Opinion | Are Conflicts of Interest Disclosures Meaningful?

Like it or not, it is routine for physicians to have financial relationships with companies that seek to market drugs, devices, or other products to the public. According to CMS Open Payments, in 2019, payments of $10.03 billion dollars were made in 6.4 million transactions to 614,910 physicians and 1,196 teaching hospitals. Therefore, of 985,000 licensed physicians in the U.S., over 60% receive money from at least one company in a calendar year. In some subspecialties (e.g., oncology, urology, and orthopedic surgery), the proportion of physicians with financial ties to industry approaches 80%. The vast majority of these payments are for trivial amounts, whereas others are quite substantial.

Some may believe that every financial relationship between physicians and industry is based on a nefarious motive. A few have concluded that money has directly “fueled” a rise in prescriptions, but little evidence exists for a causal relationship. For many physicians, industry interactions are an irrelevancy, i.e., the cost of a meal is attributed to them because they attended a lecture during which food was served but may not have been eaten. For others, industry interactions are essential to their career goals of developing new treatments for a specific disease. Physicians who seek to lead innovation cannot reasonably be expected to avoid monetary ties. No one is inclined to spend hundreds or thousands of hours providing their expertise or performing research activities pro bono. The drug and device industry develops most novel treatments for human disease; in recent years, other sources of financial support for clinical trials (e.g., the NIH) have dried up.

Are certain physician-industry relationships predicated on the desire of a company to inappropriately influence the use of a product by physicians? Sadly, the answer is yes. Such relationships are both unethical and illegal. Yet, the true nature of many unscrupulous arrangements will likely never be publicly known.

Our current system does not try to distinguish between ethical and unethical relationships. Instead, its core principle is transparency. If a financial interaction has taken place, the physician should disclose its existence. Typically, this takes the form of a “conflict of interest disclosure.” Such disclosures are now routine for those making presentations at educational or scientific meetings and publishing papers in the medical literature; it is also required in many employment agreements.

How do physicians respond to this need for disclosure? Sadly, some try to obscure these relationships, often in ways that are indisputably foolish. Here are a few examples:

1. Most medical conferences require presenters to show their “disclosures” on a slide shown immediately after the title slide. Most presenters usually race through the “disclosures” slide in a fraction of a second, ensuring no one in the audience is able to read it. Some presenters further obscure their disclosures by showing the text in a color barely distinguishable from the background. Whether presented as part of a meeting or a manuscript, no one checks whether any of the information is complete or valid.
2. Paradoxically, some physicians try to exaggerate their conflicts. Memorably, one physician with no relationships within the prior 3 years believed the sparseness of disclosures reflected poorly on his stature in the field. And so, he reported relationships that had ended 5-8 years previously, so his involvements did not seem so puny compared to others.
3. Some physicians seem ignorant of the meaning of a conflict of interest. In my role as the corresponding author for certain papers, I have been responsible for collecting the disclosure forms of all co-authors. It was well known that every author had received payments from the company who sponsored the clinical trial, and yet, many co-authors simply claimed “no conflict of interest” on the form. The forms were revised when I called attention to the error.
4. Some physicians mistakenly believe that conflict of interest disclosures represent a list of biases, rather than financial relationships — interpreting income as an admission that their work is “tainted.” Accordingly, since they do not consider the work to be tainted, they think they can claim “no relevant conflict” exists. But disclosures are intended to provide transparency; they do not make judgments about relevance or influence.
5. The time frames for disclosure vary enormously, ranging from the prior 12 months, 24 months, or 36 months. These differences inevitably lead to major differences in the substance of disclosure statements over a very short time period. To complicate matters further, most organizations do not require physicians to state whether the relationships have ended or are ongoing.
6. For many physicians, industry may provide large sums of money to their research programs. The funds are essential for the support staff, equipment, supplies, and space. If the company were to stop paying the funds, the physician’s career would be adversely impacted to a very significant degree. Yet, physicians may or may not disclose these relationships.
7. Many continuing medical education programs receive direct grants from the drug and device industry. Although labeled as “unrestricted,” these funds are often provided with the tacit understanding that the CME organizers will invite speakers who will talk kindly about a sponsor’s product. Interestingly, the opposite may also occur. Recently, a drug company that did not want me to make a presentation at a conference withdrew funding when it learned that I was scheduled to be a speaker on the program.
8. Some physicians earn significant sums of money from industry interactions they may not deem to be reportable, e.g., fees earned as an expert witness or a litigation expert in a legal matter involving industry. Amazingly, some physicians erroneously believe they are not obligated to disclose income if they are testifying against a drug company, forgetting they are still being handsomely incentivized for offering their opinions about an industry product in a public forum.

Many observers believe it is possible to validly compare a physician’s disclosures to the listing of fees reported in the CMS Open Payments database, which was developed following the enactment of the 2010 Physician Payment Sunshine Act. In fact, many employers warn physicians that such comparisons will be made and discrepancies may be used for the basis of disciplinary action. But the information reported in Open Payments is often not well aligned with a physician’s disclosures — for many good reasons.

1. Information on Open Payments is provided only for U.S. physicians and only by companies that manufacture a drug, device, or biological or medical supply covered by a governmental insurance program. That means no information is provided for payments to any U.S. physician from companies that have not yet commercialized a product. Research ties between industry and faculty with a PhD degree (but not an MD) and payments from law firms are not reported under Open Payments.
2. Open Payments makes note of payments based on the date on which the monies were paid but not based on when the work was done. For a variety of reasons, monies reported in any given year may have been earned across several prior years.
3. Companies do not report payments on the Open Payments platform in a consistent manner. Many conflate research payments with general payments. Fees earned for clinical trial activities, patents, or royalties are not reliably distinguished from income received from promotional activities.
4. If physicians and companies are motivated to hide payments, there are countless ways of doing so through third-party intermediaries.

What can physicians do to honestly fulfill their obligations? I have developed a few personal principles that I follow. But these principles should not be construed as advice to anyone else.

1. For my scientific presentations, I place my disclosures on my title slide (rather than on a ghost-like second slide), since my title slide is the one most likely to be seen by the audience for the longest period of time.
2. I describe relationships that have taken place for the prior 3 years, regardless of the specific timeframe requirements of the sponsoring organization. That ensures some degree of consistency in my disclosures.
3. Whenever appropriate, my disclosures statement describes potentially relevant relationships that no longer exist. I have led clinical trials for companies that have developed neprilysin inhibitors and SGLT2 inhibitors for heart failure. These financial relationships routinely end when the trials have been completed, since I was compensated for my time and effort and not for my advocacy. My disclosures statement reflects that information.
4. I do not give promotional presentations that are sponsored by industry.
5. Since I am no longer in clinical practice, I do not prescribe any drug manufactured by a company with whom I have a financial relationship.
6. When I report my disclosures to my own institution, I often report them twice, once at the time the work was done and once at the time the invoices were paid. It is better for a relationship to be reported several times than for someone to be tempted to make the accusation that it was not reported at all.

Above all, physicians should realize that transparency is not your enemy. For the last 36 years, I have been a Special Government Employee (SGE) to the FDA. If an SGE failed to report a financial relationship accurately, this mistake was punishable as a felony under federal law. So SGEs had a vested interest in ensuring reported information was accurate and complete.

Every physician needs to develop and follow a philosophy consistent with their personal, ethical, and legal responsibilities.

Some people may have hoped “conflict of interest disclosures” and Open Payments reporting would discourage physician interactions with industry. A few might even have expected that disclosures and payment reporting would reveal nefarious influences of industry over physicians. But it was never the intent or capacity of these disclosures to achieve either goal.

When the system works as intended, disclosure of physician-industry financial relationship is neither the problem nor the solution to our current challenges in healthcare. As a society, physicians and industry need to learn to work together vigorously, ethically, and transparently. If we fail to do so, the advancement of medicine will stall, our patients will suffer, and no dose of sunshine will save them.