Showing posts with label mifepristone. Show all posts
Showing posts with label mifepristone. Show all posts

Wednesday, January 27, 2021

The abortion bill: what a horrible way to die

The abortion pill is not a safe drug. Health Canada issued 40 adverse reaction reports on this drug. Of these, there were 26 individual women.

One woman died.

Two more experienced "life threatening" side effects.

23 women experienced "serious" side effects.

In 2017 there was one woman affected; in 2018 two women were affected; in 2019, it was six women. And in 2020 there were 16 women with serious side effects (Note that the report is only until July 31, 2020, so 2020 will undoubtedly have more serious problems reported).

Notice the trend here? As the abortion pill becomes more popular, even more women will suffer from its life threatening and possibly fatal side effects.

Not a safe drug at all.

Mifepristone (Search the database by active ingredient)

The woman who died was 27 years old. From the documented adverse reactions she experienced, it appears that her whole body, and all of her organs, went into extreme failure. Here were her symptoms:

Abdominal pain, Acidosis (a process causing increased acidity in the blood and other body tissues), Ascites (the abnormal buildup of fluid in the abdomen. Technically, it is more than 25 ml of fluid in the peritoneal cavity, although volumes greater than 1 liter may occur) Bacterial infection, Blood pressure decreased, Blood urea increased, Body temperature decreased, Cardiac arrest, Cardiovascular disorder, Chills, Dehydration, Dizziness, Endometritis, Gastritis haemorrhagic, Hyponatraemia (is a low sodium concentration in the blood), Hypoxia (is a condition in which the body or a region of the body is deprived of adequate oxygen supply at the tissue level), Leukocytosis (a condition in which the white cell is above the normal range in the blood. It is frequently a sign of an inflammatory response, most commonly the result of infection), Multiple organ dysfunction syndrome, Nausea, Oliguria (or hypouresis is the low output of urine specifically more than 80 ml/day but less than 400ml/day. The decreased output of urine may be a sign of dehydration, kidney failure, hypovolemic shock, hyperosmolar hyperglycemic nonketotic syndrome, multiple organ dysfunction syndrome, urinary obstruction/urinary retention, diabetic ketoacidosis, pre-eclampsia, and urinary tract infections, among other conditions), Palpitations, Pelvic pain, Pleural effusion (is excess fluid that accumulates in the pleural cavity, the fluid-filled space that surrounds the lungs), Pyrexia (Fever, is defined as having a temperature above the normal range due to an increase in the body's temperature set point), Sepsis, Septic shock, Uterine spasm, Vaginal discharge, Vaginal haemorrhage, Vomiting

From the data file produced: 

CAVEAT: This summary is based on information from adverse reaction reports submitted by health professionals and laypersons either directly to Health Canada or via market authorization holders. Each report represents the suspicion, opinion or observation of the individual reporter. The Canada Vigilance Program is a spontaneous reporting system that is suitable to detect signals of potential health product safety issues during the post-market period. The data has been collected primarily by a spontaneous surveillance system in which adverse reactions to health products are reported on a voluntary basis. Under reporting of adverse reactions is seen with both voluntary and mandatory spontaneous surveillance systems. Accumulated case reports should not be used as a basis for determining the incidence of a reaction or estimating risk for a particular product as neither the total number of reactions occurring, nor the number of patients exposed to the health product is known. Because of the multiple factors that influence reporting, quantitative comparisons of health product safety cannot be made from the data. Some of these factors include the length of time a drug is marketed, the market share, size and sophistication of the sales force, publicity about an adverse reaction and regulatory actions. In some cases, the reported clinical data is incomplete and there is not certainty that these health products caused the reported reactions. A given reaction may be due to an underlying disease process or to another coincidental factor. This information is provided with the understanding that the data will be appropriately referenced and used in conjunction with this caveat statement.

More information here on the abortion pill and its side effects. 

Thursday, December 3, 2020

Ontario abortion rates are going up

Ontario abortion rates as reported by the Ontario Ministry of Long-Term Care are going up. Yet CIHI shows a decrease in Ontario abortion rates. So I'm not sure why CIHI keeps reporting Ontario numbers. In any event, since the MOHLTC's numbers are based on doctor's billing records, they intuitively should be more accurate.

You can see from the chart that overall, MOHLTC's numbers went down for three years in a row (2014/2015 to 2017/2017), but then for the next three years (2017/2018 to 2019/2020), they went up.

This disturbing trend upwards is most likely due to the abortion pill which became legal in 2017. This is really bad news for Canadians, especially those still in the womb.

Previous recent posts on abortion statistics:

Ontario out of province abortions for 2017

Canadian abortion statistics: who does, and who does not, report medical abortions

Ontario abortion numbers 2017/2018 

UPDATE The facts about abortions statistics in Canada

Monday, December 4, 2017

Catholic universities don't need to defend illegal abortions

My letter in the National Post last Friday:


Science Minister Kirsty Duncan thinks the Tories should comment on the cancelling of the pro-abortion film Vessels at St. Paul’s University for free speech reasons.

First of all, this movie is about a doctor who takes her abortion trade to the open seas. Why? So she can provide abortions to women on a ship in offshore waters. Why? So she can bypass the country’s abortion laws and provide the abortion pill RU486 to women. This doctor is engaging in illegal activities to bypass the laws of sovereign countries.

Second, St. Paul’s University is a Catholic institution. Catholic institutions don’t condone abortion because Catholicism believes that abortion is an immoral act and is harmful to the woman and her family.

Duncan’s press secretary stated: “In a free society, we may disagree with a person’s views, but we must defence (sic) their right to hold them — unless those views promote hate.”

What about when those views promote illegal activities? Should we defend those views as well? I hope not. 

Patricia Maloney, Ottawa

Thursday, November 9, 2017

Health Canada ATIP on RU-486

Here is the information for an ATIP I made to Health Canada for the abortion drug RU-486.

There was one document for pages 345-2544. It is too large to be able to access from the Google drive. It appears to be 2000 pages of data, but impossible to decipher what the data means. It also seems to contain data other than misoprostol and mifepristone.

Pages 1-336
https://drive.google.com/file/d/0B_QDsYLWnwO6d1lWbDI3MXNNeVU/view?usp=sharing

Pages 337-344
https://drive.google.com/file/d/0B_QDsYLWnwO6MlItSm9Yd2lOeG8/view?usp=sharing

Pages 2545-2547
https://drive.google.com/file/d/0B_QDsYLWnwO6WDlielFDXzlQLTA/view?usp=sharing

Pages 2548-2968
https://drive.google.com/file/d/0B_QDsYLWnwO6azB5SnZqR2tIMU0/view?usp=sharing

Pages 2969-3050
https://drive.google.com/file/d/0B_QDsYLWnwO6U19VSzRIWkJpdnc/view?usp=sharing

Monday, December 5, 2016

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):

Doctor must fill out this form (2 page):

Medication guide for patient (4 pages) 

FDA warning:
"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):

Sunday, December 4, 2016

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...

Wednesday, November 30, 2016

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:

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

________________________________________________________________________________


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

4) Dr. Laura Lewis (Ontario family physician and a Canadian Physicians for Life board member)
5) Joan Dawkins (executive director of Women's Health Clinic)

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

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

8) Dr. Wendy Norman (abortion doctor)

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

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

11) Dr. Wendy Norman (abortion doctor)

12) Dr. Wendy Norman (abortion doctor)

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

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

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


17) Dr. Wendy Norman (abortion doctor)

Friday, August 21, 2015

Joyce Arthur's logic isn't logical

This letter prompted Canada's number one pro-abortion Joyce Arthur to say this:
"It is irresponsible to allow dangerous medical misinformation like this to be published. The letter writer’s sources are apparently anti-abortion and therefore ideological."
Isn't that rich? Ms. Arthur dismisses the letter writer's sources because the writer is "anti-abortion and therefore ideological". Well since Arthur is "pro-abortion and therefore ideological", why would she think we wouldn't dismiss her as well?

I wonder if Ms. Arthur has read Renate Klein's book "RU486: Misconceptions, Myths and Morals."  Dr. Klein is extremely opposed to RU-486 and backs this up with extensive research into its harms. By Arthur's own logic, this book is worthy of paying attention to, since Dr. Klein is pro-choice.

Funny that Arthur doesn't mention the book in her letter.

Wednesday, August 5, 2015

Health Canada and RU-486: fatalities, endometritis, salpingitis and haemorrhages

From Health Canada's website:
"Analysis of the pivotal trials revealed that the average bleeding time was 10.8 days including 2 days of heavy bleeding. The majority of adverse events reported were transient and mild to moderate in severity. The medication causes vaginal bleeding and commonly induced pain and cramping, which required pain medication in some women. The other adverse events more commonly reported were diarrhea, nausea, vomiting, fever/chills, headache, dizziness and weakness. Treatment failure (which was defined as viable pregnancy, non-viable persistent pregnancy, persistent bleeding and abdominal pain that required a surgical termination of pregnancy) was reported in 2% to 4.8% of women. 
A small number of patients who took Mifegymiso presented more serious complications, such as pelvic infections (endometritis, salpingitis [inflammation of the fallopian tubes]) and vaginal haemorrhages. Rare cases of fatalities were reported, therefore access to emergency care which can provide gynaecological surgical procedures, antibiotic intravenous therapy and blood transfusion in the rare cases where complications occur, is recommended in the labelling to ensure patient’s safety."

Thursday, July 30, 2015

RU-486 - you won't get the truth from the pro-abortions

Health Canada has approved the drug RU-486. What a shame. Contrary to what the pro-abortions will tell you, it's neither safe nor private.

And it is especially dangerous for women in remote areas.

There are also eight pages of side effects.

Renate Klein, a pro-choice woman, wrote a book called RU486: Misconceptions, Myths and Morals. The book is extremely well researched and completely dismantles the nonsense we are told about the safety of this drug and all of its supposed benefits.

Here's just two excerpts from the book:
"...There is much about RU 486/PG that is fraught with risk and problems. As we have queried, what is the meaning of a `private' and 'de-medicalized' abortion that requires three or four doctor visits to a specialized center, includes the taking of two and perhaps five hazardous drug combinations, is accompanied by vaginal ultrasound, and too often has complications ranging from moderate bleeding to severe pain and, for some women, blood transfusions? If this is a private and de-medicalized abortion experience, then the word `private' has lost its definitional moorings..."
"...Readers might not draw the same conclusion [that the drug is safe and effective], like hemorrhage-like bleeding, including the need for a blood transfusion, and/or re-evacuation, cardiovascular problems, a potentially lethal infection, or an ongoing pregnancy." 
More of what Klein says about this dangerous drug. Read it and weep.

Sunday, February 15, 2015

RU-486 - myth #5 - everybody else is doing it

Renate Klein from her book RU486 Misconceptions, Myths and Morals, states in her conclusion:
"There is much about RU 486/PG that is fraught with risk and problems. As we have queried, what is the meaning of a `private' and 'de-medicalized' abortion that requires three or four doctor visits to a specialized center, includes the taking of two and perhaps five hazardous drug combinations, is accompanied by vaginal ultrasound, and too often has complications ranging from moderate bleeding to severe pain and, for some women, blood transfusions? If this is a private and de-medicalized abortion experience, then the word `private' has lost its definitional moorings..."

I puzzled over why such a dangerous drug, could be so blindly promoted by the pro-abortions.

Then Klein answers this question.
"...There are many reasons why individual women and women's groups have jumped on the RU 486/PG bandwagon. The packaging of the new abortifacient has been immensely successful. `The very nature of specialized knowledge and information, the complexity of the technology, the way the `advances' have been publicized in the popular media and such places as Science magazine and the incredibly slick marketing job which is being done, have had the effect of silencing criticism' (pers. comm. to from Judy Luce, June 1991). 
Many women's groups have taken the erosion of women' right to abortion, as well as the fear of playing into the hand of the right-wing, as incentive enough for promoting RU 486/PG. The philosophy prevails that 'we' — those who are committed to women's rights — must be for whatever 'they'' — those who are not committed to women's rights, i.e. the anti-abortionists — are against. However, this defense of RU 486/PG has been too much defined by a reaction to the right wing."

Klein then questions the dumping of drugs into our bodies:
"It has been the purpose of this report to demonstrate that many of the basic assumptions about RU 486/PG abortion need to be fundamentally re-examined...most of these reproductive drugs used to intervene in women's reproductive cycle often have serious risks and complications. Thus for the last quarter of a century, feminist health activists have been put in the position of risk management and risk communication, documenting the downside of such technologies and drugs. At the same time, reproductive technologists, while admitting that there are some risks, minimize them so that the technologies and drugs become acceptable and go forward, despite the complications. They offer studies that convince women that the risks can be managed and that if women want effective contraception, abortions, and children, the risks have to be lived with. 
At a time when the rest of the planet is being warned about the risks of chemical fixes, there is an enormous increase in the number and kinds of drugs that are being prescribed for women, especially in the reproductive realm. From a girl's birth to a woman's death, she is often prescribed fertility drugs, the pill, a new generation of anti-pregnancy vaccines that are especially being promoted in third world countries, tranquilizers, estrogen — currently, hormone — replacement therapy, and now RU 486/PG, a haphazard combination of two dubious drugs..."

Finally, I have noticed that one of the main reasons we should approve this drug (according to the pro-abortion media), is that there has been a truckload of other countries that have already done so. I say so what. Just because my friend jumps off a bridge doesn't mean I have to too.

Health Canada must follow the the existing evidence, as Renate Klein has done, and not approve this dangerous drug.

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...



Wednesday, February 4, 2015

RU-486 - myth #1 - drug is safe and effective

I hope Health Canada reads Renate Klein's book (RU486: Misconceptions, Myths and Morals) before they approve RU-486. The book contains a lot of disturbing information about this dangerous drug. Information that I notice is conspicuously missing of late, from the pro-abortions' cries to have the drug approved (especially the Globe and Mail) here, here and here.

It's important to realize that Renate Klein is pro-choice.

The pro-abortions think the drug is "safe and effective". Renate Klein, the author of RU486, has issues with this sentiment:
"Readers might not draw the same conclusion [that the drug is safe and effective], like hemorrhage-like bleeding, including the need for a blood transfusion, and/or re-evacuation, cardiovascular problems, a potentially lethal infection, or an ongoing pregnancy." (Page xiv in the Preface)
Klein tells us about Regine Sitruk-Ware, an early researcher from France.
"Sitruk-Ware confirms that an average of 10% of women suffered from excessive bleeding, another 1.4% required hemorrhage-controlling curettage, and .25% a blood transfusion. These numbers appear low but extrapolated to approximately 1.5% million women in the USA alone who, according to the FDA, by 2011 had undergone an RU-486/PG abortion, this amounts to approximately 150,000 women who bled excessively, 21,000 who had to endure a second procedure (a curettage to terminate their pregnancy); and 3750 women who needed a life-saving blood transfusion." (emphasis mine) (Page xv-xvi in the Preface)
Then then there are infections: A Canadian woman died in 2001 from septic shock, after an infection with the anaerobic bacterium Clostridium sordellii. Seven US women died in 2005 from septic shock after being infected with the same bacterium. Klein states:
"The particular danger is that C. sordellii does not cause fever, so in the absence of warning sighs, the infection spreads."
Then an Australian woman died on 2010 by an aerobic Streptococcus A infection.

There is also potential danger to the fetus if in a failed abortion, the pregnancy continues, because of unknown risks to the fetus.

According to Klein, Sitruk-Ware also warns against taking RU 486/PG for women with:
"allergies, renal failure, liver failure, and malnutrition, due to the fact that specific studies have not been conducted on impaired metabolism after use of RU 486/PG. Her warning against [its] use to women with malnutrition--if taken seriously--would eliminate its use for women in poor countries (where anemia is endemic) who are said to be the major beneficiaries of RU/486PG abortion by its eager promoters." (Page xvii in the Preface)
Then Klein warns that most adverse affects, are not even reported to the DFA:
"The US Food and Drug Administration (FDA) published 'A postmarketing Events Summary' up to 30 April in 2011. It contains a list of adverse events that are reported to the FDA. We should bear in mind that only between l and and 10% of` adverse reactions to medicines are ever reported to the FDA; in other words the real numbers of adverse effects could be even 100 times higher. (emphasis mine)
With this proviso in mind, in 2011, the FDA recorded 2,207 adverse events; 14 deaths; 612 hospitalizations (excluding deaths); 58 ectopic pregnancies; 339 women who experienced blood loss requiring transfusions; and 256 infections, 48 of which were `severe' (2011a). 
Of the US deaths, the FDA reports that 8 were associated with sepsis (7 tested positive for C. sordellii, 1 for C. peifringens, another anaerobic bacterium). The FDA also mentions 5 more deaths from other countries." (Page xxiii-xxiv in the Preface)
What some pro-choice doctors say about RU486/PG
...the New York Times reported that even a number of `pro-choice' doctors voiced concern over the dangers of RU 486/PG abortion. One was Dr Warren Hern, a provider in Denver, who said the latest reports demonstrated that abortions by RU 486 (called Mifeprex in the USA), were far riskier than surgical ones. "I think surgery should be the procedure of choice," Dr Hern said. "Pills are a lousy way to perform an abortion" (in Harris, April 2006) . Dr James McGregor, a visiting professor of obstetrics and gynecology at the University of Southern California, said RU 486 might make women more susceptible to C. sordellii in part because the drug may inhibit mechanisms that moderate immunity. In cases of toxic shock, the body's immune response becomes lethal. "The body ends up attacking itself, and RU-486 may encourage this attack" Dr McGregor said (in Harris, May 2006) . The FDA put a `Black Box Warning' on RU 486's Patient Information alerting health professionals and users to the risk of serious and sometimes fatal infection and insisting that oral misoprostol be used. (A Black Box warning required by the FDA of a pharmaceutical company to put on its Patient Information sheet, is the strongest warning. It means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.)" (Page xiv-xxv in the Preface)
More later.

Tuesday, January 20, 2015

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.