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Despite improved transparency, conflicts of interest still arise in medicine
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A 2011 study published in the Archives of Internal Medicine reported that more than half of the individuals involved in writing recent American College of Cardiology/American Heart Association clinical practice guidelines reported some financial conflict of interest.
However, many physicians argue that “conflict of interest” is not an appropriate term to describe the relationships that physicians have with industry. This phrase has been rejected by the Association of Clinical Researchers and Educators because it introduces a framing bias that restricts further discussion about the working relationships physicians have with the industry.
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Photo courtesy of Options for Children in Zambia |
“‘Conflict’ implies that there is a problem or argument, and we don’t believe that these relationships are a conflict at all,” said Henry R. Black, MD, clinical professor of medicine at New York University School of Medicine. “If anything, it’s a confluence of interest or a synergy of interest. We have the same interest at heart, and that is helping patients.”
The study of guidelines and conflicts of interest is an important one, because such clinical practice guidelines may have a beneficial effect on patient care. According to James N. Kirkpatrick, MD, assistant professor of medicine at the University of Pennsylvania and a researcher of the 2011 study, clinical practice guidelines are increasingly used in medical malpractice cases and are forming the basis of many of the pay-for-performance initiatives.
“It is important that clinical guidelines be something that people can trust,” Kirkpatrick said. “We do have to be more cognizant of conflicts of interest, mainly because of the perception they bring. We have to safeguard the trust of the proven therapies we have. One of the ways to do that is to have a transparent, open process and to minimize conflicts of interest.”
But physician relationships with the industry do not just have the potential to affect practice guidelines. They have the potential to affect scientific research and patient care.
“The research shows that relationships between doctors and companies are ubiquitous in every aspect of medical education, medical research and the practice of medicine,” said Eric G. Campbell, PhD, associate professor of medicine at Harvard Medical School. “Conflicts of interest are not universally bad, but they’re not universally good.”
Industry relationships
Several studies have quantified the relationships between physicians and the industry. A Journal of the American Medical Association review published by Wazana and colleagues in 2000 suggested that these relationships affect the prescribing and professional behavior of physicians. The same study suggested that continuing medical education programs sponsored by a drug company were more likely to highlight the drug company’s product.
“These types of relationships, while beneficial to the industry, are not beneficial to the American public and are actually detrimental,” Campbell said. “Essentially, these programs are meant to serve as a marketing tool to sell drugs. The industry is not to blame, as they are motivated like any other for-profit company. Their primary goal is to sell things, and everything they do revolves around maximizing revenue.”
A 2004 study published in The New England Journal of Medicine found that 94% of physicians reported some type of relationship with pharmaceutical companies. The most prevalent relationships involved receiving food in the workplace or receiving drug samples. In addition, 35% of the respondents received reimbursement for costs associated with professional meetings or CME, and 28% received payment for consulting, giving lectures or enrolling patients in trials.
Physician relationships with the industry are beneficial in that they typically lead to innovation that leads to new drugs and devices used to enhance patient care. For example, according to Thomas P. Stossel, MD, the American Cancer Society Professor of Medicine at Harvard Medical School, there has been a 50% decrease in cardiovascular mortality since new drugs and devices were introduced to help patients with cardiovascular disease.
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“This decline in cardiovascular mortality is 100% because of the tools we got from the industry, and these tools were the result of physicians collaborating with the industry,” Stossel told HemOnc Today. “These relationships lead to improved drugs, devices and imaging modalities. No one can get up and say that these relationships haven’t been overwhelmingly beneficial.”
According to J. Michael Gonzalez-Campoy, MD, PhD, FACE, medical director and CEO of the Minnesota Center for Obesity, Metabolism and Endocrinology, physicians who are at the cutting edge of science and who are involved in clinical research are the best suited to author clinical practice guidelines.
“These physicians are paid for their work by third parties, and this is what advanced science,” Gonzalez-Campoy said. “It does not matter if it is the NIH, the Cleveland Clinic or a pharmaceutical company. Excluding the most expert physicians in the field because of their working relationships stands to hurt medicine and patients. It is naive to suggest that physicians should not have fiduciary relationships for the work they do.”
Academic physicians should not be expected to do what they do without any compensation, Black said, adding that the problem with current disclosures is that they make no distinction between the types of money received, such as that for a research grant or for honorarium, or speaking at industry-sponsored CME.
“That can be misleading,” he said. “If I get a large grant sponsored by a company or received money to give talks, these would not be distinguished from each other. We have no problem with disclosures — our universities and our societies make us disclose — but the nature of the relationships disclosed need to be distinguished.”
Research funding
Not all relationships between physicians and drug companies are negative. Pharmaceutical companies often provide most of the funding for clinical trials that evaluate potential new treatments for patients. This funding may not be available elsewhere.
“The American people support our academic institutions through research grants and contracts,” Campbell said. “They do that under the assumption that our research will make health services better for the American people. If we refused to accept research funding from drug companies, we would not be able to live up to that expectation. There is an academic and a social contract. We need to work with industry because we need to translate the results of our research into health care products and services. At the end of the day, we need to be about curing disease, ending suffering and educating the next generation of researchers.”
According to Joel Lexchin, MD, professor in the School of Health Policy & Management at York University in Toronto, a large body of research supports the notion that when the industry directly funds studies, those studies are about four times more likely to produce positive results than if anyone else funds the research. Although collaborations between industry and researchers can be useful, there should be a firewall between the researchers and industry.
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“Industry should give the money to the NIH if they want a trial on a specific drug, and then the NIH would act as a gatekeeper between the researchers and industry,” Lexchin said. “The NIH would peer-review the researcher proposals and select the research team to complete the research. The data would then be analyzed independent of the drug company.”
Gonzalez-Campoy, however, said the collaboration between physicians and pharmaceutical and biotechnology companies is what has made American medicine great.
“One could not exist without the other,” he said. “In fact, trials are designed not for marketing, but to fulfill regulatory criteria that allow medications and technologies to achieve the permissions and indications needed to come to market and benefit patients. It stands to reason that the compounds and technologies that are safe and effective are the ones that deserve attention.”
Black said the basic science research and clinical trials needed to bring a new drug or device to the market requires the expertise of physicians and fosters the collaboration between them and the industry.
“We would be nowhere without the relationships with the industry,” Black said. “The investment that a company makes to take an idea to market is about $1.2 billion.”
Uniform standards
Most, if not all, medical institutions have policies regarding conflicts of interest, as do medical journals. But their guidelines can vary widely when it comes to reporting conflicts.
“Each journal has different standards, hospitals have different standards and medical schools have different standards,” Lexchin said. “Some of these standards are stricter and some of these standards are looser. A universal policy is a useful goal that would allow everybody to be working from the same page. Investigators would understand what is or is not required from them in terms of disclosing conflicts of interest, and all institutions would then know what kind of information they should be collecting.”
A study published in JAMA in 2009 found that among 256 medical journals, 89% had author conflict-of-interest policies. However, a JAMA study published 2 years later found that among 29 meta-analyses of pharmacological treatments published in high-impact biomedical journals, information about the conflicts of interests of the 509 randomized controlled trials used for the meta-analyses was rarely reported.
Lexchin and colleagues proposed a standard form for investigators to disclose conflicts of interest in an article published in the open-access journal Open Medicine. But simply declaring conflicts of interest is not sufficient enough to deal with the problem, Lexchin said.
“There is some literature that shows that if doctors simply disclose their relationships with a drug company, others would trust those doctors more because they are being honest about their conflicts,” he said. “Unless you are an expert in the area, you cannot be sure of the accuracy of what these doctors are saying, as they might be biased by their relationships with the company.”
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According to Stossel, disclosing the sponsors of the research has always been done as a way to give credit to them for funding the studies. But the call for disclosures has become more involved.
“Disclosure policies are no longer a way to honor the sponsor of a study,” Stossel said. “Instead, it has been turned into a type of confession. I have no problem disclosing, in principle. But in practice, disclosures are being used by the media to embarrass people.”
Physician Payment Sunshine Act
According to Campbell, for a long time, conflicts of interests have remained hidden because drug companies have not had to disclose how much they pay doctors. But a provision included in the Patient Protection and Affordable Care Act of 2009 will require drug/device companies to disclose all payments and gifts made to physicians.
The provision, called the Physician Payment Sunshine Act, requires that payments and gifts of more than $100 be reported to the Department of Health and Human Services. The information will then be reported and maintained in a public database. This includes consulting fees, honoraria, research funding, stock options and travel costs, among others. Several states, including Vermont, Massachusetts and Minnesota, and the District of Columbia have already instituted reporting requirements for physicians receiving payment from drug/device companies.
This system for reporting industry payments to physicians was an idea put forth by the Institute of Medicine in its 2009 report, “Conflicts of Interest in Medical Research, Education, and Practice.” The committee also recommended that all medical institutions, including academic medical centers, professional societies, patient advocacy groups and medical journals, establish conflict-of-interest policies that require disclosure and management of individual and institutional financial ties to industry. – by Emily Shafer
For more information:
- Blum J. JAMA. 2009;302:2230-2234.
- Campbell E. N Engl J Med. 2007;356:1742-1750.
- Institute of Medicine. Conflict of interest in medical research, education, and practice. April 21, 2009. Available at: www.iom.edu/conflictofinterest. Accessed April 15, 2011.
- Mendelson T. Arch Intern Med. 2011:177:577-585.
- Rochon P. Open Med. 2010;4:e69-e91.
- Roseman M. JAMA. 2011;305:1008-1017.
- Wazana A. JAMA. 2000;283:373-380.
Disclosures: Drs. Black, Kirkpatrick, Campbell, Stossel and Gonzalez-Campoy report no relevant disclosures. Dr. Lexchin has served as a consultant to a law firm representing the generic company Apotex Inc., a consultant to the Canadian Federal Government in its defense against the challenge to the ban of direct-to-consumer advertising, and as a consultant to a law firm in a suit against Allergan alleging a death due to an adverse drug reaction. He also is a member of the management board of the group Healthy Skepticism.
Are physician relationships with industry necessary for research and continuing medical education?
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I see the relationship between academic physicians and industry as not only a good idea, but also in some ways mandatory. As physicians, what we deal with are medicines. More than 90% of all interactions with patients result in us writing a prescription or recommending treatment. Academic physicians have a compelling interest, an absolute obligation to identify unmet needs in medical care, to come up with ideas and recommendations for how those needs might be met and to collaborate with industry in addressing them. We are best at seeing what unmet needs exist; we’re best at understanding the sort of drug or device that might be in the best interests of patients; and we’re probably the best people to design studies and to be involved in the analysis and interpretation of studies.
On the other hand, one thing we’re not good at is the highly complex process of drug development. There are 1,000 or more steps between a good idea for a new drug to the point where the new drug can benefit patients. Managing that complex system of research, which consists of myriad of steps, is something that pharmaceutical companies do best. So, it’s a natural partnership. There are things that physicians can do better, and there are things that a pharmaceutical company can do better — the key is that we’re both working together as a team to create better care for patients.
In addition, who better to educate than academic physicians? We are the ones who understand the issues and understand why treatments are different from each other and why newer therapies may have advantages or why older drugs may actually be more advantageous than newer ones. We are the ones who understand the clinical issues related to disease, so we can educate most appropriately about drugs or devices or other new interventions that fit in. Sometimes, we’re paid to do it. That does not bother me because I don’t know of any professionals who aren’t paid for their valuable services. Compensation, provided that it’s transparent, is not the issue. As always, audiences will form their own judgements about what they hear.
Michael Weber, MD, is a professor of medicine at SUNY Downstate Medical Center College of Medicine in Brooklyn, N.Y. He reports no relevant financial disclosures.
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This question has no simple answer. Basic research, including by industry-employed physicians, is part of drug development itself. It cannot be divorced from industry. In contrast, clinical outcome studies that compare finished products could be done by unbiased parties — if there was funding. Fortunately, each company is financially motivated to fund these very expensive studies in order to support its own products. Unfortunately, this same motivation raises concerns about studies slanted to favor the product of the sponsoring company. In the abstract it would be best if such studies were not designed, conducted, and paid for by business interests, but the alternative of taxpayer-funded research is politically untenable for now. At least with published research findings, there’s peer review and a system set up for evaluating the science and the quality of the research. It can be examined after the fact to see if it was done well or not.
Industry sponsorship of CME is more problematic. In my view it should be ended. It’s impossible for most audiences to evaluate on their own, individually, whether the material presented is biased or not. It’s too easy to insert subtle bias in favor of sponsored products. Even physician speakers who declare themselves beyond financial influence, and who sincerely aim to be objective, may unconsciously include biased statements despite their best intentions. The national accrediting body for CME, ACCME, has numerous rules to prevent obvious commercial bias. But no such rules can fully prevent monied interests from spinning things their way. There is too much profit at stake, and too many subtle ways to promote products. Paying out of pocket to assure unbiased CME is a bargain in the long run.
Steven Reidbord, MD, is a psychiatrist in private practice in San Francisco, and is the chairman of the CME committee at the California Pacific Medical Center. He reports no relevant financial disclosures.