October 4, 2010 (Washington, DC) — The medical community needs to change its culture to make physician-industry relationships both more fruitful and honest. That was the upshot of a frank and free-flowing discussion on physician conflicts of interest at the recent TCT 2010 meeting.
"Let's face it, credibility is lacking in the clinical-trial infrastructure right now," veteran FDA reviewer Dr Bram Zuckerman told the audience of industry representatives and physicians at the session. "We need to do as much as possible to improve that credibility for our patients and for device innovation."
Zuckerman was blunt in his assessment of how real and perceived conflicts of interest have diminished the credibility of industry and physicians alike.
|Dr Bram Zuckerman|
"You all have to become more professional," he said. "I don't think [physician-industry relationships are] being managed in a professional manner, and it hurts the medical-device industry because it causes more questions and more patient distrust. . . . The situation is not good and it needs to be fixed."
Zuckerman pointed to some credibility problems currently plaguing the cardiovascular-device sector and offered some potential "basic solutions."
First, physicians, manufacturers, the public, and government have to recognize that "medical-device development occurs because smart physicians at the bedside come up with ideas that are iterated with very smart engineers." But right now, device trials, especially early trials, are often insufficiently rigorous, he said, often unblinded and lacking independent adjudication and data safety monitoring boards.
"The reality is that most of the data that we're getting outside the US, although it's shown at multiple meetings, is of lousy quality. We're missing that point and wasting patients here."
The reality is that most of the data that we're getting outside the US, although it's shown at multiple meetings, is of lousy quality.
One step that manufacturers should take to increase the credibility of medical-device trials is to bar the device's original developer from participating in the clinical trial and consider engaging an independent contractor to hold the data during the trial. "This is extremely important in this day and age of fancy and advanced clinical-trial methodology, where we talk about adaptive sample size, increases, or stopping early," he said.
Session comoderator Dr Richard Popp (Stanford University, Palo Alto, CA) said that, at Stanford, "we don't consider somebody consulting for industry to be anything but positive. That means they're considered an expert, somebody values their intellect and contributions, and usually the faculty want to go work with industry because they know that can't get some of this stuff done themselves." However, his institution bans device and drug trial investigators from having equity in the manufacturer of the product being tested or receiving any payment from the company beyond "the actual cost of the research."
Pay for Your Own Coffee
The debate about managing conflicts of interest has been going on in the medical community, industry, and government for many years, but it became more urgent last spring when Congress passed the Physician Payments Sunshine Act as part of the larger healthcare reform package. The law requires companies to report any physician payments, including everything from stock options and research grants to small gifts. It exempts payments under $10 unless the annual total per company, per recipient, is $100 or more.
One of the most common criticisms of the new law is that it compels manufacturers to keep track of "payments" to physicians as small as a cup of coffee. But session comoderator Dr Harlan Krumholz (Yale University, New Haven, CT) argued that these seemingly insignificant things are symptomatic of a larger cultural problem in medicine and industry.
"It's easy to mock tracking something like a cup of coffee. But for those of you in industry, you don't just want [doctors] to see you as somebody who is going to take them out for dinner or give them World Series tickets or buy them a cup of coffee. Doctors can buy their own cup of coffee. What you want to do is create the appreciation that [experts in industry] are a resource . . . that they have information that's valuable that would be useful to access."
This "culture" of mutual professional respect and sharing of information has certainly not prevailed in the past, Krumholz said. "I was raised on this idea that when I see [industry reps], it was 'Great, they're going to buy me something and give me gifts, and they're going think I'm attractive and interesting. I'm a center of attention.' It wasn't built on the idea that they're professionals, they're trained, and they know about their field. . . . Instead it was built on this idea of handouts, large or small, and I think we have to get away from that.
"Part of it is not vilifying [industry]. We've got to send positive messaging about the professionals that exist within industry. There are bad apples--there are bad apples in academics and bad apples everywhere--but by and large, industry is full of people who are trying to make the world better, and I don't think that is widely appreciated."
All of this 'sunshine' is good because if you're embarrassed by the relationship you have with industry, you shouldn't be having it.
Medtronic senior vice president for medicine and technology, Dr Steve Osterle, suggested that it's probably easier for hierarchical organizations such as medical-device manufacturers to change their culture with respect to relationships with doctors, but that it will be harder for the medical community to change its collective attitude toward industry handouts in the way that Krumholz suggested. But, Krumholz countered that the culture of medicine can and does change. "I don't see many doctors smoking anymore. . . . We created that change in the culture."
Popp primarily blamed physicians for creating this handout culture and argued the onus is on them to change it. "It's rare for physicians to have to worry about where the next meal is coming from, and the reason that industry has traditionally bought pizza for the luncheons and such is that doctors accepted it and wanted it, even though they can buy their own pizza," he said. "All of this 'sunshine' is good, because if you're embarrassed by the relationship you have with industry, you shouldn't be having it."
Osterle reiterated the oft-repeated argument from the device industry that, too often, politicians, regulators, and the public conflate them with the pharmaceutical industry and do not understand that device "sales reps" are often essential service personnel who help physicians get the most out of very complex devices or learn to use new devices.
Zuckerman suggested that industry could help the professional societies develop guidelines that may restrict the customer base for a particular product and that, in the end, will lead to better outcomes overall with that product, which is in the company's long-term interest, he said.
"Why do you want to sell your product to somebody who does just five implants per year, such that it's really questionable who is doing the procedure and you know that in this day and age of internet speed and other media tactics that it's not going to help your corporation or corporate [brand]?" Zuckerman asked.
Osterle replied: "The societies have tried to take this on and tried to set standards for case load, and invariably the physicians and hospitals fought this bitterly. I don't think that industry can get in the business of privileging. We still live in a highly Republican environment around the United States, where it's 'states' rights to the max.' Most hospitals wouldn't tolerate us being involved with privileging."
Many companies do set minimum training and credentialing thresholds for buyers of its products, but "once people are trained and privileged, I'm not sure that industry can really regulate the use of these devices," he said.
Zuckerman countered that industry can still do more to "get operators up on the operating device learning curve [and to] disseminate important complicated new technology in a safe manner to duplicate the [results of the] so-called highly selective pivotal trial. Yes, you don't have the wherewithal to do everything here, but a different philosophy and tone and professionalism that you embody can go a long way."
Past president and chair of the interventional cardiology committee for the Society for Cardiac Angioplasty and Interventions, Dr Michael Cowley (Medical College of Virginia, Richmond), said, "The societies are very cognizant of the need for high-quality care and training and credentialing, either individually or jointly, and have come out with training and credentialing." He added that he is confident that the manufacturers are not trying to sell their devices to low-volume operators who cannot achieve good outcomes and that often industry-sponsored education is critical to helping the low-volume operators become skilled, high-volume operators.
But professional society involvement in training and credentialing has its own hurdles--for example, the creation of guidelines and credentialing rules are also fraught with conflict-of-interest issues, as Popp pointed out. "We try to put people in the committees who have lots of expertise, so we can't avoid that some of them are conflicted, because they are accepting some finances from industry," he said. Experts without such conflicts of interest are also placed on the committees, which helps make the guidelines as objective as possible, he added.
Dr Robert Harrington (Duke University, Durham, NC) pointed out that the American College of Cardiology and American Heart Association rules state that at least half of the members plus the chair of any guidelines-writing committee must have no relevant relationships with industry.
"We need to have expertise, and so we recognize that it's not going to be 100% . . . but we want to make sure that there's independent oversight of the recommendations that are coming out. Frankly, this has been a very difficult thing to implement over the course of the past year, but ultimately it will be the right thing to do . . . and when it gets to the next phase of peer review, then we can really open it up to all stakeholders. . . . I think the college and the heart associations have done a very good job of that."
Cowley called rules like the one explained by Harrington "a model" for how to maintain a balance between independence and expertise in guidelines creation.
Zuckerman, however, hinted that it's possible to aim even higher, rejecting the notion that guidelines or FDA advisory committees can't be created without including "conflicted" members.
"The good news is that there are expert people out there who are not conflicted and we have an impartial panel process. I don't think that's the great limiting step."
Heartwire from Medscape © 2010 Medscape, LLC
Cite this: Let the Sunshine in: TCT Docs Debate Purifying Physician Relationships With Industry - Medscape - Oct 04, 2010.