American Academy of Ophthalmology Web Site: www.aao.org
Discussing the Ophthalmic Codes of Ethics
A CONVERSATION BETWEEN TWO OPHTHALMIC LEADERS ILLUMINATES THE NEW CODES OF ETHICS GUIDING INTERACTIONS BETWEEN THE PROFESSION AND INDUSTRY.
In the last several years, the relationships between the medical profession and the medical device and pharmaceutical industries have come under increasing scrutiny. As a result, existing medical ethics codes have undergone major revisions—all in an effort to eliminate any real or perceived undue conflict of interest. Both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Association (AdvaMed) overhauled their codes with new rules that took effect in 2009. At around the same time, the Academy revised a policy statement about gifts to physicians from industry, and earlier this year adopted an updated advisory opinion titled “Disclosure of Professionally Related Commercial Relationships and Interests.”
One of the latest changes to medical ethics codes came in April 2010 when the Council of Medical Specialty Societies (CMSS) adopted a new Code for Interactions with Companies designed to support a culture of transparency guiding interaction between medical organizations and industry. CMSS represents 32 of the largest medical specialty societies, and its new code of ethics was developed by a 30-member task force consisting of leaders of member societies. The Academy was one of the first societies to adopt and commit to formally implementing the new guidelines, and at the time of publication, 17 other member societies had signed and adopted the code. Recently David W. Parke II, MD, executive vice president and CEO of the Academy, and James V. Mazzo, chair of the board of directors of AdvaMed and president of Abbott Medical Optics, discussed the reasons behind the new medical ethics guidelines, what changes they might bring to the medical profession, and how they will affect the Academy as well as practicing ophthalmologists.
EYENET: Why were the new ethics codes—such as those from the CMSS and AdvaMed—put into place? And how can these new guidelines help the medical profession and the health care industry?
DR. PARKE: The major medical societies, which act as the public voice of their professions, must be trusted by their members and by patients as providing leadership and clinical guidelines that are free of any perception of financial bias. Trust is critical, and it’s very easy to damage.
The Academy has never been accused of inappropriate financial relationships, and it’s our collective job to make sure that the Academy retains that position. The Academy has had policies pertaining to conflict of interest for 20 years, and these policies have gone from aspirational, vague statements to more specific rules that provide clearer guidance on ethical relationships with industry.
The new ethics codes, as a whole, are designed for compliance and transparency across the health care industry and medical professions. In particular, the CMSS code is meant to codify a uniform approach to organizational relationships between industry and all of medicine’s major societies.
Like a lot of physicians, I’m deeply offended that someone might think my professional decisions might be influenced by a free pen or a coffee cup. But we all have to remember that what I think is less important than what the public thinks. If we want to truly speak for the health care needs of our patients, both from the industry and medical organization perspectives, we need their trust. And they must perceive us, correctly, as free of inappropriate financial relationships.
MR. MAZZO: We occasionally read about inappropriate financial relationships between the medical profession and health care industry in the news. But the point is that those who’ve abused these relationships are in the minority—and they’ve damaged the reputation of the many professionals who are physicians or are involved in the health care industry. For the most part there’s been a tremendous collaborative relationship between clinicians and industry that has helped bring science and technology to our patients.
By putting new codes and guidelines in place, we’ll be able to prevent conflicts of interest between the health care provider and manufacturer, and also alleviate the perception of improprieties. As a result, we can continue the relationships between health care professionals and industry that have helped develop and improve cutting-edge technologies.
AdvaMed has had a code of ethics since 1991, and we’ve been updating it as warranted by changes in the industry and the legal environment. We in industry are ensuring that we comply with government regulations. We’re pleased that medical device companies have been leaders in developing and enacting a robust code of ethics. To date, more than 100 companies are listed for the public to view on the AdvaMed website as early adopters of the revised code, and we’re constantly getting new members to adopt it.
EYENET: What are the most important aspects of the new CMSS code and other new ethics codes? And how might these codes affect practicing ophthalmologists and the Academy?
DR. PARKE: The CMSS code affects an organization and its physician leadership, not the individual physician in the trenches. And physician volunteers on almost all Academy committees are not directly affected by the CMSS code.
The code states that key leaders of an organization who are in a position to affect policy, to speak for the profession, to determine what is published and to lead the development of clinical guidelines should be free of any direct financial ties to industry—and this means journal editors, the society’s leaders, such as the president and president-elect, and committee leaders who develop clinical guidelines or preferred practice patterns.
What is critical to understand is that the CMSS code does not affect nonfinancial relationships, such as clinical trials work. It doesn’t affect collaborative consulting relationships that don’t have a financial component.
The new CMSS code also sets guidelines for how the organizations relate to industry in meetings, and provides rules for cosponsorship of various activities, such as continuing medical education. It doesn’t ban these activities; it simply puts appropriate parameters around the interactions. Industry sponsorship of CME is important because it promotes the kinds of communication and stimulation that lead to new trials, new devices and new drugs that help patients, and it also helps physicians access the kind of medical education that keeps them current. Yet the role of industry in funding CME has to be carefully constructed and has to follow appropriate guidelines, as well as be transparent.
MR. MAZZO: Ethics codes from AdvaMed and other organizations provide clear guidance to companies on how to manage relationships with health care professionals. They show us what actions are appropriate in regard to collaboration on research and product development, training and education about new technologies, and demonstration and evaluation of products. These codes also delineate clear rules for supporting third-party educational conferences and providing information on coverage and reimbursement.
It’s important to emphasize that this is not only a national effort, but a global effort. At AdvaMed, we hold the same standards across the globe. A practitioner is held to the same standards whether he or she is from Buenos Aires, Berlin or Boston.
EYENET: Is it desirable for most medical and ophthalmic organizations to adopt the CMSS and/or other ethics codes?
DR. PARKE: There may be some organizations with constraints that preclude signing on to ethics guidelines such as those developed by CMSS. But every organization should strongly consider signing on to these new guidelines, and developing or enhancing their own codes. Such actions provide uniformity, transparency and ethical parameters for the entire health care profession and industry.
MR. MAZZO: From an AdvaMed perspective it’s important to have all medical device companies sign on to our organization’s ethics code. Broad support from medical device companies for the new codes means that there’s a strong coalition that favors ethical guidelines in industry. This only enhances ethical relationships between industry and health care professionals, and improves the image of both industry and clinicians. We have had a lot of support from the ophthalmic industry for our code, and they’ve been fully engaged in putting the code in place.
EYENET: Some might argue that physicians need close ties to industry to guide product development so that the best health care is made available to patients. Will the new ethics codes disassociate physicians from industry, and thus stifle innovation?
DR. PARKE: I think that it’s easy to misinterpret the revisions to the ethics guidelines as draconian changes that will drive a wedge between industry and the Academy or other medical organizations. But that’s not what they are. The changes simply give us a clearly defined playing field on which to operate.
The new ethics codes are living documents. They will respond to changes in the environment and undergo multiple iterations over the years. The language of these ethics codes will change as circumstances change, and the codes will evolve. The new codes will ensure that ophthalmic and medical organizations can always partner with industry with integrity and transparency. The Academy is the central voice of ophthalmology, and we must all ensure that voice is viewed as authoritative and independent.
MR. MAZZO: The goal of the new codes, such as those developed by AdvaMed, is to create unmistakable guidelines for the interactions between the medical profession and the health care industry so there’s no misinterpretation. But the ethics codes are not meant to inhibit the strong collaborative efforts between the medical profession and industry, including those between the Academy and AdvaMed members.
Many of the major improvements in technologies that affect the eye have come about because of the direct interaction between industry and the physician who is working to save patients’ eyesight on an everyday basis, and who is always trying to improve the practice of medicine. So we don’t want to eliminate these collaborative relationships. We want to eliminate abuses and establish clear rules for these relationships. The majority of practitioners and companies are following ethical guidelines, and they’ve been doing it right for a long time.
AdvaMed's Code of Ethics on Interaction with Health Care Professionals
AdvaMed's Early Adopters
Academy's Advisory Opinion titled "Disclosures of Professionally Related Commercial Relationships and Interests"
Academy's Code of Ethics
Academy's Policy Statement on Gifts to Physicians from Industry
CMSS Code for Interactions with Companies (and List of Signers)
PhRMA Code on Interactions with Health Care Professionals (and Signatory Companies)