I have nothing to disclose.
That is the first line on my second slide in just about every talk I give. I have no financial conflicts of interest. I no longer accept meals from pharmaceutical companies, I no longer conduct pharmaceutical company sponsored research, and I no longer give talks that include honoraria from pharmaceutical companies. I turn down payments from pharmaceutical companies when I participate in drug-monitoring safety boards and advisory committees. I do not have a financial conflict of interest.
Or do I?
Dr. Matt Kalaycio
In preparing to write this essay, I searched the Open Payments website (www.cms.gov/OpenPayments/index.html) for my name. Open Payments is the product of the Physician Payments Sunshine Act passed in 2010 as part of the Affordable Care Act. The website went live in September 2014 with the intention of making public all payments made to physicians from device and drug makers. I was happy to confirm that I have received no “General Payments,” which are payments for meals, travel, honoraria, consulting, and the like. However, I was surprised to learn that I did receive “Associated Research” payments. According to the website, an Associated Research payment is “funding for a research project or study where the physician is named as a principal investigator.”
I still have a few trials open under my name, but none have accrued a patient in more than 7 years. Nonetheless, I am on record, and publicly so, for accepting an Associated payment for research to the tune of $1,308,360.06.
Upon learning this, my thoughts turned to the New York Times. The Times recently published an expose in cooperation with ProPublica. In it, a prominent cancer researcher at Memorial Sloan Kettering was accused of repeatedly failing to disclose his substantial financial conflicts of interest. The payments creating the conflict were listed on the Open Payments website. Since financial disclosure is almost always required for a manuscript listed in PubMed, a simple comparison of two public websites provided the journalists with nearly all the information they needed to conclude malfeasance in disclosure.
In response, the accused admitted the failure to disclose, but attributed it to an unintentional error. In the frenzy that followed, a man of towering stature, a paragon of cancer research, submitted his resignation. The sequence of events was tragic. Had the payments been for research instead of services rendered would the consequences have been the same?
Most of us believe corporate payments for research are less likely to influence our prescribing and consulting habits than are general payments for entertainment and speaking engagements. I remember receiving my first research grant from the now defunct pharma company Immunex. It was for $10,000 – a paltry sum – but enough for me to set up a clinical trial using Immunex’s drugs. I was flattered, indebted, and conflicted from that point forward. Funded research propels our careers forward. Thinking research payments bias our decision making less than direct payments is naive. Money corrupts, and that is why research dollars need to be disclosed whenever we discuss research at the podium or in print.
With appropriate indignation, I explored the Open Payments website to learn more of my hitherto unknown payment. It was attached to a multicenter, randomized clinical trial for which I served as local principal investigator. The payment was made in January 2017 and our research team cannot verify such a payment was ever received. According to the website, the payment was not disputed. I sought to dispute it.
Our friends at the Centers for Medicare and Medicaid Services do not make filing a dispute easy. I first had to register with my home address and create a new password that, of course, needs to be changed every 60 days. I duly registered and logged into the website as instructed. I followed instructions and filled in data fields for about an additional 10 pages before being informed that I needed to logout, then log back in, to access the Open Payments application. When I did that, I was greeted with instructions to register in the Open Payments system. I then realized that all I had done to that point was register with the CMS.gov portal, not Open Payments. In for a dime, in for a dollar, I registered with Open Payments.
I almost gave up when they asked me to provide a Physician Taxonomy Code. It took me a long time to find it. For those interested, the code for Hematology is 207RH0000X. With that code entered in the right box, I was only two pages away from being registered and ready to open the dispute. Failure hit me like a lake effect snow storm. Despite my diligence, I was not “vetted” and could not file a dispute. I must have done something wrong and cannot seem to investigate the payment further, but I’m sure the New York Times could.
Now, I don’t know if I have anything to disclose or not. I do know that I have to investigate my payment the best I can, that I have to disclose it if it is real, and that I have to check Open Payments every so often to make sure I am not surprised by an investigative journalist’s report in the future. Add these to the pantheon of onerous requirements for a successful academic career.
Many wear their entanglements as a badge of honor on slides highlighting a long list of conflicts. One speaker joked that she had so many conflicts that she had no conflicts. Clearly, much like alarm fatigue, the constant display of financial conflict of interest disclosures rarely raises red flags in an audience of peers. To an audience of interested lay persons, though, those conflicts may be very important and relevant.
It is our duty to accurately account for and report them no matter the difficulty in doing so. Failure to do so can carry tragic consequences.
Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at kalaycm@ccf.org.