Regulation of medical devices? What shocking news?

Woke up this morning to the shocking news of HSA's intention to regulate medical devices. More correctly,  the shocking news of the doctors' responses to the impending regulations. What crap!

Regulation of medical devices have lagged far behind that for pharmaceuticals, and regulations have been long overdue. While pharmaceuticals require extensive testing for safety and efficacy, medical devices have escaped such scrutiny. As a result many poor quality products have been inflicted on unsuspecting patients. These range from breast implants, stents, artificial joints and various other prostheses. (Consumer Reports reviews this problem with reference to a report from the Institute of Medicine. 4 types of devices were singled out - surgical meshes, lap-bands, hip implants and cardiac devices.)

Recently, the French Company making the Poly Implant Prosthese (PIP) gel breast implants were hit by a major scandal when it was discovered that they had been using industrial grade silicone instead of medical grade ones, leading to the company going into liquidation. Of greater concern than the financial woes of the company was the exposure of unsuspecting women to the increased risk of ruptures of the poor quality implants.

Will the new regulations slow down the utilization of medical devices? Without doubt. But this slow down is necessary until manufacturers and doctors get used to dealing with public expectations of quality. Currently device failure rates are not even being monitored so no one has any idea of of how many faulty devices breakdown or fail.

HSA's regulations are both timely and essential for the protection of consumer safety, and we should welcome them. On the other hand, our doctors' hysterical lamentations that these regulations will only increase their practice inefficiencies and reduce the quality of medical care are misplaced, and sound totally self-serving.

A practice-oriented, teaching medical school? Why not?

Minister of State Lawrence Wong recently speaking about a more diversified university environment, suggested that that could be a place for the Singapore Institute of Technology to develop into a practice-oriented teaching university. A good idea, though not an entirely novel one! After all, such universities exist successfully elsewhere. It is not even new in Singapore, since the Nanyang Technological University (NTU) was very much such a university in the early years..... until it got sucked up into the academic research game.

Our universities in Singapore have for the most part lost sight of the core objectives which are really about the  education of the next generation. These objectives have been subverted by the mad rush to play the ranking game, and to crank up the research KPIs. As a result, the universities of today all strive to look like poor simulates of high end research institutes, and generally allow their educational missions to waste away. Likewise our medical schools.

One could ask the schools who they think they are producing doctors for? The research institutes? To become award winning clinical scientists? To engage in translational research? Not that these are not important, but surely they cannot be the core objectives of the medical school? Yet, in the medical schools, it is almost forgotten that the main stakeholders are the public clinics and hospitals.

I am convinced that we need to return to basics and re-focus our energies and resources on producing good and caring practitioners who will serve and support health care delivery. We do not necessarily need the best brains for the medical profession. We don't need them to be top researchers. We need the best hearts! And we need them to care for the sick, the elderly and the handicapped.

So the MoS Lawrence Wong should consider extending idea of the practice-oriented teaching university to the training and education of doctors as well. To my mind, it is long overdue.

Research misconduct - a problem in Singapore or not?

from http://undsci.berkeley.edu/article/socialsideofscience_06

It's probably unrealistic to expect that scientists can be less unethical than salesmen or wall street bankers. Historians are by now pretty convinced that some of our most illustrious scientific minds, Gregor Mendel, Isaac Newton and even Albert Einstein misconducted themselves in their presentation of critical data. So it should come as no surprise that scientists of today do cheat. Except that because today's research stakes are so high and because biomedical research is nowadays such a big industry, we should expect that, notwithstanding all the goodie-goodie posturing, biomedical scientists do cheat a lot.

An electronic BMJ survey in the UK of 2782 respondents (out of 9036 invitations) revealed that 13% of the respondents had either witnessed or had first hand knowledge of research misconduct. Not only that, but the respondents also felt that about half of these cases had been inadequately investigated.

from http://www8.open.ac.uk/platform/blogs/society-matters/new-survey-questions-scientific-integrity

The recent unveiling of Dr Anil Potti's research dishonesty (see Wikipedia; Economist) show not only how extensive research misconduct can get, but also how large prestigious research establishments are not immune to such dishonesty. (Dr Potti was a reknown Duke University oncologist and researcher). Many felt though, that his case was a long time cooking, perhaps too long, and that this delay reflected
some reluctance in the establishment to press home early allegations.

Another kettle about to boil over involves Dr BA Aggarwal at another prestigious establishment, the  MD Anderson Cancer Center. He is apparently under investigation at the moment. In Singapore, we have the Alirio Melendez story, which has been under investigation for an extremely long time without any apparent outcome.

Is research misconduct a problem in Singapore? It is hard to tell. But there is nothing to indicate that we are any more or less ethical compared to researchers in UK or the US. The absence of any national ombudsman to investigate allegations of misconduct may limit the identification and surfacing of such cases. Blogs such as Abnormal Science and Retraction Watch do occasionally flag out some questionable practices from Singapore (see here), but there is currently no indication that our research establishments are taking any of these seriously. I guess Lord Horatio Nelson rules in Singapore with respect to investigating misconduct in biomedical research.

I should make it very clear that I make a very clear distinction between allegations and proven misconduct. Much of what has been highlighted in blogs such as Abnormal Science are little more than allegations, and even if there are malpractices, it is unclear what actually happened and who is responsible for the 'errors'. Nevertheless research establishments do need to recognize the presence of these allegations in the blogosphere and to deal with them. It is not in anybody's interested to pretend that such allegations do not exist, especially if they are accompanied by documentary evidences of questionable data integrity. We need to have these properly pinned down, and if there is any real misconduct, the research community and particularly the students need to be aware of these pitfalls and wrong doings.

For further reading, please see:
Singapore statement on research integrity
Columbia University portal for Responsible Conduct of Research

Given the amount of money we are pouring into biomedical research in Singapore, it is somewhat surprising that we do not take the policing of research misconduct more seriously. Perhaps it is time we had a national ombudsman for this purpose.

The public transport monster under the bed

So, yet another train fiasco. Just that this time, it is SBS Transit in the hotseat.

Try as I may, after many futile hours/days, Gigamole has come round to the reluctant realization that Gigamole is really too intellectually challenged to understand all the convoluted arguments explaining the Government's infusion of S$1.1 billion to the public transport operators. To Gigamole it cannot be anything other than putting money into the hands of the shareholders of inept and inefficient transport operators.

The privatisation of public transport created the initial illusion that the Government was distanced from the responsibilites of managing public transport. The monster appeared to lurk in the basement far from Governement coffers. But the precipitate and almost panic-strickened dumping of S$1.1 billion to plug the leaking boat speaks volumes about where the monster truly lived. Right under the Government's own bed.

Prof Khoo Oon Teik - Requiscat in pace

Khoo Oon Teik (Dr) (1921-2012)

Very belated condolences to the family of the late Prof Khoo Oon Teik. It's the passing of a generation. For Gigamole, Prof Khoo had always embodied the most noble values of the medical profession. A true visionary, teacher and mentor.

Gerontophobia hits Singapore!

There is actually a medical term that describes people with an abnormal fear of old people - 'gerontophobia'. But that is really too kind a description for the people in Woodlands and Toh Yi who objected so strenuously to the plans for eldercare services in their community. To my mind these people were just plain and simple - self-centred, selfish anal orifices.

But apart form this obvious truth, I wonder if the problem might have been averted if the plans for eldercare in Singapore might have been better explained and elaborated upon. Unfortunately for the uninformed it might appear that the planned-for eldercare services were just going to me one or two showcase units plonked into unsuspecting communities to service the whole of Singapore.

Unfortunately, the City For All Ages Project did not go into details about how these plans were going to transform Singapore. Why didn't they just come out and say that these eldercare services were going to be inserted into all communities just as you have community centres everywhere? These eldercare services should be numerous and fully integrated into every community. If these were made clear, then Woodlands and Toh Yi were not going to be stand alone shoulderers of the Singapore burden for looking after our aged.

But there is still time for the MCYS to explain. Meanwhile it really doesn't excuse the boorish and unacceptable behaviour of Woodlands and Toh Yi residents. Shame, shame.

Toh Chin Chye -Requiscat in Pace

Toh Chin Chye 杜进才 
10 Dec 1921 - 3 Feb 2012 


 Requiscat in Pace