Wednesday, 1 May 2013
RU 486 comes with potent and unpalatable 'side effects'By Renate Klein
The Pharmaceutical Benefits Advisory Committee (PBAC) recommended on 26 April 2013 that the abortion pill Mifepristone Linepharma (better known as RU 486) and the necessary second drug prostaglandin GyMiso® be included in the Pharmaceutical Benefits Scheme (PBS).
The Health Minister, Tanya Plibersek will now make sure that there is "a cost-effective price" and "a steady, good quality supply" (ABC News, 26 April 2013). Indeed, the first thing we need to know is how much the tax payer will have to contribute to the coffers of MS Health – the subsidiary of the abortion provider Marie Stopes International Australia (MSIA) - who obtained registration of the two drugs in August 2012. A previous amount mentioned by a Department of Health and Ageing spokeswoman for Mifepristone was $300: five times higher than the $60 charged by Exelgyn for the same 200 mg of mifepristone, available to 187 TGA Authorised Prescribers since 2006.
MSIA/MS Health sure need to recoup a lot of money, given that the application and evaluation process of including the two drugs in the Australian Register of Therapeutic Goods (ARTG) cost them in excess of $335,000 dollars according to the fee schedule on TGA website. At a price of $450 as previously charged by MSIA in one of their Sydney clinics, MSIA clinics would have to perform over 77,000 'medical' abortions at a cost of $450 per termination. This number amounts to the approximated total for all abortions in Australia in one year – suction and chemical abortions combined. If Mifepristone Linepharma (RU 486) is listed on the PBS, it might cost only $36.10. Pill abortions would then have to be considerably cheaper. So more business needs to be raised.
But this is one of the main problems with putting Mifepristone and GyMiso®on the PBS: pill abortions will become cheaper than suction abortions. This will push many more women into using the drugs instead of asking for the much safer suction abortion, preferably with a local anesthetic. I am writing this as a long-term health advocate supportive of women's right to abortion, but I want women to be able to access a safe service, not a second-rate, unpredictable and dangerous drug cocktail. A South Australian woman who had a pill abortion in 2009 commented: "I was *technically * offered the choice of either suction procedure or tablet/RU486. However, I felt I was definitely encouraged towards the latter… Basically, I felt as though I would be causing an annoyance if I were to choose the surgical option."
Contrary to the 'safe, effective and more natural' mantra put forward by the pill abortion promoters, Mifepristone and GyMiso® have a failure rate between 5 and 7 per cent (10 per cent is not unusual), which means that women then need a second suction abortion to ensure complete termination. Instead of spending 15-30 minutes in a safe clinic setting for a suction abortion, the pill abortion takes a minimum of three days as the prostaglandin needs to be taken 24 to 36 hours after the initial mifepristone tablet. In order to exclude an ectopic pregnancy and confirm the time of gestation – only up to 7 weeks since the last period – a (transvaginal) ultrasound should be performed.
So it's a myth that pill abortions are not invasive. It's just easier for doctors to hand out pills rather than doing the abortion themselves. Blood loss can be excessive, sometimes needing blood transfusions; bleeding can last up to 6 weeks. The pain is often severe and is accompanied by chills, fever, nausea and vomiting. Women have died from cardiovascular events and sepsis including a woman in 2010 in Australia in a Marie Stopes Clinic. Difficult also for many women is the fact that they see the small embryo (only about 1 cm but already formed) when it is expelled.
The problem is that no woman will know what adverse effects she will experience and whether she needs emergency treatment – which makes this unpredictable abortion method inherently ill-suited for women living in rural and remote areas. There is a black box warning in the Patient Information for Mifepristone Linepharma:"Even if no adverse events have occurred all patients must receive follow-up 14-21 days after taking mifepristone."
As the South Australian woman remembered:
Overall the worst part of the RU486 was the sheer amount of time it took for me to 'terminate' my baby: with each and every large clot of blood – which I could literally feel passing through my insides and then out of my vagina – was a reminder of the fact I was terminating a baby, for which I felt hugely saddened. More than I realized I would.
It was three days of nausea, high temperature/sweating (I was worried about infection), cramping, lots of blood, distress and swirling emotions, thoughts, etc. I would never ever go through that again.
She also said: "I absolutely support a woman's access to abortion – but I think RU 486 and prostaglandin is the wrong way to go."
Data by the TGA up to 25 June 2012 - with an estimated number of 22,500 women who had undergone a pill abortion in Australia - mentioned a total of 832 adverse events: 132 women ended up with an ongoing pregnancy; 23 required transfusion; 599 had retained products of conception and needed a second abortion (D&C). There were 29 infections and 28 women hemorrhaged (quoted in Australian Public Assessment Reports - AusPAR – for Misoprostol and Mifepristone, 2 October 2012, p. 81 and p. 80).
Not only was MS Health given the right to register Mifepristone and GyMiso® in Australia in 2012, it was also accorded the right – and indeed the mandate - to provide on-line courses to clinics, individual healthcare practitioners and other 'healthcare professionals' who might want to become 'medical' abortion providers. Once these professionals have completed the MS-2 Step™ Program of 11 Training Modules and 5 Case Studies - estimated by MS Health to take 4 hours – as well as the Pre-Course Assessment and Post-Course Assessment – 20 minutes each - they will receive a Certificate and be allowed to register as a bona fide 'medical' abortion provider. And of course, let us not forget, buy the requisite combined blister packs of 1 tablet Mifepristone Linepharma and 4 tablets GyMiso® from MS Health: the only current TGA-endorsed provider. When Tanya Plibersek says she wants to ensure a "steady good-quality supply" she is locked into the TGA registration of Mifepristone Linepharma by MS Health: no other generic (cheaper) mifepristone has been registered.
Is Marie Stopes' monopoly really in the interest of Australian women needing abortions? What about the future of providing low-tech suction abortions? Called, unkindly, an 'abortion chain' by a doctor performing suction abortions at a community clinic, many abortion providers are unhappy about MSIAs increasing power as their names will be included on a Prescriber Registry held by MS Health once they receive their Certification to become a medical abortion provider. This lets MSIA know which locations and clinics are willing to offer 'medical' abortions: a good way, perhaps, to discover untapped markets? In rural areas maybe?
If or most probably when (given we are in an election year and Labor wants to be seen as woman-friendly) Mifepristone Linepharma and GyMiso® will be added to the PBS, it is important to get the message out to women needing abortions that they should think twice before they opt for days of pain, misery and emotional upsets (possibly followed by a second abortion), rather than a 99 per cent effective and safe suction abortion in a controlled clinic environment. This is especially true for women in rural and remote areas for whom this abortion method is especially dangerous.
About the Author: Dr Renate Klein, a biologist and social scientist, is a long-term health researcher and has written extensively on reproductive technologies and feminist theory. She is a former associate professor in Women's Studies at Deakin University in Melbourne, a founder of FINRRAGE (Feminist International Network of Resistance to Reproductive and Genetic Engineering) and an Advisory Board Member of Hands Off Our Ovaries.