ALL IS NOT WELL AT THE US FDA

Many of us may feel that the USA system of government, in general, and the US FDA in particular is good and beyond reproach. Well that may not be so. These are man-made systems and they have their problems. Even if the system, may be good, the individuals in the system, sometimes makes the whole system flawed. We have recently seen how badly the US financial system have let us all down so very badly, and many of us, all over the world will have to pay ( and some pay with their lives ) because of a few " greedy " men in the US financial system.
No, I am not about to discuss politics here. My interest is medicine and in particular, cardiology.
On 3rd Feb, the US FDA advisory panel on Cardiovascular and Renal drugs, met to discuss the approval of Prasugrel, an ADP receptor blocker anti-platelet agent ( acting much like Clopidogrel ). It is now obvious that 4 days before the meeting of the panel, the US FDA received a phone call from Eli Lily ( the maker of prasugrel ) asking whether it is suitable to include a certain Dr Sanjay Kaul ( Cedar Sinai MC-Los Angeles ) in the meeting. Dr Kaul was scheduled by the FDA to be a panel for the meeting. After the phone call from Eli, Dr Kaul was asked not to go for the meeting. It is wellknown that some of Dr Kaul's research has shown that there were dangers with the use of Prasugrel, including the increase incidence of major bleeding. Of course the panel met without Dr Kaul, and unanimously decided that prasugrel should be approved. One wonder, what may have happen, if Dr Kaul had been present to give opposing views and raise the level of discussion. The approval decision by the FDA means big money for Eli Lily. In a 20th Feb 2009 interview, US FDA officials admit that they may have made a mistake in this issue of not including Dr Kaul at the last moment although he was rostered. Let us see what remedial action they will take to correct their mistake. Will they reconvene another meeting of the panel, and suspend the approval, pending the second meeting?
This to me is a clear example of industry influencing medical decisions. One wonder whether money changed hands to facilitate the non-inclusion of Dr Kaul. Of course there are now red-flags all over the place and everyone is aware that the US FDA is not so " clean " and " transparent " and fair. Nonetheless, there are some practitioners in this country who will swallow whatever the US FDA recommends as gospel truth. I dare say that there were many other decisions made by the FDA with regards to drugs for hypertension and cholesterol lowering which were also equally suspicious. Even device approvals I believe, have these problems. This is not to say that we should not read and examine what the US FDA announces or recommends. But practitioners must study their basis and make sure that the recommendations are sound, proper and without bias. Our patients expects that of us. We we owe that much to them.
Suffice to say that be it USA or Malaysia, there are no angels on earth. Angels dwell in heaven.

HYPERTENSION IN MALAYSIA

The Minister of Health opened the 7th Asian Pacific Congress in Hypertension yesterday in KL. In his opening address, he quoted the National Morbidity and Mortality Health Survey 2006, which found the incidence of hypertension among Malaysians 30 years and above to be about 43%, a 10% increase from 1995. He was also quoted as saying that of those on treatment, 26% achieved control, a figure I find had to believe. It may have been a miss quote. In an almost identical UK Health Survey 2006, the incidence of hypertension is about 60%, and about 21-22% are controlled. For those detected, about 40% are on treatment and for those on treatment, about half are controlled. I still have not seen the Malaysian National Morbidity and Mortality Health Survey data in Medical literature, so I do not know if the honorable Minister had been misquoted.
Be that as it may, the important message that I would like to highlight is the Hypertension is a silent and often serious problem. It can be prevented with diet ( less or no salt ), greens and fruits, and control of weight with a BMI of 24 and a waistline of 34inches for males. Exercises also helps. Early detection is vital. All above 40yrs should go for a medical check-up to ascertain your health status. That I think would be reasonable.

MEDITERRANEAN DIET IS GOOD FOR THE HEART . RE-CONFIRMATION

Ever since I was in medical school, we have always been taught that mediterranean diet, rich in olive oil, greens, veges, fish, all minimally processed, is good for the heart. It improves our lipid profile, prevents atherosclerotic heart disease and also lowers the risk of heart attacks and strokes. Even if that should occur ( in the minority ) it also lessens the risk of dying. Basically, the mediterranean diet is good for the heart and our health. Well, that message is re-emphasize by researchers from Boston, who presented new data from the NURSES HEALTH STUDY, and published in the on-line edition of the 16th Feb 2009, Circulation. Dr Theresa Fung and colleagues from the Harvard School of Public Health, published their 20 year followup data on about 74,900 women, who were questioned on their diet preference and followed up over 20 years. The women who were solely on mediterranean, had the lowers incidence of heart attacks and strokes, and should they occur, had the lowest risk of dying. They also had fewer documented incidence of heart disease. All the p-values given had at three zeros in front ( if you know what I mean ). With 74,000 subjects, when you are on the right track, it is so easy to get good p-values.
In writing this blog, I just wished to re-emphaize the value of the mediterranean diet. The bottomline is that mediterranean diet is good for us, and should be encouraged.

WEEKEND SEMINAR IN CARDIOLOGY 2009

We have just completed " Weekend Seminar in Cardiology 2009 ". This was held over the weekend ( 14th-15th Feb. ) at the Sunway Convention Center. It was very well attended. I was told that about 950 registered to attend. On day 1, about 600 were in the room to listen to the lectures, and on 15th Feb right up to 1pm on a sunday, there were 400+ in the room. On " Valentines " night, in the Bayer sponsored talk, we had 25 tables filled, and on Sunday afternoon at the Pfizer lunch, we had 40+ tables filled. This is amazing, in my experience, running CMEs. The scientific program over the 2 half days covered critical management issues in " Lipid lowering ", BP lowering and sugar lowering, essentially dealing with issues of control and " how low can you go ?" There were also a debate about the management of atrial fibrillation, ECG and Xray tutorials, and management of heart failure and also strokes. The Pharmas were out in full to support. There were 19 supporting pharmas and device companies. Their booths were like a "pasar malam" during the coffee-breaks. Full of funfare and I was told also direct sales of medical equipment at discounted prices.
About the only hiccup during the seminar was dealing with Sunway Convention Center. The organizers had a torrid time dealing with the convention center management team as they were most unreasonable, making demands at the last moment and threatening cancelling the meeting should their demands not be met. There was no understanding that this event was for the common good of educating doctors, and obviously, there was no attempt at corporate social responsibility, to help doctors learn so that they can better help the public. For example, after all the bills were paid ( final payment was made 1 day before the seminar ) they demanded extra. I suppose Malaysian corporations still lack social graces and an understanding of social responsibility. The doctors organizing the meeting and the NGO hosting the meeting ( in this case PMPASKL ) were not paid. They were doing it out of the goodness of their heart. The lecturers and chairperson who came to help were helping " gratis ", and the businessmen ( convention managers ) were not willing to be " flexible ". What is worse, we have been dealing with the Sunway convention center for the last 5 years, except one. They know us and what we are doing, and our good track record. Looks like a new team " hungry " has come in, and they want their pound of flesh, come what may. Well we will be looking for alternatives next year, as Sunway Convention Center has proven to be " unfriendly " to social responsibility. And mind you, it is not cheap to hold meetings in Sunway CC. The other issue with Sunway CC is the parking. For the session on Sat afternoon, the delegates complained bitterly about severe lack of parking. They had to circle many times and end up parking " illegally " . I can only conclude through both these issues that Sunway CC is doing well and that their management team has no need for a " customer-friendly, customer retention " policy. Basically, they are just " cocky ".
Anyway, all things said and done, the meeting when well ( thank God ), and all the feedback so far, was excellent. I even had one doctor ( GP ) holidaying here from USA who came up to thank and congratulate me for an excellent meeting.
Well, " syabas" to the organising committee, the lectures, chairpersons, secretariat, and all involved. " Syabas " for a job well-done.
For those interested, lookout for the next one in yr 2010. I am quite sure that despite the challenging economic times, the NGO will still want to hold the seminar, as it was obviously serving a need.

ERECTILE DYSFUNCTION, A MINOR CORONARY RISK FACTOR

There have been a strong impression that premature erectile dysfunction, from non-testicular hormonal causes may be associated with a higher risk of Coronary Artery Disease over the next 10 years. The increase risk starts at about age 40 years, and falls thereafter to become negligible by age 70 and above. This was again highlighted by a study carried out by Dr Inman of Mayo Clinic and published in the Feb 2009 issue of the Mayo Clinic Proceedings. He followed 1402 subjects from age 40-70 years who have two yearly male sexual function questionnaire. This is a longitudinal study since 1990. This are males with no overt heart disease at the start and who had normal testicular function. They have published their first ten year findings. They found that you happen to have ED at 40 years, you are 2.4 times more likely to have coronary artery disease, and the incidence drops until you are about population risk when you are 70years. There were two other previous studies that showed very much the same findings.
I suppose the explanantion may have to do with premature atherosclorosis of the little penile artery, as a manifestation of generalised atherosclerosis. Maybe there is some hormonal deficiency too. The presence of diabetes is also a strong predisposing cause. I not routinely ask about ED and sexual dysfunction in my clinical practice. Maybe I should start.
The logical conclusion would be that males at 40 yrs with ED should also get a stress ECG, as a workup towards the presence of coronary artery disease.

CT ANGIO, - LATEST POSITION, ESPECIALLY IN THE ASYMPTOMATIC POPULATION.

After years of debating and discussing the role of the 64-MSCT, the practitioners in Malaysia are still not following the evidence and guidelines. 64 MSCT are still being rampantly done, to all and sundry, as long as they can pay ( sometimes paid by insurance ). I have written on this many times before. Since, there is alot of money and " powerful boys " involved, I have chosen to quote directly from the Heart Org website, so that I will not be accused of misquoting. The latest report appeared in " Heart.org " recently. A new American Heart Association (AHA) science advisory says there are no data to support the use of cardiac computed tomography angiography (CCTA) in asymptomatic, low-risk patients, so the albeit-small risk of cancer from radiation currently outweighs the lack of any demonstrable benefit in such people . Dr Thomas C Gerber (Mayo Clinic, Jacksonville, FL) and colleagues discuss the subject in a paper published online February 2, 2009 in Circulation.
I suppose, I take two important point from this evidence base statement. Firstly, there is no point doing 64MSCT in asymptomatic, low risk individuals, as the risk of cancers, outweigh the benefit, even is there is some disease shown ( remember " Courage trial" ). Secondly, there is a real, small risk of cancers, from the radiation. If you read the small print in the article, you will also understand that radiation risk varies from machine to machine, and patient should be made aware of that. Of course, this involves calibrating the machine and checking the radiation risk at periodic intervals ( something not routinely done here ).
Balanced against this , is the fact that it is a money spinning industry, which also drives some cardiologist, interventional program. You see and blockage, you do the angiogram, and if you see anything, you dilate with the balloon and you stent ( all on very flimpsy evidence ). The pictures can be made so seductive, that the patient is convinced that the cardiologist has saved his life ( even some of my very well educated golf " kakis " have been duded ), when there is no evidence to suggest that. In fact, the medical evidence may be to the contrary.
What to do? It is all about money, isn't it?

ECONOMIC CRISIS AND HEALTHCARE

British newspaper has just announced that Glaxo Smith Klein is set to cut another 6,000 jobs, having announced 800 job cuts last October. This follows the announcement last week by Astra Zeneca of 6,000 job cuts. Of course, competition is tough from generic drugs, the economic downturn, and also perhaps lack of new drugs in the pipeline. Last week also saw Pfizer merging with Wyeth.
I am very concern as these companies have good research teams and are innovative to give us good, new therapies. They are also very supportive of CMEs for doctors. Looks like we are in for a hard time in terms of new products, marketing of new products and CMEs for doctors.
Last week also saw a generic company in USA shutting down after being ordered to remove a complete product range from the shelf across USA. The company supposedly have their drugs with doses that did not fit the labels. There were higher dosages in the drugs than that on the label. Now this is dangerous.
Well we can expect more bad news as the economic crisis deepens in the next 12 months.