Andrew Holtz is an independent health care journalist based in Portland, Oregon. He has been a medical correspondent for CNN and is past president of the Association of Health Care Journalists.
If you made a discovery that you thought could lead to a product and had named yourself CEO of a nascent company with plans to commercialize that product, would you have a financial interest in the company?
Maybe not, according to Harvard University and its Wyss Institute for Biologically Inspired Engineering.
My path to this revelation started In August with my fellow journalist Bob Roehr. He forwarded a sexy but shallow news release from the American Chemical Society (ACS): No guts no glory: Harvesting the microbiome of athletes.
The news release and a subsequent news conference at the ACS meeting had an alluring hook: Certain bacteria show up more often in the poop of elite athletes than in the poop of sedentary people. So researchers theorized that a probiotic elixir containing components of elite athlete poop could help boost athletic performance and become the next hot sports drink.
An intriguing concept, for sure. But as Roehr pointed out, there was no published research, so no way to examine the evidence. The predictable result: mostly frothy, speculative reporting.
The release and news conference made no secret of the researchers’ plans to commercialize the findings, which quelled my immediate concerns about disclosure of conflicts of interest. However, my look at Harvard’s institutional policies governing such conflicts revealed something troubling: Harvard’s official policy, which has changed a couple of times in recent years, takes a big step backward from transparency to a more relaxed public disclosure policy.
The current policy makes it more difficult for journalists and other members of the public to check the financial interests of researchers. More importantly, this case raises questions about whether the conflict of interest policies at Harvard and other academic institutions could allow industry entanglements–and the biased behavior that they promote–to worsen.
In one study, the researchers compared the poop of Boston marathon runners to sedentary controls. “Right after the marathon there is a spike in the abundance of this one bug that, in particular, breaks down metabolites associated with fatigue and soreness. So this was pretty cool,” Jonathan Scheiman, PhD, a postdoctoral fellow in the laboratory of George Church, PhD, at Harvard Medical School said in his ACS news conference. The study was done two years ago, but has yet to be published. No details or specific results were released outside a scientific session at the ACS meeting. Scheiman went on to speculate, “What if we isolated this bacteria, which we’ve already done, purify it, and now potentially could give it back to athletes as a probiotic to help maybe prevent fatigue and promote endurance.”
That speculation sparked a number of news stories. But what struck me in Scheiman’s news conference statements was the polished pitch about their startup company.
“This company is called Fitbiomics. We are the world’s first sports biotechnology company. We are sequencing the microbiome of elite athletes to identify and isolate novel probiotics that we could then commercialize and disrupt nutrition. We are currently incubating at the Wyss Institute for Biologically Inspired Engineering at Harvard University, [whose] mission statement is to commercialize technology to real world applications.”
The Fitbiomics website lists Scheiman as CEO and Church, his mentor, as co-founder. To be more precise, Scheiman could become the CEO… if Fitbiomics gets funded. You see, Fitbiomics is not actually a company, at least not in the eyes of Harvard and the Wyss Institute. I stumbled on that surprise when I asked Mary Tolikas, Wyss Institute Director of Operations, why I couldn’t find any official disclosure of a financial interest on the part of Scheiman or Church (as distinct from their informal personal declarations).
“There is no company. There is no licensing agreement. There are no IP [intellectual property] assets or financial assets,” Tolikas said. She added that if they do seal a deal, they will move their work out of the Wyss Institute. Wyss Institute Administrative Director Ayis Antoniou also told me by email that faculty are required to disclose their financial interests and move their work out of the institute when they execute a licensing agreement with Harvard. “Prior to the financial interest being created, there is no conflict in the research activities under way, and thus no need for disclosures,” Antoniou wrote. (emphasis added)
The Wyss Institute, like technology transfer programs at other universities, supports work that lays the groundwork for commercialization of academic research. In a recent article, Tolikas and colleagues described how the Wyss Institute works, and how academic standards are not the only measures of success. “[We] are also assessed based on the patent portfolio we generate and our ability to develop productive corporate alliances, licensing agreements, and new start-ups.”
Scheiman noted the assistance of Wyss Institute staff with the business aspects of his position. “Over the past two years, the institute has not only supported me in terms of the science, but in terms of business development, commercialization strategy, market research; so it is supporting and really encouraging entrepreneurship,” he said.
But when I asked about balancing academic and commercial interests, Antoniou answered by email, “There is no balancing of commercial and academic interests at Harvard and at the Wyss, because we do not engage in commercial activities.”
These emails and conversations indicate that Harvard researchers working at the Wyss Institute may hone their research to increase its attractiveness to private investors, build the framework of private companies that they will steer, and proclaim their interest in venture capital investments to the media, all without triggering either public disclosure requirements or conflict of interest restrictions.
But when I characterized these conclusions to Harvard Medical School Chief Communications Officer Gina Vild, she maintained that this was incorrect. Vild said Harvard Medical School’s policy does require disclosure of financial interests, in particular whenever researchers publish or present their work. She said that when Antoniou told me there was “no need for disclosures,” he was “describing the institutional response once a financial interest actually becomes a financial conflict of interest.”
I have yet nail down the distinction between a “financial interest” and a “financial conflict of interest” with Vild. I’m not sure it’s necessary in any case, since “financial interests” are what Antoniou said the researchers didn’t have in this situation, eliminating the need for any disclosures.
During my initial research for this story, I came across an announcement on the Harvard Medical School website about an update in 2010 to conflict of interest rules. Among the key guidelines listed in the announcement: “Ensure that all relevant faculty financial interests are disclosed publicly, on the Harvard Catalyst website.”
The Catalyst site hosts Harvard researcher profiles, including publications and certain research funding. The announcement of the 2010 policy featured prominently on web searches for Harvard conflicts of interest policies, until I asked why Fitbiomics and other spinoff companies weren’t listed. For several weeks, no one I contacted at Harvard or the Wyss Institute could answer my questions about the absence of public disclosures on Catalyst.
Ultimately, Gretchen Brodnicki, JD, Dean for Faculty and Research Integrity at Harvard Medical School, told me the article was outdated, and that the requirement to publicly post faculty financial interests was never formally adopted. The article then disappeared from the Harvard website. A PDF of the page as it appeared on Sept. 26, 2017 can be downloaded here.
Even though that manner of routine public disclosure was not adopted, apparently some Harvard faculty still pushed back against the 2010 policy, which was seen as too restrictive. A 2015 STAT article on the debate quoted Wyss Institute Director Donald Ingber, MD, PhD.: “If there were conflict-of-interest policies so that Thomas Edison couldn’t be involved in the company he formed to create the electric light, we’d still have gas lamps.”
A revised policy, adopted in 2016, says the Office of the Dean may publicly disclose faculty interests, activities, and relationships with industry. Dean Brodnicki sent links to webpages describing policies about Outside Activities and Sponsored Research Review. The latter link leads to a webpage with a section on “Public Accessibility” that discusses policies on conflict of interest disclosure. It spells out criteria that limit requests for such disclosures, contains a form that must be filled out (including an NIH Award Number), and states that a written response will be made within five business days.
Not quite as easy as the system proposed in 2010, where identifying relevant conflicts was as simple as clicking on a researcher’s profile page.
George Church, who does list his spinoff endeavors and other interests on his personal profile, says his personal preference is to be completely open. “I disclose everything the minute I have an idea. They [Harvard and the Wyss Institute] don’t pay much attention to it, but I disclose it both publicly and privately to the university.” But that much openness is not mandatory, and other researchers might not be so forthcoming. I tried contacting the committee co-chairs of the 2010 policy that included public listing of faculty financial interests. None responded with comments.
Daniel S. Goldberg, J.D., Ph.D., an attorney and ethicist at the University of Colorado’s Center for Bioethics and Humanities, says it is “ludicrous” to say that the most stringent disclosure and conflict of interest rules don’t need to be triggered until money is actually changing hands. But he also thinks that academics, journalists and others get too hung up on simple disclosure when there are more important issues to consider.
He says the real issue is relationships that alter the behavior of researchers, for example by shaping their studies and how they share their results with an eye to commercialization and future market value. Goldberg referred to a model developed by conflicts of interest expert Andrew Stark in which certain acts create a favorable state of mind and then “behavior of partiality.” Stark lays out this model in his 2003 book Conflict of Interest in American Public Life. Goldberg says studies show disclosure doesn’t curb partiality.
“It doesn’t work. It doesn’t prevent behavior of partiality. In fact, there is actually quite a bit of evidence that it [disclosure] might actually make it worse.” Goldberg says one way disclosure can backfire is that, “People who disclose feel that they have done what they are required to do, so they feel that they have a moral license: ‘I disclosed that I have this relationship with a pharmaceutical company, so now I can do pretty much whatever I want.’” He says other experiments show that when a doctor tells patients about conflicts of interest, the patients are more likely to follow the advice of their doctor. In other words, sunlight may not be such a great disinfectant after all.
Goldberg says that while disclosure is still important, in order to reveal relationships, more efforts are needed to avoid conflicted relationships in the first place. “Instead of inviting parties to get deeper and more entangled, which is mostly what we do — ‘Hello, Office of Technology Transfer at every major university’ — instead of inviting academics to get into these relationships, we would try everything we can to keep these parties at arm’s length.”
He notes that these days a school of public health would never partner with the tobacco industry. And he says people should ask questions about health researchers accepting grants from foundations funded by the alcohol industry (a topic that HealthNewsReview.org publisher Gary Schwitzer addressed recently).
Goldberg notes there can be benefits to commercial/academic partnerships, such as those the Wyss Institute touts: moving the fruits of academic research out into real world use. But he says academia should pay more attention to relationships with industry, and that journalists should be asking more questions about these relationships and not be satisfied with mere disclosure.
“Looking in the right direction is looking at the relationships and policing them and seeking to minimize them wherever we can. Oriented in the wrong direction is allowing anything to go in terms of the depth of the entanglement and focusing just on disclosure. That’s the wrong orientation.”
Now back to elite athlete poop and possible links to performance or recovery. Scheiman and Church say their experiments are moving ahead. “Okay, we’ve got an observation or a correlation, let’s turn it into a cause-and-effect experiment,” Church says. “It could be that it is all effect, rather than cause, and we’ll find that out.”
However, even before their completed studies about correlations are published, they are thinking about marketing products. Nutritional supplements are not required to prove they have real benefits, as long as their labels are carefully worded. Church says, “I think it’s appropriate given the status quo. I personally wish that the FDA and society could afford to label and test everything.” So if Fitbiomics gets funding, it could roll out probiotic product without having to prove that the components indeed boost performance.
The decision to promote this microbiome research with a news release and news conference came from the American Chemical Society. Mary Tolikas at the Wyss Institute says she did not know Scheiman had given a news conference until I asked about it. She says that they have not actively promoted news coverage of the work and have just been responding to requests from journalists. She adds that they typically put out news releases only when researchers publish in peer-reviewed journals.
A story that aired on WBUR in Boston highlighted Jonathan Scheiman’s one-time dream of playing in the NBA and how it morphed into a career researching the biology of athletic performance. The story contained only the briefest reference to an association between a type of bacteria and limiting fatigue, and that it would take future tests to find out if swallowing the bacteria could boost endurance. A story in STAT (behind a paywall) gave Scheiman free rein to speculate, but it did include independent sources who emphasized that studies so far provide only hints of associations; that is, certain bacteria seem to be more common in the guts of elite athletes than in those of regular folks, but no one knows if downing components of elite athlete poop can improve performance.
Almost every story features tales of cajoling athletes into agreeing to poop into sample collection bags. Scheiman says he would always open with, “I’m John Scheiman from Harvard Medical School.” I wonder how successful he would have been if he had introduced himself as ‘John Scheiman, future CEO of Fitbiomics.’