Time to Blow the Whistle on Proponents of Restrictive Conflict of Interest Rules in Medicine

Over the past several years, academic medical centers, professional medical organizations,industry trade groups, and federal agencies have transformed the way their institutions handle “conflicts of interest.” 

Medical schools such as Harvard, Michigan, and Yale, hospitals such as Partners, and the National Institutes of Health (NIH), have all proposed or changed their policies regarding what outside financial activities and interest’s faculty and staff can have.  Industry has also taken significant steps to address potential conflicts of interest in medicine and research through the PhRMA and AdvaMed Code of Ethics, and the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support.

In addition to these changes, the news media have fueled controversy and concern about physician-industry relationships and research, mostly stemming from leaked documents from product liability, plaintiff litigation.

This “un-perfect storm” has created an environment in the medical community that stigmatizes working with industry.  Instead of being proud of the collaboration and innovation that physician-academia-industry relationships provide, more health care practitioners are seeing their names published in local media. And for what?  Educating other doctors and providing services that will progress medicine.

As David William Rattner, MD recently noted, “it’s time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry.”  His commentary was drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting.

Dr. Rattner, chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston, asserted that, “the insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care.”

Conflicts of Interest

The Institute of Medicine (IOM) defines a professional conflict of interest as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Drivers of bias may be financial, academic, professional status, or personal.”

As Dr. Rattner pointed out, many doctors find themselves conflicted professionally when they participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor’s work. He noted how in these situations, physicians are asked to use their judgment and place the interest of what they are trying to do above their own personal interests. “Physicians are never asked to disclose these other kinds of conflicts, and it’s extremely rare that they are asked to excuse themselves from the process.”

He explained that, “one of the greatest conflicts of interest physicians have is the way in which they are reimbursed – whether by capitation or fee for service.”  What is in a physician’s personal best interest may not line up with what is best for their patients, but this is not something a physician discloses.

“So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively?”

The Impact of COI Rules

Dr. Rattner noted that he has been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years and is also a former president of SAGES.  He asserted that if the conflict-of-interest rules currently being forced on physicians had existed in the 1990s or the early part of the past decade, SAGES would not be what it is today.

When he joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. The leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them. Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass.

He note that, to the best of his knowledge, “no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that patients will benefit.”

Similarly, Dr. Rattner recognized that the most minimally invasive surgery fellowships wouldn’t happen without industry support. Obviously, the companies do derive benefits, but he asserted that, “the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques.”

Accordingly, Dr. Rattner noted that, “if future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.”

With respect to research, Dr. Rattner asserted that, “the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous.” While companies want to be successful, “doing so at the expense of patient health and safety would simply be bad business.”

He noted that, “the financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it.” Additionally, Dr. Rattner explained how drug and device companies anticipate the rigors of the Food and Drug Administration (FDA) review that is required before their products are brought to market and if fraud is discovered or a patient harmed, the consequences can put the company out of business.

Conclusion

The benefits of physician-industry collaboration are remarkable.  As Dr. Rattner pointed out, “investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly.” And what the public must realize is that the research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors.

Consequently, “before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities.”  The bottom line “is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.”

Accordingly, Dr. Rattner asserted that, “the onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.”

There is no question that “financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.”

If we continue down the path of overly restrictive conflict-of-interest policies, patients will lose access to life saving medicines and treatments and future generations of physicians will not benefit from the innovations and advances physician-industry relationships provide. As a result, institutions, academic medical centers, professional societies, and federal agencies need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.