The government goes to great lengths to control what those who speak with physicians can say to physicians. This is done out of concern that industry representatives have an agenda that could nefariously and inappropriately influence doctors. But what happens when the government starts talking to physicians? Who will be there to make sure that the government’s agenda doesn’t influence the doctor — especially when that agenda is cutting costs, not saving lives?
Under one of the less-noticed provisions in the 2009 stimulus bill, the United States government will, for the first time, start advising doctors directly on how they should treat patients — a process known as “academic detailing.”
This raises two major concerns: what will the government advise? And what rules will govern the interaction between government representatives and physicians?
Many within the medical community are concerned that academic detailing will focus on cutting government healthcare costs — an outcome that will reduce patient outcomes and quality of care.
Academic detailing is intended to communicate the findings of government-sponsored comparative effectiveness research (CER), but the government has been silent about the kinds of research projects the government will fund. In fact, it is not clear whether academic detailing will focus on clinical effectiveness research or comparative effectiveness research.
Clinical effectiveness measures outcomes on an individual patient level to improve understanding of how different patients respond to different treatments. This type of research helps inform doctor-patient discussions, and enables better individual outcomes. Comparative effectiveness research, on the other hand, measures outcomes on a system-wide level to compare drugs against each other. This type of research does not take patient differences into account. It prioritizes treatments that work for the most people at the lowest cost, even if for some people, they don’t work at all.
If academic detailing focuses on comparative effectiveness research, it could pressure doctors to recommend treatments that are more cost-effective on a system-wide basis, despite being the wrong treatment for many individual patients. This will reduce the quality of care for patients, and it could, ironically, end up increasing costs. That’s because cost-cutting will limit patient access to preventative treatments, causing greater long-term hospitalizations.
There are good reasons to be concerned about this. A number of states have used academic detailing, and while all the state programs list improving appropriateness of medication use as a primary goal, several also place a high value on reducing costs.
If there were common-sense regulations to prevent academic detailing from focusing on cutting costs, this would not be a concern. However, the government has been completely silent on the rules for academic detailing.
While the agency in charge of academic detailing, the Agency for Healthcare Research and Quality (AHRQ), has already awarded $42.3 million in grants to public relations and physician outreach firms, it has not laid out the specific activities that detailers will and will not be permitted to undertake. It has not articulated the specific rules and regulations that will govern the behavior and activities of AHRQ-funded detailers. And it has not provided information on oversight of these activities.
This lack of rules raises major concerns. Without public scrutiny, there is no guarantee that academic detailing will present information that is unbiased, peer-reviewed, and aligned with the existing evidence base. Without clear guidelines, there is nothing to prevent academic detailers from using their outreach to advocate, instead of educate. And without strong oversight, there is little to prevent academic detailing from pursuing private agendas, or engaging in corruption.
This lack of rules or oversight stands in stark contrast to the extreme scrutiny with which industry “detailers” are subject in their interactions with physicians. Starting with the Federal Food, Drug, and Cosmetic Act of 1938, and continuing through the 2010 FDA “Bad Ad Program,” the federal government has imposed a number of regulations on industry’s ability to promote their products and distribute information about their drugs to physicians and consumers.
This glaring discrepancy has caused many in the life sciences to suggest that AHRQ-funded detailers be held to the same standard as industry representatives. This simple, common-sense step would ensure providers are receiving accurate, unbiased information on the best treatment options available to improve patient care. So far, however, AHRQ has ignored these suggestions.
Peter J. Pitts is the President and Co-Founder of the Center for Medicine in the Public Interest.