Wednesday, February 11, 2015

RU-486 - myth #3 - benefit to women in remote areas

This is quite the interesting interview.

Anna Maria Tremonti from the CBC interviews four doctors on the drug RU-486.

I transcribed the interview below. What struck me about the segment, was the bias of the interview. Not that I'm surprised, being the CBC and all--but it was just so blatant.

Of the four people Anna Maria interviewed, three of them were "pro-choice" (Dr. Rebecca Gomperts, Dr. Joel Lexchin and Dr. Sheila Dunn) and only one was a pro-life doctor (Dr. Donna Harrison). Dr. Gomperts actually performs abortions on women who live in countries where abortions are illegal. Dr. Joel Lexchin wonders if "[the holdup to approve the drug] is a political decision, in other words, if this is pressure coming from the anti-abortions members of the conservative government to not approve this product". And Dr. Sheila Dunn easily sails through her questions, and is not interrupted by Anna-Maria--unlike the pro-life doctor, who is also asked, if her reasons for not supporting mifepristone, are based on ideology. whereas none of the three "pro-choice" doctors are asked the same question.

Gotta love our national broadcaster who can't get out of the way of their own ideology.

Read on, and make your own conclusions about this drug, how safe it is, and whether or not it is a good idea for women in remote areas of Canada. As it's quite long, I've bolded the good bits for your scanning pleasure.

Anna Maria: A pill called RU-486, known as an abortion pill has been available in Europe for more than 25 years, and in the U.S. for almost 15 years but is still not available in Canada. In fact, Health Canada's drug approval process for the Abortion Pill is taking longer than any previous drug approval process. Why?

It's known as mifepristone, or RU-486. Sometimes it's simply called "the abortion pill."

It's been used by women in the U.S. since the year 2000, and in France since 1988. In fact, millions of women in more than 50 countries around the world have used it. But it hasn't yet been approved for use in Canada.

Dr. Rebecca Gomperts, for one, wonders why that is. She's the founder of Women on Waves, an organization that sails a ship to countries where abortion is illegal to perform early medical abortions for women who need them. She's been using the abortion pill -- mifepristone -- with patients for more than 15 years."

Dr. Rebecca Gomperts: It's safer than Viagra, it's safer than penicillin, and it's safer than driving a car. So it's quite interesting to learn that there has been, application process has been delayed again because it's really, especially in Canada, mifeprestone can make such a difference to women's lives and health. When it comes to RU-486 this is not a new drug. This is something that's been used for decades. It's used in multiple countries around the world. So it's hard to imagine that there's a need for more information about how it works or how safe it is. That information should be readily available based on previous experience...

Anna Maria: We asked Dr. Lexchin (Dr. Joel Lexchin, Professor at York University in Toronto) what could be the reason for the delay. He offered two possible explanations.

Dr. Joel Lexchin: One of them is possible because this is a small company and small companies may not be completely familiar with how Health Canada makes its decisions and the kinds of documentation...[and] based on absolutely no evidence whatsoever, my other speculation is that this is a political decision, in other words, this is pressure coming from the anti-abortions members of the conservative government to not approve this product and that's what's holding it up but as I said I have no actual evidence to back that up.

Anna Maria: Mifespristone's effectiveness as an abortion pill was studied right here in Canada in the early 2000s. Dr. Sheila Dunn was a part of that research team. She's a family physician at Women's College Hospital in Toronto, and an Associate Professor of Family and Community Medicine at the University of Toronto.

Mifepristone has been available for medical abortions in the United States since 2000. But that's not to say that there's no debate over the drug there. In fact, some U.S. doctors don't feel that mifepristone is safe.

Sheila Dunn joins us now.

Anna Maria: Can you explain how mifeprestone works?
Dr. Sheila Dunn: Mifeprestone is a compound that blocks the action of hormones, and progesterone is a pregnancy that is produced in high levels in early pregnancy, and it really supports the development of the pregnancy. It supports the lining of the uterus, keeps the uterus quiet. It keeps things stable and growing there. So it's really a pregnancy supportive hormone. And mifeprestone blocks the action of that hormone.

Anna Maria: Is it that blocking that causes essentially a miscarriage?
Dr. Sheila Dunn: What it does is in blocking the action of progesterone it kind of destabilizes the pregnancy, it makes the uterus a little bit more irritable and then a second drug called misoprostol is administered a couple of days after the mifeprestone and that causes uterine contraction and it causes the cervix to open up and the products of conception and pregnancy is expelled.

Anna Maria: Now you researched the effectiveness of mifeprestone and just how effective is it?
Dr. Sheila Dunn: it's very effective. We know that certainly in terms of women who don't need any surgical completion of the abortion, it's probably about 97 % of women need no further treatment at all other than that particular drug. In our study we found that there was a little bit higher rate, maybe 4% of women who had a surgical procedure to complete the abortion but I think if you look at a number of different studies that that rate is potentially lower than that and it's maybe 1% of women it may not be effective in terms of terminating the pregnancy.

Anna Maria: So we can get all our cards on the table, did the drug company that developed and sells mifeprestone support or fund the trials that you did?
Dr. Sheila Dunn: no

Anna Maria: Is a medication based abortion safer than a surgical one?
Dr. Sheila Dunn: No. I'd say they are pretty comparable in terms of safety.

Anna Maria: who would benefit from mifepristone being approved in Canada?
Dr. Sheila Dunn: Women who may need abortions would benefit. First of all it would give them another choice in terms of method they might want to use to terminate a pregnancy. Many women actually don't want a surgical procedure. They might want to choose something that's more like a miscarriage such as a mifeprestone abortion. Many women don't like the idea to have instrumentation in the uterus. This would be another option for them. 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.

Anna Maria: Some doctors have expressed concern about the side effects of mifepristone , the main one being that it can lead to fatal sepsis. Are those valid concerns?
Dr. Sheila Dunn: 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 mifeprestone. 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.

Anna Maria: What about something, like does it repress the immune system?
Dr. Sheila Dunn: There had been some thoughts that might be an explanation for it but these were not found to really to explain it. There is really no significant effect on the immune system of one dose of mifeprestone.

Anna Maria: I wanted to go back to the idea that it blocks progesterone. That would mean it's blocking it throughout the body. Is that dangerous for the brain, the breasts...
Dr. Sheila Dunn: This is a one time dose that has a profound effect on very sensitive tissues, such as the tissues that would support an early pregnancy, but in terms of other impacts, no.

Anna Maria: What about bleeding?
Dr. Sheila Dunn: 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.

Anna Maria: is mifeprestone subject to a higher % of side effects than other prescriptions or even over the counter medication.
Dr. Sheila Dunn: No it's been shown to be a very safe drug we use lots of drugs over the counter that have the potential to be quite unsafe specifically for certain individuals, this is a drug that would be used by a provider who would assess a situation and there would be close medical supervision so I think it's a very safe drug.

Anna Maria: What was your reaction when you heard that Health Canada was delaying its decision on mifeprestone until the fall?
Dr. Sheila Dunn: I was disappointed. I am encouraged because I think we will see it. But it's one more length of time that Canadian women have to be without this drug that other women in other countries have access to and I think there is very good reason to think we need this drug in Canada to make sure that women across the country have good access to abortion that meet their reproductive health needs.

Anna Maria: If it is approved will it be smooth sailing after that or do you see other hurdles with this drug?
Dr. Sheila Dunn: Once its approved there needs to be some strategies to make sure that people who would be providing it would be able to provide it safely and effectively. Do the associated counseling that women women might need to make sure that there are structures in place that in terms of follow up that women can have the follow up they need, so I think there's a sort of implementation role that will need to be done that involves training and some thought but it's really not a complicated drug to use and this would just be something to ensure that its used in the most effective and safe way.

Anna Maria: Dr. Donna Harrison is next (Dr. Donna Harrison is the executive director of the American Association of Pro Life Obstetricians and Gynecologists. She was in Eau Claire, Michigan.)

Anna Maria:: You just heard that our first guest say that the research say this is a safe drug. It should be approved here for se here in Canada. What is your position on the safety of mifepristone?
Dr. Donna Harrison: I think we need to put some numbers on the word "safe". We know that roughly 1 out of every 20 women who have mifeprestone abortions will have a complication. Like major bleeding, some of those requiring blood transfusions, and emergency surgery, failed abortion with pregnancy tissue left inside, and also a need for emergency surgery to complete the failed abortion. 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 mifeprestone, 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... (interrupted by Anna Maria)

Anna Maria: Out of how many women who took the drug?
Dr. Donna Harrison: At that point we had, well that's an excellent question because although the manufacturer was supposed to have tracked the drug and kept count of it the manufacturer didn't do that, so we didn't have an idea of how many. We can say roughly it was probably in the 1000,000s, but you're still talking exactly what she said about 4% of rate of complications. But 4% means one out of 20 women. So it's not like you can look at the numbers and say oh well it's okay that these women who were previously healthy are now hemorrhaging or may have died, these are all women who were healthy who didn't have to be exposed to this kind of a risk.

Anna Maria: the FDA, the American body responsible for approving drugs in the US , and its own figure show that one and a half million women over 10 years, 14 died while taking mifeprestone, of those deaths none of those could be conclusively tied to mifeprestone.
Dr. Donna Harrison: well that's a little bit of spin there. 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 mifeprestone and the second drug misoprostol suppress the immune system. And even a single dose of mifeprestone on experimental animals causes those animals to be much more susceptible to infection in fact...(interrupted by Anna Maria)

Anna Maria: yet we just heard our last doctor tell us that it fact they looked extensively into that issue and they could not significantly tie immune suppression to this drug.
Dr. Donna Harrison: well...(interrupted by Anna Maria)
Anna Maria: ...After extensive research
Dr. Donna Harrison: Well that's actually not true, I was there at the FDA...(interrupted by Anna Maria)

Anna Maria: you're telling me she's not telling me the truth?
Dr. Donna Harrison: What I'm telling you is that there is extensive research looking at this and in fact mifeprestone 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 health 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.

Anna Maria: Is of all...there are 60 countries who have approved this drug? (stumble, stumble)
Dr. Donna Harrison: correct

Anna Maria: If it's so unsafe why have 60 countries gone along with it.
Dr. Donna Harrison: Well there's a lot of political pressure for population control and I think it's a sad thing that people are willing to give a drug that has four times as many complications as surgical abortions just simply because they...I don't know why people don't care about their women and why they think it's okay that women take a drug that is much much more associated with complications than surgical abortion.

Anna Maria: Is your opposition to this drug based on the medical analysis that you just cited or is there also an ideological stance for you?
Dr. Donna Harrison: Well I was the one responsible for, myself and another physician, looking at the first 607 adverse event reports that were submitted to the FDA and this drug as I followed it and followed it through the pharmacology, this drug is a very powerful drug and I think that the spin that is being put on it that you just pop this pill and the abortion is over--is just not true. So I think it's important that women know that when they take the drug the issue of informed consent, that this drug is associated with this increased risk of fatal infection, it's four times as likely that they will have a complication from this than if they have a surgical abortion and the drug does not work right away. It takes a week as opposed to 15 minutes for a surgical abortion.

Anna Maria: Have you ever prescribed it?
Dr. Donna Harrison: I have not, no.

Anna Maria: is it available in Michigan?
A It's available in Michigan

Anna Maria: Is it popular?
Dr. Donna Harrison: Well it depends on whether you've had a complication or not.
Anna Maria: What I mean is, is it widely prescribed?
Dr. Donna Harrison: I think the abortion in the US about one fourth of them are medical, so it is being used but there are complications from it and it's not a simple drug.

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