Good Publications Practice 2 and You (Open Session 36)

by Heather Haley

Navigating the current medical publishing environment is challenging, whether it’s figuring out which of the many CONSORT statement extensions applies to your project or collecting all the conflict of interest disclosures from ten authors in four countries. However, success starts with knowing Good Publication Practice 2. Published in October 2009 in the British Medical Journal, Good Publication Practice 2 (GPP2) captures the best current standards for communicating medical research sponsored by companies.  (For a copy of GPP2, visit the Web site http://www.gpp-guidelines.org, where you can also watch a webcast about it.)

Covered in the AMWA 2010 conference open session, Navigating the Current Medical Publications Environment, key GPP2 recommendations include:

• Written agreements between the company and academic-physician authors.
  • These author agreements can address a host of issues from access to data, author obligations to disclose conflicts of interest, author responsibilities for timely publications. The GPP2 paper has a great checklist of what to include in an author’s agreement.
• Contributorship model for the acknowledgements section for people who do not meet the ICJME authorship criteria as well as the role of the sponsoring company in funding and executing of research.
• Suggested language for contributorship is: “The authors would like to thank D, YZ Pharmaceuticals, for overall management of the trial and E, WX Medical Writing, for drafting the manuscript.”
• The role of the sponsor in the medical research needs to be detailed. Suggested template language that can be adapted to each situation is: “In collaboration with A and B, YZ Pharmaceuticals, designed the study, analysed, and interpreted the data, and edited the report. Data were recorded at participating clinical centres and maintained by YZ Pharmaceuticals. All authors had full access to the data." If journal submission requirements do not accommodate this information, then put it in the cover letter accompanying the submission.
• Creating publication steering committees to identify and oversee the communication of research results in presentations and journal publications.
• Visit the GPP2 website for ideas on who belongs on publication steering committees.

The key theme for GPP2 is transparency. In this current environment of controversy, more disclosure is the rule of thumb when in doubt. The GPP2 authors recommend going above and beyond disclosing conflicts of interest and medical writing support on posters as well as publications. Since no one becomes a Wall Street Journal story for disclosing conflicts of interest.

A highlight for GPP2 is that the update was a more collaborative process seeking input from all the key stakeholders. 116 individuals representing academic centers, journal editors and publishers, medical communication agencies, freelance medical writers, pharmaceutical, medical device, biotechnology, and professional organizations provided comment on the first draft of GPP2.

The Navigating Medical Publications talk was attended by about 30 people, and honestly I was surprised by the number of people who didn’t know the GPP2 update had come out. New publishing or research reporting guidelines can be found at the Equator network. Read Good Publications Practice 2, for yourself. It’s definitely a must if you are taking the Certified Medical Publication Professional exam (CMPP). But also, pass along some of the useful checklists or template language to your colleagues or clients to help make navigating the current medical publishing environment a little easier for everyone.

Of Sin, Salvation, and the Relationship Between Physicians and Industry

by Faith Reidenbach

I sent Dr. Thomas Stossel, winner of this year’s McGovern Award, a telepathic message before his speech. “Talk about ACRE, talk about ACRE,” I chanted mentally. He didn’t disappoint—in fact, as it turns out, his entire speech concerned ACRE’s research and advocacy work.

Thomas P. Stossel, MD, is a co-founder of ACRE, the Association of Clinical Researchers and Educators, which is “dedicated to the advancement of patient care through productive collaboration with industry and its counterparts,” according to its Web site. “ACRE seeks to define and promote balanced policies at academic medical centers and within government that will enhance rather than interfere with our highly valued collaboration.”

One might say that the group is making waves by swimming against the incredibly strong current of disapproval for “conflicts of interest” (COI) in the pharmaceutical industry. That very term has become code for “corruption,” Dr. Stossel said. All commercial research and promotion is now suspected of being corrupt, investigators’ relationships with industry are considered to bias their research, other physicians’ relationships with industry are thought to cause them to become “hooked” and prescribe the company’s drugs more often, and all gifts and payments to physicians are considered fundamentally unethical.

In a luncheon speech provocatively entitled “Commercialism in Health Care--Sin or Salvation?” Dr. Stossel argued that these allegations are weak in substance or even false. He asserted that no relevant, valid evidence exists for commercial bias in continuing medical education (CME). In addition, he claimed, “Most citizens think physicians and industry should work together.”

The “toxic” policies on COI have costs, Dr. Stossel emphasized. Pharmaceutical companies that lose a lawsuit about off-label marketing, for instance, can be debarred—banned from doing business with Medicare and Medicaid. Rather than risk that devastating outcome, the companies pay huge sums to settle lawsuits, which diverts resources from research and development of new drugs. Other costs of COI policies include inhibition of collaboration between physicians and industry, elimination of physician training opportunities (due to elimination of unrestricted company grants for fellowships), compromised innovation, and decreased funding for CME.

Dr. Stossel’s speech was rapid-fire and contained some inflammatory words, such as his “demonization list” of practices that he said “confuse evidence with arbitrary preferences.” One item on that list was ghostwriting. “True ghostwriting doesn’t happen very often,” Dr. Stossel charged, faulting the “ghost police” for blurring the definitions of ghostwriting, enforcing overly rigid definitions of authorship, and adopting a romanticized concept of scientific publication as the sharing of new truths, neglecting more pragmatic motivations such as the need to get a job promotion or “get a signal out over the noise.”

Dr. Stossel is a distinguished hematologist who has served as president of the American Society for Clinical Investigation, editor in chief of Journal of Clinical Investigation, president of the American Society of Hematology. He is now editor-in-chief of Current Opinion in Hematology. Tom Gegeny, last year’s AMWA president, confirmed with me that Dr. Stossel received the McGovern Award for these contributions as well as for his work with ACRE. That award is presented in recognition of preeminent contributions to any of the various modes of medical communication.

Dr Stossel is founding scientist and a director of Critical Biologics Corporation, which is developing what may be a life-saving treatment for severe infections based on his patented discoveries. He is also a director of Velico (formerly Zymequest) Corporation, which is developing another of his research projects into an improved method for storing blood platelets for transfusion. He previously served on scientific advisory boards of the Biogen and Dyax Corporations.

Related links

Stossel TP. Has the hunt for conflicts of interest gone too far? Yes
BMJ 2008;336:476.

Lee K. Has the hunt for conflicts of interest gone too far? No. BMJ  2008;336:477.