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The integrity of publication planning has taken some hits, but the new Sunshine Act can help restore credibility. The publication planning process, which has been fraught in past years with issues related to integrity, transparency, and trust, is still a key element in any marketing plan. Publications have suffered from a few missteps in recent years, but changes are occurring that can restore lost credibility. According to Ken Kramer, Ph.D., senior VP, medical director, Alpha & Omega Worldwide, part of The Core Nation, publication planning should never be considered a necessary evil in pharma — it is simply a necessity. “Survey after survey has reported that healthcare professionals rely on peer-reviewed articles and presentations to get critical information that helps guide treatment choices,” Dr. Kramer says. “We cannot run from the fact that the public has lost confidence in scientific publications. But any lost confidence should not and cannot reduce the role these publications play during drug development.” This is especially important during the early phases of medication development, where nonbranded publication articles are the sole way for clinical trial data to get into the public domain. For marketers, these publications are essential for market-shaping activities that lay the groundwork for why a newer drug may be a better choice than an existing one. “One way to restore confidence is by keeping nonbranded publications solely within the domain of medical affairs,” Dr. Kramer says. “This may lead to some essential shifting of budgets, but it will also return some of the credibility that has been lost.” Author acknowledgement and enhanced corporate firewalls are two examples of steps taken to increase transparency and trust in data dissemination, says Mary Anderson, president of SCI Scientific Communications & Information. Agencies should proactively mirror the industry separation and focus wholly on ways to support medical and clinical affairs and publication management in the future. “We are now focused on the next generation of issues, including how to incorporate technology such as podcasts and hosted websites without compromising the integrity and transparency of the data we communicate,” Ms. Anderson says. As long as new drugs are developed and subject to preclinical and clinical studies, there is a need for publication planning, our experts say. But the overuse of certain KOLs created a serious credibility problem across a number of therapeutic areas. “The ego needs to be taken out of medical publications by spreading the work around,” Dr. Kramer says. “We need to discover young medical professionals who are open to new challenges and willing to work within the new regulations.” The Sunshine Act The Physician Payments Sunshine Act, beginning in 2012, requires companies to record any physician payments that are valued at more than $10. This includes stock options, research grants, consulting fees, and travel to medical conferences. The details will be posted in a searchable database starting Sept. 30, 2013. “Metaphorically speaking, this will provide transparency to a system that many believe is cloaked in darkness,” Dr. Kramer says. “Practically speaking, the act will enable pharma to work within a system that re-shines the light on what is important — outcomes — and away from what is not — speculations of cronyism. The Sunshine Act will also urge pharma to seek out fresh faces and opinions to speak on behalf of the science, so that the message no longer gets lost in who is the messenger. “There is an old saying in sports that the name on the front of the jersey is more important than the one on the back,” he continues. “This philosophy may serve us well to encourage similar thinking about medical publications.” The Sunshine Act also will impact how publication planners will engage HCP authors by establishing a determination of value for all services and exchange between authors and industry, Ms. Anderson says. For example, the industry is considering whether writing and editorial support for HCP authors is of direct value to the HCP and, therefore, must be reported. Online journal hosting fees are also being reviewed to determine value. “The industry’s adjudication of these two practices will directly impact how publication planners engage HCP authors in the future,” she says. Ms. Anderson has a sunny outlook for the future of the medical publication profession. She predicts it will continue to flourish even as the industry continues to redefine itself. “Certified medical publication professionals will be seen as experts in the field,” she says. “Whether they predominantly work directly for pharmaceutical companies or function as agency support, their expertise will grow in importance. Certification, advanced study, and ongoing inquiry among publication professionals will be vehicles used to create the balance and trust critical to the health and wellness of our discipline.” “The focus is on next-generation issues, including incorporating technology into data communication. ” Mary Anderson SCI Scientific Communications & Information “The sports philosophy that the name on the front of the jersey is more important than the one on the back should apply to medical publications. ” Dr. Ken Kramer / Alpha & Omega Worldwide Experts Mary Anderson. President, SCI Scientific Communications & Information, a wholly owned separate legal entity within the Ogilvy CommonHealth Worldwide network, which was created to meet the specific needs of medical affairs and R&D teams at pharma, biotech, and device manufacturing firms. For more information, visit scicominfo.org. Ken Kramer, Ph.D. Senior VP, Medical Director, Alpha & Omega Worldwide, part of The Core Nation, is a medical communications company. For more information, visit thecorenation.com.