Saturday, October 24, 2009

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?

1 comment:

Anonymous said...

hi, could you please post this up on singaporemd. These are two articles written by a friend of mine who is a final year medical student. I think it pretty much sums up the desperation some of us are feeling now. Not everyone in the class is against the residency programme, which in fact makes those against it worst as now our class is totally divided, hence we are unable to stand up against the DMS.