Life Science Compliance Update

5 posts categorized "Academic Detailing"

April 16, 2013

AMSA Expanding Anti-Industry Scorecard to 400 Teaching Hospitals

Teaching Hospitals
We recently reported on a survey of 1,610 first- and third-year medical students and 739 residents regarding conflict of interest (COI) policies and their interactions with industry.  In our story, we noted that almost every year, the American Medical Students Association (AMSA) publishes a yearly “PharmFree Scorecard” that evaluates the COI policies at American medical schools.  Here is a little background and history on AMSA.

The PharmFree Scorecard is funded through the Consumer and Prescriber Education grant program, which resulted from the Neurontin settlement back in 2004.

It is because of organizations like PharmFree that frame all physician-industry collaboration as negative or unethical, that patients, physicians and biopharmaceutical professionals need a voice in the “conflict of interest mania,” such as the recently launched Partners for a Health Dialogue.  

Interestingly, while we cited to the 2012 results, AMSA just released its 2013 Scorecard, the sixth iteration of the scorecard.  The release comes as AMSA hosts its National PharmFree Week April 8-12, 2013.  The annual event “highlights the importance of putting patients first by addressing conflicts of interest and encouraging evidence rather than marketing-based education.”  Below is a summary of this year’s findings as well as additional information about AMSA activities. 

Interestingly, AMSA and Pew announced with this year’s data that they were also charged through a grant from the Oregon State Attorney General’s office to update the AMSA PharmFree Scorecard and expand it to 400 teaching hospitals.  Alongside Dr. Joseph Ross of Yale Medical School who served as a Methodology Consultant, AMSA and Pew developed the new AMSA PharmFree Scorecard set for release in 2014.  Given that payments to teaching hospitals must be reported under the Physician Payment Sunshine Act, the new scoring of teaching hospitals will bring increased scrutiny to physician-industry interactions at such hospitals.  

There will be two versions of the new Scorecard - one for medical schools and another for teaching hospitals.  The number of domains for the Scorecard has also expanded with 16 domains common to both versions and 2 additional domains for “Samples” and “Purchasing and Formulary Committees” specific to the teaching hospital version.  Other revisions to the Scorecard will include a new formula for assessing academic medical centers as well as revisions in the framework for grading schools.

 

2013 Findings

 

“Conflict of interest policies discourage inappropriate relationships and allow transparent and positive industry-physician collaborations to thrive,” said Daniel Carlat, director of the Pew Charitable Trusts’ prescription project, which supports AMSA’s work. “The 2013 scorecard shows medical schools are moving toward stronger conflict-of-interest standards.”

 

As of April 9, 2013, 153 out of 158 medical institutions considered eligible for grading have participated in the Scorecard, a 97% participation rate.  Of these 158 US medical schools, 40 receive “A”s (25%), 75 “B”s (47%), 14 “C”s (9%), and 13 “D”s (8%).  Thus, 115 of 158 medical schools (73%) now receive a grade of A or B for their COI policies, compared with 102 last year.  Approximately 8% of U.S. medical schools improved their COI policies since the 2011-2012 Scorecard.

 

Policies that apply only to medical students and/or residents, but not faculty, and (2) Policies that are only guidelines, without formal requirements, may only achieve a maximum grade of C.

 

13 schools (8%) receive a grade of F.  This includes 3 schools that submitted policies graded as F, two schools that stated they had no COI policy in place, and five schools that did not respond to repeated attempts at follow-up in 2008, 2009, 2010, 2011-12 and 2012-2013.  Three additional schools received an F as they did not submit new policies or demonstrate a continuing policy development process after remaining In Process for one year.  Three schools (2%) received a grade of In Process.  Here are some highlights from this year’s report:

 

  • Roughly 80% of medical schools have perfect or close to perfect policies for on-campus CME.
  • Only 4 medical schools – Univ. of South Dakota Sanford School of Medicine, Florida State Univ. College of Medicine, Stony Brook Univ. School of Medicine, and the Commonwealth Medical College -- completely ban sales representatives from campus.
  • Only 41 schools (26%) have model policy in terms of disclosure, requiring personnel to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and disclosing these relationships to patients.
  • All 8 of the Texas medical schools scored at least a B.  The University of Texas Medical Branch at Galveston, however, remains the lone A in the Lone Star state. All three of the Maryland medical schools scored at least a B, with both Johns Hopkins and University of Maryland Schools of Medicine receiving an A.
  • Schools with model policies on speaking arrangements have grown tremendously; 44 schools ban or severely restrict participation in speaker bureaus.

 

Specifically, 18 schools have banned participation by their faculty on speakers’ bureaus: Harvard Medical School, NYU School of Medicine, Duke Univ. School of Medicine, Columbia Univ. College of Physicians and Surgeons, Univ. of Arkansas School of Medicine, Univ. of Maryland School of Medicine, Georgia Health Sciences Univ., Univ. of South Carolina School of Medicine, Univ. of Hawai’i John A Burns School of Medicine, Creighton Univ. School of Medicine, Wake Forest Univ. School of Medicine, Univ. of Massachusetts Medical School, Emory Univ. School of Medicine, Stanford Univ. School of Medicine, Albert Einstein College of Medicine, Univ. of Alabama Birmingham, Univ. of Florida and Jefferson Medical College.

 

The following is a list of domains and the number of perfect scores in each in 2013:

 

  • 28 Schools have perfect scores for “On-campus continuing medical education;” improved from 20 in 2011-2, 15 in 2010, 3 in 2009 and 5 in 2008.  On-site education means within the medical school or hospital campus.  To gain a perfect score, “Industry is not permitted to provide direct financial support for educational activities, including CME, directly or through a subsidiary agency.  (However, companies may contribute unrestricted funds to a central fund or oversight body at the AMC, which, in turn, would pool and disburse funds for programs that are independent of any industry input or control.)”

 

  • 98 medical schools have “Less stringent limitations to ensure independence of educational content (e.g., standards to establish freedom from industry influence of content, such as review and approval of presentations; language that prevents industry from selecting the speaker; a requirement that programs adhere to ACCME standards; or language such as: industry funding may be allocated for a particular topic, but must be provided directly to the department, not to individuals).  Despite trying to discredit the ACCME as a “non-governmental” organization, CMS recently recognized the critical importance of the ACCME Standards for Commercial Support in the final Sunshine Act rule, and non-compliance with such standards can result in loss of accreditation. 

 

  • Off-campus continuing medical education –  102; improved from 88 in 2011-2, 75 in 2010, 49 in 2009 and 23 in 2008.  Off-site education is at outside facilities, including professional conferences.  AMSA measures this category based on how schools regulate compensation for travel or attendance at off-site lectures and meetings.  To gain a perfect score, “Personnel may not accept payment, gifts or financial support from industry to attend lectures and meetings. (An exception may be made for modest meals, if part of a larger program.)  Travel support may only be accepted if it is subject to institutional approval or industry is prevented from selecting (“earmarking”) the recipients.”  It is unclear, however, whether this category captures accredited CME or simply all off-campus educational events.

 

  • Scholarships & Funds for Trainees – 123; improved from 108 in 2011-2, 94 in 2010, 66 in 2009 and 29 in 2008.  To gain a perfect score, “The policy must either prevent industry from earmarking or awarding funds to support the training of particular individuals (recipients must be chosen by the school or department), or the policy must mandate institutional review of the giving of funds. (This does not preclude grants that fund a specific research project.)”

 

  • Gifts & Meals – 93; improved from 81 in 2011-2, 66 in 2010, 44 in 2009 and 19 in 2008.  To gain a perfect score in Gifts & meals, “All gifts and on-site meals funded by industry are prohibited, regardless of nature or value.”  Less stringent include limitations such as prohibitions above $50 per year, or gifts prohibited but meals allowed.

 

  • Disclosure – 41; improved from 29 in 2011-2, 20 in 2010,  5 in 2009 and 1 in 2008.  To gain a perfect score, “Personnel are required to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and/or disclose such relationships to patients when such a relationship might represent an apparent conflict of interest.”

 

  • Curriculum – 79; improved from 69 in 2011-2, 48 in 2010, 28 in 2009, and 12 in 2008.  To gain a perfect score, “Students are trained to understand institutional conflict-of-interest policies and recognize how industry promotion can influence clinical judgment.”

 

  • Consulting (excluding scientific research and speaking) – 71, improved from 64 in 2011-2, 49 in 2010, 27 in 2009, and 12 in 2008.  To gain a perfect score, consulting relationships “must be subjected to institutional review or approval. Additionally, they must either be described in a formal contract, or payment for services must be commensurate to the task.” 

 

  • Sales representatives – 4; improved from both 2 in 2011-2 and 2010, and both 1 in 2009 and 2008.  To gain a perfect score, “Pharmaceutical and device representatives are not allowed to meet with faculty regardless of location, or are not permitted to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non-marketing purposes, such as training on devices or equipment.)”

 

  • Purchasing & Formularies – 83; improved from 70 in 2011-2, 66 in 2010, 47 in 2009, and 22 in 2008.  To gain a perfect score, “Formulary committees and committees overseeing purchases of medical devices should exclude those who have financial relationships with drug or device manufacturers.  Exclusion may be specific to participation in particular decisions for which the staff member has a conflict of interest.  This policy does not prevent expert clinicians from advising a committee, provided that potential conflicts are disclosed.  (Note: this standard is not intended to prohibit indirect financial interests, such as investments in mutual funds that may own pharmaceutical company shares).”  

 

  • Samples – 42, improved from 31 in 2011-2, 26 in 2010, 20 in 2009, and 12 in 2008.  To gain a perfect score, “Industry samples are prohibited, except under certain narrow circumstances approved by the institution that protect the interests of patients and prevent the use of samples as a marketing tool (e.g., policies that allow samples under limited circumstances with the approval of the Pharmacy and Therapeutics (P&T) Committee or policies that incorporate samples into a larger program designed to ensure the availability of brand-name and generic medications to under-insured patients; if the circumstances of the specific program are not defined, the policy should define the approvals process). Where there is a specific program in place, the policy must prevent samples from being given directly to physicians by pharmaceutical sales representatives.”

 

  • Industry-funded speaking – 44; improved from 31 in 2011-2, 19 in 2010, 10 in 2009, and 4 in 2008.  To gain a perfect score, “Speaking relationships are prevented from functioning as de facto gifts or marketing.  An effective policy must not implicitly permit (a) long-term speaking agreements or (b) industry to have a role in determining presentation content.  (Some effective policies may explicitly prohibit participation in a speakers bureau.  Other effective policies contain elements such as limits on compensation and reimbursement and a requirement to ensure the scientific integrity of information presented.)”

 

Similar to the results of the past, the areas that garnered the greatest number of perfect scores were those addressing industry support of scholarships, off-campus “CME,” faculty participation in industry-speaking relationships, purchasing and formulary committees, and gifts.  Industry support of scholarships experienced the largest net growth in achieving perfect scores in this domain (15 additional medical schools).  New areas being addressed by schools include samples as well as purchasing and formula committees.  AMSA says that “on-campus CME remains a challenging area.

 

Regional Trends


Californian medical schools continued to excel with 7 of their 10 schools receiving an A grade.  This is in part due to the strong system-wide University of California (UC) COI policy, which when graded on its own receives an A grade.  However, some of the UC schools go even further by supplementing the system-wide policy with their own regulations.  Texan schools continue to show significant improvement.  All eight Texan medical schools score at least a B.  University of Texas Medical Branch at Galveston, however, remains the lone A in the Lone Star state.

 

Another major training ground, Massachusetts, continues to show case schools with model policies. This year, University of Massachusetts Medical School and Boston University both received a B grade while Harvard Medical School and Tufts University School of Medicine both received an A grade.

 

The nine Pennsylvania medical schools have strong policies and in Maryland, all three schools (Johns Hopkins University, University of Maryland, and Uniformed Services of the Health University) received a B grade or higher.  Finally, the state of Florida continues to perform well.

 

Methods

 

The PharmFree Scorecard methodology was developed jointly by AMSA and the Pew Prescription Project, an initiative of the Pew Health Group.  Assessed domains are broadly consistent with those identified in recent literature – primarily Brennan et al. Health Industry Practices that Create Conflicts of Interest:  A Policy Proposal for Academic Medical Centers.  JAMA 2006; 295(4): 429-433.

 

The Scorecard assesses policies related to: (1) acceptance of gifts and meals from industry; (2) consulting relationships; (3) speaking relationships; (4) disclosure of financial conflicts; (5) pharmaceutical samples; (6) individuals with financial conflicts participating in university purchasing decisions; (7) financial support for educational events (on- and off-campus); (8) industry support for scholarships and trainee funds; (9) access of industry sales personnel to medical school or hospital personnel; and (10) inclusion of education about conflict of interest within the academic curriculum. Additionally, the presence of oversight and sanctions is examined, but not included in grade calculation.

 

AMSA maintains that “Two blinded assessors independently score each set of policies in the eleven areas included in the scorecard.”  How can such assessors be blinded if they are working for AMSA/Pew, and are clearly anti-industry and biased towards any kind of industry interactions or collaboration?

 

Other AMSA Initiatives

 

Of particular interest is a new initiative known as the “2nd Slide Campaign,” which is based off the standard practice in graduate and continuing medical education (CME) to disclose conflicts of interest on the 2nd slide of one’s presentation.  “The premise of this campaign is simple: medical students should receive the same types of disclosures that educators provide in other types of medication.”  AMSA notes that “most medical schools lack clear guidelines to help faculty members disclose conflicts of interest to students.”

 

AMSA provides a sample disclosure slides and other information for medical students to bring about change in their medical schools. AMSA provides three scenarios for when a lecturer should disclose interests to students, and tailors their example disclosure slides to such scenarios:

 

-          Lecturer has conflicts of interest but they are not relevant

-          The lecturer has no conflicts of interest

-          The lecturer has relevant conflicts of interest to disclose to the students 

AMSA said that such disclosures matter because it is “vital” that medical students and “know where information comes from.”  AMSA calls for such disclosure because “research shows that financial conflicts of interest can impact (even subconsciously!)the presentation and interpretation of data.”  AMSA also has resourcs for a PharmFree Curriculum and “Best Practice Policies,” such as for gifts, meals, and samples.  

Given the already hurried schedules of physicians and medical students, will there really be enough time for medical professors to address and discuss potential conflicts with students?  Will such disclosures even matter to students?  It seems more appropriate that this subject be clearly addressed in a standard medical ethics course over the course of medical school, not during each lecture given, particularly in light of the Sunshine Act, which will allow medical students to do their own research on professors, if they desire.   

One interesting new program that AMSA appears to have started is the “National Opt Out Day.”  Specifically, AMSA “asked graduating fourth year members to tell the American Medical Association (AMA) that they are opting out of the AMA Physician Masterfile!”  “As physicians who strive to practice evidence-based medicine, we do not want our personal and prescribing information sold to the pharmaceutical and medical device industries.”  The AMA Physician Masterfile was established by the AMA in 1906 as a record keeping device supporting membership and mailing activities. The Physician Masterfile includes current and historical data for more than 1.4 million physicians, residents and medical students in the United States. 

AMSA also hosted a webinar with the University of Miami Miller School of Medicine to discuss how the school improved their conflict of interest policies as well as the barriers both current and past to implementing change.  Executive Dean of Education and Policy Dr. Laurence Gardner will be presenting

AMSA noted that in addition to Pew, it has joined forces with the National Physicians Alliance (NPA) and Community Catalyst to create both external and internal pressure for medical schools and academic medical centers to adopt strong COI policies, through a new initiative- the Partnership to Advance Conflict-Free Medical Education (PACME).  They noted how NPA’s Unbranded Doctor campaign provides resources for conflict-free medical practice including an archive of past events including bimonthly Conflict-Free Leadership Calls and National Grand Rounds

Community Catalyst is in the process of developing a series of toolkits to help institutions improve their policies with examples of language from other model institutions and provides technical assistance to schools via regional roundtable and individual consultation.

 

 

November 03, 2011

AHRQ National Resource Center for Academic Detailing

Academic Detailing 3 
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.

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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