Life Science Compliance Update

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April 12, 2011

NEJM: The Selling of Academic Detailing

Academic Detailing 2 
Almost 50 years ago, U.S. Senator Estes Kefauver (D-TN) introduced legislation to regulate the drug industry because the Food and Drug Administration (FDA) still did not have legal authority to require pharmaceutical companies to demonstrate that their products actually worked.  Before this legislation, “what physicians knew about prescription drugs was shaped predominantly by the claims their manufacturers made about them, and the evidence base underlying such claims was often rudimentary, or worse.” 

At this time, there was also an issue of “how information about a drug’s benefits and risks should be evaluated and communicated to physicians — and by whom.”  Of course then, as now, pharmaceutical companies used marketing.  However “no mechanism existed for robust, arm’s-length governmental determination of a drug’s efficacy and for the dissemination of such data — a solution that many clinicians did not favor in any case.” 

This legislation also created a mechanism to allow the federal government to “provide a more even-handed, public source of drug education for physicians: a leaflet that would accompany every prescription medication describing “all the information about the activity, uses, and untoward effects of the drug”; a compendium of such information for all products “in convenient and readable form” to be distributed widely; and an annual listof medications with high potential for serious side effects.” 

Eventually, Senator Kefauver held a number of hearings, which resulted in a new law that gave the FDA the authority to require evidence of efficacy and safety before a drug could be marketed. 

Consequently, a recent article in the New England Journal of Medicine (NEJM), written by Jerry Avorn, MD, analyzed the developments in drug marketing and labeling that have occurred over the past 50 years.  He noted that, half a century later, the question, “Who shall educate the physician?,” is still hotly contested. Dr. Avorn pointed out that the “evidence base available to clinicians to guide their therapeutic choices is still heavily shaped by industry-sponsored studies that often compare new products with placebo, measure their worth in terms of surrogate markers such as laboratory test results, or both.” 

In addition, Dr. Avorn noted that, “the recent comparative effectiveness movement holds great promise for improving this evidence base.”  However, comparative effectiveness is an economic analysis at its core, rather than a scientific compendium of drug safety and efficacy profiles.  Comparative effectiveness, according to current, global definitions, seeks to establish health outcomes, at a known cost.  Indeed, cost is a central outcome.  How comparative effectiveness will improve patient outcomes or health remains uncertain in terms of quality of life and treatment. 

He also discussed “concerns” about “undue influence of drug companies” in a “manufacturer-dominated continuing medical education industry.”  What is problematic about this comment is that it misstates the current state of the CME industry.  Industry funding of CME has been significantly reduced over the past several years, and now makes up less than half of all CME funding. Specifically, since 2007, commercial support has declined $355 million or 29.3%.  Moreover, the total percent of commercial support as part of the overall CME budget dropped from 47.5% (2007) to 39.0% in 2009. Fewer companies are funding CME programs as well. 

Additionally, Dr. Avorn’s belief that industry funded CME is producing bias or conflicts is unfounded because he provides no evidence to show that industry involvement in education is causing harm to patients, or that industry's absence from education would not increase harm.  

Interestingly, Dr. Avorn suggests that one way to address the issue of getting drug information to doctors is through “academic detailing” — educational outreach programs in which independent researchers and clinicians systematically review data for a given therapeutic area and develop noncommercial, evidence-based recommendations about treatment choices.  What is concerning about this comment is that Dr. Avorn fails to disclose the fact that he has worked on academic detailing since the 1980s and he runs a company—RX Facts—which provides these services to states and health systems.   

Despite this clear conflict of interest, Dr. Avorn describes how academic detailing involves sending pharmacists, nurses, and physicians to visit practitioners in their offices to present drug findings, drawing on the successful marketing strategies of industry but without its sales-oriented spin.  And he notes how several states, insurers, and federal programs currently fund academic detailing programs based on content developed by nonprofit organizations free of industry ties—most of which are funded through his company! 


Dr. Avorn’s failure to disclose his full involvement with academic detailing within the article is troubling, as are some of the statements he makes.  While he asserts that issues of drug marketing and education “are even more relevant and pressing today,” the reality is, industry is now developing fewer drugs and FDA approving fewer drugs. So it's not clear why or how the issue is "more pressing."  Of course, it is probably more pressing for Dr. Avorn because he stands to make more money through his company, gain recognition, and receive more grants if there is a need for academic detailing.   

Ultimately, while the idea of academic detailing certainly has promise because it could save smaller companies a lot of money they spend on sales representatives, academic detailing tends to focus on drugs with lots of supportive studies and especially generics.  These do little to establish the value and appropriate utility of new drugs/devices, which are often understood best after a substantial accumulation of direct experience.  Empiricism plays an important role in shaping hypothesis-driven protocols.  Also, many people seem to want to saddle drug companies with the cost of academic detailing while stripping the manufacturer's of input.  That's generally a lousy way to spend money. 

In the end, companies provide truthful, evidence-based data and information to doctors.  While academic detailing may be able to provide similar services, at what cost will this come to patient safety and health?  How will this effect physician knowledge, competency, and training? 

According to one CME physican leader “Shame on the NEJM who should know better than to publish anything with clear commercial bias that lacks any real evidence in their peer reviewed evidence based journal! They have violated the public trust and let down their physician readership that depends on them for scientific accuracy and unbiased review of articles.”  

If doctors didn’t want to talk to sales representatives, they would say no, as many have.  However, they find value in the information representatives provide.  Moreover, this form of commercial speech is constitutionally protected under the First Amendment, and attempts to prohibit the dissemination of truthful information are frowned upon in America.  Accordingly, underscoring one process that has been in place for 50 years to self-promote another is counterproductive.  We should be working together to get as much information to doctors as possible so that they are able to make informed decisions with patients to produce the best possible outcomes. 

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