So you think you are safe from the haze indoors? Think again.

During the current haze many people assume they are safe indoors. Many who do not have air-conditioning at home have preferred to stay in their offices thinking that they are safer there.

To some extent, it may be true, in that they are less exposed to the full brunt of the haze and noxious chemicals. But they may be less protected than they think.

The design of building ventilation systems tend to concentrate more on the replacement of stale air than the exclusion on environmental pollutants. For example, the US EPA current requirements for ventilation systems in offices and schools are air exchange rates of at least 15-20 cubic feet per minute (Cfm) per person. This ensures that the building is not "sick" and will have adequate freshness of air. There is on the other hand much less in terms of expectation to provide a barrier to environmental pollutants.

In an enclosed building, air influx from external sources occurs primarily through ventilators. One assumes that some filtration occurs, but this is not mandated. Even if filters are present these cannot be those with too small pores as they will reduce the mechanical efficiency of the ventilators. Usually I believe, contractors just suck in air from the outside. This explains why many people complain of feeling the effect of the haze and smelling the smoke even in their offices.

How much contamination of office air occurs? This is hard to predict and measure. The smaller the particle, they less likely they will be excluded from the internal air. PM2.5 therefore tends to get everywhere, even though the contamination is less visible.

This level of contamination by outside air is indexed as the infiltration efficiency. A recent study in the US reported that across many areas, the infiltration efficiency of PM2.5 may be as much as 80%.  If this is true, there is not much benefit in hiding in your offices. Ironically, it may be that sicker buildings with poorer air exchange may actually be safer.

Ng Eng Hen and Grace Fu, you are both sooo wrong!!!

First Second Minister of EWR Grace Fu said, "The health impact of the air pollutants is determined by both the concentration and the duration of exposure."

Not wrong.

Then she says, "the 24-hour measurement is a better reflection of the total exposure of the individual to particulate matter."

Again by itself not wrong. From an epidemiological perspective. Which goes to show how little insight she has into the everyday common people's perspective.

As an ordinary person, Gigamole does not know what to do with the average PSI over the last 24 hours. Gigamole is not publishing a paper about the haze. Gigamole like everyone else away from the posh offices of the EWR Ministry, is really most concerned about what is happening now. Gigamole needs to know when to stay indoors and when it has become safe to venture outside. If Gigamole has workers, Giamole will need to know when to issue that missing (from the gahmen!) order to stop work. Can this be done using a 24 hour PSI average??

Minister of Defence Dr Ng Eng Hen, lagi best, further glossed over the issue by promising to simplify the data. He pointed out that, "most studies on the exposure to pollutants are based on 24-hour measurements. That is why the government's guidelines are also based on those measurements..."

Yes, of course. All well and good if you are an epidemiologist. Nobody studies hourly peak exposures, because it is so much easier to collect averages over longer periods. But the absence of data does not mean it is unimportant. Duh....... common sense will tell you short term exposures to known toxic materials should be avoided.

So Gigamole's plea to these two smart politicians is.....to STOP TRYING TO DUMB DOWN THE DATA!

In situations such as this, more information is preferred to less. The public needs to know the real time data so that they know how to organize their daily activities to minimize discomfort and health risks. This is especially since the gahmen is reluctant to issue real advisories. No point issuing advice based on yesterday's news. We need to respond to real time events based on real time information. So please report on hourly readings of the PSI, both PM10 and 2.5. And I mean real hourly recordings and not rolling averages over last 3 hours! Please also report on the geographic information, i.e. at least North, South, East or West quadrants.

Investigations into Johnson & Johnson's marketing practice - the ongoing saga of unregulated medical devices

One thing has led to another as the US Department of Justice launched an investigation into the marketing practices of the large medical device manufacturer Johnson & Johnson. At the heart of it is the number of recalled hip replacement products since 2010. Gigamole has blogged about this before.

Do not for one moment believe this will put a dent into J&J's marketing strategies. The company is no stranger to these financial penalties. It, like many other companies, have considerable sums of money set aside to cater for these penalties. After all these, Gigamole is sure the company will still be in the black. Two years ago, J&J was forced to pay off US$78 million for having paid bribes and kickbacks. Apparently bribing orthopaedic surgeons is a common practice among device manufacturers. In a report in the Archives of Medicine in 2011, the authors reported on 5 device manufacturers (Zimmer, DePuy Orthopaedics, Biomet, Smith & Nephew and Stryker) who had paid out, in 2007 alone, US$198 million to 939 orthopaedic surgeons.

Which is why medical devices need to be regulated. HSA is being very unwise in leaving medical devices unregulated, because in so doing, they are leaving the patient-consumer at the mercy of the device manufacturers. It is foolish and naive to believe that industry have anything else on their agenda than to generate profit for their shareholders.

To date however, the problems of the recalled De Puy hip replacement devices in Singapore remain unresolved. The HSA appears unwilling to take a strong public position about this. And patient-consumers remain unprotected.

Gigamole wonders when HSA is going to do the right thing?

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?

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?

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?

Was the valve used in National Heart Centre operation approved as a medical device?

While the HSA was conducting their briefing about how they were going to tweak the regulatory processes for low risk devices, we have this bit of exciting news about the groundbreaking operation done at the National Heart Centre.

Exciting because it was the first such operation done in Asia. Essentially, the operation was a minimally invasive insertion of a bioprosthetic (cow tissue in steel) valve to correct for a mitral valve failure. The valve-in-valve design was developed in 2007 when it first underwent clinical studies. In November last year the Edwards SAPIEN valve received a much heralded approval from the FDA. But here is where there is a bit of problem. The FDA approval was only for the use of the valve for aortic valve stenosis, not for correction of the mitral valve. And only in patients who are too ill for open heart surgery. In fact the US FDA had made a note in its approval that the valvular operation, even for aortic stenosis was not without problem - patients had 3 times more chance of developing a stroke.  But there had been no similar FDA approval for a modified valve for mitral valvular disease. Gigamole is not sure if any major regulatory agencies have approved the mitral version of the valve, let alone the HSA.

So here are Gigamole's questions:

a] Did the FDA approve the mitral valve-in-valve as a medical device?
b] Did any regulatory agency world wide approve the mitral valve-in-valve medical device?
c] Did the HSA approve the mitral valve-in-valve medical device?  And if so, on what grounds? If not, what was the approval process for surgeons at the National Heart Centre to go ahead and operate using an FDA and HSA unapproved medical device?

Please do not mistake my questions as being anti-innovation and anti-progress. Devices such as this valve-in-valve device needs to be properly evaluated in terms of risk benefits before use. The aortic version was studied since 2007 before it was approved by the FDA. Although the valve had been modified for mitral valve use also in 2007, this never received the same warm response, and as far as Gigamole is aware, the FDA in its wisdom never gave approval for the mitral valve version. Treating the mitral valve is not as straightforward on terms of risk-benefit assessments as for aortic stenosis. To those who advocate that we blindly follow the FDA's approval must also accept that we should also take guidance from the FDA's tardiness in approving this procedure.

Regulation of medical devices - a follow up

Even as discussions continue in Singapore between the HSA and medical practitioners, this problem has been brewing in the US of A as well.

Recently, St Jude's Medical, Inc in St Paul, Minneapolis, USA has been involved in a spat with authors of a report entitled "Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads" in the Heart Rhythm Journal. St Jude's Medical, Inc are the manufacturers of the Riata electrodes. Concurrently, they have stopped selling two of the electrodes. Electrodes which had been 'approved' by the FDA, ..... apparently.

Truth is the FDA's way of regulating of medical devices is not exactly exemplary. A report from the Institute of Medicine has pointed out major deficiencies in the way the FDA deals with medical devices and have recommended a major overhaul of the regulatory process for medical devices. This will come as no comfort to those in Singapore who advocate blind acceptance of what the FDA pronounces as acceptable.

Globally, the experience in regulating medical devices has lagged far behind the regulation of pharmaceuticals. Is it necessary? Absolutely. But the question of how needs a lot more discussions and harmonizing. This is a rapidly growing problem that badly requires some regulatory solutions. To do nothing will be irresponsible. We need the HSA to be vigilant, and to keep their eyes on  developments not only in the US but in other countries such as Britain, Australia, Canada, Japan as well as the European Community.

So to those who are  targeting the HSA as villains in this regulatory necessity, think again. They would do better to redirect their angst towards those who are making money out of peddling inferior and/or unsafe devices.

Should the finger be pointing at the CEO? A moleview of the SMRT saga....

image from here

All of sudden there seems to be deluge of bad news for SMRT. The latest involves a woman who fell and and sustained a head injury. Apparently she remains in coma. Gigamole wishes her well.

The public outcry against the SMRT is both understandable and justified. The hounds are now baying for the head of the CEO, Saw Phaik Hwa. The mass media has been particularly unkind, I think, and has dug up as many photos as they have on  file that portray her in the most unflattering light.

However, Gigamole somehow feels this antipathy against the CEO has been somewhat misplaced. Yes, because she heads the SMRT, the responsibility for all the mishaps falls squarely on her lap. Bt we should not forget that as CEO she acts upon the guidance of the SMRT Board. It was also the SMRT Board who examined her credentials and appointed her to the post. It was the SMRT Board who crafted up the directions and strategies for the CEO. By appointing Ms Saw to the post, the Board obviously prioritized the retail agenda above operational and service needs. Whether they did this as a conscious strategic  decision is unclear. It may well have been it seemed like an OK thing to do at that time, and only now shown to be inappropriate.

It seems clear at the moment that the SMRT CEO did all she could within her capabilities. Unfortunately though her experience was principally in retail and marketing. Was she someone who had a good insight into the technical/engineering and operation needs of the SMRT? Should we blame her for  lapses in areas outside her expertise. Yes, as she is CEO; but not entirely, as the Board should account for why they did not think operational/service skills were critically important for a train and transport company. Transport Minister Lui was spot on when he picked up the phone to speak with Chairman SMRT. This is a problem squarely shared by the Board and Management.

So for those who are happily shooting off arrows at Ms Saw, hold your fire a bit, and see if perhaps some of the arrows need to be redirected towards the SMRT Board.

Black swans in Singapore?

The black swan metaphor was introduced to us by Naseem Nicholas Taleb to describe a high impact outlier phenomenon that no body expects and one that takes everyone by surprise. The recent global recession related to the collapse of Lehman Brothers was such a black swan event. And like all black swans it can be rationalized after the event, when everyone kicks themselves in the backside and wonders why they never recognized it coming.

Although not global in magnitude, there have been a number of black swans seen in Singapore recently. The GE2011 results for example, caught many people in the PAP by surprise. The flooding in Orchard Road was another such event. In retrospect however, these events could have been easily predicted, and now we have the unusual situation where many people in the gahment are kicking themselves wondering how they missed the picture.

Often therefore the black swans are not the result of extra-ordinary events but of a lack of foresight, and the reluctance to think outside of mainstream and traditional ideologies. The GE2011 black swanlette was I believe, very much a consequence the failure to really look at the signs, which in retrospect, was everywhere. There was much reluctance to listen to naysayers, and everyone was happy to fuel the emperor's vanity. The flooding story hasn't quite unfolded fully, but I believe the picture will emerge that the black swan really came about because of the reluctance to deal with changing weather patterns as a result of global warming. There was I believe, too much discomfort in wanting to move outside of traditional models looking at weather and flood patterns. After all, to do so would have been to abandon painstakingly collected historical rainfall and flooding data. Yet the world has changed, and these models need to change as well.

The increasingly recognized hospital "bed-crunch" is perhaps not unlike the flooding black swan. Caught everyone by surprise, did it? What absolute crock! The numbers were there for everyone to see. The population was growing at a phenomenal rate. People were aging. Medical tourism was being encouraged. But no one appeared to want to look seriously at the numbers. Either that or there was an absolutely wrong prioritization of healthcare resources to cater for medical tourism instead of community needs.

Bisphenol-A - time for AVA to review?

Bisphenol-A has now been banned from all baby bottles in Europe. This stems from the increasing concern about the safety of the chemical that is found in hard plastic bottles.

There have been bans in Canada and Australia, and a few US states. The US National Toxicology Program (NTP) had issued a report in 2008 expressing 'some concern' about "effects on development of the prostate gland and brain and for behavioral effects in fetuses, infants and children". earlier this year, the FDA came round to the position that there was also "some concern" on their part.

Meanwhile our AVA has been silent about this problem.

Investigating aviation errors and IVF mistakes - a fair comparison?

Minister of Health Khaw Boon Wan made an interesting reference to the investigation of aviation errors while commenting or the recent IVF mistake which occurred at the Thomson Medical Centre.

He said: "Like the health sector, the aviation sector used to approach safety and errors through a largely fault-finding approach. When a plane crashed or hit a problem, the first question was to nail down the culprit: who was responsible, was the pilot at fault, was the engineer negligent etc? This used to be their approach a decade or two ago.

But they have since moved away from that approach. Instead, they took a system approach. Each time an adverse event occurs, they will conduct an objective and thorough investigation, not to witch hunt, but to identify the causes, especially if there are systemic flaws. Because they moved away from fault-finding, everyone was open in their comments, resulting in a speedy and accurate assessment of the true situation. Under the previous approach, the tendency was to protect one’s interest, resulting sometimes in cover-ups and the truth became elusive."

It's a very enlightened approach, and one to be applauded, although at some point in time there needs to be some accountability and someone has to take responsibility for not putting in place adequate measures to prevent errors. The MOM comes in hard for employers who put their workers in jeopardy by being negligent in not ensuring adequate workplace safety. In our research laboratories, the principle investigator faces a possible jailable outcome should lab safety measures be violated, or he has been negligent. Should not we expect the same rigour when medical professionals are negligent in situations such as this?

But I digress. The real purpose of this post is to explore the appropriateness or lack of, in the comparison with the investigation of aviation errors.

Avoidance of fault finding and cover-ups are two faces of the same coin. Often breakdowns in the integrity of a system/process extends beyond the party holding the smoking gun. If an error occurs in the regulatory functions, this would be less likely to be flagged out if the investigating team comes from the regulators themselves. In the investigation of aviation errors, to avoid this conflict of interests, an independent body forms the investigating team. Only thus, can the true extent of errors be discovered. If the investigating team is formed by the regulator, it is more than likely that a "fault" will be found only in the party in possession of the smoking gun.

In this instance of the IVF error, the investigating team is the Ministry of Health team. Yet it is the Ministry of Health which audits and regulates this industry. How can the Ministry then identify weaknesses in its own audit/regulatory systems covering the IVF facilities which allowed high likelihood of errors such as this to be committed? This is uncertain.

Should we not require some sort of pre-implantation diagnosis of paternity to be documented as validation of the integrity of the process before the embryo is implanted? Doing so will at least ensure that at the very least, there are no costly mistakes beyond the irreversible step of implantation.

Perhaps the Ministry of Health could consider releasing the last audit findings of Thomson Medical Centre so that the public can gauge if the audit was done with the stringency we expect, and/or the facility failed to act of recommendations.

As the Minister pointed out, this should not be to find fault but to enable everyone to correct all the deficiencies of the system. Following which, we can move on.

Thomson Medical Centre - suspension of assisted reproduction activities

Well done, MOH!! The Thomson Medical Centre has been whacked with a suspension following the IVF mix-up. Iwould have prefered that the suspension had been immediate upon news of the mistake, but better late than never.

What is further required is a full and proper audit of all IVF facilities to ensure that procedures are not only in place, but that centres are in full compliance of procedures. In addition, regular annual audits should be implemented, perhaps with a way to monitor outcomes... for example routine genetic screening of babies to ensure babies are who the centres say they are.

Mammograms? Much ado about not much, apparently...

A new study published in the New England Journal of Medicine once again has debunked the exaggerated benefits that mammograms produce. Not much, apparently. Have to screen 2500 women over 10 years just to avoid one death. This is not even considering the numbers of unnecessary screening, false positives and needless surgeries.

But I am not surprised.

When mammograms were first introduced, it was really difficult for anyone to refute the arguments that more screenings mean more lives saved. Of course in the process, more sales of mammography machines, more money to screening clinics and more money to breast surgeons. All happy, of course.... except the women who had to undergo needless breast surgeries. They were a small price to pay for the peace of minds of everyone else, apparently.

So now we know.

$26 million loss at the casino - hard to feel sorry.

Try as I may, it is very hard to feel sorry for the businessman who reportedly lost $26 million at the RSW casino. There is no accounting for stupidity. Yet the report is indicative of the size of the social problem the casino foists upon us.

Is this the kind of society we want? The kind of money we want to make?

The cyclist vs motorist debate..... why is the LTA silent?

Yesterday's ST carried a surprising and gracious letter from a Mr Damian Evans....apologizing for some bad behaviour as a cyclist. Surprising because apologizing is not something we have come to expect in Singapore society.

Today's ST then followed with a letter from a motorist who was responsible for the incident.

It was an interesting exchange of views, which highlighted one thing for me. Neither was out to cause grief. Yet their encounter on the road resulted in a potential for conflict....or worse, for physical danger to one of them.

A major reason for this I belief is the lack of clarity of what is expected of cyclists' behaviour on the roads. Motorists are generally confused by signals being sent about how cyclists should cycle..... or not cycle. I know cyclist s who firmly believe that when they are on the roads they should cycle in the middle of the left most lane. They believe that this increases their profile and reduces their risk of being forced to the kerb or being hit by a car. To me this is foolhardiness, but this is what they believe. If cycling in a group, I have heard of cyclists being told by their group leaders that they should cycle abreast for the same reason.

Yet this is blatant violation of the law, which is explicit in forbidding cyclists from cycling abreast.

In all this time, the Traffic Police and LTA have been pitifully and disappointingly silent. Should they not come out and say clearly what is allowed and what is not? What is allowable and what not? Why are they so coy about this?

Clarity preempts conflict.... and hopefully will prevent unnecessary accidents.

When they do break their silence, they should also be explicit about what stretches of roads are out of bounds to cyclists....e.g. expressways, semi-expressways, overhead passes etc.

Impreza ploughs into 18 cyclists - or, why should you stick a christmas tree in the middle of a highway?

Early this morning a Subaru Impreza ploughed into a swarm of cyclists on the West Coast Highway, injuring 5 of them, but thankfully no fatal injuries. Even without further investigations, I would be pretty confident to say the driver was at fault. There is really no reason for a car to tear into bunch of 18 cyclists. One of the cyclists pointed out that there was no way the driver couldn't have seen them as there so many of them and they would have been lit up like a 'Christmas tree'. Was the driver drunk? Don't know, but we'll find out soon enough.

Though my sympathies are with the cyclists, there are a number of things I am not comfortable with. Firstly, should this swarm of peloton cyclists be on the West Coast Highway in the first place? The law on this is somewhat grey. It is clear that the law forbids cycling on expressways, but it is a bit unclear if this applies to the WCH. Cycling fora argue that a highway is not an expressway, so cycling is not forbidden on the WCH. But on the other hand, the LTA lists the WCH as a semi-expressway, implying that the law would likely look at the WCH as an expressway, thus cycling on the WCH is not allowed...which makes sense because it is actually a very fast and busy highway.

Secondly, is a swarm of cyclists legal? We see this more and more often. Just this morning, after my mandatory pilgrimage to the fast disappearing wet-market, I encountered a similar swarm of Sunday cyclists riding 3 and 4 abreast.... I wasn't too pleased but because the road was quite empty at that time of day, I was quite content not to let them spoil my day. But the law actually is quite explicit about this issue. I quote from Chapter 276, Section 140 of the Road Traffic (Bicycles) Rules: (1)No bicycle shall be ridden on the right of another vehicle proceeding in the same direction except when overtaking such other vehicle. (2) No bicycle shall be ridden on the right of any two other bicycles proceeding abreast in the same direction except when overtaking such other bicycles or on parts of roads or paths set aside for the exclusive use of bicycles.

So the cyclists were actually breaking the law.

So yes, the driver was at fault for running into these cyclists, but the cyclists should 'fess up to being somewhat reckless, irresponsible, and somewhat lacking in common sense. The traffic police has I believe been a bit too soft on cyclists who are clearly breaking the law, especially with respect to the above two points.

And my appeal to cyclists is this....please show some common sense.... it is fine to claim you are as lit up as a Christmas tree, but really, does it make any sense to stick the Christmas tree in the middle of a highway?

Avandia bites the dust - oh, but not quite...

So the FDA advisory panel has finally come out to put a finger on the antidiabetic drug Avandia. Or has it?

The drug has been under scrutiny since about 2007, and it has been increasingly been associated with increasing risks of heart attacks. Now the FDA says yes the evidence is clear enough for an expanded warning to be included, but not clear enough for the drug to be yanked off the market. GSK, makers of the drug apparently didn't do a good job generating safety data. FDA expert, Dr David Graham was quoted as saying the GSK RECORD trial was "garbage". Furthermore, GSK apparently withheld information, and submitted poor data, including patient deaths, of patients on Avandia. GSK has already agreed to settle over US$400 million of lawsuits.

In the light of all this, the FDA appears to be waffling a whole lot in not wanting to withdraw the drug. Benefits outweigh the risk appears to be the mantra. Certainly the mantra being chanted by GSK sources.

But this is really not the point....

The critical issue should be whether the drug is as effective and as safe than alternative options. A Japanese (Takeda) alternative, Actos currently appears to do the same job but without associations of increased heart attack risks. So Anadia currently stands as a worse option. It is also not a case of patients currently on Avandia being forced out into a vacuum, should the drug be withdrawn. There are safer alternatives.

So FDA's pussyfooting round the issue is hard to comprehend. To what extent one wonders, is this wanting to allow GSK to recover as much of the drug development costs as possible. The bulk of pharma's drug development cost is recovered in the first few decade post registration. Despite falling sales, every year of delay in taking the drug off the market is a big pot on money for the company.

Let's hope other regulatory agencies, including our own HSA, will be a bit less muddleheaded.

Obesity - a KPI? How silly can you get?

Mr Liak Teng Lit, CEO of Alexandra Hospital and the coming Khoo Teck Puat Hospital was reported as saying "....All things being equal, if you are grossly obese, we won't promote you."

My goodness! Obesity as a work KPI (key performance indicator)!

Innovative? Definitely.

Attention grabbing? Most certainly.

But it is the height of arrogance, silliness and preposterousness to even consider such an option. Mr Liak should read the CDC feature, as well as the recent article in Newsweek Magazine, "The Real Cause of Obesity. It's not gluttony. It's genetics. Why our moralizing misses the point."

Perhaps Mr Liak should also penalize those who can't pass their IPPT (Individual Physical Proficiency Test). Not to mention the elderly, myopes, diabetics and hypertensives as well.

MRSA infection rates in Singapore hospitals

TODAY newspaper published a nice article on the efforts made by hospitals to control MRSA infections. The overall infection rates (over 6 public hospitals) have fallen from from 0.4/1000 patient days in 2007 to 0.3/1000 in 2009. Whoohoo...!!

errrmmmm....

Need to look at this in a bit more detail....

Here are the figures across 6 hospitals (2007-2009):

Year 2007 2008 2009

Overall: 0.4 0.4 0.3

AH 0.2 0.3 0.2

NUH 0.4 0.3 0.1

TTSH 0.5 0.5 0.3

CGH 0.2 0.3 0.2

KKWCH 0.1 0.1 0.1

SGH 0.6 0.6 0.4

Seems like not a clear pattern here. Yes, 3 hospitals showed a drop especially between 2008 and 2009. But a couple of hospitals had numbers bouncing around. And it is unclear if the overall improvement was heavily biased by NUH's spectacular drop in 2009. (I am actually quite appalled that our SGH is the dirtiest....

Actually part of the problem looking at these numbers is the lack of clarity in the definitions used in the collection of data. An earlier report by Straits Times had pointed this out, i.e. if the bug is on the skin when patient is admitted, and an infection occurs, it is not counted as an infection....

I looked at a MOH report by Dr Helen Goh in 2007. She had then defined the rate as being based on the CDC-NNIS methodology:

"The National Nosocomial Infections Surveillance (NNIS) system defines a nosocomial infection as a localized or systemic condition that a) results from adverse reaction to the presence of an infectious agent(s) or its toxin(s) and b) was not present or incubating at the time of admission to the hospital. For most bacterial nosocomial infections, this means that the infection usually becomes evident 48 hours (i.e., the typical incubation period) or more after admission5. The diagnosis of nosocomial infection is thus a combination of clinical findings and results of laboratory and other tests."

Assuming the definitions haven't changed and are consistent across all hospitals (of which I am doubful) ....... we should be able to splice her data with TODAY's info:

Year 2002 2003 2004 2005 2006 2007 2008 2009

Overall: 0.6 0.5 0.5 0.5 0.5 0.4 0.4 0.3

AH 0.3 0.3 0.3 0.2 0.3 0.2 0.3 0.2

NUH 0.8 0.8 0.9 0.8 0.7 0.4 0.3 0.1

TTSH 0.6 0.6 0.6 0.6 0.5 0.5 0.5 0.3

CGH 0.1 0.1 0.1 0.1 0.1 0.2 0.3 0.2

KKWCH 0.1 0.03 0.1 0.1 0.1 0.1 0.1 0.1

SGH 1.0 0.9 0.7 0.8 0.7 0.6 0.6 0.4

Yes, overall the improvement is to be applauded. SGH still looks incredibly filthy. KKWCH looks too good to be true, and CGH actually getting worse.