Andy Duffy
State hospitals are dishing out unlicensed abortion pills to hundreds of pregnant women, despite the manufacturers fears that the treatment could be dangerous.
The drug, Misoprostil, is registered to treat stomach ulcers, but public hospitals in provinces including the Western Cape, the Eastern Cape and the Free State are using it as a preparatory treatment for abortion. The drug has been widely used by backstreet abortionists.
Trials for the drug are currently under way at Groote Schuur hospital, which handles most state abortions in the Western Cape, and Kalafong hospital in Pretoria, which serves Atteridgeville and surrounding areas.
The manufacturer, United States-owned pharmaceutical company GD Searle, is refusing to register the drug for abortion use. Searle says its side effects, including heavy bleeding, could make the company liable for massive damages claims.
But the Department of Health says Searle is concerned about being identified with abortion. The anti-abortion lobby in the US is particularly radical.
The Medicines Control Council (MCC), responsible for licensing drugs, has still to rule on whether Misoprostril can be safely used for abortion treatment.
The councils chair, Peter Folb, says the council will make a recommendation this month to Minister of Health Nkosazana Zuma. One option is for Zuma to ignore Searles concerns and deploy the drug for a purpose for which it was not designed a move unprecedented in South African medicine and insist the drug be used in abortions.
Zuma, however, seems to have already taken that decision. The Misoprostril treatment was part of the termination of pregnancy protocol her ministry unveiled before abortion on request was legalised in February this year.
Several provinces have refused to perform abortions unless they can use the drug. Its availability is also seen as vital to providing abortion care at clinics.
The pill is administered orally to prevent stomach ulcers, but for abortions is administered directly to the cervix. For women pregnant for less than 12 weeks, Misoprostril dilates the cervix, enabling easier access for evacuation equipment. Beyond 12 weeks, the pill prompts the uterus to contract, leading to the expulsion of the foetus, which is then followed by surgical treatment.
The drug has just come off patent, allowing another manufacturer to apply to the MCC to produce a generic substitute. The council says it has not yet received an application, and Searle says the drug, which it imports from the US, is difficult to replicate.
The council has been trying to broker an agreement between Searle and the health department for months, to extend Misopostrils registration to its use for abortion. Without MCC registration, doctors are left open to legal action from their patients if the drug harms them.
The health department delegation to Searle has included director general Olive Shisana. Legal representatives from Searles US parent company have also been involved.
Their guidance is a flat no, says Edward Gale, medical director for Searles South African operation. Searle is not going to budge.
He says there have been cases overseas where the treatment has failed, with mothers giving birth to deformed babies. The department disputes Searles fears, claiming the company is more worried about a pro-life backlash against its other products.
Department director for maternal, child and womens health, gynaecologist Dr Eddie Mhlanga, says the treatment has been used widely overseas. Tests in South Africa had so far shown no danger from the drugs use.
The department plans to draw up guidelines for the treatment, which would leave the state as a shield between its doctors and litigation. The guidelines will also enable abortion centres to plan and time treatment the patient is usually ready for the abortion two hours after the pill is administered.
There is no drug that is better or less expensive; therefore we would recommend its use, Mhlanga says.
The treatment that follows the drugs administration including surgical evacuation should prevent any ill effects, he adds.
Private abortion clinic Marie Stopes found the drug to be perfectly safe, programme director Paul Cornelissen says.