Global Group Details a Path to
Trustworthy Evidence

Marcia Frellick

December 06, 2019

Substantial changes must be made to end the commercial contamination of evidence behind treatments and technologies, says a global group of prominent physicians, researchers, regulators, and citizen advocates.

The group, led by Ray Moynihan, PhD, assistant professor with the Institute for Evidence Based Healthcare at Bond University in Queensland, Australia, lays out strategies in a paper published online December 3 in the BMJ. A full list of the authors is available with the article.

"In our view, if health systems are to produce and use trustworthy evidence, and tackle the epidemic of medical excess, decision makers at every level must disentangle from those who profit from that excess," the authors write.

Strategies must balance bolstering trust in evidence without excess medicine — overtreatment, overtesting, and overuse. Changes must also straddle the line between relationships with industry that are valuable and those that don't benefit the public or patients.

A coauthor of the paper, Cynthia Pearson, executive director of the National Women's Health Network (NWHN), based in Washington, DC, told Medscape Medical News there can be a role for industry but only within a system that has stronger checks and balances.

She said the authors are not advocating for a system under which all support comes from a government agency such as the National Institutes of Health (NIH), for instance, because treatments and technologies benefit from wide input, including from industry.

"A centralized, top-down situation where all research flows from one spot, like the NIH, for example, leaves us vulnerable to rigid ideas and lack of willingness to take risks," she said, but added there must be more controls on the relationships with industry.

Industry influence extends to advocacy groups, which is why the NWHN has never accepted support from industry, she said. That is rare among health advocacy organizations, she said, but accepting funding can have consequences.

When advocacy groups are financially tied to industry, they may not speak up against a particular drug or treatment that has safety concerns, she said.

Specific Recommendations

The global group lays out potential solutions in three areas: research, education, and practice.

Specifically, the authors recommend that governments require independent evidence in healthcare decision making, including when evaluating new treatments, tests, and technologies.

The group recommends that policies shift to ensure that only education free of industry support counts toward professional accreditation.

Additionally, reliance should shift to practice guidelines produced by groups that have no financial ties with industry and that have access to evidence that is free of industry influence.

Medical journals and their editors, the authors say, should end their reliance on income from industry.

The panel also calls for groups that synthesize research to ensure reviewers have access to all information on study methods and all results, and that the synthesizing is conducted without industry funding.

Start With Continuing Medical Education

Pearson says a first step would be removing industry support from all continuing medical education (CME).

"Taking drug company money out of medical education is imminently feasible. It could be done in a year's time. No one would suffer," she said. "I think the reason professional societies haven't jumped on the bandwagon is there are few that are not themselves, to some extent, supported by industry."

Clifford Perlis, MD, MBe, a dermatologist in King of Prussia, Pennsylvania, who has a master's in bioethics, agrees education is the first place to start. He told Medscape Medical News that education is not as dependent on industry support as is research, so replacing the financial support would be more feasible on a shorter timeline.

In research, cutting out industry involvement is a harder call, he said. "We've had tremendous breakthroughs with collaboration of industry and public funding for research."

Additionally, he said, "There's no question that financial incentives have driven a lot of important research."  

"If you start with education, that will have a tremendous impact on quality of care and costs because education is influencing the decision makers who are oftentimes the physician," Perlis said.

Roy Poses, MD, clinical associate professor of internal medicine at Brown University in Providence, Rhode Island, said all of the proposals the authors suggest are important and reasonable.

However, he told Medscape Medical News that he would start with targeting medical school leaders who are on the boards of pharmaceutical companies,  which he says is "the worst kind of conflict of interest."

"There are people in academic leadership position on the boards of big for-profit healthcare companies pulling down $200,000 and $300,000 a year in pay and stock options and in that role are sworn to uphold the financial interests of the companies," he said.

Poses said he would advocate for a phased-in ban on anyone in a leadership position in academic medicine being on the board of a for-profit healthcare corporation.

"That to me is unconscionable," he said, adding, "It is more common than you would think."

Poses emphasized that the upheaval of phasing out industry's involvement in certain areas of medicine will be very uncomfortable for some groups.

In the United States, 60% of research is industry-funded, prior studies have found.

When industry provides the money, that means government, private foundations, and academic institutions don't have to, he notes.

But the stakes are too high to give industry control when clinical trials are experiments on human beings, Poses said.

He suggests that one option is redirecting industry money. If governments tax pharmaceutical companies, he says, and put that money into an agency for independent research, control of research would change hands.

"Of course, people in the pharmaceutical industry may not be happy with that because they may lose the benefit they get from controlling the research," he noted, adding that a government agency would also have more requirements and bureaucracy.

Some Countries, Organizations Shunning Industry Support

The authors say removing commercial contamination of evidence is altogether attainable; some countries, organizations, and publications are already changing the culture and initiating reforms. They cite several examples.

  • In Italy, pharmaceutical companies pay a 5% tax on promotional expenditures to support independent research on drugs in an effort coordinated by the Italian Medicines Agency.

  • Cochrane, a global not-for-profit firm for synthesizing research, now requires with systematic reviews that at least two thirds of authors have no financial ties to industry.

  • In Denmark, "doctors who advise drug companies can't be involved in national guidelines," and Australia "now 'strongly encourages' guideline panels to be free of financial conflicts," the authors write.

  • In Norway, the Norwegian Medical Association forbids industry-sponsored meetings and courses from being counted in formal education needed for accreditation.

  • PLOS Medicine and Emergency Medicine Australasia have stopped accepting pharmaceutical ads.

  • The BMJ now declares all drug company revenues and publishes articles only from writers without relevant industry relationships.

Perlis, however, is skeptical. He says that although the article is important because it heightens attention to the dangers of conflicts of interest in research and clinical practice, its impact in the United States will be negligible.

He added that medicine puts such emphasis on evidence guiding practice, "and yet if we look [at] the evidence on financial conflicts of interest, it's huge and we've been very slow to act on that evidence."

In the US, the focus has been on disclosure of conflicts of interest, he said — but that has been "inadequate."

For one thing, authors don't disclose consistently, and people don't quite know what to make of conflicts of interest and how they should view findings through that lens.

"What will have to happen is the stakeholders — the people who are hurt by this — will have to stand up and care," Perlis said, adding that so far the public doesn't seem to have taken an active role.

He pointed to the Open Payments Act, part of the Affordable Care Act, that allowed the public to view financial ties between physicians and industry.  

"If I saw 100 patients this week, I would be amazed if any looked at it and I'd be amazed if two or three even knew it existed," Perlis said.

Coauthor Joel Lexchin was a paid consultant on two projects: one developing principles for conservative diagnosis for the Gordon and Betty Moore Foundation and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient-Oriented Research Support Unit, and the St Michael's Hospital Foundation). He also received payment for being on a panel at the American Diabetes Association, for a talk at the Toronto Reference Library, for writing a brief for a lawyer in a case about side effects of a drug, and from the Canadian Institutes of Health Research for presenting at a workshop on conflict of interest in clinical practice guidelines.

Lexchin is a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer for books he has written.

Coauthors Helen Macdonald and Fiona Godlee work for the BMJ. Peer review and editing of the article was managed and overseen by editors who were not involved as authors.

Perlis and Poses have declared no relevant financial relationships.

The BMJ. Published online December 3, 2019. Full text

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