The rate at which medicine, science and technology advance our current health care system is rapid. Each day, more and more companies are filing applications to begin research and clinical trials and new drugs, devices, biologics, vaccines, and treatments that will one day hopefully cure cancer, AIDS/HIV, and assist in managing chronic diseases such as asthma, heart disease, diabetes and obesity.
However, these advances do not happen overnight, and the time it takes to get them from the bench to the bedside is a long and extremely difficult process. And it’s not cheap.
Practicing physicians and clinicians in the American healthcare system are already overwhelmed and overburdened. Reimbursement rates are at an all time low, malpractice insurance costs are soaring, overhead for running private practices make it almost impossible for small groups of physicians to keep their heads above water, and the massive changes coming to our healthcare system as a result of the Affordable Care Act have left everyone very confused.
While all of these issues create a perfect storm of difficulties in our health care system, the role of industry and physician-collaboration and relationships have also raised concerns, especially with respect to marketing and detailing.
Marketing and detailing is a process by which drug and device manufacturers educate and inform practicing physicians and clinicians about new products, treatments, devices, and clinical data regarding a specific product that has been approved by the Food and Drug Administration (FDA). The process of detailing, although not perfect, and subject to recent federal prosecution and significant regulation, is extremely important for physicians who spend their busy days treating patients every 15 minutes.
Yet, some believe that marketing and detailing raises costs to our healthcare system and raises issues of bias and conflicts of interest. Many argue that detailing leads to the use of brand name drugs and higher prescription costs, as well as the use of products that have significant risks for patients. These claims are heavily misguided considering over 75% of prescription drugs in the U.S. are generic.
Academic Detailing
Over the past few decades, an effort to counter detailing has begun to grow. Academic detailing“ was pioneered by Jerry Avorn and others over 30 years ago as a “method of educational outreach that provides prescribers with accurate, non-commercial, and relevant data on medications in a user-friendly, interactive format that is proven to change practice.”
Academic detailing is noncommercial education of health care professionals, typically conducted by physicians, pharmacists, and nurses, about the evidence-based efficacy, safety, and cost of therapies. It is designed to counter detailing by pharmaceutical and device manufacturers, which critics contend can be biased because of commercial interests.
Consequently, the academic detailing movement has begun to pick up. “In fact, a recent initiative was funded and supported by a grant from the Agency for Healthcare Research and Quality (AHRQ).
The grant is part of funding from the American Recovery and reinvestment Act, which gave the Department of Health and Human Services (DHHS) $1.1 billion to conduct comparative-effectiveness research designed to compare therapies for various conditions to determine what treatments work best. Consequently, DHHS spent $300 million through AHRQ, in part to conduct an Academic detailing Initiative.
The program, known as the National Resource Center for Academic Detailing (NaRCAD), has the goal of promoting “the use of evidence-based medicine by supporting programs of academic detailing.” According to their website, NaRCAD:
– Promotes the use of evidence based medicine by supporting the establishment and improvement of academic detailing programs.
- NaRCAD provides training, materials, and consultative support to health care organizations to establish effective academic detailing programs.
- NaRCAD aims to establish a network of programs sharing best practices in academic detailing to further the use of comparative effectiveness data in medical practice.
Consequently, the AHRQ grant and NaRCAD also got recent attention in an article in the Journal of the American Medical Association (JAMA). Unfortunately, the article is very slanted in its portrayal of detailing. For example, the author cites data from 1995, which showed that “11% of statements made by drug company detailers about drugs contradicted information readily available to them.” In the almost 17 years since that research was conducted, monumental changes in the industry and because of government regulations and legal cases have significantly changed the nature of statements detailers can make. As such, this kind of past abuse is almost non-existent.
AHRQ is also funding a number of other programs including:
- Total Therapeutic Management Inc. (a quality improvement company providing outcomes research) to provide in-person visits to clinicians and health care system decision makers to help them understand and use comparative effectiveness research.
- Ogilvy Public Relations to create a publicity center to promote the academic detailing resources and to establish dissemination partnerships with national organizations, as well as establish regional dissemination centers to enhance awareness and use of academic detailing;
- Prime Education Inc, which will provide continuing medication education (CME) to clinicians. A fourth entity; and
- IMPAQ International, which will determine the effectiveness of the 4 projects
How NaRCAD Works
The website notes that, “despite the availability of a growing body of comparative effectiveness research (CER) weighing the risks and benefits of therapies in a wide range of clinical areas, non-evidence-based medical care is common.” Accordingly, NaRCAD provides organizations with support and guidance in establishing new academic detailing programs, as well as evaluating and improving existing ones.
- The Center works with partner organizations to perform a needs assessment of their current patterns of medical care and lay the groundwork for establishing academic detailing programs.
- Our core staff and clinical specialty consultants adapt AHRQ’s CER findings for important clinical areas (including diabetes, use of anti-psychotic drugs in dementia, pain control in arthritis) into tools that can be used for effective academic detailing.
- The center provides training sessions on the principles of social marketing, techniques of academic, and the clinical content of the adapted CER findings. These sessions will be offered on multiple occasions over the coming months and years.
- NaRCAD works with each partner organization to evaluate its academic detailing activities across multiple dimensions. We collaborate with programs to gather qualitative data on the process of implementation, the quality of training, and the experiences of clinicians receiving the academic detailing messages. The resource center also provides guidance to participating programs on performing patient-level assessments of the impact of their interventions.
The website notes that, “guidance on the establishment of detailing programs, training on the techniques and content of academic detailing, assistance in the evaluation of program effectiveness and the provision of adapted AHRQ review material will help organizations to transform evidence-based information into improved patient-care decisions.”
Network for Academic Detailing
Consequently, the website notes that, “NaRCAD is establishing a network of organizations seeking to implement the findings of AHRQ’s CER work in their own settings.” Organizations that have already implemented academic detailing or other innovative educational program are welcome to partner with NaRCAD and to take advantage of the training and resources that the center provides.
NaRCAD aims to create a community of programs using academic detailing to disseminate non-commercial, evidence-based information on the benefits and risks of treatment options. This sharing of ideas will enable us and partner organizations to identify best practices that lead to successful academic detailing programs, as well as pitfalls to avoid. By sharing information in this manner, NaRCAD will facilitate the development and improvement of academic detailing programs nationwide.
After 3 years, the AHRQ hopes to have enough data to enable it to understand the impact of the academic detailing process, the development of partnerships, the types of outcomes it can expect during different phases of the project, and the influence of various detailing methods on health care worker behavior.
Jean R. Slutsky, PA, MSPH, director of AHRQ’s Center for Outcomes and Evidence, said the initiative is targeted at primary care physicians working in small and large practices. “We are bringing unbiased, high-quality information to health care professionals. It is really face-to-face education with trained professionals who have no conflicts of interest who are trained in how to discuss the information,” Slutsky said.
“A key message we try to bring is the balance of benefits and harms of different health care interventions—allowing primary care providers to understand where one option may provide more of a benefit than another option,” Slutsky said.
Discussion
Consequently, while this program may be important to educate doctors, it is equally important, especially in light of the recent Supreme Court decision in IMS v. Sorell, that academic detailing does not attempt to discredit other forms of education, particularly traditional forms of detailing and promotion.
Industry regulations such as the PhRMA and AdvaMed Codes of Ethics, as well as oversight from HHS OIG, FDA, DDMAC, and DOJ, all ensure that the future of marketing, promotion and education will be of the highest quality and integrity, and most importantly, will be truthful.
In fact, the Pharmaceutical Research and Manufacturers of America (PhRMA) addressed the issue in a statement it made last year regarding a hearing in the Minnesota legislature about health care legislation. In the statement, PhRMA Senior Assistant General Counsel Marjorie Powell said, “The final proposal could expand academic detailing programs that, elsewhere, exist solely to boost the number of generic drugs that physicians prescribe.”
Powell noted that this kind of “single-minded focus raises the question of the merit of such a program in Minnesota, where generic dispensing rates already approach 80%.” Furthermore, while the industry has specific required regulations and policies,someself-imposed and some required by government, that they need to adhere to when presenting information.
However, as Powell recognized, “counter-detailing is not subject to rigorous federal oversight, which requires that the information shared with physicians be accurate, fair, balanced, and reflect the federally approved medicine label.”
Echoing the cost-pressure concern is Joshua D. Lenchus, DO, RPh, an associate associate professor of clinical medicine at the University of Miami Miller School of Medicine and associate director of the University of Miami-Jackson Memorial Hospital’s Center for Patient Safety in Florida. In a legal backgrounder for theWashington Legal Foundation wrote, “Physicians and other medical professionals are certainly conscious of the cost of drugs and medical devices, but our primary duty is to provide each patient with the care best suited to them individually. Tools such as comparative effectiveness research and academic detailing have been developed and applied in response to intense political and fiscal pressure to reduce health care costs”
Ultimately, as the Supreme Court recognized in IMS, “the fear that people would make bad decisions if given truthful information cannot justify content-based burdens on speech.”
The Court explained that “many listeners find detailing instructive,” and that while some people and States may be displeased that detailers with prescriber-indentifying information are effective in promoting brand name drugs, “the State may not burden protected expression in order to tilt public debate in a preferred direction.” Accordingly, academic detailing should keep these points in mind as they move forward.