The recent revelation that a leading official at Memorial Sloan Kettering Cancer Center failed for years to disclose lucrative financial conflicts of interest might have been surprising in its scale. But it’s old news that many researchers aren’t fully transparent when it comes to their financial relationships with industry.
So why should we keep up the charade? And why, given the clarity of the problem, do medical journals continue to take authors at their word — only to wind up looking like dupes?
According to an investigation by ProPublica and The New York Times, Dr. José Baselga — who was chief medical officer of the venerable cancer clinic until resigning Thursday — has what can charitably be described as an inconsistent personal policy on revealing companies that have given him cash or other potentially lucrative fillips. Baselga also has stayed mum about his conflicts of interest — which also involve research funding and seats on advisory boards — in many of his publications, including those in high-rent titles like the New England Journal of Medicine, and despite policies from the journals demanding that authors reveal such relationships.
To be fair, some of the reason we know that Baselga wasn’t fessing up was because some journals — including the NEJM — publish conflict-of-interest disclosure forms that authors submit. That’s not a uniform practice; the Journal of the American Medical Association doesn’t, and in at least one case declined to release the form when pressed by a reporter.
Journals that don’t publish such forms are telling readers that the only judgment of whether a conflict is relevant is theirs. They’re also leaving it unclear whether — when a conflict such as Baselga’s is found — it was the author who didn’t declare it, or the journal that didn’t find it important enough to mention.
So as a first step, journals should publish those forms. Second, just as nearly every publisher now screens submissions for evidence of plagiarism, it’s time the journals do the same for conflicts of interest.
Journals already have some of the tools they need to look for conflicts. A 2010 law, the Physician Payments Sunshine Act, established a government database called Open Payments to disclose industry payments to physicians. Dollars for Docs, from ProPublica, also tracks these ties. However, neither database, as Matthew Herper at Forbes has noted, catches participation on corporate boards or work on drugs or devices that the Food and Drug Administration hasn’t yet approved. Nor do they include patents for relevant discoveries, which a comprehensive repository should house.
The Baselga affair and others illustrate how flawed the system is, but even when journals do learn of undisclosed conflicts of interest, they tend to respond weakly. Although the Committee on Publication Ethics says failure to disclose a major conflict of interest can be grounds for retraction, journals almost always choose to issue corrections instead. At the time of this writing, our database of retractions shows 114 removals of papers for undeclared conflicts of interest, less than 1 percent of the more than 18,000 total retractions, and most of those include other reasons without which the article more than likely wouldn’t have been retracted. That sends the message to authors and readers alike that journals don’t take these issues seriously.
It seems clear, then, that it is time to take this responsibility away from journals, or at least add another layer. What’s needed is a single pool of conflicts data — one that captures cash payments, patents, stock holdings, board seats (both corporate and foundations), funding sources for research — against which editors can screen authors. Given that unscrupulous or indifferent authors are likely to omit potential conflicts, the burden of tracking them on an individual level must be as automated as possible. The names of authors would be linked to their entries in the database, so any reader could click and judge what’s relevant and what isn’t.
We note that this will not be a simple task, and would probably be best tried as a pilot program first, in a small area of research, with some government or foundation funding. The system also needs some sticks. Journals could let authors know that if they find out about relevant conflicts later, they won’t publish work by that author until the database is complete. A version of that approach has worked when it comes to pre-registration of clinical trials, although it took an act of Congress to really cement that incentive — and as STAT has shown, sharing data itself on that platform isn’t quite there yet.
Of course, and this point is critical, a disclosed — or even an undisclosed — potential conflict of interest does not necessarily mean that a study, guideline, or bit of clinical advice is unreliable. Indeed, scientists often are highly sought after by industry because they have a reputation for integrity, fairness, and expertise in their field. Yet evidence shows that physicians who take money from industry are more likely to prescribe brand-name (and therefore more expensive, generally) medications. And, as ProPublica found, the more money, the greater the effect on prescribing habits.
But as the ethicist Art Caplan of New York University tweeted in response to the Baselga news: “We have yet to figure out what [conflict of interest] means or how to manage it in a health care world where industry ties are everywhere.” The trick, to paraphrase Bruce Springsteen, is not to be blind to those ties that bind.
I’ll keep it simple. Those who deceive providers must remember, they too, may be a patient one day. And their provider may be using (at the minimum), useless information. No one is exempt from disease.
Ethics folks….keep it simple.
Conflicts of interest also include workforce reports by MD DO NP and PA programs, schools, and associations. These claim to be able to resolve shortage areas. The financial design prevents any training intervention (expansion, special training) from resolving deficits of workforce.
Too few dollars go into generalist and general specialty services which are 90% of local in-county services where 40 – 50% of Americans reside. Deficits of primary care, mental health, women’s health, and basic surgical workforce are the result of designs that support only half enough physicians, clinicians, and team members.
Research is supposed to rule out alternative hypotheses. This plays out in two main areas – workforce deficits and outcome measures.
Expansions of MD at 6 times the population growth rate, 8 times for DO and PA, and 12 times for NP annual graduates has not resolved deficits.
Special training can boost the proportions of basic specialties, rural location, or low workforce concentration result from the program or school – but this only rearranges the deck chairs as success for one only displaces other MD DO NP and PA. This is what happens when infinite expansion attempts to resolve finite health care dollars.
Even worse, HITECH to MACRA to PCMH have taken billions more that primary care practices must pay just in the last 10 years. This is seen in 2621 counties lowest in MD DO NP and PA concentrations where 38 billion was once available for primary care delivery but 8 billion now goes for digitalization, regulation, and innovation. This adds to the problem of 15% lower payment for services, 5 to 10% lower collections, and most costly turnover at $100,000 per physician FTE per year. The financial design is the problem and it is broken utterly – as long as others can claim that they can fix it outside of addressing the financial design.
There can also be no coordination, integration, or outreach improvement as claimed for primary care until the basic deficits are addressed in physicians, clinicians, and team members in places with half of the US population.
The Dean’s Lie is a recognized entity where Deans claim primary care result yet the truth is that few enter and few remain.
Even worse, the truth is that we have runaway workforce proliferation will worsen the financial design with increased turnover, increased abuses of MD DO NP and PA graduates, increased new graduate debts, and worsening ability to resolve their debts.
Schools, programs, deans, and workforce researchers must be held accountable for the serious and worsening situation. By 2040 over half of the US population will have half enough local generalists and general specialties in 2661 counties lowest in workforce concentrations. This will be the result of failure in awareness, misguided workforce research, the financial design, and the housing design shifted steadily more of the population from higher to lowest concentration counties as they can no longer afford or find housing. These will be the most financially and medically vulnerable adding to disparities that already exist in social and other determinants of health, in health care workforce distribution, in health care dollars spent locally, and in health access.
The only available information on conflicts of interest are deliberately deceptive. They made it appear to be the factual when it really obscured significant financial ties. This deception has had a deadly and severe impact on Americana public health. In essence we are all being Gas Lighted, not only by the limited information, but by the failure of the industry to take this seriously, publish misleading, incomplete or deceptive papers that have a negative effect on people lives. We are in Post Truth America, where it is easy to lie, mislead and deceive while dangerous ideas get amplified by media, or used to market dangerous drugs, procedures, and devices. We really need a reckoning, especially since Americans are dying, experiencing dire financial consequences, and are not even allowed to know the facts.
Before I start reading a research paper, I usually look for a disclosure statement and sometimes check with Dollars for Docs and Open Payments. However, I heard that researchers and medical doctors have threatened lawsuits to keep their info private. Many of them work in multiple countries, so the scope of the problem is global and not limited to the US. It’s also a major scam that institutions rake in tons of cash and other rewards that aren’t credited to their individual personnel. There’s too much sleight of hand going on to keep track of all the corporate money that goes into the medical community strictly for promotional and marketing purposes.
I believe it has to be taken for granted that researchers/scientists in a position of power are in the pockets of someone, especially if they are medical doctors.
The news would be someone that is not!