The Unhealthy Separation of Marketing and Education Support from Research
It is often quoted by critics that “if only industry funded research alone and stopped spending on marketing or supporting education that the world would be a better place”. Today, there is even a conference promoted by alternative medicine advocates dedicated to those ideals. The thought is without marketing we would have some sort of medical nirvana.
Realty is starkly different. If there is no marketing or education, there would be no product research, and even if there was research, no one would know about it anyway.
It is naive to think that physicians will receive all their knowledge from medical journals, and even childish to think that medical journals who derive a majority of their income from product advertising would stay in business without advertising support from the same marketing dollars that many prominent journal editors are calling to eliminate.
How does it benefit patients if their healthcare provider has a total lack of knowledge about new therapies, techniques and procedures? If there were no marketing or education, the multiple billions of dollars spent on research would come to naught and patients would suffer.
A study published in the Archives of Internal Medicine attempted to investigate the “subtle” bias or “potential conflicts of interest” in the most recent American College of Cardiology (ACC) and American Heart Association (AHA) guidelines.
We previously recognized that this article was problematic because the authors admit that, “the actual degree to which any individual may be influenced by any specific type of conflict of interest (or even a specific dollar amount) is impossible to assess.” Additionally, the study is biased because although several controversial episodes involving COIs in guideline production have surfaced in recent years, these incidents are extremely rare.
In addition to these problems, 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 (ACRE) because it introduces a framing bias that restricts further discussion about the working relationships physicians have with the industry.
As Henry R. Black, MD, clinical professor of medicine at New York University School of Medicine pointed out, using “conflict” implies that there is a problem or argument, and we don’t believe that these relationships are a conflict at all.” Dr. Black explained that, “if anything, it’s a confluence of interest or a synergy of interest because CME providers and faculty have the same interest at heart, and that is helping patients.”
James N. Kirkpatrick, MD, assistant professor of medicine at the University of Pennsylvania and a researcher of the 2011 study, noted that clinical guidelines must be something that people can trust because they may have a beneficial effect on patient care. As a result, Dr. Kirkpatrick asserted that we have to be “more cognizant of conflicts of interest, mainly because of the perception they bring.” To do so, Dr. Kirkpatrick recognized the need for a transparent, open process to minimize conflicts of interest in clinical guideline making.
Physician Industry Relationships
Industry critic Eric G. Campbell, PhD, associate professor of medicine at Harvard Medical School, asserted that, “relationships between doctors and companies are ubiquitous in every aspect of medical education, medical research and the practice of medicine.” He claimed that, “conflicts of interest are not universally bad, but they’re not universally good” because they have the potential to affect scientific research and patient care.
However, Campbell’s reasoning for such claims is problematic (as usual). He goes on to cite the misquoted Wazana study, which recommendations suggested that industry-physician relationships affect the prescribing and professional behavior of physicians though these recommendations were not supported by the data presented in the same article.
Specifically, Campbell argued that industry-physician relationships are detrimental to the American public and these programs are meant to serve as a marketing tool to sell drugs. Additionally, he argued that such programs have the primary goal of maximizing revenue. However, Campbell’s assertions are misguided because the Wazana study used no patient outcome measures and did not show a single negative clinical outcome.
Contrary to Campbell’s arguments, 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.
Dr. Stossel asserted in a recent article in HemOnc Today that, “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.” Further, he added that, “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.”
J. Michael Gonzalez-Campoy, MD, PhD, FACE, medical director and CEO of the Minnesota Center for Obesity, Metabolism and Endocrinology, echoed Dr. Stossel’s comments and recognized that, 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.
Additionally, Dr. Black noted that academic physicians should not be expected to do what they do without any compensation. Moreover, Dr. Black recognized that the problem with current disclosures is that they can be misleading since 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.
For example, Dr. Black noted that if he gets “a large grant sponsored by a company or received money to give talks, these would not be distinguished from each other.” As a result, Dr. Black asserted that the nature of these disclosed relationships need to be distinguished.
Research Funding
One problem with recent press regarding physician-industry relationships is their failure to recognize that 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, and this funding is usually not available elsewhere.
Even Campbell recognized that if academic institutions refused “research funding from drug companies, we would not be able to live up to the public expectation” that academic research will make health services better for the American people. Campbell further asserted that, academia needs “to work with industry because we need to translate the results of our research into health care products and service” in order to cure diseases, end suffering and educate the next generation of researchers.
Some believe however, that although collaborations between industry and researchers can be useful, there should be a firewall between the researchers and industry. Despite this belief, Gonzalez-Campoy recognized that 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.
He added that, “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.”
Dr. 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
The article also discussed the idea of medical institutions and journals having policies regarding conflicts of interest. Joel Lexchin, MD, professor in the School of Health Policy & Management at York University in Toronto, noted how “each journal, hospital and medical school has different standards, some being stricter and some looser. As a result, 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.
However, Lexchin argued that simply declaring conflicts of interest is not sufficient because “unless you are an expert in conflicts of interest, you cannot be sure of the accuracy of what these doctors are saying, as they might be biased by their relationships with the company.” Such reasoning is extremely problematic. The idea that only “experts” can detect bias is not supported by any evidence and contrary to the years of training physicians receives to understand research and results.
This kind of reasoning has led to disclosure policies now becoming a type of “confession.” Dr. Stossel recognized that physicians have no problem disclosing in principle, but in practice, media are using disclosures to embarrass people, instead of crediting them for funding the studies. In fact, a recent surge of articles from “investigative journalists” such as ProPublica, have been using payment data from drug companies—published in anticipation of the Physician Payment Sunshine Act—to write sensationalist articles about physician-industry relationships. None of these articles discusses the benefits or positive outcomes physician-industry relationships create.
Physician-Industry Relationships: Debate
Steven Reidbord, MD, a psychiatrist in private practice in San Francisco, and chairman of the CME committee at the California Pacific Medical Center, asserted that industry sponsorship of CME is problematic and should be ended because “it’s impossible for most audiences to evaluate on their own, individually, whether the material presented is biased or not” and “it’s too easy to insert subtle bias in favor of sponsored products.” However, he cites no evidence to support this claim, and ignores three very large studies from last year which showed almost no perception of bias in commercially supported CME programs (Cleveland Clinic; Medscape, and UCSF).
He also claims that, “physician speakers who declare themselves beyond financial influence, and who sincerely aim to be objective, may unconsciously include biased statements despite their best intentions.” Yet, he acknowledges that the ACCME has numerous rules to prevent obvious commercial bias.
But Dr. Reidbord believes that “no such rules can fully prevent monied interests from spinning things their way” because “there is too much profit at stake, and too many subtle ways to promote products.” As a result he believes that paying out of pocket to assure unbiased CME is a bargain in the long run. Interestingly however, he believes that research, including by industry-employed physicians, cannot be divorced from industry because “taxpayer-funded research is politically untenable for now.” To believe that industry can work in research but not education is hypocritical and illogical, especially considering taxpayer-funded CME is also highly unlikely.
Conversely, Michael Weber, MD, professor of medicine at SUNY Downstate Medical Center College of Medicine in Brooklyn, N.Y., noted that, “relationships between academic physicians and industry are not only a good idea, but also in some ways mandatory.”
He recognized that more than 90% of all physician interactions with patients result in doctors 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.
Dr. Weber noted that doctors are the best at seeing what unmet needs exist; understanding the sort of drug or device that might be in the best interests of patients; and designing studies and to being involved in the analysis and interpretation of studies. On the other hand, doctors are not good at the highly complex process of drug development.
He recognized that 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 physicians and industry are both working together as a team to create better care for patients.
In addition, who better to educate doctors than academic physicians? Dr. Weber noted that physicians 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. Further, he added that physicians are the ones who understand the clinical issues related to disease, so they can educate most appropriately about drugs or devices or other new interventions that fit in.
Conclusion
Ultimately, receiving compensation from industry for consulting, teaching or research should raise no serious concerns for critics such as Campbell or Reidbord because all professionals are paid for their valuable services. Compensation, provided that it’s transparent, is not the issue because doctors are more than capable of forming their own judgments about whether the research or CME they use is biased or not.
In the end, “it does not matter if it is agovernment agency, academic medical center or a pharmaceutical company” compensating a physician. Excluding the most expert physicians in the field because of their working relationships stands to hurt medicine and patients and it is “naive to suggest that physicians should not have fiduciary relationships for the work they do.” As Dr. Gonzalez-Campoy explained, physicians are paid for their work by third parties and this is what advanced science. Moreover, CME providers and faculty who work with industry all have the same interest at heart, and that is helping patients.
Accordingly, continued usage of terms such as “conflict of interest” and the framing bias associated with such terms will only increase the potential of harming patients, stalling advances and progress in medicine and science, and leaving physicians without the up-to-date training and education necessary to address the rapidly evolving medical landscape of the 21st century.
Medical nirvana is patients going home from the hospital healed and increased life expectancy anything short of that is dire straights.