5th H1N1 (aka American flu) case in Singapore... hmmm ....worry or don't worry?

We we now have 5 cases of H1N1 in Singapore.

It's kinda surreal isn't it? I think we should worry...oh no, we shouldn't worry. It's life as per normal...oh no, it cannot be normal, we must be careful. Is it a pandemic? Not a pandemic? Or a qualified pandemic? Is the sky falling? Who knows anymore?

I think the regulatory authorities, and health ministries, including the WHO and our own MOH have kinda painted themselves into a corner, don't you think? Is it ever going to get better? Obviously not, because the number of cases will just increase until the virus loses steam. Maybe then we can live outside our artificially constructed bubble. What if it doesn't? Well, I think we got to get used to living in our bubble, cos the WHO too 'paiseh' to admit they got it wrong.

I wonder if anyone is keeping track of the economic costs of maintaining this charade?

The murky world of drug trials in Singapore

I don't particularly like Strait's Times' Andy Ho's writing. They often tend to be over-jargonized, pretentious and generally confusing.

But this Saturday under the Daedalus column, he touched on a topic that has been somewhat troubling to me, that of the conduct of clinical trials by mega pharma companies.

Drug companies claim that the cost of developing a new drug ranges anywhere between US$0.5 -2 billion. (Other people have suggested that this is grossly inflated and that perhaps only about a fraction of 10% of this is actually spent on FDA required activities.) Although the patent life of a drug is 20 years, about half of this is taken up by research activities before licensing of the drug, hence most new drugs entering the market have only about 7-12 years of effective patent life during which to recover the cost of drug development.

There is therefore a mad rush by mega pharma companies to get their products to the FDA finish line. Not many make it. Last year (2008) only 24 made it through. To regulate this R&D process and to make sure that there is global acceptance of the data generated by these rushing mega pharma companies, the clinical trials are 'regulated' by a series of harmonized dos and don'ts called the Good Clinical Practice (GCP) guidelines. There is a global set that has been harmonized by the International Conference on Harmonization (ICH). Singapore has a set that had is based heavily on the ICH-GCP document.

These guideline do give some comfort that the human experimentation that occurs as a result of the need to do clinical trials is to a large extent highly regulated. Even in Singapore. In Singapore, the Health Product's Act covers all such activities and the Health Science Authorities is the delegated authoritiy that approves the conduct of all clincal drug trials. Every investigator that is involved in clinical trials need to be trained in GCP. Every institution/hospital involved in clinical trials needs to have an instituional review board (IRB) which will provide the ethical review for all protocols.

All this looks very nice and comforting. As usual in Singapore, when we want to tell the world we are 'world class' we make sure that we have all the bases covered. At least on paper, lah....

Let me tell you what I have been concerned about... (and I hope the Ministry of Health are listening here)

a] Despite the existence of IRBs in all the restructured hospitals, not all the IRBs function at the same level of professionalism and competence. This gets worse outside of the restructured hospitals. There is no mandated 'training' or certification of IRB members so we do not know how competent or committed IRB members are in reviewing the clinical trial protocols. Most are just 'arrowed' to do the work, without any proper recognition of work done. To make matters worse, none of the IRBs are ever audited to make sure the processes are as intact as people assume they are.

b] Investigators(consultants,professors etc) are supposed to undergo training and be competent in GCP. But the only institutional expectation at both SingHealth and NHG clusters are only for them to be certified through a nominal online certification programme run by the Collaborative Institutional Training Initiative (CITI) (this one, anybody can pass...!!).

c] The IRBs never ever audit the clinical trials done in the hospital unless some shit hits the fan.

d] The HSA never ever audits any institution to see if they have the processes in place, and if they are actually compliant with whatever they say they are doing. I think basically HSA would rather not know.

e] The clinical trial units that do human experimentation are never audited, and there is no mandated certification of the facilities, so we can only assume that these units can handle emergencies and and manage the subjects if anything goes awry.

So do I have much faith in the environment that has been set up in Singapore so that we can play in the big league? Sadly, no. That we have not had a major incident here is probably more due to good fortune, than any good organization.

So do the investigators do what they say they are doing? Who knows? Does anyone really know what is happening? I have my doubts.

Militant secularism?? - Thio Li-ann's parliamentary speech

Wow....I learnt a new phrase today - "militant secularism".

Prof Thio's speech in parliament was report in today's TODAY:

Prof Thio argued: “Secular fundamentalists are oppressive where they seek to mute religiously-informed convictions in public debate.” They do so “by demonising a view as religious in attempting to make religious faith a cause for embarrassment, or to distract citizens from the merits of an argument by discounting a speaker whose values are shaped by a religious” faith. Such militant secularism is “a recipe for social disharmony”, she added.

Actually, she's right. The environment for public discourse at the moment seems to me, a little lop-sided. One one hand, views based on religious convictions are easily demonized and discounted because of the religious affiliations of the proponent, while the opponent camp is relatively free to scream foul at every turn of the debate. I can understand and accept this if the secular voices are un-organized and free roaming, but if the secular views are part of an orchestrated chorus, shouldn't they be subject to the same criticisms and scrutinies levied against religious groups? I mean, isn't organized secularism just another religion?


I have raised this issue previously, independently of Prof Thio (whom I am not acquainted with at all), but it appears that she is voicing similar reservations that I had.

University ranking - another example of management by metrics

While we are on the topic of 'management by metrics', Prof Lily Kong of the NUS wrote a rather defensive letter to the Straits Times about the NUS apparent fall in ranking during the recent publication of the Quacquarelli survey.

Prof Kong's response says a lot but actually says nothing much that we don't already know. ..that NUS looks very good on paper, when the right parameters are used. This is because NUS has a strategic approach based on certain metrics that will do well in ranking exercises. The fact that when the ranking metrics are altered, ranking falls so precipitously suggests a lack real 'health' in the system. I have posted recently on the management by metrics approach that many organizations take nowadays, and this is really what is happening here. So little of what Prof Kong says reflects on the NUS real commitment to teaching and training. Recruitment of new staff is fundamentally based on the research accomplishments rather than on a passion for students and teaching.

For professional schools such as engineering and medicine, this will result in sub-quality practitioners and professionals produced by the schools.

My suggestion to NUS....and NTU as well....get away from these artificial metrics and go back to basics about your strategic directions as a university. By all means recruit people who are good academics but please make sure they are also good teachers, and are people who have a heart for students.

H1N1 (aka American flu) - lockstep with WHO

Day by day, it's becomeing increasing clear that we are not dealing with a vicious virus. Infective, yes but vicious,....no. It is no less menacing than the seasonal flu, although there was early indication that it might have been (which was the reason for the original panic). In the US (epicentre's closest neighbour), there has only been 9 deaths in 6552 cases, giving a case fatality rate of less than 0.15%.

So why this continuing alert that refuses to go away?

I suspect it is largely due to our being locked into the SARS frame of mind. Dr Margaret Chan's perception of the 'pandemic' has been framed largely by her extensive involvement with the SARS situation. Likewise, following upon SARS the global pandemic management processes are largely geared towards preventing a pandemic worse than SARS.

So now the world (responsible countries of the world) are locked in step with the WHO, who has been super 'kiasu' about a SARS type situation, and now too 'paiseh' to step down too quickly because that would be an admission that it had overreacted. Now everyone is in a pseudo state of alertness, in the midst of a toothless pandemic, pretending to be frightened and fanning a panic that no one believes in.

It's not a very healthy situation. Day by day, I see staff at hospitals and various organizations going through the motions of being concerned, but breaking rules and bypassing procedures. Persisting with this false alarm just breeds complacency and sloppy attitudes towards infection control procedures.

It's really about time people just come out and say, quite honestly, that the sky isn't falling.

Sexuality Education in Singapore - did MOE botch it up?

There was a report in today's ST entitled 'Sex Education: Experts identify 2 weak links'.

The report prompted me the consider if MOE did make a mistake in managing this...and if it did, why? I have no insider insight into the workings of MOE, but certain patterns of events (some would say lapses) that have occured in civil service suggests perhaps that some systemic problem might underpin these apparently unconnected dots.

I am probably overstepping the boundaries of my expertise, but it seems to me as an observer that management in the civil service and many of the quasi-government organizations (including hospitals or course, and the universities) now heavily adopt the management style that is based on meeting various metrics. This is what management circles sometimes refer to as 'management by metrics' . The advantage of this kind of approach is that certain goals are set, and the management performance can then be assessed through their ability in meeting these emprically set goals. The disadvantage is that many important strategic goals may not be easily codified, and therefore can only be indirectly identified as a performance goal. Management then becomes artificially and wrongly fixated on delivering with respect to these proxy goals rather than the true goal (uncodified). (Read related posts on the Giraffe's neck.)

Take this sexuality education thing.

We all agree that sexuality education is important and long overdue. MOE sets goals to implement sexuality education. Timelines are set (checked). Get the vendors (checked). How many teachers do we need? (checked). Is there a curriculum? (checked). Anyone vetted? (checked). Which schools? (checked).

Yay!! Great work guys! Right on schedule! Somebody give the man a Tiger!

What could not be codifed were the softer issues like, content, appropriateness, acceptability, parent's buy in... So these don't appear on the radar screen.

So did MOE cock-up? I leave it to you to figure out.

Suffice to say we need to be careful about managing by metrics. Because efficiency isn't all there is about management. It's often really not just about how fast and expedient we are in getting to our goals.

Exposure to virus 'a bad idea'....Really?

I was quite amused reading about MOH Director of Medical Services, Dr Satku having been quoted as saying 'Generally, as a principle, it is not good practice to expose an individual to a contagious disease to gain immunity as any infectious disease might give rise to complications'.

Really, Dr Satku?

I think the good doctor meant well in defending his Ministry, but I think he is way off wrong.

Infections occur all the time, and being contagious have always spread through the community in some way or other. This is the way the community builds up 'herd immunity' to bugs. We are not talking about some serious illness, or devastating infection, rather in this case, a viral infection that has way less bite than the seasonal flu.

Dr Satku, in case you haven't noticed, we don't live in a sterile bubble.