GIven

the furore over mifepristone (RU486), it is ironic that in Australia we have several older medications that also have the potential to induce abortion.

For example, while the prosta-glandin analogue misoprostol is primarily used to treat gastric ulcers and induce labour at term, it can also be used alone or in conjunction with methotrexate for medical abortion, and is currently being used in several Au

stralian states for this purpose.

Because of the established use of misoprostol and methotrexate for other conditions, the legislative restrictions applying to mifepristone would not seem to apply to these drugs.

Unfortunately, neither of these treatments are as safe and effective as the mifepristone/misoprostol regimen used routinely elsewhere in the world.

MIFEPRISTONE AND MEDICAL ABORTION

France, in 1998, was the first country to license mifepristone for medical abortion and since then other countries have followed suit

China, the UK, Sweden, Austria, Norway, Belgium, Denmark, Finland, Germany, Greece, The Netherlands, Spain, Switzerland, Israel, Russia and the US. In all these countries, it has not replaced surgical abortion but seems to have provided an acceptable a

lternative for some women.

The medication is only effective in early pregnancy, less than eight weeks from the date of the last menstrual period, and is therefore usually prescribed in a community setting. Most pregnancies end within a week of treatment, but the small risk of fai

lure, incomplete miscarriage and subsequent bleeding mandates that medical intervention should be available.

There is no evidence that making medical abortion available increases the overall number of abortions performed, and in countries where medical abortion is available, 10-40% of women choose this option over the surgical alternative.

MIFEPRISTONE IN AUSTRALIA

What on the surface appears to be a straightforward application to assess a drug on its merits is not that simple. In June 1996, at a time when a Right to Life proponent held the balance of power in the Senate, the Australian Therapeutics Goods Act 1989

was amended to introduce special procedures for drugs intended to be used to induce medical abortion. Under this amendment, the federal health minister is required to personally approve the importation, evaluation, registration and listing of these dru

gs, and any such ministerial approval must be tabled in both houses of Parliament within five sitting days.

Although ministerial approval is not required if such drugs are intended for purposes other than medical abortion, the usual Therapeutic Goods Administration permit is still needed for importation. Several legitimate clinical trials of mifepristone for

other purposes, including use as an emergency contraceptive, have been plagued by administrative delay, and an unprecedented degree of regulatory audit and ethics committee scrutiny. In the earlier trials, some researchers had their homes visited and we

re questioned by the federal police in order to ensure there had been no illicit importation of the preparation.

CURRENT MOVES

Dr Edith Weisberg, director of research at FPA Health and an investigator in previous mifepristone trials, has been quoted requesting an amendment to the special restrictions on the drug. According to Dr Weisberg, mifepristone should be evaluated by the

same criteria as any other drug, and she encouraged the community and medical profession to lobby for change.

The opposition, however, will be strong. For example, in October 2000 Right to Life Australia

s chairwoman Margaret Tighe said in the

Sydney Morning Herald

that only a

very courageous or politically naive

”

politician would approve the importation of mifepristone into this country. She said Right to Life Australia would continue to lobby the government to ensure the drug was banned.

LESSONS FROM THE US

The policy on abortion illustrates the influence of governments on sexual health matters. We have only to look to the US to see the impact of the personal philosophies of leaders and minority groups on the delivery of reproductive services. In 2004 the

US Food and Drug Administration rejected an application to make Plan B (the equivalent of emergency contraceptive Postinor-2) available from pharmacies as has occurred in Australia since January 2004. The decision was not made on the grounds of safety,

but on the basis that women under the age of 17 would not be able to understand the product

s instructions.

Undeterred, the pharmaceutical company amended its application so that the product would be available over the counter to women who were 17 and over. Peak bodies such as the American College of Obstetricians and Gynecologists, the American Public Health

Association and the FDA

s own expert committee, which voted 23-4 in favour, strongly recommended adoption of the proposal.

However, in August 2005 the FDA again rejected the application, this time on the basis that pharmacists could not accurately determine the age of those requesting the medication. No date has been set as to when, or whether, the FDA will reconsider the m

atter. A statement by its spokesman said:

There are unique regulatory issues that need to be addressed.

”

It appears that even prestigious organisations such as the American National Cancer Institute (NCI) and the Centers for Disease Control (CDC) are not immune from political influence and interference. Before 2002 the NCI web site endorsed the consensus v

iew that there was no evidence showing an increased risk of breast cancer after abortion. In 2002 this advice was altered to say there was an increased risk of breast cancer after abortion. The change is said to have been prompted by pressure from some

members of Congress, and occurred despite the fact that the small studies on which this statement was based have largely been discredited. Medical reaction to the change was swift, and a further high-level review of the available evidence was undertaken

. In early 2003 the NCI quietly reinstated its previous advice.

Similar pressure saw the CDC remove its earlier instructions on correct condom use as a means of preventing sexually transmitted infection and replace it with the instruction that

the best way to avoid transmission of sexually transmitted infections is to abstain from intercourse, or to be in a long-term mutually monogamous relationship

”

. True, of course, but not exactly practical or pragmatic.

THE‘GLOBAL GAG RULE’

The influence of government policy on health matters extends further. The so-called

Mexico City policy

was conceived during the Reagan administration in 1984 and was revived under the present Bush administration in 2001. Popularly referred to as the

Global gag rule

, this policy states that no US funds can be provided to any foreign non-government organisation that uses the money to provide abortions, or to provide advice or information regarding abortion or emergency contraception. This provision extends to organ

isations in countries where abortion or emergency contraception is legal, such as Australia, even though such a policy would be illegal in the US because it would violate the US Constitution

s guarantee of free speech.

This policy compromises Australian overseas aid projects, which are often partly US funded, and deprives communities of information that might be critical in protecting women against unintended pregnancy and its consequences in underdeveloped countries.

THE ROLE OF THE MEDICAL PRACTITIONER

Most doctors are not overtly political. However, they can speak out against those who seek to cloak control and manipulation under the more palatable terms of beneficence and protection.

As a profession, doctors can effectively use their authority to insist that decisions on reproductive health policy are evidence-based. Standing up for patients is a proud tradition going back thousands of years, and those in power must understand that

doctors will not back down on this vital issue.

Dr Foran is a sexual health physician and co-ordinator of the undergraduate course in women’s health at the University of New South Wales.