An anti-abortion advocate claims that RU486 is dangerous. Here is a medical response to those claims.

By PHILIP GOLDSTONE

On Sunday 11 August, The Age published an opinion piece by Melinda Tankard Reist, entitled ‘RU486 is not the ‘safe’ DIY method for women it is claimed to be.’ Marie Stopes International is very concerned about the misleading information she provides in relation to medical abortion in Australia.

Ms Tankard Reist begins her opinion piece by stating that RU486 is promoted as ‘do-it-yourself’.

While for most women the abortion process is completed at home, it is by no means “do-ityourself”. The medications used in medical abortion, Mifepristone Linepharma and GyMiso® must be prescribed by a certified medical practitioner who has undergone an additional training course.

This training course is endorsed by the Royal Australian & New Zealand College of Obstetricians and Gynaecologists (RANZCOG).

The prescribing doctor is responsible for the care of the patient, including initial assessment and suitability of the method. In line with the Therapeutic Goods Australia (TGA) approved Product Information governing the use of these medications, the prescribing doctor must ensure access to 24-hour emergency care if required and provide follow up 14- 21 days after treatment. In addition, all women prescribed Mifepristone Linepharma and GyMiso® have access to a 24-hour Nurse Aftercare service provided by MS Health. This is clearly not “do-it-yourself” as claimed by MsTankard Reist.

READ MIA FREEDMAN’S PIECE ‘IF YOU’RE GOING TO WRITE ABOUT ABORTION, YOU HAVE TO REVEAL THIS’ HERE.

Ms Tankard Reist cites four examples from women who have taken RU486 to procure a medical abortion who experienced cramping, nausea and loss of blood, amongst other side effects. Ms Tankard Reist appears to have cherry picked examples that support her opinion and this does not reflect most women’s opinion, given that 91% of women who have used medical abortion in Australia would recommend the method to a friend. While we acknowledge that these symptoms were clearly distressing for the women in question, and without negating their personal experience, these are all expected and well-documented side effects of a medical abortion, and are experienced to different degrees by different women.

As part of an observational study involving 13,345 women and published in the Medical Journal of Australia (September 2012), over 6,000 women from the study reported on their pain, bleeding and overall experience of medical abortion. Most women said the bleeding (83.8%) and pain/cramps (76.2%) and the overall experience (90.3%) was either as expected or better than expected. Most tellingly, 78.0% of respondents said they would use the method again. In line with the training, certified medical practitioners are required to provide the patient with information outlining the possible side effects of bleeding and cramps, nausea and vomiting, diarrhoea, and fever and chills.

These side effects are well documented in all product materials for medical practitioners and patients. Patients are provided with information to take home with them describing the common symptoms of the abortion process, how to manage these, when to seek further medical advice and care, and the additional risks that may arise from using this treatment.

Ms Tankard Reist states that “In Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) agreed to a request from Marie Stopes Health, a subsidiary of Marie Stopes International, to list Mifepristone Linepharma (RU486) and the misoprostol GyMiso on the Pharmaceutical Benefits Scheme (PBS) for termination up to 49 days gestation”. The language that Ms Tankard Reist has used here seriously underplays the rigorous submission process that MS Health undertook in order to have Mifepristone Linepharma and GyMiso® registered with the TGA and subsequently listed with the PBS. This is the same process that all other pharmaceutical companies go through to have their products registered and listed on the PBS and includes a comprehensive review of scientific and clinical data along with health economic modelling. The PBAC is an independent body made up of experts who advise the government as to the efficacy, safety and cost effectiveness of a product to be considered for reimbursement under the PBS. The PBAC made a recommendation to list Mifepristone Linepharma and GyMiso® on the PBS based on the quality of MS Health’s submission and the recommendation was ultimately accepted by the Federal Government.

Ms Tankard Reist has repeated an accusation made previously by Renata Klein that a woman had died in a Marie Stopes Clinic in 2010 as a result of sepsis from a medical abortion. We consider this accusation factually inaccurate. A woman did not die in a Marie Stopes Clinic in 2010. We are aware of the tragic death of a woman from sepsis. However, following a review of medical reports and other evidence, the Coroner’s office did not proceed with an inquest and closed the case. Ms Tankard Reist claims that “In a study by Marie Stopes’ staffers published in the Medical Journal of Australia (September 2012), this death was callously attributed to the woman’s own negligence because she didn’t “seek medical advice” and died of sepsis”.

In fact, the article in question, whose principal author is a fully qualified medical practitioner, states that “This woman suffered fever and flulike symptoms about 6 days after taking mifepristone, but unfortunately did not seek medical advice, despite urging from family members.” In no way, here or in any other publication on the matter, has Marie Stopes International ever “attributed” this death to the “woman’s own negligence” as Ms Tankard Reist claims. It is important for clinicians to understand, however, that this death occurred in the setting of untreated infection.

Ms Tankard Reist goes on to state in her article that about 1 in 30 women will need a second termination procedure after a medical abortion. The product information available to doctors clearly outlines the failure rate at between 2 and 7% and the rate of ongoing pregnancy at 1%. Prescribing doctors must ensure patients are fully informed of the possibility of needing a surgical procedure to complete the abortion process. The inference made by Ms Tankard Resit that this makes the medicine inappropriate or unsafe is misleading and biased.

Ms Tankard Reist cites ‘medical bodies’ who say that a lack of nearby emergency facilities is a reason not to use medical abortion. It is part of the training and Product Information supplied by MS Health that the prescribing doctor ensures access to 24-hour emergency care.

Finally, Ms Tankard Reist states that ‘pushing this drug combo as simple is disrespectful of a woman’s right to know what she might face’. Ms Tankard Reist has not provided any evidence, apart from one anecdotal citation from “Rose” that medical abortion is being promoted as simple. In fact, MS Health is very clear about the symptoms and side effects that women can expect to experience when having a medical abortion and requires all certified prescribers to fully inform patients before prescribing these medications.

Philip Goldstone is the medical director for Marie Stopes International.

Marie Stopes International Australia is a non-profit organisation dedicated to, amongst other things, improving the availability of abortion services to Australian women.  It established MS Health with a view to having Mifepristone Linepharma and GyMiso registered for use in Australia and supported through the PBS thus contributing to the ongoing achievement of this goal and ensuring long-term, sustainable access to medical abortion for Australian women.

After re-investment in our Australian operations, all surpluses made by MS Health and Dr Marie clinics are donated to support Marie Stopes International’s international development programs in the Asia Pacific Region and to explore further opportunities to extend access to sexual and reproductive health, family planning and abortion services in Australia.

Note from MM Publisher Mia Freedman: Melinda Tankard Reist is perfectly entitled to her philosophical views on abortion. But when she cherry-picks facts to create a misleading medical impression despite having no medical background and using this to give credence to these views without openly declaring them this is deeply troubling. This post (nor this one) is an attack on Melinda. It’s simply informing readers of her position and the facts surrounding the use and prescription of RU486 as well as refuting some of the claims in her original op-ed published by The Age. No comments that are abusive or disrespectful towards Melinda Tankard Reist will be published by Mamamia.