Thursday, September 24, 2009

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.

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