Showing posts with label mifegymiso. Show all posts
Showing posts with label mifegymiso. Show all posts

Thursday, 3 November 2016

Ruckus Raising Time. Again.

Up here in smug Canada -- and getting smugger by the minute as the US election approaches -- it's not often that the US has us beaten on any aspect of abortion care.

Well, they've got us all beat to hell on medical abortion.

Although many limitations remain, innovative dispensing efforts in some states, restricted access to surgical abortions in others and greater awareness boosted medication abortions to 43 percent of pregnancy terminations at Planned Parenthood clinics, the nation's single largest provider, in 2014, up from 35 percent in 2010, according to previously unreported figures from the nonprofit.

To recap, the abortion pill, aka mifepristone or RU486, was just approved in Canada in July 2015, a mere three decades after France approved it and two decades after the US did.

Juxtapose this. A year later, in July 2016 the assisted dying bill became law.

Estimated number of assisted deaths in the three months since, about 200.

Number of medical abortions in the fifteen months since the abortion pill's approval: ZERO.

There has been unconscionable fuckery associated with the abortion pill.

Looooong approval process, stupid dispensing requirements, mandated online training for physicians, weird bureaucratic hurdles for its inclusion in provincial drug plans.

But assisted dying? No such rigamarole. Law is passed. Doctors offer it. Patients want it. So.

In sensible places with universal healthcare, medical abortion is recognized for the boon it is -- both to patients and to the system. Like Australia.

But here, the regulators and politicians are kow-towing to the minuscule -- but LOUD -- anti-choice fringe who call the abortion pill "human pesticide".

It's time to do something about this idiotic situation.

An NDP MLA in Manitoba is calling for the province to cover the abortion pill.
A new resolution from St. Johns MLA Nahanni Fontaine describes the Mifegymiso pill as an essential medicine for women that should be easily accessible.

And it's not just Ms Fontaine who describes it as essential medicine. The World Fucking Health Organization listed it on its List of Essential Medicines in 2005.

Action Canada for Sexual Health and Rights has a new campaign to help persuade the powers that be to get the damned lead out and make this essential medicine available.

Check it out.

Under Take Action there are five steps you can take.

1. Write and/or meet with your local MPP, MP, Provincial/Territorial Minister of Health, and/or Federal Minister of Health.
2. Write an op-ed or pitch the story to local news outlets.
3. Take to social media! 
4. Engage your community: host an event, share information through your networks. 
5. Encourage your physician to become a medical abortion provider of Mifegymiso.

After all, provincial healthcare plans fund surgical abortion. Why would they not embrace this earlier, quicker, less expensive alternative?

Wednesday, 28 September 2016

"A Bad Precedent"? You Betcha!

Some follow-up to my post yesterday about the bungling around the approval of Mifegymiso (abortion pill) for inclusion in taxpayer-funded provincial healthcare plans.

The Globe and Mail is still on the story.

It seems that when Mifegymiso's manufacturer, Celopharma, began the long and winding (and politically stymied? remember, there were CONservatives in charge then) process, there were no costs associated with the Common Drug Review.
[Paula Tenenbaum, president of Celopharma] said that when the company began the Health Canada application process in late 2011, the Common Drug Review – which is a separate process, not run by Health Canada – was offered at no cost to pharmaceutical companies. “As a result, we did not budget for the $72,000,” she said. The company asked for a fee reduction or a two-year payment plan, but that proposal was rebuffed.

The Canadian Agency for Drugs and Technologies in Health (CADTH), which oversees the Common Drug Review, confirmed the fees only came into effect in September of 2014. (Ms. Tenenbaum said the full process would actually cost between $100,000 and $150,000; CADTH disagreed and reiterated the $72,000 figure.)

Brent Fraser, the vice-president of pharmaceutical reviews for CADTH, said on Tuesday that giving Celopharma a break on the fees could set a bad precedent.
Here's the short version of drug approval works in Canada.

First, a new drug has to go through Health Canada's Health Products and Food Branch (HPFB), where it is assessed for safety, quality, and effectiveness.

How long does this take? Well, it's hard to say from the website's blah-blah.
HPFB has set internationally competitive performance targets for its conduct of reviews. The length of time for review depends on the product being submitted and the size and quality of the submission, and is influenced by HPFB's workload and human resources.
This part of the ordeal was finally completed and the good news reported in July 2015.

Then Health Canada issues a monograph detailing who may prescribe it, with what training, and other restrictions. That link is from April this year, when abortion providers were getting worried about the folderol being proposed.

But getting provincial healthcare plans to pay for it is a whole other regulatory nightmare.

And of course, Quebec is slightly different.

Here's how it works in Quebec.

Authorization from Health Canada is the first step common to both Quebec and the rest of Canada.

In the rest of Canada, new non-cancer drugs go to Canadian Agency for Drugs and Technologies in Health (CADTH) for what is called a Common Drug Review (CDR). Cancer drugs go to the pan-Canadian Oncology Drug Review.
In Quebec, both cancer and non-cancer drugs go to the Institut national d’excellence en santé et en services sociaux (INESSS).

Expert committees evaluate the new drugs.

If the drug’s therapeutic value has been established, INESSS then evaluates the drug based on four criteria: reasonableness of price charged; cost-effectiveness ratio; impact on the health of the population; effect on the basic prescription drug insurance plan.

Then provincial health departments decide whether to include it. In Quebec, the article notes, sometimes politicians have over-ridden recommendations to include very expensive drugs.

So. Celopharma entered the labyrinth in 2011 and budgeted based on the rules at the time. Health Canada took its sweet time to approve a drug that has been in use in France for 30 years and in the US for over 15 years.

Meanwhile, the independent agency, CADTH, that must review it before provincial healthcare plans will pay for it, slaps on some whopping big fees.

And CADTH can't give the company a break because it would "set a bad precedent."

The rules were changed in the middle of the game -- a game that Celopharma had zero control over -- and there's no relief offered?

This seems unfair to say the least.

There's got to be a way around this. In Australia, a Real Feminist PM, Julia Gillard simply ordered that the drug be listed on its taxpayer funded Pharmaceutical Benefits Scheme.

I realize that things are done differently here, but surely our globally touted FeministPM™, with his gender-balanced cabinet and other meaningless fripperies of respect for women and their rights, could bloody well do something.

Unless of course this whole schmozzle has been engineered as a sleight-of-hand slap in the face to Canadian women, while keeping the Blue Liberals onside.

Whaaaat? I hear you say. Liberals saying one thing and doing another?????????

Tuesday, 27 September 2016

Abortion Access? Another slap in the face for Canadians

Gee. You'd almost think that the gynoticians politicians don't want women to access the abortion pill, widely touted to improve access for people living in the wide swaths of remote, rural, and medically underserved Canada.

The Globe and Mail reported yesterday.
When the gold standard in medical abortion drugs finally becomes available in Canada later this year, the $300 cost of the pills will not be covered by most provincial drug plans, The Globe and Mail has learned.

The company that makes Mifegymiso has bowed out of an essential step on the path to public reimbursements for new drugs over the $72,000 price tag for a standard review of the medication’s cost effectiveness.

Provincial governments everywhere but Quebec say the company’s decision is preventing them from adding the two-drug abortion regimen to their list of publicly funded drugs, meaning women will have to reach into their own wallets or rely on private insurance to pay for Mifegymiso.
This "essential step" is called the Common Drug Review.

Today the Globe published an editorial.
Already the victims of Health Canada’s glacial bureaucracy, and of its paternalistic view of their ability to safely administer prescription drugs to themselves, Canadian women waiting to be able to use the most commonly prescribed medical abortion treatment in the world woke up to a fresh slap in the face on Monday.
The editorial recalls the ridiculously long and tortured approval process in Canada and points out that RU486, or mifepristone, has been available since 1987 in France, since 2000 in the US.

The writers also note that abortion is a common medical procedure, with surgical abortion being delivered at no cost as part of taxpayer-funded Medicare.

This latest bad news – that women will have to pay for a medical treatment to which they have a right – is the last straw. Ottawa should find a way to waive the cost of the Common Drug Review and make Mifegymiso available for free as quickly as possible.

Want to see how a Feminist PM™ handled this situation?

Like this.

Julia Gillard's last act as prime minister included signing off on cabinet approval for slashing the cost of abortion pill RU486 to as little as $12.

Listing the abortion drug on the taxpayer-funded Pharmaceutical Benefits Scheme (PBS) will see the price of a medical abortion in Australia drop from up to $800 to just $12 for concession card holders from August 1.

Women not eligible for concessions will pay around $70 under the PBS.

This is what a Feminist PM™ looks like.


This is what a Fake Feminist PM™ looks like.



UPDATE: Rules changed on fees for Common Drug Review during the process.

Wednesday, 10 August 2016

BREAKING! Feminist™ PM Declares "What's Sauce for the Goose. . ."



DAMMIT JANET! has learned that Canada's feminist Prime Minister has taken note that just about nobody is pleased with Health Canada's idiotic rigorous dispensing rules for the so-called abortion pill, Mifegymiso.

From Newfoundland and Labrador, to Prince Edward Island's pharmacists and physicians, to Manitoba and British Columbia, just about everybody who has anything to do with reproductive healthcare is pissed off.

Heck, even the Globe and Mail's editorial writers are miffed.
If this restrictive handling of the abortion pill is meant to reflect safety concerns, it is misguided. Many prescription drugs, used wrongly, have the potential to do harm and yet we trust pharmacists to dispense them, because that is their specialty. Why should Mifegymiso be any different? The damage done by preventing women from obtaining the abortion pill they need will outdo any good that comes from excessive caution about patient safety.

But if these restrictions stem from residual nervousness about easier access to abortion, even in pill form, that is completely wrong. Women have a right to this drug and they should be able to get it without further obstruction.
Among the many objections to the regime are requirements that doctors -- not pharmacists -- maintain an up-to-date supply of the drug, set up billing systems for it, and watch the patient take the first dose.

Responding to criticism that absolutely NO OTHER drug -- not even powerful, potentially lethal chemotherapy drugs -- is treated like this, feminist™ PM Trudeau reportedly said: "All righty then. We'll change the rules on erectile dysfunction drugs like Viagra. Physicians will control dispensing and patients will be required to take the pill in their presence. What's sauce for the goose should be sauce for the gander.

"Happy now?"

Um, no. We are not happy, Justin.



Inspiration from Abortion Rights Coalition of Canada's Facebook page
‪Pudgy Quast‬ Perhaps more people would understand this if men were forced to visit their Doctors to take their viagra pills in the doctor's presence rather the filling their prescriptions at a pharmacy! Women have been dispensing medication to their families forever…I think we can manage to fill a prescription and take a pill ourselves!

Friday, 31 July 2015

RU486: Game. Set. Match.

Further to the long overdue approval by Health Canada of RU486 or mifepristone, the 'gold standard' of medical abortion: an explanation and a clarification. (And some gloating.)

Medical -- non-surgical -- abortion is not new to Canada. But the protocol doctors have been forced to follow up to now is outmoded, unreliable, and subject to screw-ups.

Here, an expert explains:
"We're absolutely thrilled," Jill Arkles, from the Sexual Health Centre in Saskatoon, told CBC News Thursday.

According to Arkles, some doctors in the province were already providing an alternative to surgical abortion, using a combination of an injection and medication to induce a miscarriage.

She called RU-486 a welcome advancement. The injection-and-tablet method can take up to five weeks to complete, and involve up to five medical appointments, while RU-486 is two pills taken a day or two apart.

"It's more cost-effective than other current medications that we're using, as well it requires less time overall," she said.
So, quicker, easier, more cost-effective. Not to mention less time and stress for patients.

Thus: gold standard.

The news story I based my blogpost yesterday was less than clear on how widely available the new protocol will be.
[Vicki] Saporta [president and CEO of National Abortion Federation] said initially the drug will probably only be available through health-care professionals who already provide abortion services.
It seems that Saporta's judgement was not based on any Health Canada requirement, but on training issues and individual doctors' inclinations.

Here's part of the Society of Obstetricians and Gynecologists of Canada's statement.
The SOGC is working with the College of Family Physicians of Canada (CFPC), using the expertise of our members to develop clinical practice guidelines on the use of mifegymiso [Canadian brand name] and to provide educational opportunities to physicians to ensure that they are well-prepared to counsel and care for women requesting medical abortion.

More on the inclinations of doctors:

Canadian doctors who were wary of the makeshift cocktail [injection and tablets] will likely be more willing to prescribe an abortion drug that’s approved by Health Canada for that purpose, said Jennifer Blake, the CEO of the Society of Obstetricians and Gynaecologists of Canada. She expects the society to provide formal training around the drug and its side effects to doctors who want to offer it, and said family doctors and obstetricians will both be able to qualify. Doctors’ approaches to abortion “depends on the community,” Dr. Blake said.

“I think if you look at physicians in general as coming from the fabric of Canadians society, Canadian society on the whole feels this is a decision that is best made by a woman herself, and I would expect that to be the same among health-care providers.”
We'll have to wait and see how many doctors -- and as critically, where they are located -- will decide to offer this solution.

Now for the gloating. CBC notes that as we head into a protracted election campaign, this might not be the best timing for CONservatives wanting to placate the fetus freaks among their base.

Indeed, the initial reaction among cabinet ministers was to run like hell.
[Health Minister Rona] Ambrose told reporters in St. Albert, Alta., that the decision did not rest with her.

“It’s out of my hands and the decision is final,” she said.

“Any of those details you would have to speak to the officials at Health Canada and the scientists that actually manage the regulatory approval process. I’m not involved in it.”

Ambrose cancelled two events scheduled for Thursday afternoon and Friday in Edmonton and area. No reason was given.
Except for one CON MP (so far), David Anderson, who issued a foot-stomper of a press release demanding Ambrose roll back the clock to the 1950s.

To sum up, yes, medical abortion has been available in Canada but not very widely offered or actually undertaken, precisely because it was arduous for all involved.

The fetus freaks are particularly pissed over RU486, precisely because it is easier and more effective.

And they have good reason to be pissed. As SUZY ALLCAPS herself admits.

http://www.bigbluewave.ca/2014/10/will-collapse-of-planned-parenthood.html

The problem with this [medical abortion] model, from the pro-life perspective, is that it's a little harder to protest the GP who does abortions, when he treats the community's ear infections, sore throats, STD's and so on.

If you make life hard on this person, it won't just be abortion clients who'll be unhappy. It will be all the patients this doctor sees.
When GPs, nurse practitioners, midwives, and hopefully, eventually pharmacists are able and willing to help end an early pregnancy, it's not just a game-changer. It's a game-ender.

Game. Set. And soon, the whole fucking shooting match.


ADDED: Health Canada Regulatory Decision Summary.