Full Disclosure: Tighten Pre-Publication Rules to Eliminate Ghostwriting

After Antidote wrote about new ways to tackle the problem of pharma-sponsored ghostwriting, Dr. Mark Kramer, the past head of the clinical psychopharmacology group at Merck Research Laboratories and as a mostly inactive adjunct professor of psychiatry at the University of Pennsylvania, sent in a thoughtful comment. He made some great points that were worth sharing, and so I asked him to put together a guest post. He has a good perspective on the issue, having served as an academic and as an industry insider who has authored and overseen clinical trials, and who currently works as a consultant to several pharmaceutical firms, as well as Penn. He has presented his original, industry-sponsored research, as an employee of Merck and Co., to academia worldwide.

By Dr. Mark Kramer

Who would deny that those who work in academia, pharmaceuticals (their in-house personnel as well as their contractors), research-granting agencies, communications and journalism are all in the business of exchanging money, services, material products, and political capital? Such exchanges may violate, barely or brazenly, the time-honored exacting ideals of academia, enlightened self-interest of business, and no-nonsense government. Yet the existence of the institutions involved and their root credibility ride on maintaining the highest-minded values.

The potential impropriety of ghostwriting - the devil being in the details! - must be vetted carefully, non-politically, from an open-source academic point of view.  It is probably not as black or white an issue as the headlines imply.

At the beginning of this Full Disclosure series, Antidote highlighted a possible ghostwriting scandal at the University of Pennsylvania. The fact that questions surrounding the propriety of ghostwriting are now focused on Penn underscores how deep this potential problem has burrowed into American medicine.

Penn is the original home of the American Medical Association, as well as the first school of medicine in the United States. It stands for something great, and it is becoming ever more selective about the students it accepts and the faculty it hires.  It has much to lose in the way it addresses this issue.

Penn each year receives about a half billion dollars annually in private support, and it receives huge amounts from the government for medical research.  If Penn is contributing now to a climate of systemic hypocrisy, then Benjamin Franklin is soon to be reanimated, uncomfortably. Has anyone checked the sign at 5th and Arch? Literae sine moribus vanae ("Letters without morals [are] useless").  

Indeed. 

The problem of ghostwriting will not be solved simply by blame, punishment, and tabloid journalism. Instead, ghostwriting should be viewed merely as a window into the much more important issue of the potential corruption (creeping or blatant) of academicians. As such, it can be viewed as an unheralded opportunity for America's first university, not a problem to be cloaked. 

Being of academia, industry, and government and having authored publications, I feel qualified to advance one possible solution. It will be a little onerous for some. But, that is all right.  

Here it is. Journals should require, prior to publication of an article:

1. Each of the listed authors personally and privately writes, seals, and submits a 1,500-word-or-less scholarly critique of the soundness and limitations of the scientific methods that were used to address the central hypotheses of the article and each and every argument made in the discussion sections and conclusion sections.   

2. In the case of a clinical trial, the authors would have to submit the numbers of patients that each evaluated directly

3. Authors would have to disclose the name of any researcher, writer, editor or other contributor who had a direct role in the research or writing but was ultimately excluded from authorship and then explain why that person was excluded.

4. Authors would have to explain their exact role in the research (from the design of the study to the writing of the piece), including an estimate of the number of hours served.

Up until the manuscript's acceptance and publication, the individual authors' critiques and other information will remain sealed until the paper is published and then be included, possibly anonymously, as an internet special addendum of the journal. 

To be clear: I have no objections to a pharmaceutical company initiating a first draft of pharma-sponsored research. In doing so, though, the person who writes the draft should be named as an author, and the pharma affiliation should be noted. No writer should be a ghost.

Under this proposal, every author would make plain their affiliations, conflicts-of-interest, and contributions to the actual study (or review) and the manuscript.  I seek to squeeze out ghosts and academic or industry gaming.  Pharmaceutical industry authorship, as well as its collaboration with academic researchers, need not be squeezed, only strained.

The purpose here is not mere disclosure, which has many limitations. The purpose here is to tighten pre-publication scholarship, to ensure that minority views are documented - without paralyzing the main consensus - and to elevate enlightened interests in the name of science. 

This would add richness to the science, which is sometimes diminished due to expediency, conflict-of-interest, power-brokering, and information overload. Some elements of this proposal are already in practice, helter-skelter. Rigor is required.

For schools such as Penn that are caught in the middle of this controversy, it's not just the institution's reputation at stake. It's the reputation of medical science.