Monday, October 19, 2009

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.


Anonymous said...

George says:
More than 40 years ago, I watched a documentary about some German clinic giving this foetal cell jabs on the butt of patients as part of rejuvenation treatment.

After such a long time, still no decision/conclusion on its safety and efficaciousness or otherwise?

But as far as the authorities are concern surely it must be either a 'GO' or 'NO GO' case?

They don't know or don't want to know, until someone kick up a ruckus about it?

gigamole said...

Methinks the crux of the matter is that stem cell therapy isstill in its very early days. Most of these fetal cell/stem cell treatments being pushed outside are pretty much preying on patient's anxieties and hopes for cures, or reversal of aging processes.

Regulatory authorities should be clearer about how they 'license' these products. In Singapore it would seem that there are currently no regulations for the import of these cell-based products.