A new study released today on the benefits of cardio resynchronization therapy (CRT) devices is especially intriguing if one considers the way medical devices are often marketed. Many device makers pay physician consultants hefty fees to conduct research that turns out to provide a favorable view of the manufacturer’s products. In other instances, these physician consultants – usually influential doctors in their field – make referrals and recommendations that favor the devices made by companies that pay their fees. Patient advocates have long wondered if these arrangements are causing patients to undergo unnecessary procedures or receive devices that are unsuited to their needs.
Take CRT devices, for example. According to a report in The Wall Street Journal, treatment guidelines for such devices – which are designed to correct an electrical disturbance in which the right and left ventricles aren’t contracting together – were formulated based on several large studies that demonstrated CRT can save lives and prevent hospitalization among heart-failure patients. Those guidelines recommend that the devices be implanted in patients whose QRS duration measured by an electrocadiogram measured 120 milliseconds or longer. Now, a study published online by the Archives of Internal Medicine has found that CRT doesn’t provide any benefit to almost 40% of patients who are candidates for them under current treatment guidelines.
The question has to be asked: Is it possible that financial relationships between the researchers and the makers of CRT devices unduly influenced the adoption of treatment guidelines? We don’t know the answer to that specific question yet. But there is a lot of evidence that in many instances, financial incentives from a heart device maker may have influenced some doctors’ treatment decisions.
For example, The New York Times recently ran a couple of articles detailing the relationship one device maker, Biotronik, has with its physician consultants. In April, the Times reported that Biotronikâ€™s national share of the heart-device market barely exceeds 5 percent. But last year at the University Medical Center of Southern Nevada, 95 percent (250 out of 263) of patients receiving a heart device received a Biotronik product. According to report, some of the hospital’s doctors using those devices were receiving as much as $5,000 per month from the device maker.
Late last month, another New York Times report raised further questions about Biotronik’s relationships with some consultants. For example, there is the companyâ€™s relationship with Dr. Monty C. Morales, a general cardiologist in Tucson. According to the Times, Dr. Morales doesn’t implant devices, but â€œexpressed strong opinions about the implant brand his patients should get.” In a report apparently written by a sales representative for a Biotronik distributor called Western Medicale, Dr. Morales is portrayed as saying he would not refer patients to another doctor in his OWN Practice unless that doctor agreed to use Biotronik devices. According to the Times, in 2008 Biotronik retained Dr. Morales as a consultant under an arrangement that paid him up to $2,000 a month.
Other documents detailed in the Times piece also indicated that Biotronik may have made it a practice to hire doctors’ spouses or other relatives to get their business. According to one internal company report, Biotronik officials suggested that an implant specialist practicing at a California hospital where the company wanted to increase sales could be “wooed if Biotronik offered him concessionsâ€ that included hiring his son. According to the Times, this particular doctor’s wife and son were working for a competing device maker at the time.
The same New York Times article also reported that Biotronik appeared to be using lucrative research deals to garner business from doctors. For example, an email from Thomas V. Brown, a Biotronik executive vice president, indicated that doctors wanted implant makers to produce more clinical trials of devices to help them generate income from research fees. To compete, Brown wrote, â€œWe must be able to â€˜answer the bell.â€
According to the Times:
“The documents show, for example, that device makers recruit not only implant specialists as consultants but also general cardiologists who refer patients. Those cardiologists, called feeders in one of the documents, can benefit by enrolling the referred patients in a company-financed study that can pay a cardiologist up to $4,800 a patient.”