Sen. Chuck Grassley released a report shedding light on the controversial practice of ghostwriting. Some say his findings are based on outdated publication-planning practices. How should we put Sen. Grassley's report in context?
Robert J. Matheis, PhD, CMPP*
Head, medical comms., sanofi-aventis US;
The field of medical publishing is continually evolving with unprecedented changes in how pharmaceutical firms collaborate with researchers who develop peer-reviewed medical publications. Many companies have realigned their organizational structures to separate medical and commercial groups, developed policies and procedures consistent with external guidance, and focused publishing efforts toward filling knowledge gaps within the peer-reviewed literature. At various companies, including sanofi-aventis US, some employees have attained certification as medical publication professionals promoting best practice standards across the industry. Clearly, there have already been positive changes in the transparency of publication practices and I expect that the future will hold continued internal and external scrutiny and increased organizational insistence on the professional and ethical development of medical publications.
*This response represents the opinion of the respondent and does not necessarily reflect the opinions of sanofi-aventis US
The increased spotlight on authorship and transparency as a result of Sen. Grassley's work and media coverage of the ghostwriting issue has led many journals to re-examine their processes and policies, significantly increase their scrutiny of author listings and financial relationships and better enforce their improved disclosure policies—all leading to improved transparency for readers. ISMPP's GPP 2, ICMJE's new financial disclosure form, and MPIP's Authors' Submission Toolkit are guiding principles for authors and journals. Although it may take more time until all authors, institutions and journals can achieve full compliance with these high standards, we're certainly headed in the right direction.
President & CEO, MedErgy HealthGroup;
The International Society for Medical Publication Professionals (ISMPP) believes the takeaway from Sen. Chuck Grassley's report should be the ongoing call for increased transparency, and ISMPP supports this call through its education and advocacy initiatives. However, we think it is time to move on from emphasizing findings related to practices of the past, whether as part of the senator's report, or as is being continually revisited in the media. Standards have evolved significantly over recent years. Having said this, some are still not aware of, or adhering to, today's standards despite the clear guidance that now exists. Since this remains unacceptable, ISMPP will continue to put the emphasis on educating on, and ensuring support for, all elements of today's best publication standards and practices.
Chuck Grassley (R-IA)
Drug and device companies are in business to develop and sell their products, which sometimes involves initiating and paying for medical publication articles that cast the products in a positive light. My interest is whether the companies' role is transparent to readers. Physicians read medical articles, often relying on the articles to make decisions about patient health and safety. Because of this, it's important that all parties contributing financially to the articles be acknowledged so the reader is aware of any commercial or financial interests that may influence the results or recommendations presented. Some publications have moved toward more disclosure of authorship and funding, and that's a trend that will benefit consumers.