A few tiny steps towards transparency: how the Sunshine Act shone light on industry’s influence in medicineBMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3229 (Published 17 September 2020) Cite this as: BMJ 2020;370:m3229
About 10 years ago President Barack Obama signed the Affordable Care Act. It included a small provision—called the Physician Payments Sunshine Act—that I initially drafted and then worked on for years.
At the time, I was working as an investigator for Senator Charles Grassley on the US Senate Finance Committee. Although not stated explicitly, the power of Congress to investigate is implied in the constitution. These powers have been affirmed through the courts1 and include the ability to demand access to documents held by private companies and government, and to interrogate citizens. Senate Finance has jurisdiction over Medicare and Medicaid—federal healthcare programmes—so most of my investigations involved corruption in medicine and science.
The Sunshine Act was congressional staff’s attempt to tackle many of the unseemly financial ties between physicians and industry that we kept uncovering when we examined problems with drugs and medical devices.
The push for the bill began when I walked into my boss’s office, the Finance Committee’s chief of investigations, with a story from the New York Times. It reported on a girl who was dealing with multiple side effects caused by drugs she was prescribed off label to treat bipolar disorder. The article detailed the various tricks the industry used to get doctors to prescribe drugs, including payments for research, consulting fees, and speaking gigs.2
One of the physicians mentioned in the article was at the University of Cincinnati and had received support for research from a pharmaceutical company and was paid to give promotional talks. The physician said the payments did not influence the research or the talks and when asked how much money the company had paid, responded, “Trust me, I don’t make much.”
Staff on the committee had long known that there were problems with physicians’ ties to industry. During the Vioxx scandal we had pressed the US Food and Drug Administration to understand how they had approved the drug. We learnt that many of the physicians on the panel that approved Vioxx had ties to drug companies.
My boss had drawn a schematic map to show how all this money kept flowing from companies to various actors in healthcare: physicians, universities, medical education, professional societies, and so on. It was big and complicated. “How could we slow it down?” she asked.
I had some idea about medical ethics and physicians, and knew that doctors were expected to put patients first. They did the research, gave the promotional talks, performed the surgeries, and wrote the prescriptions—I suggested we focus on them.
We wanted to draft a law that would require companies to report monies they gave to physicians, so I ran upstairs to Senate Legislative Counsel to get a bill drafted. I then wrote a speech for Senator Grassley, who jump started the discussion by talking about all the money that was floating around in medicine and how we needed a law to make this funding more transparent.3 We introduced the bill in September 2007.4
Six months later, we received data on prescribing rates by physicians and payments to them from the drug company AstraZeneca. The allegation was that the more money AstraZeneca paid these physicians, the more company products they prescribed. We couldn’t, however, find any pattern between the payments and prescription rates. But one thing caught my eye.
AstraZeneca was the company mentioned in the New York Times article that first got my attention. I’d sent a letter to the University of Cincinnati asking to see how much money AstraZeneca had been paying the physician named in the article.
The university told me around $100 000 (£131 000; €111 000) had been declared for lectures and consulting fees. But when I looked at the payments AstraZeneca had reported it was more than double what the university had told us she had received.56
I looked this physician up in the grants database for the National Institutes of Health (NIH) and saw that she was receiving federal grants. The NIH required institutions to manage a grantee’s conflicts of interest. But if the University of Cincinnati didn’t even know about all this extra money, then how could they manage the conflict? They couldn’t.
As the saying goes in Washington, “With federal money, comes federal scrutiny.” The federal money was our hook. We sent a second letter to the University of Cincinnati asking them to explain the payments discrepancy. I sent an accompanying letter to the NIH asking them how they were managing the physician’s grants when she was under-reporting her outside income.
During this period, doctors kept turning up in the news for taking money from companies. But these mini-scandals were inevitably dismissed by the medical community as isolated incidents involving “bad apples.” In just one example, in 2006 the Wall Street Journal ran a story7 on financial ties between a medical company and a department chair at Emory University that had not been disclosed in a journal article that that physician had authored praising the company’s product. After the story appeared, several dozen physicians sent a scorching letter to the Wall Street Journal that defended the Emory physician, instead of castigating him for not disclosing. This was just one example. Our research and interviews with experts told us that hidden money was pervasive.
To get the Sunshine Act passed, I realised we would have to run a campaign pointing to multiple “bad apples” to make the case we had a “bad barrel.” After some research, I collected the names of over a dozen academic physicians who were suspected of taking hidden money from industry. I then figured out the country’s top 10 largest drug companies based on annual sales.
We then sent letters to over a dozen universities demanding they turn over the disclosure forms of the physicians we suspected were not reporting all their outside income. At the same time, we sent letters to the top pharma companies asking them to report monies they had given to these same physicians.
It was then a simple task to match up what physicians reported receiving from companies with what the companies reported paying them.
Two pronged success
In June 2008, we started rolling out the results of our investigation. The first story involved physicians at Harvard who had failed to disclose millions in outside income, followed by similar findings at Stanford.8 Further reports found problems at Emory University,6 the University of Texas,9 the University of California at Los Angeles,10 and other academic research centres. Pretty much anywhere we looked, we found hidden financial influence.
I wish I could say that the medical community rallied to our cause. But they didn’t. Websites attacked me and our investigations, and lobbyists began spreading rumours that we were Scientologists—a group that opposes psychiatry. At one point, I had to file a report with the Federal Bureau of Investigation when I realised that a person who called me on the telephone posing as an attorney with the Department of Justice was likely working for a private investigative firm.
But the constant pressure that we brought with each report we rolled out eventually eroded this resistance.
On several occasions, we brought the head of the NIH in to speak with Senator Grassley and explain how he was going to fix the agency’s disclosure policies. This was an important back-up. Passing a bill involves determination and skill but also a huge amount of luck. We were never certain the Sunshine Act was going to be passed, so I wanted to also force the NIH to tighten up their disclosure policies. This wouldn’t affect all physicians, but it would create greater transparency among academic doctors receiving NIH grants—those most influential in medicine.
In the end, we got both. The Sunshine Act was passed as part of healthcare reform, and the NIH instituted new regulations for grantee disclosure. Neither the bill nor the new agency disclosures were perfect, but they were both improvements on the status quo.
Today, sunshine laws on industry payments to physicians have gone global.11 Many countries have passed or considered similar laws, including Australia, Canada, France, Japan, Scotland, Slovenia, and Turkey. Still, several academics say that transparency is a false solution that provides the illusion that financial influence has been fixed. The problem is that we cannot study and tackle this influence unless we have transparent reporting of money.
This law was the response to corporate influence in medicine, a problem that physicians and journalists had been documenting for decades, causing the New England Journal of Medicine to announce the first conflict of interest policy for any major science journal in 1984. JAMA instituted similar policies the next year. The BMJ has long held strict policies, announcing a further tightening of its zero tolerance policy to editorials and education articles in 2014.12
In the opening chapter for a new book on bioethics I documented the history of corporate influence in biomedicine, finding that the National Academies of Sciences put together the first conflict of interest policy in the US in the early 1970s.13 Since that time, researchers have published hundreds of studies, creating a rich literature on conflicts of interest and corporate influence in medicine.
My concern is that we are spending too much time wringing our hands about disclosing conflicts of interest instead of tackling the well documented problem of financial influence itself.
The problems we found are present throughout science, not just medicine. Before coming to the Senate Finance Committee, I worked as a journalist covering environmental topics. I interviewed academics working in different fields who didn’t know each other, but who all told me stories about industry campaigns to undermine their research and attack their professional credibility. This included tobacco, climate change, and synthetic chemicals.
First medicine, next science
Medicine has made a start in trying to tackle the problem, but the rest of science is lagging. A recent book on corporate corruption in nutrition found only 11 studies that examined financial influence on nutrition studies, while pointing out a large number of studies into the pharmaceutical industry’s influence on medicine.14 And while NEJM and JAMA instituted reforms in the mid-1980s, the two leading science journals didn’t catch up until 1992 (Science) and 2001 (Nature).
It’s important to continue research on conflicts of interest in medicine, if only to keep reminding people of the problem. But it is also time to take what medicine has learnt in the past few decades and apply it to other areas of science, which also affect health.
Researchers have documented corporate influence skewing research in food, synthetic chemicals, risk analysis, pesticides, air pollution, genetic technology, and climate change. Unlike medicine, these areas of science do not have the same volume of peer reviewed literature documenting corporate influence on academics, journals, regulatory bodies, and research. But these scientific disciplines have an enormous impact on public health.
Further, we have not examined whether companies are engaging in the same types of behaviour in other areas of science as has been documented in medicine, because we haven’t really looked. And whereas the principle of financial conflicts of interest is readily discussed in medicine, in many cases scientists feel comfortable denying that money influences.
The New York Times published a front page story exposing a University of Florida professor’s financial ties to Monsanto.15 Instead of apologising, he sued the newspaper, a case the judge later dismissed with prejudice. On the other hand, when the New York Times published a front page story documenting a cancer researcher’s failure to disclose his financial ties to industry, the physician resigned from Memorial Sloan Kettering Cancer Center a week later.16
Physicians need to take the principles and research on conflicts of interest first established in biomedicine and use them to clean up other areas of science that impact public health. Ignoring how corporations corrupt these areas of science only harms patients, the practice of medicine, and public trust in research.