At the end of last year Webdiarist Mary Lander contacted us about the use of RU486 in the treatment of various forms of cancer. She wrote:

Perhaps Webdiary would be interested in this research and or interested in generating views on the need for government to fund clinical trials using this drug. I've just had a story published in the Medical Journal of Australia which can be referenced via a link to the MJA site from other websites (but not reproduced): The fight for a life-saving drug: a personal perspective [1].

In addition to that which I explained in my article, I feel the government should fund the drug via the Special Access Scheme for those patients who have an application approved surely and there are no other viable treatment options that do not carry a high risk of adverse outcome (they'd paid their taxes all their lives and deserve to be treated better. It is hardly their fault that they happen to have a progesterone dependant tumour or cancer and such groups of patients have been disadvantaged for long enough surely).

While 36,000 people die of cancer every year the government has not to date provided funding for such drugs via the so-called Special Access Scheme.

…

Nothing further will happen on this unless the Australian public demand the government does something about this issue. Certainly with a change of government that may now be possible given the background to this issue and the controversy surrounding the drug due to one of its uses which co-incidentally wouldn't even be relevant for people with life-threatening tumours and cancers.

Mary and I exchanged emails for some time trying to work out a way of presenting the issues in an accessible (non-medical) manner. Fortunately, Mary was wise enough, given my lack of expertise in the area (not to mention chronic shortage of time), to bring the matter to the attention of Crispin Hull [2] of the Canberra Times. As a result, the following article appeared in the Canberra Times on 31 May 2008 [3]. Crispin has kindly given us permission to republish his article on Webdiary. Thank you Crispin, and thank you Mary for your persistence on this important subject.

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Pro-life policy on RU486 condemns tumour sufferers to die
by Crispin Hull

It is a little more than two years since the Federal Parliament on a conscience vote removed the power of veto of the Health Minister then Tony Abbott over the approval of the abortion drug RU486.

It is 12 years since it was made a prohibited import by the Howard government, to the satisfaction of anti-abortion Independent Senator Brian Harradine, whose vote in the Telstra privatisation Bill was crucial to the then government getting it through the Parliament.

RU486 remains essentially a prohibited import. It remains in a category of its own too hard for doctors and pharmacists to get approval to prescribe it and too hard for drug companies to get approval to make it available. And this is having a sad and costly side-effect. You see, RU486 is not only an abortion drug. It has life-saving effects for patients with cancer and benign tumours, among others. The drug shuts off progesterone a hormone essential for the continuation of pregnancy, but also a hormone that tumours can feed on. Shut out progesterone and tumours' growth will slow or stop.

Scores of drugs are available to shut off the production of various hormones that tumours feed on. They help people with lots of types of cancers and benign tumours. But pity help you if your tumour happens to be progesterone-receptive. If you want effective treatment with RU486 you, your doctor and your pharmacist will be dragged through a bureaucratic quagmire all because of prejudice, phobia, bias, political cowardice and religious zealotry.

Mary Lander, of Torrens, was diagnosed with a benign tumour on her auditory nerve in 2005. Surgery was an option at the risk of the deafness, blindness or other disability that comes with virtually any brain surgery. Her tumour was progesterone-receptive. RU486 was an obvious drug for her. If it had been a different hormone or a different sort of tumour, her doctor would have had no difficulty writing out a prescription or a pharmacist filling it. But it was RU486. There is no Australian manufacturer or supplier because of the right-to-life-inspired import prohibition.

To import the life-saving drug you have to get a special permit from the Therapeutic Goods Administration under the special access scheme. It takes time. Too much time in the case of Senator Peter Cook, who died before he could get a permit.

Once you get a permit, you have to source the drug. The TGA does not help with sourcing, even though Customs regulations suggest that the permission to import should include the name and address of the supplier.

Sourcing the drug in France or China takes critical time. Drug companies do not like to advertise that they are suppliers of RU486 lest they be targeted by anti-abortion groups. You won't see their ads on the internet unlike the plethora of unwanted ads for unwanted drugs that clogs everyone's emails. You see a few medical and information sites and then an avalanche of anti-abortion hysteria.

Once a patient gets a permit and a source, the drug has to clear Customs which requires production of the original permission and more cost and delay. And speaking of costs, the drug is not under the Pharmaceutical Benefits Scheme. A daily pill to keep Lander's benign tumour at bay costs about $4000 a year. She can afford it, but she points out that others she has helped to source the drug cannot. One is a pensioner who has lost the sight of one eye and risks the sight of the other with surgery.

The system will fund surgery, carers and all the other costs associated with other treatment, but not RU486 because that is shock, horror an abortion drug. The drug has had some clinical trials. It has been shown to be effective in cases of meningioma (mostly benign tumours of the brain benign meaning slow-growing but not capable of spreading to other organs of the body); ovarian cancer; Cushing's disease and lymphoma.

Another difficulty is arising. The physiological properties of RU486 are now well known it prevents progesterone reception. And the patent on the drug has expired. It means no drug company will be interested in funding clinical trials for new uses of the drug because it could not get a new patent for the new use of a known property of a known drug. For a new use of it to be patentable, it would have to be a new use which was due to an unknown or unsuspected property of the drug.

Drug companies are not philanthropic societies. They want a return. It means government would have to fund the clinical trials. Given the hassle that authorities now place in front of single patients, there seems little chance of that.

This drug is damned as guilty by association.

All of this is cruel. RU486 should be on pharmacists' shelves in Australia and be subsidised under the PBS, at least for benign brain tumours.

It is a classic case of ignorance, fear, loathing and prejudice resulting in bad public policy.

One last irony. Because authorities are making it so difficult for RU486 to be imported as an abortion drug, doctors are resorting to the anti-cancer drug Methotrexate for use to produce chemically induced abortions.

So you can easily obtain a tumour drug to produce an abortion in Australia, but it is near impossible to get an abortion drug to treat a tumour.