0
Medical Ethics |

Shadows Amid SunshineSunshine and Financial Conflicts: Regulating Financial Conflicts in Medical Research FREE TO VIEW

Richard S. Saver, JD
Author and Funding Information

From the University of North Carolina School of Law and University of North Carolina School of Medicine, Chapel Hill, NC.

Correspondence to: Richard S. Saver, JD, University of North Carolina School of Law, Van Hecke-Wettach Hall, CB #3380, Chapel Hill, NC 27599-3380; e-mail: saver@email.unc.edu


Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;145(2):379-385. doi:10.1378/chest.13-1719
Text Size: A A A
Published online

Under brand new rules implementing the Physician Payments Sunshine Act (Sunshine Act), a wide range of financial relationships, including many research-related payments, between industry, physicians, and teaching hospitals will be publicly disclosed through comprehensive, standardized payment reporting. The Sunshine Act represents the latest in a series of regulatory attempts to address financial conflicts of interest that may bias research conduct and threaten subject safety. This article summarizes the major aspects of the Sunshine Act affecting medical research, how it interacts with existing laws and policies, and identifies important unresolved issues and implementation challenges that still lie ahead with the rollout of the legislation underway. The Sunshine Act primarily depends on disclosure as a regulatory tool. As such, its long-term impact remains open to question. Disclosure in this context may have limited utility given, among other reasons, uncertainty about who the intended recipients are and their ability to use the information effectively. Apart from the insufficiency of transparency, this article further explores how proportionality, fairness, and accountability considerations make optimal regulation of financial conflicts in medical research quite challenging.

Financial conflicts in medical research attract increasing concern. The Institute of Medicine’s (IOM) influential 2009 Conflict of Interest Report identified serious risks posed by financial conflicts, including withholding of negative results, erosion of trust, and harm to patients.1 Even following the IOM report, questionable research conduct continues to be linked to financial ties. For example, a 2011 systematic review of earlier trials of bone morphogenetic protein as an adjunct to spine surgery found that study authors underestimated adverse events while failing to disclose financial relationships with the commercial sponsor, including lucrative consulting arrangements.2

Such financial relationships will come under increased scrutiny as a result of the new Physician Payments Sunshine Act (Sunshine Act).3,4 Under this significant change in federal law, many research-related payments between industry and academic medicine will be publicly disclosed through comprehensive, standardized payment reporting.

As Justice Brandeis long ago famously observed, “Sunlight is said to be the best of disinfectants.”5 Indeed, in theory, the Sunshine Act’s disclosure approach offers many advantages. Transparency has long been a preferred strategy for advancing important health law and policy objectives and for optimal regulation more generally.6 It can facilitate market discipline and incentivize participants to self-regulate problematic behavior.

Nonetheless, there are reasons to question whether sunshine has its limits. Disclosure in this context may have limited utility given, among other reasons, uncertainty about who the intended recipients are and their ability to use the disclosed information effectively. Apart from the insufficiency of transparency, this article explores how proportionality, fairness, and accountability considerations make optimal management of financial conflicts in medical research quite challenging. In addition, this article summarizes the major aspects of the Sunshine Act affecting medical research, how it interacts with existing laws and policies, and identifies unresolved issues and implementation challenges that still lie ahead with the rollout of the legislation underway.

What Gets Reported

A distinct part of the federal health-care reform law (the Patient Protection and Affordable Care Act of 2010), the Sunshine Act attempts to shine light on a broad range of financial relationships among industry, physicians, and teaching hospitals, not just research-related payments. After extensive public comments, the Centers for Medicare and Medicaid Services (CMS) issued final implementing regulations in February.4 The Sunshine Act requires that manufacturers of products covered by the Medicare, Medicaid, or Children’s Health Insurance Programs, and group purchasing organizations (GPOs) report annually to CMS ownership or investment interests held by physicians and their immediate family members. In addition, manufacturers must report annually to CMS all “transfers of value” to physicians and teaching hospitals. CMS will release most of the data on a publicly available website.

The dollar threshold to trigger reporting of a transfer of value is quite low: Payments of > $10 per instance or $100 per year must be disclosed. In addition, manufacturers must name the recipient’s identity and provide a reason for the payment by placing it within a broad range of reportable categories, including consulting fees, entertainment expenses, gifts, and speaker fees.4 Limited exceptions to the reporting requirements apply, such as for providing physicians with product samples.

Reporting of Research Payments

A distinct reportable category covers “research” payments that are subject to a research protocol or pursuant to a written agreement, such as the typical clinical trial sponsorship contracts between pharmaceutical companies and academic medical centers. It is expected that many payments related to clinical trial work will be reported under this category. Manufacturers making research payments must generally report the entity paid (either directly or through a contract research organization), as well as the name of the principal investigator(s), the total amount paid, the study name, and the associated investigational technology.

Manufacturers may worry that public disclosure of research-related payments will let competitors know about proprietary information and business strategies. To address this concern, the Sunshine Act allows delayed public disclosure. If the research payment relates to a new product still being tested and developed for regulatory approval, CMS will grant a delay before the information is made available to the public until the earlier of (1) the approval by the US Food and Drug Administration (FDA) of the study product or (2) 4 years after the date of payment.3 There was some initial confusion as to whether the delay process would apply to research payments concerning off-label uses for already approved drugs, a rapidly expanding area of research. CMS clarified in the final rule, however, that research-related payments for such off-label studies will be disclosed to the public without delay and under the ordinary time frame.4

Timing, Challenging Report Accuracy, Sanctions

Under the final rules, manufacturers had to begin collecting data on August 1, 2013, and must submit the information to CMS no later than March 31, 2014. CMS will release most of the data on a public website by September 30, 2014.4

While the initial burden of reporting falls on manufacturers and GPOs, erroneous reports could damage a physician’s reputation, subject the physician to unwarranted regulatory scrutiny, or at least give a misleading view of how funds flow in the research system. CMS is to provide each physician at least 45 days to review and dispute reported information before posting it on the publicly available website.4 Physicians will want to carefully scrutinize the information and access the dispute resolution process promptly to address any errors.

The Sunshine Act provides civil fines up to $10,000 for each violation of the reporting requirements, capped annually at $150,000. Knowing violations are subject to civil fines up to $100,000 for each incident, subject to annual caps of $1 million.3 The fines apply not to physicians but to the entities that actually must report under the law: manufacturers and GPOs.

Interaction With Existing Laws and Policies

The Sunshine Act breaks new ground by imposing a uniform reporting requirement, at least at the federal level. Only a handful of states, including Massachusetts, Minnesota, and Vermont, previously enacted state sunshine laws. But these state laws vary in terms of the minimum value that triggers reporting of payments, the exceptions that apply, and other material terms. Importantly for the research context, many of the state sunshine law laws exempt reporting of clinical trial payments.7 Also, while the Sunshine Act merely regulates by disclosure, a few state laws go farther and restrict certain payments, such as Minnesota’s general ban on manufacturers providing gifts to physicians.8

At the federal level, the National Institutes of Health (NIH)9 and FDA10 regulations are the other significant laws impacting financial ties in research. The NIH regulations require that NIH grantees disclose to their institutions “significant financial relationships,” such as consulting payments or equity interests, that relate to their research-related and institutional activities. Under 2011 revisions, the threshold for what constitutes a reportable financial interest has been lowered to $5000 from $10,000.9 An institution must evaluate the disclosed financial relationships and report to the Public Health Service any interests identified as conflicting and the institution’s management plan for dealing with the conflict.9 Meanwhile, the FDA regulations require a party seeking FDA approval of a new technology to disclose to the agency certain financial relationships with clinical investigators and any steps taken to minimize the potential for bias. A disclosable financial interest is a payment of > $25,000, equity interests > $50,000, or other financial relationship in which the value of the compensation could be affected by the study outcome.11 Apart from the FDA and NIH regulations, the Department of Justice has negotiated fraud and abuse settlements with several pharmaceutical companies, such as Eli Lilly and Co, requiring public disclosure of their payments to physicians.12

The Sunshine Act, thus, both supplements and goes far beyond existing law in terms of which payment information will get collected and publicly reported. Parties covered by the Sunshine Act, NIH regulations, and FDA rules will have to comply with all three reporting systems. But the Sunshine Act casts a wider net and will reach new financial relationships not covered by current laws, as the threshold for triggering reporting of payments is only $10 compared with the significantly higher thresholds under the NIH and FDA rules. Payments for reimbursing the costs of conducting a clinical trial are generally excluded from reporting under many state sunshine laws but will be disclosed under the Sunshine Act. In addition, the NIH and FDA rules apply only to payments arising in certain clinical trials, whereas the Sunshine Act applies broadly to most research activities. Finally, the degree of public accessibility differs. The reported information is not made easily available online under certain state sunshine laws7 and, under the NIH regulations, institutions can opt out of posting to a public website if they make the information timely available upon request.9 The Sunshine Act, however, will make all reported payments automatically available on the publicly available website maintained by CMS.

A few key questions about the law’s implementation remain unresolved, and other factors threaten to blunt its overall effectiveness. First, what about state sunshine laws? The Sunshine Act contains a preemption provision, but its scope is uncertain. It preempts state laws that require the reporting of the same information, but it also saves from preemption state laws that require reporting of this same information for “public health surveillance, investigation, or other public health purposes or health oversight purposes.”3 The final regulations provide limited clarification of these key statutory terms and, under broader interpretations, portions of several state laws could arguably be saved from preemption. Moving forward, then, physicians in several states may face required reporting under both state and federal sunshine laws, with various differences in the information reported and formats used. Rather than clearly harmonizing existing laws and policies, the Sunshine Act threatens to exacerbate differences in an overall fragmented system.13

A second key issue concerns which health-care providers will be covered by the reporting as payment recipients. In the final regulation, CMS stuck with a broad definition covering any physician licensed and legally authorized to practice in any state. Thus, payments to an investigator primarily engaged in research and not clinical practice must still be reported if the investigator is licensed to practice as a physician. Medical residents and nonphysician personnel, however, are excluded from reporting.4 Accordingly, there is risk that some key financial relationships will not be disclosed, such as research-related payments to residents, physician assistants, and nurse practitioners for activities outside the teaching hospital environment. While less common than other research funding, such arrangements do exist and the Sunshine Act may encourage manufacturers to divert funds in this manner to evade reporting obligations.

A third, and somewhat related issue, concerns the other side of the transactions: Which entities making payments must report? Some health-care attorneys interpret the law to require reporting only by manufacturers who actually have title to a product that is reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Programs. Under this view, other entities in the normal production chain with interest in the product’s success, such as distributors, would not have to disclose their payments to physicians.14 This may further encourage evasion of reporting obligations through restructuring of research funding with greater participation by affiliated or cooperating distributors.

Fourth, what about the Sunshine Act’s costs? Manufacturers and GPOs must collect the data, provide for physician review and dispute resolution, and maintain the records in case of CMS audit. This will entail significant administrative burden. CMS estimates compliance costs to industry of about $180 million annually.4 Given this amount, it is fair to ask whether the law will be cost-effective in terms of the benefits likely achieved.

A final concern is the Sunshine Act’s targeting of only financial ties. It does nothing about nonfinancial interests, such as investigative zeal, career advancement, reputational enhancement, and political predispositions, that can also bias research conduct. Financial disclosure regulations may be inadequate when they address research misconduct that is driven in large part by nonfinancial interests.15 The Sunshine Act’s exclusive focus on financial ties continues an unfortunate pattern of disparate regulatory treatment, with far greater attention paid to financial conflicts than nonfinancial interests.16

The Sunshine Act’s implementation challenges might be outweighed by the overall benefits of greater transparency, but there are reasons to question whether public reporting will work as planned. The legislation builds upon a general trend favoring greater disclosure of financial ties, including recommendations of the IOM and Medicare Payment Advisory Commission, voluntary codes of conduct adopted by various health-care provider and industry organizations,17 and disclosure policies required by medical journals.18 Despite this consensus, an important threshold issue concerns who is the intended audience for the payment information: patients, physicians, regulators, others? Senator Charles Grassley of Iowa, one of the key legislative sponsors of the Sunshine Act, has been less than clear on this point, arguing that “Disclosure brings accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas, and ultimately the practice of medicine.”19 There seems to be optimism that simply getting the information out there will work some good. But to be truly effective, disclosure rules needs to better account for the needs and abilities of the targeted information recipients.

If patients/subjects are the intended recipients, legitimate questions arise whether they will appreciate the overall research context to distinguish appropriately between beneficial and problematic financial relationships. Reported payment amounts that are large might, at first blush, seem most significant to a research subject even though they cover a clinical trial’s legitimate operating expenses. Smaller payments, not made for bona fide services, might actually raise more risk of bias.20 More importantly, a growing body of research demonstrates that financial conflict disclosures have limited sway over research subject behavior, possibly because subjects care more about other factors or may not appreciate the risk posed by conflicting financial ties. For example, one study found that a majority of research subjects found it acceptable for an investigator to own stock in the company making the experimental drug or to have a consulting arrangement with the company sponsoring the research.21 A systematic review of several previous studies found that while most research subjects expressed a general desire for greater disclosure of financial ties, fewer believed disclosure would affect their decision-making and most were not concerned about investigators’ financial ties with industry.22 Similarly, several studies found that a majority of subjects reported that they would not change their decision to participate in research if they knew about such financial ties.23,24

Arguably, physicians are the better intended audience. Investigators forced to disclose questionable financial ties may heavily self-scrutinize entering into such relationships in the first place. Also, physicians’ prescribing behavior and treatment recommendations may favorably change. In deciding whether to use certain technology with patients, physicians can perform the role of trusted intermediaries and discount research results linked to reported financial conflicts. However, the evidence base is quite limited as to whether public reporting of payments deters physicians from entering into financial relationships with industry.25 Further, behavioral studies indicate that the very act of conflict disclosure can have unintended, confounding effects. It may embolden persons disclosing to engage in more biased conduct, possibly to offset anticipated discounting of their recommendations because of the disclosure, or because they feel less concern about possible bias due to the act of disclosure.26 Moreover, it is not clear that physicians sufficiently weigh financial conflicts in evaluating evidence from clinical trials performed by other investigators. While some studies indicate physicians interpret research findings more negatively when industry finding is present,27 other studies suggest that physicians do not routinely discount for financial conflicts.28

Perhaps physician groups are in the better position to use Sunshine Act disclosures than individual clinicians. Professional societies distill clinical trial evidence for clinicians in the trenches by convening expert panels to develop practice guidelines and arranging for research presentations at professional meetings. Yet, professional societies continue to struggle with what to do about speakers and guideline participants with conflicting financial ties.29 The Sunshine Act offers a more robust mechanism for vetting speakers and guideline panelists prospectively and by careful deliberation, rather than relying on subsequent conflict disclosures.

Another possibility is that payers and government regulators will use the disclosed information effectively. Payers questioning the validity of certain research results or the conduct of specific investigators due to financial conflicts can limit reimbursement or contract with only select providers.25 Regulators can use this information to map the full extent of financial ties arising in research and track associated outcomes. Already, the information collected under state sunshine laws, such as Massachusetts’, has yielded interesting data in terms of how industry payments vary significantly in amount and format by physician specialty.30 Regulators can use this information as a better evidence base for carefully targeted legal controls. Disclosure also supports enforcement of the health-care fraud and abuse laws31 by identifying financial relationships that may warrant further scrutiny for association with problematic referrals or false claims.

An entirely different concern with the Sunshine Act relates to its overall message and how it may influence research norms. Critics worry that the law’s “beefed-up,” broad disclosure requirements encourage unhelpful moralizing and reflective skepticism about all financial relationships in medical research, however benign.32 As the IOM has cautioned, the mere existence of a financial conflict does not necessarily reflect a negative ethical judgment; each financial interest varies in concern depending on its risk of undue influence and the seriousness of harm that could result.1 The Sunshine Act’s bright-line approach, however, may detract from the important need to assess each financial interest contextually. Also, transparency may breed complacency by seeming a quick fix for managing conflicts while discouraging more carefully crafted, labor-intensive approaches.

If the Sunshine Act will likely disappoint as an incomplete strategy for managing financial conflicts, what else can be done? One possibility is to amplify its disclosure requirements. Under this approach, manufacturers would have to disclose not only financial relationships but many more details of the underlying clinical trials, including the raw data and statistical analysis. Proponents claim this would facilitate more independent assessment of study results and make it harder to hide research related risks from public view.33

Other commentators advocate even stricter regulatory controls, such as banning certain financial ties, restricting investigators with financial interests from direct participation in the research,1 or moving clinical trials to other institutions with no direct financial interest in the study outcome. Related reforms would require that independent entities overseen by government agencies entirely take over the design and conduct of clinical trials.34

Such proposals may not be politically sustainable in the current environment that favors industry collaboration in research and protection of proprietary interests. Even more important, there are no clear solutions to the conflicts problem. Optimal regulation in this area proves challenging due to many factors beyond the insufficiency of transparency. First, there are proportionality considerations. Not all financial ties arising between industry and academic medicine have been worrisome; indeed, properly designed financial interests align researchers’ incentives with public interests and can yield greater work effort, productivity, and innovation. Thus, stricter controls could deter beneficial arrangements along with problematic ones.

Next are fairness considerations. Some investigators do not perceive the existence of a conflict if their overt intent is to help patients. Others question the seriousness of harm that can result, pointing to the limited evidence that causally links financial conflicts to negative effects such as increased adverse events in clinical trials.35 Perceptions that regulation inequitably burdens entrepreneurial investigators can encourage disregard and noncompliance, making the rules more costly and difficult to enforce.

Third, accountability becomes difficult to promote, both because of complicated dynamics at play and limited assessment of actual conflicts oversight. Financial relationships in research form in a variety of ways (clinical trial support, consulting agreements, equity interests, etc), among many different players (sponsors, contract research organizations, teaching hospitals, investigators, etc), and at various levels (sole investigator, academic department, research institution, etc), resulting in diffusion of responsibility. Also, the practical enforcement of conflict-of-interest rules, at the institutional level, remains often too dependent on investigator self-reporting in the first instance and, ultimately, conflict-of-interest committees that vary dramatically in their expertise and ability to detect problematic financial conflicts and to implement safeguards. Further, the failure to subject conflicts oversight to rigorous assessment means that conflict-of-interest committees operate without a strong empirical basis for determining which conflicts pose greater risk of bias and which management plans prove effective.36

The Sunshine Act goes far beyond existing law in terms of disclosure of financial ties arising in medical research. Whether the law will be effective remains to be seen, given the limits of disclosure and the challenges in managing financial conflicts generally. Perhaps the Sunshine Act’s greatest impact will be the systematic accumulation of data about financial interests arising in research. Also, the law’s rollout provides an intriguing opportunity to observe whether and how research conduct changes in an era of greater disclosure. Hopefully, more sunshine will provide a firmer evidence base for future regulation and ethical guidance regarding financial conflicts.

Financial/nonfinancial disclosures: The author has reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

CMS

Centers for Medicare and Medicaid Services

FDA

US Food and Drug Administration

GPO

group purchasing organization

IOM

Institute of Medicine

NIH

National Institutes of Health

Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC; 2009:102-109.
 
Carragee EJ, Ghanayem AJ, Weiner BK, Rothman DJ, Bono CM. A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors. Spine J. 2011;11(6):463-468. [CrossRef] [PubMed]
 
Patient Protection and Affordable Care Act of 2010, S 6002, HR 3590, 111th Cong, 2nd Sess (2010).
 
Centers for Medicare & Medicaid Services (CMS), HHS. Medicare, Medicaid, Children’s Health Insurance Programs; transparency reports and reporting of physician ownership or investment interests. Final rule. Fed Regist. 2013;78(27):9457-9528. [PubMed]
 
Brandeis LD. Other People’s Money: And How The Bankers Use It. Washington, DC: National Home Library Foundation; 1933:62.
 
Madison K. Regulating health care quality in an information age. UC Davis Law Rev. 2007;40(5):1577-1652.
 
Gorlach I, Pham-Kanter G. Brightening up: the effect of the physician payment sunshine act on existing regulation of pharmaceutical marketing. J Law Med Ethics. 2013;41(1):315-322. [PubMed]
 
Minn Stat Ann §151.461.
 
Department of Health and Human Services. Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors. Final rule. Fed Regist. 2011;76(165):53256-53293. [PubMed]
 
21 CFR Part 54.
 
21 CFR §54.2.
 
Department of Justice. Eli Lilly and Company agree to pay $1.415 billion to resolve allegations of off-label promotion of Zyprexa. January 15, 2009. US Department of Justice website. http://www.justice.gov/opa/pr/2009/January/09-civ-038.html. Accessed June 26, 2013.
 
Institute of Medicine. Discussion paper: harmonizing reporting on potential conflicts of interest: a common disclosure process for health care and life sciences. Institute of Medicine of the National Academies website. http://www.iom.edu/~/media/Files/Perspectives-Files/2012/Discussion-Papers/IOM%20Conflict%20of%20Interest%20Disclosure.pdf. Accessed June 26. 2013.
 
Bouchard S. Sunshine act breaks through in final rule. PhysBizTech. February 5, 2013. www.physbiztech.com/news/sunshine-act-breaks-through-final-rule. Accessed June 26, 2013.
 
Feldman Y, Gauthier R, Schuler T. Curbing misconduct in the pharmaceutical industry: insights from behavioral ethics and the behavioral approach to law. J Law Med Ethics. 2013;41(3):620-628.
 
Saver RS. Is it really all about the money? Reconsidering non-financial interests in medical research. J Law Med Ethics. 2012;40(3):467-481. [PubMed]
 
Agrawal S, Brennan N, Budetti P. The Sunshine Act—effects on physicians. N Engl J Med. 2013;368(22):2054-2057. [CrossRef] [PubMed]
 
International Committee of Medical Journal Editors. ICMJE form for disclosure of potential conflicts of interest. International Committee of Medical Journal Editors website. http://www.icmje.org/coi_disclosure.pdf. Accessed November 22, 2013.
 
Weixel N. Data collection starts in August under final physician payment sunshine rule. Bloomberg BNA Life Sciences Law & Industry Report. 2013;7:161.
 
Pittman D. Will Sunshine Act dim innovation? MedPage Today. March 12, 2013. www.medpagetoday.com/PublicHealthPolicy/Ethics/37831. Accessed June 26, 2013.
 
Hampson l., et al., Patients’ views on financial conflicts of interest in cancer research trials. New Eng J Med. 2006;355:2330-2337.
 
Licurse A, Barber E, Joffe S, Gross C. The impact of disclosing financial ties in research and clinical care: a systematic review. Arch Intern Med. 2010;170(8):675-682.
 
Grady C, Horstmann E, Sussman JS, Hull SC. The limits of disclosure: what research subjects want to know about investigator financial interests. J Law Med Ethics. 2006;34(3):592-599.
 
Weinfurt KP, Hall MA, Dinan MA, et al. Effects of disclosing financial interests on attitudes toward clinical research. J Gen Intern Med. 2008;23(6):860-866.
 
Rosenthal MB, Mello MM. Sunlight as disinfectant—new rules on disclosure of industry payments to physicians. N Engl J Med. 2013;368(22):2052-2054.
 
Sah S. Conflicts of interest and your physician: psychological processes that cause unexpected changes in behavior. J Law Med Ethics. 2012;40(3):482-487.
 
Kesselheim AS, Robertson CT, Myers JA, et al. A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012;367(12):1119-1127.
 
Silverman GK, Loewenstein GF, Anderson BL, Ubel PA, Zinberg S, Schulkin J. Failure to discount for conflict of interest when evaluating medical literature: a randomised trial of physicians. J Med Ethics. 2010;36(5):265-270.
 
Ioannidis JP. Are medical conferences useful? And for whom? JAMA. 2012;307(12):1257-1258.
 
Kesselheim AS, Robertson CT, Siri K, Batra P, Franklin JM. Distributions of industry payments to Massachusetts physicians. N Engl J Med. 2013;368(22):2049-2052.
 
Krause JH. Kickbacks, self-referrals, and false claims: the hazy boundaries of health-care fraud. Chest. 2013;144(3):1045-1050.
 
Transparency or suspicion. A wrong turn for reports on financial ties in medicine. American Medical News. November 12, 2012. http://www.amednews.com/article/20121112/opinion/311129961/4/. Accessed June 26, 2013.
 
Krumholz HM, Ross JS. A model for dissemination and independent analysis of industry data. JAMA. 2011;306(14):1593-1594.
 
Rodwin MA. Independent clinical trials to test drugs: the neglected reform. Social Sciences Research Network website. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2193594. Accessed June 26, 2013.
 
Stossel TP. Regulating academic-industrial research relationships—solving problems or stifling progress? N Engl J Med. 2005;353(10):1060-1065. [CrossRef]
 
Taylor PL. Innovation incentives or corrupt conflicts of interest? Moving beyond Jekyll and Hyde in regulating biomedical academic-industry relationships. Yale J Health Policy Law Ethics. 2013;13(1):135-197.
 

Figures

Tables

References

Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC; 2009:102-109.
 
Carragee EJ, Ghanayem AJ, Weiner BK, Rothman DJ, Bono CM. A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors. Spine J. 2011;11(6):463-468. [CrossRef] [PubMed]
 
Patient Protection and Affordable Care Act of 2010, S 6002, HR 3590, 111th Cong, 2nd Sess (2010).
 
Centers for Medicare & Medicaid Services (CMS), HHS. Medicare, Medicaid, Children’s Health Insurance Programs; transparency reports and reporting of physician ownership or investment interests. Final rule. Fed Regist. 2013;78(27):9457-9528. [PubMed]
 
Brandeis LD. Other People’s Money: And How The Bankers Use It. Washington, DC: National Home Library Foundation; 1933:62.
 
Madison K. Regulating health care quality in an information age. UC Davis Law Rev. 2007;40(5):1577-1652.
 
Gorlach I, Pham-Kanter G. Brightening up: the effect of the physician payment sunshine act on existing regulation of pharmaceutical marketing. J Law Med Ethics. 2013;41(1):315-322. [PubMed]
 
Minn Stat Ann §151.461.
 
Department of Health and Human Services. Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors. Final rule. Fed Regist. 2011;76(165):53256-53293. [PubMed]
 
21 CFR Part 54.
 
21 CFR §54.2.
 
Department of Justice. Eli Lilly and Company agree to pay $1.415 billion to resolve allegations of off-label promotion of Zyprexa. January 15, 2009. US Department of Justice website. http://www.justice.gov/opa/pr/2009/January/09-civ-038.html. Accessed June 26, 2013.
 
Institute of Medicine. Discussion paper: harmonizing reporting on potential conflicts of interest: a common disclosure process for health care and life sciences. Institute of Medicine of the National Academies website. http://www.iom.edu/~/media/Files/Perspectives-Files/2012/Discussion-Papers/IOM%20Conflict%20of%20Interest%20Disclosure.pdf. Accessed June 26. 2013.
 
Bouchard S. Sunshine act breaks through in final rule. PhysBizTech. February 5, 2013. www.physbiztech.com/news/sunshine-act-breaks-through-final-rule. Accessed June 26, 2013.
 
Feldman Y, Gauthier R, Schuler T. Curbing misconduct in the pharmaceutical industry: insights from behavioral ethics and the behavioral approach to law. J Law Med Ethics. 2013;41(3):620-628.
 
Saver RS. Is it really all about the money? Reconsidering non-financial interests in medical research. J Law Med Ethics. 2012;40(3):467-481. [PubMed]
 
Agrawal S, Brennan N, Budetti P. The Sunshine Act—effects on physicians. N Engl J Med. 2013;368(22):2054-2057. [CrossRef] [PubMed]
 
International Committee of Medical Journal Editors. ICMJE form for disclosure of potential conflicts of interest. International Committee of Medical Journal Editors website. http://www.icmje.org/coi_disclosure.pdf. Accessed November 22, 2013.
 
Weixel N. Data collection starts in August under final physician payment sunshine rule. Bloomberg BNA Life Sciences Law & Industry Report. 2013;7:161.
 
Pittman D. Will Sunshine Act dim innovation? MedPage Today. March 12, 2013. www.medpagetoday.com/PublicHealthPolicy/Ethics/37831. Accessed June 26, 2013.
 
Hampson l., et al., Patients’ views on financial conflicts of interest in cancer research trials. New Eng J Med. 2006;355:2330-2337.
 
Licurse A, Barber E, Joffe S, Gross C. The impact of disclosing financial ties in research and clinical care: a systematic review. Arch Intern Med. 2010;170(8):675-682.
 
Grady C, Horstmann E, Sussman JS, Hull SC. The limits of disclosure: what research subjects want to know about investigator financial interests. J Law Med Ethics. 2006;34(3):592-599.
 
Weinfurt KP, Hall MA, Dinan MA, et al. Effects of disclosing financial interests on attitudes toward clinical research. J Gen Intern Med. 2008;23(6):860-866.
 
Rosenthal MB, Mello MM. Sunlight as disinfectant—new rules on disclosure of industry payments to physicians. N Engl J Med. 2013;368(22):2052-2054.
 
Sah S. Conflicts of interest and your physician: psychological processes that cause unexpected changes in behavior. J Law Med Ethics. 2012;40(3):482-487.
 
Kesselheim AS, Robertson CT, Myers JA, et al. A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012;367(12):1119-1127.
 
Silverman GK, Loewenstein GF, Anderson BL, Ubel PA, Zinberg S, Schulkin J. Failure to discount for conflict of interest when evaluating medical literature: a randomised trial of physicians. J Med Ethics. 2010;36(5):265-270.
 
Ioannidis JP. Are medical conferences useful? And for whom? JAMA. 2012;307(12):1257-1258.
 
Kesselheim AS, Robertson CT, Siri K, Batra P, Franklin JM. Distributions of industry payments to Massachusetts physicians. N Engl J Med. 2013;368(22):2049-2052.
 
Krause JH. Kickbacks, self-referrals, and false claims: the hazy boundaries of health-care fraud. Chest. 2013;144(3):1045-1050.
 
Transparency or suspicion. A wrong turn for reports on financial ties in medicine. American Medical News. November 12, 2012. http://www.amednews.com/article/20121112/opinion/311129961/4/. Accessed June 26, 2013.
 
Krumholz HM, Ross JS. A model for dissemination and independent analysis of industry data. JAMA. 2011;306(14):1593-1594.
 
Rodwin MA. Independent clinical trials to test drugs: the neglected reform. Social Sciences Research Network website. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2193594. Accessed June 26, 2013.
 
Stossel TP. Regulating academic-industrial research relationships—solving problems or stifling progress? N Engl J Med. 2005;353(10):1060-1065. [CrossRef]
 
Taylor PL. Innovation incentives or corrupt conflicts of interest? Moving beyond Jekyll and Hyde in regulating biomedical academic-industry relationships. Yale J Health Policy Law Ethics. 2013;13(1):135-197.
 
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
Guidelines
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543