Opinion
Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.
EDITORIAL
Medical Communication Companies and Continuing Medical Education Clouding the Sunshine? Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS
It’s always intriguing to open e-mail in the morning and look at the latest crop of continuing medical education (CME) invitations. And dream. Who wouldn’t want to go to Maui to discuss common issues in primary care? Or travel to Cancun to learn about Related article page 2554 using laboratory and clinical parameters to assess cardiovascular risk. But getting time off can be difficult and travel is increasingly expensive. Fortunately, abundant CME opportunities are available online. Physicians can meet licensure requirements without leaving home and often can do so for free. Where do all these CME invitations come from? Many come from medical communication companies, largely for-profit entities that create, organize, promote, and run CME activities. Instead of CME, however, some medical communication companies focus on promotional services, such as recruiting and training for the pharmaceutical company’s speakers bureaus and preparing their slide decks; assisting with publication planning for medical journal articles, or even writing them. Some companies engage in both promotion and education. But that can be problematic. Education should be evidence based and unbiased: getting clinicians the facts. Promotion is, well, promotional: persuading clinicians to use a particular product. Companies that do both promotion and education are required to maintain a strict “firewall” between these activities—no contact between teams working in the same clinical arena. The obvious concern is conflict of interest. Without a strict firewall between promotion and education, promotional interests may bias educational efforts. Medical communication companies must be certified by the Accreditation Council for Continuing Medical Education (ACCME) for their CME to count toward licensing requirements. Accreditation standards include establishing that industry clients were not involved in the creation of the educational activity and that presentations are balanced and unbiased. The ACCME certifies CME for a broad array of clinicians including trainees. Most CME participants are physicians, but nonphysicians (eg, nurse practitioners, physician assistants) are catching up. From 2003 to 2012, the number of physicians participating in CME-accredited activities increased 133% from about 6 million to 14 million participants. (Participants can be counted more than once depending on the type of CME activity.) For nonphysicians, participation increased by 233%, from about 3 million to 10 million.1,2 Medical communication companies account for only 7% of all accredited CME organizations, yet they account for 30% of physician and 43% of nonphysician participation in CME activities.1
Who do the medical communication companies work for? Industry accounts for half of the revenue of medical communications companies.3 However, details about actual financial arrangements are sparse. In this issue of JAMA, Rothman et al,4 shed some light into this largely unexplored world. In 2010, as a result of voluntary and Department of Justice required actions, 14 drug-device manufacturers posted grant registries on their websites. According to the analysis of these registries by Rothman et al,4 the 14 companies issued more than $650 million in nonresearch grants. Almost one-third of the grant money went to medical education companies, more than any other category of recipient: academic medical centers were a close second and disease-targeted advocacy groups were close behind. Medical communication companies were the leading grant recipients for 10 of the 14 manufacturers (or 8 of 11, if the analysis was restricted to largest manufacturers—top 20 for US pharmaceutical sales). According to the report by Rothman et al, Medscape/WebMD received the most support by capturing 12% of the grant money. Medical communication companies' reliance on industry funding highlights the importance of keeping promotion separate from education. All companies will feel unconscious (and perhaps explicit) pressure to present their clients’ products in the best light. Bias can easily occur in the selection and training of speakers, in their presentations, on the websites, and even in test questions. Industry's adherence with regulation is concerning, particularly for the promotion of off-label uses. In 2007, for example, the US Senate Finance Committee held hearings on industry conflicts of interest and noted that [t]he Committee staff became aware through reports that pharmaceutical companies were routinely using educational grants to help build market share for their newer and more lucrative products … [for example] using educational grants to fund purportedly independent educational programs that actually served to promote the anti-epilepsy drug Neurontin for offlabel uses. In 2004, Warner-Lambert paid $430 million to settle claims involving off-label promotion of Neurontin.5 In 2012, as part of largest fraud settlement in US history, GlaxoSmithKline was fined more than $750 million for off-label promotion of Wellbutrin. The remainder of the $3 billion fine was for problems related to Paxil—promoting the off-label use for children, misreporting a clinical trial as demonstrating efficacy when it did not, and withholding data from 2 clinical trials that also failed to demonstrate efficacy—and for Avandia, failure to report data on cardiovascular harm. According to the Department of Justice, GlaxoSmithKline used “supposedly independent Continuing
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JAMA December 18, 2013 Volume 310, Number 23
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 06/02/2015
2507
Opinion Editorial
Medical Education programs to promote Wellbutrin for these unapproved uses [weight loss, sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder].”6 Continuing medical education that is tainted by promotion is marketing masked as education. It can lead to inappropriate prescribing that can harm patients and waste money. To remove promotion from CME, some have called for eliminating all industry funding.7 The ACCME did not accept this idea, instead recommending that enhanced oversight and disclosure could keep industry-funded CME free of bias.8 Similarly, many medical schools have adopted policies to limit—rather than eliminate— industry on campus or faculty on speaker's bureaus. Nevertheless, close to half of medical school CME revenue in 2012 was commercial, ranging from 50%, if advertising and exhibits are counted as commercial revenue, to 41% if only “total commercial” revenue is counted.1 In the absence of a systematic review of CME materials, it remains unclear how well these policies are working. However, a cursory look at the 18 medical communication CME websites highlighted by Rothman et al shows room for improvement: the prominence of the industry funding disclosures varied from obvious (large logos visible without scrolling) to obscure (smallprint text requiring extensive scrolling). Medical communication companies are not the only reason promotion creeps into CME. True believers, clinicians or researchers whose careers have been built on a particular therapeutic approach, also contribute. Thus, even if all industry money were removed, routine independent vetting of CME modules for balance (Were evidence-based, nondrug drug treatment options presented? Was the evidence from systematic reviews?9) would still be needed. The recently enacted Sunshine Act will soon mandate public reporting of all industry “transfers of value” to physicians and hospitals. Medical communication companies can undermine the intent of the Act because of a CME exemption: compensation to CME speakers (including reimbursement for travel, meals, and lodging) does not have to be reported if a third party, rather than industry, chooses the speaker.10 This exemption may allow indirect industry influence through the medical communication com-
ARTICLE INFORMATION
REFERENCES
Author Affiliations: Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire, and the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.
1. 2012Annualreportexecutivesummary.Accreditation Council for Continuing Medical Education. http://www .accme.org/sites/default/files/630_2012_Annual_Report _20130724_2.pdf. Accessed November 18, 2013.
Corresponding Author: Steven Woloshin, MD, MS, Dartmouth Institute for Health Policy and Clinical Practice, 35 Centerra Pkwy, Lebanon, NH 03756 ([email protected]). Conflict of Interest Disclosures: Both authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Schwartz and Woloshin reported that they are cofounders and shareholders of Informulary Inc. Additional Contributions: We thank James D. Sargent, MD, Department of Pediatrics, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, for insightful comments, for which he received no compensation. Correction: This Editorial was corrected on February 26, 2014, to clarify a sentence.
2508
pany while keeping speakers (and their reimbursement) out of the “sunshine.” The government's Sunshine Act website directs people to Medscape—which is, according to the study by Rothman et al, the top industry-funded medical communication company—to learn more and, ironically, earn CME credit. Health care professionals who sign on to medical communication websites to obtain CME credit should be aware that all of these sites collect personal information. Eleven of the 18 websites evaluated in the study by Rothman et al state in their privacy policies that they may share this information with third parties, although Rothman et al did not report why the companies collect this information. It seems possible that physicians' personal information (eg, specific identifiers like medical school, year of graduation, specialty, training level, and sometimes National Provider Identifier and their responses to the before and after assessments, information-seeking patterns) might be used to tailor subsequent advertising efforts to them. These may range from selectionofpop-upads,follow-upe-mails,telephonecalls,oreven deployment of increasingly scarce detailing visits to these physicians’ offices. Collecting personal details about physicians from CME sites is simpler and possibly less expensive than purchasing individual prescribing data from vendors like IMS Health. Or the information may simply be sold to ordinary data brokers who bundle consumer information to sell to marketers.11 As evident by the substantial investment in medical communi-cation companies as described in the report by Rothman et al, the pharmaceutical industry is invested in the continuing education of physicians and nonphysician prescribers alike. Past abuses by the industry have spawned policies by the ACCME, medical schools, and government to enforce separation between education and promotion largely through greater disclosure and limit-ing money and gifts. Closing loopholes that allow medical communication companies to bypass some of these policies would be an important additional step in ensuring that marketing is not confused with education. Keeping physicians and other health care practitioners up to date with balanced evidence about the safe and effective use of prescription drugs is in everyone’s interest.
2. 2003 Annual report executive summary. Accreditation Council for Continuing Medical Education. http: //www.accme.org/sites/default/files/null/Annual Report Data-2003.pdf. Accessed November 18, 2013. 3. Lo B, Field MJ, eds. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies; 2009. 4. Rothman SM, Brundney KF, Adair W, Rothman DJ. Medical communication companies and industry grants. JAMA. doi:10.1001/jama.2013.281638.
data. Washington, DC: Dept of Justice; July 2, 2012. http://www.justice.gov/opa/pr/2012/July/12-civ-842 .html. Accessed November 18, 2013. 7. Hager M, Russell S, Fletcher SW, eds. Continuing education in the health professions: improving healthcare through lifelong learning; Proceedings of a conferencesponsoredbytheJosiahMacyJrFoundation; November 28-December 1, 2007; Bermuda. http: //macyfoundation.org/docs/macy_pubs/pub_ContEd _inHealthProf.pdf. Accessed November 18, 2013. 8. Steinbrook R. Future directions in industry funding of continuing medical education. Arch Intern Med. 2011;171(3):257-258. 9. Lo B, Ott C. What is the enemy in CME, conflicts of interest or bias? JAMA. 2013;310(10):1019-1020.
5. Finance Committee staff report to the chairman and ranking member. Use of educational grants by pharmaceutical manufacturers. http://www.finance .senate.gov/newsroom/chairman/release /?id=af4af834-3fab-4293-be6d-ca7f1246484f. April 25, 2007. Accessed November 22, 2013.
10. Medical Learning Network. Centers for Medicare & Medicaid Services OPEN PAYMENTS—policy updates on payments [transpcript]. http://www.cms .gov/Outreach-and-Education/Outreach/NPC /Downloads/080813-Open-Payments-NPC-Transcript .pdf. Accessed November 26, 2013.
6. GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety
11. Singer N. You for sale: mapping, and sharing, the consumer genome. New York Times. June 17, 2012:BU1.
JAMA December 18, 2013 Volume 310, Number 23
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 06/02/2015
jama.com
Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.
EDITORIAL
Medical Communication Companies and Continuing Medical Education Clouding the Sunshine? Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS
It’s always intriguing to open e-mail in the morning and look at the latest crop of continuing medical education (CME) invitations. And dream. Who wouldn’t want to go to Maui to discuss common issues in primary care? Or travel to Cancun to learn about Related article page 2554 using laboratory and clinical parameters to assess cardiovascular risk. But getting time off can be difficult and travel is increasingly expensive. Fortunately, abundant CME opportunities are available online. Physicians can meet licensure requirements without leaving home and often can do so for free. Where do all these CME invitations come from? Many come from medical communication companies, largely for-profit entities that create, organize, promote, and run CME activities. Instead of CME, however, some medical communication companies focus on promotional services, such as recruiting and training for the pharmaceutical company’s speakers bureaus and preparing their slide decks; assisting with publication planning for medical journal articles, or even writing them. Some companies engage in both promotion and education. But that can be problematic. Education should be evidence based and unbiased: getting clinicians the facts. Promotion is, well, promotional: persuading clinicians to use a particular product. Companies that do both promotion and education are required to maintain a strict “firewall” between these activities—no contact between teams working in the same clinical arena. The obvious concern is conflict of interest. Without a strict firewall between promotion and education, promotional interests may bias educational efforts. Medical communication companies must be certified by the Accreditation Council for Continuing Medical Education (ACCME) for their CME to count toward licensing requirements. Accreditation standards include establishing that industry clients were not involved in the creation of the educational activity and that presentations are balanced and unbiased. The ACCME certifies CME for a broad array of clinicians including trainees. Most CME participants are physicians, but nonphysicians (eg, nurse practitioners, physician assistants) are catching up. From 2003 to 2012, the number of physicians participating in CME-accredited activities increased 133% from about 6 million to 14 million participants. (Participants can be counted more than once depending on the type of CME activity.) For nonphysicians, participation increased by 233%, from about 3 million to 10 million.1,2 Medical communication companies account for only 7% of all accredited CME organizations, yet they account for 30% of physician and 43% of nonphysician participation in CME activities.1
Who do the medical communication companies work for? Industry accounts for half of the revenue of medical communications companies.3 However, details about actual financial arrangements are sparse. In this issue of JAMA, Rothman et al,4 shed some light into this largely unexplored world. In 2010, as a result of voluntary and Department of Justice required actions, 14 drug-device manufacturers posted grant registries on their websites. According to the analysis of these registries by Rothman et al,4 the 14 companies issued more than $650 million in nonresearch grants. Almost one-third of the grant money went to medical education companies, more than any other category of recipient: academic medical centers were a close second and disease-targeted advocacy groups were close behind. Medical communication companies were the leading grant recipients for 10 of the 14 manufacturers (or 8 of 11, if the analysis was restricted to largest manufacturers—top 20 for US pharmaceutical sales). According to the report by Rothman et al, Medscape/WebMD received the most support by capturing 12% of the grant money. Medical communication companies' reliance on industry funding highlights the importance of keeping promotion separate from education. All companies will feel unconscious (and perhaps explicit) pressure to present their clients’ products in the best light. Bias can easily occur in the selection and training of speakers, in their presentations, on the websites, and even in test questions. Industry's adherence with regulation is concerning, particularly for the promotion of off-label uses. In 2007, for example, the US Senate Finance Committee held hearings on industry conflicts of interest and noted that [t]he Committee staff became aware through reports that pharmaceutical companies were routinely using educational grants to help build market share for their newer and more lucrative products … [for example] using educational grants to fund purportedly independent educational programs that actually served to promote the anti-epilepsy drug Neurontin for offlabel uses. In 2004, Warner-Lambert paid $430 million to settle claims involving off-label promotion of Neurontin.5 In 2012, as part of largest fraud settlement in US history, GlaxoSmithKline was fined more than $750 million for off-label promotion of Wellbutrin. The remainder of the $3 billion fine was for problems related to Paxil—promoting the off-label use for children, misreporting a clinical trial as demonstrating efficacy when it did not, and withholding data from 2 clinical trials that also failed to demonstrate efficacy—and for Avandia, failure to report data on cardiovascular harm. According to the Department of Justice, GlaxoSmithKline used “supposedly independent Continuing
jama.com
JAMA December 18, 2013 Volume 310, Number 23
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 06/02/2015
2507
Opinion Editorial
Medical Education programs to promote Wellbutrin for these unapproved uses [weight loss, sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder].”6 Continuing medical education that is tainted by promotion is marketing masked as education. It can lead to inappropriate prescribing that can harm patients and waste money. To remove promotion from CME, some have called for eliminating all industry funding.7 The ACCME did not accept this idea, instead recommending that enhanced oversight and disclosure could keep industry-funded CME free of bias.8 Similarly, many medical schools have adopted policies to limit—rather than eliminate— industry on campus or faculty on speaker's bureaus. Nevertheless, close to half of medical school CME revenue in 2012 was commercial, ranging from 50%, if advertising and exhibits are counted as commercial revenue, to 41% if only “total commercial” revenue is counted.1 In the absence of a systematic review of CME materials, it remains unclear how well these policies are working. However, a cursory look at the 18 medical communication CME websites highlighted by Rothman et al shows room for improvement: the prominence of the industry funding disclosures varied from obvious (large logos visible without scrolling) to obscure (smallprint text requiring extensive scrolling). Medical communication companies are not the only reason promotion creeps into CME. True believers, clinicians or researchers whose careers have been built on a particular therapeutic approach, also contribute. Thus, even if all industry money were removed, routine independent vetting of CME modules for balance (Were evidence-based, nondrug drug treatment options presented? Was the evidence from systematic reviews?9) would still be needed. The recently enacted Sunshine Act will soon mandate public reporting of all industry “transfers of value” to physicians and hospitals. Medical communication companies can undermine the intent of the Act because of a CME exemption: compensation to CME speakers (including reimbursement for travel, meals, and lodging) does not have to be reported if a third party, rather than industry, chooses the speaker.10 This exemption may allow indirect industry influence through the medical communication com-
ARTICLE INFORMATION
REFERENCES
Author Affiliations: Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire, and the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.
1. 2012Annualreportexecutivesummary.Accreditation Council for Continuing Medical Education. http://www .accme.org/sites/default/files/630_2012_Annual_Report _20130724_2.pdf. Accessed November 18, 2013.
Corresponding Author: Steven Woloshin, MD, MS, Dartmouth Institute for Health Policy and Clinical Practice, 35 Centerra Pkwy, Lebanon, NH 03756 ([email protected]). Conflict of Interest Disclosures: Both authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Schwartz and Woloshin reported that they are cofounders and shareholders of Informulary Inc. Additional Contributions: We thank James D. Sargent, MD, Department of Pediatrics, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, for insightful comments, for which he received no compensation. Correction: This Editorial was corrected on February 26, 2014, to clarify a sentence.
2508
pany while keeping speakers (and their reimbursement) out of the “sunshine.” The government's Sunshine Act website directs people to Medscape—which is, according to the study by Rothman et al, the top industry-funded medical communication company—to learn more and, ironically, earn CME credit. Health care professionals who sign on to medical communication websites to obtain CME credit should be aware that all of these sites collect personal information. Eleven of the 18 websites evaluated in the study by Rothman et al state in their privacy policies that they may share this information with third parties, although Rothman et al did not report why the companies collect this information. It seems possible that physicians' personal information (eg, specific identifiers like medical school, year of graduation, specialty, training level, and sometimes National Provider Identifier and their responses to the before and after assessments, information-seeking patterns) might be used to tailor subsequent advertising efforts to them. These may range from selectionofpop-upads,follow-upe-mails,telephonecalls,oreven deployment of increasingly scarce detailing visits to these physicians’ offices. Collecting personal details about physicians from CME sites is simpler and possibly less expensive than purchasing individual prescribing data from vendors like IMS Health. Or the information may simply be sold to ordinary data brokers who bundle consumer information to sell to marketers.11 As evident by the substantial investment in medical communi-cation companies as described in the report by Rothman et al, the pharmaceutical industry is invested in the continuing education of physicians and nonphysician prescribers alike. Past abuses by the industry have spawned policies by the ACCME, medical schools, and government to enforce separation between education and promotion largely through greater disclosure and limit-ing money and gifts. Closing loopholes that allow medical communication companies to bypass some of these policies would be an important additional step in ensuring that marketing is not confused with education. Keeping physicians and other health care practitioners up to date with balanced evidence about the safe and effective use of prescription drugs is in everyone’s interest.
2. 2003 Annual report executive summary. Accreditation Council for Continuing Medical Education. http: //www.accme.org/sites/default/files/null/Annual Report Data-2003.pdf. Accessed November 18, 2013. 3. Lo B, Field MJ, eds. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies; 2009. 4. Rothman SM, Brundney KF, Adair W, Rothman DJ. Medical communication companies and industry grants. JAMA. doi:10.1001/jama.2013.281638.
data. Washington, DC: Dept of Justice; July 2, 2012. http://www.justice.gov/opa/pr/2012/July/12-civ-842 .html. Accessed November 18, 2013. 7. Hager M, Russell S, Fletcher SW, eds. Continuing education in the health professions: improving healthcare through lifelong learning; Proceedings of a conferencesponsoredbytheJosiahMacyJrFoundation; November 28-December 1, 2007; Bermuda. http: //macyfoundation.org/docs/macy_pubs/pub_ContEd _inHealthProf.pdf. Accessed November 18, 2013. 8. Steinbrook R. Future directions in industry funding of continuing medical education. Arch Intern Med. 2011;171(3):257-258. 9. Lo B, Ott C. What is the enemy in CME, conflicts of interest or bias? JAMA. 2013;310(10):1019-1020.
5. Finance Committee staff report to the chairman and ranking member. Use of educational grants by pharmaceutical manufacturers. http://www.finance .senate.gov/newsroom/chairman/release /?id=af4af834-3fab-4293-be6d-ca7f1246484f. April 25, 2007. Accessed November 22, 2013.
10. Medical Learning Network. Centers for Medicare & Medicaid Services OPEN PAYMENTS—policy updates on payments [transpcript]. http://www.cms .gov/Outreach-and-Education/Outreach/NPC /Downloads/080813-Open-Payments-NPC-Transcript .pdf. Accessed November 26, 2013.
6. GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety
11. Singer N. You for sale: mapping, and sharing, the consumer genome. New York Times. June 17, 2012:BU1.
JAMA December 18, 2013 Volume 310, Number 23
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 06/02/2015
jama.com
