As reported in the NY Times:

Last summer, rival cardiologists in Rock Hill, S.C., decided to learn how to perform a lucrative new procedure, implanting a defibrillator, a device that protects against fatal heart rhythms.

Dr. Paul G. Colavita of the Sanger Clinic says Biotronik is trying to tie implant training to device sales.

Piedmont Medical Center in Rock Hill, S.C., has set its own standards for implanting defibrillators.

One doctor attended weekend classroom sessions sponsored by a professional medical organization, passed a daylong written test given by that group and implanted defibrillators in 10 patients while an expert observed.

But by then, four other doctors at a competing practice had left him in the dust, implanting 75 devices. They chose a separate training program, provided free and tailored to their liking by a little-known device maker named Biotronik. Only one of the four doctors so far has taken the recommended daylong competency test. The training also apparently had unorthodox elements: two doctors sometimes trained together on one patient, a technique that experts called highly unusual.

The different training regimens like the ones followed by the Rock Hill physicians are at the center of a growing and often contentious debate. As companies develop more sophisticated devices like advanced pacemakers and carotid artery stents, medical experts are asking how doctors should best be trained -- and who should train them -- to implant such devices without compromising patient safety.

The growing use of the costly defibrillators is drawing particular attention. Until recently, such units were typically implanted by highly trained heart device specialists. But since last year, when the government agreed to pay for tens of thousands more patients annually to get such devices, many new practitioners like those in Rock Hill have entered the field. One result is that patients do not realize that the training and experience of doctors can vary widely.

"A patient does not know whether they are a doctor's third implant or their 300th," said Dr. Charles E. Swerdlow, a heart device expert in Los Angeles who advocates rigorous training standards.

To meet patient demand, the Heart Rhythm Society, a professional group that represents experts like Dr. Swerdlow, adopted so-called fast-track training guidelines two years ago for doctors who had not implanted defibrillators before. But those guidelines, of which the daylong written test is one part, are voluntary. No one knows what percentage of physicians who have recently begun to put in defibrillators are following the guidelines.

At the same time, makers of the devices have jumped into the mix by offering free schooling. That has prompted concerns about possible conflicts of interest, since doctors may return the favor when deciding which company's units to implant in patients.

Separately, federal officials started collecting data last year to determine, among other things, if the rate of complications from implant surgery differs between heart device specialists and other doctors. Such specialists, who are known as electrophysiologists, are cardiologists who undergo a year or more of added training at a teaching hospital in the treatment of abnormal heart rhythms, including device use.

That reporting has just started. Patient deaths during defibrillator implants are extremely rare. Recent government data indicates they occur at a rate of about .03 percent. An analysis by The New York Times of the first 45,000 implants reported into the Medicare database indicates that the death rate for patients of nonelectrophysiologists was 1.5 times that for patients of the specialists, and that the complication rate was slightly higher as well. Medical statisticians cautioned that such raw data would have to be analyzed further to determine whether significant differences existed.

It is in places like Rock Hill, a city of 50,000 people, located 30 miles south of Charlotte, N.C., that the broader national debate over physician training, and the role of device makers in it, has been playing out.

The tab for Biotronik for training the four physicians, for example, could total $50,000 or more, according to a consultant's contract and company data. But since last year, Biotronik has more than recouped those costs in sales of defibrillators, which sell for about $20,000 each.

By their own accounting, those doctors estimated that, with only a few exceptions, all of their 100 defibrillator patients got a Biotronik device. That provided the company, which has a scant 1 percent market share nationwide, with an estimated $2 million in revenue.

The doctors, who belong to a practice called Carolina Cardiology Associates, said in an interview that they used Biotronik devices because they thought they were superior, and not because of the free training. They also say they have a strong patient safety record.

"No one can buy my business," said Dr. Jugalkishor K. Shah, the president of Carolina Cardiology. "I think that Biotronik has very good technology."

To read more about this important topic, use the link below:
http://www.nytimes.com/2006/08/01/business/01train.html?_r=1&oref=slogin