BusinessReport.com

Baton Rouge is home to the largest single-specialty vascular medicine practice in Louisiana or Mississippi, with an annual patient volume of about 10,000 a year.

Vascular Surgery Associates' clientele is so large, in fact, that it exerts a gravitational pull on companies that need to test their new vein-medicine technologies and techniques in clinical settings--on people, in other words.

Clinical trials are new territory for the VSA. It generates extra revenue, of course, but VSA's vein docs say the best thing about clinical trials is they let physicians work with cutting-edge products and methods not available on a wide scale.

VSA has been in Baton Rouge for decades but only got into clinical trials in 2000 when a company called Corgentech Inc. approached VSA's surgeons about participating in a nationwide clinical trial to test a technology designed to keep vein bypasses from closing over time, as they tend to do.

The practice was able to muster enough patient-volunteers to become one of the top five 'enrollers' in the country. That got the practice's name attached to a high-profile national study, and that got the clinical-trial ball rolling. Suddenly, VSA was able to offer its patients the latest innovations in vascular medicine while getting paid for its trouble.

VSA recruited Dr. Albert D. Sam II, who trained in clinical research at Northwestern University in Chicago, to set up a full-time clinical trail division. Sam says clinical trials in vascular medicine traditionally have taken place in academic settings--in university hospitals with the staff and resources to accurately manage the complex protocols and heaps of data clinical trails generate.

But from the perspective of vascular device companies, a private practice has advantages over an academic setting, he says. University hospitals are part of lumbering, bureaucratic beasts with a slower response time than a relatively small organization like VSA, which can give the private sector a fast answer when new proposals come through the door.

'We've got the patient volume, data keeping capability and fast turnaround,' Sam says. 'That's what gives us a leg up on academic centers.'

The revenue VSA gets from clinical trials, though not insignificant, pales in comparison to the several million dollars a year generated by VSA's other divisions: the core practice, a research lab separate from the clinical-trial division and Total Vein Care, which focuses on treatment for varicose and spider veins.

The real point is getting the latest technology ahead of other practices, says Donald Varnado, VSA's chief operating officer. 'It's very important to us because it's how we stay out on the cutting edge,' he says. 'It's what keeps us on our toes. We have [the competition] looking over our shoulder with everything that we do.'

Less invasive procedures are where the field is moving, Sam says, and most of the trials VSA does involve devices and techniques that make it possible to work on veins with less cutting into patients or filling them full of radioactive dyes. Patients appreciate less invasive approaches.

At the same time, a practice can get hurt if it is unable to thoroughly budget for a study on the front end--something easier said than done in medicine. It can be difficult to get reliable cost-data from hospitals, Sam says, and Varnado adds uncertain or razor-thin margins are not desirable from a business standpoint.

Hospitals can get hurt, also, if an insurer balks at paying. This happens often enough that some facilities--such as Our Lady of the Lake--have liability clauses that stick the bill to the private practice conducting the clinical trail.

Explains Varnado, 'If somebody has a $50,000 hospital bill and we're just handling one little piece of it for the clinical trial, and if the insurance company says, 'We're not paying that' for any reason, we're responsible for the whole bill. We can't afford that.'

VSA does all its clinical trials through Baton Rouge General because of the hospitals with which the practice is affiliated, it's the only one without such a stipulation.

Chuck Daigle, head of management and professional services at the Lake, says the hospital does plenty of clinical trails with practices willing to accept its terms. 'I think everybody's got their counsel and terms of what they can and can't do,' he says. 'We don't want to have clinical trials whereby we're put it in the position financially that we're totally responsible for absorbing the cost.'

Plus, Daigle adds, 'For hospitals, [trials] have not been a particularly lucrative business.'