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.
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.