Monday, September 29, 2014

CURRENT STATE OF HEALTH THERAPIES AVAILABLE FOR PATIENTS AND CONSUMERS ( besides conventional, evidence based medicine- EBM ).


I was asked to reply to an article that appeared in the Star yesterday entitled " The Art of Dispensing Drugs".

This is what I wrote. I would like to post it here.

INTRODUCTION
There are currently 4 forms of heath therapy.
1.       Firstly there is Evidence Based Medicine ( EBM) . This is commonly called western medicine,  which has been extensively studied, has a lot of clinical data, with set training programs ( undergraduate and post graduate ) and with clinical practice guidelines for their use.
2.       Secondly there is alternative therapy. This refers to the use of approaches that are not part of EBM medicine but is used  as replacements for, rather than complements to, EBM.
3.       Thirdly complementary medicine. This refers to a group of diverse medical and health care systems, practices, and products that are not generally considered to be part of conventional medicine ( EBM ).  This Complementary Medicine is often  practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals such as physical therapists, psychologists, and registered nurses. . Complementary medicine includes natural products, such as dietary supplements, herbs, and probiotics, as well as mind and body practices, such as meditation, chiropractic, acupuncture, and massage. This form of therapy is very common and is often used together with ( complements ) evidence based medicine.
4.       Fourthly, there is integrative medicine. Integrative medicine combines conventional and complementary approaches in a coordinated way.
      Number one we all know well and has proven itself to be safe and largely effective ( except for a few exceptions like certain malignant diseases.  As EBM physicians, we all have taken an oath that we will first do no harm, and so EBM is largely safe. Although it is true that we comfort always, relief often and cure sometimes. Sad to say, in this day and age, there are still many conditions that we do not yet fully understand, and some we cannot cure.
      Number 2, I shall dismiss by just reminding that it should NOT be undertaken except with advise from trained professionals, because it may do harm. Stage 1 Ca Breast, which in this day and age, is curable, may be fatal, if proper therapy is delayed because of the use of alternative therapy.
     Number 3 is where we will spend some time discussing.
Complementary medicine
This is gaining much popularity because it is often perceived to be safe with no side effects and since the marketing of these therapy is not regulated as strictly as conventional medicine, the advertisements are often too good to be true. Nonetheless, worldwide, there is an increasing trend. It makes money.
A few important  points must be emphasized and consumers are advised to take note.
  1. Firstly, this market is very poorly regulated. Any registered company  can manufacture and market a product.  Before we dwell into the issues of effectiveness ( clinical efficacy ) let us spend some time on safety standards. There is little  oversight  during the stage of manufacture. ( good example can be found in milk powder manufacture in China ). There is some oversight when it comes to the Ministry of Health  for approval. Besides paper documentation, there is also batch testing of the drug and also random testing post approval. However, as often the case, for batch testing for approval by the Ministry, the company will very likely follow  all the procedure but as for random batch testing, your guess is as good as mine. Thereafter, we depend on adverse reaction reports for the seller and customer.  Again, your guess is as good as mine. So there is a big question mark over safety. There have been many who have suffered renal failure, liver failure, occult malignancies, and of course, allergies with these medications. In some ways, all these batch testing steps are easier when you are dealing with chemical compounds known to science. What about those herbal preparations which appear in almanacs and past me down records, where the chemistry department do not even know how to analyse the main ingredients. How then can you predict the effects and side effects? How then do you know it is safe when we do not even know the herbal compounds?. Some like “cordiceps” we know. There are so many that we have no idea.
2.Secondly, there is the issue of effectiveness. Obviously, complementary medicine have almost no clinical data. No one will invest in doing medical trials on complementary medicines, because they cannot be patented. Many of these complementary medicines are natural  products  and belong to nature.  So if you try to do a clinical trial on a certain product, that you cannot patent, ( after spending millions and you prove  that the product effective, your competitor will just produce their version and sell. That is why, for example, no one wants to prove the effectiveness of Co-enzyme Q10, papaya leaves for dengue, snake grass for cancers, etc etc, ( except perhaps a non-profit organization, or a government agency ).
So effectiveness of complementary medicine is based very much on here say and also a theoretical basis. For example, normal brain function uses Omega 6 fatty acid, so the more I give a young child, the better the child’s brain. In a way, I appeal to reasoning and emotions of “helping my child”. Data is lacking. The body cells has enzyme Q10 for energy generation, so if I give you Co-enzyme Q10, it will benefit you. That is the kind of reasoning. No data.
3.Thirdly, the marketing strategy for these companies are usually very aggressive. They use direct selling and unethical advertisements, making all sorts of claims, usually half truths. Regulators are over stretched to cope with them and there are usually multiple government agencies overseeing their marketing techniques, and so unless there is a death, or a catastrophe, these companies get away scott free.
Conclusion
Evidence based medicine has evidence to support its used or tell us its dangers. In that sense, its use is safe and regulated. Alternative medicine should only be embarked upon with good medical advice. Complementary medicine has little medical data on safety and effectiveness and should not be simply consumed. Many have suffered from consequences of taking the wrong complementary medicine. Some have even died. Integrative medicine will have the benefit of medical advice because it still has an element of conventional medicine.
  


Thursday, September 25, 2014

TREATING MILD HYPERTENSION IN PEOPLE AT LOW RISK

Mild Hypertension in people at low risk
                                                       BMJ 2014, Vol 349
Dr Stephen Martin ( Dept of Family Medicine and community health, University of Mass. Medical School ).

This is essentially a thought provoking editorial of the effectiveness of treating low risk mild hypertensives.
This paper is controversial. It is part of a series of papers on over-diagnosis and over-treatment                          

Introduction
                 Mild hypertension, as defined by BP of 140-159 / 90-99 mmHg ( JNC 7 and JNC 8 ) forms about 60% of the hypertensive population  presently. This is NOT a uniform class. We do have to separate them out into       1. White coat hypertension
                                           2. Primary Mild Hypertension without complications
                                           3. Primary mild hypertension with complications.
Conventional  View.
                             There is a large body of evidence that any rise in BP above 120/80 mmHg carries with it an increase cardiovascular risk of strokes, heart attacks and cardiovascular death ( example the Framingham studies and MR FIT ). There were some large scale studies which showed that treating hypertension, including mild hypertension, would reduced CVS mortality and morbidity. Most of these studies were done in the 90s and 2000. Since that time, two things have change. Medicine ( especially cardiology ) has found a new research tool. The office conducted “ trial by Meta-analysis “  and we have also realized that office BP may be erroneous and Home BP monitoring may be a better reflection of  genuine hypertension.
Till date all the hypertension clinical guidelines have been based on clinic BP monitoring and also clinical trials which included a whole bag of BP ranges. Some of those trials were based essentially on BP reduction and not on long term CVS morbidity and mortality reduction ( Just a numbers reduction ).

BMJ paper

                        What Dr Stephen and group is saying in the BMJ editorial is that we should re-think how we treat mild hypertensives discovered in the office clinics, especially the group without any co-morbidities ( the safe group, or low risk group ). Basing heavily on a meta-analysis carried out by the Cochrane Collaborators ( a group of experts who group together and analyze trials by meta-analysis ), published in 2012, together with analysis of some other studies.                         

They made a few points.
1.      1.  That the evidence for benefit in treating, safe, low risk mild hypertensives is small and may not out-weigh the risk of side effects.
2.       2. We need to encourage home BP monitoring and non-pharmacological means t lower BP
3.       3. That be treating almost 60% of hypertensives we increase healthcare cost , without any obvious benefits
4.       4. Treat the patient and NOT the number.
5.       5.  All the above does not apply to patients with mild hypertension with co-morbidities, like diabetes, or who have suffered previous CVS events like strokes, heart attacks, undergone by-pass surgery, renal impairment, etc etc.

My opinion
It is true, that we should treat the patient and not the number. We should empower the patient to
1.      1.  Do home BP monitoring.
2.      2.  Lifestyle modifications with diet, exercise, weight lost, stop smoking, prevent diabetes

My fear is that Patients may get the wrong message, that hypertension is not a serious disease. The danger from Stephen’s paper is that since it is low risk, mild hypertension is OK. That would be the wrong message for our population. There is a small risk with mild hypertension, and they need treatment but not necessarily with drugs.  They need to be monitored. In the event that they should develop co-morbidities like diabetes, then the mild HBP may require drug treatment.

And getting patients to do home BP monitoring is possible. More and more of my patients are doing it. I foresee that soon, smart phones will come with apps that can do that too.

Please know that this paper is controversial and thought provoking but is not yet the standard for medical practice.

Monday, September 22, 2014

IVABRADINE DID NOT DO WELL IN SIGNIFY.

I must say that nowadays, at clinical meeting, we are hearing reported, more negative trials.
In the recently concluded European Society of Cardiology Annual Scientific Congress,, one such trial reported was the SIGNIFY trial. This trial was to a randomised, double blinded, placebo control trial to test the benefits of Ivabradine against the placebo in patients with stable angina pectoris, without heart failure and worse heart rate was greater than 70 beats per minute. Ivabradine was a heart rate slowing drug working through the If  channel n the SA node. I suppose the investigators were hoping to show that by slowing the heart rate from 70 to 60 per minute, it would make a better outcome. The PI was Dr Kim Fox of London. The paper was also published simultaneously in the New England Journal of Medicine 371:1091, 2014. They managed to enrol 19,102 patients who had stable coronary disease without heart failure and whose heart rate was more than 70 / min. It is important to note that of the 19,000 or so patients, 12,000 or so had class 2 angina or more ( Canadian classification ). The primary endpoint was CVS mortality and non fatal MI. Half the patients were given Ivabradine and the other half, a placebo.


After 27 months of follow-up. it was true that the Heart Rate was lower in the treated arm. There was however no significant difference in the primary endpoint. But in the 12,000 patients with Canadian class 2 or more angina, there were more deaths and non fatal MI. There also seemed to be a higher incidence of atrial fibrillation in the treated arm.

Now, this last two points have given rise to some concern. We now know ( 19,000 is a large number ) that there is no point using ivabradine in patients with stable angina pectoris without heart failure. Secondly, we have to be careful in those with Class 2 or more angina, as it may do harm. Why? we are not certain.

IMPROVING PATIENT SAFETY - REPLY.

I wrote this reply to A Prof Azmi article in Saturday's Star, on "Improving patient safety".

Having read the interesting article by Assoc. Prof Mohammed Azmi, it is important to emphasize a few crucial points. What ails Malaysian Healthcare is basically a lack of funding. With 4.6% of GDP, we have done remarkably well. Healthcare transformation with greater public – private integration of course is greatly welcomed. However, retaining a two tier system of public-private healthcare is crucial to a successful healthcare system. It provides for a check and balance. This promotes healthy competition and no one is left out without the care that he or she needs. Having just a one tier system ( like NHS-UK ) would be a step backwards, as the public has less choice, greater taxation and when that one system fails ( as evident in UK now ), many now buy their own private insurance. Alas, our wish would be that with a greater Healthcare expenditure budget the public sector may be transformed to be on par with the private sector.

We all agree that improving patient safety is very important. We differ that setting up another body is the answer. Medical care has now progress from just curative medicine to preventive medicine and in the area of curative medicine, from just diagnosing and treating a condition to diagnosing, treating and also counselling. It is in this area of counselling that much can be done to improve patient care especially patient safety. Doctors are spending more time to counsel patients on their illness, and their treatment regimes. And if drugs are involved,  their effects and side effects. In this y age of information and the internet, even if the doctor fail  to mention, the more knowledgeable patient will ask. This is the best way to improve patient safety. Patients talking to their doctors, and doctors empowering their patients. That is also why we are concern about this talk every now and then to restrict dispensing to pharmacy alone. Should the government be so silly as to do that, it invites trouble. Asking a family to go searching for a pharmacy at 2 am in the morning, when a crying, wailing child has fever is ridiculous, bordering on irresponsibility, when his doctor is sitting just in front of him and can explain the medications, the effects and side effects. Yes, the pharmacist has the theoretical knowledge of the effect and  side effects of drugs. but which drug and dose is  suitable for his illness and his body, only his caring doctor knows, unless the government is of the view that all patients are the same and all illnesses are the same and one size fits all. The current system of prescribing dispensing allows for choice.  No exclusiveness, allow free choice. We are certain that this is what the patient wants, although it may not be what the pharmacists want. 

This reply was send to the Star editor on Saturday evening.

Wednesday, September 17, 2014

KEMBALI NEGARA-KU

This morning I join the Kembali Negara-Ku Piknik at Taman Jaya. I reached the site at 8.20 am and found the action point, sat down and had breakfast with y friend Dr KB Ng.

The crowd started to build up at about 8.45 -9 am. By the time the speeches started, I think (guesstimate ) there were about 200 people, who had come fairly prepared. Some chit chat, like us. Some played badminton ( father and son ), and most just sat down and ate mostly nasi lemak.
Of course the VIP was Zaid, Samad, aand Ambiga. I also shock the hands of Maria Chin ( Bersih ) and Haris Ibrahim ( ABU ). maybe there were others there that I did not recognise. I believe there were no politicians there.
After some chit chat fellowship, the speeches started at about 9.45 am with Zaid ( chairman ) speaking first, then the poem by Samad, and a short encouragement by Ambiga.
Their speeches were all short. Samad seemed rather weak. I could hardly hear him reciting his poem. To conclude the morning of fellowship, Kembali Negara-Ku Piknik, we sand Negara-Ku with some gusto and also Rasa Sayang.
We dismissed at about 10 am.
It was a simple memorable morning.
Well we are 52 years old ( half a century ), and we are still as divided as ever. This racist UMNO must be held responsible for most of this.

Monday, September 15, 2014

THE ABSORB STENT. WILL IT LIVE UP TO EXPECTATION?

In the field of interventional cardiology ( which is plateauing ), obviously the latest stent impacting us is the Absorb bioresorbable vascular scaffolding, which reach our Malaysian shores about 4-5 years ago. Of course the initial results were excellent, Absorb cohort A, Absorb cohort B, ABSORB I trial ( we are awaiting the 5 year follow-up results ) and the ABSORB II study, the prelim 1 year FU data was just released by Patrick Serruys at TCT. From the CV, looks like Patrick, the cornerstone of ThoraxCenter, Rotterdam, for so many years, have now moved to Imperial College, London ( need to check this out ). Well, Patrick released the Absorb II interim analysis and showed that the Absorb was as good as the good "old" Xience V ( good DES ), except for some less acute lumen gain. That is a minor point according to Patrick but I think that that point cannot be simply dismissed.
Anyway, between Absorb I and Absorb II, investigators ( not from the Patrick group ), the other European investigators have published the GHOST-EU registry at Eurointervention 2014. Led by Dr Capodanno, these investigators publish their registry of 1,189 patients, across 10 European Centers,  who had the Absorb bio-resorbable vascular scaffolding implanted between Nov 2011 - January 2014 ), and followed up. This seemed more real world, when compared to the "mastery" skills of Patrick and team. They found that there were significant problems. Over follow up of 6 months, there were 2.1% stent thrombosis, death rate 1.0%, target lesion MI of 2.0% and TLR of 2.5%. TVR was 4.0%. These are not small numbers. And it is only 6 months.
Of course, I have always shy away from using Absorb because Abbott Vascular's Xience Prime was working excellent in my hands and not to forget, the Xience Prime DES was much cheaper, making it more cost effective ( value for money ), except that this Xience Prime cannot disappear.
Looks like Absorb is a good stent but there are still issues to be resolved. Xience Prime is a very good stent and is much cheaper.
I hear that there is a company call Elixir, who also has a bio-resorbable vascular scaffolding. The drug is different,another -limus, called novolimus. So competition is on the way. Looks like prices will becoming down.

HAPPY MALAYSIA DAY, MALAYSIA

Tomorrow is Malaysia Day. This should be our National Day. It was the day our Sarawak and Sabah brothers and sisters join us to form the Federation of Malaysia, 16th September 1963.

Just to remind us all.
                 After 51 years of Malaysia.
                 Borrowing a line from Charles Dickens -
                                         It is the best of times, we have seen tremendous progress of iconic buildings and disconnected monorails / LRT services, a so called "booming economy" propped up by great household debt. A government trumpeting economic numbers that many have trouble trying to understand as things on the ground is a far cry from things declared in Putrajaya.
                                          It is the worse of times , as we become a laughing stock to the world, with one country, two Allahs, laws meant for prosecution are used selectively to become laws for persecution. The constitution challenged with impunity with government tacit support. It is the worse of times, when clicking "like" in a facebook page can be deemed as seditious. When we have many "hot crimes" without criminals.
We must all come together and remember the Philosophy of Malaysia as stated in our Rukun Negara.
We must believe in God. Please call it whatever name you wish, but believe in God. I will respect your Allah, and you please respect mine too. I will be loyal to the king and our country and I hope that the Kings will also be loyal to king and country. The Constitution is SUPREME and so also the RULE OF LAW ( not rule by law ). We must have mutual respect for each other as fellow Malaysians and have good social behaviour.
We are all Malaysians first and only Malaysians. Let not the racist politicians divide us.


We are all one, a Malaysian 


I was born here and I will die here. I hope that I do not have to die saving my country from pseudo-Malaysians who are out to divide us. 
Please come and join us for a morning picnic.
16h September 2014
8.30 am - 10 am
Taman Jaya, PJ

Thursday, September 11, 2014

#MansuhAktaHasutan. STUDENT MINI DEMO IN UM

I was at UM campus yesterday to be with the students at their mini demo next to the UM bus station.

Also there with the students ( at least those that I could recognise ) were Nurul Izzah ( looks like crowd favourate posing fo pics all the time ), Rafizi, Ong Kian Meng and Haris Ibrahim. There may be other YBs that I may not have notice. We small people stand at a corner.
The crowd must be about 300-400 mainly students. Looks like there were some outsiders.
We all left after singing the Negara-Ku.
When you are there, it is heart warming to see these young ones speaking, walking and taking up the challenge against a corrupt and abusive government. I only hope that they were persevere and persist in their strive to build a new Malaysia.
They made a severe mistake detaining so many under the Sedition Act. And an even bigger mistake, charging a law lecturer, who teaches the young minds. That is a severe mistake which I am sure thay will regret.
#MansuhAktaHasutan

Wednesday, September 10, 2014

#MansuhAktaHasutan



See you all at the UM camps at 1pm.

We need to repeal the Sedition Act. It has been grossly abused.

Friday, September 05, 2014

Negara-Ku to picnic on September 16 to reclaim Malaysia.

This is the tagline civil society movement Negara-Ku is using as it seeks to battle the wide use of the Sedition Act against political opponents and the stifling of dissent among academicians and the media.
Organising chairman Zaid Kamaruddin said in line with its “Kembalikan negara-ku” effort, the movement's steering committee will hold a “Piknik Rakyat” on Malaysia Day, September 16 at Taman Jaya in Petaling Jaya from 8.30am until 10am.

Please come and join us for a morning picnic.
16h September 2014
8.30 am - 10 am
Taman Jaya, PJ