Life Science Compliance Update

April 29, 2011

A Federal Unsales Force?: “Academic Detailing” On Medical Treatments And The Oversight Imperative

Academic Detailing 3 
Advances in medicine, science, and health care happen at revolutionary pace.  Unlike legal principles, which can take decades to change, progress in science and medicine frequently happen every day and sometimes overnight.  The rapid pace of medical advancement is beneficial to patients and Americans for a number of reasons.  Progress in medicine and health care often leads to new jobs, both directly and indirectly.  It leads to healthier patients, more accurate diagnosis, and better treatments.  However, with the promise of new medical progress also come challenges.

The biggest challenge facing today’s health care practitioners is staying up to date and trained in the newest medical treatments, technologies, and devices.  This requires a thorough understanding of new clinical trial data and information provided by the Food and Drug Administration (FDA).  Such knowledge must be constantly and consistently reinforced through continuing medical education (CME) and other resources such as commercial speakers, consulting, journals, and “detailing.” Detailing refers to the information physicians and other health care professionals routinely receive from visits by drug and medical device company representatives.

Interestingly however, over the past three decades, a practice known as "academic detailing" (or "counter-detailing") has developed and been embraced by some health insurers and state governments to address rising health care costs.  As a recent article from the Washington Legal Foundation (WLF) explained, “independent academic detailers (typically clinicians, nurses, or pharmacists) meet with health care professionals and share information and educational tools about treatment options which are, according to the detailers' research, as effective as those advanced by company salespeople, and available at a lower cost.”

The article, written by Dr. Joshua D. Lenchus, Assistant Professor of Clinical Medicine at the University of Miami Miller School of Medicine, noted that the U.S. government is currently working to implement academic detailing on a national level.  While “programs which enhance medical professionals' knowledge should certainly be welcome by all who work in and benefit from America's health care system,” the article noted concerns “with regards to the government regulatory oversight of such academic detailing.” 

Medical product industry detailers must comply with state and federal rules, as well as voluntary industry codes, with regards to their contact with physicians.  However, no such standards presently exist for federally-funded academic detailers to ensure transparency, impartiality, and quality in the information and provider interactions.

Academic Detailing Evolution and Adoption. 

Dr. Jerry Avorn of Harvard Medical School is acknowledged as the godfather of academic detailing.  In a 1983 New England Journal of Medicine article, he and Steven Soumerai described a randomized, controlled trial of clinical pharmacists visiting physicians' offices with the aim of reducing the excessive use of specific drug groups.  The article relates that these visits led to a fourteen percent decrease in prescribing the drugs.  The authors concluded that "academically-based ‘detailing' may represent a useful and cost-effective way to improve the quality of drug-therapy decisions and reduce unnecessary expenditures.” 

The concept of academic detailing attracted insurers like Kaiser Permanente, who has used it for over 2 decades.  In addition, Pennsylvania, Vermont, and South Carolina have created academic detailing programs.  Pennsylvania's Independent Drug Information Service (IDIS), initiated in 2005, has been cited as a model and noted as a success by the Pew Prescription Project for generating cost savings from decreases in "inappropriate prescribing" that offset program expenses.  In fact, the state's Department of Aging has been paying Dr. Avorn’s foundation $1 million a year for three years to compile data on doctors who have at least 25 patients who receive state assistance to pay for their drug treatments, and who treat such ailments as chronic pain, hypertension, gastrointestinal symptoms, and high cholesterol.

Emergence at the Federal Level. 

While the federal government was largely uninvolved in academic detailing, the American Recovery and Reinvestment Act (ARRA) included $1.1 billion for the Department of Health and Human Services (HHS) for the purpose of conducting "comparative effectiveness" research. $300 million of the ARRA appropriation was directed to lay the groundwork for a broader HHS-led academic detailing program. 

Additionally, the Patient Protection and Affordable Care Act (PPACA) signed into law in March 2010 further solidified the government-funded comparative effectiveness research by creating the Patient Centered Outcomes and Research Institute (PCORI). 

Consequently, “in April 2010, AHRQ put out a solicitation for contractors to support an "Academic Detailing Initiative" with the overall goal of "contract[ing] with an organization to conduct activities related to Academic Detailing.”  On September 28, AHRQ awarded an $11.7 million, three-year contract to Total Therapeutic Management, a physician and patient education company, to integrate the agency's comparative effectiveness tools through on-site visits with clinicians, nurses, health plan formularies, and professionals. 

AHRQ awarded four other contracts that day for the Academic Detailing Initiative: one for $18 million to Ogilvy Public Relations to create a publicity center, as well as another to the firm for $8.6 million to create regional dissemination centers; a $4 million continuing education award to Prime Education; and a $2.4 million contract to IMPAQ International “to evaluate the impact of the other four contracts.”

Standards and Restrictions on Industry Detailing. 

As the article notes, the “Federal Food, Drug, and Cosmetic Act, its amendments, and scores of FDA regulations, guidance documents, and policies govern medical product companies' outreach and promotional efforts to health care providers and the public.”  For example, all promotional materials distributed by companies must undergo a rigorous FDA review process.  Information must be accurate and fair regarding the products' risks and benefits.  Omissions of material facts, including risk information in advertising or promotional materials, can result in criminal sanctions. 

As a result, FDA closely monitors all communications between care providers and company representatives, including audio conferences, pamphlets handed out at professional meetings, mailings to physicians, and advertisements in medical journals.  Federal regulators and prosecutors have focused especially strict enforcement on perceived promotion of "off-label" uses of drugs and devices, extracting billions of dollars in the settlement of such cases in recent years. 

However, other than generalized references in the AHRQ contract solicitation that "Communication to these target audiences must be consistent with FDA policies,” no specific standards have been publicly announced to which federally-funded academic detailers must conform. An absence of such rules “lies in stark contrast with the extensive state and federal controls placed on how pharmaceutical, medical device and other health product businesses can conduct outreach and education.”

The Oversight Imperative for Academic Detailing. 

When the lack of specific oversight for government-funded academic detailers was noted by an industry spokesperson, Dr. Avorn "defended his team's information as being above reproach" and retorted that such criticism was "ridiculous, offensive, self-serving, and ill-informed.”  However, “one should not assume that educational activities and materials are inherently impartial, accurate, and balanced simply because they are being presented and funded by academics and government, rather than industry.”

In fact, Dr. Lenchus pointed out that, “Dr. Avorn himself owns and operates a for-profit academic detailing company, an obvious business and financial interest in his ensuring that academic detailing is above reproach.”

Discussion

While health care practitioners should be “conscious of the cost of drugs and medical devices, their primary duty is to provide each patient with the care best suited to them, individually.”  Ideas such as comparative effectiveness research and academic detailing came in response to “intense political and fiscal pressure to reduce health care costs,” not improve the health and outcomes of patients.

Consequently, “with the attendant impetus to reduce costs, what safeguards will be in place to ensure that academic detailers are not exceedingly influenced by those pressures?”  In other words, what is to stop an academic detailer from telling your doctor not to prescribe a treatment because in the end it will save the government money first, and make you “healthy” second?

Will governmental academic detailers receive compensation in a pay-for-performance model, that is, bonuses based on how much they saved?  Also, will specific doctors or those in certain practice areas be targeted based largely on those doctors' or the practice area's patterns of prescribing newer or more expensive treatments?  Who will make those determinations and how?  Will the same restrictions that apply to industry detailers apply to academic detailers?

Dr. Lenchus noted that, “accounts of Pennsylvania's IDIS program report that counter-detailers offer free copies of Dr. Avorn's book, allow visited physicians to take a quiz and receive continuing-medical-education credits, and occasionally provide lunch.”  As a result, he asked, “who will police their activities and investigate and prosecute flagrant disregard of the same rules that govern industry detailers? Also, will there be consequences if medical professionals choose not to meet with federally-funded detailers? Will such meetings be mandated for physicians who wish to care for patients receiving Medicare?”

Conclusion

In the end, Dr. Lenchus recognized the need to develop clearer standards and oversight for academic detailing equal to the rules enforced on industry. Specifically, Dr. Lenchus pointed to a bill introduced in 2009 by Senator Kohl, The Independent Drug Education and Outreach Act.  The bill, on which Congress never took action, specifically:

-       Defines types of entities are eligible to receive a federal detailing program grant;

-       Includes quality of educational materials among criteria for contract award; and

-       Requires that the HHS director review and approve all educational materials, and that such materials be updated and reviewed again every two years. 

The bill also specifies that preference for federally-funded detailer visits be given to those medical professionals with a high percentage of Medicare and Medicaid patients.  Finally, it requires HHS to promulgate regulations aimed at preventing conflicts of interest and ensuring the accuracy of the educational materials. Such legislation, according to Dr. Lenchus, must address:

-       Whether studies and other materials academic detailers provide be peer reviewed and/or evaluated by federal health authorities 

-       If materials offer clear and balanced risk and benefit information 

-       What level of expertise and training must an academic detailer have 

-       Whether academic detailers can discuss off-label use of drugs/devices

Ultimately, Dr. Lenchus recognized that, “policy-makers must address these issues to ensure that medical professionals, and in turn their patients, are confident in the accuracy and reliability of the academic detailing initiative and the information it disseminates.”  Accordingly, he noted that “further elaboration is needed on the general statement in the AHRQ solicitation that federal detailing contractors must comply with FDA policies.”

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! 

Discussion 

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. 

April 19, 2009

Academic Detailing the New York City Way (Public Health over Rhetoric)

NYC Department of Public Health

Congress and others have been promoting the value of academic detailing as a way to reduce drug costs by promoting generic drugs.  The New York  City Department of Public Health has a better idea.  The City has solicited help from pharmaceutical executives to design and execute a public health academic detailing campaign focusing on influenza and pneumococcal vaccine distribution and education, colon and rectal cancer screening and smoking cessation. 

In the last 10 months, the City has spent nearly $900,000 on half a dozen detailing campaigns.

Rather than fighting industry to promote older cheaper drugs, the New York City Department of Public Health has come-up with a detailing plan that serves “the public.”

The proponents of academic detailing should learn from their colleagues in NYC.  If your goal is promoting “public health,” then focus in those areas that will really make a difference and not just on campaigns to get doctors to write generic scripts.  In the end, we will all be healthier for the effort.

The New York Times: Taking a Page, and a Pen, From Makers of Medicines

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