RU486? IM4 Due Process

1996 - Senator Brian Harradine successfully introduces the Therapeutic Goods Amendment Bill 1996 to limit the introduction of pharmacological abortifacients (drugs intended to induce abortion) by taking away the Therapeutic Goods Administration's (TGA's) ability to assess any such drugs unless prior approval is given by the Minister for Health and Ageing. All such drugs are classified under the name of "Restricted Goods".

"restricted goods means medicines (including progesterone antagonists and vaccines against human chorionic gonadotrophin) intended for use in women as abortifacients.
— Therapeutic Goods Amendment Bill 1996

The intention was to introduce an added layer of Governmental scrutiny to any attempts to widen the options for women seeking abortion, and presumably to deter any health providers from offering pharmacological abortion (a de facto ban).

Since that time, no pharmaceutical company has made any attempts to apply to import or supply RU486 (Mifepristone) for pharmacological abortion in Australia, most likely on the belief that all presiding Health Ministers would have declined to permit the application from proceeding.

October 2005 - Debate develops over Health Minister Tony Abbott's public anti-abortion stance, and the Democrats state their intention to repeal Tony Abbott's right to veto any application to introduce pharmacological abortifacients (in particular RU486).

November 2005 - Tony Abbott clearly states his opposition to the use of RU486 on the basis of a report from the Chief Medical Officer Professor Andrew Child which is widely criticised.

29 November 2005 - Thoughful Parliamentary Library article on current status of RU486 in Australia.

December 2005 - Professor Caroline de Costa makes the first application to the TGA for a license to prescribe RU486 as a test case.

8 December 2005 - This application prompts Senators Nash, Troeth, Allison and Moore seek to introduce the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. Background report here.

8 January 2006 - Several more Obstetricians state their intention to apply for a license to prescribe Mifeprostone.

13 February 2006 - The Bill is debated and passed in the Senate.

16 February 2006 - The Bill is debated and passed in the House of Parliament despite attempts to confuse the voting process with multiple amendments.

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On Due Process
The TGA has the power as an independent statutory authority to assess all medicines, pharmaceuticals, and therapeutic devices. The items it assesses are not always used only for therapeutic purposes, and often they are used in combination with other procedures or medicines. It has an expert, world-recognised panel to do these assessments, and we entrust them on a day-to-day basis to assess and approve (or decline) all medicines and medical instruments that are in current use.

So why did Senator Harradine wish to remove the authority to review abortifacients from the TGA? This has nothing to do with the TGA's ability or suitability to objectively assess this class of drugs, but merely with his own personal viewpoints that abortion is not acceptable, and any means of preventing access to abortion should be implemented. Therefore a class of "restricted goods" was created which was intended purely to stop one drug entering the country for one specific purpose. This creates an administrative and logical divide - that surgical abortion is allowed but pharmacological abortion is not. This has nothing to do with safety, but was merely Senator Harradine's first step towards banning abortion altogether.

It was about time that commonsense prevailed, and the TGA was allowed to go back to doing its job - assessing the risks and benefits of all therapeutic agents presented to it and making sure that they are used safely and appropriately without the interference of the Parliament.

If the Government wishes to outlaw abortion, then introduce a law to outlaw abortion, do not undermine the currently effective system for assessment and regulation of therapeutic agents by adding beauracratic red tape.

There is a reason why the TGA is empowered to review these agents - because they are experts and they review medical and scientific evidence critically. Based on the tragic misuse of statistics, omission and manipulation of facts, pseudofacts, and illogical arguments during the course of the recent debate in the House of Parliament, it is self-evident why politicians and the Parliament is not entrusted with the critical evaluation of drugs and medicines.

On Abortion
There is no doubt that the whole issue about access to abortion facilities (including counselling services) is one that generates major angst amongst parts of the community. Any event that leads to a perception of loss is traumatic and distressing. As doctors we deal with this every day, patients get upset when their body changes, either because of their own pathology or disease, or because of what is done to them.

The loss of a foetus is even more distressing for any woman because not only is there a perception that their own body is affected, but a potential life. I deliberately use the word "potential" because there is no way to know, either as a layperson, a scientist or any other professional, at what stage a life is involved. What matters most is how the patient or mother regards that potential life, and what attachment she holds to it, and the consequences of allowing that potential life to develop (or not develop, as the case may be). It is her body, and she is the major stakeholder.

Just as the public have no right to tie her down and make her abort or miscarriage, the public have no right to tie her down and stop her from aborting or miscarrying. It is not practicable to deny this choice to women, so the goal of facilitating abortion is one of harm minimisation. Those who reject a woman's right to supervised abortion services must in principle also reject anti-smoking advertisements.

At the Coalface
A purely hypothetical young lady in her early 20s presented to a country hospital with severe right iliac fossa pain (right lower abdomen) for several days. She was also 12 weeks pregnant, which was not wanted. Her obstetrician was a devout Catholic who had declined to perform a suction termination of pregnancy on religious grounds, and no other obstetrician was available to treat her. When it became clear that this young girl had appendicitis she declined surgery, hoping that this would lead to a spontaneous abortion. After 2 days she got what she wanted, at the cost of a perforated appendix and a big scar down the middle of her belly.

COAG: Clueless Organisation of Anacoluthic Gits

Last week I was driving home when I heard the ABC's PM show (yes, I am one of those pompous ABC listeners) summing up the recent COAG meeting.

While the news about investing in preventative health, mental illness (not that anyone has specified what changes will actually happen - will there be more acute care beds, institutional beds, community housing, CATT teams, or just bureacracy?) is essentially just feel-good news for the benefit of the media, what blew me away was firstly the ongoing failure of the Federal and State Governments to understand the workforce bottlenecks in medical training, and secondly, Peter Beattie's inane suggestions to reform the health system.

In regard to the Australian "doctor-shortage" - the Howard Goverment fails to realise that this is a problem on multiple levels created by its own attempt to reign in Medicare. On defeating the Keating Goverment in 1996 one of the early acts of the Howard Government was to restrict the availability of Provider Numbers. These numbers are how GPs and specialists are paid by Medicare every time they see a patient. The goal of this was obvious - fewer doctors who can claim money from the public purse means paying out less money, and encouraging competition for scarce funds. It also meant that the Federal Government could then place restrictions on what doctors had to do to earn the right to a Provider Number (e.g. work in the country, complete a specialist or Family Medicine training program). Many organisations spoke out against these changes, and doctors went on rallies and strikes to oppose it.

Doctors who were graduating from medical school found that they could no longer work as GPs, so what happened? They either did what the Government wanted and stuck around for training, or headed off overseas ( the so-called "brain drain" - which actually works both ways). Within a few years, the number of GPs who were able to get Provider Numbers (and thereby work in the public sector) was choked and limited by the State and Federal Government's willingness or otherwise to fund Family Medicine Training positions. Now we see the Howard Government complaining about GPs charging above the (meagre) Medicare Schedule Fees - all because there is now more demand than supply and John Howard's competitive marketplace is coming to fruition. Mind you, this is happening not only in GP-land, but in every specialty of modern medicine.

So what does COAG do? It announces that (from PM) "While for now the Federal Government won't lift the number of medical students it funds to go to university, there will be more room for full-fee paying students." Well, DUH! The Federal Government didn't need to do that... Universities could have done that all on their own. All that means is that: 1. More overseas students can come and train in our universities and hospitals so that they can then go back to where they came from and Australia gains no benefit (besides pocketing their money); and 2. More doctors will graduate and increase the backlog of doctors that can't work in the community.

Yes, you read me correctly, doctors that can't work. The people that are rubbing their hands with glee are the hospital administrators who are seeing the number of hospital resident and registrar applications increase, but only small increases in the number of registrars completing their training and becoming Specialists who can go out and serve the Australian community.

The stranglehold on Specialist Training rests with the State Governments (and in the case of GPs, the Federal Government). Specialist colleges like the Royal Australasian College of Surgeons, Royal Australasian College of Physicians, and Royal Australian College of General Practitioners merely accredit jobs as being suitable for training, and administer the courses and examinations to ensure that graduating specialists are up to scratch.

For surgeons and physicians, these are hospital posts that are funded by the State Government via each Hospital's budget, and are decided between each State Governement and Hospital. For GPs, these are via the allocation of restricted Provider Numbers by the Health Insurance Commission (and therefore, Federal Government).

So for the State and Federal Government to blame the Colleges for restricting specialist numbers is farcical. There are literally hundreds if not thousands of hospital doctors half-way through their training, waiting for a funded position to become available so that they can complete their training. Perhaps 1 in 3 of these applicants will get a position each year. The rest either become disenchanted and drop out of medicine (there are plenty of companies looking for such bright-minded people), head overseas, or fill in as locum doctors for all the gaps in the public health system. Even worse, there are those who have completed their specialist training but cannot find a hospital with enough money to employ them... so they head overseas!

At least Peter Beattie understands this part of the equation when he commented:

"…that we've got to stop thinking just about public hospitals being the provider of clinical training. The proposal that I've talked about and which I put to COAG today involves, in Queensland at least, Greenslopes Private Hospital will actually provide that training. Now, yes, there will be some follow-up that'll have to be done by the public hospital system, but we've got to stop thinking about training just being in the public system. We can do this in partnership with the private system. The whole area of health is public/private anyway, here you've got a hospital that will 60 doctors, hopefully starting – up to 60 doctors – hopefully starting this year."

Note that he actually means 60 full-fee paying medical student places, not doctors. But then, why would we quibble over that when what he is actually doing is single-handedly re-defining the whole paradigm of public/private medicine in Australia.

There are a number of reasons why doctors are not routinely rotated to private hospitals for training.

1. Patients in a private hospital expect to be treated by their chosen doctor or specialist, not a junior doctor whom the specialist has no choice in and is only doing a 3 month rotation.
2. Quality resident medical officers are paid handsomely by private hospitals because they are hand-picked and vetted to do a good job. This new arrangement is a cynical exercise at either cost-cutting at private hospitals (since these training-in-private doctors would presumably be paid at award rates only) and/or reduction in the quality of patient care for the sake of a 30 second soundbite.
3. In those rare private hospitals where private surgical registrars have rotated as part of their training program (yes, they already exist), they have no input into the patient's care, and only assist during operations, without performing the crucial parts of the surgery that are the core goal of their training. This is great for the patient, but not good for the trainee.

Peter Beattie's problem (and not only his, since the same issues simmer away in every other Australian State and Territory) is that working in a (particularly Queensland) public hospital is an increasingly unpleasant and unrewarding job. The pay is paltry per-hour, overtime is routinely being refused, all the responsibility (legal liability) rests with the doctor - which means that any demarcation dispute among nurses, allied health, cleaners etc must be solved by the doctor (read "more unpaid work"), the career-progression is stymied by the lack of Government funding, and then you get screwed over to make sure you aren't another Dr Death (don't even get me started on that one...).

When doctors are appreciated and rewarded for their work, and allowed to go about their jobs without being pressured left right and centre, they will come back to the public health system. Otherwise, strap yourselves down and get ready for a ride into privatised US-style health care!

Welcome to The Paper Mask.

I always wondered why people write blogs - why would you go to the trouble of telling the world about all of your mundane little trivialities? Does anybody care? My personal opinion is that it is merely a way to say all of those things that the normal inhibitions of daily life prevent you from doing because you don't want to take responsibility of what comes out of your mouth. You know, all those day-to-day comments like: Did you fart? Those breasts must be fake. George Bush seems like a nice guy. (You get the drift.)

Anyway, I think that the Blog or Weblog must be a way to establish an identity purely on what you say on the blog, not where you live, what you do, what you look like. And if you are embarrassed by what you have said, you just close up shop and move to a new blog. Not, of course, that I am intending to do that.

So what do I have to blog about? Well, not much at the moment, but I am sure that it will come to me. It's inevitable that little details will leak out about who I am or what I do, but there is no need to hurry any of that along.

On the subject of Paper Masks, however, I did notice something rather odd the other day. One of the hospitals I work at uses Kimberly Clark face masks in the operating theatre. My personal preference is the orange ones, and I hate it when they only come with the big clear plastic shield - I have to carefully rip it off without damaging the rest. So as I was scrubbing, I noticed that the boxes come with this notice on them: “The COLOR ORANGE is a Registered Trademark of Kimberly-Clark Worldwide”.

Now perhaps I'm alone on this one, but I find it rather odd that a company can trademark a colour, or even the phrase “COLOR ORANGE”. Does this mean I now have to pay fees to KC because I've put it up 3 times on a blog? How bizarre!

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