Our hospitals' creative definitions of charity.....

Leong Sze Hian's expose on the NUH (Patient Care Charity Fund) and TTSH  Community and Charity Funds' use of collected money provided another jaw dropping moment for Gigamole.

What's going on here?

How can you use funds collected under the guise of charity to pay for education and training of staff, and the building of hospital infrastructure? For the NUH Fund, only 52% of expenditure apparently went to needy patients, while 48% went to medical education, training and research. For the TTSH Fund, apparently only 47% went to real charity-worthy needs. The rest of the expenditure apparently went to finance the building of infrastructure in the form of a new Emergency Diagnosis and Therapy Centre.

If these revelations are true, Gigamole is extremely offended. Clearly these are abusing donor's and patient's trust, not to mention demeaning to the idea of charity.

The Commissioner of Charities should have something to say about these.

The Alirio Melendez research misconduct issue finds resolution.... well, at least some kind of resolution ...!

After one and a half years of dingdonging, the Melendez research misconduct investigations  finally get an NUS report. Twenty one papers were associated with plagiarism, fabrication and falsification. Strangely, the NUS refuses to say which papers. But the NUS apparently exonerated all the co-authors. Whoohoo......! Nobody else were responsible!

Incredible news, I must say. The lead authors of the papers not responsible? I am sure Melendez was not the lead author for all 21 papers. How can this be?

In the NUS, I am told, there is a scheme of apportioning glory and credit for scientific publications. This is for the purpose of chalking up points for promotions and other 'rewards'. The lead and the corresponding authors get 50% of the credit each. All the other co-authors stuck in between get 10% each. On this model, one published paper with a mass grave of 10 co-authors can chalk up a total of 180% credit.

Contrast this with research misconduct, where suddenly everyone in the mass grave is invisible and not involved, and only one person takes the blame for everything.

You go figure the logic!

Depuy hits the headlines in Singapore - finally!

Straits Times Health Correspondent Salma Khalik finally decided the Depuy hip implant problem was important enough to highlight. A half-page spread today.... whoohoo....! Gigamole had been beating this gong for the last 6 months and wondering if anyone was listening. So....thank you Ms Khalik!

Truth is HSA has floundering somewhat with respect to medical devices regulation. With all good intention, it started to do something about it but mismanaged the implementation. After an hysterical outcry from suppliers and practitioners, it pulled back from doing the right thing. Kinda like 3 steps forward and 2.9 steps back.

The Depuy hip implant failure is now subject of a national class action lawsuit in the USA. Just a few days ago, Johnson & Johnson agreed to settle in Australia for A$30,000 per patient. In Singapore however, the situation is far from clear.

There are many problems.
a] Lack of patient awareness. A dear doctor letter was sent out, but there has been no follow up by any responsible party.
b] No one has any idea who received the implant. There is no registry of such implant use.

c] HSA has no idea who is affected, and what to do about it. Gigamole thinks they have just been hoping the problem will fade away in time.
d] There is no service laboratory in Singapore that will measure chromium and cobalt for toxicity.

There is no equivalent of a lemon law for medical devices in Singapore, and no patient consumer movement to look into the interests of the patient-consumer. Like it or not, the only authority who can do this is the HSA, but they seem clueless and toothless.

Silence is golden, NUS? I am disappointed.

Sometimes I wonder if the National University of Singapore (NUS) values good press above doing the right thing. I understand that managing the corporate profile is important, and that for a school such as the NUS that relentlessly chases the rankings, avoiding bad press is important. But there are other ways of managing your reputation than just avoiding difficult issues.

Here the imposed silence on student blogger Alvin Tan's punishment says a lot about NUS character and maturity. I am not interested in the sordid details about what the blogger did, but the consequences of what he did especially while he was a scholarship holder. Whatever NUS's disciplinary decision was, there are important lessons for everyone. Transparency in dealing with such a difficult issue will show to the world the heart and soul of the university. We need to know what value systems, the NUS stands for. If the disciplinary action was fair and honest, why is there a reluctance to make it known? There are lessons for everyone.  As a world class university aspirant, the NUS should not fear engaging in public discussions and debate, even about its own corporate decisions.

But I am disappointed. Because it seems clear that the NUS has opted to hide behind zipped lips and walls of silence rather than bravely engaging the public. This has been how the NUS has chosen to manage previous incidents - from research malpractices to spectacular lab accidents. To date, the public remains in the dark about what mistakes were made and what actions taken. Valuable opportunities to learn from these incidences have been lost. This over-reliance on the strategy of retreating behind walls of silence is very damning, and I believe in the longer term, will stunt the intellectual growth of the university. Perhaps some timely advice from the managing editor of the SPH who sits on the NUS Board of Trustees is appropriate here.

It's time the NUS grew up.

The patient-doctor relationship - a relationship between unequals

Today's Straits Times carried an interesting report of  contest in a coroner's court between a mother who is a nurse, and a surgeon. The mother, who had lost her daughter in a liver transplant contended the surgeon provided sub-standard care because she had a spat with the surgeon earlier.

She did not convince the coroner. However, the case highlighted the inherently unequal relationship that exists between a patient (and relatives) and the doctor. Here, every patient is in essentially a subordinated position, and generally hesitant to offend the attending physician/surgeon. This is generally the case, unless the relationship is based on a completely elective and unnecessary procedure, when a more commercial/contractual relationship may apply.

This is why I am concerned about how the physician/surgeon goes about taking consent for procedures. Often the consent is taken by the care giver. In this case, the patient is often afraid of offending the doctor. This unequal relationship very clearly does not create the circumstance when a truly voluntary consent can be obtained. This ethical lapse, also applies to the situation when consent is being sought for participation in a experimental procedure or clinical trial when the researcher or care giver is himself/herself the one administering the informed consent.

The more academic hospitals compound the problem further by expecting patients on admission to consent to giving up rights to tissues and genetic material for research purposes. This consent is often taken at most inappropriate times when the patient and his/her relatives are most dependent and submissive.

The hospital ethics committees applying their very utilitarian logic, obviously do not disapprove of these ethical lapses.

Sex and corruption in medicine

 

The recent sex and corruption case at the Central Narcotics Bureau has certainly woken many people up. But there is really nothing new here other than the titillating stories of trysts  and late night sexting between two very gatal (itchy) people. Sex sells. And all through history women have used their wiles to charm their way into position, power and wealth. So was this corruption, or just two very gatal people acting out their fantasies? We won't know for some time, and Gigamole will not speculate.

Nonetheless, Gigamole is reminded that the medical and health industry is not immune to such sex and corruption issues. Just that many do not get flagged out.

The WHO has estimated that the about US$4.1 trillion is spent globally on health services and of this, US$750 billion was on pharmaceuticals. It is a massive industry. The pharma companies aggressively compete for this market, and many (if not all) resort to unsavoury methods to market their wares.

Recently GSK was fined US3 billion for illegal marketing of its products. Part of these charges relate to providing junkets for doctors and various other kickbacks. J&J also had to pay up US78 million to settle charges of bribery and kickbacks it had provided.

Does this happen in Singapore? For sure. But perhaps not so obvious, because of our CPIB. But bribery and kickbacks in some form definitely occurs. Our doctors (especially)  go on junkets all the time. Not to mention kickbacks of various sorts. These are supposed to be regulated and notified to senior management, but nobody really scrutinizes anything, and consultants regard these as the perks of their practices. Medicines Australia reported that the annual spending by Pharma companies in wining and dining doctors and healthcare workers amounted to about A$24 million. How much "hospitality" spending in Singapore? Gigamole doesn't know. In fact the authorities don't really want to know.The public should insist that this be reported and made known publicly.

Any sex involved? Gigamole cannot prove anything. But suffice to point out that the industry is much bigger than selling the odd IT systems. Anybody stopping to point out that the sales reps for pharma companies are invariably attractive young ladies in short skirts?

This is not a problem that affects just pharmaceuticals. Medical devices suffer the same corruptibility. The susceptibility also extends up all levels of the health care chain....all the way from the prescriber, procurer and possibly even the regulator. Can we trust that we have only the best medical information, drugs and devices? Possibly not.

We need to look at this more carefully. The trouble is that the medical industry is seems rather "protected" and few want to stir the pot to root out these problems within the industry.

The PSLE should merely be a competency exam!

In case the point had been lost before, Gigamole is saying it again. The PSLE should remain, but only as a competency exam. We have compulsory primary school education in Singapore, and a competency exam is required at Primary Six so that we can be assured that all children have achieved a minimum level of education when they leave Primary Six to go to secondary school. There is really no necessity to grade this exam.

Gigamole cannot understand why secondary schools should be allowed to select students based on grades. If you are a good secondary school, prove it by the product that leaves the school, not by the students admitted to the school. All this talk of de-banding the secondary schools is hogwash, and a red herring to the discussion. The schools' reputation will become known in time, with or without banding. What credit is there to the school if it is enrolling only the best performers at PSLE? The Ministry of Education in retaining the graded PSLE seems to only be interested in protecting the positions of established elite secondary schools.

Please protect our your children by removing this unnecessarily competitive exams from their educational experience. There is more than ample opportunity to compete after they have left primary school. Shifting the competitiveness in education later will also be fairer to students who are naturally late bloomers.

"You ignore me, how, how, how?"

Sounds like the plaintive cry of a woman scorned. And we all know enough to beware that woman scorned.

Yet, often we Singaporeans are made to feel like the woman scorned. By the gahmen (and their extensions) we love. Gigamole feels that way sometimes. Important issues brought up often meet that deadly wall of silence. The icy stare. The cold shoulder.

Issues that continue to bounce off the wall of silence::

a] Illegal street racing. All we hear are the Ferrari engines that continue to roar down our city streets in the dead of night.

b] Lab explosions in the NUS. A lab accident after another, yet the Ministry of Manpower, for all their new empowerment through the WSH Act, and the NUS, continue to maintain their walls of silence.
 
c] Research misconduct. The Alirio Melendez story came and went. Yet for all Singapore's vaunted push for research integrity, the Melendez related dirt seems to have been conveniently swept under the carpet.

d] Unregulated wacko medical devices. The HSA sweeps some more dust under the carpet as they maintain their wall of silence of some pretty disturbing information about medical devices let loose in Singapore.

e] Disbarred doctors who can practice in Singapore. The latest question mark that needs to be unmarked by the Singapore Medical Council. Don't hold your breath waiting for an ans They'll intubate you!

You ignore me, how, how, how?

The PSLE - Is it so difficult to see what the problem really is?

Gigamole is glad to see the discussions about childhood education shift towards the Primary School Leaving Examinations (PSLE). To scrap or not to scrap, seems to be the focus of the debate. To Gigamole, it seems they are missing the point. An exam is necessary at the end of Primary Six. There is no doubt about this. But people are (deliberately, perhaps) forgetting that Singapore has compulsory education up to Primary Six. The PSLE is appropriately named the Primary School Leaving Examinations. The PSLE should not be anything other than a competency exam. Somewhere along the way, the Ministry of Education allowed the PSLE to morph and mutate to become the grotesque thing it now is. Currently the PSLE is an uber-competitive exam to identify top students who can be streamed into elitist schools to fuel an even more uber-elitist agenda. The banding of schools serve no other function that to feed this elitist mindset. To disband the schools is however, only a symptomatic response to the real problem, which is that as long as the PSLE remains a competitive exam, parents will relentlessly drive their children into excelling so that they will have a chance to enter elitist secondary schools.

Gigamole says that if you really want our children to have a proper educational experience and a wholesome childhood you need to remake the PSLE into just a competency exam. That's really what is only required at Primary Six. Is this so difficult to see?

Has our traffic police fallen asleep at the wheel....again?

It seems like the illegal street racing problem highlighted elsewhere before has not been curbed at all. One wonders what the traffic police have been doing all this while. One of Gigamole's blog readers had pointed out that was this going on along Orchard Boulevard. Surely the Traffic Police cannot be aware? Surely it cannot be so difficult to clamp down on this? All it takes a a couple of discretely placed CCTV cameras, or speed cameras. Or even a strategically placed patrol car.

It really boils down to whether they want to act or not. All this talk about providing a racing track is pure hot air.  For once and for all, just go ahead and clamp down on it.

The jaw dropping revelation about NUH's Dr Jay Jiade Lu

Gigamole was not the only one taken aback by the revelations about Dr Jay Lu's past history of being stricken off from the medical register in Florida. The relative silence from the medical community cannot be taken as a general lack of concern. Rather it reflects the discomfort many doctors have about pointing fingers at one of their colleagues. At least publicly.

The issue however should not be lightly dismissed and swept under the carpet.

The Singapore Medical Council has made it very clear that all applicants for registration must have a certificate of good standing and must not be under complaints, pending investigations or any disciplinary actions. That Dr Lu was actually under investigation at the time he applied for registration seems evident. Furthermore, there is no doubt that he failed to 'fess up when he was struck off the register in Florida.  He had a free run for 11 years.

NUHS and NCISs' big heartedness in publicly forgiving Dr Lu is laudable but grossly misplaced. But this is not a Jean Valjean story. The Singapore Medical Council cannot prevaricate in this instance and must act decisively.The damage done institutionally and nationally cannot be easily undone.

How about a Lemon Law for medical devices?

Gigamole was delighted to read about the Lemon Law for Singapore. Kicks in today! Gigamole wonders why it had taken so long to want to protect consumers, but ne'er mind, better later than never.

Gigamole also wonders how the Lemon Law might protect the patient consumers from faulty medical devices such as heart stents, and other prostheses. It would seem that that the prostheses itself should be covered under the current Lemon Law, since the patient did "purchase" a device. The surgery to implant the device is not covered, as it would be a "service". On the other hand, the surgeon would actually be the retailer of the device, so should be responsible for the replacement of the device if it were faulty within 6 months.

The problem with medical devices is that defects often do not reveal themselves within 6 months. So the patient often has to shoulder the burden of proving that the defect did not live up to expectations of quality.

This raises a further question of who actually provides assurance of quality of the product and who protects the patient consumer from exploitation by manufacturers. One may expect that the HSA, as the government regulator to provide assurances that any device entering the market has an acceptable level of quality and safety. But this is not the case at the moment. The nascent attempts to regulate medical devices ran into bad publicity, and the HSA has since appeared to shrink from doing the right thing.

So now no one knows if the medical devices that are stuck into a patient's body is of acceptable quality and safety. No one knows who is actually protecting the patient consumer. Recently Gigamole has flagged up issues with metal on metal hip implants, transvaginal meshes, cardiac stimulators, heart valves, which have increasingly been cited in various regulatory withdrawals and law suits overseas. But locally, there has only been a deathly silence from the HSA. So no one apparently wants to inform the patient consumer the bad news. No one wants to point the finger at surgeons for retailing faulty devices. Seems to be that the patient's only recourse is through litigation. Even so,  there should be adequate awareness among patient-consumers that there is a problem. Sadly, there is so little local information available for the patient-consumer to use. HSA's silence is certainly not helpful.

Gigamole believes we need a Lemon Law for medical devices. But not just a law,  we need a healthy consumer protection movement for drugs and medical devices.

Returning Singapore to Singaporeans? Dare we wish?

It is hard to feel betrayed. Gigamole says 'feel' because that is what it is, only a feeling. Gigamole can understand the logic of our political leaders, and I don't think they had any real malice in the decisions they took. But Gigamole thinks they were misguided, and Gigamole, like many others, feel betrayed.

Mind you, Gigamole was one of those who stood in the rain for the first National Day parade. And Gigamole was one of those who dug into pocket money to give to the Singapore National Defence Fund.

Whether it is about birth rates, education or academic achievements, where we are now, and who we are is a result of policies in place during the early years of nationhood. Until the 1980s, the thinking about university education was that we were training too many graduates. University education was seen to be an 'evil' contributing to frustrations and social discontent. The university was deliberately kept small. We were producing too many doctors. Not good, because doctors were woolly headed and bleeding hearted.

Gigamole remembers that medical research was regarded as a 'luxury'. Research funding was only available to allow medical scientists to 'tickle' their minds and keep them interested in their science. Gigamole remembers how we all had to troop, hat in hand, to the Singapore Turf Club to ask for a small sum of money to do some research.

What a turn around in the 1980s when the university began to expand, and research became a much sought after activity. In the years that followed, Gigamole has seen hard working colleagues given the boot because they did not have the research track record that was comparable to academics from developed countries who had spent a lifetime doing research. Foreign talent they were called.

Since then or universities and research establishments have turned into wonderful performing whale-ariums populated by non- Singaporeans. Mind you, Gigamole is not against foreign talent. Just that it has become too easy a solution to rent (not buy, mind you) performing whales in order to vicariously capture research glory. It is really no different from buying Olympic gold medals on Ebay. Now almost every department in the Universities and Research Institutes are headed and staffed by non-Singaporeans. It looks fantastic on paper, but only on paper. The reality is that the local content has been severely hollowed out. To make matters worse, the current crop of 'foreign talent' mostly do not want to teach, and do not engage in any technology transfer. The Nanyang Technological University, for example, under their Swedish President, is fast becoming a totally foreign university, desperately trying to catch up with the NUS in glbal ranking. The Lee Kong Chian Medical School with their Deanery imported from Imperial College, London, seems engaged in political struggle with the more indigenous Tan Tock Seng Hospital for pre-eminence. No prizes for guessing who is backed by higher forces, and who will eventually win.

Even the student population appears to have been done in. Gigamole has often wondered about the logic of building so many elitist universities, that our own Singaporean children have no choice but to venture overseas if they want a university education.

So Gigamole is not happy. Gigamole can't help feeling betrayed.

Sussing out the Susan Lim saga...

Gigamole is deadset against Dr Susan Lim's grotesque charges for her services... especially as Gigamole has to seriously contemplate a car-less future, in view of the even more grotesque COE values.

Even so, Gigamole has to confess to not even coming close to understanding the charges brought against her.

Singapore has no accepted fee structure for medical consultations. A previous non-binding guidelines published by the Singapore Medical Association was unilaterally and mysteriously scrapped in 2007. Apparently this was to make SMA compliant with the Singapore Competition Act of 2004.  Methinks however, it was in response to pressure to free up the fee structure to market forces so that the competition will drive down health care costs. What the policy makers didn't reckon with however, was that this would work only if it is a perfectly free market. But it never was a buyer's market, and fees were not significantly driven down. Instead, the deregulation allowed the high flyers such as Dr Susan Lim to escalate their costs. She is not the only medical consultant in private practice to exploit the deregulation, just the most obvious and noteworthy one. It might never have surfaced if not for the fact that some rich royalty called the Ministry of Health.

One might argue that the 'over-charging' occurred prior to the deregulation in 2007. But for the 20 years before 2007, even with the guidelines in place, there was never anything binding to the extent that anyone could be penalized for over-charging. Therefore, Gigamole is totally mystified as to how the Singapore Medical Council can determine that Dr Susan Lim over-charged anyone.

The Singapore Medical Council owes us an explanation here.

The cyclist-motorist conflict - It's time the LTA did something

A paralysis of indecision happens when someone cannot decide between two or more courses of action that will independently lead to conflicting outcomes. We have seen how this can affect regulatory agencies such as the HSA, when trying to decide between pleasing the biomedical industry and protecting public interests A proper balance between conflicting outcomes may be difficult to strike. The indecisive will often just sit on their hands, and hope the problem will blow away, or at the very least stay away until the decision maker can escape to another, usually higher appointment.

The problems between cyclists and motorists have been brewing for a very long time. It's not as if the LTA has not been aware of it. Gigamole had posted before on this conflict almost exactly 2 years ago. Yet no action had been taken since then. Recently, this has blown up again because of some tragic and unnecessary accidents between cyclists and motorists. 

An increasing cyclist lobby are rightfully clamouring for more space, more consideration and more safety. On the other hand motorists say cyclists are often irresponsible on the roads, that motorists feel they have more rights to, as they pay road taxes while cyclists do not. Truth be told, both parties do engage in risky, irresponsible behaviour. Who is right?

It is during times like this that the LTA need to step in and openly declare the appropriate boundaries, physical as well as behavioural. It is in this situation that the LTA has been neglectful, and in my mind irresponsibly indecisive. I can appreciate their dilemma. On one hand they do not want to restrict the behaviour and recreational choices of the growing cycling population. Yet the road system is far from adequate to accommodate both cyclist and motorist needs. Motoring traffic is congested enough as it is already. S what does LTA do....? It appears they just want to sit on their hands and hope the problem will be delayed to the next cohort of managers.

So here is Gigamole pleading again with the LTA.... please do something about this. Before more unnecessary deaths occur. Make the rules clear to both the cycling and motoring populations, and be committed to enforce them until such time as behavioural norms can be established.

Selamat Hari Raya Aidilfitri!

I love the Malay greeting for Hari Raya. Asking for forgiveness is just so much more meaningful then wishing for prosperity and wealth.
Maybe we should all go round first thing in the morning and wish everyone, particularly our muslim friends, "Maaf zahir & batin".

Selamat Hari Raya Aidilfitri all!

Workplace Safety and Health Act - a case of "I see nutting,I know nutting"?

Gigamole remembers somewhat fondly, an old TV comedy series called Hogan's Heroes, where one of the most colourful characters was a German POW prison seargent, Sgt Schultz, who regularly articulates his famous line, "I see nutting, I know nutting...". Sometimes, I get the feeling that our Ministry of Manpower indulges a bit in this.

The Ministry of Manpower had taken a fresh and refreshing new position with respect to workplace safety in 2005. This was followed up by the enactment of the Workplace Safety and Health Act in 2006. Many of us involved in research labs, were encouraged by this new commitment to workplace safety, and despite the increased administrative, operational and logistic demands, faced up seriously to the challenges. Indeed, there was a flurry of activity on the ground to get procedures and guidelines up and going. Of all the research labs I know of, the National University of Singapore, I think, has been the most systematic and fervently active in pursuing this mission. That's why it's somewhat ironic that they have been the facility in Singapore whose labs have been most frequently blowing themselves up. (see 1, 2, 3, 4)

But despite all these incidents, there is no evidence that the Ministry of Manpower is noticing or doing anything about it. They seem to be content merely in inspecting construction sites. If there had been any action taken about the lab accidents cited above, it's all shrouded in secrecy. Gigamole maintains this is counterproductive. All accidents are learning opportunities. It is only through the systematic revelations of mistakes made at all levels that the infrastructure, management and operators can improve. This is the best way forward to better workplace safety.

Gigamole is really puzzled by the MOM's reluctance to discuss lab accident investigations publicly. Gigamole is reluctant to believe that this is because, unlike construction sites where the subcontractors are relatively lowly placed on the foodchain, the most liable person in the research lab is usually a high value researcher, or a high value institutional leader.

The amazing exploding NUS solar cell laboratory

from Channel NewsAsia

Barely a day after the National Day parade fireworks, the NUS put up its own pyrotechnics display when a laboratory in Engineering Block E3A blew up. The lab was apparently involved in the production of solar cells. Will we ever know the reason for this massive explosion which thankfully did not result in any serious injury or death? I don't think so, given our local tendency to hide everything. Pity, because there are lessons in it for all.

The link between the manufacture of solar cells and the explosion may not be readily apparent to the uninitiated, but actually solar cell manufacturing is extremely dangerous because it deals with highly explosive materials. Those within the industry will know that the easiest and cheapest way of bonding layers of silica to make the solar cells is through the use of a gas called silane. Silane is actually a combination of silica and hydrogen, and is a very capriciously flammable gas. In chemical terms, the gas is termed pyrophoric, which means it can readily burst into flames even without any sparks to trigger it off. This explosiveness is quite unpredictable and can occur after a delay in exposure.

Over the last few decades, many spectacular silane related explosions  (Bangalore, Taiwan, Osaka to mention a few)  have been reported which have killed a total of at least 20 people. That there was no loss of life at the NUS explosion was more a result of good fortune than good lab practice.

Truth is, silane is a very dangerous gas, whose capriciousness needs to be managed extremely carefully. One of the most dangerous places to use silane, in fact, is in small enclosed spaces - like university labs, or fume cupboards. I need to point out that I have no inside info about whether silane was involved in the NUS accident, but everything I have read points to it being the reason behind the explosion. If so, one wonders how approval was obtained to store and use silane in a relatively common area university laboratory where students come and go.

I really hope the results of lab accident investigations can be made public, the way flight accidents are, so that we all can learn from any mistakes made. But in Singapore, that may be too much to ask.

Recommended reading:
ANSI standards on how to store and handle silane - CGA G-13

Procurement issues - a problem with competence? Surely not.

DPM Tharman Shanmugaratnam's announcement that the government will look into widely criticized e-procurement issues is timely and very much appreciated. But his comment that this was all to do with incompetence and compliance shows that perhaps he hasn't quite appreciated what the real problem is.

If indeed compliance was the problem, surely this would have been detected easily through the regular audits, and the necessary corrective action taken. If corrective action had not been taken despite non-compliance having been diagnosed, something is seriously wrong with management. To lay the blame at the level of the procurement officer is misguided to say the least.

If anything, the procurement officer is only all too careful to follow all procedures. He knows he will be caught out by the audit if he is non-compliant. I am not talking here about any intention to cheat. This can happen even if procedures are followed. That is why Minister Khaw can confidently attest in the NParks wayang that "procurement formally observed and complied with the existing rules".

The real problem is not one of incompetence and lack of compliance at the level of the procurement office. Rather it is the lack of understanding at the level of the approving officers and senior management about why the procedures are in place. It is the fallacy that being right is only about procedural correctness.

Dr Yahaya Sanusi's Mango Tree - a poem for our times

I reproduce an excerpt of Dr Yahaya Sanusi's "Mango Tree" here. It's a wonderful poem that spoke so much to me about the travails of our time - the passing of the old, the abandonment of the weak, voiceless and powerless for new commercializations, the loss of our soul.

tapi apa kan daya 
waktu telah tiba 
mereka membunuh aku bila aku tak terdaya 
mereka pengecut, penipu 

aku mati untuk kau hidup 
kau adalah warisanku 
jagalah martabatmu 
selamat tinggal 
sayangku 

(the time has come 
and now it's done 
they take me down, I cannot fend 
cowards and liars, they still pretend 

I die, so that you live 
my legacy, you shall receive 
hold your head high with dignity 
fare thee well till eternity 
my dear)

The full poem and the story of Hidayah Amin's mango tree can be found at Ms Amin's Gedung Kuning blogsite.

Majulah Singapura

Indeed, we do love Singapore, our home. Here's my wish list for this year's birthday celebrations:

a] that while we react very publicly against some government policies and misdeeds, we do not run down our beloved homeland;

b] that we learn to distinguish between ruling party, government and country;

c] that the government will re-commit to focusing on the poor, unable or incapable - and generally those among us who need a hand in this difficult world. The current balance is not right. Too much of our resources has been devoted to building up those who are already successful. The government has to date been too miserly in its dealings with the other end of the spectrum in our society;

d] that the government will stop this idiocy in buying cheap glory through the wholesale import of "foreign talent". What pride is there in this vicarious pursuit? While I was cheering on Ms Feng Tian Wei during her table tennis matches, I found myself strangely more drawn to support Malaysian badminton champ Lee Chong Wei when he was playing Lin Dan. I have to confess to some envy of the Malaysians among us, that they should have someone so homegrown and local as their champion. Though Malaysian, Dato Lee could easily pass off for the boy down the road here in Singapore. A real ka kee nang. It didn't matter that he lost. He was the object of much love and adulation even in defeat. And whatever problems the Malaysians may be struggling through in the lead up to their national elections, Dato Lee's defeat brought the people together. A lesson for the government here. It really isn't about winning or losing, but what participation truly means to the people. Solidarity doesn't come from buying cheap (not so cheap considering the $$$ spent) cosmetic simulates of glory. This only serves the interests of the 'elite' who want to posture on the world stage.

So thank you Minister Chan Chun Sing for acknowledging this problem. It's time to put a stop this lunacy.

e] that we all learn to be more gracious and welcoming to the new immigrants among us. It doesn't matter what their reasons are for taking up citizenship here. Our forefathers all came here to make money and to find a better life for themselves and their families. Our new comrades deserve an equal chance at this. Let us welcome them and make them feel at home. Singaporeans are much more caring and gracious then what has been portrayed in the more xenophobic blogs. Let's not forget what being Singaporean means.

So we turn 47 today. Cheer up, we'll survive this mid-life crisis if we but pull together, and remember our love for Singapore.

Majulah Singapura!

The exploding laboratory....who is responsible?

In 2008, an accident in a University of California, Los Angeles (UCLA) chemistry lab claimed the life of a young research assistant Sheri Sangji. An inflammable chemical she was working with had burst into flames. Not even wearing a protective lab coat, her sweater caught fire. Her lab colleagues didn't even know how to put out the flames, and she didn't even know well enough to get under the safety shower in the lab.

In the aftermath, UCLA and the Principle Investigator of the lab were charged as there was evidence of negligence with respect to lab safety procedures and training. Just a week ago, the university reached a settlement and had charges dropped after agreeing to put in place extensive corrective measures for lab safety, and also setting up a half a million US$ scholarship in Ms Sangji's name. Charges against the investigator Prof Patrick Harran, however, remain. At least for the moment.

Meanwhile, the outcome of the investigations into the NUS lab accident last year remains unclear. I hope there is no intent to sweep the proceeding under the carpet, because there is so much for us to learn from the accident. The WSH Act has yet to be clearly applied to lab safety in Singapore, and it is instructive for all involved in the labs to see how lines of responsibility are drawn should accidents occur. This is not a matter to be played out behind the scenes but a lesson to be placed in the public domain. Safety in our research labs is an important message to drive home.

So how often do Professors have romantic relationships with their students? More common than we want to admit.

The university campus experience is a very exciting one, for a variety of reasons. For many a young adult, it is an escape from parental/family control and the first tastes of being an independent individual. For many it is their first experience of being free to think, as well as to make independent lifestyle choices. The interactions with charismatic professors who seem to know everything can also be quite intoxicating and .... seductive. Especially when hormones are raging.

On the other side of the corridor are the professors who, being married to their science, often live lonely dysfunctional lives .... and by the time they achieve some seniority invariably suffer from some undiagnosed mid-life crises.

Under these circumstances, it is not difficult to understand why a professor may fall for the charms of a young nubile female student. Or why a young female student may develop an infatuation with the middle aged academic demi-god / authority figure. This relationship is obviously inappropriate. But it takes a clear head and strong principles to be able to step away, and do the right thing. Unfortunately, university eggheads are not necessarily clear headed people.

Of course, there are also those with more sociopathic inclinations who will exploit the situation. Female students who try to sleep their way to better grades, for example. Or predatorial professors who take advantage of susceptible young female students. Worst, the senior academic who engages in habitual sexual harassment for cheap gratification.

How often does this occur in our campuses? No one has done a survey to find out. I don't think the universities really want to find out, so don't hold your breath in expectation of some expose to be published. The only survey I have come across was one conducted in a major US university campus. There, from 235 male faculty respondents, 26% reported sexual involvement with female students. This was a survey done in 1988 in a major US campus (Fitzgerald et al, 1988). I leave it to you to figure if the situation in a Singaporean campus, in 2012, is likely to be better .... or worse.

I personally think the situation is more prevalent than we care to admit. There is a tendency on campuses to look the other way unless there is frank criminal intent. Honest though inappropriate relationships just make for interesting gossip. Just think of how many senior 'respected' academics marry their graduate students. In these situations don't imagine that their relationships began after graduation.

The NParks wayang - Problems with GeBIZ that everyone knows about but the auditors turn a blind eye to.

When the NParks Brompton bicycle story first broke, I daresay many had already guessed at what lay behind the procurement/tender fiasco. I am not referring here to the allegations of corruption, or the buddy-buddy relationships between procurer-approver-supplier. Simply, the GeBIZ system is kinda screwed up and pretty much every procurement officer is well aware of these problems and knows exactly how to navigate (read 'cheat') the system to get what they want. It is not as if the auditors don't know. They generally pretend not to know and are pretty 'satisfied' so long as the documentations are in order. Minister Khaw's mistake was his over-eager endorsement of the purchase of the bikes on the assurance of procedural and documentary 'correctness'.

All tenders need to go through the GeBIZ system, yet many of the small suppliers are not registered on GeBIZ. Therefore if the product depends on small suppliers, how do you open a tender on GeBIZ, and expect a reasonable response from suppliers? In the NParks case, what is the likelihood that bicycle shops will be registered on GeBIZ, and will be aware of the tender? Ultimately this will depend on some non-GeBIZ way of disseminating the tender information and hoping the suppliers will go into GeBIZ and tender. This non-GeBIZ way of information dissemination is already subjective and selective to only a limited number of suppliers. And therefore open to abuse.

Secondly, very often procurement offices already have a specific product in mind. This is not necessarily dishonest, but operational centres often have a preference for a specific product. Sometimes this is logical, but often they are not.This is not necessarily the cheapest, but is often perceived to be the most 'desired' product. What makes this product most desirable depends on many factors, most of which are not codifiable. In the laboratory for example, many researchers have preferences for certain branded products, names which they associate with reproducibility or reliability. If they open the tender for the equipment, they run the likelihood of being swamped with cheaper but less desirable products. And endless needs to justify awarding the tender to the non-cheapest tenderer. So what do they do? They word the tender in such a specific way that only one brand name matches the tender specifications. In the NParks case, the wording of the tender was so obviously directed towards a very specific product.

The above are without doubt 'bad practices' but superficially may be viewed as being procedurally 'correct'. I challenge any auditor to say that he/she is unaware of these practices but has not looked the other way in performing the audits.

Another problem contributing to this fiasco is the familiar end-of-financial year monkeying with the accounts. How many of us are unfamiliar with the regular message that comes down from senior management that there is left over money that needs to be spent? Rather than to return the money and risking a reduction of next year's budget, the instruction that comes down from senior (or very senior) management is to spend the money. It is under these circumstances that the most wasteful expenditure of public funds occur. It is under these circumstances that you see the sudden purchase of weird, expensive and poorly justifiable items. Perhaps 26 expensive Brompton foldable bikes?

Regulatory conflicts of interest - lessons for the HSA from SMRT/LTA COI

The recently released findings of the Committee of Inquiry for the SMRT breakdowns has some important lessons for the HSA. Apart from pointing out the lapses in SMRT, it also fingered the failure of the regulator, LTA, in managing the intrinsic conflicts of interest inherent within the workings of the regulator. But the LTA is not alone is this regard. Many, if not all of Singapore's regulatory agencies are stacked full of these conflicts.

The HSA is similarly affected. Gigamole has pointed out these conflicts of interests before. How can a regulator do its job when it has also been tasked with befriending and facilitating growth of the very industry it is supposed to regulate? In some cases, the HSA is itself, also the service provider in the areas where it is supposed to regulate.

 In the recent brouhaha about medical device regulation, the HSA came across looking almost afraid of the industry it is supposed to regulate. Note how very quickly it capitulated to the demands of industrial players. To Gigamole, "regulate with a light touch" really means "I will look the other way while you do your thing. Just don't get into trouble".

In the hurriedly convened "closed" town hall meeting, HSA met up with 370 of the industry players to anxiously reassure them of this "light touch". Conspicuously absent was any representation from any consumer groups. Do patient-consumers not have a voice, and do they not need to be protected? It used to be that we can depend of the Ministry of Health, or its proxy, in the form of a governmental regulatory agency, to have the interests of the public first. But nowadays, this cannot be assumed, because regulators have to be industry friendly, and promote the development of these very industries. And the biomedical industry has become significantly more powerful and insistent of late. The need to "perform" with respect to the Pro-Enterprise Index, speaks volumes.

The LTA had been found wonting because it did not adequately firewall its regulatory functions from the need to also promote. Likewise, Gigamole predicts that it is only a matter of time before the HSA runs into serious problems with major consequences for the patient-consumer if it doesn't make a serious attempt to deconflict these functions.

Selling off our heritage: How our medical school disappeared. Happy birthday, our grand old Alma Mater!

Few will, or will care to remember that our present Medical School and indeed, the National University of Singapore was born July 3rd, 1905. So sad.

Towards the end of the 19th Century, Singapore was still training "doctors" by sending qualified students off to Madras. In 1904 a tin trader, Tan Jiak Kim collected the necessary funds and spearheaded a move that would eventually lead to the establishment of our own true-blue Singaporean medical school. This was initially called the Straits Settlements and Federated Malay States Government Medical School.

The building it operated in was actually an old women's asylum, located somewhere behind the current grand looking College of Medicine Building at Sepoy Lines (Ministry of Health). The precious heritage building is no more there because in the early 80s, after the medical school relocated from her birthplace to Kent Ridge, the huffy Ministry of Health decided that such useless heritage was not worth preserving and promptly flattened the historical building - replacing it with of all things, a car park!

Ever forward looking, the National University of Singapore seemed also little interested in heritage issues. When in 2005, the Yong Loo Lin Trust donated a "transformational gift" of $100 million to the medical school, the school threw heritage out the window and gratefully renamed itself the Yong Loo Lin Scool of Medicine. It simply didn't matter that no one actually knew who Yong Loo Lin was.

A hundred million dollars was apparently the biggest gift the University had ever received. But it was in truth, a relatively small sum compared to the operating budget of the university. One wonders what would happen now if Gigamole donates $105 million to the University. Can I get the medical school named after me?

It is so easy to sell off our heritage. Sad, and tragic, because it is our heritage that ties us together, and makes us who we are.

But Gigamole remembers. So here's wishing you a happy happy birthday, our dear Alma Mater. Though I am not sure where you are now. Sadly, I don't think the NUS or YLLSOM will remember your birthday today. Last I checked, nothing on their websites.

Smith & Nephew R3 recall - MHRA advisory

Here's a follow up of the Smith & Nephew R3 acetabular system that Gigamole had highlighted a while back. The UK regulators, MHRA (Medicines and Healthcare products Regulatory Agency) has now issued an advisory about the recall. Their advice is pretty similar to the FDA advisory for the DePuy ASR implant recall.

All patients, symptomatic or not, should undergo MRI or ultrasound scanning. They should be followed for the lifetime of the implant in the body. Blood levels should be checked for cobalt and chromium levels. If either scans are abnormal, or metal levels are rising, surgical revision should be considered.

HSA meanwhile is maintaining their wall of silence.

The Sunday Times greatest mess up of all time - ROTFL!!!

I was literally ROTFL as I read this morning's Sunday Times report on Euro 2012. Even as a non soccer fan, I was able to pick up a gazillion hilarious typos. Someone had a bit much ethanol last night and didn't do the proof before print! To be fair, the article was attributed to the Times, London. But still.....  :)

See if you can pick out more errors than me...

Hero 2012
Carotid
Coats
Andrews Anisette
Zealander Del Pierre
Diego Marauding
Lineal Mess
ghostly pale modified player
Serge Roams
Cyst Fibreglass, Spain attacking modified

I didn't even try to decipher the nicknames - Little Ghost, Pale knight and Liver Atom.

Latest medical device alert about the DePuy ASR hip replacement recall! Please tell your friends and relatives who have had any hip replacements done.

Gigamole had posted on the DePuy ASR hip implant before. Here is an alert issued from the UK Regulators (MHRA - Medicines and Healthcare products Regulatory Agency) just yesterday.

The United Kingdom with Australia are the two regulatory agencies who have tracked this problem, and had been responsible for flagging up the very high rates of surgical revisions for patients who have been implanted  with these prostheses. In 2010, the UK reported revision rates of about 12-13%, compared to usual revision rates of about 1-3%. This prompted DePuy to implement a global recall of the implants. In Singapore, the HSA reported that there were only 319 implants done, with only 1 revision. One must seriously doubt this figure because HSA does not regulate such medical devices and do not have any kind of tracking process in place, so the revision rates they report are only what surgeons and DePuy want to tell them about. One revision in 319 is an amazingly unbelievable success rate by any standards, so clearly the surgeons are not telling anyone about their surgical failures and the need for surgical revisions.

The HSA has generally left it to the company DePuy and the surgeons to muddle through by themselves, thereby leaving the patients entirely at the mercy of those responsible for this mess.

In any case, the MHRA has deemed it important enough to issue another alert, this one just coming off the press yesterday. You can look through the alert yourself, and if you don't understand the technical aspects, you can just email me and I will try and explain to you.

All patients who have had hip replacements done should get their surgeons to give them the details of surgery and the type of implant that was used.

To summarize, the MHRA recommends that all patients having these Depuy ASR implants, whether symptomatic or not, to undergo an MRI or ultrasound scan. If the images are abnormal, surgical revision should be considered.

All patients should have their blood analysed for chromium and cobalt levels. If the levels are high and rising, surgical revision should be considered. Patient follow-up should be for as long as the implant is in the body.

Obviously these costs should not be borne by the patient.

It is very unlikely that surgeons are either able or willing to recall all their patients who have had such implants done, so many patients will not be aware of the need for follow up or for implants to be removed.  And HSA isn't really doing very much about this. So please feel free to circulate this information to friends or family members who have had hip replacements done. At the very least, they should get the relevant details from their orthopaedic surgeons.

More tales from the crypt - Don't mess with the mesh!

Lest people think I am somehow targeting my orthopod colleagues in sharing about failed and faulty hips, here is a story from a different part of the body.

Johnson & Johnson's Ethicon subsidiary has very recently been involved in a voluntary recall (called by the company, a "discontinuation") of a series of their products -the Gynecare vaginal meshes. These include -the GYNECARE TVT SECUR™ system, GYNECARE PROSIMA™Pelvic Floor Repair System, GYNECARE PROLIFT™ Pelvic Floor Repair System, and GYNECARE PROLIFT+M™ Pelvic Floor Repair System. These are meshes which are being used in women for the repair of urinary incontinence and droopy pelvic floors. The problem was that these meshes were associated with frequent and severe problems such as - pain, infection, bleeding and painful intercourse.

The story leading up to these recalls is a fascinating study of why medical devices should be better regulated.

• Boston Scientific was the first to introduce the vaginal mesh (essentially a modification of a mesh used for repair of hernias) in 1996. 
• Two years later a few companies, including J&J, got approval under the "similarity" regulatory loophole to market similar meshes. 
• The very next year, Boston Scientific recalled their mesh due to safety reasons. Despite this, the other meshes continued selling into the market. 
• In 2005, J&J sneaked through a number of other meshes without even telling the FDA. The FDA only found out about this in 2007, when J&J tried to get approval for another mesh through the 510(k) loophole. 
• This was regularized in 2008 when the FDA approved all the meshes, but without any clinical data being provided.

Very soon after that, problems began to surface, and the FDA in 2008 issued a warning that adverse events were serious but rare. By 2011, a lot of stuff had already accumulated on the fan. The FDA upgraded meshes to high risk devices, and issued a warning that adverse events were not only serious, they were not rare! In addition they wanted more clinical studies if the meshes were intended to remain in the market.

Two weeks ago, J&J informed that instead of doing more clinical studies, they were 'discontinuing' the meshes from the market. The earlier mesh would remain in the market but with modified warning labels.

In the midst of all this, the situation in Singapore, is as usual, business as usual. These meshes, despite the warnings by FDA have continued to be offered as primary solutions in all our major hospitals - KKH, SGH, NUH. There is no evidence that the 'discontinuation' of the meshes by J&J/Ethicon have been implemented here. HSA has been deathly silent. I am not even sure they have been tracking the problem. A search on their website reveals nothing.

The FDA had made a number of recommendations about the use of these meshes (not just the J&J/Ethicon ones):

For health care providers:
• Recognize that in most cases, Pelvic Organ Prolapse (POP) can be treated successfully without mesh;
• Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
• Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and
• Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.

For patients:
• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

So, some more questions for our HSA, :
Why haven't we done anything about these meshes, since the earliest problems with respect to the Boston Scientific product got recalled; since the first FDA warning in 2008; and the second warning in 2011?

Are these meshes regulated in any way in Singapore?

Is our practice with respect to the use of these meshes consistent with the FDA recommendations above? How do we know?

What is the legal recourse for patients who have been 'misguided' by J&J/Ethicon?

Selling off our heritage - the plight of Kampong Glam

Most would have missed the plaintive appeal (tucked way down on Page 42, Sunday Times 17 June), of Ms Hidayah Amin about how Kampong Glam may be losing  its story to the glitz of Omani wealth. Kampong Glam was a Malay enclave, originally designated for the occupation of Sultan Hussein Shah (himself of Bugis heritage) and his family. The area was primarily populated by immigrants from Java, Sulawesi and Bawean. There were Indian and Middle Easterners as well, but they mostly assimilated into the Malay culture. Ms Amin would know as, being the great grand-daughter of Haji Yusoff the belt merchant, she lived in the big yellow house, smack in the middle of Kampong Glam. At least until the government forcibly acquired the property.

She is so right, and her appeals should not go unheeded. The Malay culture needs to be protected, and it is fundamentally wrong to continue to assume that propagating a pseudo Middle Eastern Islamic facade is  equivalent to preserving the Malay heritage. The richness of Malay, Javanese, Sulawesian and Boyanese cultures need to be specifically protected as well. Unfortunately though, there are few who are wealthy and powerful enough on their side to fight for them.

Their voice desperately needs to be heard. We have lost too much of our true Singaporean heritage already.

Another medical device bites the dust - the Smith & Nephew R3 acetabular system

Here we go again. Now it's the Smith & Nephew Acetabular System, being voluntarily recalled by the manufacturer, Smith & Nephew Surgical Pty Ltd. Here is an announcement carried through the Australian Therapeutic Goods Administration (TGA). In 2010, the company had actually been issued a warning letter by the FDA about non-compliance with Good Manufacturing Practice. Doesn't this sound similar to the recent mess about the DePuy hip implant recall?

Well, now they finally have to issue a voluntary recall of the hip implant prosthesis, after unusually high failures recorded in Australia and UK. Launched in 2007, apparently about 7700 of these metal liners have been used globally. There is no record of how many of these metal upon metal implants have been used in Singapore itself. To date, it is uncertain how this recall is being implemented in Singapore. One of the recognized problems with metal on metal implants is the potential for erosion and resultant cobalt and chromium poisoning. The recommendation now is for patients who have had such implants to be subjected to life-long screening for toxicity.

So more questions for the HSA:

a] Do we know how many of these implants have been used in Singapore?
b] Do we have a record of patients who have received these implants, and are there processes in place to recall these patients for observation and toxicological screening?
c] How is this being tracked? How are patients expected to know?
d] Why is there no public dissemination of this information? Is this recall being implemented at all in Singapore?

What sort of role model do we want our kids to have? Woffles or Vincent?

Over the last week 2 characters have emerged from mundane Singapore life that exemplify very contrasting personal values and characters. To me, they are lessons for us as to what our noble values should be. In today's world our kids are in great danger of being lured into the fast road to wealth, fame and self-centredness.... at all costs. We need to take a pause in our mad rush to wealth to think about what values we should want our kids to have.

On one hand we have a uber-wealthy and influential cosmetic surgeon and socialite, Woffles Wu, hiding behind an old employee just to get out of 2 speeding summons. Whether he pulled strings to get off with a mere slap on the wrist is not the issue here.


On the other side of the coin, we have a working class tour guide, Vincent Toh, leading a group through the deserts of Sinai. When the tour group was unexpectedly attacked by Bedouins, Vincent selflessly offered to be the hostage so that his tour charges could go free. To everyone's relief, Vincent was released after 8 hours of captivity. Two contrasting characters with very different personal value systems. Who do we want our kids to emulate?

Is Justice blind in Singapore?

Recent happenings have prompted many to ask if justice is indeed blind in Singapore. Intriguing question, since I wasn't at all sure how the idea that justice should be blind actually came about.

The only Greek goddess that regularly had a blindfold was actually the goddess of fortune/fate (Fortuna, Tyche/Dike). It really wasn't until about the 15th century that a number of goddess imageries were conflated to give the idea that justice is scaled, sworded and also blind. Even so, the goddess of justice (Justitia) is not always portrayed outside our courthouses as being blind. For example, outside the Old Bailey in London, Justitia is clearly sighted. Outside the Legislative Council Building in Hong Kong, on the other hand, Justitia is presented as wearing a blindfold.

Interestingly, On top of our old Supreme Court Building, the tympanum carries a scene conceptualized by artist Rodolfo Nolli, where Justitia is represented. The scene apparently depicts: "......the central figure represents Justice; to the left is a person begging for mercy (or protection), and next to him are the legislators with books in hand, representing the Law. On the other side of Justice is a figure showing gratitude, then a man and a bull, and two children holding a sheaf of wheat, all representing Wealth, Prosperity and Abundance where Law and Justice prevails."

But the scene looks too intriguing to just refer to official interpretations. In the spirit of the book Da Vinci's Code, I tried my hand at explaining the scene as I saw it. Firstly it should be noted that the Singapore version of Justitia is similarly scaled, sworded but fully sighted. On the right of Justitia are two very sorry looking figures. At the extreme end, the one with the snake is probably Adam wallowing in his sin, unforgiven. Just next to Justitia is another unforgiven figure begging for mercy. Between them, a pair of very conspiratorial looking figures, plotting to throw the book at the guilty ones. On Justitia's left however, by the hand that holds the sword, is a very grateful forgiven woman. One can only guess at why she has been forgiven. Following her however, is an entourage bearing icons of power and prosperity - cattle and grain.

Was the artist trying to make a statement about how justice operates? Here clearly justice is not blind. Does wealth and prosperity feature in the dispensing of justice? I leave it to your interpretation of this very interesting and oft overlooked piece of public art. After all art, like beauty, lies in the eye of the beholder.

Oscar Wilde did write that "Life imitates Art far more than Art imitates Life".

More loopy unregulated medical devices horror stories - the Myxo annuloplasty ring

Gigamole had posted previously on the Edwards SAPIEN heart valve operation recently carried out at the National Heart Centre. It seems that the Edwards Lifesciences company has been getting into all kinds of problems recently also with respect to their Myxo annuloplasty ring. (Online references at the end of this post)

Essentially, the problem was triggered by the complaints from one patient at the Northwestern University research hospital, who claimed that the valve that was inserted into her heart in 2006 was not a FDA approved device, and she was not made aware that it was an experimental option. Furthermore, the surgeon who operated on her was an inventor of the valve and also received royalties from the marketing of the device. The fallout from her complaints have been significant and protracted. Although the university has denied any wrong doing, the patient's position has been supported by another of her doctors at Northwestern.

The background information, very simply outlined here, about this saga, are as follows:
a] In 2001, the FDA apparently rubber-stamped the industry's petition to reclassify heart valve annuloplasty rings to a lower risk category so that it can qualify for the 510(k) regulatory loophole. This meant that the industry can avoid doing clinical trials of an innovation if it can be shown to be insignificantly different from an earlier invention. Edwards Lifesciences used this loophole to launch their Myxo annuloplasty rings, even though they had filed for patents documenting significant differences from older versions.
b] Consequently, at the time the patient received the implant, the FDA did not even know of its existence. The FDA says it therefore never gave any approval. If it is an unapproved device, it should be regarded as an experimental device. The company and the university says it is not experimental, and that it did not require FDA approval under the 510(k) loophole. Meanwhile the surgeon has published the data as part of a clinical study.

The controversy continues to brew and has provoked cries for the FDA to review its approval procedures for medical devices.

Further readings here:
http://www.theheart.org/article/1230079.dohttp://www.theheart.org/article/960385.do http://articles.chicagotribune.com/2011-05-22/health/ct-met-medical-devices-20110521_1_annuloplasty-rings-faulty-heart-valve-diana-zuckerman
http://online.wsj.com/article/SB126151643854401921.html http://www.medicaldevicestoday.com/2009/07/medical-device-fda-510k-policy-modifications-faces-mounting-scrutiny-.html

What have all these got to do with us here in small, faraway Singapore?

For starters, we should not be too over-reliant on decisions made by FDA, and should develop our own opinions on the matter. This is not to say we have to duplicate all the evaluations, but merely we need to scrutinize all innovative medical devices to form our own opinion as to how much pre-marketing data is required. The FDA is wrong to say "... companies, not the agency, are best qualified to determine whether modifications affect a device's safety or effectiveness." Companies are motivated by self interest. Mostly of the commercial sort. Interestingly the HSA has a pdf file on this Myxo ring, but the file is mysteriously not accessible.

Secondly, doctors do not have the inalienable right to stick all kinds of experimental devices into patients with firstly getting ethics approval, and regulatory approval. It is unclear how many similar annuloplasty rings have been used on our patients without notification and approval of the HSA, or even ethics committees. It remains unclear whether the previously blogged about SAPIENS tricuspid valve prosthesis was approved by the ethics committee as an experimental procedure, since it was not an approved medical device.

Thirdly, proper informed consent by the patient is required. Gigamole notes the favorable developments recently to develop better informed consent procedures. This has been long overdue. Gigamole hopes that the consent process will make the distinction between routine accepted practice and experimental procedures using methods that have not been approved by the HSA. Patients are not all willing to be guinea pigs.

Just a parting trivia...... The company Edwards Lifesciences makes exciting new valves here in small faraway Singapore. Their factory in Changi North Crescent, opened in 2008.

Get tough on speeding? Why the kid gloves in the first place?

DPM Teo Chee Hean posted on Facebook that he wanted the Traffic Police to get tough with reckless drives and speedsters.  Better late than never.

The question is why did the Traffic Police have kid gloves on in the first place? Why the reluctance to prosecute these illegal street racers? Why did they have to wait till the DPM chides them for being soft, and tell them to get tough?

Still, it was good that DPM Teo took it up. As I said, better late than never. Unfortunately it was 2 lives too late.

The Ferrari accident and illegal street racing in Singapore

Gigamole is not the only one in Singapore horrified by the fatal Ferrari accident 4 days ago. Mr Gerard Ee, Chairman of the Public Transport Council seems to have missed the point totally in rejecting what he felt were unfair and harsher calls to restrict high-performance cars in Singapore. But he may be right in that it is not the ownership of the cars that is the problem. It is the irresponsible and reckless behaviour of the car drivers that needs to be reigned in.

It doesn't take a rocket scientist to figure that the Ferrari was involved in some sort of street race. Perhaps not in a group, but almost certainly the driver was using the streets of Singapore as his own F1 race circuit. The comment from his wife is quite telling. The deceased Mr Ma was fond of driving his car in the middle of the night because there were few cars on the road.

Illegal street car racing is not unknown in Singapore. Several years ago people and the media were already reporting about it. There are videos on You Tube about it. It is not as if the Traffic Police does not know about it. They were supposed to have cracked down on this.

But no.... illegal street racing has gone on unabated. Read these posts about illegal street racing in the Trip Advisor site for Marina Mandarin Hotel. These posts are as recent as April 2012. So it is public knowledge that this is happening. Can it be that the Traffic Police is unaware of this? Read the post by Frequent Traveller. He called the Police at 3am, and the racing was still going on at 5pm.

So my question is, what the hell has the Traffic Police been doing? Are they really unaware that illegal street racing is going on? That these high-performance cars are tearing up our roads in the wee hours of the morning? Mr Gerard Ee, are you unaware of these illegal street races?

Can it be that the Traffic Police is really aware of these races, but have deliberately turned a blind eye to these races? Why they have done so can only be guessed at. Perhaps it is to allow the rich and irresponsible a place to play their fancy cars? To make Singapore an exciting destination and home for the rich and irresponsible?

The Workplace Safety and Health Act - Safety in the lab

One of the great things the Ministry of Manpower has been doing over the last decade has been the increasing legislative muscle to ensure workplace safety. The Workplace Safety and Health Act that came into force in 2006 was a major milestone in this direction. Although obvious directed at industrial workplaces, there has been an increasing impact of the Act felt in our research laboratories. Without doubt, our labs are far safer than the labs of old where pretty much anything was possible. Now all labs are covered by safety SOPs, and both students and staff are definitely more aware and safety conscious in all that they do.

However we are still pretty much on the learning curve and there is still some way to go before the safety culture becomes internalized, and people do something because it is actually safer, and not because it was mandated by a line in the SOP.  

The NUS Office of Safety, Health and Environment has actually done a good job in translating and applying the WSH Act to the research labs. In this translation the responsible person in the lab for safety is the investigator in charge of the lab. For more general aspects of lab safety, the employer or the laboratory/institution may be responsible. Even so, things still do go wrong, and when they do sometimes it is difficult to be clear about who the responsible person is.

Many of us have been watching for the outcome of investigations surrounding a lab accident which occurred almost a year ago at the Centre for Life Sciences in the NUS. The accident was apparently a chemical explosion occurring in a lift which resulted in injuries to two men. Technically the WHS and the OSHE interpretation would identify the Principle Investigator as ultimately being responsible for any lapses in safety procedure that resulted in the explosion. But I think there is some shared responsibility with the Centre management.

Investigations have been going on for almost a year without any public statement about the progress of the investigations. According to the WSH Act, penalties can be quite serious. If guilt is found, this may be the first case where a researcher is charged for a lab safety offence.

So we are watching very intently as to how this will play out. The situation may be complicated by the fact that both the investigator and the Centre management involve high profile foreign talents.

Shooting from the hip: Another unregulated medical devices horror story

Gigamole had posted earlier about the possibility that a recent heart valve replacement surgery may not have been approved. Now for those who still insist on the "I-see-nothing" approach towards the issue of medical device regulation, here is a story to think about before you go to bed. Especially if you were one of those who had received a metal-on-metal hip replacement.

There is a kind of total hip prosthesis manuctured by a company called DePuy Orthopedics, a subsidiary of Johnson & Johnson. These hip replacements called the ASR Resurfacing System and the ASR XL Acetabular System, have metal cups as well as metal heads fitting into the cups. That's why they are referred to as metal-on-metal prostheses.

The prostheses first appeared at about 2003 and 2005 respectively, and were allowed into the US market without the need to do any clinical trials, through an FDA regulatory loop-hole called the 510(k) clearance. All seemed well and rosy until 2007 when Australia, one of the first to have a National Joint Replacement Registry detected that the prostheses had a relatively high rate of failure and surgical revision. Although the company knew about this, it continued to market the prostheses world-wide while phasing it out in the US. In 2010, the UK found similar failure rates and also issued 3 safety alerts. It wasn't just the hip prostheses failing. The metal surfaces grating on each other tended to flake of and expose patients to high levels of chromium and cobalt; some as much as 600 times higher than physiological levels.

In August 2010, the company finally issued a global recall.

In Singapore, these prostheses had been available since 2006. These entered the market and have been in use in patients for 4 years without any kind of regulatory approval. Because we do not have a joint replacement registry like Australia and do not track the post-surgical performance of these prostheses, we have been completely blinded when it came to device failures, and potential toxicities. Without a registry it has been almost impossible to enure that all patients implanted with these artificial joints can come forward to have their replacements replaced. We do not even check on whether these patients had or continue to have cobalt or chromium toxicity.

So patients in Singapore have a very serious problem. How many of our patients even know if they have had a DePuy hip replacement done? (Patients should ask their surgeon and call DePuy) Of these, how many have come forward and have been appropriately advised to get the corrective surgery done, at the cost of the company? Does the HSA know the extent of the problem? How are they looking after our patient's well being? Is anyone tracking cobalt and chromium levels in our patients?

The ASR problem hasn't quite gone away yet despite the global recall in 2010. The manufacturers have set aside billions of dollares to deal with potential lawsuits. Do our patients know they can sue the company?

Recently the BBC and the BMJ jointly reported on this regulatory failure. The manufacturer's apparently continued to market the device despite being aware of the problems.

The Lancet also carried a recent report, after analyzing the Joint Registry data from England and Wales, about how bad these metal-on-metal implants were.

Meanwhile, in Singapore, we don't even have a compulsory registry to know what is going on. The industry, media (and sadly the medical professionals as well) continue to whip up the hysteria suggesting that we should all leave well enough alone and not regulate medical devices at all. Gigamole is all for the HSA taking a stronger proactive position in protecting the interests of our patient-consumer. Methinks they have looked the other way long enough.

Where is Salma Khalik when you really need her?