TCT 2009 SAN FRANCISCO, A SUMMARY

TCT 2009 had just concluded in San Francisco. I must begin by stating for the record that I did not attend, and that my observations are all from the internet. Looking at the program, I did not see anything outstanding or revolutionary. I see evolution of better stents and more data on the established stents especially the DES ( drug-eluting stents ). The new kid on the block is the Biomatrix DES by Biosensor ( initially a Singapore base company ), which has released very good two year followup results. This DES looks promising. Otherwise, a quick review of the meeting showed that the first generation DES ( namely stainless steel Cypher and Taxus ), has been easily surpassed by the second generation thin strut, cobalt chromium DES like the Endeavor and Endeavor Resolute and also the Xience V. In all the trials which compared second generation DES against first generation DES, the second generation wins easily. BUT this brings me to my next point. It would seem that although initial 12-24 months data would favour the second generation DES, after 5-7 years, the curve seem to merge back again, and they are almost equivalent. This has thought us a valuable lesson. That with DES, we need to observe short term, and also medium and long term. In other words, we must be vigilant all the time. Do not just take the initial results as gospel truth. " Old may still be gold ".
The meeting also saw some new pharmacological agent that may prove useful, including " Ticagrelor ", but this certainly need more studies. It was unfortunate that they decided to re-hatch the " COGENT study", a study that was prematurely halted for lack of funding. The authors now claim that Plavix + PPI does no harm. I will take it with a large pinch of salt for the simple reason that the study was abandoned.
Perhaps TCT 2009 will be remembered for what was not presented at SanFrancisco. And that is, that senators are investigating the star of all previous TCT, namely Dr M Leon , for alleged conflict of interest and non-declaration. This is a serious matter. I have not noted Dr Leon's reply to the accusation. Perhaps, he has replied to Columbia University, I do not know. But this accusation, coming on the second day of TCT 2009, must certainly have change the mood in San Francisco. Maybe there was less bounce in his step, as he stepped to the podium.
Is this the end of our cardiac intervention version of Hollywood?

THE INTERVENTIONAL CARDIOLOGIST ENTREPRENEUR

Let me digress a little from my previous focus on stretching the healthcare dollar, into a somewhat related topic, of medical business.
It is commonly accepted that as medicine evolved into more and more high tech, there is obvious benefit in saving lives and also improving quality of life. However, high tech medicine also brings with it sophisticated medical therapies, that need sophisticated machines and devices and also sophisticated skills. These skills have to be acquired through steep learning curves. Angioplasty is a very good example. When I was in medical school, about 30years ago, coronary angiogram was just being discovered and realised as a tool for the investigation of coronary artery disease ( thanks to Dr Mason Sones working in the Cleveland Clinic ). In 1977, Dr A Greuntzig performed the first angioplasty ( plain old balloon angioplasty ) on a dentist, using a balloon cathether that was suposedly fashioned in his kitchen. Dr Greuntzig knew that he was on to something great, and wanted to teach as many cardiologist as he can, the new technique, so that they can learn from his experience and help more patients ( the teacher-multiplier effect ). This was the beginning of live demo courses, to teach the technical details of a new procedure quickly, to as many as who would learn, in the hope of helping more patients. This challenge was furthered ( after Dr Greuntzig's untimely death at a young age ), by his good friends and colleague Dr G Hatzler and Dr Richard Myler. I am a student of Dr Myler's course in San Francisco in April 1988.
The whole process was prodding along and more and more cardiologist were trained and more and more patients were aided.
As the procedure evolved, the plain old balloon could not do everything and so new devices were being invented. I remeber the laser balloons, the artherectomy devices, the rotablators, and of course the stents.
With the advent of new devices, there was then a need to teach people the use of new devices, of course with the assistance of the device companies who wished to market their devices. Then came along the " Cardiovascular Research Foundation ( CRF )" founded by a certain cardiologist named Dr Martin Leon, with his friend Dr Gregg Stone. They set up the CRF to run an annual program called the " Transcathether Cardiovascular Therapeutics" at Washington. From humble beginnings, Dr Leon and Stone worked hard to market the meeting amongst cardiologist ( interventionist ) and the industry ( device companies ) to use this meeting to show piece their new devices ( some FDA approved, and many not approved ). The TCT then became " THE meeting " annually for interventionist. It was essentially " cardiac hollywood ". Of course when the meting became successful, CRF began to demand more and more money from attendees and also the industry sponsorship. Dr Leon became THE authority on interventional techniques and devices, and his word became almost law ( safe for the few of us who were always sceptical that one guy could endorse so many products, some for conflicting and some for the same use ). What he said was sometimes too good to be true. But he was the man of the moment.
After this long foreword, now for the crust of the problem. The New York Times reported on the 22nd Sept 2009 ( the day following the opening of TCT 2009 in San Francisco ), that two senators ( senator Herb Kohl and senator Charles Grassley ) have written to Columbia University ( the University where Dr Leon and Dr Stone is based ), to charge Dr Leon with failure to declare millions of dollars that he had received from device companies from 2003-2008. Apparently, Dr Leon has been working with device companies, and collecting large amount of money, and not declaring it. There was obvious conflict of interest. This is not the first time. A few years ago, Dr Leon was also charged by the American College of Cardiology with disclosing details of a clinical trial to Wall Street journal, before the trial results were announced at the College meeting ( he broke an embargo ). Not an ethical thing to do. This problem of non-declaration and conflict of interest is a very serious thing n our community, as many pivotal ( he does not go for little bread ) clinical trials were done either with Dr Leon as PI ( principal investigator ) or with his endorsement at TCT or other international angioplasty meeting.
Now that poses two very important problem for us. Firstly, was Dr Leon paid to say what he said, and the trials results were not as good as it was made out to be? Will all the trials that he is directly or indirectly involved, now have to be reviewed ( there are too many and it is too late for that )? Are the devices ( some of whom are from companies initiually owned by him and sold off later ( after he has endorsed the product ) for a hugh profit ( again undeclared ), to also be reviewed? Of course the third point is, is Dr Leon the only one. Some of the " Star interventionist " has achieved almost Hollywood like status. Are the other members of the CRF board, also to be investigated for non disclosure and conflict of interest?
This year 2009 has really seen so many revelations about pahrmas, device companies and doctors misconduct. How then do we trust all the clinical trials that come before us. To be too critical and sceptical will be to deny our patients good modes of treatment, and too loose and attitude which is to keen to accept everything thrown to us by the American demi-gods, will also do our patients a disservice.
Give it to the Europeans. They have always been sceptical of CRF/TCT and the Washington " mafias " . They sit together and outwardly are friends, but it is obvious that the Europeans loathe the Hollywood approach of the American group. Suffice to say that the Europenas are not perfect. Perhaps the same problem also exist with them? But on the whole, I find the Europeans more practical, less showy and less money minded.
In closing, I must also say that when we first started on this road of interventional cardiology and stents, those Americans that we worked with were humble, not Hollywood like and they work hard for their little money. Not all the Americans were ugly. Well, the US senate have found one. Let us see what they intend to do him.
What would Dr Greuntzig have done if he were here? We can only wonder.

STRETCHING THE HEALTHCARE DOLLAR ; BAN PUBLIC SMOKING

One of the " easiest " thing that giovernments can do to save healthcare dollar is to stop public smoking. Of course, that raises important economic issues of big cigarette company endorsements and lost of tax revenue. I suppose this is not a perfect world and we cannot please everyone. However, it is very true that banning public smoking saves lives and saves money.
The latest issue of the Journal of the American College of Cardiology 54:1249, 2009 carried an article by Dr D Meyers and group from the University of Kansas School of Medicine entitled " Cardiovascular Effect of Bans on Smoking in Public Places. A Systematic Review and Meta-Analysis ". They did internet research ( the trend nowadays ), and put in keywords to research the effects of a public ban on smoking and cardiovascular benefits. They were able to trace 11 studies at 10 locations which fitted their protocol. They found that overall there was a 17% reduction in heart attack rates in the first year with a 26% incremental gain over subsequent years. Meaning that we can save one third of our population from heart attacks if we decide to ban public smoking, thereby reducing primary and secondary smoke. Unfortunately, few studies study the overall economic benefit ( or loss ), should we ban public smoking. I suppose the impression must be that it will be an overall gain, as the smoking related heart attacks can strike young adults at the prime of their career.
This is however not the only study for this month. There is another study by a group from University of California San Francisco, under Dr James Lightwood, that also study the effects of banning public smoking in UK from July 2007, and they found almost similar finndings. That banning smoking reduced the heart attack rates by 17% in the first year and 36% in the next.
These are very large numbers of heart attacks prevented. There is no doubt in my mind that stopping smoking saves lives, saves money.
I am sure that if the government is sincere about stretching the healthcare dollar, banning smoking in public places is the way to go. There again, there is the issue of enforcement. At this moment, if I am not wrong, smoking advertisement, and smoking has been banned in certain public places like hospitals, government buildings and restaurants. Go to any common restaurants, and see the many still puffing away. Oneday, I decided to raise the attention of the smoker to the no smoking sign. I nearly had my head bitten off. He just told me, in not so polite terms, to mind my own business. Of course the restaurant owner is not interested in my complaint. It is business and all about money. Who cares about heart attack rates, and who cares about saving healthcare cost, until they need healthcare. Our enforcement agencies are legendary. What then are we talking about?

STRETCHING THE HEALTHCARE DOLLAR : LIVE 10-15 YRS LONGER

Following on the series of trying to stretch the healthcare dollar,I would like to highlight how we can do that and live 10-15 years longer. In fact, I am re-packaging an old story and putting in some numbers to drive my point home. We all know that healthy lifestyle, helps us all to live longer especially cardiac wise. We know the major modifiable coronary risk factors like hypertension, diabetes, raised cholesterol, cigarrette smoking, obesity, etc, etc. and how, reducing those risk factors would help us avoid coronary artery disease and in that way, live longer. If you are not convinced, let me give you more evidence.
In the Sept 17, online edition of the British Medical Journal, a group of researchers from University of Oxford ( ivory league UK ), led by Dr Robert Clarke, reported their 38 year followup ( 38 years I mean ), on 18,863 male civil servants, who were first recruited in 1967-1970. The study is called the " WHITEHALL " study. They recruited the subjects, who were apparently healthy civil servants, have them each fill a questionaire about their medical background including their smoking habits, job and employment staus, marital staus, etc, etc. Then they examined the subject as regards their blood pressure, cardiac status, their total cholesterol ( fasting ), and their blood sugar. They were then followed up and had a reassessment in 1997, and 2008. They found that during the followup, 13,501 had died. So we were left with a followup of 4,811. Those who had raised cholesterol ( above 5.0 mMols/L, raised BP and who smoke had a 10 year shorter life expectancy. Those who modify their risk factors and returned them to normal, had the same life expectancy as normal.
This study mirrors the " PHYSICIAN HEALTH STUDY " in USA. Both studies are simple, not pharma driven, had a large cohort followed over a long period of time, and give us invaluable data. It is straight and simple, if you lower your T. cholesterol ( dont have to go into those fancy apo particles or ratios, that create confusion, and that is only good for research papers ), stop smoking and lower your blood pressure ( by whichever means and pills that you wish ), you will live 10-15 years longer, and not tax our healthcare system so much.
That will be stretching our healthcare dollar. In fact, that can also form the basis of asking our health insurers to give us a " no claim bonus ", almost like our car insurance, if we take precaution, prevent disease and stay healthy. It is a win-win ( just to borrow a political phrase ) situation for all us. A very good way, in my opinion, of stretching the healthcare dollar. I will write more about health insurance in the near future.
I just wish to re-emphasize that preventing diseases, in this case heart disease, is a very good way of stretching the healthcare dollar, and I cannot understand why the government do not wish to do it. Is it because there is not much money to be made by third parties, in preventing diseases?

STRETCHING THE HEALTHCARE DOLLAR ; EAT LESS SALT, PREVENTS HYPERTENSION

We are constantly reminded that healthcare cost is rising and society ( any society ) cannot afford to pay for the rising cost. President Obama is having a very hardtime trying to push through healthcare reform, which will see less people not insured, and also in his own way, try and cut down healthcare cost.
Malaysia has been looking to reform her healthcare system,for as long as I can remember ( since the early 80s, I think ). We are reforming, on the premise that privatising healthcare will reduce cost and improve efficiency. In my opinion, both assumptions are wrong and it may end up, after one year ( initial feel good 1 year ), that the whole Malaysian Healthcare Reform had been piratised.
To this end, I wish to write a few blogs and share how, in my opinion, healthcare cost can truely be reduced, and the healthcare dollar stretched. The first point is that " prevention is better then cure " . This cliche has been repeated so often that I sometimes think that it has lost its meaning. Well, in health and disease, this saying is very true.
The Sept-Oct 2009 issue of the American Journal of Health Promotion, carried an article by Drs Kartika Palar and Roland Sturm on " Potential societal savings from reduced sodium consumption in the US adult population" ( Am J Health Promot 2009; 24: 49-57 ). This study was carried out by the RAND Pardee Graduate School at Santa Monica. What the authors found out was that if the US population will consume less salt, ( they were consuming 3.4gms/day of sodium when the recomended amount was 2.3 gms/day ), then they could reduce the number of patients suffering from hypertension and save direct healthcare cost for HBP treatment and also improve " Quality adjusted life years - QALYs ). Using the National Health and Nutrition Examination Survey (NHANES 1999-2004) as their basis, they estimated the salt consumption in the population and also that 30% of Americans suffer from the kind of hypertension that can be prevented by reducing salt consumption. Putting all these in dollars and cents, they estimated that the US government could save USD 18 billion in direct healthcare cost and USD 32 billion in QALY cost ( from the complications of hypertension and loss of QALYs. In total, the US government could save about USD 50Billion a year, for their population of 270million people. All this just by consuming 1.1 gm less salt a day.
Translated to Malaysia, it would mean a cost savings of RM 5 billion a year, if Malaysians would consume 1.1 gm less salt a year. This number can be enhance if we will eating more green veges and fruits to increase our potassium intake, and drink enough water. Such simple lifestyle changes can help to save so much money and also give all of us a better " quality adjusted life years ".
So yes, healthcare dollars can be saved, if we as a nation, is prepared to make some sacrifice. Of course the government can help, by labelling food and controlling the amount of salt additives sold. When there were rumours of sugar shortage, the government should have taken the opportunity to encourage everyone to cut down carbohydrate consumption and sugar consumption, to reduce obsity. Another very important strategy to save healthcare dollar. Instead, our YB minister of tourism is trying to encourage eating as a important way of bringing in the tourism dollar, of course at the expense of the healthcare dollar.
It is often said, in the coffee shops, that this government is somewhat schizo., on the one hand they wish to make tourism dollar to the detriment of good health, and on the other they complaint about rising healthcare cost, which we all know, is due to eating all the wrong things.
Anyway, we will keep discussing the issues. Maybe along the way, some will listen. If not for the country's sake, at least for your own good health sake.

IVABRADINE : BEAUTIFUL, PITIFUL AND MUST WE WAIT FOR SIGNIFY

Last year, in the European Congress of Cardiology 2008, with some pomp, Dr Roberto Ferrari ( how can you forget a name like that ) , presented the results of the BEAUTIFUL trial. BEAUTIFUL stands for " Morbidity-Mortality Evaluation of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease and Left Ventricular Dysfunction (BEAUTIFUL) " trial. The acronym is less easy to remember. Essentially, this is a trial in the use of Ivabradine ( a new If channel blocker), for the reduction of major CV events in patients with LV dysfunction, in patients with HR >70/min. As we know from ESC 2008, the study failed to show that and Ivabradine is struggling to find a place in our heart failure treatment armentarium.

Well, at the just completed ESC 2009 at Barcelona, Dr Ferrari ( the present president of ESC ), again presented a post-hoc analysis of a subset of patients with stable CAD, significant angina and HR>70/min, and found that ( listen to this ), Ivabradine was shown ( post-hoc subset analysis ) to reduce major CV events espcially in those with LV dysfunction, with a HR of >70/min.

If this is not dredging a study for some positive result, I dont know what is. And for a reputable company like Servier to do this, with the president of ESC to do this, is surely disappointing and PITIFUL. He and servier must know that such findings, from a post-hoc analysis, is at best, hypothesis generating and cannot have any clinical relevance now, until more studies are done. We are promise that SIGNIFY is on the way, and will shed us more like, so let us all wait for SIGNIFY.

I suppose, I should give ervier credit for not using " ghost writers" and "guest authors" ( but then the study was basically useless, so why waste the money ). Well, although essentially useless, servier still completed the study and published it. That deserves some credit too. Maybe, to re-cycle a post-hoc analysis is to dredge and get whatever mileage out from the study that is possible, as money has already been spend.

Perhaps it may be better for big pharmas with negative studies, to let sleeping dogs lie and do another, properly conducted trial that will show whatever benefit the drug is proported to have so that we can study the data and see how to use the drug to benefit our patients. That of course assumes that the drug does have a role, and the research ( backroom boys ) have not made a mistake and wasted the company's time and money.

Yes, we know about BEAUTIFUL, and it is so PITIFUL the way Servier is going about it, and we all await SIGNIFY to tell us better. For the moment, nothing has changed. The good old drugs are still good.

CREDIBILITY OF CLINICAL TRIALS AND PRACTICE GUIDELINES

September 2009 is a very upsetting month for clinical research and practice guidelines. This is because in September, two important clinical papers were publish, further casting doubts to the value of clinical trials in guiding clinical practice and care of patients.

We have stated before in previous blogs, the issue of " ghost writers " . We have also highlighted the severe biaseness in the FDA for approval of some drugs, applying clinical trials in a rather bias manner. Remember the " prasugrel " issue with Dr Sanjay?.

In the month of September 9th, Dr Ross and colleagues published a paper entitled " Trial publication after registration in ClinicalTrials.Gov: A cross-sectional analysis. PLoS Med 2009; Similarly, Dr Sylvain Mathieu and colleagues across the big pond published "Comparison of registered and published primary outcomes in randomized controlled trials". JAMA 2009; 302: 977-984.

Both these papers dealt with the issue of clinical trials publication after registration. In 2005, the US government mandated that all clinical trials, must be registered with the "International Committee of Medical Journal Editors (ICMJE)", before they can be given permission to begin enrolment. This was a result of problems with the failure to complete clinical trials, especially those sponsored by pharmas, when the trial results seem unfavourable. The US government then decided that that will give the readers a very bias opinion about the drug as only positive views are reported. Sometimes, negative trials also teach us alot.

Dr Ross and colleagues found that from Dec 1999 - June 2007, 7,515 clinical trials were registered. 53% of them failed to report the closing date of the trials when it was ? finished, 66% failed to report the Primary Outcome of the trial, and 87% failed to report when the trials were commenced. Then they took a 10% samples of the 7515 trials, which were completed. Of these 10% completed trials, less then half, only 46% were published, supposedly, the results were favourable. When he did a breakdown, only 40% of trials sponsored by pharmas, had their results finally published, 47% of trials sponsored by the government, were finally published and 56% of trials sponsored by academic institution were finally published. One obviously wish to know, what happened to those trials that were never published. Is it because the authors had inadequate funding, were the authors in some way physically could not complete, or worse of all, is it because the trial results were negative and they wanted to hide that fact.

Dr S. Mathieu's paper had to do with the fact that, not only are trials selectively published, very often, their reported, registered outcomes, are not the same ( significantly different ) from their published outcomes. Somehow, between reporting to the authorities and sending it in for publications, other facts seemed to have come up and be included. This again does not give confidence to the system of scientific research.

Having seen all these facts, should we still trust clinical trials and by extension, clinical guidelines. I suppose, to some degree, many still do because they have nothing better. I am much more sceptical. Those pharmas who come to promote their products to me using clinical trial results, will be told that the trial results are interesting, but should not be taken at face value. The clinical trial results must be compartible with accepted pathophysiological mechanisms. In other words, it must make medical sense. A clinical trial results that is too good to be true, like the old cliche goes " is probably, too good to be true ". A case in point is, the association of COX2 inhibitors and coronary thrombosis. Many studies have shown that COX2 and COX1 inhibitors bothe have the same problem of coronary thrombosis. A study of the patho-physiological mechanism will show that COX2 agents are more prone to coronary thrombosis then the COX1 agents, because COX2 agents cause more " endothelial cell-platelet aggregation" imbalance then COX1. In other words COX1 is safer, from the coronary thrombosis stand point.

Anyway, I must not digress too much. What I was trying to highlight is that clinical trials are not as truthful as they are made out to be. Negative trials are often not reported and may be just as important for clinical practice guidelines than positive trials.

Can we then trust clinical trial results, and by extension, can we then trust clinical practice guidelines that are form on the basis of the clinical trial results?

Like everything else human, the system is not perfect. A sound scientific mind and good medical sense is still very important for patient care.

INTERVENTIONAL CARDIOLOGY UNDER ATTACK AGAIN. NEWS FROM ESC 2009

The just concluded European Congress of Cardiology ( ESC ) 2009, brings more bad news for interventional cardiology. Back in 2006, at the ESC in Barcelona, the Interventional Cardiology world was rocked by the announcement from ESC that DES was killing patients ( the problem of late stent thrombosis ). Well, we got over that after about two years, basically with re-defining stent thrombosis and also recalculating the trial data with these new definition.
In the just concluded ESC, two papers will surely impact on Interventoonist. One was discussed in a previous blog, namely the 2 year follow-up of the SYNTAX trial, showing that after two years, PCI for left main stem was obviouly inferior to CABG, in terms of re-intervention rates and also rates of AMI.
Well, another paper presented in this ESC 2009, was a small paper by a group of German workers under Dr Rainer Hambrecht ( Kliniks Links der Wesen, Bremen, Germany ), which showed that regular exercise over 2 year period, was as good as PCI in terms of symptom relief and improvement in Myocardial Perfusion. This study, reported in Barcelona in Sept 3rd 2009, is actually a combination of two studies, one carried out, almost similarly, in 2004, but not completed, together with renewed patient enrollment by Dr Rainer and group. What is obvious, is that a regular exercise regime, is as good as PCI in patients with chronic stable angina. Something which is supported by the COURAGE trial.
What this will translate out for patient care is that in patient with stable coronary artery disease ( assymptomatic, or with just a positive stress ECG, or found incidentally by one of the many MSCT scans around the place ), can be managed by intensive medical therapy and a regular exercise program. Buying a bicycle is certainly cheaper than undergoing PCI, and obviously less rsiky too. However, it must be poited out that in the symptomatice stable CAD group, PCI will relieve chest pains in minutes and medical therapy will take longer.
It is not difficult to understand why intensive medical therapy and rugular exercise will help. It is well known that regular exercise and medical tehrapy will promote collaterisation and also ischemic preconditioning, so that after two years, there will be more collateral vessels and also the myocardial cells will become adapted and more resistant to ischemia.
When we first planned to do ad hoc angioplasty ( angioplasty done right after a coronary angiogram, at the same sitting ) it was to save cost, and we had no COURAGE trial to guide us. In fact, we were guided by the " oculo-stenotic reflex ". Simply put, you see a stenosis, that is the bad guy. You dilate and remove the stenosis ( bad guy ), you should then have done some good for your patient. How simplistic, and now we know also how wrong. Angioplasty has a risk. Even amongst the best of us, we do have the occasional mortality and morbidity. What's even worse is that ad hoc angioplasty has spawn a whole industry od " dilating for bread ". Angiograms are done for no rhythm or reason ( often pprompted by MSCT scans for completely assymptomatic patients ( MSCT is a commercialised examination for checking yoyr heart artery ). Then the see and blockage on the scan. The guy who sees the blockage, so called, will scare the life out of the ignorant patient and subject him / her to a coronary angiogram and before you know it, the blockage ( sometimes insignificant blockages ), have been dolated. All these for RM 30K for " saving your life ". Medicine has become a business.
Blogs like this is to educate the public and also some doctors, so that they will be wiser ( hopefully ) and not be so easily " conned ".

THE SYNTAX TRIAL : RESULTS 2 YEARS ON

It was with some fanfare last year, at the same meeting that Dr Patrick Serruys announced to a packed audience the 1 year results of the SYNTAX trial. This is a landmark trial of 1,800 patients with left main stem disease randomised ( not blinded ) to receive either PCI with the Taxus ( DES ) or CABG. Cardiac surgeons were very happy to know that the 1 year result showed that CABG was superior to PCI, overall, in the treatment of Left Main Stem Disease. But cardiac interventionist, led by Dr Serruys was equally happy to note that over 1 year, in the subset of left main stem disease patients with less complex disease ( subset analysis ), PCI was better than CABG, except perhaps in diabetics. So everyone had something good, from the SYNTAX trial, so the debate went on. In fact, on the basis of SYNTAX and the LE MANS registry, the ESC may review the clinical guidelines to make PCI a class 2A indication in the management of left main stem disease.
Well, just 3 days ago, in Barcelona, at the just concluded ESC ( European Society of Cardiology ) meeting , Dr Pieter Kappatein ( Erasmus Medical Center, Rotterdam ), ( I wonder where Patrick Serruys was ), presented on behalf of the SYNTAX investigators, the 2 year follow-up of the same cohort of patients. In summary, the grafts continue to divurge, meaning that over the next 12 months, CABG continued to do better ( can you hear the surgeons sniggering ) then PCI. There were more heart attacks in the PCI group and of course more repeat revascularisation. Strokes, the main downside to CABG in the 1 year result, stabilised over the next 12 months and that graph remain basically the same.
What all this jargon means is that except for the very simple left main stem, and also those left main patients who do not want cardiac surgery, or who cannot undergo cardiac surgery, CABG should be the prefered mode of therapy. Meaning that although PCI can be done, over 2 years, there were more heart attacks and repeat PCI. I suppose interventionist will find comfort in the findings that although there was an increase in heart attack rates, the overall death rates were the same in both arms, even after two years. You see, all is not lost for PCI. Please remember that I am an interventionist.
Locally, having travelled the country and seen the work, and also having reviewed cases at many meetings, local cardiac interventionist do do quite alot of left main stem PCI. At one local meeting, I commented that they were doing PCI that I would not think of touching. Well I suppose the usual indication is that the patient did not want surgery. That is always a mood point. If the interventionist paints a picture that PCI is possible and is just as good, then I believe most patients will choose PCI, being less invasive. But if they are advised that PCI has know dangers, including, increase procedural risk, increase rates of heart attacks, and increase repeat PCIs over 2 years, and they be given time to reconsider ( not an ad hoc, I hope ) then the decision may be different.
Well, at the end of the day, the patient must decide and we are trying to educate patients so that they can make a good informed decision. That is the aim of this blog.

STRETCHING THE HEALTHCARE DOLLAR

Sunday STAR August 30, 2009

Stretching the healthcare dollar

By Dr NG SWEE CHOON

Last week, we discussed the issues concerning the choice between generic and branded drugs. Now, we look at whether switching to generic drugs will boost our healthcare budget.

ONE of the main reasons for the push to use generic drugs is cost. It is often claimed (but not well substantiated by data) that drug cost forms a substantial part of our healthcare budget.

In researching this article, I discovered that in 2005, we spent about 8% to 10% of our healthcare budget (at that time the healthcare budget was about RM7.8bil) on medicines and drugs.

There are important and sometimes crucial differences between generic drugs and branded ones.

This is similar the world over. For example, according to the National Health Expenditure Report 2004, the US spent about 11 cents for every healthcare dollar (11%) on drugs in 2002. In fact, drug expenditure is much less than administrative expenditure.

Despite worldwide data to the contrary, many countries are embarking on a policy of using generic drugs in the treatment of diseases whenever possible.

I suppose they wish to cut down drug cost from 10% to 5% of the healthcare budget, but at what cost to the patient?

Would a better strategy be to try and reduce administrative expenditure by greater use of digital technology and computerisation, and also streamlining administrative procedures?

Substitution

As the subhead implies, this is the policy to use generic drugs as a substitute for branded ones. This can take one of two forms.

Firstly, the healthcare governing body can mandate that their healthcare facilities only stock generic drugs. Doctors are asked to prescribe the proper drugs using the generic (pharmacological) name and the healthcare facility will then buy the generic (copy) version of that prescribed drug.

For example, in the treatment of dyslipidaemia, the doctor may prescribe the branded drug simvastatin (Zocor). The healthcare facility may carry a generic drug called covastin. So the patient treated in that healthcare facility will get covastin.

In this case, the patients who go to that healthcare facility know that he/she will be getting a generic drug. This is commonly done in general hospitals.

The second form of substitution, which is more subtle, is the replacement of drugs (substituting with a generic) by the pharmacy. For example, the patient with dyslipidaemia is prescribed simvastatin (Zocor) by his doctor. He goes and buys the drug from the pharmacy. That pharmacy carries the generic covastin, and dispenses that to the patient, without the doctor’s permission.

Strictly speaking, this is unethical. The doctor should be contacted first and his permission sought in generic substitution. But this is not often done.

Potential dangers of generic substitution

Is it wrong to substitute generic drugs for branded ones? The advantage is obvious. There is usually cost savings. But there are also potential dangers, which is why a list of drugs that should not be substituted by generics is necessary.

There are some drugs that should not be substituted. For one, drugs with low “therapeutic index” should not be substituted.

Therapeutic index refers to the drug dosage difference between the effective dose of the drug and the dangerous dose of the drug. The wider the therapeutic index, the safer the drug, as the difference between the drug’s effective dose and toxic dose is wide.

This means that for a generic drug with a low therapeutic index to substitute for a branded one, a delicate balance has to be maintained. If the effective dose of the drug is not achieved and maintained constantly, the patient could suffer a relapse instantly.

This is particularly true with generic substitution of anti-epileptic drugs and anti-psychotic drugs.

There have been many reports from the US, Canada, Germany, Austria, Switzerland and others, of patients who suffered relapses when they received generic forms of their anti-epileptic drugs, and who again came under control when they were given the branded product.

One study in the US found that a certain form of generic diphenylhydantoin (a drug widely used to control seizures/fits), had a bio-equivalence 31% lower than the branded one.

I feel that drugs for fits should not be substituted.

Clearly, reducing healthcare costs and stretching the health dollar may have to come from other measures, like trimming administrative “fat” and “leakage.”

Personally, I am very concerned about generic drug substitution of vital drugs, especially cardiac drugs, where one or two doses missed could have a catastrophic effect.

Let me give you an example. In interventional cardiology, we implant drug-eluting stents (DES), which mandates the use of dual anti-platelet therapy to prevent acute clotting of the DES, especially in the first three to six months (with most FDA-approved DES). The usual dual anti-platelet therapy is aspirin (there are many generic forms) and clopidogrel (brand name Plavix).

There are many studies to show that acute clotting of a recently implanted DES may result in an acute heart attack, from which a patient may die.

It is also well documented that one of the commonnest causes of acute DES clotting is the avoidance of Plavix. (These studies were done by reputable cardiac institutions.)

Generic substitution of drugs for the control of hypertension in a high risk population may result in stroke. On the other hand, generic substitution for vitamins and other OTC products should be much less dangerous.

Taking cognizance of this, the Ministry of Health, Pharmacy division, asked the Federation of Private Medical Practitioners’ Associations of Malaysia to come up with a list of drugs that should not be substituted at the last Malaysian National Medicine Policy workshop.

Is generic substitution good for the patient?

I believe that the choice of whether to use a generic or branded drug lies with the patient. For those who are happy to carry on using generics, do so by all means.

The purpose of my sharing with you is, as always, to give you an informed choice. The next time your doctor writes a prescription for you, I hope that you can also ask him a few questions for clarification.

There are important and sometimes crucial differences between generic drugs and branded ones. Substitution should not be taken lightly.

We are all for saving on healthcare costs, but they should not come at the expense of a person’s health and life. After all, we are here to help a patient live longer, and better.