Saturday, August 15, 2009

Ethical conundrums?

Para 4.1.4 of the Singapore Medical Council Ethical Code and Ethical Guidelines states very explicitly: "A doctor shall treat patients according to generally accepted methods and use only licensed drugs for appropriate indications. A doctor shall not offer to patients, management plans or remedies that are not generally accepted by the profession, except in the context of a formal and approved clinical trial."

Two clinical situations appear to violate this principle:

a] The use of a medicine for an indication that has not been approved by the Health Sciences Authority (HSA). All medicines marketed in Singapore are licensed only according to approved indications. In any other situations, these would be considered 'off-label' use. In most cases, these indications have not been approved because no clinical trials have been done for these indications and therefore there is no proof of their clinical efficacy, and importantly, there is no evidence of their safety. However, doctors very often use these medicines for indications outside approved indications even if no evidence exists of their safety and efficacy. Technically, these doctors using drugs in an 'off-label' capacity would not be treating patients according to generally accepted methods, and are not using drugs for appropriate indications. And as these treatments are most often not offered in the context of a clinical trial, their use would place these doctors in violation of Para 4.1.4.

b] New surgical procedures. Surgical procedures, unlike, new drugs do not require to be clinical trialed before they are applied in the operating theatre. Hence, there is actually no proof of efficacy or risks. Surgeons remain quite free to offer anything they come up with, and can make fanciful claims of success without need to show proof of their claims. Too what extent are these 'new procedures' a remedy 'generally accepted by the medical profession'? It is hard to tell. The Singapore Medical Council generally looks the other way when it comes to doctors making outlandish claims about such new therapies.

The question I have is why publish guidelines such as Para 4.1.4, when it is not the intention of the SMC to consider the above as violations?

Perhaps the patient public should raise a few complaints where these are concerned to prompt the SMC to review their guidelines.

Tuesday, August 11, 2009

Ethics in Medicine and Biomedicine - The Singapore Story (Part 2)

To be fair, the MOH did start looking at the ethics of medical practice as early as 1994. It was then that the shadowy National Medical Ethics Committee was set up. I say shadowy because it is really difficult to find information about the NMEC, its functioning, who the Chairman is and who her members. Contrast this to the more recently set up Bioethics Advisory Committee which was set up by Cabinet in 2000, "to address the ethical, legal and social issues arising from biomedical sciences research in Singapore".

Anyway, the NMEC was established by MOH in 1994.

The NMEC published "Ethical Guidelines on Research Involving Human Subjects" in 1997, but the real driver for development was the implementation of the Singapore Good Clinical Practice programme in 1997/8, which was driven by the increasing pressures to have internationally acceptable levels of human research subject protection as we engage in clinical research (particularly pharmaceutically related research) and human experimentation.

The clinical research heritage of our ethics committees can be seen in what exists in the hospitals today. After 10 years of development, the restructured hospitals utilize centralized institutional review boards (IRBs) operating at the cluster level. Thus SingHealth has its Centralised IRB model, and NHG calls hers the DSRB (Domain Specific Review Board). A visit to their respective websites will show very clearly that their mission is essentially to review and approve clinical research.

SingHealth CIRB does not publish its mission but their website makes it clear their work is principally to review research protocols : "...clinical research protocols involving any number of SingHealth institutions and hospitals will be reviewed by one Centralised Institutional Review Board (CIRB)."

NHG DSRB on the other hand, states more clearly: "The DSRB's primary objective is to safeguard the rights, safety, and well-being of human research subjects in the National Healthcare Group and her institutions."

So in Singapore at the moment,:

a] there are three bodies, The Singapore Medical Council, The National Medical Ethics Committee of the MOH and the Bioethics Advisory Committee, who issues guidance documents and advisories;
b] medical practice and clinical research is covered legally under the rather outdated and unwieldy Medicines Act 1975 and the Medicines (Clinical Trials) (Amendment) Regulations 1998;
c] Local hospital ethics committees interpret said guidelines issued by above committees, and approve clinical research protocols.

A number of things need to be recognized:

a] The regulation of ethics in the medical profession exist only in the form of guidances and advisories.
b] The regulation of medical ethics is principally towards meeting pharmaceutical research needs, and exists only in the authority invested in local hospital ethics committees.
c] Lastly and most importantly, the function and performance of the local ethics committees is poorly regulated. Although there is guidance provided with respect to the structure and procedures, there is no systematic regulation of the quality of work. It remains unclear how 'trained' and 'professional' ethics committee members are. Ethics committees even at the centralised IRB systems have never been formally audited and only recenty (2007) did the NHG DSRB seek accreditation with the US based Association for Accreditation of Human Research Protection Programs (AAHRPP).

Do we have a robust enough system in place to deal with the impending tsunamis of organ trade, euthanasia, embryonic stem cell research and cloning technologies?

Ethics in Medicine and Biomedicine - The Singapore Story (Part 1)

Historically and traditionally, there has always been a very strong sense of ethics in the medical profession. We look back frequently at the Hippocratic traditions, but in reality the professional codes that governed the practice of healers are evident even in the early civilizations in Mesopotamia and Egypt.

Nonetheless, the immense influence that the Hippocratic Oath had on our ideas of professional conduct cannot be easily discounted. This was subsequently morphed at the 1948 Geneva Declaration by the World Medical Association into the Physician's Oath. But it wasn't until 1995 that we tweaked that to become our very own Physician's Pledge - one that newly graduating doctors in Singapore are now required to take. The Singapore Medical Council didn't publish their Ethical Code and Ethical Guidelines until 2002.

Prior to 1997/8, medical ethics existed in a loose unstructured environment that was heavily influenced by the Helsinki Declaration (1964) and the Physician's Oath (Geneva, 1948).

The major impetus to firming up the ethics environment can be traced to the growing pressures to comply with international expectations with respect to clinical trials and human experimentation. In 1996, the International Conference on Harmonization (US, Europe & Japan) adopted a set of 'Good Clinical Practice' guidelines with respect to the 'Technical Requirements for Registration of Pharmaceuticals for Human Use. (This is a bit of a misnomer as it is not really about clinical practice but more about good clinical research practice.) In response to this, Singapore published and implemented its own GCP compliance program in 1997, and which was revised in 1998.

This is therefore an important milestone for us in 1997/8, because it was through the implementation of GCP in Singapore that ethics committees were formally constituted in the major restructured hospitals in Singapore. Prior to this, everything was pretty ad hoc. Hospitals were required in 1997 to comply with the “Ethical Guidelines on Research Involving Human Subjects” (NMEC Guidelines) issued by the National Medical Ethics Committee (NMEC).

But we should be clear that the driver for these developments was not so much to improve medical care, but more the pressure to get engaged in clinical research and human experimentation.

More about this later.

Speak up on science issues? Where are our ethicists when you need them?

Straits Times Science Correspondent Chang Ai-Lien wrote a commentary today entitled "Speak up on science issues before it's too late" in which she bemoans the lack of a public voice with respect to new scientific developments.

A timely piece. And she's absolutely right. (I'm actually quite surprised that over the past less-than-a-year I have posted no less than 19 times on ethics.)

But yes, we are a nation that does not find it comfortable discussing ethics. We prefer things to be black and white. We would actually much prefer to be told what is ok and what not. To a large extent, I believe the gahment has been responsible for this malaise. For a long while, we were 'taught' to be pliant.... and to accept oracles from the Temple of Delphi. Oracles that will tell us what to do about abortion, the death penalty etc. How else could we have so successfully 'engineered' Singapore society, in such a short span of history?

So today, even as our society 'opens up', our people still wait to be told what is right and what not. We wait with bated breath for proclamations from the Ministry of Health about the rightness and wrongness of organ trade, of euthanasia, of embryonic stem cell research and cloning. If the National Medical Ethics Committee (who?) says it is OK, then it must be.

Our ethicists generally shy away from any public discussions where their ideas may be challenged or tested. Instead, they prefer to cloister in hallowed august bodies where they have safety in numbers, and can make wise (and politically correct) pronouncements (advisories).

The lack of a public voice on ethics is unhealthy. It may however, be convenient for the government, because it allows for a relatively unhindered implementation of policies which may be 'gray' with respect to ethics. But this silence is without doubt, unhealthy for the development of our civic society.

So thank you, Ms Chang, for your commentary. But sadly, the cynical in me believes it will likely fall on deaf ears.

Sunday, August 9, 2009

Kit Chan's Home 家 - my all time favourite

The English version

Majulah Singapura

As a post-war baby boomer, who's been here when we were a brit colony to being in Malaysia and then out, I think that painful moment of separation in 1965 turned out to be the best thing that ever happened to us. Some may scoff, but I think it liberated us to be truly able to reach for heights we otherwise might never have scaled. My family and I have definitely been beneficiaries of the 'peace, progress and prosperity' that our little island has made over almost half a century.

I look back now at 44 years, and see that we actually haven't done too badly. And I find enormous confidence that my children and their children can continue to hope for things much better. We have nothing to be ashamed about, nothing to apologize for, and certainly a whole lot to be proud of.

This year I will not be at the NDP, as I have been every National Day, but watching the fireworks from a distance nonetheless with that pounding in my heart and that knot in my throat.

Go for it Singapore!

Friday, August 7, 2009

Stem-Cell challenge for the Singapore Medical Council

I was offline for a while for various reasons, and came back today to this curious flurry of reports in My Paper (1, 2 , 3 & 4) about the use of 'stem cells' for the treatment of aging and heart failure (many thanks to Ms Dawn Tay!!). The reports refer to two clinics, one in Parkway's Mt Elizabeth (TheraVitae), and the other in Paragon Medical Centre (Clinique Suisse). Clinique Suisse's Dr YM Wong, incidentally was also featured in a previous blog-post about another whacko scheme.

I must admit I don't know too much about these fancy therapies but a number of bizarre and confused things pop up in the reports:

a] The inconsistent picture of whether these were offered as part of a clinical trial. Both Dr Wong himself and Dr Eugene Sim of Parkway, offerred that these were not part of clinical trials, yet Dr Sim said that these were approved by the Parkway ethics board and the HSA (which would only happen if they were formal trials).

b] These therapies are 'unproven' and are not currently acceptable methods of treatment. Dr YM Wong was quoted as saying:
"We don't talk about clinical trials. We're not reducing people to digits and statistics. We treat people as a whole. I don't think like most doctors do. I'm different. Singapore doctors don't believe that stem cells can be used to delay ageing. They're very conservative and feel that stem cells should be used only in leukaemia and other incurable diseases."

c] Most importantly, the offering of unproven therapies is strictly deemed unethical. Para 4.1.4 of the SMC Ethical Code and Ethical Guidelines state very explicitly: "A doctor shall treat patients according to generally accepted methods and use only licensed drugs for appropriate indications. A doctor shall not offer to patients, management plans or remedies that are not generally accepted by the profession, except in the context of a formal and approved clinical trial."
MOH and HSA was quick to point out that doctors who flout these guidelines are liable for disciplinary action. (The SMC was however, strangely silent.)

But what was really disturbing was that this was going on for about 10 years.

So here is what I believe is an important and very timely challenge for the Singapore Medical Council, especially in the wake of recent discussions about her ability to 'self-regulate'. Did she know about the offering of unaccepted therapies? Or did she conveniently blind herself to the violations and clung obstinately to the mantra that she cannot act unless someone complained officially?

Time for a serious re-boot of the system?