Thursday, May 17, 2012

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.

Tuesday, May 15, 2012

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.

Monday, May 14, 2012

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?

Friday, May 11, 2012

The SMRT fiasco - identifying the root causes?

In the midst of the chaos surrounding the Committee of Inquiry proceedings, senior management of the SMRT has of course, very predictably, made all kinds of promises to identify the root cause of what went wrong. Mr Ong Ye Kung, an independent director of the SMRT board has been appointed to do this "root cause analysis".

Fancy words, that sound good. The question is, can they?
The ideas of cause and effect go back a very long time in history. But the concept of root cause analysis can perhaps be traced back in more recent times (about 50 years ago) to when Sakichi Toyoda of Toyota fame, introduced the concept of the 5 Whys in identfying what actually caused something to wrong. The idea of asking whys 5 times to arrive at the root cause was perhaps too simplistic, but at least moved the inquiry beyond just fingering the finger that pulled the trigger, to a more fundamental cause.

Root cause analysis has since then become pretty much an industrial standard of identifying the fundamental causes of any industrial or public health incident. But it is not without its limitations. Dean Gano about 20 years ago pointed out some of the limitations in the cause-effect reasoning. He identified 4 principles of causation that we should take note of :

 1. Causes and effects are the same thing only seen at a different point in time.
 2. Causes and effects are part of an infinite continuum of causes.
 3. Each effect has at least two causes in the form of actions and conditions.
 4. An effect exists only if its causes exist at the same point in time and space.

Points 2 and 3 are particularly useful for us to take note of, i.e. that this whole process is pretty much an infinite continuum, and that apart from the action there are conditions that are involved in causation.

When investigating root cause of any event, the assumptions, prejudices and perspectives of the investigator becomes critically important because they determine the conduct of the investigation and interpretation of the events.

Applied to the SMRT conduct of root cause analysis, we can see that the Chairman did the "right" thing in appointing Mr Ong Ye Kung, an independent director of  the board to lead the investigation. However we should note that Mr Ong, although an independent director, is nevertheless a board member. Can we expect that he will be able to properly identify board related deficiencies? Furthermore, he is a PAP member who was on the teams that wrote the Land Transport White Paper, and  that established the LTA in the first place. How objective will he be in drawing that line of causal continuity back to those original ideas? Certainly the conditions for failure are equally important to the actions/inactions that resulted in the failure.

So I am not holding my breath that they will find the answer. The COI has identified the leads. Here's hoping there will at some point in time, be some real experts who will be capable of a truly independent conduct of the root cause analysis.

The SMRT monster-under-the-bed is emerging......

Day by day as the proceedings of the Committee of Inquiry for the SMRT fiasco plays out in the press, it has become clearer and clearer how big the monster under the Transport Minister's bed really is. This is one big mess. How can it be that the problem of national transport can be privatized to a company that showed such wanton neglect of operational necessities? The long awaited appearance of the beleaguered CEO at the COI really only served to confirm how misplaced the entire SMRT agenda was.  But much as we would like to just hang everything on the pathetic past CEO, Ms Saw, we should not forget she was not the only one responsible for this mess.

She essentially reported to the Chairman of the Board, Mr Koh Yong Guan, an eminent guy, but essentially a money guy. Eyeballing the SMRT 2010 Annual Report, we can see that the priorities of the Board really centred around fiscal prudence and health. Corporate risks were essentially only related to financial risks and not operational risks. Clearly the SMRT mission the Board set out for CEO Saw was really about growing the commercial and financial stature of the organization. Was she incompetent? Obviously not by the evaluations of the SMRT Board. At least not until the claws fell off the track and the poo hit the fans.

But who was behind the Board? Who put all this money people into the Board of an operational unit that was supposed to deliver a world class transport service? And how can it be that the transport regulator LTA can audit the SMRT year after year and find nothing but a bed of roses?

Now of course we know that bed of roses really harboured a huge stinky monster.

But going off on a tangent, as I am wont to do, it should be noted that this SMRT fiasco is really not merely an aberration in an otherwise healthy Singapore. Singapore, notwithstanding all the glowing reports in the mainstream media, is really quite dysfunctional. The sickness comes from the government's fixation on high GDP growth at the expense of everything else. Anything of worth is Singapore is denominated in dollar terms. The SMRT and the transport sector are not the only places where there are grossly misplaced missions. The health sector has been hugely corrupted by the pursuit of the medical dollar at the expense of affordable health care for the public. While lamenting the inadequacy of hospital beds, the Ministry of Health encourages corporatized hospitals to continue to build to cater to high end private patients. Meanwhile the universities chase bloated KPIs that have to do with ranking and research glory, rather than focusing on providing solid and affordable tertiary education for the average Singaporean.

There are monsters hidden under these beds that will, like the SMRT one, eventually emerge one day.

So as we head into the Hougang by-election, here is my plea to the Prime Minister. As a Singaporean I am increasing disillusioned by this overemphasis on wealth and elitist ideals. It is as if Singaporeans are not worthy of consideration and support unless they are megadollar earners. Prime Minister, you are wrong in this. Every Singaporean is worthy of support regardless of whether they are able bodied, able minded or not. Or even if they are just plain not-very-smart.

At this year's National Day Parade, I want to be able to say the pledge and mean it.