Academic journal article Law and Contemporary Problems

Transparency and Innuendo: An Alternative to Reactive Over-Disclosure

Academic journal article Law and Contemporary Problems

Transparency and Innuendo: An Alternative to Reactive Over-Disclosure

Article excerpt

INTRODUCTION

Transparency has become the new watchword in public policy and political debates about pharmaceuticals. From medical journal editors to the U.S. Food and Drug Administration (FDA), stakeholders have called for increased transparency of pharmaceutical research and safety information in the wake of recent, well-publicized safety issues with some drug products. (1) For example, the American Medical Association (AMA) approved a resolution in 2004 recommending the public registration of all clinical trials at inception, with the results from these trials then made publicly available through either journal publication or an electronic data repository. (2) Bills proposing similar registration and disclosure requirements for ongoing and completed clinical trials have been introduced in Congress and in several states. (3)

The pharmaceutical industry is firmly committed to the transparency of clinical research and safety information. Although additional improvements in risk communication undoubtedly can and should be made, it would be a mistake to overlook the significant progress to increase transparency achieved to date by the pharmaceutical industry. In 2002, for example--well before the current debate over transparency erupted--the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade organization representing the innovative pharmaceutical industry, adopted the Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results (PhRMA Principles). (4) Among other things, the PhRMA Principles clearly state the industry's commitment to the "timely communication of meaningful results of controlled clinical trials of marketed products or investigational products that are approved for marketing, regardless of outcome." (5)

The PhRMA Principles were revised in June 2004 to better clarify when clinical trial results would be made public. (6) Four months later, PhRMA established a centralized electronic database to facilitate the public's access to clinical trial results, particularly unpublished study results. (7) In addition to the approved labeling, the database is intended to contain citations or links to published journal articles reporting on clinical studies of the drug in question, as well as summaries of unpublished studies in a standardized, non-promotional format. (8)

Although transparency generally benefits the public health, it presents risks when taken to extremes. Countervailing and equally legitimate interests must be balanced against transparency when implementing any public policy on the disclosure of clinical trial and safety information. For instance, disclosure policies that fail to protect proprietary research data could undermine competition and curtail incentives for innovative research, thereby ultimately harming the public health. Likewise, policies that require the disclosure of very preliminary data of unknown significance also pose public health risks. Such information is the scientific equivalent of rumor and innuendo and, particularly when disseminated by a public health agency like FDA, risks confusing or misleading healthcare providers and patients about the true risks and benefits of drug products. Thus, although transparency is an important goal, it must be pursued in a balanced manner that accommodates other legitimate public health interests.

This tension between transparency and other public health interests has become particularly acute in debates about the disclosure of clinical trial information and the creation of publicly available, searchable databases. Physician groups, medical journal editors, pharmaceutical manufacturers, state governments, the Institutes of Medicine, and even the World Health Organization, have all entered the fray. (9) However, as these debates about clinical trial information disclosure have been raging, the transparency issue has quietly emerged in another venue: FDA. In May 2005, FDA announced it was planning to create a "Drug Watch" website that would communicate information about the safety of drug products at a very early stage, (10) sometimes even before FDA had made a decision about the relevance (or lack thereof) of the reported information. …

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