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.

Traditional medicine and all that Andy Ho stuff......

Andy Ho did us all some service when he wrote that pretty accurate piece about the placebo-ness of traditional chinese medicine (TCM). Pity, but expectedly I suppose, he caught a lot of flak over the articulation of those truths.

What disappointed me most in the whole episode was the realization that the Singapore Medical Association was all for the legitimization of TCM, because by their response, they are signalling rather publicly their intent to maintain their role as a trade guild rather than a professional association. It's all about earning those few extra bucks peddling snake oil if necessary, since the patients seem to want it. Shame, shame.

So what is traditional medicine? Really nothing more than a primitive form of rationalized medicine based on empirical observations. No mystery. Nothing more, nothing less. The Chinese are not the only people who engaged in such practices. Our good old friend Hippocrates, whom many of us would regard as the father of modern medicine, was famous for his practice of observational medicine. Not that his theories were correct, or that his cures are still being applied today, but he based his practice on rather astute but emprical observations of the world around him at that time. So did many physicians over the years, until modern scientific theories caught up with practice of medicine.

TCM is the Chinese form of that empirical practice. It has maintained its mystique today to a large extent because in the isolation of the cultural revolution, TCM was pretty much all that was available in rural China. Now that mystique is carried by the sentimentalities of the very (very) large Chinese diaspora.

One can predict, very legitimately, that traditional or TCM when brought to its logical conclusion will very much resemble modern medicine. Useful herbs are of limited utility until the active ingredient is identified, purified and proved in clinical trials. Until that happens, TCM will remain a fairly emirical practice. Placebo effects? Perhaps.

So let's be very clear about it. TCM is a stunted version of rationalized medicine. There may be some limited utility to the herbs being used, but it will remain stunted because of the empirical environment it remains locked within. Much research is required, and much willingness to move out of the box of traditional sensitivities.

The SMA needs to get back to basics and hold on to the truths and defence of science and professionalism.

Ineffective screening for breast cancer?

A new study published in the British Medical Journal has raised new questions about the effectiveness of large scale breast screening programmes.

The report in Times Live can be found here. The abstract of original paper in the BMJ here.

The Danish study reports that they were "unable to find an effect of the Danish screening programme on breast cancer mortality. The reductions in breast cancer mortality (they) observed in screening regions were similar or less than those in non-screened areas and in age groups too young to benefit from screening, and are more likely explained by changes in risk factors and improved treatment than by screening mammography."

Late last year the U.S. Preventive Services Task Force (USPSTF) revised the recommendations for screening mammograms in women between 40-50 years of age.

Methinks it's about time our breast oncologists did some serious and honest review of the situation, though I seriously doubt they will say anything other than to defend the need to do lots more screening.

Unethical screening - a timely warning

Minister of Health's recent blog on the ethics of unnecessary screening is very much welcomed.

There has been too much alarmist report of late particularly related to cancer screenings, many of which are nit really borne out by evidence based logic. It is easy to fuel panic and guilt. We have commented on the mammogram issue before.

Once we could count on the government hospital to do the essential, and only the essentials. The necessary and the needful. But nowadays, the government hospitals have become 'restructured' and often compete with the private sector for business. Who do we go to for sound advice on what is really necessary? I would really like to see the HPB come up with a sound evidence-based advice for the patient consumer, instead of just telling what services are available.

Meanwhile, caveat emptor.

More on mammograms

Singapore M.D. reminded us about the recent guidance provided by the US Preventive Services Task Force on the relative uselessness of mammograms. No doubt the post was instigated by Minister Khaw's recent blog on the use of medisave for mammograms.

I had posted on this previously. I hope rational thinking will prevail here, and that we return to a clearer practice of evidence-based medicine.

Seems like too much of recent public health utterances have been based on fear mongering rather evidences of real therapeutic benefits. "Do this, or you will get cancer, or die....and it will be all your fault" seems to be the mantra, nowadays. One wonders if the rationale is driven by altruist concern for patient's well being, or just commercial returns.

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?

East vs West - Minister Khaw's endorsement of anecdotal medicine?

I have to confess I was more than a tad disappointed by Minister of Health, Khaw Boon Wan's blog about his positive experience with TCM. No doubt he was narrating a personal experience, but it sounded too much as if he was endorsing an anecdotal approach towards the practice of medicine.

Is this the death knell for evidence-based medicine?

Cervical cancer and the Pap smear - another set of revised guidelines

Following upon the mammogram revisions, the American College of Obstetricians and Gynecologists have issued their own guideline revisions for the Pap smear in young girls. But not much debate here.

The timing of the revisions is pure coincidence, they say.

Mammogram madness - where is the objectivity?

A raging debate has emerged in the US over the recent release of the report by the U.S. Preventive Services Task Force (USPSTF) revising the recommendations for screening mammograms in women between 40-50 years of age. Stridently vocal critics of the report argue that this was part of some cost cutting measures, and that relaxation of these guidelines would lead to breast cancers not being detected early in these women and consequently more cancer deaths. The trouble with the arguments from these critics was that there was little to offer other than anecdotes.

The debate did focus my attention on how difficult it is to get truly objective information. I don't really know too much about who is right in this debate, but it did seem to me that at least the Task Force did try and base their findings on objective scrutiny of evidence. What disappointed me was that the major physician and oncology groups just lent their voices to the din by adding more and more anecdotes to support screening. Where is the objectivity? Where is this much touted 'evidence-based' medicine? (see NPR Report)

My question is, can we count on doctors to be objective in their recommendations? Can we even count on governmental reports to be objective given that governments themselves have become players themselves in this game of medical monopoly.

In a recent CNN report Alice Park writes: "If the brouhaha following a government advisory panel's recent change in breast-cancer-screening recommendations has proved anything, it is that even modern medicine does not rely on statistics, scientific facts and clinical outcomes alone."

How true. How sad. Oncology groups tend to gain by increasing hype and hysteria since they result in more screening, and more early treatment revenues.

This debate will not end soon. So far the Ministry of Health and Health Promotion Board have remained silent. How objective will they be, I wonder?