ROSIGLITAZONE, THIS IS THE END.

The DG of Health released a statement over the weekend ( carried in this morning's new daily ), cautioning medical practitioners on the potential dangers of Rosiglitazone ( tradename: Avandia ). This warning is appropriate.
Glaxo Smith Kline, the manufacturers of Rosiglitazone has been battling the action for the last 3 years. Rosiglitazone is a drug for the
diabetes that acts by enhancing the peripheral utilisation of sugar by the the body cells. It is what we call an " insulin sensitiser ), as opposed to glibenclamide ( popularly called Daonil ), that acts by stimulating the pancreas to produce more insulin ( the secretogogues ). By a large, in adult diabetics ( especially those who are obesed ), there is adequate insulin in the blood stream, in response to a glucose load, but the peripheral tissues ( like muscles ) are resistant to the insulin ( insulin resistance ), so that the glucose cannot enter the cells for metabolism. In these cases, insulin sensitisers like rosiglitazone, helps to move the glucose into the peripheral cells, thereby enhancing cellular metabolism and in so lowering blood sugar. Sad to say, there are only two groups of drug at the moment who are commercially available, to fulfill this function, namely the biguanides like metformin, and the " glitazones " like rosisglitazone. The only other member being pioglitazone.
Back three years ago, the FDA had advised the company to put in a blackbox labelling, warning patients that there are risk with the use of rosiglitazone. They did not wish to ban its use. Recently, the FDA had again asked the company ( GSK ), to put an additional box labelling. They still did not wish to ban it. The UK Medicines and healthcare products Regulatory Agency ( MHRA ), has called for the drug to be removed, citing that it is a danger to health. Looks like the DG of Health Malaysia, has come to the same conclusion. However, he did not ban the use.
I can understand why? Afterall , we have only two group of drugs to help diabetics who have insulin resistance. Banning one of them ( " glitazones " ) will only leave us with Metformin. And as we all know, some patients cannot tolerate metformin, or should they have renal failure, they can't take metformin. Then what do we do? If we do not have the " glitazones "?
Anyway, what is the problem with rosiglitazone?
4 years ago, data came out from clinical research, that when they followup patients taking rosiglitazone, there was an increase incidence of water retention and swelling, almost like heart failure ( earlier posting ), and later it also became apparent, that there were more heart attacks amongst the diabetics taking rosiglitazone. Because of this increase incidence of water retention ( fear of heart failure ) and also increase incidence of heart attacks, the first warning came out. What made it worse was when the news first broke of these adverse effects of rosiglitazone, the manufacturers denied it. In fact, there were reports alleging that they were trying to hide the facts. That made us all very angry. It is now obvious, that there is some merit to the dangers reported. Now, the day of reckoning has come. Looks like more and more government will caution against the use of rosiglitazone, citing that the dangers of rosiglitazone far outweighs the benefit.
What I would like to know is if I have an obese patient with insulin resisitance, who cannot tolerate metformin, what shall I do?

PAY RISE FOR PRIVATE DOCTORS

I almost forgot.

I spend the whole of yesterday afternoon at the MOH, to discuss amendments to the fees schedule mandated in the Private Healthcare Facilities and Services Regulations. We had help from some unexpected quarters. The meeting ( these meetings had been going on for months with any action ) began by the chairman ( Deputy DG- Bahagian Amalan MOH ), informing us that the Prime Minister is enquiring why private doctors are so lowly paid ( I almost fell off my chair ). Apparent a patient complaint to him. He has asked at the cabinet meeting on Wednesday, for MOH to look into it and report back to the cabinet. So the Minister-MOH, is asking the Task Force for the Fees Schedule Amendment, to look into it quickly and make a proposal.

I had proposed at the previous meeting in early September that as an interim measure, all fees in the fees schedule to be raised by a factor of 30% to keep up with inflation. We are mindful of the fact that the 13th fees schedule was based on the MMA 4th schedule which was drawn up in yr 2000, and it is now 2010. Adjusting for an annual inflation of 3% over 10 years, we have asked for an increase, across the board of 30%. This was accepted and we are now rushing through all the details so that we can present a draft to the cabinet hopefully by the second week of October. The next committee meeting to finalise this is on 7th October. Of course, the draft will include all that is missing from the 13th schedule and all the anomalies hopefully will be corrected. No more multiple codings, and unbundling. The final draft will be presented to the cabinet, then given to AG chambers for " legalising " and then implementation.

Let see what happens. It is almost too good to be true. I won't go and order my new car just yet.

ALL FEEDBACK AND SUGGESTIONS WELCOMED. THE NEXT MEETING OF THE TASK FORCE COMMITTEE IS ON 7th Oct 2010, to finalise.

ARE NEW INNOVATIONS NECESSARILY BETTER FOR PATIENT CARE

I must say that I am troubled by some of the innovations are new therapies presented to the medical community by the US medical industry last week. Three items in particular merits attention and will certainly drive up the cost of healthcare ( in my opinion ). I am waiting to see how NICE of UK will view it.

1. Last week, we saw the FDA approving the use of Dabigatran for the prevention of strokes in patients with atrial fibrillation. Atrial fibrillation ( quite a common arrhythmia in the elderly ). In these patients, the heart beat becomes irregularly, irregular, and make them prone to strokes, especially if they also have diabetes , hypertension. Currently, I treat them using drugs to control the rate ( so that it does no beat too fast ) and anti-coagulate them with warfarin ( rat poison ). It is true that warfarin has a narrow therapeutic index and close monitoring is required, with regular blood test ( RM20 per test ). A complaint patient helps in the monitoring of side effects ( which includes life threatening bleed ). It has served my patients well for so long. Warfarin cost a few cents a tablet. Now, some clinical trial data has come out in support of a new anti-thrombotic agent call Dabigatraned ( by Boeringher-Ingelheim ) which has been proven to reduce strokes in patients with atrial fibrillation. This new drug does not require meticulous monitoring ( easier to use ), but cost RM 20 per tablet and you need 2 tablet a day. Since atrial fibrillation is usually chronic, patient may need it life-long. Can you imagine RM 40 daily for one drug? I am concern that with shrewed marketing, it may become the norm, and so healthcare cost will go up. I am also concern as to what longterm adverse effects this drug will have?

2. I also read that at the ongoing TCT meeting ( this Transcatheter Therapeutic meeting is probably the largest interventional cardiology meeting in the world currently and is use as a show piece to showpiece all the latest innovations in interventional cardiology ) in Washington, some US investigators have presented some positive results in the use of a percutaneously inserted valve that can be used as a valve replacement in patients too sick to undergo. The trial is called the PARTNER trial, and it showed that the percutaneously inserted, implanted aortic valve helped patients who would otherwise only have medical therapy. There are too issues with this trial. Firstly, this percutaneously valve system, cause about RM 100,000 each. Secondly, it is very difficult to use and should only be used by people who have substantial training. The indication for the use of this percutaneously inserted valve is also very vague. Patients unfit for surgery, can be interpreted in so many ways. Those who are unfit, in a vigorously audited medical system, may be entirely different from " unfit " in another self conflicted, unaudited medical system. I have heard it been said like this, " now we can put in an artificial valve without the need for operation. Your father is too weak for surgery ". Whatever it is, it is bound to be abuse. Maybe any patient age 70 yrs and above maybe offered this percutaneous valve, under the pretext that age makes one not fit for surgery. This will definitely raise the cost of healthcare.

3. I also read that at this same TCT meeting in Washington, our US colleagues have started experimenting the use of robotics in angioplasty. It saves the physician from too much radiation, and the procedure is suppose to be faster with the use of less contrast dye. I am sure also at added cost. I have no experience with robotics angioplasty. I can only say that nowadays, we interventionist are quite good and have learned to do cases quite fast and safe. I am very worried that robotic systems ( these can be purchase by any businessmen ), put in a cath lab with any physician with little training and used on patients. I am sure this cannot be cheap. I do not think that this is good for the patient.

This brings up the next question. It what is innovated by the Americans good for patient care? How do we decide that matured treatment techniques, is good enough and we do not need expensive toys to do what an able bodied physician can do? I am very concern that what the Americans can do is good and we must follow them? How then can we contain healthcare cost?

CAROTID STENTING OR ENDARTERECTOMY, FOR CAROTID ARTERY STENOSIS?

The carotid artery is that artery which carries blood supply to the brain. Any interruption with the blood flow to this artery may result in lost of brain function, if acute, we call it a stroke. There are two carotid arteries ( left and right ), just as there are two sides to the brain, the left half and the right half.
The carotid artery, like all arteries in the body, is prone to cholesterol deposits ( atherosclerosis ), which has the same risk factors as cholesterol deposits in heart arteries, namely cigarette smoking, hypertension, diabetes, raised serum cholesterol levels, familial, etc..
The carotid arteries can become narrowed to various degrees and when blood flows through them, the cholesterol deposits can flake ( washed ) off, and travel along the artery until it lodges in one of the small end arteries, blocking it off. This will then cause lost of brain function of that part of the brain resulting in lost of motor power, lost of vision, lost of speech, etc.. Sometimes the small cholesterol flakes, then dislodges ( luckily ), and the blood flow is restored again, so that the lost of brain function is temporary. The motor weakness is but for a few minutes, before it is restored again. We call this a transient ischemic attack ( TIA ). If the cholesterol flake is too large, it may not get dislodged or cleared, the lost of function may become prolonged or even permanent, and we call this a stroke. So a TIA is usually the result of a small blood clot or cholesterol flake, flying off a cholesterol deposit, and transiently blocking of a small brain artery, and a stroke is when the blockage is permanent and the deficit remain permanent.
This gave rise to the strategy that we must clear all cholesterol plaques in the carotid artery. In the good old days, we use to practise that if a carotid artery narrowing is >70% and the patients has had TIAs, then the blockage should be removed. In the 70s and 80s, this was done surgically, by a procedure called carotid endarterectomy ( literally opening the carotid artery surgically, and shelling out the inner layer of the artery, which contains the cholesterol plaque ). You can imagine that this is a major procedure, not without its own risk. But surgeons got better and those who do a lot if it ( pass the learning curve ), had very good results. There fore removal if the cholesterol plaque was an attempt to prevent TIAs and strokes.
With the advent of coronary angioplasty, vascular interventionist began to copy the idea, and felt that they can also use the balloons and stents, to clear carotid artery blockages. It is true, they can and the post procedure pictures look great and pretty. The narrowing is nor more, but did it do good for the patient?
Since the 90s and early 21st century, numerous clinical trails had been done to see if carotid artery stenting, is superior, or at least, not inferior, to carotid artery endarterectomy.
Well, the long and short is that carotid artery stenting is inferior to carotid artery endarterectomy.
This blog is prompted by a Lancet September 10 paper, which reported on a meta-analysis of three big trials comparing carotid artery stenting with endarterectomy ( the Carotid Stenting Trialist Collaboration ), and also a presentation at the just concluded American Neurological Association annual scientific session, on the CREST ( Carotid Endarterectomy Vs Stenting Trial ). All the reports showed that carotid endarterectomy was better in terms of stroke prevention, but suffered from an increase rate of heart attacks, post op, and was not so good for older ( >70 yrs ), patients, Stenting was inferior in all the primary outcome indices and had a higher TIA and stroke rates, especially peri-procedure. The results are highly dependent on the centers and surgeons doing carotid artery endarterectomy had to have specially certification.
Yet, it is somewhat disheartening to note ( as an interventionist ) that many interventionist are doing carotid artery stenting, having had very little training and they are literally learning on the job. And these procedures are not cheap, in terms of financial cost and patient physical cost ( morbidity and mortality ).
I do not do carotid artery stenting, as I feel that it should left to people who are trained in this and who do tens if not hundreds of this a year. You cannot get pass your learning curve, if you only do 2-3 a year. I am an interventional cardiologist.

TAI CHI HELPS HEART FAILURE PATIENTS. IS IT MOTIVATION AND SELF BELIEF?

Dr Gloria Yeh from Beth Israel Deaconess Hospital Boston, presented an interesting paper at the recent Annual Scientific meeting of the Heart Failure Society of America 2010, entitled " Tai chi exercise improves quality of life in patients with chronic heart failure in a randomized controlled trial. "
This group from Boston studied 100 patients with class 1-3 heart failure and documented LVEF of <40%. They were divided into two groups, 50 doing Tai Chi, twice weekly for 12 weeks and the other group were given education and tutorial classes on heart failure rehab., and reading materials, twice weekly for 12 weeks. At the end of the 12 weeks period, there was no difference in the measured heart unction indices like 6 minute walk time, peak O2 utilisation on a bicycle ergometer, or BNP levels. But those patients on Tai Chi had a much better quality of life. They were able to do more activities, and had a more positive outlook. Granted, all these are very soft end points, but they were obviously better off.
Interesting, but I must say that the study design could be better. Perhaps, a larger patient cohort may have helped. 50 in each arm is a small number. I am sure that you could get more than 100 heart failure patients in Boston area. It may have been reasonable to measure improvements over followup of 1 - 5 years ( if funds allow ), how many were re-admitted for heart failure ( an index used in many heart failure treatment clinical trials ).
Nonetheless, we can say a few things. Obviously Tai Chi, is not contraindicated in heart failure patients once they are treated and controlled. Secondly, motivation and a positive frame of mind is very important. Acceptance of one's condition and motivation to move forward in life makes all the difference. Drugs and medical therapy is obviously important, to improve survival, but living life to the fullest, is what it is all about. What is quantity without quality?

EAT MORE POTASSIUM SALT TO LOWER BP

For a longtime now, we have been advocating a low salt diet to lower Blood Pressure, as exemplified by the DASH diet. There have been so many studies that have shown that, and it is something that we can do, that is virtually free ( in fact there may be cost savings ) and also without side effects.
The Arch of Internal Medicine, Sept. 13, carried a research paper by a group of Dutch workers led by Dr Linda A J van Mierlo, which showed that increasing dietary potassium intake, reduces blood pressure and more importantly, clinical events, especially strokes, heart attacks and heart failure.
What the Dutch researchers did was to go into on-line database ( as is the trend nowadays ), and look at all the clinical trials and surveys, that had records of dietary potassium intake and also blood pressure recordings over time. They collated the data and analysed it. They accepted the US Nutritional recommendation of an optimal dietary potassium intake of 4.7gms of potassium daily. They worked out that most countries across Asia, Europe and USA had mean dietary potassium intake lower than the recommended. For example, the mean dietary K intake in China is about 1.7gm/day, USA 2.7gm/day, UK and most European countries 3.7gm/day. They also found that if we were to increase our K intake to 4.7gm/daily ( this is theorectical calculation and extrapolation ), we will be able to reduce the incidence of stroke by 8-15% and deaths from CAD by 6.11%, almost as good as a low salt diet, and almost as good as some of the drugs. It is true that increasing dietary K intake is unlikely to control those with severe hypertension, although it may help, but it should help those with mild or borderline hypertension or pre-hypertension, which forms the bulk ( majority ) of the hypertensive population.
And whats more, the solution is easy, cheap, cost savings and for many of us , even pleasurable.
Just eat more fruits, green veges, whole grain, dairy products, and would you believe it, drink more coffee. There is some extra potassium in coffee drinking. Maybe that is why the Chinese have a low K intake ( they are mainly tea drinkers ), when compared to the English and Europeans, and Americans. We are not encouraging potassium salt supplements as tablets. Anyway, there seem ti be a difference between the various kinds of anions. It appears that potassium chloride is not as effective as potassium citrate. We would rather that each of us eat more fresh veges and fruits, eat more whole grains, and drink more coffee.
Of course the findings of this study is very much in keeping with the findings of the earlier INTERSALT study.
There is a downside which must also be said. That those who have kidney failure may need to seek the advise of their own doctors, and high potassium intake may be dangerous in patients with kidney failure.
I think that for the sake of good health, especially for those of us who are above 40years, eating more greens, fruits, whole grain, and drinking not more then 4 cups of coffee daily, makes alot of sense, and also may save many dollars.

MORE DATA ON CORONARY FRIENDLY FOODS

More data is emerging, giving support to the age old believe that red meats are bad and white meat is good, and more info on what other foods are good. This re-confirmation comes from a very important long term study called the NURSE HEALTH STUDY. The latest results from a subset analysis of the NHS was reported by Dr Adam Bernstein ( Peter Bringham and Women's hospital, Boston ) in the Aug 16th issue of Circulation. Dr Berstein studied the effect of switching protein source, on heart disease. It was a simple, but time consuming study. The Nurses Health Study, is an on-going study. For his study, Dr Berstein and colleagues, looked into the records of 84,136 nurses, age 30-55yrs. These nurses are already on follow-up for 26yrs. Every 4 years, the nurses filled in a food questionaire. They were asked to declare what kind of food that they were taking 4 yearly. It appears that the nurses have been changing from red meats to white meats, with an increase in the consumption of polyunsaturated fats and also nuts and low fats dairy products.
Dr Berstein and group found that over the 26years follow-up, there were 2210 non-fatal MIs and 952 deaths. In those who switched from red meat to fish, there was a 24% reduction in heart attacks, for low fat diary products, a reduction of 13%, and in those who switched to poultry, a reduction of 19%. They also saw a greater consumption of nuts. In those who just stop using saturated fats, there was no reduction in heart attacks. But in those who switched from saturated fats to polyunsaturated fats, there was a significant reduction in heart attacks.
This important study clearly shows that we should all eat less red meat, and more white meat. We should substitute saturated fats with polyunsaturated fats, and eat more nuts, for munchies. Oh yes, I forgot to mention that preserved meats are tabooed. Preserved meats contain much too much salt ( sodium ), and heme ( iron ) and of course fats. In another related study, the investigators found that the incidence of CAD was higher in those who consume mainly preserved red meats when compared to those who ate fresh red meats.
The other not mentioned fact is that over the last 26years, the nurses are also more concern about cardiac disease, and so live a better cardiac lifestyle. They are also probably eating less salt and should they have any hypertension or diabetes, it is probably detected at a very early stage, and so are easily reduced and controlled.
Basically, lifestyles are better and we hope that it will continue. We are however all very concerned that the rates of obesity is rising, I am not sure about Boston nurses but it is surely true all over the whole. All the good that we have done so far, may be negated by the rising rates of obesity, world-wide. We must all stay lean and mean.

MORE BAD NEWS ABOUT NSAID. RISK OF STROKES

NSAIDs ( Non-steroidal anti-inflammatory drugs ) are pain killers that we all use every now and then for those occasional troublesome bone pains and muscle pains. I was using it for a while for my left hip pains from 2005-2009. Then we became concerned that NSAIDs may be associated with an increase risk of heart attacks, which seemed to have happened in those at risk of heart attacks ( the elderly with chronic joint pains ). This worry was initially sparked by VIOXX, which incidentally was a COX2 inhibitor and not a true NSAID. Anyway, VIOXX is history, and they have all been removed.
Now I learn that a paper presented by the Danish workers at the just ended European Society of Cardiology Congress in Stockholm, showed that the incidental taking of NSAID in healthy individuals is associated with an increase in the risk of strokes. Please note that this study was in normal individuals. Led by Dr Gunnar Gislarson, they studied normal individuals in Denmark ( about half a million of them ). They were able to find this " healthy individuals because in the Danish Healthcare system, they have health records of the whole population. Dr Gislarson and team looked into all individuals who were 10 years or older, who had no hospital admission in the last two years, without any prescription for chronic illnesses like hypertension and diabetes, for the last two years, and who had any prescription for use of NSAID. They then looked at the health records to see the incidence of strokes in these people. They found that those who had taken some NSAID, who were " normal " had an increase incidence of strokes. Whose with the diclofenacs ( locally they are voltaren and cataflam ) and least with ibuprofen. The risk also seemed to be dose related. The higher the dose, the greater the risk.
This paper is important because, many " healthy " individuals take NSAID for all kinds of aches and pains, and NSAID is available over the counter ( no need for prescription ). If these agents can cause strokes, then we may have to lobby the government to take these agents off the OTC ( over the counter ) list.
Obviously, this is an epidermiological study and is not confirmatory, but it certainly makes us sit up and take note. NSAIDs can be dangerous and should not be used simply.
Only take drugs when you have to, when the benefit outweighs the risk.

Man awarded RM1.2m for losing eye during surgery.

I just read this on the on-line edition of NST. I do sympathise with Mr Megat Noor, that he has lost one eye, following surgery, but I cannot agree with the statement that he is alleged to have made ( according to NST ), following the decision of the High Court. He is quoted to have said

"Since the public pays so much for medical services, it is time we raised expectations of the treatment we receive. ". That is shortsightedness ( sorry, no punt intended ).
Firstly ( with all due respect to the Judicial Commissioner ), whether surgery would have saved the eye, or he would have gone blind anyway ( he is suppose to have a retinal detachment ), I do not know. This case was 11 years ago. Retinal detachment, a condition where the retina is detached from the back of the eye, can cause blindness. It appears that the ophthalmologist was trying to push the retina back, but failed ( ? why ), and he became blind. Something must have happened in OT, as the anesthetist was also sued. The OT nurses must have squeal ( whistle blower ).
I was concern ( this article, non cardiac, is for lay public consumption ), that if the public expect every dollar compensation for every " perceived" medical negligence then there will be consequences to the public. Firstly, cost of medical indemnity will rise. As courts award million dollar compensation, the doctor does not pay. The medical professional insurance will pay, and so the medical professional insurance fees will rise. That will result in the specialist either refusing to take on tough cases, because he no longer wish to pay for the hefty insurance cost, or the specialist will just raise his charges, to cover the increase cost of medical indemnity. For example, when I first started to practice as a cardiologist, my annual medical indemnity fees for a cardiologist, then was RM800. This year, my medical indemnity is RM4,000+. The ones paying the most are the Obstetricians ( about RM 30,000+ ). That is why, in USA and even here now, some obstetricians are opting not to do deliveries. They just practice gynaecology ( safer and medical indemnity fees less ). Secondly, if you wish your doctor to be super safe ( as if there is such a thing ), he will be very defensive. The practice of defensive medicine will mean more evaluation tests, more cross specialist consultation for every little thing ( sometimes you see 6 consultants in charge of one case, more cases going to ICU ( intensive care monitoring ), which will all lead to increase medical cost. Is that what the public want?? Even with all these defensive stunts, the patient may still die or suffer morbidity.
What then is the answer?
Looks like, on the medical end, there must be a good level of communication regarding risk of disease and risk of procedure. There must be no super sell to say that I can cure all ills. For surgery, there must be good informed consent. On the patient end, there must be a good understanding of his disease condition and not just to sue to get revenge or to get money. There must be a certain degree of trust in the doctor, otherwise go find someone that you trust. When a surgery turns sour, doctors feel it ( even though it may not be their fault ) and they empathise with the patient. They feel sorry. We only hope that the compassionate part of the doctor is more often seen, and not the money minded part. The human body is a very complex machine, created by God. No human can predict with 100% certainty what can go wrong. I have done thousands of angioplasties in my career. Believe me, I still have the greatest respect for every single lesion that I dilate. Sometimes the simplest lesion is the one that gives the most trouble. The complex ones, you have planned the steps so well, may be the smoothest one to go through.
Human doctors carry out treatment, it is God who decides the final outcome. It is humbling to know that.
Suing for revenge, so shortsighted. Is that what you want?

HOME BP MONITORING. HOW TO?

I have been asked very often to explain the importance of self BP monitoring. So I decided to write about it.
Obesity and stress are two very common problems in our hassle and bustle society. We are in a rat race, running around all the traffic jams like trapped rats. Tension and hypertension is becoming more and more common. That is probably why more and more people are buying digital BP sets to self monitor. That also means that many companies are selling ( direct sells ) of BP sets ( mostly digital ) to the public. This is not necessarily a bad thing. Creating awareness is always good. It helps prevention. The professional bodies, like the American Heart Association and the European Hypertension Society, have gone ahead to formulate guidelines for early management of even " pre-hypertension ".
The problem is that blood pressure is also a very labile entity. It rises and falls with tension and the state of mind. It is very suggestible. If you feel tension, it is very likely that you will record hypertension, which when you have less ( or no ) tension, the blood pressure may become normal rather quickly. That is just labile hypertension and not true hypertension.
Therefore, how and when you take your BP when you have a machine, and is self-monitoring, is rather important.
I always discourage my patient from spot checks when they feel tension and unwell. The chances are that the BP will be high and that drives subsequent BPs higher ( self fulfilling ). Avoid that if possible. If you are not well, see your friendly GP and get a proper assessment.
Firstly, for those who are self monitoring their BP with one of those digital machines, remember that those digital machines have IC circuits, must be properly stored and may need repeated calibration, almost every year or two years. The old fashion mercury column machines ( the one in the doctor's clinic ) is very hardy and does not require such frequent calibration.
Secondly, take the BP at the same regular hour every day as a routine. Sit down for 5 mins, try to relax before inflating the machine. Take it three times a day, say morning after wash-up, evening when you return after work and at night before bedtime. That day's BP will then be the average of the three recordings. Keep a record book. You will find that the morning readings will be the highest ( morning surge ) as our BP through-out the day also have a certain circadian cycle. We like all average readings to be 130/80mmHg or less.
Any reading between 130/80 - 140/90 mmHg should make you aware that you need life-style modification ( mainly, no added salt in food, alot of green veges and fruits, lose weight and have regular exercise ). Any reading consistently beyond 140/90 mmHg, should be brought to the attention of your family doctor.
Prevention is better then cure. Hypertension is a chronic lifestyle disease and the management must begin with life style modification.

PHCFS ACT / REGULATION : FEES SCHEDULE

The Private Healthcare Facilities and services Act was passed in 1998 and gazetted, and the Regulations to the Act was launched in 2006. On the day of the launch, the Federation of Private Medical Practitioners of Malaysia presented a memorandum to the Minister, YB Dato Dr Chua Soi Lek, declaring that the Regulations had many discrepancies and needed to be amended. There were many of the regulations that were unfair and not practical in our Malaysian context. He agreed. Then began the long journey of meetings after meetings, trying the iron out the details of the amendments to the Regulations. Till this day ( 4 years later ) we are still working out the amendments and the discrepancies and unfairness continues, and some doctors have been harressed by " little Napoleons " when they do their inspection rounds that things in the clinic are not conforming to the regulations, although the amendments were accepted by the MOH, many moons ago.
Of particular relevance was the fees schedule. For some reason ( known best to the politicians and the MOH ), doctors fees in private hospitals ( which form approx. 15-20% of the overall private hospital bill ) should be regulated and capped, but the private hospital charges ( which form 80-85% of the private hospital bill ) need not be capped. Such wisdom and discrimination, perplexes all of us. So we have been negotiating with the MOH, to revised the fees schedule. The last meeting was on the 3rd Sept 2010. The MOH is very keen to revise the fees schedule as there were allegedly, many cases of overcharging, using multiple coding for one procedure ( we call salami, they call unbundling ) and other abuses. We are keen to revise and amend because the fees schedule was base on MMA fees 4th schedule ( drawn up in 2002 ) and is now 8 years old. In fact, YB Chua agreed that the fees should be revised every 2 years. Well, it is now 4 years pass 2006 and 8 years pass 2002. So it is time for review. We have also made a point, repeatedly, that there should be no doctors fees schedule ( abolish the doctors fees schedule ), if there is no hospital's fees schedule. The point was simple, how can you justify controlling the 20% of the bills when you make no attempt to control the 80% of the bill, that rises at will? Well at last Friday's meeting, they again mention that they will look into a private hospital's fees schedule.
Anyway, this blog is to inform one and all, that the MOH has set up a mechanism to review the fees schedule. Basically, all specialist in all their different specialties will their own fees schedule working group. They will then submit their fees schedule to a Task Force Committee for vetting and coordinating. This Task force committee will then submit their recommendations on the fees schedule to the Main Committee on the fees schedule. This main committee is headed by the DG of Health with all the deputy DGs. This is the final authority.
Being of small little faith and knowing how long this will all take ( in the meantime, abuses go on allround ), I have proposed for a 20% across the board increment on the fees of the present fees schedule. ( the MMA was in support and in fact recommended a 30% increase across the board ). All procedures not in the present fees schedule, to be submitted to the present Task force, as soon as possible, so that the present fees schedule be updated and be more comprehensive. To this they agreed. Lets see how long it will take to come about.
The whole mechanism sounds very good. Almost as good as the concept of 1Malaysia. But let us see the working out. Somehow, when I set through the 3 hour meeting, I did not have a sense that they were serious, or keen to revise quickly. We were discussing over and over, what we had agreed many moons ago, and coming back to the same point. I hope that it will all come through, for the sake of the patients and the doctors, but I will not hold my breathe, waiting for it to come.
Dealing with civil servants and politicians, require a different set of skills, which many of us physicians are not so attuned to, and comfortable with.
Fees schedule for private hospitals, lets see what happens. We will keep bringing it up, whenever there is an opportunity.

LESSON 1. SIROLIMUS COMPARED TO EVEROLIMUS DES. LESSONS FROM STOCKHOLM

One of the more interesting presentation from the just concluded ESC 2010, Stockholm, is lesson 1. As we all know, interventional cardiology has advanced by leaps and bounds. I must say that the transition from bare metal stent to DES ( drug eluting stents ) at the turn of the century, is revolutionary. As a result, the DES stent market is now very competitive and each stent is trying to outdo the other in marketing, so that they can increase their market share.
On the clinical end, we have ( as physicians ) seen the evoulution of the first generation DES ( Cypher and Taxus ) to the second generation DES ( Endeavor, Xience V, Promus, and maybe biomatrix ), and in the horizon, we see the third generation undergoing intense clinical study, and waiting to burst into the market.
Yesterday, I received a text message from a stent company staff telling me that their DES has outdone the benchmark first generation Cypher, in the latest clinical trial, just presented at ESC 2010 at Stockholm. The clinical trial is called LESSON 1. So I decided to look into it. The market earlier had told me that the result is borderline, even before the presentation. ( We always have corridor talks and hunches. I must say that in my experience, hunches have more often been right then wrong ). Anyway ..............
LESSON 1, is a clinical trial led by Dr Stephen Windecker, a prominent interventionist from the University of Bern Hospital. He studied 1342 matched pairs of patients. Half of them had cypher implanted, in the early years, with 3 year follow-up, and then matched them with the next half who had Xience V implanted. They were propensity matched, and followed up. The primary end point was death, MI and TVR ( target vessel revascularisation or restenosis for the laymen ).
Well, the corridor talk is correct. If you take the primary end point, the P value is 0.056 ( near but not yet significant ). If you massage the results a little and do some unbundling and cheery picking, you will find that the Xience V stent, did do a little better in terms of less stent thrombosis in the early years and also less target vessel revascularisation.
The long and short is that from LESSON 1. we learn take the second generation DES is a little better then the first generation -limus DES. We know that. That is why we called them second generation improvements.
But, in my opinion, LESSON 1 was not a very fair trial. From the first group of patients to the second group of patients, interventionist have become wiser as to when, how and how to implant DES better. The technical aspects have improved overtime. We also began to understand stent thrombosis better ( especially after 2006 Barcelona when we faced the stent thrombosis storm ). We then became more obsess with dual anti-platelet therapy, and the importance of continuing.
It is of course true that the Xience V DES is physically better, having learned the lesson from cypher as to how not to have too thick a polymer coating and also what dose of everolimus is optimal. Of course the Xience V stent is of much thinner strut and much easier to deploy.
Basically, what I am trying to say is that LESSON 1 did not tell us what we did not know. It confirmed what we knew all along, when Xience V was launched. Xience V is technically a better stent, and the Cypher stent is one generation earlier. That also means that we have better knowledge of cypher's long term behaviour. As I always tell my patients, a stent implanted is permanently there in your body. Long term results about their good and bad effects are very important. In business, you call it track record. The cypher stent has a longer track record ( a track record of about 10 years ). The Xience V track record is half that.
Xience V may be technically a better stent, but how will it perform in 10 years, only time will tell. Cypher has that record already.
There is no easy answer. That is what makes interventional cardiology and medicine, so interesting. The debate goes on.

THE UGLY SIDE OF THE BUSINESS OF MEDICINE. THE NEED FOR MEDICAL AUDIT

Recently, two US interventional cardiologist, both in Maryland, had been indicted by the US Federal court on charges of medical fraud, including the implantation of unnecessary coronary stents. I believed that one has been found guilty and the other is awaiting trial. Besides many other irregularities in their practice, they were alleged to have implanted stents in lesions that did not require them. Sounds familiar. I believe that the medical insurance fraternity in USA is looking into many other centers to see how rampant the problem is.
I must say that as a senior interventionist in this country, I have also heard of many such instances of stents being implanted for patients with almost no symptoms and lesions of almost no significance. But then, those who complain unofficially usually have a conflict of interest. I have always maintain that should such practice occur, a report should be made to a neutral body and both sides of the story be heard as it is a very serious allegation.
I fee l in someway responsible because when we started the coronary angioplasty program in this country in 1988, that was what we advocated, thinking that there was cost savings. What do I mean.
In 1988, after the intensive training program by Dr David Clark and Dr Tim Fischell, both of USA, we began to do angioplasties. That was the start of the angioplasty program. Dr Clark and Dr Fischell, had both advice that we should do the diagnostic angiogram, and discuss the findings with the patient and also get cardio-surgical backup ( this was the era before the introduction of coronary stents for bailout ). Therefore, angioplasty was not performed at the same sitting as angiogram. Probably about 2-3 weeks later. That was how we started. Then we began to hear patient feedback that it would have been more cost effective and time effective to do the procedures, one following the other at the same sitting. Some of the feedback implied that we were separating the procedures so as to gain more fees ( something I was very uncomfortable with ). You see how things change.
Then was got the coronary stents and cardio-surgical standby was much less an issue. And with cost savings in mind, we told the hospital that since coronary angioplasty is always preceeded by a routine check coronary angiogram, when angioplasty is done at the same sitting, the coronary angiogram fees should be waived by the hospital. To this, they agreed. We then begin a startegy to brief patient on coronary angiogram and coronary angioplasty, during the clinic and pre-angiogram discussion / consultation, explain all the risk and benefits, and proceed to list for coronary angiogram +/- angioplasty. Upon completion of the angiogram, when a significant lesion ( usually a lesion narrowing of 70% or more ), we would then again ask permission from the patient and relatives waiting in attendance, the consent to proceed on to angioplasty. This then slowly became routine, I believe for the country. All was done in one admission and only angioplasty fees were levied. Nice and tidy.
Little did I realise at that time that I was committing a gross error in medical audit. That I was the one who decided on the need to do the angiogram, and that following the angiogram, I was also the one to decide on the need for angioplasty. I was severely conflicted and my decision may be open to questioning.
This may have contributed to the many " so-called " unnecessary stenting that some are now accused of doing. In the initial strategy of separating the angiogram from the angioplasty, the patient had a chance to leave the angio suite, back to the ward, consult their friends and relatives, and maybe even a cardiac surgeon, and then return ( if he/she so wishes ), for the angioplasty.
Should we now return to this strategy? seeing what is happening in the USA. The Europeans, ( many centers are also doing the same as us ), is now advocating a return to the old ways. They call it a heart team. Each medical center will have a Heart Team. After each angiogram, the findings will be presented to the heart team and a collective decision made as to the need for optimal medical therapy, angioplasty, or bypass surgery. I suppose this is ideal, but is it enforceable in Malaysia? At this point in time, I really doubt it.
I suppose, my thoughts were to throw this out in a blog like this and to continue to educate the public. At the end, it is the payers, who will decide and control what a doctor can and cannot do. Those are the facts of life. Is the future going back to the past?

STATINS, LOW LDL-C AND CANCER RISK

This question again came up at the concluding ESC 2010 ( European Society of Cardiology Congress 2010 ) at Stockholm. The UK cardiologist have formed a Cholesterol Trialist Collaboration group, much like the anti-platelet trialist collaboration group and the aspirin trialist collaboration group. Led by Dr Jonathan Emberson of Oxford U-UK, the CTT group meta-analysed 21 clinical trials on Statins and heart disease, involving 130,000 patients. There was also a separate meta-analysis performed on a further 5 studies involving 40,000 patients comparing different statin doses and heart disease. Although these studies were all not primarily statins and cancer studies, the collaborators were hoping to see if people taking statins had a higher incidence of cancers went compared to placebo, at least up to 5 years follow-up.
Well the findings were that, taking statins did not put one at risk of cancers, up to 5 years. Low LDL-C did not put one at risk and the risk of cancers were also not dose related.
That is all well and good. Except that the data is up to 5 years. What happens after that? I suppose we are quite sure that statins does not cause cancers. What we are perhaps not so sure about is whether taking cancer puts one at long term risk.
Cancer is a rather complex disease. It can involve so many different organs with so many different outcomes. It is unlikely to be uni-factorial. More likely multi-factorial. Does taking statins, and having a super-low LDL-C, predispose one to the risk of cancers. Will statins, or super-low LDL-C, alter the cell structures, or alter the immune system, in such a way as to alter the triggers of programmed cell death ( apoptosis ), or does it affect the telomeres of the cells, all these after more then 5 years of course.
Looks like the data to 5 years of statins, is good. Statins is quite safe. More then 5 years, lets see? I am sure that the CTT group will be following up the cohort and will be reporting to us again.
Whatever it may reveal later, the saying is true, " Only take medications when the benefit outweights the risk, or potential risk ". No one should take any medication " just for the fun of it ". We never know what can happen 20-30 years down the road. This strategy, to drive LDL-C as low as possible, has some meager benefit, but does it outweight the risk? at the moment, only God knows.