunn, and Dr. Donna Harrison, differed on the safety of the drug, and whether or not it caused immune suppression in women, and whether or not it is a good idea for women in rural or remote areas.

My take away from the interview was that the drug is not safe, it does cause immune suppression in women, and that it should not be give to women in remote areas. Yet look at how The CBC's Current, and the Women's Health College tweeted the interview.

I wonder if they listened to the same interview that I did?

Dr. Sheila Dunn - On the immune system and side effects Dr. Donna Harrison - On the immune system and side effects
There is really no significant effect on the immune system of one dose of mifepristone.

There is bleeding associated with any kind of miscarriage. The abortion process of a medical abortion involves bleeding and involves cramping. So that's an expected effect. There are unusual situations where the bleeding is excessive, there needs to be a surgical aspiration to stop that bleeding but that is an uncommon situation. And it could be something that would be experienced in a miscarriage, or even potentially after the occasional surgical abortion, that could be a complication or side effect.

Well we are always concerned about side effects. But this drug has been used extensively by millions of women over the last 20 or so years. There certainly were a few reports in the early 2000's of some fatal infections that were associated with the use of mifepristone. they were extensively investigated and there was really no causal association found, it was found to be associated with it, the same types of infections also associated with miscarriage, with delivery, with certain gynecological procedures so it's not exclusive to mifepristone abortions but these were unusual infections and I don't think we know now even, have an explanation for what happened but were extensively examined by the FDA and there was really no causal determination made in terms of the effect of mifepristone in the cases.
14 died and what that means is that 1 out of 100,000 rate of death which is exactly what we got with the rate which was initially looked at by the FDA for the rate fatal sepsis. Now when you look at the infection rate which is 1 out of 100,000 for this clostridium sordellii, the reason for that infection, that fatal infection is that both mifepristone and the second drug misoprostol suppress the immune system. And even a single dose of mifepristone on experimental animals causes those animals to be much more susceptible to infection in fact...

There is extensive research looking at this and in fact mifepristone is responsible for immune suppression and if you look at the transcript of the meeting the FDA meeting and I was there they did tie it. In fact it's clearly tied to suppression of the immune system for this particular bacteria that killed women and in addition to that misoprostol has been extensively looked at in animal models and it also suppresses the immune system so you are taking two immune suppressant drugs and the women that died were healthy before and dead a week later. These are not women who are immune suppressed like HIV patients or diabetic, these were previously completely healthy women that died from a bacteria because their bodies could not respond, that's the reason why they died they were taking two powerful immune suppressing drugs, so if you actually look at the transcript, you'll see that the FDA and CDC clearly tied it taking these drugs.

Dr. Sheila Dunn on - Rural and remote areas

In my opinion the big benefit in terms of Canada would be that it would offer women who are living in areas where access to abortion may be difficult for them: sort of northern, rural, remote, and in some provinces, like PEI, maybe NB, where women really can't easily access a surgical abortion, they may have to travel etc.Mifepristone could be provided in a village or a town by a primary care provider, the woman's own physician, and she could have the abortion in her own community instead of having to travel. That would enable her to get it more easily, it would probably enable her to get it sooner, the sooner a woman has an abortion, the safer it is. Every time it's delayed or its later in pregnancy it becomes a little less safe to have a surgical abortion. And just in terms of making it easier for her. So that she doesn't have the expense, the cost, and potentially difficult issues with childcare etc. that may be associated with having to travel.
Dr. Donna Harrison on - Rural and remote areas

So that the women in rural areas that our first guest was talking about who are being targeted for this drug are exactly the same women who will be at much higher risk with serous complications, simply because they don't have access to that emergency surgery. And in the US one of the requirements for using mifepristone, is that a woman have 24 hour access to surgical completion in case she hemorrhages. See it's convenient for the abortion provider to give these drugs and walk away but an abortion provider in a rural area is not going to be there when the woman hemorrhages so that's a big concern especially for rural women. So I think you have got to put some context into a word like "safe". When I reviewed and published the first 607 adverse event reports that were reported to the FDA, there were 237 of those who hemorrhaged and of those 237, one of them was fatal, 42 were life threatening, that means they lost over one half their blood volume, and 168 were serious cases of which 68 required transfusions...

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