The Legitimate Relationship Between Physicians and Industry

With the amount of negative attention lately surrounding relationships between physicians and industry, some doctors have had enough. In response to the recent criticisms, Bradley P. Knight, MD, FACC, FHRS, Editor-in-Chief of the Electrophysiology Lab Digest, wrote an article defending the “Legitimate Relationships Between Physicians and Industry.”

Dr. Knight recognized that in light of the recent data being published about payments to physicians, “the reactions by the media, legislators, and some professional medical associations (PMAs) have demonized all relationships between physicians and industry.”

For example, he pointed to a proposal for controlling conflicts of interest between PMAs and their relationships with industry published last year by the Journal of the American Medical Association (JAMA). He noted how the proposal “described several underlying principles and premises, and provided some valid suggestions that most physicians would agree with the following:

The pharmaceutical and medical device industries make important contributions to medical progress.

Dr. Knight recognized that “no one in the highly technology-dependent field of electrophysiology can argue against this. The pacemakers and defibrillators we implant, the tools that we use during catheter ablation procedures, and the antiarrhythmic drugs that we prescribe have all been developed by industry. Often these devices were found to be effective through industry-sponsored clinical trials involving practicing electrophysiologists.”

Physicians should fully disclose financial relationships with industry.

As Dr. Knight pointed out, full disclosure and transparency is now widely endorsed, and will be reported in 2013 under the Sunshine Act, contained within the Affordable Care Act. He further emphasized that “resolving issues of conflict of interest is not best accomplished by avoiding all relationships.”

Physicians should not receive gifts from industry.

PhRMA, AdvaMed, medical societies, and the overwhelming majority of companies have banned gifts and created rules prohibiting such payments for several years now.

“Funds from industry (to PMAs) should be unrestricted.”

Dr. Knight acknowledged that “physicians are able to easily identify when industry support comes with strings attached.”

“Physicians and medical societies should avoid marketing industry products.”

Academic institutions and physicians who are involved in industry-sponsored educational activities have already implemented this recommendation by defining which “activities are related to product marketing and should be avoided, and which activities are supported by unrestricted industry funding and are acceptable.”

No Need for “Zero Tolerance”

Some JAMA recommendations however are not as commonsense. For instance, JAMA called for “PMAs to exclude from Professional Guideline and Scientific Session committees persons with any conflict of interest ($0 threshold) involving direct salary support, research support, or additional income from a company whose product sales could be affected by the guidelines.” Dr. Knight recognized that “restrictions on who can serve on PMA committees are unnecessary and fail to recognize that most relationships are legitimate.” JAMA asserts that such restrictions are necessary because “disclosure of industry relationships by committee members is not sufficient protection.”

However, as Dr. Knight identifies, “these zero tolerance recommendations regarding committee membership fail to differentiate two very separate types of relationships between physicians and companies: those that are real conflicts of interest and those that could be perceived.” This distinction is important because “not all relationships with industry are created equal.”

As Dr. Knight explained, a “real conflict of interest should be defined as one where the person or a member of the person’s household, has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues or content addressed by the committee.” For example, when physicians are company employees, receive direct salary support, own company stock or stock options, or receive royalties.” He noted that since in these cases “the physician has potential for future additional income based on the success of the company,” it would be appropriate and probably necessary to prohibit participation on a guideline or session committee.

In contrast, Dr. Knight recognized that “physicians who provide legitimate advice to a company, participate in industry-sponsored clinical trials, or are involved in an unrestricted industry-sponsored educational activity are not in a position to directly gain personally in the future based on the financial success of the company.” As he pointed out, these activities “are not the same as making an investment in a company.”

As a result, Dr. Knight asserted that these “activities should be encouraged, fostered, and promoted, and physicians involved in these activities should not be restricted from being involved in leadership positions and roles in medical societies.”

To Dr. Knight and many physicians who regularly work with industry and see the value in collaboration and innovation these relationships promote, “It only makes sense that physicians should continue to work directly with companies to develop better products used for patient care.” Accordingly, “it only makes sense that these physicians should be compensated for their efforts.”

Conclusion

In the end, Dr. Knight noted that by “restricting leaders in our field from participating in legitimate activities with industry only perpetuates the misperceptions in the media and by the public that all relationships between physicians and industry are illegitimate or suspect, and by those misperceptions physicians can be persuaded to deviate from the best possible medical care.”

While there may be evidence that “receiving gifts has been shown to influence physician prescribing patterns,” Dr. Knight asks, “where is the evidence that consulting for a company alters clinical decision making?” Until such evidence exists, Dr. Knight recommends that physicians who work with industry should address the “inaccurate perceptions by education and awareness.” Physicians can do this by “discouraging real conflicts of interest and being proud of the accomplishments that have been made for patients as a result of productive and honest relationships with industry.”

Ultimately, Dr. Knight wants the “public to know that if they ever have to undergo a heart rhythm procedure, there will likely be a company representative in the procedure room. This person will be there to provide inventory, optimize device programming, facilitate cardiac mapping, and provide expertise.”

More importantly, Dr. Knight wants the public to understand “that it is critical that physicians continue to work with the companies that make these devices to improve the care of patients with heart rhythm disorders.”