CBC - big abortion's mouthpiece - Part 3

(Part 1)
(Part 2)

"I cannot understand the need for that. There isn't a medical reason we would need that." Dr. Wendy Norman

So let's look at these strict accessibility guidelines for RU-486 (mifepristone), based on the US example, a country ten times the size of Canada.

Is there a "medical reason" for these guidelines or isn't there?

The CBC has interviewed Dr. Norman at least six times, and each time she questions why Canada has chosen to only allow doctors to dispense this drug, and not pharmacists. Dr. Norman calls this behaviour "strange and bizarre", "highly unusual", an "absolutely inexplicable regulation" and "demeaning".

Decide for yourself.

All the information and links below are from the US's Food and Drug Administration's (FDA) Approved Risk Evaluation and Mitigation Strategies (REMS). (All emphasis in red added)

I. GOAL

The goal of the Mifeprex REMS is to mitigate the risk of serious complications associated with Mifeprex by:

a) Requiring healthcare providers who prescribe Mifeprex to be certified in the Mifeprex REMS Program.

b) Ensuring that Mifeprex is only dispensed in certain healthcare settings by or under the supervision of a certified prescriber.

c) Informing patients about the risk of serious complications associated with Mifeprex 

II. REMS ELEMENTS

A. Elements to Assure Safe Use

1. Healthcare providers who prescribe Mifeprex must be specially certified.

  a. To become specially certified to prescribe Mifeprex, healthcare providers must:

  i. Review the Prescribing Information for Mifeprex.

  ii. Complete the Prescriber Agreement Form. By signing the Prescriber agreement Form, prescribers agree that:

    1) They have the following qualifications:

      a) Ability to assess the duration of pregnancy accurately

      b) Ability to diagnose ectopic pregnancies

      c) Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

    2) They will follow the guidelines for use of Mifeprex (see b.i-v below).

  

b. As a condition of certification, healthcare providers must follow the guidelines for use of Mifeprex described below:

  i. Review the Patient Agreement Form with the patient and fully explain the risks of the Mifeprex treatment regimen. Answer any questions the patient may have prior to receiving Mifeprex.

  ii. Sign the Patient Agreement Form and obtain the Patient’s signature on the Form

  iii. Provide the patient with a copy of the Patient Agreement Form and Medication Guide.

  iv. Place the signed Patient Agreement Form in the patient's medical record.

  v. Record the serial number from each package of Mifeprex in each patient’s record.

  vi. Report any deaths to Danco Laboratories, identifying the patient by a nonidentifiable reference and the serial number from each package of Mifeprex.

c. Danco Laboratories must:

  i. Ensure that healthcare providers who prescribe Mifeprex are specially certified in accordance with the requirements described above and de-certify healthcare providers who do not maintain compliance with certification requirements 

  ii. Provide the Prescribing Information and Prescriber Agreement Form to healthcare providers who inquire about how to become certified. 

The following materials are part of the REMS and are appended:

• Prescriber Agreement Form

• Patient Agreement Form

2. Mifeprex must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.

  a. Danco Laboratories must:

    i. Ensure that Mifeprex is available to be dispensed to patients only in clinics, medical offices and hospitals by or under the supervision of a certified prescriber.

    ii. Ensure that Mifeprex is not distributed to or dispensed through retail pharmacies or other settings not described above.

3. Mifeprex must be dispensed to patients with evidence or other documentation of safe use conditions.

  a. The patient must sign a Patient Agreement Form indicating that she has:

    i. Received, read and been provided a copy of the Patient Agreement Form.

    ii. Received counseling from the prescriber regarding the risk of serious complications associated with Mifeprex.

B. Implementation System

1. Danco Laboratories must ensure that Mifeprex is only distributed to clinics, medical offices and hospitals by or under the supervision of a certified prescriber by:

  a. Ensuring that distributors who distribute Mifeprex comply with the program requirements for distributors. The distributors must:

    i. Put processes and procedures in place to:

      a. Complete the healthcare provider certification process upon receipt of the Prescriber Agreement form.

      b. Notify healthcare providers when they have been certified by the Mifeprex REMS Program.

      c. Ship Mifeprex only to clinics, medical offices, and hospitals identified by certified prescribers in the signed Prescriber Agreement Form.

      d. Not ship Mifeprex to prescribers who become de-certified from the Mifeprex Program.

      e. Provide the Prescribing Information and Prescriber Agreement Form to healthcare providers who (1) attempt to order Mifeprex and are not yet certified, or (2) inquire about how to become certified.

    ii. Put processes and procedures in place to maintain a distribution system that is secure, confidential and follows all processes and procedures, including those for storage, handling, shipping, tracking package serial numbers, proof of delivery and controlled returns of Mifeprex.

    iii. Train all relevant staff on the Mifeprex REMS Program requirements.

    iv. Comply with audits by Danco Laboratories, FDA or a third party acting on behalf of Danco Laboratories or FDA to ensure that all processes and procedures are in place and are being followed for the Mifeprex REMS Program. In addition, distributors must maintain appropriate documentation and make it available for audits.

    b. Ensuring that distributors maintain secure and confidential distribution records of all shipments of Mifeprex.

  2. Danco Laboratories must monitor distribution data to ensure compliance with the REMS Program.

  3. Danco Laboratories must audit new distributors within 90 calendar days after the distributor is authorized to ensure that all processes and procedures are in place and functioning to support the requirements of the Mifeprex REMS Program. Danco Laboratories will take steps to address distributor compliance if noncompliance is identified.

  4. Danco Laboratories must take reasonable steps to improve implementation of and compliance with the requirements of the Mifeprex REMS Program based on monitoring and assessment of the Mifeprex REMS Program.

  5. Danco Laboratories must report to FDA any death associated with Mifeprex whether or not considered drug-related, as soon as possible but no later than 15 calendar days from the initial receipt of the information by the applicant. This requirement does not affect the applicant's other reporting and follow-up requirements under FDA regulations.

C. Timetable for Submission of Assessments

Danco Laboratories must submit REMS assessments to FDA one year from the date of the initial approval of the REMS (06/08/2011) and every three years thereafter. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 days before the submission date for that assessment. Danco Laboratories must submit each assessment so that it will be received by the FDA on or before the due date.

_________________________________________________________________________

What do participants need to know?

Healthcare Providers who prescribe and dispense Mifeprex must To be able to prescribe:

• Review the drug’s prescribing information.
• Complete and submit the Prescriber Agreement Form.

Healthcare Providers who prescribe and dispense Mifeprex  must Before dispensing

• Review the Patient Agreement Form with the patient and fully explain the risks of the Mifeprex treatment regimen.
• Provide the patient with the Medication Guide.
• Complete the Patient Agreement Form with the patient. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.
• Complete the Patient Agreement Form with the patient. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.

Patients who are prescribed Mifeprex Before receiving

• Review the Patient Agreement Form.
• Complete the Patient Agreement Form with the prescriber.
• Receive counseling from the prescriber on the risks associated with Mifeprex.

Distributors that distribute Mifeprex must To be able to distribute

• Establish processes and procedures to ensure that the drug is distributed only to clinics, medical offices, and hospitals identified by certified healthcare providers.
• Establish processes and procedures to maintain a distribution system that is secure and confidential.
• Establish processes and procedures to maintain a system for proper storage, handling, shipping, tracking package serial numbers, proof of delivery and controlled returns of Mifeprex.
• Train all relevant staff involved in distribution of Mifeprex on the REMS Program requirements.

Distributors that distribute Mifeprex must At all times

• Maintain confidential distribution records of all shipments of Mifeprex.
• Cooperate with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.

Patient must fill out this form (1 page):

http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_Patient_Agreement_Form.pdf

Doctor must fill out this form (2 page):

http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_Prescriber_Agreement_Form.pdf

Medication guide for patient (4 pages) 

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088643.pdf

FDA warning:

Do Not Buy Mifeprex Over the Internet

"You should not buy Mifeprex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others). 

Mifeprex has special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities. 

To learn more about buying drugs safely, please see Buying Prescription Medicines Online: A Consumer Safety Guide"

Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011 (including deaths, hospitalizations, blood transfusions, ectopic pregnancies and infections):

http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM263353.pdf

CBC - big abortion's mouthpiece - Part 2

CBC can't see how biased they are. I have detailed their bias here in part 1 as it relates to the abortion pill RU-486.

The Ombudsman thinks that I am concerned about Health Canada's position on the drug:

"the CBC covered the introduction of Mifepristone into Canada over a period of time and on multiple platforms and programmes. Many of those did adequately represent the position of Health Canada and its reasons for the regime required for use of the drug in Canada."

My complaint made no mention of Health Canada. Yet the Ombudsman talks about their story being balanced as regards to Health Canada, which I never mentioned in my complaint. Rather my complaint was about the fact that the CBC chose only ever to ask an abortion doctor her opinion as to why the drug was being dispensed this way [by doctors and not pharmacists]. The CBC did not ask that question of a pro-life doctor. Why not? If the CBC had asked a pro-life doctor, I'm pretty sure they would have received quite a different answer.

The Ombudsman said my complaint was not about the safety about the drug but rather accessibility of the drug. My point was that you cannot properly discuss the accessibility of the drug, if you don't also discuss its safety. That is because accessibility is directly related to the fact that the drug is so dangerous. What part of this does the CBC not understand?

The person the CBC chose to interview on accessibility is an abortion doctor who naturally has a vested interest in abortions. And RU-486 is abortion. The CBC did not interview a pro-life doctor on accessibility, and I can guarantee if they had, that doctor would have brought up the important issue of the dangers of the drug. But the CBC did not do this. And as I already pointed out in the first installment on this, the CBC didn't do this over time either. Nearly all their reporting on this drug has been biased for abortion as they only ever interview people from the abortion industry.

Why doesn't the CBC interview someone not from the abortion industry and let the reader make up their own mind?

Let's look at another controversial issue which is currently being debated and a recent decision made this week by the government: pipelines. CBC interviews people on both sides of that debate, those who oppose the proposed pipelines and those who support them. The CBC would never think of interviewing only those people who support pipelines or only those who oppose pipelines when covering the government's decisions regarding the Kinder Morgan and the Northern Gateway pipelines. Like pipelines, RU486 is controversial. Both involve government's decision whether to approve or not and both involve regulations if/when they are approved,  Those who oppose pipelines will be more likely to focus on the negative things that result from allowing the pipelines to be built; those who support pipelines will be more likely to downplay the negative aspects of the pipelines and highlight the positive. Surely the CBC can see that if they interviewed only people who held the former position, or only those who held the latter, they would be biased. No different with RU-486: If someone supports RU-486 in the first place, their views on accessibility will be coloured by that, as will someone who opposes it.

The Ombudsman also seems to issue with my calling Dr. Norman an "abortion doctor":

"You describe her as an “abortion doctor”. As Ms. Hiscox mentioned in her introduction her qualifications are extensive in the field of public health as well as family planning. According to the Canadian Institutes of Health Research (the federal funding agency for health research) website, she is also the Applied Public Health Chair of that organization."

That's because:

"Dr. Norman has been a family physician since 1985 and has practiced exclusively in the area of abortion since 1997". (emphasis added)

More later...

CBC - big abortion's mouthpiece - Part 1

I complained (again) to the CBC Ombudsman that their coverage of the abortion drug RU-486 was biased. After waiting three months for a response; after three follow up emails; after a telephone call; I finally received a response this week.

Here is the result of that complaint to the CBC Ombudsman Esther Enkin:

http://www.ombudsman.cbc.radio-canada.ca/en/complaint-reviews/2016/balance-and-controversial-issues/

As expected, the decision was that the CBC is not biased.

(NOTE: the CBC Ombudsman's role is supposed to be independent ("The ombudsman acts as an appeal authority for complaints about journalistic standards and is independent of CBC program staff and management.) But the position is as a CBC employee, who also happens to be a career CBC employee. Why isn't this role given to someone who is at arm's length from outside of the CBC?)

Let's discuss the Ombudsman's conclusions.

Ombudsman:

"The Managing Editor for CBC News Network, Jennifer Harwood, replied to your complaint. She stated that the interview was not a debate about the safety of the drug. Rather it was about the issue of accessibility. She said that in “that context, it is my view that the coverage was fair and balanced.”"

Jennifer Harwood said the interview was not about the safety of the drug, but accessibility. My point was that it is precisely because the safety of the drug is dangerous, is exactly why accessibility should be more difficult. This point is ignored by the Ombudsman. And since there are issues about the drug's safety, which was the whole basis of my complaint--that is why doctor's must dispense it and not pharmacists. I contend that this is the exact reason the US insists that doctors dispense it and not pharmacies. So my whole point is ignored, so how can the coverage be fair and balanced?

Ombudsman: Regarding Dr. Norman's "strange and bizarre" comment that I took issue with:

HEATHER HISCOX 

You’ve used a couple of interesting words – you called this very unusual regime around this, you said “have bizarrely put in place”. Why do you think they’ve put this extra layer or these extra additional requirements around this particular drug?

Dr. Wendy Norman 

"Well, this is a gray question, Heather, and I think it is a little bit inexplicable, a little bit hard to explain. In Canada, for many years, the safety mechanisms for drugs have required pharmacists to dispense them and even some of our most concerning drugs, for example, methadone, pharmacists are able to dispense this drug, so for all of a sudden out of the blue to have a normal woman’s health medication such as Mifepristone, the RU-486, requiring this very unusual mechanism, is strange."

"all of a sudden, out of the blue"? I don't think so. After much evidence that the drug is dangerous, this was decided by Canada, and the US did the same. And RU-486 isn't really like Methadone though is it? I contend that allowing doctors only to dispense RU-486 is not "bizarre and strange" at all. If a first world country (like the US) that is ten times the size of Canada does it this way (for safety reasons), that is something to heed, and Canada followed suit. Sounds prudent to me and not "bizarre and strange". 

Ombudsman:

"The host of CBC News Morning Live introduced the interview with Wendy Norman in this way:
Canadian doctors say Health Canada’s strict guidelines will limit access to the abortion drug RU-486... "The host says that Canadian doctors say..." 

This statement implies that "[ALL] Canadian doctors say..". Bias again. Not all doctors say this, only some doctors. More precisely, some abortion doctors. Did the the interviewer try and find any doctors who disagreed with this statement? Apparently not. 

Dr. Norman calls Mifepristone a "Normal woman’s health medication". I fail to see what is normal about a drug that has killed women, causes excessive hemorrhaging, and the multitude of serious side effects "normal". Again, my whole point is about the danger of the drug, a point the Ombudsman has neglected to address. In fact these side effects are mentioned in only two of the CBC writings on the subject. There truly is nothing "normal" about RU-486. This is why Health Canada felt it important to have doctor's dispense it, just like it is done in the US (my US point was also not addressed by the Ombudsman).

Ombudsman:

"On issues of controversy, we ensure that divergent views are reflected respectfully, taking into account their relevance to the debate and how widely held these views are. We also ensure that they are represented over a reasonable period of time."

So the CBC represents a "widely held views...over a reasonable period of time"? I beg to differ. I googled "RU486 and CBC" and "abortion pill and CBC".

Below are all the links that came up. I found 20 CBC links related to RU-486 (there could be more). The first four might be said to be somewhat neutral, so let's ignore those articles. 

The remainder 16 CBC articles on RU-486 all quote only pro-abortion advocates, and no alternate pro-life viewpoints, with Dr. Wendy Norman a seemingly favourite of CBC journalists. Dr. Norman is quoted six times. 

The CBC gets millions and millions of dollars a year from the taxpayer. It should be impartial on such controversial subjects like abortion. But is the CBC biased for abortion or not? You be the judge.

Part 2 here

________________________________________________________________________________

1) Michelle Wyand, P.E.I. College of Pharmacists

https://www.google.ca/search?q=cbc+abortion+pill&rlz=1C1CHMO_enCA568CA568&oq=cbc+abortion+pill&aqs=chrome..69i57j69i60l3.11137j0j9&sourceid=chrome&ie=UTF-8#q=cbc+abortion+pill&newwindow=1&start=10

2) http://www.cbc.ca/news/politics/ru-486-s-approval-comes-at-bad-time-for-conservatives-1.3174061

3) Vicky Sapporta (National Abortion Federation) and Mary Ellen Douglas (Campaign Life Coalition)

http://www.cbc.ca/news/politics/abortion-drug-decision-pushed-back-by-health-canada-1.2899723

4) Dr. Laura Lewis (Ontario family physician and a Canadian Physicians for Life board member)

http://www.cbc.ca/news/canada/ru-486-what-you-need-to-know-about-the-recently-approved-abortion-pill-1.3173657

5) Joan Dawkins (executive director of Women's Health Clinic)

http://www.cbc.ca/news/canada/manitoba/doctors-approach-limits-access-1.3712205

6) Dr. Wendy Norman and Dr. Ellen Wiebe (abortion doctors)

http://www.cbc.ca/news/canada/british-columbia/new-abortion-pill-bc-1.3668080

7) Dr. Kelly Monaghan (of abortion Clinic 215 in St. John)

http://www.cbc.ca/news/canada/newfoundland-labrador/abortion-pill-nl-1.3676798

8) Dr. Wendy Norman (abortion doctor)

http://www.cbc.ca/news/thenational/abortion-pill-still-unavailable-in-canada-1.3668100

9) NDP MLA Nahanni Fontaine (NDP is officially pro-choice)

http://www.cbc.ca/news/canada/manitoba/abortion-pill-pharmacare-manitoba-ndp-1.3834932

10) Leigh Anne Caron, (team manager of health services at Women's Health Clinic in Winnipeg)

http://www.cbc.ca/news/canada/manitoba/abortion-pill-s-approval-could-help-manitobans-in-rural-remote-places-1.3174952

11) Dr. Wendy Norman (abortion doctor)

http://www.cbc.ca/radio/the180/pharmacists-should-dispense-ru-486-a-noticeable-silence-on-chief-wahoo-and-non-sport-related-concussions-1.3812701/health-canada-rules-will-keep-abortion-from-the-women-who-need-it-most-1.3812867

12) Dr. Wendy Norman (abortion doctor)

http://www.cbc.ca/news/canada/british-columbia/abortion-pill-restrictions-mifegymiso-1.3547582

13) Lyndsey Butcher (executive director at Planned Parenthood Waterloo Region)

http://www.cbc.ca/news/canada/kitchener-waterloo/ru-486-pill-to-improve-abortion-access-in-waterloo-region-1.3174825

14) Dr. Wendy Norman (abortion doctor) and Judith Soon (assistant professor in the faculty of pharmaceutical sciences at the University of British Columbia)

http://www.cbc.ca/news/health/abortion-pill-dispense-1.3808150

15) Vicki Saporta (president and CEO of the National Abortion Federation and its Canadian offshoot, NAF Canada), Dr. Erika Feuerstein, family physician at Women's College Hospital and Bay Centre for Birth Control in Toronto and Rebecca Cook, a law professor in the International Reproductive and Sexual Health Law Program at the University of Toronto

16) http://www.cbc.ca/news/health/ru-486-abortion-pill-approved-by-health-canada-1.3173515

17) Dr. Wendy Norman (abortion doctor)

http://www.cbc.ca/news/politics/ru-486-abortion-pill-canada-1.3665865

18) http://www.cbc.ca/player/play/2672836959 (Srinivasan Krishnamurthy, director of gynecology at the Royal Victoria Hospital)

19) Jill Arkles (from the Sexual Health Centre in Saskatoon)

http://www.cbc.ca/news/canada/saskatchewan/do-you-agree-with-health-canada-approving-the-ru-486-abortion-pill-1.3174093

20) Sandy Kershaw, executive director of the Mokami Status of Women Council

http://www.cbc.ca/news/canada/newfoundland-labrador/ru-486-could-grant-labrador-women-easier-access-to-abortion-1.3181684

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...

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

Not available in Canada

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, again...an 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: ...so 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 your...um...first 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.

More reasons why RU-486 is a very bad idea

The pro-abortions are jumping up and down, yelling at Health Canada to approve mifepristone or RU-486. They want Health Canada to hurry up, but I don't see the pro-abortions telling you all of the risks and issues that must be addressed before it's approved.

Important considerations the pro-abortions aren't telling you about:

1) As I've already written, RU-486 is not a good idea for women in remote areas. And the FDA agrees:

 "Doctors must have the ability to date pregnancies accurately and to diagnose tubal pregnancies. Doctors must also be qualified to provide any necessary surgery, or have made arrangements for any necessary surgery. Doctors must ensure that women have access to medical facilities for emergency care...it is important for women to be fully informed about how Mifeprex works and about its risks, as well as the need for follow-up visits with their health care provider, especially on the 14th day after mifepristone is administered."

2) In Ontario when women die from RU-486 and or have serious complications like septic shock, we'll never know that, because, as I've said before, Ontario's cover up of all things relating to abortion. There will be no way to get any information in Ontario on abortion complications from this drug, or from any other forms of abortion either.

3) There is no mechanism in place (like in the US) to give us statistics on women who die from RU-486. The FDA does have a reporting system of "adverse events". So how does Health Canada plan to ensure adverse events are reported and made public in Canada when they don't do this now? Compound that with Ontario's abortion secrecy law, and women could be seriously harmed, even die, and nobody will ever know it was linked to RU-486. How is this in the best interests of women?

4) Read what Renate Klein--who is pro-choice--has to say about RU-486 in "The ethics of disclosure: RU486 and the suppression of facts".

"Together with colleagues, Professor Janice Raymond and Dr Lynette Dumble, I have been researching the RU 486 abortion story since 1988, when what was then called "the French abortion pill" made its debut on the world-stage. As long-term women's health researchers and supporters of safe abortion, we watched in astonishment as many international women's health groups uncritically greeted the arrival of this chemical abortifacient. We wondered why the progesterone antagonist RU 486, a largely untested chemical, was hailed as a new "miracle drug" and the "moral right of women." 

The result of our three-year investigation was the book RU 486: Misconceptions, Myths and Morals, published in 1991. We concluded that the "safe-and-effective" mantra that RU 486/PG abortion had acquired was misleading: the adverse effects of the two drugs were unpredictable and dangerous and the research undertaken inadequate. The new "demonising" of suction abortion as "surgical" abortion (conjuring up knives and requiring a general anaesthetic, both wrong) was worrying. We said that the drawn-out and painful process of chemical abortion (our preferred term; but I also use pill abortion or "medical" abortion) was emotionally and physically hard on the women. The abortion process lasts a minimum of three days - when all goes well - but women can bleed up to 6 weeks. Moreover, between 5 and 8% of women need a second abortion when the drugs fail to completely terminate their pregnancy and remaining products of conception need to be removed to prevent an infection. This is a very draining and unpredictable time for women, especially so when compared to the 15-30 minutes a suction abortion takes in the relative safety of a clinical setting. In particular, we worried that because the second drug, the prostaglandin, is taken outside a clinic, the woman's life would be at risk if she was haemorrhaging excessively and needed a blood transfusion but was away from an emergency clinic. 

We concluded that the RU 486/PG abortion had the making of a new wave of DIY backyard abortions which burdened women who had decided they needed an abortion with unnecessary days of agony: haemorrhaging, vomiting, cramping and the well-founded fear of sepsis. We predicted deaths and also wondered why pro-choice activists could not see that this abortion method only benefited pharmaceutical companies and doctors. For the latter, it is much easier to prescribe pills than actually perform an abortion: only die-hard abortionists "like" to do them, while most other doctors perform them out of a sense of duty. We warned that the push for RU 486/PG - especially when it is cheap - could be particularly dangerous for poor and/or Indigenous women. And we were concerned that the uncritical - and endlessly repeated - promotion as "safe, effective and more natural" in a society that has a pill for every ill, would lead to RU 486/PG abortion becoming the preferred abortion method. This would result in clinics offering the much safer and 98 to 99% effective suction abortion folding as they were too expensive compared with the cost of the RU/PG abortion." (emphasis added)

I hope Health Canada doesn't cave to the pro-abortions. I hope Health Canada does not approve this terrible drug.

Creating embryos using DNA from three people

Scary scary scary:

"The provocative notion of genetically modified babies met the very real world of federal regulation Tuesday, as a government advisory committee began debating a new technique that combines DNA from three people to create embryos free of certain inherited diseases."