Tuesday, April 24, 2012

The bathtub effect? A Singapore problem.

When Transport Minister Lui Tuck Yew was recently pressed on why newer train systems were breaking down, he attributed this to the "bathtub effect". This is a cutesy metaphor that engineers like to use to give the impression that they have a human side, and that they do take baths.... sometimes. Essentially the metaphor refers to the high frequency of breakdowns in machines early during installation, and then again much later in its life cycle. The breakdown frequencies show a bathtub shaped curve.

The early breakdowns are usually due to the operator being relatively naive. The later breakdowns are due to the expected wear and tear when the machine nears the end of its lifecycle.

By referring to the bathtub effect, Minister Lui is essentially telling us that the SMRT had synced the train systems so well that the old system was failing at the same time as the new ones were. The sides of the two bathtubs were in perfect alignment. Well done, guys! You were precise about this, at least.

There is actually another interpretation of the bathtub effect. This is a metaphor used more by environmental scientists. Essentially here, the bathtub represents that container where the water level is determined by the rate of water flowing in and the rate of water draining from it.

The ENV people know this very well as this is the cause of the frequent 'ponding' observed in recent times, during heavy rainfall.

This is actually a more important interpretation of the bathtub effect, because it explains so many of the problems we see in Singapore nowadays. So much of the Singaporean angst, whether it is about housing, transport, healthcare or education is really about the water level in the bathtub. The capacity of these systems are woefully inadequate compared to the demand. So the water overflows from the bathtub.

One can't help wondering why this is so. Considering the 'excellence' of our civil service and that the government has had uninterrupted power for such a long time, it seems a critical neglect that they have gotten the models all so screwed up. Why they did not anticipate the rate of population growth and did not build enough capacity to cater for this growth, I simply cannot understand. Was it because all these scholars were so blind that they did not see the threat of overflow? Or was it that they were all only concerned about short term KPIs? Let the bathtub overflow on someone else's watch! 

So much for a government that claims credit for long term planning. So, thank you Minister Lui for sharing with us this important metaphor. Now we understand why the bathwater is ponding all over the living room floor.

Friday, April 20, 2012

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.

Wednesday, April 18, 2012

Research misconduct: continuing concerns, and the great wall of silence

As perhaps a sign of the increasing global concern about what appears to be an epidemic of misconduct among the scientific community, the New York Times has published an article titled "A Sharp Rise in Retractions Prompts Calls for Reform" by Carl Zimmer.

In it, Dr Ferric Fang, Editor in Chief of the journal Infection and Immunity is quoted as saying  "Nobody had noticed the whole thing was rotten."

The article further reports that "Dr. Fang became curious how far the rot extended. To find out, he teamed up with a fellow editor at the journal, Dr. Arturo Casadevall of the Albert Einstein College of Medicine in New York. And before long they reached a troubling conclusion: not only that retractions were rising at an alarming rate, but that retractions were just a manifestation of a much more profound problem — “a symptom of a dysfunctional scientific climate,” as Dr. Fang put it."

Should Singapore be concerned? The answer is an obvious "Yes!"

Yet there is this great wall of silence, as if no one wants to talk about it or publicly deal with the problem, potential or real. Alirio Melendez's publications have been under investigation for too long with any resolution. But not only Melendez, a number of other big and not so big names have been flagged out by blogs such as Abnormal Science. In these there are allegations of self plagiarism, image manipulations, data mislabelling etc. Yet there has to date, been no public acknowledgement of these problems, exoneration or evidence of any actions taken. Sadly silence just serves to condone such practices.

I think we owe it to our students and future generations of scientists to deal promptly, impartially and publicly with these problems.

Saturday, April 14, 2012

Happy Vaisakhi!

Wishing my Punjabi friends, a very happy Vaisakhi. Have a great time today!

HSA and the regulation of medical devices - an exercise in agenda setting?

The theories of agenda setting are well known, I believe, to all mass comms graduates as well as journalists. Although the formal theories were only formulated about 40 years ago, ideas that the media can influence public opinion have been recognized since the early part of the 20th century.

The recent brouhaha about the regulation of medical devices by the HSA can perhaps be seen in the context of agenda setting. That the media plays an important role in agenda setting is beyond doubt. How the agenda is set however depends on who plays the media. To the media savvy, the media becomes a collaborator in the shaping of public opinion. A media-savvy politician therefore gets a pretty smooth road.

Where HSA failed has been in not recognizing how important the management of public expectations was in the implementation of complex and public-sentiment sensitive policies such as the regulation of medical devices. By defaulting on this, it has willy-nilly allowed the media to set the agenda in a direction contrary to public policy. So, not only has the media been allowed to tell us what issues are important, but it is being allowed to tell us what opinion we should form  about the issue. Note the teaser on the front page of the Straits Times today - "Patients should worry about vanishing medical devices". Really? Vanishing medical devices?

Poor HSA CEO John Lim is in the hot seat now. It seems like it is the fashion nowadays to run down the CEOs! I am waiting for the day when someone flashes an old D&D picture of him on a sedan chair carried by half maked women! But it should be recognized that the move towards regulating medical devices had not been developed overnight, but has been on the stove for about a decade. During this decade, the policy has been deliberated and refined under the guidance of 2 Ministers of Health and 2 Board Chairmen. I guess the second team has been quite unlucky to be on watch when this policy was finally ready to be implemented. But seeing how the SMRT issue developed, it seems highly unlikely even this team will get any credit for the mess. So, sadly, it looks like CEO John Lim will be the one catching the ball.

Wednesday, April 11, 2012

Research misconduct - the ball passes to the institutions....

A consortium of journal editors have ganged up on institutions that have previously employed disgraced Japanese anaesthetist Yoshitaka Fujii, asking them to authenticate up to 193 publications, or else these publications will be retracted. These allegations were based on a letter by John Carlisle, published in the journal Anaesthesia. (See letter by Editors).

Yoshitaka Fujii has been the subject of alleged scientific fraud since 2000 when a group of researchers led by Peter Kranke accused Fujii in a letter to the journal, Anesthesia & Analgesia. Despite these allegations, neither journals nor institutions that Fujii worked for, attempted to do anything about it. Anesthesia & Analgesia, in fact, continued to publish up to 10 papers by Fujii. The University of Toho eventually sacked Fujii in February this year, for ethical breaches in a number of studies.

What has been exceptional in this recent move by the journal editors, has been the bold, albeit overdue response to act on these allegations of fraud. The threat to retract 193 publications if carried out will represent the most drastic journal action for serial scientific fraud ever. The public communication between the consortium of journal editors and Japanese institutions may represent the first such concerted action to force the institutions to take research misconduct seriously. This passes the ball back to the institutions. Let's hope that institutions around the world will not continue to buat bodoh about allegations of research misconduct. There is no place for Lord Horatio Nelson in research.

Monday, April 9, 2012

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.

Saturday, April 7, 2012

Regulation of medical devices? What shocking news?

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

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

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

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

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