Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary (2014)

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4 Public Perceptions of Conflict of Interest Important Points Highlighted by Individual Speakers • Decades of important medical progress has been achieved through physician–industry collaborations. • The goal of communicating conflict of interest with the public is to promote innovation and meet patient needs while simulta- neously gaining and maintaining public trust. • One objective for patients is to understand the goals, context, and benefits of physician–industry collaborations and the extent of those relationships as it relates to their care. • A central, publicly available database provides patients with access to more information about the relationships between their physicians and industry that they can use to inform deci- sions about their care. • Freely available databases will provide necessary transparency about financial relationships, but it is important that the context of those relationships and their value is also conveyed in order to avoid negative presumptions that might be made about col- laborations. • Communicating to patients the nature of the relationships and the benefits of those relationships is just as important as sharing information about the risks of physician–industry collaborations. • The establishment of a single standard for disclosing relation- ships would provide a mechanism for encompassing both phy- sician and non-physician conflict of interest. 31 

32 COI AND MEDICAL INNOVATION Policy makers and the public obtain information about conflicts of interest from many sources, including the media, websites, health care providers, and other people with whom they interact. The media has an important role in informing the public, and, in doing so, a fuller picture of conflicts of interest should be portrayed, said Hartzler Warner. A bet- ter understanding is needed of what type of information is of interest to the public and which elements members of the public need to know about in order to obtain a better understanding about why collaborations are desirable. COMMUNICATING CONFLICT OF INTEREST Often when members of the public learn about collaborations be- tween a physician and a health care company, they infer that the relation- ship has negative consequences. But physician–industry collaborations have produced three-quarters of a century of medical progress, said Mary Grealy, president of the Healthcare Leadership Council. Penicillin, heart and lung bypass machines, statins, deep brain stimulation, and many other advances resulted from physicians, researchers, and manufacturers shar- ing their expertise. “It’s not a coincidence that we are a healthier nation today because of companies and physicians collaborating on innovations for the betterment of society. . . . As we look at the conflict of interest problems and the remedies that can and should be taken against the truly bad actors and bad actions, we need to keep this documentation of health care progress in mind,” Grealy said. Relationships between physicians and industry have received a good deal of scrutiny in recent years from the media and from policy makers. As a result, far more people are aware of payments between physicians and medical innovation companies than in the past, and this awareness will increase dramatically with the implementation of the Physician Payments Sunshine Act. However, the public may not be more aware of the purposes of those relationships, Grealy said. “The goals of the Physi- cian Payments Sunshine Act are laudable,” she said, “the public does have a compelling reason to know about these relationships. But the ef- fectiveness of the Physician Payments Sunshine Act will be in the de- tails. Will [the public] simply see columns of names and numbers without background, context, or meaning? Or will they understand the degree to which their lives and their health are affected by these ex- changes or by these collaborations?” 

PUBLIC PERCEPTIONS OF CONFLICT OF INTEREST 33 Providing raw numbers without context can have a number of unfor- tunate repercussions, Grealy said. It can create negative presumptions and cynicism over relationships that serve the interest of society. It could lead more physicians to avoid clinical trials, educational conferences, scientific advisory board meetings, and other opportunities that could benefit their patients. It could have a detrimental effect on the dissemina- tion of medical knowledge if it results in less participation in conferences and seminars in which pharmaceutical or medical device companies are involved. “In a worst-case scenario, it could [be misleading] as people pore over the Physician Payments Sunshine Act database to identify which physicians have received the most dollars, even if those dollars are compensating them fairly for their expertise on a project that will ad- vance modern medicine,” Grealy observed. In 2010 the Healthcare Leadership Council created the National Dia- logue for Healthcare Innovation as a forum for diverse voices to address issues of conflict of interest and progress in health care, Grealy said. The initiative was designed to bring industry, health care providers, academ- ics, government officials, and patients to the same table to share their views and to work on how to continue to innovate while earning the trust of the public. The dialogue reached consensus on four points: that inno- vation is critical and collaboration is necessary for innovation, that work is needed to enhance trust in collaborations, that maintaining public trust and transparency is important for collaborations and innovation, and that solving challenges related to collaboration are an economic necessity for the United States, said Grealy. Four key principles to guide collabora- tions were agreed upon, and the group also pointed to the need for strong internal self-regulation in addition to federal regulation (see Box 4-1). BOX 4-1 Summary of Keys to Principled Collaboration as Developed by the National Dialogue for Healthcare Innovation • Collaboration must always be first and foremost for the benefit of patients. • Researcher and health care autonomy and independence must be protected. • There must be reasonable access to meaningful and relevant in- formation about how physicians, researchers, and companies en- gage in collaborative relationships. • All participants across the health care system must be accountable for their actions. SOURCE: Mary Grealy, IOM workshop presentation, June 5, 2013. 

34 COI AND MEDICAL INNOVATION MEDIA PORTRAYALS OF CONFLICT OF INTEREST What do drug companies pay health professionals, and what do they get in return? What do doctors prescribe, and how do they compare with their peers? For the past several years these are the questions that Charles Ornstein, a senior reporter for ProPublica, and his colleagues have examined. In 2010, ProPublica, an independent nonprofit news organization, launched a project called Dollars for Docs, which compiles publicly available data from pharmaceutical companies about their payments to health professionals into a single easy-to-search freely available data- base. The database started with 7 companies; it now includes 15 compa- nies, representing about 47 percent of the U.S. pharmaceutical sales market and about $2 billion in disclosed payments. Furthermore, the Physician Payments Sunshine Act will require nearly all companies to report such information, which will allow the Dollars for Docs database to be even more robust, Ornstein said. The database distinguishes the types of interactions that physicians have with industry, Ornstein said. For example, it distinguishes grants for research from fees for speaking and consulting. For research, it notes that the amount shown does not reflect the actual compensation received by the physician listed as the principal investigator. It includes the compa- ny’s definition of the activity it is supporting and the context and value the company ascribes to that activity. ProPublica has used the database to write stories on who is getting the payments and the apparent objectives of the payments. For example, companies typically claim that they support experts who are leaders in their profession. But one story demonstrated that among the doctors who were the highest paid, some did not have board specialty certification, many were not associated with academic medical centers, many had not published academic research papers, and some had disciplinary records such as losing their state medical licenses (Ornstein et al., 2010). As a result of that story, the industry has changed how it checks state discipli- nary databases to look at the credentials of people employed as speakers or consultants, said Ornstein. The impact of funding on professional societies was the subject of another ProPublica story (Ornstein and Weber, 2011). It focused on the Heart Rhythm Society, which received about 50 percent of its funding from the pharmaceutical and medical device industry, Ornstein said. The tip sheets to patients from the society left out pertinent information re- garding the drugs and devices that people who have heart rhythm irregu- 

PUBLIC PERCEPTIONS OF CONFLICT OF INTEREST 35 larities may consider, Ornstein said. “It was not a balanced perspective and, in fact, was tilted in favor of industry.” Ornstein acknowledged that payments for research or consulting ac- tivities designed to produce innovations in science differ from those for outreach or marketing. But, he added, “a lot of doctors receive the bulk of their money for giving paid promotional talks on behalf of compa- nies.” For example, one physician was recently the first to exceed $1 mil- lion in speaking and consulting fees over the past 4 years, even though not all of the companies in the database have disclosed for that entire period and not all companies are in the database. The website provides lists of the notable drugs made by each compa- ny as well as links to an NIH website providing impartial information about those drugs. In addition, the page provides a checklist of questions that patients might want to ask their doctors, including: What are the specific circumstances of this payment?, What is your current relation- ship with this company?, What drugs have you prescribed me that are manufactured by companies you’ve taken payments from?, Are there non-drug alternatives that I may want to consider first?, and Are there less expensive generic alternatives to the drugs you have prescribed? The idea is to neither support nor disparage relationships between physicians and companies, Ornstein said. Rather, it is “to allow [patients] to have more informed decisions with their clinicians.” Not all patients are interested in this information, Ornstein said, but some are, and “each patient needs to make a decision for him or her[self] about how interested he or she is in this information and whether or not it’s worth a conversation with their physician about it.” Some patients may decide to choose another doctor, while other patients trust their phy- sicians to make the decisions that are appropriate for them. “We’re not trying to undermine that trust,” he said. PROVIDING CONTEXT FOR CONFLICT OF INTEREST The public receives a lot of information about innovation and collab- oration, Ornstein said. In fact, “the amount of information they are get- ting about medical journal articles and presentations at conferences far overwhelms information about conflicts of interest.” What is needed, he said, is follow-up on the promises of studies to determine whether ad- vances have resulted. However, Grealy said that when members of the public learn of conflicts of interest, they do not hear about the value of 

36 COI AND MEDICAL INNOVATION the collaborations at the same time. Patients need to know the context of the relationship between collaborators, specifically the purpose of the relationship and what would be considered fair compensation for the val- ue that comes from that relationship, she said. Characterizing all educa- tional programs as marketing and targeting them for elimination is not a balanced approach. The ProPublica site does distinguish research payments from pay- ments for presentations, Ornstein said. “Research collaboration is vital to innovation. Where it breaks down is on the issues of speaking and con- sulting. That’s what we’ve chosen to focus on—the areas where there is less uniformity of perspective.” While the work of ProPublica is important, there is concern that the presentation of the conflict of interest data may diminish the significance of the role of these collaborations for supporting research, said Paul Billings, chief medical officer at Life Technologies. For example, the stories about individual physicians who had received large compensa- tions for their presentations did not contain much detail about why they earned their money, and “they have a right to [their] privacy,” he said. Ornstein countered that ProPublica had repeatedly tried to contact the individuals and the companies about whom reporters have written, but obtaining responses has been challenging. More information is need- ed from these parties to provide the necessary context for their compen- sation, he said. Additionally, the information provided by companies contains many inaccuracies, but because the information is now more readily available in one place, companies are taking pains to make sure that it is accurate, Ornstein said. A process will need to be established to maintain the accuracy of the data, correct mistakes, and provide context for the information, Grealy said. Industry websites as well as ProPublica’s website are used by the Cleveland Clinic to verify physician disclosures to the institution, said Chisolm. If any discrepancy is more than a small amount, the physician will receive an e-mail asking the physician to look into the difference, with the institution volunteering to get in touch with the company if the information is wrong. For that reason, Chisolm and his institution are strong advocates of transparency and disclosure.1 However, Chisolm said, the media could do much more to educate the public about the nature of and the benefits to society of interacting with industry, as opposed to focusing on egregious missteps by industry 1 Cleveland Clinic: Integrity and Innovations. http://my.clevelandclinic.org/about-cleveland- clinic/overview/who-we-are/integrity-innovations.aspx (accessed January 9, 2014). 

PUBLIC PERCEPTIONS OF CONFLICT OF INTEREST 37 and academia. For example, the name Dollars for Docs carries certain negative connotations, and some things are emphasized while others are de-emphasized on the site, such as the funds going for research. “Maybe there could be a less disingenuous way of portraying that,” he said. The checklists of questions for patients to ask their doctors on the ProPublica website may be better received if the questions came from a professional society rather than from the media, said Lavezzari. The way that the con- flict of interest information and the questions are presented drives the reader to draw conclusions before he or she has all of the information. Grealy said that ProPublica has done a “nice job of trying to provide some context,” but whether the information provided and the way in which it is provided are appropriate is debatable. The pharmaceutical industry has been critical of Dollars for Docs, but it does not have easy-to-use websites to provide more of this context, Ornstein said. Consulting can encompass a very wide range of activities, from marketing to service on drug safety boards. “Those both would be lumped in under consulting, but they’re two totally different things,” he said. Having more information about the role of the physician would be helpful. Some pharmaceutical companies are even using the data to push back against physicians who are making money from other companies, Ornstein said. “The industry, which before only had access to its own information, now has access to a competitive body of information that will help them do their jobs better.” Conflict of Interest in Prescribing Practices Conflict of interest issues extend past collaborations involving phy- sicians. Because non-physicians will be increasingly prescribing medica- tions as health care reform proceeds, such non-physicians will need to be included in any effort to monitor conflicts of interest, a workshop partic- ipant observed. One project at ProPublica that is doing just that collects data about prescriptions that health providers across the country have written in the Medicare Part D program. The resulting database, which has records of prescriptions written to the program’s 35 million Ameri- cans, can be used by members of the public to look up their physicians or other health providers to see what they are prescribing. Financial disclo- sures are not the only important conflicts of interest to be aware of, Ornstein said; patients should also know if providers are “prescribing drugs in a way that’s reasonable, in a way that’s consistent with the ac- cepted standards in their field. Patients right now don’t have the re- sources or tools at their disposal to know whether or not that’s the case.” 

38 COI AND MEDICAL INNOVATION A single standard for disclosures for physicians and non-physicians could create a reasonable framework for those who might have a conflict of interest, Grealy said. A single standard also could reduce the amount of resources that go into compliance and thus leave more resources for patient care, research, and other useful activities. Meaningful information needs to be collected in a useful and efficient way, Grealy said. Many companies supported the Physician Payments Sunshine Act because dif- ferent states were passing their own disclosure legislation with different rules, whereas the Physician Payments Sunshine Act will impose a na- tionwide standard, Ornstein said. The question then becomes whether institutions and agencies will follow suit and use the same standard or continue to use different standards for non-physicians.