When the Advocates of Full Disclosure Go too Far

“I believe that, in order to protect our constitutional rights, everyone should refuse to permit inquiry into his political beliefs.” -- Published testimony of Linus Pauling to California Senate Investigating Committee on Education in 1950

In the 1950s, during the McCarthy communist witch hunts, the U.S. Public Health Service revoked grants it had awarded Linus Pauling, the intellectual father of molecular biology, because of his opposition to demands that scientists disclose their political associations.

Half a century later, the International Committee of Medical Journal Editors (ICMJE) has promulgated a new Uniform Disclosure Form for Potential Conflicts of Interest that should cause Pauling to turn over in his grave. In addition to requiring information about financial interests, Section 5 of the form asks authors of journal articles to “report any personal, professional, political, institutional, religious, or other associations that a reasonable reader would want to know about in relation to the submitted work.”

Journals that have adopted the new disclosure policy include the New England Journal of Medicine, the Annals of Internal Medicine, The Lancet, the Journal of the American Medical Association, and the British Medical Journal.

Beyond the obvious and profound assault on privacy and liberty, the notion that personal beliefs, as signaled by political or religious affiliations, are relevant when assessing peer-reviewed research, is an assault on science itself.

The scientific enterprise is built on the idea that theories rise and fall on objective criteria. Experiments can be independently reproduced — or they can’t. A hypothesis is testable — or it isn’t.

This is why, in the 21st century, science has emerged as a truly global enterprise. Collaborations flourish without regard to national borders, creeds or ideologies. Indeed, in an ideal world, peer reviewers of articles about research would be blinded to an author’s identity, so judgments could be made solely on the merits of the science.

But let’s imagine the ICMJE world.

BioCentury asked Christine Laine, editor of the Annals of Internal Medicine and a member of the ICMJE secretariat, why it would be legitimate or necessary to require disclosure of a religious affiliation by the author of an article describing clinical or basic research.

Laine replied that if an author of a study revealing safety problems with a contraceptive was an official in a right-to-life organization, a “reasonable reader” would want to know that information to evaluate the research. If the author were a devout Roman Catholic, disclosure of her or his religious views wouldn’t be mandatory, “but it might be that the person would want to disclose it,” she said.

Leadership roles in advocacy organizations, even if they are uncompensated, must be disclosed under the new standards, Laine said.

By those standards, a “reasonable” reader would want to know that a scientist who has published on evolution, genetic testing, embryonic stem cells and similar issues was a born again Christian and the founder of a foundation dedicated to reconciling religion and science. This “reasonable” reader thus would expect articles by NIH Director Francis Collins would be embellished with a footnote indicating that he is the founder of the BioLogos Foundation, which “emphasizes the compatibility of Christian faith with scientific discoveries about the origins of the universe and life.”

By the same token, it would be “reasonable” to expect that any paper written by molecular diagnostic pioneer Randy Scott, executive chairman of Genomic Health Inc., would also be asterisked because he is chairman of BioLogos.

Collins hasn’t been shy about disclosing his religious associations, but a young scientist just starting a career in genetics would be foolish, indeed, to advertise similar associations.

It is hard to believe that peer reviewers and editors, the gatekeepers to publication in prestigious journals, won’t be influenced by knowledge of an author’s association with an organization they find repugnant.

That researcher also would have to be quite brave to keep her associations private because it is unclear what needs to be disclosed under the new rules. ICMJE has intentionally kept the standard for reporting non-financial associations ill-defined, Laine said, “to cover all the bases.” A narrower definition, she said, would allow authors to find loopholes.

Ironically, an example of a situation where the author’s potential conflict of interest would have been of interest to readers — but wasn’t mentioned by the journal — appeared in the New England Journal of Medicine on Oct. 14, the day after NEJM announced the new ICJME disclosure policy.

NEJM published a commentary about intellectual property policies related to biosimilars, and informed its readers that “no potential conflict of interest to this article was reported.”

The journal apparently didn’t feel it was necessary to note that the lead author, Alfred Engelberg, is the former counsel to the Generic Pharmaceutical Industry Association, or that he represented generic companies in suits against brand drug companies.

Reasonable readers might also want to know that Engelberg is an advisor to Sen. Chuck Schumer (D-N.Y.), the sponsor of legislation that seeks to implement the policies recommended in Engelberg’s commentary.

NEJM spokesperson Jennifer Zeis told BioCentury the non-financial disclosure policy wasn’t in place when the Engelberg commentary was submitted. This is a thin umbrella to hide under, as there is a clear financial interest in this industry dispute. And NEJM arguably should have known that transparency should have been considered in the case of commentaries and editorials, which by definition comprise opinions that are not subject to recapitulation and validation via the scientific method.

Every journal sets its own punishments for failure to make appropriate disclosures. According to Laine, the Annals of Internal Medicine publishes a correction in the journal that is permanently attached to PubMed citations, and it often sends letters about the incident to the department chair and dean of an academic author’s university.

While they are so busy guarding the gates of scientific integrity, maybe the ICMJE editors have not gone far enough.

If the political and religious affiliations of study authors are somehow relevant to the scientific enterprise, why shouldn’t those who conduct peer reviews have to disclose their religious and political beliefs as well?

And does anyone who has spent time in academia really believe that the political or religious beliefs of either study authors or peer reviewers are really more important than who denied whom tenure, who trumped whom for an NIH grant, who got the chairmanship of the medical faculty, or whether a study author was a post-doc for the study reviewer?

Let’s disclose all that as well. In fact, let’s see if we can make the entire scientific enterprise grind to a halt by simply declaring everyone conflicted and lacking in integrity.

Advocates for disclosure of non-financial associations may come up with elaborate hypothetical scenarios to justify the requirement, but these can’t come close to balancing the very real harm that the practice will do to individual scientists and to the scientific enterprise.

Linus Pauling provided more than scientific leadership — he promoted civic responsibility. Like him, every study author will need to decide how he or she will stand up for the bedrock values of democratic societies.