On June 10th, we did the first in a series of articles regarding the basic medical issues involved in the St. Joseph Medical Center/Dr. Mark Midei stent scandal. This second installment begins in the year 2000 – a period in time the cardiology industry calls the STENT WARS.
The early part of this decade was a period when interventional cardiologists, such as Dr. Midei, were aggressively seeking to demonstrate a short and long term successful alternative to open cardiac bypass surgery for patients. While there is no doubt that these specialists were seeking better approaches for their patients by avoiding, if possible, open heart bypass surgery, it is also evident that these endovascular procedures were quite lucrative for interventional cardiologists as well. It was reported that drug eluting stents generated a world market revenue of $5 billion annually in the early 2000′s. In 2001, more then 500,000 procedures involving stents and balloon angioplasty were being performed in the United States annually. The “war” for market position was on. Who would win top position among manufacturers and grab this pot of gold?
The STENT WARS were also being fought around the globe and included familiar company names: Cordis, Boston Scientific, Medtronic, Abbott, Conor MedSystems, OrbusNeich, Biosensors, and Xtent. Mergers, acquisitions, partnerships abounded. As you can imagine, clinical trials were also proliferating throughout the medical world. Investment money was flowing. Interventional cardiologists invested in their own technology and made money on both the procedures and their investments. During this period of enormous expansion, Dr. Midei became co-founder of a large cardiology practice in the Baltimore metropolitan region. In the latter part of 2007, he was recruited away from his group practice and hired by St. Joseph Medical Center as its Director of Interventional Cardiology (Cardiac Catheterization).
So what was stent research showing? What was the science that gave Dr. Midei an open door to placing numerous unnecessary stents at the cost of $10,000 – $15,000 a stent.
Early clinical trials were positive for the industry. Data revealed drug-eluting stents (DES) reduced re-stenosis (i.e. re-narrowing of the cardiac blood vessel) from 20-30% to single digits and continued to show better outcomes than bare metal stents (BMS) and balloon angioplasty. These favorable results led to the official FDA approval of two drug-eluting stents in 2003 and 2004 for use in the USA although clinical trials had been underway in major cardiac centers for several years. The stent type, coating of the stent with a particular drug, and key decisions made by the interventional cardiologist during stent placement were reportedly all factors necessary for favorable outcomes. Using coronary angiography, the interventional cardiologist determined the proper stent length and diameter needed to repair a blocked artery and was able to ensure proper stent placement within the artery. There was enough new scientific research data for the American College of Cardiology and the American Heart Associated to update and publish clinical practice guidelines for both hospitals and cardiologists in 2001.
Landmark studies during this time were also revealing more new information about progressive heart disease. Research studies demonstrated coronary artery atherosclerosis usually affected more then one vessel and was, therefore, often a diffuse disease.
While these results led to the positive development of conjunctive drug therapies, they also opened the door for exploitation.
An interventional cardiologist, seeking to line his/her own pockets and/or gain a position of power within an organization for whom he/she worked could place many stents in multiple coronary vessels regardless of size or complexity. In other words, stents could be placed in symptomatic large blockages, and stents could also be placed in those small areas that MIGHT, in the so-called clinical judgment of the operator, develop into a blockage. Clinical practice guidelines were silent as to what should be done to lesser size lesions. In the absence of data, the cardiologist could choose to be aggressive or conservative. However, clearly an avenue for financial abuse and gain was opened for some interventional cardiologists to push acceptable judgment boundaries.
You might ask: weren’t there provisions and systems in hospitals to prevent such exploitation if it were to occur. Unfortunately, nether the ACC nor AHA 2001 clinical practice guidelines contained any recommendations for peer review or oversight of this burgeoning stent industry. It was left to hospitals to establish their own monitoring guidelines to oversee the conduct of their physicians.
Join our next blog to learn more about the introduction of peer review guidelines that were finally published four years later in 2005.