What You Should Know About the Resignation of a Leading Cancer Doctor
Last weekend, the New York Times and ProPublica jointly released a story showing that Dr. José Baselga, a top cancer researcher, journal editor, and chief medical officer at Memorial Sloan Kettering Cancer Center failed to disclose millions of dollars of income from businesses closely tied to his research. It’s completely legal for him, and any other doctor, to take this money. In fact, you can look up any physician in the Open Payments Database, which tracks how much money drug and device companies have paid out. Last night, ProPublica announced that Baselga had resigned his position after less than a week of criticism.
When it comes to doctors taking money, transparency wasn’t always so easy. In 2010, the bipartisan-initiated Physician Payments Sunshine Act was passed as part of the Affordable Care Act, but it wasn’t until 2013 that the federal government mandated that all health care programs report financial relationships. Since then, the site has made over $8.4 billion of payments visible to the public.
Dr. Baselga only accounts for about $3.5 million of that, but his failure to disclose it, even in cases when all of his co-authors disclosed their financial data, is mind-boggling at best. Part of it likely has to do with the relatively low stakes of not disclosing one’s data — journals don’t really have the manpower to look into the financial disclosure statements they send authors or put in place (or enforce) penalties for omission (though it looks like some are going to start after this very public debacle). Baselga said he would go back and add the information to the online versions of 17 articles, but not for dozens of others that he personally feels were not affected (the authors report that last year alone he failed to disclose any financial ties in 87 percent of the articles that he wrote or co-wrote). As of Thursday, he had at least sent amendments for his articles in the New England Journal of Medicine, but was subject to further questions by the editors. He could potentially put his co-authors’ work in jeopardy if journals retract his articles.
It’s not a good look for a high-profile researcher. While his employers at Sloan Kettering came to his defense, stating that they were not only fully informed of his alternate income but that major research centers depend on these sorts of payments from industry, it leaves the rest of us wondering just what that money pays for. There are plenty of recent examples showing that high-profile researchers have hidden or embellished research results or participated in dishonest marketing after receiving a payout from a major pharmaceutical company. We don’t know what role the administration at Sloan Kettering played in his decision to resign, but ProPublica reported that the week had been full of emergency meetings to mitigate the damage to the facility’s reputation.
Now that ProPublica has started digging, we may get more information on his finances, since he also has a financial stake in some start-up companies. As the New York Times reports, “Companies that have not received approval from the Food and Drug Administration for their products — projects still in the testing phases — do not have to report payments they make to doctors.”
Baselga’s defense boils down to an assertion that he is a good guy and careful researcher who cares about cancer patients and the future of research. This could all be true, but the fact that he had any say in which companies get to conduct trials at Sloan-Kettering puts not only his but the entire Center’s research agenda in the spotlight. And perhaps that’s where it belongs.
Don’t get me wrong, companies SHOULD pay for the expertise of top researchers; it’s worth a lot of money to them. One might imagine that instituting a system where ethicists examine these relationships, especially in high-stakes situations (such as undertaking potentially life-saving research, even in its earliest stages) would be a good idea. Sloan-Kettering insists it “has a rigorous and comprehensive compliance program in place to promote honesty and objectivity in scientific research.” Clearly that needs some work. It also doesn’t help that there’s constant complaining from academics and researchers that bureaucratic infrastructure, like ethics boards, is expensive and inconvenient, and there are frequent calls for them to be disbanded or decentralized (with responsibility for policing given right back to the people who need to be policed).
Before you freak out and swear off the modern medical system, it’s important to know that a payout doesn’t necessarily mean there’s a conflict of interest. Once you’ve seen that your own doctor received a couple of hundred dollars from a major pharmaceutical company (probably in the form of a steak dinner or something), you realize that’s just part of how the system works. The Institute of Medicine (IOM) defines a 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.” But money can certainly create that set of circumstances, and the lack of care taken by Baselga in simply covering his bases leaves him wide open to suspicion.
Bias enters science at every step of the process, even the earliest steps that Baselga insists don’t warrant disclosure. Simply building an experimental design can be tainted by money, career advancement, and the need to see research succeed. We interpret evidence and eliminate outliers based on what we want to see. Bias can be totally subconscious, which is why good science relies on blind peer review to keep it honest. But how can we expect that process to work if people don’t disclose things that might get in the way of their objectivity? I would argue that not only is Baselga’s own research potentially in question, but any research he helped review as well. Failing to fill out the paperwork, if that’s all it truly comes down to in this case, now entangles more researchers. Avoiding this kind of mess is why we put that professional obligation in place.
In the immediate wake of the allegations, Sloan Kettering has sent an e-mail around to their staff insisting that they do a better job disclosing their financial interests. Ironically, the message came from its chief executive, Dr. Craig B. Thompson, who settled with the University of Pennsylvania in 2012 after absconding with research from his lab to start a biotech company he did not disclose ties to. It remains to be seen how much damage has been done, how much research will be retracted, how many careers will end, or if anyone will have grounds for a lawsuit, but it’s yet another high-profile case that will hopefully force medical professionals, grantmakers, and journals to take disclosure more seriously.