No. 2: Regulatory Vigilantism

Vigilantism, in this case, is not necessarily meant in a negative way and certainly not in an unorganized way. The chief story underscoring the selection for the number-2 pick of 2007 is, of course, the string of independent safety assessments of Avandia (rosiglitazone; GlaxoSmithKline) published separately in the NEJM, JAMA, and Lancet in May and September. The strengths and weaknesses of these assessments and the overt or covert motivations behind them won’t be discussed here, but their power (along with the associated media attention) to instigate more than just passing reactions from GSK and the FDA cannot be denied (not to mention the arguably irrelevant input from congressional members).

The public-relations department at GSK clearly worked overtime responding not only to these 2- or 3-authored meta-analyses but also to the numerous editorials and letter responses and the multitude of lay-press reports that followed. A quick review of the Avandia Press Kit site (not to gloss over the fact that an Avandia Press Kit site even exists) reveals a string of PR responses, letters to the likes of the Baltimore Sun and the LA Times, and GSK testimony.

Fallout from the NEJM article prompted the FDA to appoint a 15-member advisory panel in June to review the safety data associated with Avandia and those of the thiazolidinedione class at large (which includes Actos [pioglitazone; Takeda]). Ultimate props should be given to the FDA for prevailing under the media-powered storm to pull Avandia, when it reported in August that the drug was sufficiently safe to remain on the market, but that a so-called black box warning would be added to the labels of all thiazolidinedione-containing drugs, emphasizing the risk of heart failure in certain patients. (This recommendation was in keeping with that of the advisory committee.) In November, the FDA announced that an additional warning would be added to the Avandia label, which references data from the NEJM meta-analysis.

The Avandia story also created a nice storm in the blogosphere, which introduces the complement of this regulatory-vigilantism post: the emergence and growth of medical/pharmaceutical blogs. These blogs—particularly those associated with established press organizations (eg, Pharmalot and the WSJ health blog) and even moreso those regularly written by active physicians or scientists (eg, Aggravated DocSurg, The Carlat Psychiatry Blog, and In the Pipeline)—are beginning to importantly inform the way we view the good and the ugly of the medical and pharmaceutical industries through their growing and active readership. The necessary irreverent nature of the blog format meshes nicely with any educated finger pointing, finger wagging, or all-caps screaming that may be considered necessary when distributing information or editorializing about these traditionally stodgy, cloaked industries to the big, bad world—this site not excepted.