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Editorial

The Process of Publishing Industry-Affiliated Articles in Plastic and Reconstructive Surgery

Rohrich, Rod J. M.D.

Author Information
Plastic and Reconstructive Surgery: March 2014 - Volume 133 - Issue 3 - p 757-760
doi: 10.1097/PRS.0000000000000036
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“Doing well is the result of doing good. That’s what capitalism is all about.”

—Ralph Waldo Emerson

As a practicing plastic surgeon, I read five to six peer-reviewed journals every month. What I expect from each, including Plastic and Reconstructive Surgery, is the ability to read and review in an objective manner the best quality data on what is new and innovative in our field. In this pursuit, I find myself reading several different articles supported by the pharmaceutical and/or medical device industry among the literature. It is my goal, as Editor-in-Chief, to ensure that you, our readers, are presented with the very best science and all the information you need to fully consider the conclusions on the tools, devices, techniques, and medicines described, to help you better treat your patients.

Biomedical publishing relies on the symbiotic relationship between industry and medicine. On the surface, it appears to be a simple supply-and-demand equation: industry needs doctors and patients; doctors need pharmaceuticals and devices. But nothing about this equation is simple, especially when it comes to the publication of industry research and results in journals. It is the source of an ongoing ethical and moral dilemma: can the presence of money taint the science?

Reports indicate that Jonas Salk would have made $7 billion from his polio vaccine had he patented it.1 Would the literature published regarding the polio vaccine have been less efficacious had Salk earned remuneration? We want to live in a fully altruistic world, where the Jonas Salks of our field are always at the helm. In our society, this is not always possible or realistic; medical research today requires significant financial support. One would usually require some sort of sponsorship or beneficiary structure to conduct meaningful, large-scale research. As Ralph Waldo Emerson intimates, the mere presence of profit in an equation does not indicate impropriety.

The purpose of medical journals is to publish peer-reviewed science; in many cases, some of the most timely and impactful articles with the highest levels of scientific evidence come from industry. It can be controversial, and it can carry the potential for perceived bias, but if the science behind an industry-supported article is excellent, it can be published—as long as transparency is maintained to empower the reader. That is exactly what Plastic and Reconstructive Surgery strives to do to gain and keep your trust in this ever-changing and challenging arena of health care innovation and devices.

Sometimes, though, the lines blur and impropriety develops when a journal lacks the proper checks and balances. That is why Plastic and Reconstructive Surgery has such stringent rules and policies in place to protect the integrity of the peer-review process, provide a fair and balanced editorial process, and provide you all the tools needed to objectively consider each published article. This is not always an easy task. The peer-review system largely relies on the honesty of our authors and reviewers and is, of course, only as infallible as the men and women who operate within it; the system is imperfect.

That said, Plastic and Reconstructive Surgery policies have grown even stronger over the past 10 years and now provide the best platform to date for mitigating bias in the editorial process and final product. If you see an article published in Plastic and Reconstructive Surgery, you can trust we have followed our guidelines to the best of our ability, and each article that has passed the peer-review process has earned a spot on the table of contents. In this editorial, I will review our policies, so you can see what we do to help you fully and honestly read all articles. With our policies enacted and all the information presented, you can decide for yourself whether each article’s conclusions are something you may want to incorporate into your practice or not.

CONFLICT OF INTEREST STATEMENTS FOR REVIEWERS

It is widely understood that perceived bias can go both ways: not only must the readers be informed of potential bias by revealing the source of a manuscript, but the authors of that manuscript must also be protected from potential bias by the peer reviewers. To protect against this, Plastic and Reconstructive Surgery requires reviewers to openly report any conflicts of interest at three key points: (1) we perform a regular collection of self-reported financial disclosures for all reviewers; (2) each year, the American Society of Plastic Surgeons gathers an in-depth conflict-of-interest document from all Editorial Board members, who are our key reviewers; and (3) with every invitation to peer-review a manuscript, we encourage the reviewer to decline if he or she feels undue bias.

We trust our pool of reviewers to let their conscience be their guide. Only they truly know whether they are biased against the material because of its source or some other factor. If it becomes clear that a reviewer is misusing our trust to offer biased critiques, corrective action is taken.

DOUBLE PEER-REVIEW PROCESS

Given the sensitive nature of industry-sponsored supplement articles or industry-affiliated manuscripts, I go one step further to help ameliorate any bias in the review process. Most original and experimental articles are peer reviewed by two to four reviewers. For industry-related manuscripts, I have implemented a practice of “double peer review.” These articles can be initially reviewed by as many as eight people.

Having a larger reviewer pool for such manuscripts allows me to more easily spot any bias and shape my final decision with fairness and scientific scrutiny. Ultimately, this team of reviewers informs my final decision. As I synthesize the critical reviews of extra-large panels of your peers, it is the scientific basis of the article and not its authors’ institution or employer that leads to the final decision. A doubly large panel of peer reviewers helps me realize this goal.

FINANCIAL DISCLOSURES OF AUTHORS

Every manuscript published in Plastic and Reconstructive Surgery is accompanied by a financial disclosure statement provided by the authors. Our policy states the following:

Each author must disclose at the time of submission any commercial associations or financial disclosures that might pose or create a conflict of interest with information presented in any submitted manuscript. Such associations include consultancies, stock ownership, or other equity interests, patent licensing arrangements, and payments for conducting or publicizing a study described in the manuscript.2

Given that some research has shown “systematic bias favors products which are made by the company funding the research,”3 it is crucial information for the reader to know whether a product-specific manuscript is written by a company employee, competitor, or someone with no disclosures at all. In industry-sponsored supplements, we publish these disclosures twice: once in an appendix to the entire supplement and once on each respective article. This redundancy is intentional: our readers have the right to know.

Our goal is to provide full transparency for the reader to be fully informed. The article’s publication in the Journal indicates that the science was deemed worthy of publication by the peer reviewers, Editorial Board, and Editor-in-Chief. What the reader ultimately takes from the published information—including results, disclosures, and conclusions—is fully up to him or her.

DRIVEN BY PHYSICIAN AUTHORS

To further help prevent real or perceived bias, Plastic and Reconstructive Surgery has a very pointed policy regarding author roles:

Any clinical manuscript… must have as its first and corresponding author a practicing physician(s). Coauthors from industry can certainly be included on a paper, but the corresponding author who takes ultimate senior responsibility on the paper must be a practicing clinical physician.2

It becomes clear why this is our policy when one considers the implications of a listed author not being responsible for the content. The New York Times reported on the authorship of a sponsored drug trial published in Annals of Internal Medicine, which was later proven to have omitted some trial participants’ deaths. When questioned about his role, the first author said, “[The Company] designed the trial, paid for the trial, ran the trial…[The Company] came to me after the study was completed and said, ‘We want your help to work on the paper.’ The initial paper was written at [the company], and then it was sent to me for editing.”4 It is for this reason that Plastic and Reconstructive Surgery, and nearly all journals worldwide, now have authorship policies centered on responsible physician authors for clinical studies.

The order of authors must be a true reflection of the level of involvement in the work. If this trust is later discovered to have been violated, actions including retraction could be taken, as our editorial policy indicates:

Authors accept responsibility and accountability for the content of the article; the authors—not an industry sponsor—have the final say in what goes into a manuscript.2

COMPLETE AUTHORSHIP AND ACKNOWLEDGMENT LISTS

“Ghostwriting is not permitted by the Journal.” Plastic and Reconstructive Surgery’s position and policy is clear, both in our Editorial, Legal and Ethical Policies2 and in our past position papers.5

Our policy continues: “Professional writers and medical writers who contribute substantially to the writing or editing of a manuscript should be acknowledged with their permission or credited in the author list.”5

It is not inappropriate to have a “paid” author. It is widely understood in medicine that many company employees or consultants must be authors of their company’s articles; the data are often proprietary and, therefore, the manuscript must be written by someone on the “inside.” In other instances, medical writers or editors are employed to help get the manuscript published. In either case, it is the official policy of this Journal, and most others industry-wide, that as long as all contributors are listed or acknowledged, this is acceptable practice. As mentioned above, however, these industry employees and medical writers must not be the primary authors—both in the listings and in actual practice. Plastic and Reconstructive Surgery entrusts its readers to use information regarding authorship in their overall understanding of the article.

CONCLUSIONS

It is a fine line we walk in peer-reviewed medical publishing. Physicians study medicine and practice it daily using devices and drugs made by industry. These companies attempt to position their own products in the marketplace as honestly as possible, in most instances. It is the Journal’s role to keep bias from seeping into the publishing process and to keep that line from becoming blurred. I have outlined our safeguards in this editorial so you can rest assured that we do all we can to give you good and solid science-based data. All papers are judged on their scientific merits; controversial, innovative, and potentially biased articles receive an even more scrutinized critical appraisal because of their nature.

We at Plastic and Reconstructive Surgery are proud to work every day to live up to our promise to you, the reader, that we accept and reject manuscripts regardless of what companies support Plastic and Reconstructive Surgery through advertising. If Plastic and Reconstructive Surgery did not so methodically try to eliminate bias by fully disclosing the financial relationships of authors, collecting the conflicts of interest of reviewers, doubly peer reviewing controversial or industry-specific materials, pushing members of our medical specialty to be primarily responsible for the content, and requiring the listing of all people with authorship roles, then we would not continue to be the number-one peer-reviewed plastic surgery journal in the world.

The Plastic and Reconstructive Surgery policies reviewed in this editorial ensure that the Journal remains a level playing field for all authors, regardless of their nationality, background, or affiliation. For every manuscript, we take steps to uphold this pledge so that we can continue to deliver the best clinical and academic studies in plastic surgery, so you can deliver the best available care to your patients.

“He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all.”

—William Osler

ACKNOWLEDGMENTS

The author thanks Aaron Weinstein, M.S. (Managing Editor of Plastic and Reconstructive Surgery), for written contributions to this editorial, and Mike Stokes, M.B.A. (Publications Director of the American Society of Plastic Surgeons), for copyediting assistance. Both Mr. Weinstein and Mr. Stokes are employees of the American Society of Plastic Surgeons.

REFERENCES

1. . How much money did Jonas Salk potentially forfeit by not patenting the polio vaccine. Forbes. Available at: http://www.forbes.com/sites/quora/2012/08/09/how-much-money-did-jonas-salk-potentially-forfeit-by-not-patenting-the-polio-vaccine/. Accessed November 8, 2013
2. Plastic and Reconstructive Surgery. . Editorial, legal, and ethical policies. Available at: http://journals.lww.com/plasreconsurg/Pages/EditorialLegalEthicalPolicies.aspx. Accessed November 8, 2013.
3. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: A systematic review. BMJ. 2003;326:1167–1170
4. Berenson A. Evidence in Vioxx suits show intervention by Merck officials. The New York Times. April 24, 2005 Available at: http://www.nytimes.com/2005/04/24/business/24drug.html?pagewanted=print&position=&_r=0. Accessed November 8, 2013.
5. Sullivan D, Rohrich RJ. Authorship and medical ghostwriting: Plastic and reconstructive surgery policy. Plast Reconstr Surg. 2011;127:2496–2500
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