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.

Key Findings From the AMWA-CMR Research Project (Open Session 11 and Poster)

by Sue Hudson

How are medical communication departments organized in major pharmaceutical companies? How is the productivity of writers and editors measured? What impact does outsourcing have on document quality or on productivity?  In an open session and poster presentation at this year's conference, results of a landmark 2009 survey conducted by AMWA and CMR International were reviewed.

Key findings:
1. Regulatory departments in most companies who responded to the survey outsource many document types, but not Phase 1, 2, and 3 clinical study reports.
2. The fact that 100% of respondents’ companies outsource the development of protocols for clinical studies was a surprise to the audience in the AMWA open session; discussion centered around the critical nature of these publications to any clinical study. (Maybe future research could find out why they’re outsourced.)
3. About half of manuscript writing is outsourced by big pharmaceutical and biotech companies that responded to the survey (good news for freelances and agencies).
4. Only 2.5% of respondents used out-of-country vendors (defined as vendors outside the country of the company doing the work; for example, for a company in Germany, sending a project to the U.S. would be out-of-country).
5. Document quality and lack of face-to-face communication were cited as obstacles to out-of-country outsourcing.
6. Resource constraints are the most common reason for the outsourcing of documents. Good experience with vendors, specialized vendor expertise, and cost were also noted.
7.   Managers in 57% of companies said the quality of work done by in-house staff was better than that of vendors.
8. Managers in 62% of companies said there was no difference between the productivity of in-house staff and outside vendors; when a difference was seen, in-house staff was more productive…. BUT
9. Documents developed by outside vendors took longer to produce than those developed by in-house staff.

(And 10. Research is hard work and takes a long time.)