Botox? Bollocks!

I had a little chuckle when I saw the Cosmetic Physicians getting upset at what they perceive to be the underhanded tactics of some Cosmetic Nurses.

For the benefit of those who have been living under a rock, there is a movement called Cosmetic Medicine. It is championed by the Cosmetic Physicians Society of Australasia the Australasian Society of Cosmetic Medicine and the so-called Australasian College of Cosmetic Surgery.

In a sense, many doctors practice cosmetic medicine in some way. Some skin lesions aren't likely to be cancers but are removed anyway at the patient's insistence. Some varicose veins are more a nuisance than a risk to life or limb and still get removed. Some footballers have surgery to speed their recovery and short term function when they would have healed on their own anyway. The line between what is truly deserving medicine and what is discretionary (or "cosmetic") is a very fuzzy one.

Nevertheless, cosmetic medicine is a booming industry. They like calling it Cosmetic "Medicine" because it is much more acceptable to pop a pill or have an injection than to have "Surgery" these days.

I have occasionally been caught at the dinner table between a plastic surgeon and a "cosmetic surgeon" having a good go at each other. The plastic surgeon (who, like me, undertakes a minimum of 5 or more years of basic surgical principles and practice after at least 2-3 years of general medical experience, followed by specialist surgical training in plastic surgical and reconstructive surgical techniques, and often further subspecialty fellowships locally or overseas) argues that cosmetic surgeons are not trained in the basics of surgery and surgical techniques, the care of the complex patient, the management of severe complications after surgery, and the wide range of techniques required in modern surgery.

The cosmetic surgeon (who could be from a wide range of backgrounds such as a doctor who has not undertaken any form of specialist training and just decides to set up shop, or a specialist in another field like a dermatologist or a GP who decides to extend their practice into cosmetic fields, or any of these people who choose to undertake a 1-3 year informal apprenticeship with another "cosmetic surgeon") argues that you don't need to learn how to do a microvascular anastomosis in order to inject collagen, do tummy tucks, perform liposuction, or do a boob job. Instead, they say that you need an "eye for aesthetics" which they say plastic surgeons lack, and you need experience in a dedicated cosmetic clinic where finer and more subtle work is done rather than a public hospital where plastic and reconstructive surgeons deal with major deformities and mangled patients.

Obviously I am a little biased, but cosmetic physicians are really in a much bigger mess because firstly they have failed to set common standards for themselves. This is inevitably because they come from very disparate backgrounds, and therefore any attempt to standardise a training program akin to surgical training runs the risk of rendering a whole generation of self-taught cosmetic physicians unable to meet their own standards, without very prolonged and generous "grandfathering" provisions.

Secondly, cosmetic physicians perform a wide variety of procedures, from Botox injections, Collagen or dermal filler injections, liposuction, abdominoplasties, breast enhancements, facelifts, dermabrasion, laser skin therapy, varicose veins surgery, and all sorts of procedures related only in the fact that their goal is to make you look better. There is no common set of skills. There is no fundamental "principle". There is, in short, nothing to base a training program upon other than learning a few tips and tricks here from as many other disciplines as possible. It's like taking a random factory production-line worker off the Boeing production line and saying "Why don't you ask everyone else in the factory a few questions, then we'll give you a building and you can build the new 787 Dreamliner for us?" From all the trouble that Boeing is having, perhaps that is really what is happening!

Thirdly, once you leave the moral high ground and start sniping at your own colleagues and lowering the standards of training necessary to perform these procedures, there is really no limit as to how low it can go. Cosmetic physicians standing up and saying that you don't need to be a surgeon to do cosmetic procedures is only step one. Step two (as described below) is cosmetic doctors supervising procedures done by cosmetic nurses in order to make more money. Step three (also described below) is for Cosmetic nurses standing up and saying that you don't need to be a doctor to do these procedures. Step four is beauticians standing up and saying that you don't need to be a nurse to do these procedures. Step five is some bloke in Mexico who does breast implants with a second hand diathermy machine and a spoon in his garage.

Just like Melissa Blandfort who is a travelling cosmetic nurse performing invasive procedures in patients for cosmetic purposes in various beauty salons, and without the review or approval of a doctor. Her website does not mention Botox by name, but clearly says that she performs:

Injectable wrinkle treatments
Injectable wrinkle treatments have now been in use as a cosmetic treatment for over 20 years. They relax a wrinkle causing muscles, to help improve the appearance of the wrinkle. It is extremely effective in treating crows feet, frown lines and other wrinkles caused by a muscle contraction. It is generally most effective in people aged form 25 to 55 years of age. It takes up to ten (10) days to have full effect and can last up to four (4) months.

Now, last I checked Botox and similar paralytic or neuromuscular blockade agents were prescription-only in Australia, so unless she takes a doctor around with her to write out scripts for these patients, I can't see how she can be legally injecting anybody with Botox. Her website says nothing about her being accompanied by a doctor, and I would hate to be the 20th patient receiving Botox out of her multi-dose vial that mysteriously appeared out of nowhere.


Links:

• Botox trend creating worry lines - Brisbane Times
  (Click to Expand)
  
  
  

  Botox trend creating worry lines
  Jill Stark
  August 23, 2009
  
  DOCTORS groups claim nurses are putting patients at risk by illegally performing cosmetic procedures such as Botox, wrinkle fillers and fat-dissolving injections without supervision.
  
  The Cosmetic Physicians Society and The Australasian Society of Cosmetic Medicine say nurses are increasingly injecting the restricted drugs in beauty salons and at Botox ''parties''.
  
  They claim nurses should administer anti-ageing medication only after patients are assessed by a doctor. But they say people are often injected without medical checks and prescriptions are provided for patients doctors have not met.
  
  Complaints have been made to nursing boards in three states, including Victoria, amid fears that nurses lack the medical expertise to deal with infections, allergic reactions or nerve damage from injections.
  
  One nurse in Victoria is being investigated amid claims she administered Botox and fat-dissolving injections over a 12-month period at regional beauty salons without having patients checked by a doctor. The doctor she claimed to work for is only registered to practice in a neighbouring state.
  
  But nurses deny breaking the law and have accused doctors of a scare campaign to protect their own profits.
  
  The Sunday Age believes two nurses reported to the Nurses Board of Victoria have had cases against them dismissed.
  
  Botox is a schedule four, prescription-only drug. It cannot be advertised directly to the public and must be used under medical supervision.
  
  Nurses board chief executive Nigel Fidgeon said he could not disclose information on hearings but added: ''There is no legislative restriction preventing a nurse from administering Botox as long as they have a doctor's order. There is also no requirement for a nurse to be supervised by a doctor when administering such medicines.''
  
  Gabrielle Caswell, who heads the Cosmetic Physicians Society, said she had no problem with nurses administering the drug if a doctor had examined the patient. But she said: ''We are getting situations where nurses are now holding Botox parties. So you get together with friends and usually there's alcohol around, you have a bit of a drink, no medical history is taken, you just wait your turn, get your Botox and it's all just a bit of a laugh,'' Dr Caswell said.
  
  ''But the moment you've taken a drink, then you're not giving informed consent. There's no doctor there to check if you're psychologically or physically suited to Botox or fillers.''
  
  Melissa Blandfort, a nurse who has been visiting beauty salons across Victoria to inject clients with Botox for nine years, said the claims were nothing more than a ''turf war''.
  
  ''They [doctors] don't like nurses injecting Botox because it means less business for them. This isn't about patient health concern. You can actually have more of a problem taking too many Panadol than you can taking Botox,'' she said.
  
  Ms Blandfort conceded the law on cosmetic treatment was a ''grey area'' and said she would welcome regulation that provided more clarity.
  
  But Alicia Teska, board member of The Australasian Society of Cosmetic Medicine, said nurses were trivialising the specialty. ''These are medical procedures and they shouldn't be trivialised as being of no more importance than having a manicure or having your hair done,'' Dr Teska said. ''It's the standards that are not being met and people should be quite concerned about that.''
  
  Dr Caswell said patients might not have legal recourse if such a procedure went wrong.
  
  ''The nurse is not technically responsible for the treatment, it is the prescribing doctor. If you have never met the prescribing doctor and haven't undergone a medical examination and history-taking, it may be difficult to discover who the doctor is.''
  
  Ms Blandfort said she had full insurance with a reputable provider. ''All the nurses that I know who do this have indemnity as well … I've had people abuse me for not treating them because I thought they might be a high-risk person and I sent them away.''
  
  Victorian Health Services Commissioner Beth Wilson said Botox was a relatively safe drug if used responsibly. ''If a nurse is adequately trained and they understand infection control and they know how to get informed consent, then I can't see a problem with it. However, I don't think alcohol and medicine should ever be mixed and to have people come to a Botox party and get injected is asking for trouble.''

  
  
• Four Corners 2006 Episode "Buyer of Beauty, Beware" - MUST SEE! The reporter for this episode is Jonathon Holmes who currently fronts Media Watch. Watch out of the liposuction procedure gone wrong at about 40 minutes in.
  
  
• A death after liposuction exposes busy illegal clinic - The Boston Globe, 2006
  
  
• Ex-footballer Colin Hendry's wife dies after operation to repair botched cosmetic surgery - Daily Mail UK 10th July 2009
  
  
• Choice Magazine review of Cosmetic Surgery
  
  
• Patients at risk in ugly cosmetic surgery wars - SMH, 2006
  

Scan Me, Scan You

"Mrs Burns?"

40 heads turn around in the outpatients waiting area as I call for the next patient. "Mrs Burns?"

A chubby elderly lady stands up with her daughter and they make their way into the windowless consulting room.

It's a fairly standard consultation. Her GP has referred this moderately obese woman in her late 50s with two episodes of colicky abdominal pain over the last six months. An ultrasound shows some small gallstones but no CBD dilatation. LFTs are normal.

It's clear that the problem is not reflux, and it has only happened twice - after Christmas dinner and a big Easter Lunch. Diagnosis: Biliary Colic.

"There's really no need to worry, Mrs Burns. The likelihood is that you will get some discomfort, maybe some diarrhoea, if you eat a very fatty meal, such as fried food. There's a very small chance that the stones could block the bile duct or gall bladder and that you might get inflammation or infection, in which case you would get quite unwell and should come to the Emergency Department. Otherwise, I would only recommend surgery if you were to develop frequent pain whenever you eat."

"Are you sure it's not cancer?" says the daughter. "My boyfriend's father's second cousin's next-door neighbour had pain like this and they found a cancer in his pancreas. He died in agony after five operations. They say it's a hidden killer."

I struggle to keep a straight face. "There is no reason to think that a cancer is there. Your mother's bowel actions are normal. Her weight is, er, stable. The blood tests are normal... at this time. I think it is just the gall stones. I'm happy to keep an eye on things, and if things were to change then I'd consider a CAT scan, but there's no reason to do that now."

"Wouldn't it be too late if she had symptoms? Why not scan her now? We don't want to end up like that bloke on the news." I sigh, silently to myself. Last week a poor chap died of a subarachnoid haemorrhage because the experienced ED physician decided that a 35 year old man with a long history of migraines didn't need yet another CT brain for yet another headache.

I could give the spiel about unnecessary radiation exposure. I could talk about blowing out the public healthcare budget and our taxes on inappropriate investigations. Or I could reach for the request slip.

"Leave the young man alone, dear. He's told us what the problem is. Don't you trust him?"

I smile to myself as I show them the door. The patient herself has let me off the hook, and highlighted the inter-generational change in "health consumer" behaviour. I cross my fingers and hope I'm right.

That was my 100th blog post. I realise that as an irregular blogger it is challenging to build up a large readership but I hope that those of you who happen to stumble upon my blog find it interesting and thought-provoking. Please keep up your comments, as that is the only way to know that somebody actually reads my blog!

The Unwanted Child: Part 2

As a followup to my earlier post, The Unwanted Child, I thought that I would link to more recent reports in this case.

Basically the parents have been unsuccessful in their lawsuit, and I breathe a sigh of relief (as a medical professional). For more information, follow these links.

• Lesbians fail in lawsuit over child (SMH) (Click to See)
  

  Lesbians fail in lawsuit over child
  Melissa Jenkins
  July 25, 2008
  
  THE lesbian mothers of IVF twin girls have lost a legal bid to sue their doctor for the cost of raising one of the toddlers.
  
  The women, whose names have been suppressed, sued a Canberra obstetrician, Sydney Robert Armellin, for more than $400,000 for implanting two embryos instead of the requested one.
  
  The ACT Supreme Court yesterday ruled in favour of Dr Armellin, and ordered the couple pay his legal costs.
  
  The couple, whose combined income is more than $100,000, sought $398,000 from Dr Armellin to cover the cost of raising one of the girls, including fees for a private Steiner school in Melbourne. The girls are now aged four.
  
  The court was told the twins' birth mother had lost her capacity to love and the couple's relationship suffered as they became mired in everyday tasks associated with raising two children.
  
  Dr Armellin's lawyer said it was common for parents to experience a loss of freedom.
  
  The couple said it was Dr Armellin's responsibility to ensure his patient's wishes were carried out at Canberra's John James Memorial Hospital on November 12, 2003.
  
  Dr Armellin said the birth mother only told him she wanted one embryo minutes before she was sedated, after previously signing a form consenting for up to two embryos to be implanted.
  
  Justice Annabelle Bennett said Dr Armellin had not breached his duty of care to the birth mother and was therefore not negligent.
  
  The women did not mention in a conversation with clinic staff the day before the procedure that they wanted only one embryo implanted, Justice Bennett said. "The plaintiff had the right to choose the number of embryos to be transferred, they also had the responsibility to communicate that decision," she said.
  
  AAP

  
  
• Court dismisses IVF negligence case (ABC News) (Click to See)
  

  Court dismisses IVF negligence case
  Posted Thu Jul 24, 2008 6:26pm AEST
  Updated Thu Jul 24, 2008 6:31pm AEST
  
  Lawyers for a Melbourne couple suing for the wrongful birth of their child have not ruled out appealing a judgement in favour of their Canberra obstetrician.
  
  The women went to Doctor Sydney Robert Armellin for IVF treatment in 2003, but two embryos were implanted instead of one, resulting in the birth of twin girls.
  
  The court heard evidence that the birth of the twins had a dramatic impact on the couple's careers and relationship.
  
  They sued Dr Armellin, seeking $400,000 in compensation to cover the cost of raising one of their twin girls.
  
  But today Justice Annabelle Bennett dismissed the application, saying the fertility clinic staff and the birth mother failed to confirm the number of embryos to be implanted and staff did not follow it up.
  
  She said this meant that Dr Armellin was not negligent, and she ordered the couple to pay his costs.
  
  The lawyer for Dr Armellin, Kim Burke, says her client is relieved but understands the court's decision could be appealed.
  
  "Well I've not yet read the judgment so obviously we'll look at the judgment carefully to see whether there are good grounds and if we're advised by the plaintiff's representatives that they intend to take that step well, we'll take the appropriate steps ourselves," she said.
  
  The lawyer for the women, Thena Kyprianou, says the couple are disappointed by the decision.
  
  "They said that they're shocked and that they would consider their options further once we have an opportunity to read the judgment," she said.

  
  
• IVF negligence case shouldn't have gone to court: AMA (Click to See)
  

  IVF negligence case shouldn't have gone to court: AMA
  Posted 2 hours 5 minutes ago
  
  The Australian Medical Association (AMA) says the case against a Canberra obstetrician for the wrongful birth of their child should never have made it to court.
  
  A Melbourne couple went to Dr Sydney Robert Armellin for IVF treatment in 2003, but two embryos were implanted instead of one, resulting in the birth of twin girls.
  
  The women then tried to sue Dr Armellin for $400,000 to cover the cost of raising one of the children.
  
  Justice Annabelle Bennett yesterday ruled the doctor was not negligent, saying the fertility clinic staff and the birth mother failed to confirm the number of embryos to be implanted and staff did not follow it up.
  
  AMA ACT president Dr Paul Jones says the judgment is a good outcome.
  
  "The AMA's view is that if there's an outcome which is a healthy, live baby that these things shouldn't end up in the courts," he said.
  
  "I think the medical profession in general will welcome this case."
  
  Dr Jones says ACT laws surrounding IVF treatment need to be clarified to avoid legal action.
  
  "In other jurisdictions they've already moved, for example in Queensland, and I understand there are moves in New South Wales to change the law to clarify these very difficult points," he said.
  
  The lawyer for the lesbian couple says they are still deciding if they will appeal against the ACT Supreme Court judgment.

Heart Check? Blank Cheque! Part 2

ACA - Heart Check ConLast year, I wrote a blog entry entitled Heart Check? Blank Cheque!.

It looks like our good friend, A Current Affair, has put their "investigative skills" to the case and done a slag piece on Heart Check. Please note that I had absolutely nothing to do with this - but I don't feel the least bit sorry for them.

Clearly this piece has had more effect than my blog entry, as this Heart Check Clinic Manager reports in her blog. Hopefully it has had no involvement in her marital difficulties.

Click on the image above to see the ACA video.

Pssst! Pass it on!

A few months ago, one of my private patients took a turn for the worse. She had had a minor procedure which had gone smoothly. Unfortunately, in the several hours after the operation she developed some bleeding under the wound. I was not notified.

I returned the next day to find a tennis-ball sized haematoma, five layers of gauze and combine reinforcement, and a drain bottle that had fallen out. Multiple entries were made in the notes of the increasing haematoma, but no attempt made to contact me.

The patient was, thankfully, not upset or distressed. She was in some discomfort and agreed with me that the safest thing to do would be to return to theatre to evacuate the haematoma later that day.

Unfortunately, my secretary spent the better half of the day trying to track down an anaesthetist without success. Such is life in the private sector. Most private hospitals do not have on-call rosters, because most surgeons have direct relationships with anaesthetists that they use regularly. Unfortunately, none of mine were available at short notice, and in this situation you have to scratch around for anyone who is available and willing to come in after hours for a half-hour operation that doesn't pay very well.

After making some more phone calls myself, I managed to find a friend of a friend of a friend who was available to come in for the case. It was a simple job. A light anaesthetic, a small cut. A gentle squeeze and a few spots of diathermy. A drain tube was repositioned and the wound closed with interrupted sutures. We were all in and out of there in under an hour. The anaesthetist was jovial and friendly, and genuinely helpful. He made a point to give me his business card so that I could "Call me anytime."

As I was writing up my notes, however, one of the anaesthetic nurses approached me. "Doctor, I'm not sure whether you know, but there's a reason Dr Anaesthetist is usually available for these cases. Apparently a few years ago he was involved when some Fentanyl went missing from the DD (Drugs of Dependency) cupboard."

It turns out that the rumour was widely known - over a period of several months, the drug cupboard counts were intermittently short one or two ampoules. Not on a regular or frequent basis, but allegedly usually after a list involving this anaesthetist. It was said that he had been questioned by administration but no action taken. Since then no more drug counts had been suspicious. But the implication was clear. The anaesthetist is, or was, a drug addict.

This was a terrible allegation against an anaesthetist. It was an unproven one. No charges were laid, no disciplinary action taken. Not enough evidence existed to involve the Medical Board. All that was left was circumstance, gossip, and rumour. And a reputation that was now shattered, a career decimated.

Apparently work dried up. Lists were dropped. Phones stopped ringing. In response, this anaesthetist was forced to scrounge around for work. He had no public appointments to fall back on. He had no ICU experience to rely on. He put his name down at every private hospital in town for emergency anaesthetic work. He never said no to a case. But he had no regular lists.

I struggled with the thought of whether I should use him in the future. He seemed nice. He was competent (albeit anyone can be competent when the job is simple). The allegations were just talk and innuendo. But if they were true, how could I entrust my patients to his care? If they were false, how dare I prejudice someone based on rumour?

I never used his services again. I tell myself that it was not because of what was said - I have my regular anaesthetists, and a situation like that has not arisen since. But I feel terrible. His business card still sits in my desk drawer. I always think whether he is surviving. Occasionally we hear about an anaesthetist overdosing - I always wonder whether it is him. I have done nothing, and yet I feel guilty. That has been my secret.

I don't care...

This article in Academic Medicine recently caught my eye, observing that US medical students have a declining level of empathy for their patients during the course of their studies.

March 2008, 83:3
Fulltext | PDF (82 K)

Is There Hardening of the Heart During Medical School?
Physician-Patient Relationship

Academic Medicine. 83(3):244-249, March 2008.
Newton, Bruce W. PhD; Barber, Laurie MD; Clardy, James MD; Cleveland, Elton MD; O'Sullivan, Patricia EdD

Abstract:
Purpose: To determine whether vicarious empathy (i.e., to have a visceral empathic response, versus role-playing empathy) decreases, and whether students choosing specialties with greater patient contact maintain vicarious empathy better than do students choosing specialties with less patient contact.

Method: The Balanced Emotional Empathy Scale was administered at the beginning of each academic year at the University of Arkansas for Medical Sciences for four classes, 2001-2004. Students also reported their gender and specialty choice. Specialty choice was classified as core (internal medicine, family medicine, obstetrics-gynecology, pediatrics, and psychiatry) or noncore (all other specialties).

Results: Vicarious empathy significantly decreased during medical education (P < .001), especially after the first and third years. Students choosing core careers had higher empathy than did those choosing noncore careers. Men choosing core careers initially had empathy exceeding population norms, but their empathy fell to be comparable with that of norms by the end of their third year. The empathy of men choosing noncore careers was comparable with that of norms. Women choosing core careers had empathy scores comparable with those of norms, but the scores of women choosing noncore careers fell below those of the norms by their second year.

Conclusions: The findings suggest that undergraduate medical education may be a major determinant differentially affecting the vicarious empathy of students on the basis of gender and/or specialty choice. The greatest impact occurred in men who chose noncore specialties. The significant decrease in vicarious empathy is of concern, because empathy is crucial for a successful physician-patient relationship.

(C) 2008 Association of American Medical Colleges

Let me summarise this briefly. Conclusions:

• "Vicarious empathy" is the empathic response you can't control, the "gut feeling".
  
• "Imaginative empathy" is something that can be acquired - "What if I were in their shoes?"
  
• Empathy = Good (a generalisation)
  
• The more empathic you were before you started medicine the more likely you would be empathic at the end.
  
• Everybody loses vicarious empathy during the course of their degree.
  
• If you chose to specialise into surgery pathology or radiology you were (likely to be) less empathic.

I'm no rocket scientist, but I take issue with the belief that Vicarious Empathy is a good thing. Getting teary when discussing the risks of intraoperative death during elective surgery is not a good thing. Getting butterflies when a patient tells me about their grandchild with a congenital heard disorder distracts me from looking after the patient. But then again I'm a surgeon... who am I to comment?

The Unwanted Child

This case disturbs me in the same way that it would disturb much of the community:

• Should a couple who are unable to have children naturally due to a lifestyle choice be allowed to do so via IVF?
  
• Should the birth of a healthy, but unintended child be something for which compensation should be claimed?
  
• Should the ACT continue to have medical negligence laws that are out of step with the rest of Australia?
  
• Should you be able to sue for relationship stressors which are a normal part of parenting?

What makes me more uneasy is, however, the thought that "There but for the grace of God, go I".

I could be the parent with unexpected twins and a strained relationship and career.

I could be the surgeon who performs or supervises a completely routine procedure while the patient utters something minor, innocuous, or unheard while sedated.

Nobody outside the theatre can profess to know what happened during that procedure, or what the successful conception rates of IVF are now, or whether it is unusual to implant a single or multiple embryos in a mother-to-be who is desperate to have children.

Just imagine - you are about to wheel into the operating room when the patient says "Doc, don't messh up my tatt. Ith really importanth to mee... zzzz..."

The patient is half awake and non compos mentis, there is no way to remove the skin cancer without cutting through the tattoo. You have a signed consent form authorising removal of the lesion. You can't remember whether you discussed the tattoo at the time of consent - but it's hard to believe that you didn't. It's highly likely that the patient won't remember making that comment. Do you cancel the case? Do you proceed?

That may or may not be what happened - but I can imagine it happening to me tomorrow.

I am trying out a new JavaScript function from here. Let me know what you think.

SMH: Lesbian sues over IVF twins (Click to See)

Lesbian sues over IVF twins
September 18, 2007 - 2:50PM

A lesbian woman felt violated and devastated when she learned she was pregnant with twins, after she had told a Canberra obstetrician she wanted only one child through IVF, a court heard yesterday.

In what is believed to be the first case of its kind in the ACT, the former Canberra woman and her female partner are suing obstetrician and gynaecologist Sydney Robert Armellin for the wrongful birth of one of their twin girls, now aged three, claiming more than $400,000 for the cost of raising her to the age 21.

They claim the twins' birth mother had told Dr Armellin minutes before she was sedated and implanted with two embryos that she wanted only one embryo implanted. They had previously told him they wanted only one child.

However, an embryologist under Dr Armellin's supervision implanted two embryos, resulting in the birth of non-identical twins.

The birth mother, now working in Melbourne as a social research and planning consultant, wept as she told the ACT Supreme Court how hard it had been to cope with the unplanned twin pregnancy.

"I remember sitting on the couch and feeling devastated, absolutely devastated," the 40-year-old mother said.

She and her partner, who were living in Watson at the time, had planned to go to England after the birth, but their plans were scrapped when they discovered they would be having twins, jeopardising their careers, relationship and health.

She suffered pre- and post-natal depression, could work only a few hours at a time because of the pain, and she and her partner needed relationship counselling for about 18 months.

"We argued and we had a terrible time with the stress of what we had expected to be a time of great joy."

They also had to confront the options of aborting one of the embryos, or giving up one of the children for adoption. They decided to keep both children as an abortion would have put the other child at risk, and adoption would have been too painful.

"The experience of my pregnancy was so far removed from what I had anticipated that I was in relationship counselling, in a great deal of pain, and someone was suggesting that [adoption] was an option."

The women's names were suppressed until today, when visiting judge Justice Annabel Bennett will make a ruling as to whether to permanently conceal their identities.

The women's barrister, Hugh Marshall, SC, argued it could be distressing for the children to discover several years down the track that their mothers did not want to have them both.

The birth mother told the court she earned more than $100,000 in the recent financial year, and her partner also worked full time.

They had first gone to Dr Armellin, who has a private practice in Deakin and also does work for John James Hospital and Calvary Hospital in December 2002, seeking artificial insemination treatment. They chose to use sperm from a Danish donor, as the father of one of the women was German.

After three unsuccessful treatments of artificial insemination, Dr Armellin recommended in-vitro fertilisation.

The mother told the court she and her partner had told Dr Armellin and a nurse at the Canberra Fertility Centre that they wanted only one child.

However, they had been under the impression that they could only decide how many embryos to implant on the day of the procedure, depending on the quality of the embryos.

They had signed a pre-admission form two months before the procedure, saying they consented to one or two embryos being implanted, but claimed the nurse at the fertility centre had said: "Just put 'up to two' and you can let us know any time up to the procedure."

Consequently, the mother had told Dr Armellin she only wanted one embryo implanted only minutes before she was sedated, in November 2003.

As well as seeking damages for the cost of raising a child, the birth mother is claiming about $17,000 for lost earnings as a result of an extra two months' maternity leave, and for the physical problems and medical expenses incurred as a result of carrying twins. She was rendered almost immobile in the second and third trimesters of the pregnancy.

Dr Armellin's barrister, Kim Burke, told the court her client admitted being told by the birth mother shortly before the procedure that she wanted only one embryo implanted, but this did not amount to negligence.

"The defendant's position is that the duty of care did not extend to preventing or avoiding multiple births," Ms Burke said.

"The conversation [minutes before the procedure] is not a negligent act because there was a document signed saying one to two embryos."

Bris Times: Lesbian IVF case divides community (Click to See)

Lesbian IVF case divides community
Carol Nader | September 20, 2007

They wanted to have a child together. Instead, they got two. Some might call it a blessing. But to this couple, the unexpected addition to their family was devastating. So devastating, that the unnamed lesbian couple are now suing Canberra obstetrician Dr Sydney Robert Armellin for more than $400,000. Most of it is to cover the cost of raising one of their twin three-year-old girls.

The couple allege they had made it clear that they wanted only one embryo transferred during the IVF process. Instead two were transferred, leading to the twin birth. The impact on their relationship and indeed their lives, according to evidence given in court this week, has been considerable.

"She always said that she had a big heart filled with love," the non-birth mother said of her partner in the ACT Supreme Court yesterday. "I find (now) that she doesn't have the same ability to love that she used to and the same capacity to, I guess, embrace differences and issues as a couple or as a team."

The case has divided public opinion and dominated talkback radio. It would have been particularly poignant for couples who have spent years going through the rollercoaster of IVF only to end up childless.

"A number of people seemed quite surprised that they would be complaining about such good luck," says Melbourne IVF director Dr John McBain.

The case, while the first of its kind, mirrors another, legal experts say. Carmen Currie, a senior associate at law firm Holding Redlich who specialises in IVF law, says it resembles a "wrongful birth" scenario. In 2003, the High Court decided that damages could be awarded to a couple after a woman's failed sterilisation operation resulted in a pregnancy. The doctor had failed to tell the woman the sterilisation might not work.

"The High Court has already formed its view that damages are available in those circumstances, and they were careful in that case to not reflect upon the worth of the child or whether they were wanted or unwanted," Currie says. "The focus is on whether there was an act of negligence that should be compensated."

There seem to be two arguments, says medical ethicist Dr Leslie Cannold. The first is straightforward — that this is an allegation of medical negligence like any other. But the complicating factor is where the second argument comes in — that this happens to be about the birth of what is believed to be a healthy child.

Traditionally, she says, the law has been happy to compensate for the birth of a child born unhealthy as a result of negligence. But there is discomfort when it comes to compensating for a healthy child. This is because of a popular perception that a healthy child's birth is always a blessing.

"These cases reflect the tension between our old ideas about children … and our new ideas that reproduction is a choice, and sometimes we don't want to have a child — healthy or not," Cannold says.

The landmark case will be watched with great interest by IVF clinicians around the country.

"We knew that if we put two embryos back when a person only wanted one, this would be the very situation that would arise," says Melbourne IVF chairman Dr Lyndon Hale. "All units are required to have a risk assessment of all the things they do, and we've always considered this an area of risk."

Melbourne IVF requires its doctors to ask patients how many embryos they want transferred. That is put in writing and signed by the doctor — but not the patients. Hale says the other safeguard is that the patient can actually see how many embryos will be transferred during treatment via a video link from a microscope. "What we do to all the patients is we show them the embryos before they get loaded into the catheter," Hale says. He says a patient would only be required to sign on embryo transfers if they wanted to have two embryos transferred against medical advice.

Melbourne's other major IVF clinic, Monash IVF, requires patients to sign consent forms (pictured above) that specify how many embryos will be transferred. Managing director Donna Howlett says couples have to sign a new form each time they start a new cycle, because their treatment might change. "If the couple decide prior to the embryo transfer that they only want one back, the only way that would be changed on the day of the embryo transfer is if there was a discussion with the couple and the clinical decision was that the embryos were of a very poor quality," Howlett says.

If it was decided that day that they would transfer two embryos instead of the previously agreed one, the couple would be required to sign a new consent form. "You can't have a consent form with one and then transfer two."

Hale says the other things that could potentially go wrong during IVF are implanting an embryo belonging to the wrong couple, or putting the wrong sperm with a woman's eggs. There is, after all, such a thing as human error. Even if only one embryo was transferred, twins would still be a possibility. The embryo could split and then the couple would have identical twins. There's nothing anyone could do about that, Hale says. "That's an act of God or nature."

The other thing that could happen, in the case of a heterosexual couple, is one embryo could be implanted and then the couple has sex and conceives naturally — again the result would be twins. It's a rare situation, but possible.

Where in past years as many as four embryos have been used in an IVF cycle, doctors now agree that one is best practice. Multiple births come with increased risks of complications in pregnancy or premature labour, leading to the birth of sick babies.

Doctors and patients must carefully weigh the risks associated with multiple births against maximising a woman's ability to get pregnant. In some cases, the fear of not getting pregnant at all may be stronger. It is rare for clinics to transfer more than two embryos at once. Monash IVF won't do it under any circumstances, even if the woman is over 40. "We try and encourage one embryo for everybody under 40 unless there's another clinical indication that two is warranted, particularly for a first cycle for someone under 40, we would strongly encourage one embryo transfer," Howlett says.

HALE says the possibility of litigation is a fact of life for all doctors. "This is not just about IVF … doctors are human like everyone else. Things go wrong with medical procedures, and one course of action open to patients is obviously a legal one."

The couple in the Canberra case, whose names have been suppressed by the court, wept in court this week as they told of the emotional consequences of learning they were having twins.

Gerard Brick, a member of the Australian Multiple Birth Association who has naturally conceived 10-year-old twin boys, says the cost of having multiple births goes beyond the fiscal.

"If you've got one child that's ill who is up all night or won't settle and it disturbs another child, you've then got two children that are disturbed and upset," Brick says.

"When you've got two babies, it's very difficult. If you've never had a child before, as a parent you're a fish out of water anyway … If you don't know what to do with one, you don't know what to do with the other. It does take its toll."

That emotional toll of a multiple birth can also be felt on relationships. That was highlighted in the Canberra court yesterday, when the non-birth mother said she felt at times their relationship would not survive the stress.

Brick says he knows of people who have "packed up and left and walked out on marriages" because of a multiple birth. Others stick it out and work as a team. "There's financial stresses, there's social stresses, there's emotional stresses and not all relationships will survive that, but then it could be the same with a single child. It's not necessarily multiple-specific."

The Australian Family Association, however, says the problem with the case is it highlights a "consumeristic mentality".

"Here we have a case where the addition of a sibling is deeply resented because it's impinging on the adults concerned, their lifestyle and their economic aspirations," says spokeswoman Angela Conway. "This second child is a blessing and a gift to them and also to their other child and it is tragic that they're not able to see it."

In Victoria, a lesbian couple can access IVF only if they are medically infertile. Such restrictions don't exist in the ACT. The Victorian Law Reform Commission has recommended that the infertility requirement be abolished, and the State Government will make a decision by the end of the year. But the consensus appears to be that the couple's sexuality in this case is irrelevant, because a married couple could have found themselves in the same predicament.

John McBain, who helped pave the way for single women and lesbians to legally access IVF in Victoria if they are medically infertile, says sexuality is beside the point. "I think it's lucky she's part of a couple and that would make the rearing of twins so much easier, in terms of being able to cope with a multiple pregnancy. In general you would think that two incomes were better than one and two pairs of arms were better than one when it comes to raising twins."

Gerard Brick points out there's another side — what if only one embryo was implanted and it did not result in pregnancy? There's financial expense in having another IVF cycle. "Do you sue for not actually conceiving a baby?" he says. "The whole point of the exercise is to have children, and now they want to sue because they have children, as opposed to a child."
With AAP

News.Com.Au: Lesbian IVF case leaves ACT vulnerable (Click to See)

Lesbian IVF case leaves ACT vulnerable
September 25, 2007 11:16am
Article from: AAP

THE ACT risks becoming a litigation tourist destination if the law is not changed to prevent people suing over the birth of healthy babies, the Australian Medical Association (AMA) said today.

A lesbian couple has been subjected to widespread condemnation after they last week launched civil action in the ACT Supreme Court, suing prominent Canberra obstetrician Dr Sydney Robert Armellin.

The pair, who are the parents of twin girls, are seeking more than $400,000 in damages for the cost of raising one of their children because Dr Armellin implanted two embryos instead of the requested one.

ACT Opposition spokeswoman for family, community services and women Vicki Dunne is planning to move an amendment to the Civil Law (Wrongs) Act 2002 in parliament tomorrow to remove the potential for parents to sue over the birth of a healthy child.

AMA ACT president Dr Andrew Foote is a father of twins and supports the law being changed to enshrine the principle that a healthy baby is not a loss.

"I think that a healthy baby is not a damage and that loop hole should be closed off as they have done in Queensland, NSW and Victoria,'' he told ABC radio today.

"In particular this couple became tourists and came back to the ACT to mount this case so we now have the dubious reputation of being a litigation tourism destination.

"It is something that really gets my blood boiling.''

Dr Foote, who is an obstetrician and gynaecologist, said it was unfair Dr Armellin had been named but the women suing could keep their identities secret.

Chief Minister Jon Stanhope said he found the suggestion that he and the Labor Party believed a healthy child was a loss was highly offensive.

He said the issue was about maintaining a legal avenue for patients whose doctors have not met their duty of care, not about emotions surrounding children.

"We are talking about ... the right to sue in an instance where one has actually invested one's trust in a professional, a doctor, to prevent or provide a service and for that duty of care not to have been met,'' Mr Stanhope said.

"That's the legal principle, let's thrash that principle out rather than get into this 'oh you don't love children as much as I do' nonsense that Dr Foote is going on about.''

Heart Check? Blank Cheque!

I recently came across a group of clinics called Heart Check. Clearly there is some controversy about how they operate. They advertise "free" (subject to bulk-billing conditions) heart checkups on TV and radio and encourage patients (or customers) to spread the word amongst their friends and relatives. They even advertise via Shop-a-dockets!

My patients have been telling me about their visits to these clinics. On arrival the clients fill out a questionnaire which encourages them to report the most trivial of potentially cardiac-related symptoms. An on-site GP railroads them into describing any palpitations, chest, shoulder, arm or neck discomfort, shortness of breath on (extreme) exertion, smoking history, and any personal or family history of diabetes, ischaemic heart disease, hypertension, hyperlipidaemia, obesity or any form of cardiovascular disease. There is a minimalist history or examination otherwise.

They then automatically get an ECG, and barring someone who is going to keel over and die if they walk for 2 minutes, they are then recommended to have an exercise ECG. Anyone who reports palpitations gets a Holter monitor.

Depending on the results, you are either sent to hospital, a cardiologist, a surgeon, or a GP. By depending on the results, I mean that if you are a robot whose heart rate does not vary from 60 bpm ever, you might get sent to your GP with an "All Clear" report. Otherwise, you are almost guaranteed a referral to a specialist of some sort (though if you develop an AMI on the treadmill they terminate the test and call an ambulance). Even better, sometimes they send you to your GP to get a referral to a specialist.

This is not a new idea - I suppose it all started with screening tests such as the urine dipstick for glucose (looking for diabetes) and proteinuria (for early renal failure), breast cancer and prostate cancer screening (with mammograms, breast and rectal exams and serial PSAs), and now FOB tests (for possible early bowel cancer). These are all targeted as a public service, rather than a profit-making exercise. A great deal of thought has been put into working out the pre-test probabilities for these screening tests (well, maybe not for serial PSA). Ever since then a whole series of very questionable clinics have set up shop - ranging from those offering coronary calcium scoring to whole body CT scanning. Of course Heart Check is not alone in this business (WA Cardiology offers CT Coronary Angiography).

Now, I have mixed feelings about all of this. Firstly, I have to admire Heart Check's efficiency and protocol. It is almost an ideal setup for a surgical practice. Shoehorn your patients quickly and efficiently into a provisional diagnosis, investigation protocol and treatment plan. It doesn't matter whether they really have something wrong or not - there is always someone else to palm the patients off to afterwards. Get them in and out, and make a mint along the way. My accountant would love a practice like that.

After a great deal of consideration, though, I have decided that what they do is blatantly unethical. The fact is that they prey on public fears of heart disease. Like all good advertisers, they create a need by convincing the general public that they could have a hidden risk of dropping dead - all preventable by having an ECG. Even better - it's free!

They skirt around Medicare requirements by employing an on-site GP, even though the GP has no role other than to initiate these investigations, and in fact, does not even need to hold any qualifications such as an FRACGP. They perform an abbreviated stress test (on behalf of an off-site cardiologist), and consider abnormal what most sensible doctors would see as normal findings (so that the patients feel that they "found something"). They then take no responsibility for subsequent care, and refer off to a host of other specialists via the patient's normal GP.

And then they dare to claim it all on Medicare so that our taxes foot the bill. Generally there is a gap fee for anything other than the basic 12-lead ECG, but you wouldn't know it from the advertising. When noise-complaints group Noisewatch tried to stop Heart Check's rather annoying advertisements they lost out. Perhaps they might have had more luck if they'd focused on the last line in the ad: "It's fully covered by Medicare."

But how can I complain when they introduce patients back into the health system, ultimately providing me with a source of referrals, all of whom I can safely pat on the back and say that despite what the doctor at the Heart Check clinic told them, their tests results are well within normal range, their lack of symptoms are nothing to worry about, and send them on their way with a nice fat bill (again, largely subsidised by Medicare). Sometimes I even find something real, such as a hernia, on my clinical examination which I can, in turn, investigate and treat even though the patient never complained of anything in the first place!

Have I been seduced by the referral merry-go-round? Am I getting sucked into the unnecessary investigation whirlpool? Perhaps it is normal practice in somewhere like the US - but it seems decidedly out of place in Australia.

• "Heart Check" Clinics
  
• Palpitations over high cost of free heart checks, SMH 10 Feb 2007
  
• Media Release: Heart Check Working Within Medicare Guidelines also here
  
• Heart Check Clinics “not overservicing” from 6minutes.com.au (Press Release from Heart Check).
  
• Heart Check Shop-a-docket
  

ACCC strikes again

Doctors fined for breaching trading laws from The Australian, July 5 2007.

Doctors fined for breaching trading laws
July 05, 2007
TWO leading Adelaide heart surgeons have been fined a total of $110,000 for trying to stop a third surgeon operating on private patients in South Australian hospitals.
In a judgment handed down in the Federal Court today, John Knight and Iain Ross were each fined $55,000 and ordered to attend a compliance seminar after breaching competition laws.

In action brought by the Australian Competition and Consumer Commission (ACCC), Judge John Mansfield ruled that doctors Knight and Ross had come to an arrangement to hinder or prevent a colleague, Craig Jurisevic, from performing surgical services on private patients unless he underwent further training.

The judge said on six occasions between February 6, 2001 and March 9, 2001, Knight and Ross advised hospitals where Dr Jurisevic had wanted to work or surgeons who had been asked to support his applications, that he was insufficiently trained or had not completed his training.

This was despite Dr Jurisevic having been legally qualified and being admitted as a fellow to the Royal Australian College of Surgeons after completing the advanced surgical training program.

Judge Mansfield said Ross and Knight had also come to an arrangement with another surgeon, James Edwards, not to work at a hospital where he operated provided he did not work at a hospital where they performed surgery.

Judge Mansfield said the admitted conduct of Knight and Ross involving Dr Jurisevic stemmed from a decision by him not to take up an 18-month training position in Boston and to begin performing surgery on private patients in Adelaide instead.

"This upset Messrs Knight and Ross,'' the judge said.

He said it was not possible to determine the extent of loss suffered by Dr Jurisevic.

But he said the actions of Knight and Ross had raised barriers to other surgeons entering the Adelaide market.

"As a result ... newly qualified cardiothoracic surgeons in Adelaide were likely to consider they were, in effect, required to undertake further training, overseas or interstate, in order to practise as a cardiothoracic surgeon,'' Judge Mansfield said.

He said the result of this case should serve to ameliorate the impact of any such ongoing effect.

The judge said he also accepted that both Knight and Ross genuinely believed Dr Jurisevic needed more training and praised the two doctors for cooperating with authorities.

Their admissions had saved both the court's and the ACCC's time, he said.

In a statement Knight and Ross said their actions were motivated by concerns over patient safety.

"At all times, patient safety was very much in our minds,'' the surgeons said.

They also expressed concerns over the operation of competition rules on the medical profession.

"Whilst we recognise the importance of competition rules in the market place, we are concerned that the legislators have had insufficient regard to matters of patient safety in seeking to apply those rules to the medical profession,'' they said.

What bothers me about this case is how close a line we tread to breaking the law.

For example, doctors in Australia are not allowed to advertise their services. But when does marketing become advertising? How big an entry in the Yellow Pages is allowable? Is it OK to have a small sign outside your clinic, or a big sign outside your clinic, or a big billboard down the road?

When we give advice to each other about which areas are underserviced and would be better places to practise, is that inviting someone into a non-compete arrangement?

Judge Mansfield said the admitted conduct of Knight and Ross involving Dr Jurisevic stemmed from a decision by him not to take up an 18-month training position in Boston and to begin performing surgery on private patients in Adelaide instead.

...

But he said the actions of Knight and Ross had raised barriers to other surgeons entering the Adelaide market.

"As a result ... newly qualified cardiothoracic surgeons in Adelaide were likely to consider they were, in effect, required to undertake further training, overseas or interstate, in order to practise as a cardiothoracic surgeon,'' Judge Mansfield said.

Hang on, I thought that there was already an expectation that some form of post-fellowship training or experience was desirable. Perhaps this means I can cancel the PhD and the two unpaid overseas posts I had planned?

I love LUSCS?

Doctors told to reduce caesarean births

The New South Wales Health Department has issued a new directive aimed at trying to reduce the number of unnecessary caesarean deliveries in state public hospitals.

The new policy says a request from a mother to have a caesarean section is no longer a justifiable reason for performing the procedure, if there is no medical reason.

Dr Andrew Child from the Health Department says under the changes a doctor must fully explain to a woman all of the risks associated with a caesarean section before one can be performed.

"It will change the attitude of the staff," he said.

"At the moment the staff are tending to just give it a quick tick whereas this will enforce the need to make sure that all the risks and dangers are very clearly put on the table."

Firstly, does the NSW Department of Health seriously believe that anybody performs Caesarean Sections on a whim, without due consideration for the indication, benefits and risks? Or that women agree to a Caesarean Section without appropriate consultation, advice and consideration?

Secondly, like any surgical procedure, it is normal practise to explain to the patient the risks associated with the procedure that is planned. The only exception to this rule is where the patient is incapacitated (and therefore the explanation goes to the person who is most responsible for the patient), or in the setting of a life or limb-threatening emergency where the patient is unable to understand or comprehend the situation, or time is so critical that there is no option (these usually all happen together). Though obviously in the Health Minister's mind, a Caesarean Section is not like any other operation. Perhaps the only "change in attitude" should start at the top. A Caesarean Section is an operation. A Caesarean Section is an operation. A Caesarean Section is an operation...

Lastly, perhaps there should be a similar edict warning mothers of the risks of not proceeding with a Caesarean Section when recommended, the risks or home birthing, or the risks of getting pregnant in the first place!

Perhaps it might have kept this poor couple out of trouble: Twins' home birth risk 'downplayed'

I am sure that Dr Crippen would have plenty to say, given his Campaign Against Reckless Midwives (or "Madwives", as he prefers). Perhaps we are inevitably heading towards the NHS model of perinatal care - though not if this article from The Times has anything to do about it.

Personally, having just been through the whole business recently, we had a fantastic obstetrician and some excellent midwives in the delivery suite, though once we left for the post-natal ward the quality and empathy of the ward midwives left a great deal to be desired. You get the whole range from the uncaring to the overbearing. Nevertheless, we have each other. And now two little boys.

Can't you take a hint?

Betty was 95. She lived in a nursing home. She was delirious and bedbound. She had diabetes, emphysema, untreatable ischaemic heart disease, and a recent stroke. And now she had a fever and a gangrenous leg.

She was going to die, sooner or later.

"She's a fighter" her son said. "Before she became delirious, she told me that she'd rather lose her leg than die."

I didn't say what I was thinking - "This is not a life. You are just torturing her. She is going to die anyway."

Instead I say: "I appreciate what you are saying, but you must understand that amputating her leg has a very high chance of killing her, both immediately and in the near future. And even if she were to survive that operation her quality of life would only be worse, not better. She would definitely never walk again."

"We know that, doc, but we'd rather she die under an anaesthetic than like this. We know that's what she'd want. She doesn't walk as it is."

Perhaps I am weak, but I cannot flat out refuse to do it. I don't know for certain that she will die. She might pull through. Her chances are poor, but they are not zero.

Two days later she is awake and talking to her family. She thanks me for doing the amputation, and goes back to her nursing home. A week later I hear that she has had a "heart attack" and has passed away.

-----

Jerry is 70. He came from a hostel. He was confused but relatively independent , until he developed acute appendicitis. A diagnosis made at laparotomy. He makes a good recovery, but unfortunately, a pressure sore develops on his heel. Bone is exposed, and needs debridement. Malnutrition limits what healing is present. The arterial supply is limited. He is too confused to eat. He needs nasogastric feeding, an angiogram and a small operation to clean his ulcer.

"We don't think he would appreciate it, doc." said the daughter. "He doesn't know what is going on. He won't want to risk losing his leg. We're sure he wouldn't want a tube in his nose. Why can't we let him die with dignity?"

"He is not going to die anytime soon." I say. "But this ulcer will be with him for the rest of his days unless we remove the bone and put a skin graft on it. The ulcer won't kill him but it will cause him pain."

"We think he's had enough. We'd like to speak to the palliative care nurse."

Palliative care takes him over and he is dosed up to his eyeballs with subcut morphine. A month later he is still alive. I wonder how long he will last at the hospice, and how much morphine he can handle.

-----

John was 65, living with cerebral palsy, schizophrenia, and a recently fractured humerus. Paraplegic and confused. He had recently been transferred into a nursing home where he was fully dependent. Now he had severe, sudden onset abdominal pain. There was gas under his diaphragm. There was no doubt he had a perforated viscus. Probably a duodenal ulcer. Laparotomy would be straightforward and life-saving. "I'm not going to die, doc. Just give me some pain killers and let me go home. I don't want an operation." he said.

There was no family. They had abandoned him years ago. His sister hung up the phone when rung at 2am in the morning. The GP that normally treated John was on holiday. From the little information I could gather, his quality of life was non-existent. Who do I ask? Who do I turn to? Do I have the right to decide whether to operate or palliate? In his incapacitated state does he have the right to refuse surgery?

So I passed the buck, and called the Chief Medical Officer. "What do I do?" I ask. "You are authorised under law to do as you see fit. As the clinician on duty, the hospital will support your decision." came the drab reply over the telephone.

So I wrote up the omeprazole, turned up the morphine infusion, and went back to sleep.

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.

---

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.