Letters

wanted CPR for sudden cardiac arrest (P = .93). In multivariable models, female sex, divorced marital status, and lower educational attainment predicted refusal of thrombolysis (Table 1). Poorer physical health, previous stroke, and possession of a health care advance directive predicted refusal of CPR (Table 2).

Role of the Sponsors: The sponsors had no role in the design of the study; analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Discussion | When an incapacitated older patient’s treatment preferences are unknown and surrogate decision makers are unavailable, there are equally strong empirical grounds for presuming individual consent to thrombolysis for stroke as for presuming individual consent to CPR. Because the presumption of consent is generally accepted for CPR, this finding provides empirical support for policy positions recently taken by professional societies that favor the use of thrombolysis for stroke in emergency circumstances under a presumption of consent. Even though such emergency presumptions are supported by the treatment preferences of most older adults, it is noteworthy that nearly one-quarter of older adults would not want either intervention. Also, our experiment was only designed to address the empirical basis of the ethical and legal presumption of consent. Policies regarding the applicability of this presumption must also be informed by normative considerations such as the role of clinical judgment and the values of life and independence.

1. Rubin EB, Bernat JL. Consent issues in neurology. Neurol Clin. 2010;28(2):459-473.

Additional Contributions: We gratefully acknowledge the technical contributions of Carolyn Chu, Stefan Subias, and other staff of GfK; and the assistance of Amy J. Markowitz, JD, and John M. Neuhaus, PhD (both with the University of California, San Francisco), in drafting the manuscript. None received compensation for their contributions.

2. American Academy of Neurology. American Academy of Neurology policy on consent issues for the administration of IV tPA. http://www.aan.com /uploadedFiles/Website_Library_Assets/Documents/6.Public_Policy/1.Stay _Informed/2.Position_Statements/3.PDFs_of_all_Position_Statements/IV.pdf. Accessed August 28, 2013. 3. Jauch EC, Saver JL, Adams HP Jr, et al; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(3):870-947. 4. Callegaro M, DiSogra C. Computing response metrics for online panels. Public Opin Q. 2008;72(5):1008-1032. 5. Gadhia J, Starkman S, Ovbiagele B, Ali L, Liebeskind D, Saver JL. Assessment and improvement of figures to visually convey benefit and risk of stroke thrombolysis. Stroke. 2010;41(2):300-306. 6. McNally B, Robb R, Mehta M, et al; Centers for Disease Control and Prevention. Out-of-hospital cardiac arrest surveillance—Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, 2005—December 31, 2010. MMWR Surveill Summ. 2011;60(8):1-19.

COMMENT & RESPONSE

Winston Chiong, MD, PhD Anthony S. Kim, MD, MAS Ivy A. Huang Nita A. Farahany, PhD, JD S. Andrew Josephson, MD

Financial Relationships Between Medical Communication Companies and Industry

Author Affiliations: Department of Neurology, University of California, San Francisco (Chiong, Kim, Huang, Josephson); School of Law, Duke University (Farahany). Corresponding Author: Winston Chiong, MD, PhD, University of California, 675 Nelson Rising Ln, Ste 190, San Francisco, CA 94158 ([email protected]). Author Contributions: Dr Chiong had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Chiong, Kim, Farahany, Josephson. Acquisition, analysis, or interpretation of data: Chiong, Kim, Huang. Drafting of the manuscript: Chiong, Huang. Critical revision of the manuscript for important intellectual content: Chiong, Kim, Farahany, Josephson. Statistical analysis: Chiong, Kim. Obtained funding: Chiong. Study supervision: Josephson. Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kim reported receiving grants from SanBio Inc outside the submitted work. No other disclosures were reported. Funding/Support: This work was supported by grant K23AG043553 from the National Institute on Aging, grant KL2TR000143 from the National Center for Advancing Translational Sciences, and by funding through the American Brain Foundation Clinical Research Training Fellowship Program. Data collection was provided by Time-sharing Experiments in the Social Sciences with National Science Foundation grant 0818839 (Jeremy Freese, PhD, and James Druckman, PhD, principal investigators). Time-sharing Experiments in the Social Sciences provided data collection using the GfK KnowledgePanel and survey weights for matching participants’ responses to the US Current Population Survey.

To the Editor I believe Dr Rothman and colleagues1 misrepresented the Accreditation Council for Continuing Medical Education (ACCME) system and the rules safeguarding continuing medical education (CME) from industry influence. The authors asserted that the organizations in their report are all ACCME accredited and that the organizations also provide marketing services to industry, including “prelaunch and branding campaigns.” I do not believe these assertions are true, for the following reasons. First, 2 of the 18 organizations analyzed in Table 3 (Clinical Care Options and Institute for Medical Education and Research) were not accredited by the ACCME in 2010. Second, organizations that provide marketing for industry are not eligible for ACCME accreditation.2 Third, the authors implied that organizations involved in industry marketing collaborate with ACCME-accredited providers to develop accredited CME. The ACCME Standards for Commercial Support: Standards to Ensure Independence in CME Activities prohibit such arrangements. No organization that is involved in marketing products can control the content of accredited CME.2 In addition, the authors stated that “Industry contracts with [accredited providers] are not publicly available.” The ACCME, in fulfillment of its public interest purpose and mission, requires transparency from accredited providers regarding commercial support. I believe it is important that every written agreement for every commercial support grant in all

jama.com

JAMA April 23/30, 2014 Volume 311, Number 16

Copyright 2014 American Medical Association. All rights reserved.

Downloaded From: http://jama.jamanetwork.com/ by a Tulane University User on 05/13/2015

1691

Letters

ACCME-accredited CME programs has been available to the ACCME for review since 1992.2 Also, the statement by Rothman et al1 that the organizations that they called “medical communication companies [MCCs]” are “supported mainly by drug and device companies” is not validated by the ACCME’s published data. In 2012, publishing/education companies (as they are categorized in our data) received an average 38% of their total income from commercial support.3 A primary goal of the ACCME system is to separate accredited CME from health care product promotion. I think it is important that the ACCME system has multiple layers of requirements and procedures that ensure accredited CME is independent of industry. The ACCME’s data demonstrate that accredited providers meet these requirements.4 The claim by Rothman et al1 that accredited medical education companies are performing marketing services for industry maligns an entire segment of accredited CME providers. These organizations produce 17% of the more than 130 000 activities produced each year. They are an integral part of the accredited CME community, providing physicians with independent, practice-based CME in support of health care improvement. Murray Kopelow, MD, MS (Comm) Author Affiliation: Accreditation Council for Continuing Medical Education, Chicago, Illinois. Corresponding Author: Murray Kopelow, MD, MS (Comm), Accreditation Council for Continuing Medical Education, 515 N State St, Ste 1801, Chicago, IL 60654 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported that he is president and CEO of the ACCME. 1. Rothman SM, Brudney KF, Adair W, Rothman DJ. Medical communication companies and industry grants. JAMA. 2013;310(23):2554-2558. 2. Accreditation Council for Continuing Medical Education. Standards for commercial supports: standards to ensure independence in CME activities. http://www.accme.org/requirements/accreditation-requirements-cme -providers/standards-for-commercial-support. Accessed January 29, 2014. 3. Accreditation Council for Continuing Medical Education. ACCME annual report 2012. http://www.accme.org/news-publications/publications/annual -report-data/accme-annual-report-2012. Accessed January 29, 2014. 4. Accreditation Council for Continuing Medical Education. Executive summary of December 2013 ACCME board of directors meeting. http://www.accme.org /news-publications/publications/executive-summaries/executive-summary -december-2013-accme-board. Accessed January 29, 2014.

To the Editor The article by Dr Rothman and colleagues1 contained 2 inaccuracies in Table 4 related to our group, Research to Practice (RTP). The table indicates that RTP has a parent company. Research to Practice has no parent company, affiliates, or any related entities. Also, Table 4 states that RTP “may share information with third parties.” Research to Practice does not report individual information to any third party but instead only compiles and shares aggregated metrics on program usage as part of our grant reconciliation processes. Neil Love, MD 1692

Author Affiliation: Research to Practice, Miami, Florida. Corresponding Author: Neil Love, MD, Research to Practice, 2 S Biscayne Blvd, Ste 3600, Miami, FL 33131 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported that he has received grants and other awards from AbbVie Inc, Algeta US, Allos Therapeutics, Amgen Inc, ArQule Inc, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Biodesix Inc, Biogen Idec, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Co, Celgene Corp, Daiichi Sankyo Inc, Dendreon Corp, Eisai Inc, EMD Serono Inc, Exelixis Inc, Foundation Medicine Inc, Genentech BioOncology, Genomic Health Inc, Gilead Sciences Inc, Incyte Corporation, Lilly, Medivation Inc, Merck, Millennium: The Takeda Oncology Co, Mundipharma International Limited, Novartis Pharmaceuticals Corp, Novocure, Onyx Pharmaceuticals Inc, Prometheus Laboratories Inc, Regeneron Pharmaceuticals, sanofi, Seattle Genetics, Spectrum Pharmaceuticals Inc, and Teva Oncology. 1. Rothman SM, Brudney KF, Adair W, Rothman DJ. Medical communication companies and industry grants. JAMA. 2013;310(23):2554-2558.

In Reply We believe Dr Kopelow misrepresents our methods and analysis. We explored the financial relationships between the pharmaceutical industry and MCCs, whose primary business is disseminating information about disease prevention and management. Our article does not focus on the ACCME. It is mentioned once and Kopelow misstates the sentence: “The authors asserted that the organizations in their report are all ACCME accredited.” We wrote that the top 18 MCC industry grant recipients (not all 363 MCC recipients) were “approved” by the ACCME to deliver CME. We said “approved” because 2 of the top recipients were “joint sponsors” of CME.1 Kopelow also misquotes us on the public availability of industry grants. We wrote: “Industry contracts with MCCs are not publicly available and until recently neither were industry grant awards.” Kopelow rewrites the sentence to read: “Industry contracts with [accredited providers] are not publicly available.” He claims that commercial grants have been “available” to the ACCME. What available means in this context is not clear. We could not locate on its website a list of the commercial grants and sums received. The grant data are not publicly available. Kopelow claims: “[T]he authors implied that organizations involved in industry marketing collaborate with ACCME-accredited providers to develop accredited CME.” We neither said nor implied that accredited providers collaborate with industry specifically to develop CME. Rather: “Known best for arranging continuing medical education programs, they [MCCs] also develop prelaunch and branding campaigns and produce digital and print publications.” Kopelow asserts that our claim that MCCs are mainly supported by drug and device companies is inaccurate. But he presumes that our category of MCCs and the ACCME category of “education/publishing companies” are identical; they are not. He also relies on 2012 aggregated and self-reported data. We used 2010 nonaggregated, non–self-reported data. The ACCME also omits “in-kind” support from parent companies, which likely reduces the actual level of commercial support. Kopelow ignores one of the major conclusions of our article, that information physicians submitted to gain CME credit was shared with unnamed third parties for commercial purposes. The ACCME should address the need to protect physicians’ privacy when registering for online CME.

JAMA April 23/30, 2014 Volume 311, Number 16

Copyright 2014 American Medical Association. All rights reserved.

Downloaded From: http://jama.jamanetwork.com/ by a Tulane University User on 05/13/2015

jama.com

Letters

Dr Love questions our categorization of RTP as affiliated with a parent company; this information came from several sources. The Lilly Grant Registry lists the “requestor” for 10 of its grants as “NL Communications, Inc. DBA Research to Practice–Research to Practice.”2 When we Googled RTP’s website, we found links to NL Communications. NL Communications sponsors RTP’s 401k plan.3 Its website, http://www.breastcancerupdate.com, links to the RTP website. The 2 companies also share the same address and suite. Our analysis did not distinguish between individual and aggregate data sharing. Research to Practice declares that it only shares aggregate data with third parties. It will inform a sponsor of “what percentage of our registered users resides in a particular geographical area or their practice specialty.”4 However, RTP uses personal information to “target our advertising or marketing activities based on information we have about users.”4 Sheila M. Rothman, PhD Author Affiliation: Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York. Corresponding Author: Sheila M. Rothman, PhD, Columbia University, 630 W 168th St, PH15-25, New York, NY 10032 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Rothman reported having served as a consultant to the Office of the Attorney General of the State of Texas in litigation against Johnson & Johnson related to risperidone and receiving travel support from the North American Spine Society to attend the society’s board and ethics committee meetings.

tion adherence. First, expectations about the effects of educational and financial interventions should be realistic. When nonadherence is the result of a gap between intentions and behaviors, providing more information and reducing costs may have only modest effects; patients already intend to do the right thing. Second, much nonadherence may be the result of forgetting and procrastinating when it comes to taking medications and refilling or renewing prescriptions. For patients with these problems, reminders (eg, pill bottle timers), automatic scheduling and delivering of refills, and prescription renewal assistance can be especially effective. Devices that eliminate the problem of forgetting can be especially effective as seen in the case of long-acting reversible contraception methods.5 Nonadherence is a multifaceted challenge with no clearcut solution. For some patients, the barriers to adherence are those implied by Zullig et al1: lack of clear information, inability to afford medications, and the like. For others, the barriers to adherence are behavioral (ie, they spring from inattention and inertia). In practice, systems and approaches are needed that identify which patients are likely to have problems staying adherent to medication, that quickly and accurately diagnose the barrier at the individual patient level, and then tailor the intervention to the needs of the patient. Sharon Glave Frazee, PhD, MPH David J. Muzina, MD Robert F. Nease, PhD Author Affiliations: Express Scripts Holding Company, St Louis, Missouri.

1. Accreditation Council for Continuing Medical Education. Joint providership. http://www.accme.org/requirements/accreditation-requirements-cme -providers/policies-and-definitions/joint-sponsorship. Accessed February 4, 2014.

Corresponding Author: Sharon Glave Frazee, PhD, MPH, Express Scripts Holding Company, 4600 N Hanley Rd, St Louis, MO 63134 ([email protected]).

2. Lilly Grant Office. Registry report. www.lillygrantoffice.com/_assets/pdf/q4 _10_registry_report.pdf. Accessed February 4, 2014.

Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. All authors reported holding stock and stock options in Express Scripts.

3. Find The Best. Research to Practice 401k savings plan. http://401k-plans .findthebest.com/l/661662/Research-to-Practice-401k-Savings-Plan. Accessed February 4, 2014.

1. Zullig LL, Peterson ED, Bosworth HB. Ingredients of successful interventions to improve medication adherence. JAMA. 2013;310(24):2611-2612.

4. Institute on Medicine as a Profession. The WebMD health professional network privacy policy. http://imapny.org/File%20Library/JAMA/privacy _policies.pdf. Accessed November 21, 2013.

Strategies to Overcome Medication Nonadherence To the Editor The suggestions by Dr Zullig and colleagues1 for improving medication adherence are laudable, but we believe their list of barriers to nonadherence overlooks 2 fundamental features of human behavior, inattention and inertia, while overemphasizing the need for engagement. Human attention is both scarce and fragile, with most behaviors occurring automatically rather than being deliberate and overt.2-4 Humans devote their attention to that which is either pleasing or pressing; thus, things that do not immediately demand attention may not receive it. Because many behaviors are important over the long-term but not immediately pressing, inattention often leads to inertia, which creates a gap between good intentions (more exercise, better diet, taking medications as prescribed) and action. The realization that inattention and inertia are fundamental forces has 2 important implications for managing medica-

2. Duhigg C. The Power of Habit: Why We Do What We Do in Life and Business. New York, NY: Random House; 2012. 3. Kahneman D. Thinking, Fast and Slow. New York, NY: Farrar, Straus and Giroux; 2011. 4. Simon HA. Rational choice and the structure of the environment. Psychol Rev. 1956;63(2):129-138. 5. Winner B, Peipert JF, Zhao Q, et al. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366(21):1998-2007.

In Reply As stated in our Viewpoint, the problem of medication nonadherence is often multifactorial, and there is no universal formula that will resolve adherence issues for every patient in every situation. The key is to identify characteristics and situations making patients vulnerable for medication nonadherence and subsequently provide a personalized program to address specific needs in the mode and time that will be most effective to motivate adherence. We fully agree with Dr Frazee and colleagues that providing enabling strategies to patients so that they can better take ownership of their health, specifically by taking their medications as prescribed, is important to establishing long-term

jama.com

JAMA April 23/30, 2014 Volume 311, Number 16

Copyright 2014 American Medical Association. All rights reserved.

Downloaded From: http://jama.jamanetwork.com/ by a Tulane University User on 05/13/2015

1693

Financial relationships between medical communication companies and industry.

Financial relationships between medical communication companies and industry. - PDF Download Free
71KB Sizes 2 Downloads 4 Views