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.

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.

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.

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.

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".

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.

Turning a blind eye.....

Partial blindness presents an interesting physiological problem. This is because the nerve fibres on the way from the eyes to the brain partially cross over. At about where the pituitary gland is, the nerve fibres from the inner side of the each eyeball switch sides. This creates a situation where, depending on where the damage is, you may have very different kinds of blindness.

For example, if you lose an eyeball, because of the overlapping of the visual fields of each eye, you do not lose half of your vision. The actual amount of loss of the total visual field is only about 25-30%. What is most disturbing about loss of an eye is the loss of binocular perception and consequently, loss of depth perception.

If on the other hand, if there is complete damage to the optic fibres after the crossing has occurred, there will be potentially greater loss of the visual field, up to 50%.

Intuitively however, we are misled to think a person with an eyepatch is more blind (loss ofvisual field) than a person who may appear normal externally but has a lesion of one of the optic tracts or has damage to the visual cortex of the brain.

So there are times the eyes see but the brain is unable to process the information, while at other times, the eye appears not to see but the brain is actually visually aware. There are social equivalents to these kinds of blindness. For example, data and information is available but the brain is quite blind in not being able to perceive the real signals. The recent discordant interpretations of rainfall patterns show a bit of this hemianopsia. The brain has been conditioned to only see no change despite the signals it received. Likewise, the Central Narcotics Bureau last year was caught in the embarrassing situation of having to 'fess up to misreading the data it had collected. Instead of a downward trend in drug addiction, the numbers had actually been trending upwards.

By contrast, there is the other kind of blindness where people can actually see but pretend to be more blind than they actually are. Such was the case with the famous British naval hero Lord Horatio Nelson. He was well known to be blind in one eye. Now we now know that losing one eye only loses about 25-30% of your visual field, but when he was given a visual signal to withdraw during a battle, he famously quipped, "You know, Foley, I have only one eye - and I have a right to be blind sometimes... I really do not see the signal." So thanks to Lord Nelson, we now have the expression, "turning a blind eye", when we choose not to see something very obvious.

Our vice squad appear to be somewhat guilty of this, when they appear to be blind to the numbers of streetwalkers lined up along the roadside in Geylang. Sometimes the policeman does this when you complain of something illegal happening. The Lord Nelson in him tells you that it never happened unless someone made a official report. Sounds a bit like our Singapore Medical Council. Medical wrong-doings never happened unless someone had officially made a report, even when things were as evident as day.

There are many Lord Nelsons ruling in biomedical research nowadays apparently. Despite detailed evidences of unethical and fraudulent behaviour flagged up in a number of websites such as Retraction Watch and Abnormal Science, journal editors, research institutes and universities continue to feign ignorance while professing to hold high standards of ethical practices. Just ignore the reports from blogs.

Lord Horatio Nelson will be proud.

High salaries discourages corruption? A reality check.

Singaporeans woke up this morning to the alarming news that the Chiefs of both the Singapore Civil Defence Force (SCDF) and the Central Narcotics Bureau (CNB) have been relieved of their position pending investigations by the Corrupt Practices Investigation Bureau (CPIB).

This must have shaken the civil services to the core.

Without presuming guilt of these two guys, but if the suspicions are true that they have engaged in corrupt practices, it must surely raise serious concerns about the validity of the logic that corruption is prevented by paying high salaries. These guys have certainly not been paid peanuts.

To my reckoning, if we use money as the main lure into public service, surely that must attract only those for whom money and more money becomes the driving force for their ambitions. Corruption is fueled by greed, and there is never enough to assuage that thirst.

The most effective way to stem corruption is to have an independent, transparent and effective CPIB, and a vigilant public who is prepared to whistleblow. Our CPIB has done an excellent job so far, thankfully. But if we want our politicians to be free from corruption, then the CPIB must have the freedom to investigate all officials including the cabinet and even the Prime Minister. That the CPIB reports to the Prime Minister's Office does not give it a freehand in performing this critical function. Perhaps this line of reporting should be reviewed? Since we have an elected Presidency, should not the CPIB report to the President, rather than to the Prime Minister?

LTA and regulatory capture? HSA are you listening?

A week ago in the Sunday Times Senior Correspondent  Christopher Tan write a nice article about the recent SMRT wayang and the LTA, raising the issue of a regulatory capture occurring between the transport regulator LTA and the transport industry.

The concept of regulatory capture is very much assocated with Economics Nobel Laureate George Stigler. It refers to the type of government failure when a public sector regulator has a cosy cosy relationship with the regulated service provider, to the extent that the regulator becomes a promoter of the regulated rather than a protector of the public needs.

Is the LTA a victim.... or are we, the public, victims of the regulatory capture between LTA and the transport industry.

This is actually not an isolated problem affecting the LTA, but can be seen to exist in many of Singapore's regulators.

The HSA (Health Sciences Authority) for example may be in such a predicament. Formed in the past from all the disparate MOH subunits in the Ministry of Health that the MOH wanted to decant from the Ministry, the functions of the various parts of the HSA range all the way from service provision, regulatory and promotional. Regulatory capture?...certainly many opportunities for this to develop in the HSA. Successive Board Chairmen and CEs have not made any attempt to deconflict all these functions, choosing instead to keep the easy and cosy relationships which made their work easier. However, unless this regulatory captures are dismantled, one has to question to what extent public needs are sacrificed to meed the needs of the industry.

By the way, George Stigler was also well known in medical circles for his attempt to optimize the daily recommended diet. Like all economic solutions, the result was totally unpalatable.

Curiouser and curiouser..... sharing the skeletons

Image from here

An independent investigation is not always the most intuitive thing to do when a problem arises. The management of an organization will always seek to retain control of the proceedings so that the damage can be contained should any wrong doing be uncovered. Yet we all know that a less than independent investigation will in the end prove to be the least beneficial for the organization in the long run.

A number of recent incidents locally highlight the need for external and independent invistigations or audits.

Late last year, an IVF mistake occured in Thomson Medical Centre. In response, the Ministry of Health held its own investigation rather than to leave it to the TMC to uncover and report its own lapses.

More recently, an accident occured in the Singapore Air Force. Apparent a technician ruptured his liver during an induction exercise. The internal Board of Inquiry, disclaimed any association with the activities during the induction. It was only after the coroner made its findings that the BOI backtracked and agreed to consider that the ruptured liver could have been related to the tunnel crawl during the induction activities.

Now there are allegations of publication fraud and self-plagiarisms at the NUS. One wonders if the NUS sees it as in their interest to keep the investigation 'in house' and secret. Should it not be in everybody's (including NUS's interest), to have an external party audit whatever happened? This is especially as senior members of the faculty are associated with the allegations. Even if the senior members are innocent of any wrongdoing, the perception that the investigations are less than independent is damaging to the credibility of the NUS.

Instead, there is this very bizarre situation where the lead investigator is a Director of Research Admin, in the Office of the Deputy President (Research&Technology) while his boss himself is the subject of certain allegations of self-plagiarism and is associated with two of the Melendez list of publications.

Curiouser and curiouser.

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.

Climatology - Post-Normal Science

Some might wonder why discussions about climate change often sound as if it was more of a debate about religion than it were about science; and fret about how political the whole issue has become. All this has apparently been because Climate Science is typical of a 'new' kind of scientific process called post-normal science (PNS).

Actually post-normal science (PNS) is not that new. It was first proposed by a pair of academics, Silvio Funtowicz and Jerome Ravetz in 1992 to characterize that type of scientific process that dealt issues of some urgency and where facts are sparse and uncertain. It is in effect, a kind of problem solving approach to complex science related issues. Because of the unavailability of good accurate data, all kinds of data from non-traditional sources can be used in finding urgent resolution to the problem. much of which did not require validation or proof. Much of medical science can be of this sort, where significant uncertainty exists in the management of critical and urgent clinical problems.

The Wikipedia entry reads: "According to its advocates, "post-normal science" is simply an extension of situations routinely faced by experts such as surgeons or senior engineers on unusual projects, where the decisions being made are of great importance but where not all the factors are necessarily knowable. Although their work is based on science, such individuals must always cope with uncertainties, and their mistakes can be costly or lethal. Given the greater importance of climate systems and the fact that less is known about them, conventional methods of inquiry, based on determining all relevant information before proceeding, are too slow and uncertain to deal with an issue too complex to be fully understood and too important to wait for confirmatory results."

Because this form of scientific approach cuts short many of the processes required to generate accurate and detailed data, it is important that the process relies on an 'extended peer community' (EPC) to provide quality assurance for the proposed solutions. This EPC consists "not merely of persons with some form or other of institutional accreditation, but rather of all those with a desire to participate in the resolution of the issue."

Funtowicz and Ravetz further point out that "Statistical theory tends to undervalue another sort of error, ironically called Type III, when the whole artificial exercise has no relation to the real issue at stake. Type III errors are a characteristic pitfall when the ‘normal science’ approach is deployed in post-normal situations. Modelling exercises are particularly prone to this sort of error, as when the gap between the available data and a manageable model on the one hand, and the real policy situation on the other, cannot be bridged."

The PNS approach is without doubt effective and necessary. However it does have a tendency, because of its relative lack of traditional scientific rigour and objectivity, to drift into an approach that is resembles activism or advocacy. Without checks and balances, the solution soon becomes orthodoxy. That is why the 'extended peer community' is essential to keep this paradigm 'honest'

The science of climate change fits exactly into this form of a scientific approach, being complex, urgent and bereft of good accurate data and understanding. The problem with it has been that the protagonists in the story got carried away with their zeal and lost their objectivity. The solution became orthodoxy. They proclaimed the science settled, and excluded the EMS, branding them deniers and skeptics etc. In so doing, they became advocates and activists. Some might say priests of a new religious order.

Ravetz's own critique of climate change as PNS is recommended reading.

He writes: "We can understand the root cause of Climategate as a case of scientists constrained to attempt to do normal science in a post-normal situation. But climate change had never been a really ‘normal’ science, because the policy implications were always present and strong, even overwhelming. Indeed, if we look at the definition of ‘post-normal science’, we see how well it fits: facts uncertain,values in dispute, stakes high, and decisions urgent. In needing to treat Planet Earth like a textbook exercise, the climate scientists were forced to break the rules of scientific etiquette and ethics, and to play scientific power-politics in a way that inevitably became corrupt. The combination of non-critical ‘normal science’ with anti-critical ‘evangelical science’ was lethal. As in other ‘gate’ scandals, one incident served to pull a thread on a tissue of protective plausibilities and concealments, and eventually led to an unravelling. What was in the e-mails could be largely explained in terms of embattled scientists fighting off malicious interference; but the materials ready and waiting on the blogosphere provided a background, and that is what converted a very minor scandal to a catastrophe."

An early post by Elizabeth Bury (before Climategate broke) on this issue is also a good read.

H1N1 and Big Pharma

Anyone still interested in the H1N1 shamdemic, and the role of Big Pharma should this expose from Der Spiegel. It is by far the most comprehensive chronicle of the events which enveloped us last year.

I just quote a couple of excerpts from the report below, but you should read the whole thing and form your own opinions.

"According to the regulations, phase 6 becomes effective when a new virus is spreading uncontrollably in several regions of the world. The regulations say nothing about the severity of the disease.

In fact, the vast majority of experts on epidemics automatically associate the term "pandemic" with truly aggressive viruses. On the WHO Web site, the answer to the question "What is a pandemic?" included mention of "an enormous number of deaths and cases of the disease" -- until May 4, 2009. That was when a CNN reporter pointed out the discrepancy between this description and the generally mild course of the swine flu. The language was promptly removed.

Apparently German infectious disease experts also misunderstood the official WHO definition of phase 6. An influenza epidemic, according to Germany's national pandemic plan -- updated in 2007 -- is "a long-lasting, international situation involving substantial loss…and causing such lasting damage as to jeopardize or destroy the livelihood of large numbers of people."

The situation on June 11, 2009 did not correspond with these descriptions. Critics were already asking derisively whether the WHO had any plans to declare the latest outbreak of the common cold a pandemic. "Sometimes some of us think that WHO stands for World Hysteria Organization," says Richard Schabas, the former chief medical officer for Canada's Ontario Province."


""The pharmaceutical industry did not influence any of our decisions," says Fukuda. But in mid-May, about three weeks before the swine flu was declared a pandemic, 30 senior representatives of pharmaceutical companies met with WHO Director-General Chan and United Nations Secretary General Ban Ki Moon at WHO headquarters. The official reason for the meeting was to discuss ways to ensure that developing countries would be provided with pandemic vaccine. But at this point in time the vaccine industry was mainly interested in one question: the decision to declare phase 6.

Everything hung on this decision. At stake was nothing less than a move to supply large segments of the world's population with flu vaccine. Phase 6 acted as a switch that would allow bells on the industry's cash registers to ring, risk-free. That's because many pandemic vaccine contracts had already been signed. Germany, for example, signed an agreement with the British firm GlaxoSmithKline (GSK) in 2007 to buy its pandemic vaccine -- as soon as phase 6 was declared. This agreement could explain why Professor Roy Anderson, one key scientific advisor to the British government, declared the swine flu a pandemic on May 1. What he neglected to say was that GSK was paying him an annual salary of more than €130,000 ($177,000)."

"What was this pandemic? Was it all just "good practice for an emergency," as WHO advisor and industry lobbyist Osterhaus puts it? Did the authorities do everything right, as Australian epidemiologist John Mackenzie insists?

Certainly not. No one at the WHO, RKI or PEI should feel proud of themselves. These organizations have gambled away precious confidence. When the next pandemic arrives, who will believe their assessments?"

What has the 3rd medical school got to do with GSK and the H1N1 pandemic?

A strange nexus seems to have developed between the much anticipated 3rd medical school and happenings with respect to GSK and the H1N1 story.

As we all have been told the planned for 3rd medical school was supposed to be a tie up between Tan Tock Seng Hospital, NTU and Imperial College. One of the champions of the proposed tie up was apparently the past rector of the Imperial College, Professor Sir Roy Anderson. Sir Roy is a pretty influential person and has been listed as a VIP on the Board of GSK. But he apparently has a bit of checquered past. In July last year he was in the middle of a controversy about his role in the British SAGE (Strategic Scientific Advisory Group for Emergencies), a 20-strong task force drawing up the action plan for the H1N1 virus, while holding a highly paid position with the drug and vaccine manufacturer, GSK. Earlier he had been in another series of controversies which led to his resigning from Oxford University. You can read the details here.

In November last year, he abruptly stepped down as Rector for Imperial College. The reasons for his departure is unclear and there have been a number of speculations. His departure has however created a bit of a hiatus in leadership for Imperial College. Sir Keith O’Nions, the Director of Imperial’s Institute for Security Science and Technology, took over as Acting Rector. It is also not clear if the new leadership is as enamoured with the tie up with NTU/TTSH for the 3rd medical school. I hear in the grapevine that the vibes are not that positive. Which means the 3rd medical school is now left in a bit of a lurch and scrambling to find a suitor.

So ....a right royal mess......

ClimateGate - Who's who...

Climategate - the unravelling academic scandal that threatens the credibility of the anthropogenic climate warming position

One of the greatest academic scandals of this generation is unraveling, and the mainstream media is strangely silent.

Earlier this month, the scandal now nicknamed 'Climategate' began with the publication of hacked emails from the Climatic Research Unit, University of East Anglia, showing how corrupted and conniving the climate change scientists (big guns, not small fry, mind you....from the IPCC - Intergovernmental Panel of Climate Change) have been in promoting the global warming agenda.

For details please read Lord Christopher Monckton's report.
The Daily Telegraph's report is also good reading.

For me, this is a sad indictment of how far academia has sunk. Once we could trust the objectivity of reports that came from academic centres. Or at least it did seem that way. Now, it seems the universities and research centres have all fallen prey to money wielding organizations, or self serving politicians. Can we trust academicians now?

Some may say that this is an isolated incident involving a unrepresentative group of academics, but the cynical in me believes this may in fact be more prevalent than we want to admit.The silence of the main stream media is deafening. Governments and politicians who have invested much in the global warming hypothesis have much to lose should it be proven to be a hoax. A gargantuan industry has already been built up around technologies to mitigate global warming. What will become of these should there be no global warming?

Let's not even think of the possibility that we might not have been told the whole truth about other issues such as the H1N1 pandemic, or stem cell research, or gene therapy, or the need for cancer screenings.... The list goes on.

I had made the point earlier about the need for more objective data. This is even more urgent now. The question is where will it come from?

Why was animal cell therapy allowed to be imported for use?

The Martin Huang saga has created quite a bit of consternation in the public as well as the medical profession. Even the Director of Medical Services was prompted to come public with a reprimand of sorts. Many people thought the poor sod had gotten off with little more than a mere slap on the risk. Which was true. A fine of a mere $5000. Loose change for this guy.

But the question must also be raised as to what actual law did he break, and what crime did he commit? Apparently he done the unconscionable and had injected sheep foetal cells into patients to slow aging. The Medical Council screamed that this was offering unproven therapy, and not allowed. Such unproven therapy violate the SMC Code of Ethics :

The SMC Ethical Code and Ethical Guidelines para 4.1.4 state very explicitly: "A doctor shall treat patients according to generally accepted methods and use only licensed drugs for appropriate indications. A doctor shall not offer to patients, management plans or remedies that are not generally accepted by the profession, except in the context of a formal and approved clinical trial."

What Martin Huang did was offering a therapy that was uproven, and which was not part of a formal clinical trial. Bad guy.

But then again ( and I have posted on this conundrum before) so many of our doctors are clearly in breach of this. Unproven therapies? All off label use of medications are unproven therapies. Furthermore, their use are often not in the context of a formal clinical trial. How about off-label stent operations? The recent media reports on inappropriate slimming pill prescriptions fall into this category of offense. Yet the SMC did not act.

Not that I am a supporter of Martin Huang. I totally disagree with what he did and fully support the SMC's actions in his case, but the SMC's actions now look horrendously inconsistent. How did the SMC arrive at the conclusion that the offering of sheep fetal cells was so wrong compared to surgeons sticking all kinds of un-trialed appliances into our bodies, and physicians offering all kinds on drugs for un-trialed and unproven indications?

I wonder.

One last bit of ranting before I go for my teh-see....

Were the sheep cells licensed to be imported for cosmetic therapy? Here is where HSA has to explain their position. There apear to be regulations for medicines, for biosimilar products, for some medical devices and for cosmetics (external applications)..... but for cell based therapies?? Silence.

So were the cells allowed into Singapore for such use. If they were licensed imports, would this license represent tacit approval by HSA for their use? If they were not licensed, was Martin Huang guilty of breaking an import law? If so, he should be hit with the full weight of the law, as would any merchant intending to trade in an illegal product. Or does this indicate there is a legal loop hole for doctors to violate patients' safety? If so, why is there such a loophole and what are we doing about it?

What are the conflicts of interests within HSA, as they themselves begin to offer cell based therapies? How do they regulate themselves, in the absence of proper legislation for this, and as they come into competition with commercial providers of cell-based therapies?

We need to know.

Taming doctors' greed....?

Salma Khalik continues the doctor bashing in today's Straits Times with a report entitled "Tame doctors' greed and protect patients", essentially addressing the GPs' greedy right to make money through dispensing of medications. Hmmmm........

This is really not a new issue. From time to time, this gets surfaced.... the MOH suggestively indicates that we can change.... meets a brick wall of resistance, then it's back to status quo.

www.GeraldTan.com has done us the kindness of logging some of these public dicussions all the way through from 2005-7.

For me a number of things are obvious....

a] There is an enormous professional conflict of interest when doctors make money from dispensing. This is without doubt. The Singapore Medical Association, in all its protestations have never disputed that reality. I am not sure what the average proportion of a GP's revenue come from dispensing, but it must be substantial.

Given this conflict of interest, the burden of responsibility must naturally fall upon the shoulders of the profession to explain how the patient/consumer can know if the best and most cost-effective drug solution is being prescribed. I don't want to suggest how often this occurs, and it may well be limited to the practices of a few bad-hats, but it is clear that over-prescribing and inappropriate prescribing are certainly practices which litter the medical landscape.

b] The only real defence for maintaining the system is 'patient convenience'.

This controversy, to my mind, can be easily resolved if only the Singapore Medical Association can bring itself to face up to the reality that there is a real conflict of interest. There is nothing intrinsically wrong in GP clinics wanting to meet their bottom line, and for doctors to bring home the bacon. But the lack of separation between the doctor's role from that of a money-making dispenser potentially compromises the doctor's objectivity in prescribing. I think it would certainly allow the journalists at SPH (and me too) sleep a lot easier if the SMA itself devices a strategy to deconflict the situation instead of pretending the problem doesn't exist.

One such solution might be to financially decouple without physically separating the two functions. Make clinics lease out the dispensing space to a bona fide dispenser and make it illegal for doctor/proprietors to make money from the dispensing rights. This will remove the financial incentives that compromise medical objectivity, without taking away the patient's convenience of receiving their medicines at the clinics.

HSA, cell therapies and conflicts of interests...

As if providing an example on cue, for what I had recently been posting on the potential conflicts of interests in our regulatory agencies, the HSA announces the setting up of a S$9 million facility for cell processing.

Now, I am not arguing against the need for such a facility....just the appropriateness of parking such a facility in the HSA.

HSA is our regulatory authority for health sciences and health services. By owning such a large service facility, does it not create conflicts of interests within the organization? How will it view commercial units who may intend to offer similar services? How will it ensure, that the services offered are at the best value for MOH hospitals? What would be fair value for patients? How would it regulate supply to non-MOH entities? How about best practices? Will it be able to ensure, its own facility operates according to best practices? Who will audit them?

Wouldn't it be wiser (but perhaps not as expedient) to have it operate as a stand alone unit, perhaps with the entire hived-off Blood Services Group, so that they will be more independently accountable.

Are our regulatory agencies adequately china-walled against conflicts of interests?

The recent Auditor General's audit thrashing of the MDA (Media Development Authority) and today's report on the MAS's (Monetary Authority of Singapore) management of the financial institutions re-awoke that niggling feeling in me that there is something not quite right about the way our regulatory agencies are structured.

You see, most of our regulatory agencies serve at least two masters - one that is promoting the industry and the other protecting the public. Some agencies are more of one than the other. This duality of mission creates an immediate conflict of interest within the agency's decision making process. If it single-mindedly protects the public, it may over-restrict the activities of the industry, and possibly destroy it. On the other hand if it is over-friendly to industry, it will clearly compromise its role in protecting public interests.

One common refrain heard is that Singapore is very small and we have limited expertise, and therefore often the same bigwigs sit on committees serving regulatory as well as promotional roles.

The question therefore is how do we ensure that public interests are actually being looked after, and not held to ransom by big industrial interests.

In MAS's situation, how does the agency balance public interest against the interests of the the big financial insitutions? How does MDA balance the consumer needs with the mission to please the industry? How does the AVA protect us with respect to industrial poisons, without compromising big business' interests and possibly losing industrial investors?

Closer to home, how does the HSA protect medical consumers without losing big pharma investments for our biomedical initiatives?

In short, what has never been very clear is if the decision making processes in our regulatory agencies are adequately china-walled against all these conflicts of interests?