I wrote about the Australia import restrictions on RU486 back in December, when this article by Mary Lander appeared in the Medical Journal of Australia: “The fight for a life-saving drug: a personal perspective”. RU486 is a progesterone antagonist – it blocks the action of the hormone progesterone in the body. This makes it useful for inducing abortion, or for emergency contraception. It is also useful for the treatment of certain tumours, such as the brain tumour meningioma.
Crispin Hull from the Canberra Times is now onto the story. From his article “Pro-life policy on RU486 condemns tumour sufferers to die“. Hull outlines the series of obstacles to obtaining RU486 if you’re unlucky enough to be ill in Australia:
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.
[...]
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.
[...]
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.
Rudd and Roxon? Fix this.
[via WebDiary.]
The person responsible for the administration of the Scheme is none other than John Howard appointed Jane Halton who is currently still the Secretary of the Department of Health and Ageing but I understand her contract comes up for renewal in October this year so it will be interesting to see what develops at that time.
A little more on her involvement on this issue:
During the 2005 Senate Inquiry into the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, the Secretary of the Department of Health and Ageing advised that she “believes the Department administers the existing legislation in place with due diligence”. That, of course, applies to the administration the Special Access Scheme as well.
Despite this claim, the Secretary has in fact not meeting her due diligence obligations under the Customs (Prohibited Imports) Regulations 1956, given that Part 5, Clause 11(b) of the Regulations state that:
“A permission to import the drug shall be in writing and shall specify (b) the name of the supplier of the drug and his address in the country from which the drug is exported”.
Based on copies of written permissions and permits I have obtained from the Secretary and her authorised officers, the Department has not complied with their obligations under law. Ordinarily, when legal acknowledgement is extended to a moral duty of care obligation, then this duty becomes a legal requirement.
Of note is an extract from a Senate Estimate Hansard from June 2006 as copied below. Senator Peter Cook was of course best known for his role as Chair of the Senate Inquiry into a Certain Maritime Incident and then later in establishing the Senate Inquiry into treatment options for persons with cancer noting also the extent of interest taken by the responsible Secretary:
Therapeutic Goods Administration
….Senator WEBBER—There does seem to be some confusion about the length of time, because this issue was certainly raised with me by the late Peter Cook, whose medical practitioner tried to import it, but by the time they got through the process the drug got into the country too late. Ms Halton—In terms of RU486?Senator WEBBER—Yes, mifepristone. So there seems to be some misunderstandings of the processes, perhaps…
My comments with respect to the above would be to suggest to Ms Halton that it would not be contrary to her due diligence obligations to actually monitor the effectiveness of the Special Access Scheme to ensure that it meets its objectives and that the system in place ensures the provision of, and timely access to, unapproved drugs for patients classified as Category A patients.
Or would that be too big an ask of the responsible Secretary.
Of note also is the following extract from a recent speech by the Human Rights Commissioner:
“…the government has no structure in place within which to self monitor the human rights impacts of laws or policies. As a result, despite there being a national human rights institution devoted to human rights protection, there are serious gaps in human rights protection in Australia. In practical terms, we must ensure that human rights are taken into account during governmental processes, including law-making, policy-setting and decision-making.”
Now would that come as a surprise to anyone?
[...] Across the ditch, Lauredhel points out that the anti-abortion lobby is preventing cancer sufferers from using a drug that can treat certain tumours, because it can also be used for abortion: RU486 Import Restrictions in Australia. [...]
Here’s another research trial. So how many deaths have there been to date since this drug was prohibited in this country?
1: Anticancer Res. 2009 May;29(5):1611-3.
Mifepristone may halt progression of extensively metastatic human adenocarcinoma of the colon – case report.
http://www.ncbi.nlm.nih.gov/pubmed/19443374?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
Check JH, Dix E, Sansoucie L, Check D.
BACKGROUND: Mifepristone, a progesterone receptor antagonist has been found to improve the length and quality of life in various spontaneous murine cancer models including tumors without progesterone receptors theoretically by inhibiting an immunomodulatory protein that suppresses natural killer cell function in the tumor microenvironment. MATERIALS AND METHODS: Mifepristone 200 mg per day by mouth was given to two patients with stage 4 colon cancer with extensive metastases. RESULTS: Both patients not only survived far longer than expected but had marked improvement in their quality of life similar to mice. Though the metastatic lesions did not disappear, no new ones appeared for a long time and the ones present did not grow. The drug was extremely well tolerated. CONCLUSION: The use of progesterone receptor antagonists may present a novel immunotherapy to help fight cancer. A larger controlled study is needed.
1: Clin Exp Obstet Gynecol. 2007;34(4):207-11. Links