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August 19, 2010

Is the Campaign on Conflict of Interest In Medicine an Attack on Patient Rights?

Henry black Weber_michael
In a recent interview on Medscape, Henry Black, M.D., Immediate Past President of the American Society of Hypertension and a Clinical Professor of Internal Medicine at the New York University School of Medicine, had a discussion with former President of the American Society of Hypertension, Michael Weber, M.D., from the State University of New York.

The interview focused on answering the important question of whether a "Conflict of Interest" is Actually Conflicting with the Interests of Patients.

To start off the interview, Dr. Weber explained that a major problem with using the term “conflict of interest” is that it’s a “pejorative term that indicates that a person is doing something under some form of inducement that they wouldn't otherwise do.” To use this kind of terminology you have to establish that “someone has a conflict of interest (COI), and they're doing something, which results in harm.” But to date, no scientific evidence has shown that any harm to patients has come from potential, perceived or real conflicts of interest.

Dr. Weber further added that the term "conflict" has hurt the whole process of collaborating with commercial entities and industry because “it immediately alarms people that maybe what's being written about and what research is being reported isn't quite on the level, because otherwise there wouldn't be a conflict.”

In Dr. Weber’s perspective, he asserted that conflict of interest, “in a way, is an accusation of unprofessional conduct.” To accuse a physician of having a conflict, one would have to show that a physician received “some sort of an inducement, and then did something that's harmful to patients or to other key participants in healthcare on the other.” But an inducement that would help patients get better, such as a physician learning about a new treatment or drug at a continuing medical education (CME) program or journal article would not be a conflict of interest.

Instead, Dr. Weber acknowledged that patients who receive better treatment and care from their physicians ongoing and continuing education or training, regardless of the source of funding, is “a duality of interest or an aggregation of interest or a confluence of interest.”

Looking for Vulnerabilities Other Than Financial for COI

In the academic world, Dr. Black discussed how intellectual conflict of interest, stature, importance, promotions, and deanships “are much more important than money” (financial conflicts of interest). But in Dr. Weber’s opinion, the most vulnerable persons to a “conflict of interest” in the academic world would be a person at the National Institutes of Health (NIH) whose grant is about to expire and who has to publish something or make some kind of a research offering that will ensure a continuation of their grant support.

Under those circumstances, Dr. Weber asserted that “the temptation to do something wrong -- the possibility of conflict there -- is far higher than someone getting an honorarium for giving a talk or an honorarium or a fee for participating in research.”

There is also the issue in academia of being on a board that decides the ranking of grants, and a competitor has put in a proposal that conflicts with yours. For most granting agencies like NIH however, they are “sensitive to that issue so that you can't necessarily be a judge of someone else's work if you are a direct competitor.”

The more difficult issue are the subtle things (e.g. a person's religion or political affiliation) that can have a far “greater impact on behavior than a few dollars one way or the other,” especially in activities such as “reviewerships for journals, where nonfinancial conflicts are very important.”

Dr. Weber added further that “it’s not right” just to include money on disclosure forms because everybody who matters in this world, whether they're a politician or a regulator, expects, and rightly so, to be paid for what they do.” And that payment is expected to be a “fair amount of money for a service provided.” People who think that “someone who is paid to do something can't be trusted,” must not be able get on an airplane again or drive a car again or believe in the integrity of any law again,” since they all get paid for what they do.

ACRE

To address these attitudes, which negatively associate working with industry and receiving payments, the Association of Clinical Researchers and Educators (ACRE) was formed to deal with this issue head on, and to get more and more press, more and more acknowledgement, and more and more involvement in this debate.

ACRE, which Drs. Weber and Black are both members of, “began out of a sense of frustration that academic physicians, in particular, but physicians in general were under attack by politicians and by the media for having some sort of a relationship with industry, as though participating in the development of a new heart valve or a new defibrillator or a new drug was somehow not a good thing to do.”

What led to their frustration was the fact that advice from physicians about the development of new drugs, devices and treatments is “beyond critical.” As Dr. Weber pointed out, if doctors “don’t participate in the process, we wouldn't see those new drugs. We wouldn't see those new devices. We wouldn't have new hips.”

Accordingly, Dr. Weber recognized that it is this extraordinary relationship between academia and industry “that has saved people's lives, prolonged people's lives, prevented pain, improved quality of life, and in every way has been a terrific story of success.” As a result, he found it shocking that such a successful relationship could be criticized, but offered his insights as to why this trend has occurred.

Academic and Industry Collaboration -- Its History and Implications

In discussing the background of industry-academic relationships, Dr. Black noted that since the Bayh-Dole Act was passed by Congress in 1979 and 1980, which mandated that anything developed at an academic [institution] had to be commercialized and could be patented, “academic and industry partnerships have been made available to save quality of life, reduce heart attacks, and improve so many things that would never have happened unless we did that.”

Dr. Weber agreed with this observation, and noted that in a way, physicians in academia and industry are being penalized for their success. He acknowledged how we now have drugs that prevent heart attacks, prevent strokes, make people live longer, actually keep people out of the hospital in many instances, and prevent major catastrophic events like strokes and heart attacks. But physicians and companies are being attacked “because it's costing money to provide these wonderful lifesaving drugs, and they're being accused of driving up the costs of healthcare.”

As Dr. Black correctly pointed out, while so many critics are worried about the amount of money being spent on lifesaving drugs, no one has “done a very good job at really assessing the amount of money we've saved by not hospitalizing somebody for a stroke, not hospitalizing somebody for a heart attack.”

The problem is that these critics should not be discussing money first. Instead, “the first priority physicians, industry, academia, and government need to consider is what can we do to make people live as long and as well as possible. Dr. Weber then said America has to look at whether we can afford what it takes to make people live as long and as well as possible, and ask ourselves as a nation, “What are we willing to spend so that we can live an extra 10 or 15 years of good life?" Most people would answer “I'm willing to spend.”

So where does this money come from? Dr. Black pointed to the fact that more than half of the research that we are now doing -- biomedical research -- comes from industry, not from government and not from governments abroad either. He also recognized, as Research America has shown, that “the public seems to not mind that” more than half of that funding comes from industry, even though our politicians and to some degree our deans seem to have a problem with that.

Another problem that money presents in collaborating with industry and academia is that people are now living longer, and health insurance companies (as well as Social Security and Medicare/Medicaid) are picking up the bill. As a result, health insurers become critics of collaboration between academia and industry because they “would rather not see physicians and industry doing more research and more education because when doctors in the community learn about new and innovative therapies, the insurers say, "That's going to cost us more money and cut into our profits."

Despite the negative attention and portrayal of industry, Dr. Weber pointed out that ACRE has made important progress in the area of CME, by encouraging organizations, such as the AMA, to keep their industry funding, especially because industry has no say in what’s done in these activities. In addition, Dr. Weber emphasized the fact that companies give only give educational grants to CME providers who show that “something good is going to be done with it in terms of educating doctors.”

ACRE’s efforts however, did not reach other organizations, which “were unwilling to have scientists who worked in industry to even speak at a meeting when that scientist knows more about the subject than anyone else does.” As Dr. Black pointed out, this kind of “ban” seems so counterproductive because it disregards the fact that “some of the best science in the world is done in industry by individuals such as Nobel Laureates.”

COI and Publishing Studies

Dr. Weber also discussed the fact that journals need to stop using the terminology of conflict of interest, and instead simply call it disclosure. He agreed that disclosing the funding source, whether it be government or industry, is important but that it’s equally important not to call it a conflict. In his experience, Dr. Weber said he resented the use of the term conflict because “it implies that if he hadn't got it from that source, he wouldn't have written the paper the way he wrote it.” But in all the years he’s written papers, he asserted that he “can't recall once being told by a company or anyone outside the group of academicians who were working on the paper what to say or how to interpret the data.”

Adding to his support, Dr. Black further noted that there are safeguards to ensure that companies don’t influence articles. For example, he noted how companies often have the data they collect, “but they do nothing about the interpretation, and they do not affect what the author says.” He added further that the overwhelming majority of physicians “would have not signed off on any paper where they had.”

Additionally, Dr. Black brought up the fact that if journals can set up firewalls, such as separation between business offices that accept money for advertising (mostly from industry) and editorial offices, then why can’t academics who work with industry? The answer is, they can, and should.

Attack on Industry-Funded CME and Its Effect on Patients and Residents

In their last major topic of discussion, Dr. Weber noted how the attack on CME meetings and promotional meetings is hurting patients “because it's having the effect of keeping doctors away from sources of new information.” As a result, while “there may be some very important new drugs, new ideas, new devices, nothing to do even with therapies, just new approaches for understanding medicine, doctors are not hearing about them because of these inhibitory forces.”

Dr. Black added his concern in this area because quite a few university hospitals have banned anybody from industry to talk to residents about things. This troubled him because academic medical centers “train their residents right now to be very good at extremely complicated issues, which for the most part they'll never see again after they're finished unless they become hospitalists.” By taking away industry, residents lose the ability and training on “how to deal with the marketing or the discussions that come from industry, where they ought to be able to separate wheat from chaff, ask hard questions, learn the answers, and understand when they're not getting the whole story.”

Accordingly, Dr. Weber asserted that we don’t need these kinds of bans because they prevent doctors, residents, medical students, and health care providers from learning how to analyze information that is being given to them from sources such as industry. The reality is, when industry is kept in the equation, students and doctors in training learn very quickly what they’re comfortable with, and how to know what is meaningful and what's helpful.

Conclusion

In the end, the discussion between Dr. Weber and Dr. Black highlighted the fact that it shouldn’t be a problem to have academia and industry collaborate together because all the innovations are going to come with this partnership, and they can't come otherwise. In fact, as Dr. Weber maintained, if it were not for the “people in industry and the investment made by industry, other scientists, physicians, and researchers would not be around functioning and doing good things. One only has to think for a second where we would be if practicing doctors didn't have a chance to educate themselves through the CME process or through the promotional process?

As Dr. Weber asserted, without the kind of industry sponsored CME, research, seminars, etc., doctors would only “get a diet of information that's approved by government agencies, insurance plans, and others who want to tell doctors only what they would like doctors to know about, not the full spectrum of knowledge.” In other words, doctors would first get information about how to save money, instead of lives.

The point that must be taken away from this discussion is the fact that physicians like Dr. Weber, after hundreds of papers and talks, have always maintained their firewall between what they earn and what they put out as their honest and sincere belief about what’s going on in medicine and new developments in medicine. And that is the practice, not the exception. Accordingly, keeping these partnerships is the best way to address our growing health care system and educate our physicians. If we continue to allow critics to negatively label and prevent such collaboration, without any evidence of harm, we will hinder the progress of medicine and hurt many patients along the way.

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