What??? No regulation for stem cell products also? !!!

Today's Straits Times carried a special report on stem cell treatments. But it totally misses the point that stem cell treatments are a poorly regulated area in Singapore.

I remain horrified that we insist on regulating drugs to the nth level. Preclinical studies, clinical trials.... and what not. Pretty much about 10 years of generating data on safety and efficacy before we allow them into the market place. But when it comes to cell based products, whether of animal or human origins, there is this huge blindfold on. The Bioethics Advisory Committee is only concerned about the ethics of doing such research. But if it is for clinical use, there are no regulations in place, and it's pretty much a hands off approach.

I am particularly surprised that when the Health Products Acts was passed in 2007, it only applied to First Schedule items such as Medical Devices and Cosmetics. Wasn't it considered then that cell based products were something to be concerned about? Or for that matter, any biological products that were not technically 'medicines'.

Oh yes, we can argue that such experimental practices fall under the scrutiny of the Singapore Medical Council, who have a Ethical Code and Ethical Guidelines to hit people on the head with. Para 4.1.4 particularly. But this is too ambiguous and subjective to have any real meaning. I mean, what are unproven therapies? If I have 20 anecdotal reports, does that mean it is proven? How about 50? 5000? or 5?

So why aren't cell-based products registrable? Where are the legislative powers for HSA to do this work? Why is there such a big blindspot in our regulatory environment?

H1N1 vaccination, anyone?

So Singapore gets her H1N1 vaccine fix in a couple of week's time. I think the MOH had spent about S$10-20 million to the one million shots for us so we should grateful for the preparedness. Word out is that most of these are the Australian CSL Panvax vaccines, and about a third might be the GSK version, Pandemrix. But no idea how these gets distributed so you might want to ask when you do go for your shots. Pandemrix is the one with the AS03 adjuvant.

A couple of things bother me though. There's been a lot of talk about a second wave emerging. The reason for the vaccinations are to mitigate against this second wave. But I never quite bought into this second wave thing for Singapore. If indeed there is a second wave, given there will be more herd immunity, it would be a lesser wave than the first, would it not? Unless of course, the virus mutates. But it hasn't as yet, and it looks like we are dealing with the same, not so virulent, not so lethal , not so pandemic virus.

Also seasonal flu? That applies to temperate countries with summer/winter type seasons. Since the only winter we have in Singapore is the styrofoam/soap variety in Orchard Road, there isn't going to be much in terms of seasonal change in flu transmission. In fact, a scan of the MOH epidemiological stats over 2004-2008 confirm that the incidence of acute respiratory infections were pretty flat throughout each year. The only interruption to this flatness was the rather short-lived H1N1 pandemic earlier this year. So the only seasonal change we may expect in H1N1 would be due to increased seeding by travelers from temperate zones who carry the virus to us. And given the increased herd immunity, such seeds may not transmit that well.

Actually, I wonder why the MOH does not survey the level of herd immunity in our population beefore embarking on any immunization programmes? This developing herd immunity would certainly be one of the reasons why the earlier first wave pandemic fizzled out. After representing more than 60% of samples at the peak fo the pandemic, it is now hovering at about 24% of cases surveyed.

So is there a rush to get vaccination? Apparently not if the health care workers are polled. But these are still early days.

No regulation of xenotransplantation in Singapore?

Martin Huang's administration of sheep foetal cells for rejuvenation, is technically classified as a form of xenotransplantation.

Other types of xenotransplants would be - sticking an animal (e.g.pig) organ (heart, liver, kidney etc) into a human recipient, or putting animal (again usually pig) cells into people (e.g. pancreatic islet cells).

Strangely xenotransplants seem to be a relatively unregulated medical procedure. The HSA regulates medicines, complementary medicines, cosmetics and medical devices but apparently not animal cells. It would seem that xenotransplants would be regulated under transplantation laws, but not so. The Human Organ Transplant Act doesn't cover animal cells into humans, just the use of human organs.

So doctors seems to be pretty unregulated with respect to their sticking animal bits and pieces into people. Possibly it may be considered an experimental surgical technique, but one could argue that sticking sheep fetal cells into someone isn't really surgery. It could possibly be regarded as an experimental procedure or a clinical trial; in which case it should be approved by the ethics committee. But this would assume the doctor would classify it as an experiment. If he maintains that the procedure is not experimental he need not subject it to ethics review.

It then becomes the responsibility of the Singapore Medical Council to consider it under Para 4.1.4 of the ethical guidelines. Unproven therapies. And that seems to be pretty inconsistently interpreted at the moment.

It would seem that Singapore is quite backward and confused where this is concerned.

Here is a list of site where you can read about regulations elsewhere:
http://www.biosafety.be/GT/Regulatory/Guidelines_CTXeno.html

Wet markets to stay!!

A small victory of sorts.

Now if we can only prevail upon the HDB to be sensible about the remaining19 wet markets run by private companies...

Why was animal cell therapy allowed to be imported for use?

The Martin Huang saga has created quite a bit of consternation in the public as well as the medical profession. Even the Director of Medical Services was prompted to come public with a reprimand of sorts. Many people thought the poor sod had gotten off with little more than a mere slap on the risk. Which was true. A fine of a mere $5000. Loose change for this guy.

But the question must also be raised as to what actual law did he break, and what crime did he commit? Apparently he done the unconscionable and had injected sheep foetal cells into patients to slow aging. The Medical Council screamed that this was offering unproven therapy, and not allowed. Such unproven therapy violate the SMC Code of Ethics :

The SMC Ethical Code and Ethical Guidelines para 4.1.4 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."

What Martin Huang did was offering a therapy that was uproven, and which was not part of a formal clinical trial. Bad guy.

But then again ( and I have posted on this conundrum before) so many of our doctors are clearly in breach of this. Unproven therapies? All off label use of medications are unproven therapies. Furthermore, their use are often not in the context of a formal clinical trial. How about off-label stent operations? The recent media reports on inappropriate slimming pill prescriptions fall into this category of offense. Yet the SMC did not act.

Not that I am a supporter of Martin Huang. I totally disagree with what he did and fully support the SMC's actions in his case, but the SMC's actions now look horrendously inconsistent. How did the SMC arrive at the conclusion that the offering of sheep fetal cells was so wrong compared to surgeons sticking all kinds of un-trialed appliances into our bodies, and physicians offering all kinds on drugs for un-trialed and unproven indications?

I wonder.

One last bit of ranting before I go for my teh-see....

Were the sheep cells licensed to be imported for cosmetic therapy? Here is where HSA has to explain their position. There apear to be regulations for medicines, for biosimilar products, for some medical devices and for cosmetics (external applications)..... but for cell based therapies?? Silence.

So were the cells allowed into Singapore for such use. If they were licensed imports, would this license represent tacit approval by HSA for their use? If they were not licensed, was Martin Huang guilty of breaking an import law? If so, he should be hit with the full weight of the law, as would any merchant intending to trade in an illegal product. Or does this indicate there is a legal loop hole for doctors to violate patients' safety? If so, why is there such a loophole and what are we doing about it?

What are the conflicts of interests within HSA, as they themselves begin to offer cell based therapies? How do they regulate themselves, in the absence of proper legislation for this, and as they come into competition with commercial providers of cell-based therapies?

We need to know.

Happy Deepavalli!! Happy Harvest!!

Today my Hindu friends celebrate Deepavalli. With this celebration of Deepavalli, the third of our ethnic groups complete their festivals during this time of year (the earlier ones being Zhongqiujie and Hari Raya). There is really no great mystery surrounding the clustering of these festivals during this part of the calendar. They all probably had their origins as autumnal agricultural festivals which subsequently took on spiritual and religious (or national) significance.

Deepavalli's roots are shrouded in mystery, but most believe it has its origins as a harvest festival.

Autumn is a significant time of year in the agricultural calendar of the northern hemisphere. Crops planted in Spring ripen and are collected in the harvest. Agricultural communities celebrate this gathering of the harvest through various thanksgiving feasts. Often lights are featured, as in Deepavalli, perhaps as a recognition of the lengthening nights as Winter approaches. Even the Jewish communities celebrate a Festival of the Ingathering. This subsequently became the Feast of the Tabernacles which they use to commemorate the exodus out of Egyptian slavery.

But what of the harvest in Singapore? We have left our agricultural roots long ago.

We need to remember that our plenty of today is a harvest of the seeds sown by the previous generation. As we continue to reap the harvest despite the economic downturn, we should remember those who had planted seeds with foresight and diligence. Some thanksgiving in due.

But going forward, we should also be very mindful of what we are sowing for the next crop. So here's my plea to the leaders of today. Do not look just at the short term gains as indicated by superficial metrics. This has tended too much to be the management norm of today. While there is little doubting the longer term mission spelt out by our senior political leaders, the middle management levels have tended too much to just focus on short term metric indicators of performance. It's tempting to do so because individual performance looks good, but too much preoccupation with short term goals may ultimately undermine our very existence.

So where medical education and practice is concerned, let us please look at look the ultimate future of our health care system. Let's not screw it up or (as frighteningly overheard coming from a very senior person in YLL), cause it to implode.

Happy Deepavalli, all. And have a great weekend.

Medical ethics - Prof Satku's blogpost

Let me be among the first to congratulate Prof Satku, Director of Medical Services, on his blog comments on Dr Martin Huang's recent escapades with animal stem cells.

Well said, Sir!

I hope Prof Satku's public comments on topics pertaining doctor's professionalism and ethics will not be a one-off event. There is much out there that requires a re-boot. Ethics and professionalism has been fast tracking down the wrong road as the medical market place develops. Sometimes legislation is required. But often it is just the regular and consistent articulation of what is acceptable and what not that puts peer pressures on doctors to 'conform' to best practices. I believe most doctors want to do their best, but if things are left unsaid, errancy can fast become the norm.

I firmly urge our medical professional leaders to take up more visible, clear and vocal positions about medical ethics and professionalism. Not just generic statements, but targeted specific comments about issues. This includes not just the Ministry of Health but also the Medical Council and the Medical Association.

It's time to stop the rot.