Cardiac Societies Scrutinized for Industry Conflicts: Fair?

	Thomas M. Tu, MD
	John M. Mandrola, MD

Thomas M. Tu, MD, an interventional cardiologist, and John M. Mandrola, MD, an electrophysiologist with Baptist Medical Associates in Louisville, Ky., discuss the complex relationships that medical societies and physician specialists form with the cardiac device and pharmaceutical manufacturers that provide the products to support their specialties.

Q. A May article in USA Today, written by Charles Ornstein and Tracy Weber of ProPublica, stated that "societies that represent specialists" are "one of the areas of medicine that still welcomes largesse." In evaluating the societies that represent your specialties, do you agree with this assessment?

Tu: The purpose of my professional organization, the Society for Cardiovascular Angiography and Interventions, is to promote excellence in the care of patients undergoing cardiac catheterization procedures. Symbiotic relationships are inherent between those who use cardiovascular devices and those who make the tools. Financial donations support physician education, research, quality initiatives and patient programs. If this funding results in better patient care, it is not inappropriate. Of course, vendors are not completely motivated by altruism. As with all corporations, they are interested in profits as well. The public has a right to know the amount of money contributed and for what it is being used. If the true funding was revealed, the public would likely find it primarily reasonable.

Mandrola: It is not surprising that physician-leaders of medical societies welcome largesse, as it would be against human nature to turn it down. The question is not whether financial relationships between industry and medical societies exist, but whether the largesse adversely affects patient care, which is a very difficult question. However, investigative organizations, like ProPublica, keep the important issue of how bias and influence might affect patient care in the minds of both patients and doctors, which is positive.

Tom is right about the symbiosis between industry and medical societies. Such partnerships have facilitated tremendous advances in heart disease care. When I studied cardiology, all we could offer a patient with heart attack was aspirin, beta-blocker and a diagnostic catheterization. Now, we whoosh them into a cath lab, infuse complex blood-thinners, and prop open their blockage with metal stents. People not only survive heart attacks, but they continue their lives seamlessly. This kind of life-saving care required doctors to partner with industry.

Tu: The ProPublica article and other media stories tend to stir up controversy while failing to acknowledge the positive work that results from these relationships.

Mandrola: The ProPublica investigation downplays the fact that real people enjoy the benefits of technology, which I call the "fury of medicine." The same companies that lavish the largesse also make life-saving medical devices. While most investigative journalists, like Ornstein, are well-intentioned, they cannot accurately report from the perspective of a doctor who knows how a cutting-edge device may help his or her patient. Journalists can read manuals and scrutinize p-values, but until they have felt a proprietary wire traverse an impossible s-shaped vein, and then experience the gratitude of the same patient weeks later, it is very difficult to tell the whole story. These upbeat stories are the norm for physicians, yet they are seldom celebrated in mainstream media.

Q. Do medical societies need better disclosure policies?

Tu: Disclosure is mandatory for all scientific meetings and working group sessions. Speakers list companies that sponsor their research or provide them with consulting income. Yet, the lists become moot as everyone receives some support, and therefore, is not an indication of improper conflict. It is naïve to think the sheer presence of industry involvement is inappropriate. In fact, industry often seeks to partner with highly accomplished physicians with unique experiences or ideas, who should not be penalized for their accomplishments. For example, FDA policy prevents its physicians from having any interaction with device companies related to their regulatory duties. The unintended side effect is that the agency has difficulty finding experienced individuals to perform essential clinical studies because those doctors are disqualified.

Mandrola: Tom correctly points out that nearly all experts have relationships with industry. However, the amount of support matters. A researcher (or institution) who receives an appropriate amount of support for studying a device should not be lumped in with those that receive egregious "consulting honaria." Disclosing the specifics of the relationships can only help with appropriate relationships. More forthright disclosure amplifies the voice of the honest.

Tu:  A few stakeholders have an equity interest in certain devices, while conducting the clinical research. Sometimes, these people also are responsible for the educational and marketing avenues for popularizing the technologies. While this in itself does not denote wrongdoing, it creates the appearance of potential conflict. In this situation, physicians must be careful to maintain credibility and scientific rigor, which is best achieved by complete transparency.  

Better than the required list of companies would be context of that relationship. It is more important to know the details of the relationship between a trial's principal investigator and its sponsor than the fact that a certain company bought a physician a cup of coffee while they trained him or her on its latest device. Transparent information should be easily understood and put into proper perspective.

Q. At scientific meetings, should there be a clearer delineation between exhibitions/vendor events and educational presentations/sessions?

Tu: There is already a clear delineation between scientific presentations and exhibitor marketing events. The sessions are separated by physical space and time. Marketing activities are confined to the exhibitor hall during working hours and offsite at after-hour sessions. Attendees should not have any problem distinguishing scientific presentations from marketing events.

Mandrola: National meetings have always required us to walk through vendor exhibits to get to scientific posters. Like most heart physicians, I do not see a fundamental problem with vendors. They sell devices and drugs that we use every day. Here are three points about exhibitors:

1. Physicians in private practices often have difficulty discovering new tools. I can remember handling a catheter, which ultimately proved very useful, for the first time in a vendor booth. Why should this be perceived negatively?
2. Who doubts that the plush carpets, HD monitors, beautiful people and free espresso are not overt marketing tactics? Can't we trust our doctors to sift through glitz? One could even argue that the overtness of the exhibition hall is better than the covert nature in other forms of advertising.
3. The proximity of vendors and scientific posters results in larger crowds, which of course, increases the chance of meeting colleagues. These chance human-human interactions are still one of the greatest values of national meetings.

Q. Is industry involvement integral to medical meetings and CME programs that focus on electrophysiology (EP) and interventional cardiology?

Mandrola: I am uncertain if device-intensive fields like ours can altogether remove industry from education. It's a nebulous line though, because of the obvious profit motives of industry. Medical device makers clearly have wiggle room to emphasize their products' advantages while downplaying risks. The profit-driven free-market system of U.S. healthcare further amplifies the possibility that industry largesse could bias medical education. In cardiology, industry and doctors should be partners. Of course, there should be more transparency and greater specifics of relationships divulged. But I see everybody winning when doctors use devices that are safe and effective. Tom rightly calls this symbiosis.  

Tu: Industry involvement is an integral part of our fields. All of the medical advances from which we have benefited result from cooperation between physician innovators, scientists, clinicians and device/pharmaceutical companies. No single group has the expertise and capital to accomplish this alone. All of the phases of innovation, from initial conceptualization to bench-top testing, to clinical trials, to training are dependent on industry funding. Neither academic medicine nor the government can replace this fiscal support.

Q. Has industry competition intensified in the current economy?

Tu: Economic factors have had a major impact on the profitability of device makers and pharmaceutical companies. As healthcare expenditures in the U.S. decline, companies have been forced to change their business model. There have been significant layoffs recently. The money invested in research and development in the U.S. has decreased substantially. As developing countries become greater consumers of healthcare, companies have re-focused to these growing sources of revenue. The effect on U.S. practicing physicians is a reduction in the amount of money put into both innovation and marketing in our fields. While the effect may not be felt by patients today, it will become readily apparent when medical advances are developed, researched, produced and utilized outside the U.S. first.

Mandrola: The intensity of industry competition is not any greater now. Dogfights between the device makers and statin purveyors, along with competing drug lunches, occurred many years ago. It's the same. It's capitalism, and the competition allows for a healthy, open market.

Q. Will the practice/hospital integration trend affect conflicts of interest for providers?

Tu: The increasing rate of physician/hospital integration is changing the dynamic between physicians, hospitals and device/pharmaceutical manufacturers. Many physician leaders now have a fiduciary responsibility to their hospital organization, which may lead to further disclosures of conflict of interests, as well as limitations of external relationships.

Mandrola: Employed physicians who have a stake in their hospital's bottomline may find themselves working more [cost]-efficiently. They will now have an incentive to get by with less. How would this play out for patients? The answer really depends on whether one can justify the extras afforded us in the present system. For example, at most U.S. hospitals, atrial fibrillation ablation is aided by luxurious benefits like general anesthesia and intra-cardiac echo. In Europe, the same ablation gets done without anesthesia or expensive echo catheters. It's hard to answer which method is better, but my guess is that if costs were not prohibitive, European ablationists would be happy to use anesthesia and extra imaging catheters. They might even tout the benefits of such conveniences.

Another potential conflict that could arise might be if device companies offered financial rewards for exclusivity agreements. Company A agrees to "help" a hospital/doctor in return for exclusive use of their device. This system works well until Company B gets approval for a better device. In this case, patients could rightly ask whether their implanted device was the best one for them, or one from a company that had ties with the doctor or hospital.

Q. Will a movement away from the fee-for-service (FFS) model make potential conflicts less prevalent?

Mandrola: The default of most doctors is to do what is right for their patients. In doing so, we must work within our healthcare system. Going forward, our system will be much more constrained by costs. In this way, U.S. healthcare is nearing the European model. However, if less care is incentivized, who gets to decide which technologies constitute quality and which are superfluous? Will it be your doctor, your congressman or a think-tank? Though our current FFS model has flaws, patients can take solace that their caregivers are not motivated to do less. Because humans practice medicine, conflicts will never cease; they will simply change.

Tu: Any new reimbursement model would still require choices to be made between competing products and therapies. Physicians will still need to play an essential role in evaluating the relative merits of these treatments and make decisions in the best interests of patients. The prevailing reimbursement scheme will not affect that.

Mandrola: Most physicians try to balance the societal costs of advancing technologies with the needs of their patients. We know that not all patients get significant benefit from the latest gadget. We subconsciously ration care because we see the limits of what we can afford. This will soon change. As the FFS model devolves, the pressure to contain costs will increasingly become more overt.