In 2010, the Healthcare Leadership Council (HLC), a coalition of chief executives representing all sectors of American healthcare, formed the National Dialogue for Healthcare Innovation (NDHI). HLC created the NDHI to serve as an interactive forum for leaders from government, academia, industry, payers, providers, societies, and patient and consumer organizations to engage in constructive dialogue aimed at building better understanding and consensus around critical issues affecting healthcare innovation, and, ultimately, patient care.
Co-chaired by David Barrett, M.D., CEO Emeritus of the Lahey Clinic, and Bill Hawkins, Chairman and CEO of Medtronic, NDHI brings together a broad spectrum of leaders and organizations involved in healthcare delivery and policy for discussions on subjects related to medical innovation in the United States, its importance and the opportunities and challenges affecting its progress.
In October of last year, NDHI held its inaugural event, the NDHI Summit on Physician-Industry Collaboration, in Washington, D.C. At the Summit, 107 high-level representatives from academia, providers, institutions, societies, government, payers, patient and consumer advocacy groups, and industry attended the day-long event, focusing on identifying areas of consensus and alignment, as well as raising divergent viewpoints and key issues surrounding physician-industry collaboration.
The Summit was the first in a series of planned NDHI forums on topics of importance to innovation in healthcare. Moderated by Susan Dentzer of the journal Health Affairs, the Summit program consisted of interactive sessions in which thought leaders identified opportunities and challenges presented by physician-industry collaboration, and began the process of answering some fundamental questions, such as:
- How to determine when collaboration is necessary and appropriate
- How compensation is structured
- How to minimize conflicts of interest
- How to facilitate collaboration and innovation while maintaining healthcare affordability, and
- How to appropriately regulate physician-industry relationships
Background
The executive summary of the Summit sets the tone by first recognizing that few of “the breakthroughs and miracles of U.S. healthcare innovation over the past several decades, would have been possible without close physician-industry collaboration, or more appropriately termed, cooperation, that drives innovation.”
The cooperation between physicians and industry is essential because “healthcare professionals are often the best source of ideas about how to develop complicated drugs or bio-pharmaceuticals and medical devices like artificial joints, neurostimulators, and pacemakers.” Pharmaceutical or medical device companies are able to cooperate with physicians by having “the expertise to engineer and manufacture the new products.”
Despite the enormous success of physician-industry cooperation over the past century, “physician-industry collaboration also presents the potential for conflicts of interest, as many doctors who are paid to collaborate with companies to develop new drugs or products, and train and educate other doctors on their use, are often the same doctors who prescribe or implant them.”
Recognizing these conflicts, both real and perceived, is important because they “can affect patient and stakeholder confidence in clinicians, products, companies – and the entire industry.” However, as the summary points out, physician-industry collaboration in the U.S. over the past several years “has come under critical review, both as a result of increased media scrutiny and the budgetary constraints of healthcare payers, including federal, state, and local governments.”
These criticisms have “fueled increasing demands to ensure that healthcare decisions remain unbiased, and to preserve the integrity of the physician-patient relationship, and address conflicts of interest, both real and perceived.” To preserve the importance of physician collaboration in the pharmaceutical and medical device industries, many U.S. companies have already taken voluntary steps to make payments to physicians transparent to the general public. Congress this year also passed transparency requirements that will establish a uniform set of federal disclosure requirements for physician payments for all drug and medical device industries in the United States.
In addition to these transparency requirements, which will help ensure that treatment decisions remain driven by patient needs and physician expertise, “innovation also involves principled collaboration, with appropriate guidelines, and communication between a number of additional key groups, such as those who attended the Summit:
Government: U.S. Senate Committee on Finance, CMS, HHS OIG, DOJ, U.S. Senate Special Committee on Aging
Physician Inventors: Fogarty Institute for Innovation
Drug Industry: Pharmaceutical Research and Manufacturers of America (PhRMA), Pfizer, Merck & Company, Eli Lilly, Novo Nordisk, Ikaria
Device Industry: Advanced Medical Technology Association (AdvaMed), Medtronic, Johnson & Johnson, ResMed
Patient Advocacy: Friends of Cancer Research, Society for Women’s Health Research (SWHR),
Payers: Blue Cross and Blue Shield Association, Aetna, Health Care Service Co.
Medical Societies: American Osteopathic Association, AAMC, ACC, CMSS, Association of Perioperative Registered Nurses, Care Continuum Alliance (CCA)
Providers: Walgreens, Cleveland Clinic, MedAssets, NY-Presbyterian Hospital, Rockpointe, Carolina’s Medical Center
Academia: University of Virginia, Stanford, Duke, Vanderbilt, Stanford, IOM
Providers/Industry: Fresenius Medical Care North America
Drug Research: Quintiles(Association of Clinical Research Organizations)
Stakeholders from each of these groups were then organized into six sessions:
Framing the Discussion
- Collaboration Opportunities and Challenges
- Current Practices and Gaps
- What Collaboration Means for the Patient
- Role of Government and Other Payers in
- Physician-Industry Collaboration
- Lessons Learned and Next Steps
Framing the Discussion
The first panel of stakeholders came to consensus on several topline observations about the collaborative process in healthcare:
Innovation is critical to improving patient care, and collaboration between industry and the commercial sector is vital to innovation, to training of doctors, including continuing medical education (CME).
Maintaining public trust is vital to preserving collaboration for the benefit of patients, and that trust has eroded due to a variety of factors.
Much work needs to be done on balancing the two: continuing to collaborate and innovate, while maintaining public trust by educating the public on the process and becoming more transparent about the collaboration, ultimately to eliminate misunderstandings and negative perceptions on conflicts of interest.
Collaboration Opportunities and Challenge
This panel explored the benefits and challenges of collaboration and how guidelines should be developed and maintained to ensure acceptable standards of collaboration while maintaining forward progress in medical innovation. The participants agreed that there is value in innovation and the partnerships between healthcare providers and industry are critical and good for the economy.
Moreover, participants agreed that in order to improve the image of the physician-industry collaboration, there is a need for a cross-stakeholder group such as NDHI to work collaboratively across stakeholder groups to develop consensus-based shared principles to guide appropriate and ethical partnerships and to communicate with the public about how appropriate collaboration is essential. A group such as this is critical because it can address the gaps and inconsistencies that have been created by multiple guidelines and standards for collaboration.
To address these gaps and inconsistencies, the participants agreed that disclosure guidelines could be consistent between industry and academia in order to provide a level of transparency that is understandable to the public/patients that are ultimately making decisions about their own healthcare.
In addition, participants agreed that information from industry must be clear and understandable for patients because patient groups rely on industry for information and resources that enable them to educate stakeholders in government and advocate for cures and research funding, and also in educating patients about how to manage their treatment. Included in this education, participants agreed that it is necessary to create an unbiased history of the extent to which industry/healthcare professional/biomedical research scientist interactions have resulted in therapies – unique drugs or advanced medical devices – that have improved and saved the lives of patients.
Participants further agreed that individual academic medical centers need to reach a consensus on guidelines they have in place to avoid (such as the divergence on policies with respect to participation in speakers’ bureaus, or the difference between treatment of adjunct vs. full-time faculty). AMC’s should also strive to improve their cooperation with industry for research and development of new technologies.
There was significant agreement among participants that collaboration is important in ensuring patient safety because of the need for physicians to work with industry in educating and training healthcare professionals on the safe and effective programming or implantation of products. Participants further added that:
- Trusted collaboration will occur when an educated public and government develop an understanding of and cultural tolerance for the existence of inherent conflicts that are managed through principled guidelines. There is also a need for monitoring and accountability around these guidelines.
- A key question in developing guidelines is the threshold at which a physician inventor or discoverer needs to remove him/herself from patient-facing care or evaluation because of his or her financial conflict.
- Industry needs to acknowledge excesses that have occurred, and develop lessons learned, as part of restoring a positive image.
- Collaboration must demonstrate added value for patients and the healthcare system, and not exist solely for financial gain.
A significant development that came from this panel was that participants recognized that in developing guidelines for physician-industry collaboration, there must be “communication that separates the perception from the reality of the relationships, and an appreciation that applying standards that are unnecessarily and overly restrictive can stifle innovation and lead to a exodus of scientific talent from the United States.”
Current Practices and Gaps
The next panel examined the policies and standards that currently govern collaboration between physicians and industry, and whether patients/consumers are well served by the status quo. Most important, it focused on how to optimize collaboration to maximize innovation.
First, participants recognized the need to compile a comprehensive inventory of the existing guidelines and principles regarding collaboration and conflicts of interest that have been developed by various stakeholder groups. After examining this inventory, participants agreed on developing a unified, cross-disciplinary set of guidelines, principles and best practices and to identify any gaps that exist.
Contributors acknowledged that since healthcare is driven by rapidly developing new scientific technologies and demographic change (i.e. race, age), there is need to drive innovation by bringing minds together across groups in an open way, such as with regular forums, and sabbaticals for physicians with industry. Participants agreed that in order to meet the necessary insistence by public and private payers for evidence that innovation delivers value, technological and scientific convergence will require more collaboration, not less, in order to achieve the innovation needed to benefit our healthcare system.
Participants agreed that academic medical centers especially have a responsibility to encourage this sort of principled and optimized collaboration, which is as much about alignment of interests always for the benefit of patients as it is about managing conflict. Additional perspectives included:
- Guidelines should provide an oversight mechanism to ensure accountability.
- Analyze guidelines to ensure that they are actually restoring public trust.
- Transparency in payments must include the context of such payments
- Outcomes registries can be very helpful in driving collaboration and innovation, by encouraging the adoption of best practices and therapies, and driving evidence-based conclusions.
One example of encouraging collaboration that results in innovation is Stanford’s successful SPARK program that brings together pharma, biotech, graduate students, venture capital, and faculty regularly to talk about opportunities for transfer of knowledge from academic-developed discoveries into industry.
Executives in industry and leaders in academic medical centers would rather have their colleagues come to them and ask, “How can I get this done?” as opposed to, “What are the rules that keep me from interacting?”
What Collaboration Means for the Patient
Participants heard from two patients, who described in personal terms the benefits that they have received from innovative products and therapies in treating chronic illnesses. They also heard from the patient advocacy organization Parkinson’s Action Network (PAN), which recognized that patient’s have an interest in collaboration because:
- It gives them access to newer treatments faster in terms of the drug development and biomedical research pipeline, and
- It gives them better quality of care in terms of ensuring that physicians have access to the greatest amount of and newest information, whether about devices or drugs, so that they can give their patients the best care possible.
- Patients have an expectation that their own physicians have access to the best information, and clinical medical education is part of that process.
Role of Government and Other Payers in Physician-Industry Collaboration
The Summit’s next session focused on the government’s expectations and current areas of concern of payers, with respect to physician-industry collaboration, and how payers, providers and industry can work together to ensure collaboration results in improved patient outcomes. One of the central perspectives offered by panelists and thought leaders was that the government is deeply skeptical of collaboration, including the financial impact on patients, as well as the conflicts and possible fraud to which it can lead.
Part of the reason why government maintains this perspective is because as a payer, the government is interested only in collaboration that will advance the “triple aim”: better health, better care, at a better cost, and in improved integration of care and alignment of incentives across stakeholder groups. As a result, government and private payers are very interested in promoting collaboration that leads to integrated and coordinated care that delivers better outcomes at lower costs, and integrating and aligning the delivery system to drive quality, affordability, and access.
The problem with this perspective is that instead of acknowledging the positive steps that industry has taken in a short time on issues of conflicts-of-interest, the government continues to ignore the large public perception problem on the issue of collaboration. This has led to institutions, organizations, and law enforcement demanding more regulation and even outright bans on physician-industry collaboration. It has also led to an emphasis on removing potential conflicts of interest because these groups see effective compliance programs and transparency programs as going a long way to achieving these goals.
Consequently, participants acknowledged that one way industry can address the public perception problem on collaboration is by making technological innovation a more patient-centered process that is integrated across disciplines. Another important perspective that was offered recognized that government and payers need to be careful not to confuse cost with value and improvement of care to patients. If the focus is too much on cost at the expense of value, it will strangle innovation, and that will have an adverse impact on both patients and the economy. The emphasis should be on cost-effectiveness rather than cost.
Participants also explained the need for divergent institutions of the federal government to develop a unified position on legitimate collaboration, including recognition of the different types of collaboration, to provide clarity on what collaboration is allowed.
Summary and Next Steps
At the Summit’s final session, panelists and participants established consensus around the day’s key points:
- Innovation in healthcare is critical for both the well-being of patients and the sustainability of the healthcare system, and collaboration is necessary for that innovation to continue.
- Public trust and communication are vital; and substantial work is needed to enhance trust in the collaboration model.
- Maintaining balance is important: continuing to collaborate and innovate, while maintaining public trust by educating the public on the process and becoming more transparent about the collaboration.
- Solving collaboration challenges is an economic imperative for the U.S.
Following the Summit, participants agreed to work within NDHI to continue engagement on this issue in three areas:
Guidelines & Principles
- Assemble a thorough inventory of current guidelines and best practices by stakeholder group.
- Work toward consensus and alignment around clear, cross-disciplinary principles and guidelines on collaboration and transparency.
Education & Outreach
- Assemble an honest, neutral, and credible history of successes showing benefits and risks.
- Conduct research to define and prove the value of collaboration in innovation.
- Develop a plan for effective public education around collaboration process and benefits to address skepticism and mistrust.
Improving Innovation
- Develop innovation in the collaboration/innovation process.
- “Spark” program as model at Stanford Medical School
- Sabbaticals of physicians in industry to participate in academia
- Encourage broader, proactive collaboration across stakeholder groups in a neutral/noncompetitive space to work on specific areas of research (the “democratization of innovation”).
NDHI expects to engage smaller working groups beginning in early 2011 to make progress over the next year on these areas, in order to maximize trust and preserve innovation, both for the benefit of patients and for continued U.S. leadership in the critically important healthcare industry.
Discussion
One physician, who attended the Summit on behalf of a major medical society, noted that the executive summary did not reflect “the emotional atmosphere of the meeting.” He asserted that many of the “multinational-organizations present realized that physician/corporate interactions were essential to benefit patient care.”
He noted how Robert Conley, a neuroscientist working for Eli Lilly, went so far as to say “that the company realizes that it would not exist without collaboration with doctors. On the other hand, he noted that Philip Pizzo, Dean of Stanford Medical School asserted that most industry supported CME programs had only a marketing goal. That Dr. Pizzo was clueless when it came to product research and development and the need for experts throughout the entire cycle of creating healthcare products.
On the contrary, Guy Chisolm, a PhD researcher at the Cleveland Clinic stated that partnership with industry was essential, that the public needs to be educated about the benefits of physician-industry collaboration. Dr. Chisolm also recognized that while transparency in itself does not eliminate bias, a dialogue is necessary and that while there was some evident public mistrust, the key to getting trust back lay in communication. John Mack, a psychiatrist from Duke, stated that while science drives innovation, innovation drives business and all, especially patients, benefit.
Conclusion
The significant level of engagement and discussion from thought leaders across stakeholder groups at the Summit illustrated a firm desire across disciplines to work together to protect physician-industry collaboration in order to drive innovation and most importantly, advance patient care. The Summit has set the stage for ongoing dialogue and work over the next year ultimately to forge consensus across all stakeholder groups on shared principles and guidelines to guide collaboration, as well as how collaboration produces tangible benefits to public health.
It is crucial that stakeholders stay involved in this dialogue and promote the importance of collaboration because otherwise, our innovation(s) will be transferred to China or India where they do not have these regulatory problems.