A recent article from the New York Times examined a brand of heart device that patients at a majohospital get. According to the article, “a little known company called Biotronik has cornered the market on pacemakers and defibrillators at the University Medical Center of Southern Nevada within the last few years.” Specifically, 250 of the 263 patients, or 95 percent, who had a heart device implanted at the hospital center got one made by Biotronik.
What is surprising about this data, according to the article, is that the “implants were not used there before 2008, and its national share of the heart-device market barely exceeds 5 percent, according to industry estimates.” So what explained this sudden increase in use?
The NYT story says that in mid-2008, Biotronik hired several cardiologists who implant heart devices at the Las Vegas hospital as consultants, paying them fees that may have reached as high as $5,000 a month. It was suggested that these consultants are the reason for the increase in use of Biotronik devices, and that “the hospital’s chief executive never asked during the hospital’s switch to Biotronik whether those physicians had a financial connection to the company.”
Now, a federal investigation is examining Biotronik’s marketing and sales practices. Consequently, the entire article is based on investigations the Times did on documents they received from the ongoing litigation. What is problematic about this article is that no evidence was ever discussed that the device in question is better or worse than any other or that anyone has been hurt. In fact, the article specifically states that, “for patients, the use of Biotronik devices by doctors who were hired as consultants does not seem to have posed safety issues.”
Moreover, the article recognized that, “several of those doctors said they switched to Biotronik devices because they believed they were more reliable and less prone to recalls than competitors’ models, even though they had previously used those products.”
In response to this story and allegations of wrongdoing, an outside lawyer for Biotronik, Christopher A. Myers, stated that, “Biotronik paid its consultants for legitimate services and at rates comparable to those of competitors. He added that Biotronik adhered to an industrywide code of ethics.”
Discussion
While “in recent years, payments to doctors from makers of drugs and medical devices have come under intense scrutiny because of concern that such ties can affect physician practices,” little if any evidence has shown that physician-industry payments harm patients. While the article may suggest kickback payments from the unverified documents they “investigated,” behind all of the smoke and mirrors surrounding this case are disgruntled competitors and the idea that doctors being paid is somehow evil, even though every physician asked said payments were for value-adding contributions.
The reality is, “doctors and device makers describe themselves as partners in an effort to best serve the needs of patients.” Would a highly trained surgeon really risk his entire career, possible legal repercussions, and even losing his or her license for a couple of tickets to see a show in Vegas? The answer is clearly no.
Physicians choose devices based on patient needs, not consulting arrangements, and when a doctor “agrees to consult with a company because of the confidence level they have in the company and the quality of its products.”
Ultimately, if Medtronic and Boston Scientific dominate the market and a small competitor enters with an approved product, is it nefarious to concentrate marketing where it has the best chance of promoting adoption? Small businesses are at the heart of America, and medical device companies make up a significant portion of them.
At a time when innovation in medical devices is dwindling in America because of an uncertain regulatory regime at the FDA and America’s current economic crisis, should the Times really be spending its energy and resources attacking the little guys out there, who are trying to make all of use healthier? No one doubts that kickbacks are wrong and that industry interactions with doctors should be transparent, but a more balanced approach to this story seems necessary, especially considering nothing was shown to harm patients in the use of Biotronik’s device.