Saturday, December 8, 2018

Conflict of Interest: a growing awareness of the issue

In Prescription for Bankruptcy, I document the many possible conflicts of interest inherent in the relationship of doctors and the pharmaceutical industry. These range from the ubiquitous “free lunches” brought in by the companies’ reps, that have been shown to clearly influence prescribing patterns, to the more pernicious large financial amounts the industry gives to opinion leaders. Many of the “thought leaders” who write guidelines and lecture at medical meetings are heavily subsidized by Big Pharma, either in the form of research support and/or generous speaking fees. In addition, many of the experts who sit on FDA panels deciding whether to approve new drugs for marketing have strong financial links to the pharmaceutical companies.
Well, it turns out that this same issue is a potential problem in the medical device industry. Medical devices range from simple products such as syringes and canes to coronary stents and joint replacement prostheses. The global medical device market was estimated in 2015 to be worth $370 billion, about half the global market for prescription medications, and is growing faster than the pharmaceutical market. In the European Union and the United States, medical devices account for 6-7% of total health expenditures. A study published in the journal Health Affairs in October 2018 found that there is an enormous variation in what is paid for the same device. It will not shock readers of Prescription for Bankruptcy to learn that cardiac implant devices may cost up to six times as much in the U.S. than they do in some European countries. The researchers also found enormous price variation within the same country, based on the bargaining power of the purchaser.
With this background, a study presented at the November 2018 Scientific Sessions of the American Heart Association takes on particular relevance. They analyzed data now made public under the Sunshine Act to review payments made by device manufacturers to cardiologists. Biomedical manufacturers distributed about $520 million to some 30,000 U.S. cardiologist from 2014 to 2016, averaging over $17,000 per cardiologist. This was NOT evenly distributed: 1,067 doctors received over $100,000 during the three-year study period, and they got almost two-thirds of the total payments. The payments were most often for speaker’s fees (54%), consulting fees (18%) and ownership stakes (12%). Based on what we know about the tactics of Big Pharma, we can assume the largesse was focused on the “opinion leaders” who were likely to have outsized influence on device selection. The researchers found that physicians with financial relationships to manufacturers were up to twelve times more likely to use an implantable cardioverter-defibrillator or similar device from that company than from another.
The good news is that there did not appear to be any patient harm from this bias. There was no evidence of increased rates of complications or in-hospital deaths among patients whose doctors had financial ties to industry. The impact on the cost of care is another story.

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