We have the evidence that change is needed, says Paul D Thacker
Last month the New York Times reported that José Baselga, the chief medical officer at Memorial Sloan Kettering Cancer Center, had failed to disclose millions of dollars in payments from drug and healthcare companies. The story was not terribly complex to report. Accessing payments made to Baselga found on the Open Payments database and in corporate filings, the reporters then checked to see if these monies had been disclosed in his research articles. In many cases, they had not.
Within a week, Baselga had resigned. Meanwhile, the New York Times continues to uncover further conflicts of interest at Sloan Kettering. Last weekend they reported that some of the nonprofit cancer center’s board members and executives were found to have lucrative ties with for-profit companies.
None of this is surprising. I spent three and a half years working for Senator Charles Grassley on the Senate Finance Committee tasked with investigating corruption in science and healthcare. This effort helped lead to the passing of the Physician Payments Sunshine Act and the creation of the Open Payments website, which made the New York Times’s investigation possible. Over time, we discovered that financial conflicts of interest affected every aspect of biomedicine—including federal agencies, medical journals, and universities. Whenever we called someone from any of these groups into our office to explain themselves, their stories had a common theme: “We’ve done nothing wrong; and we’re not doing it anymore.”
We knew that a website that disclosed company payments to physicians would allow public interest groups and journalists to expose more of the financial links that we had begun uncovering. Unfortunately, what hasn’t changed with the passing of the act is the response that greets these investigations.
Sure enough, when the New York Times story broke, criticisms of the story began appearing on industry friendly websites, downplaying the significance of financial conflicts of interest. These claims are familiar because they were thrown at us during our investigations, and have been bandied about since the early 1980s when critics first began expressing concerns about corporate influence on science and medicine.
A common strategy to downplay unreported industry ties is to pose the question, “Is it wrong for academics to collaborate with industry?” The answer is quite obviously “no” and this was not the intention of the Sunshine Act. We pushed for greater disclosure of corporate payments to physicians because they are the nexus of various entities in modern medicine. Physicians write prescriptions, implant medical devices, author studies, and sit on critical government panels. We never intended to eliminate all interactions with industry; we merely wanted to shine a light on financial interests and hopefully curb some bad behavior. Nonetheless, this strawman is still a common counterargument, which is used by industry defenders attempting to imply that critics are being unfair and trying to stop all industry and academic interactions.
A related diversion is to hint or state that unreported financial ties are irrelevant because critics have no evidence that funding biased a study’s results. This argument overlooks the mountain of evidence on funding bias. A Cochrane review found that funding is a known bias that should be assessed. Yet how can we assess for bias created by industry sponsorship if the funding is hidden?
Another distraction is claiming that just because a study has undisclosed industry funding, this does not prove that any patients were harmed. This creates an absurd level of evidence.
Another ploy is to raise the specter of “ideological” or “intellectual” conflicts of interest. I was once told a ridiculous example of this by someone who’d served on a panel to evaluate the toxicity of chemicals. She mentioned that many of her fellow panelists who claimed that the chemicals were safe had financial ties to chemical companies. One of these panelists countered by noting that, because she was a mother and a research pediatrician, she was also conflicted: she was biased in favor of children.
The theory that “intellectual” bias skews science was dismissed back in 2009 by the National Academies report on conflicts of interest and has also been rejected by experts in other peer reviewed publications. Still, when research scandals appear in the media you will find “ideological conflicts of interest” shambling through discussions and social media like a zombie, shot through the head, yet back from the grave.
We have decades of peer reviewed research on conflicts of interest. However, pundits and reporters who would feel unqualified to opine on treatment for cardiovascular disease, diabetes, or brain surgery feel entitled to lecture about financial conflicts of interest.
My Senate colleagues and I were aware that the passing of the Sunshine Act was not going to fix everything in medicine—the problems were too entrenched. Yet going forward, there are three potential solutions to fix ongoing problems with financial influence that should be considered.
Firstly, policies on conflicts of interest vary among institutions, journals, and professional societies. This creates honest confusion about which financial relationships need to be disclosed and for how far back in the past or in the future. Experts on financial conflicts should be consulted to create one disclosure form that can be used by researchers to comply with transparency policies at their institution, science journals, or when giving lectures at conferences. Current practices are simply too confusing.
Secondly, when someone is caught not disclosing their financial ties they rarely face disciplinary action. Yet a leading researcher on conflicts of interest has stated that evidence in the field is sufficient to begin treating undisclosed corporate ties as a type of research misconduct. Research misconduct is currently defined by fabrication, falsification, or plagiarism. Government bodies should consider adding unreported financial ties to this definition.
Finally, disclosing financial ties might be insufficient, and one expert has argued that it distracts us from managing and limiting industry interactions to ensure trust in medicine. During many interviews, Senator Grassley stated that if the evidence accumulates that financial ties are harming the practice of medicine, then transparency might not be enough. As evidence continues to accumulate, we may need to look at whether some of these affiliations between doctors and companies should be limited.
All these ideas are worth considering, but first we must change the rhetoric around this matter, and lay distracting zombie arguments to rest. We have the evidence that change is needed, and the time is now to act.
Paul D Thacker is a freelance journalist.
Competing interests: I have read and understood BMJ policy on declaration of interests and note that I am paid to write for various media outlets, consult part time for a nonprofit research institute that studies brain disorders, and have had universities provide expenses for talks on corruption in science and medicine. I drafted and then helped to pass the Physician Payments Sunshine Act, while working in Congress.