Science, medicine, advocacy and politics

Recently, there’s been a shake-up in medicine, as medical professionals begin to get serious about cleaning up conflicts of interest in research, journal articles, clinical guidelines and continuing education, and are adopting new disclosure policies. As is becoming increasingly recognized, financial and ideological interests are polluting the scientific integrity of medicine and using science for financial or political purposes. Even the scientific literature has become tainted, as studies are funded that have poor methodologies, designed to produce results that can be used to further interests.

Thus far, however, while eyes are most intensely turned towards industry conflicts, nonprofits and foundations have generally continued to fly under the radar. Peer-reviewed medical journals typically follow the same disclosure regulations for research receiving public funds issued by the Office of Research Integrity at the U.S. Department of Health and Services, which have one major loophole. Funding that comes through nonprofit foundations, institutes and professional or patient advocacy organizations, and salaries and grant funding that comes through institutions and university programs, don’t have to be disclosed, enabling well-funded and savvy nonprofit or “advocacy” groups to silently influence research, expert committees writing clinical guidelines, and public policies.

A business reporter in New Haven, Connecticut, described the efforts to influence science and policy by one organization, providing helpful insights for medical professionals and consumers. Reporter Liese Klein wrote:

Sacramento is a long way from New Haven, but documents crafted on Edwards Street in the Elm City may play a key role in how Californians dine in the future. A bill on Gov. Arnold Schwarzenegger's desk this fall would require chain restaurants to post calorie counts on their menus and menu boards. Yale's Rudd Center for Food Policy and Obesity, headquartered on Edwards Street, has joined the debate with case studies, amicus briefs and opinion pieces in support of the bill…

It's not often that Yale scientists take positions on issues of the day, much less actively speak out in favor of specific legislation. But Brownell and the Rudd Center have become major players in the arena of obesity research and public policy… Key to the Rudd Center's prominence is the concept of "strategic science," explains Rebecca Puhl, its director of research. Rudd is the only institution of its kind that takes such an active role in using its work to shape public policy.

"Our idea was to work at the intersection of science and public policy," Brownell says. "We don't do advocacy, but what we want to do is inform the debate." The overall message is urgent: More than two-thirds of American adults are currently overweight or obese, and numbers are rising all over the world. "The health and financial consequences are severe," Brownell says. "There are few conditions out there that would rival it."

Brownell, a professor of psychology at Yale with a longstanding interest in obesity and nutrition, founded the center in 2005. More than 20 people now work at the center and this year's budget will top $4 million…

Klein asked some tough questions and went on to share interviews with the center’s CEO and founder, and director of research, describing how they fund and use research:

Having a private funding source also allows the center to direct its efforts toward research that can have the most impact on policy, Puhl adds. "We really have a unique opportunity here," Puhl says. "We can do science faster and we can do the science we think is meaningful, and that is a very rare occurrence." "We saw an important gap between public policy and science," Brownell says. "What we want to do is inform the debate."..

Puhl says "That's one thing as scientists we just don't do very well is get the word out there and the kinds of messages we want people to be hearing."… To enhance that outreach, Rudd experts distill their own research and other studies into policy briefs and presentations, says Roberta Friedman, the center's director of public policy. "My role involves translating the research that is done here and elsewhere into policy implications and letting policy makers know about them," Friedman says...

The center must also toe a fine line between education and actual advocacy, prohibited due to Yale's nonprofit status...

The Rudd Foundation is a private, non-profit organization funded in 1998 by Leslie G. Rudd, who is also the co-founder and benefactor of the Rudd Center for Food Policy and Obesity at Yale University. As the Rudd Center for Food Policy and Obesity states on its website:

The law has proven an integral part of many major public health victories over the past century… many experts consider obesity to be the next frontier of public health law. Among the most important subsets of obesity law are laws requiring menu labeling, those regulating marketing of non-nutritious foods to children, and the role litigation may play in addressing nutrition and obesity issues on all fronts… The Rudd Center expects many obesity-related issues will be resolved through regulation, legislation and litigation, and we are pleased to remain on the cutting edge of these legal initiatives and developments.

Rudd’s website supports the information presented by Klein in Business New Haven. “At the Rudd Center, we conduct our own research, track others’, and alert policy makers when the findings can be used to write policy,” its website states. One example of Rudd research is an article published in the American Journal of Public Health and distributed through its website. It was authored by professors Lenny R. Vartanian, Ph.D., Marlene B. Schwartz, Ph.D., and Kelly D. Brownell, Ph.D.

It was a meta-analysis, reporting to show an association between soda pop and obesity and health problems. As we’ve extensively covered the shortcomings and misuses of data dredges and meta-analyses, and reviewed another meta-analysis on sweet drinks with nearly identical methodologies, it’s the disclosure statement as published in the journal article that is today’s focus:

About the Authors

The authors are with the Department of Psychology, Yale University, New Haven, Conn. [contact information follows]

Contributors

L. R. Vartanian co-originated the project, retrieved and coded the relevant articles, conducted the analyses, and cowrote the article. M. B. Schwartz assisted in the coding and analyses and cowrote the article. K. D. Brownell co-originated the project and cowrote the article.

Acknowledgments

This work was supported in part by the Rudd Foundation. We thank all of the authors who responded to our request for unpublished and in press research.

Note. Personnel from the Rudd Foundation were not involved in this work in any way. All of the authors of the present article had full access to the data.

The editors of this peer-reviewed journal permitted this misleading disclosure, leaving healthcare professionals unaware of interests that might have helped to alert them to examine this paper with special care — the very purpose of disclosures. No mention was made of the Rudd Center for Food Policy and Obesity at Yale University. Nor was it revealed that the authors were the co-founder and director [Brownell], and deputy director [Schwartz] of the Rudd Center for Food Policy and Obesity.

As professor Brownell told the New York Times in an April article on the ethics of scientists and academics accepting money from industry, associations can affect a person’s objectivity and it’s easy to offer subtle statements that would favor one’s associations. “You do it for two reasons,” he was quoted as saying. “You’ve got a money stream coming in, and you get to like the people who work for the companies. You feel like you’re on a team.” He says he no longer accepts industry funding.

Speaking out against the team, the consensus of one’s peers, and being an independent thinker is a responsibility of any independent advisor, noted Joe Collier, emeritus professor of medicines policy at St. George’s Hospital and Medical School in London and former Editor of Drug and Therapeutics Bulletin. In an analysis and commentary in the British Medical Journal which was part of ongoing discussions among healthcare professionals on disclosures and conflicts of interest, he wrote that “career pressure and a focus on payment by results are making the critical and impartial thinker an endangered species.”

Independence in itself does not make the advice right, and, conversely, partisan advice is not necessarily wrong. Similarly, an adviser's bias will not necessarily colour all of their judgments adversely… What independence does is to improve clarity.

“Full independence and the capacity to give totally impartial advice are not achievable,” he cautioned. But there are levels of risk based on conflicts of interest, and it goes beyond industry. It must be “extended to relationships with other powerful bodies, such as employers and government,” he wrote. “Independent advisers must declare each and every one of their competing interests that might have a bearing on the advice. It is for the recipient of the advice, not the adviser, to decide what that bearing might be.” He closed by writing:

For me, independence has meant saying what I mean and often being seen as rude and uncaring; holding no favours; deciding on each issue on the basis of the evidence rather than blindly following the majority; risking being seen as inconsistent (a loose cannon); not necessarily being able to support friends and colleagues; giving advice that runs counter to my personal interest; and criticising employers or senior members of the establishment. Perhaps predictably, the positions I have taken have often caused me difficulties. I have lost friends, been ostracised by the establishment, and had my career advancement undermined. But the freedoms and intellectual satisfaction gained by being allowed to be an independent thinker giving unfettered advice have far outweighed these burdens. Moreover, for each of the friends I have lost, I believe I have gained professional colleagues who value and trust my judgments. My career progression is not necessarily what one would advise for someone starting out in medicine, but for those who put independence of thought high in their hierarchy of values, the stance is worthwhile and rewarding.

Professor Collier, a long-time whistle blower against discriminatory and unsupportable clinical care guidelines and public policies, spoke at the DURG meeting in London on February 7^th earlier this year. He discussed “What is evidence-based medicine.” As he noted, studies and meta-analyses can be easily skewed to favor a sponsor. His key point bears repeating, as everyone — healthcare professionals, public policy makers and consumers — is increasingly inundated with studies being used to support conclusions and interventions that go beyond the best evidence.

What is evidence-based medicine? The practice of medicine based on the integration of well-controlled (scientifically valid) clinical trials, along with clinical expertise and patient values, he said.

Best evidence doesn’t mean “best in terms of availability,” he said, but “best in terms of scientific validity.” That evidence can only come from well-controlled clinical trials and meta-analyses using primary data. One cannot just tally the studies published on one side or another, but must continually assess the data, as well as the body of evidence. “Clinicians should be honest, recognize their limitations and wherever possible ensure that their decisions have a rational basis,” he concluded.

The very real problem we face is that so much published clinical trial data isn’t scientifically valid, has flawed designs, partisan bias and distorts the evidence, he said. It’s unrealistic to believe we can create perfect, universal evidence-based medicine. But in the interests of patient welfare, he said, biases should be made clear in the publication of trials and taken into account by clinicians before applying the advice in their individual clinical practices.

“We shouldn’t have to rely on investigative journalists to ask the difficult questions,” professor Collier has said. “Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking.”