Performance Measures for Cardiology Focus on Improving Patient Outcomes

Abstract

M. Schwartz, MD, MS, of Dartmouth Medical School in Hanover, NH, have noted that while the FDA has been criticized for being too close to industry, its reviews are a unique source of published and unpublished data about drug performance (a search page for FDA reviews of drugs is available at http://www .accessdata.fda.gov/scripts/cder /drugsatfda/index.cfm), and readers can learn of the reviewers’ opinions of the drugs they evaluated (Woloshin S and Schwartz LM. Arch Intern Med. 2009; 169[21]:1985-1987). However, they also noted that the FDA should make its reviewers’ knowledge more accessible through standardized executive summaries of drug reviews. Other critics point out that the FDA does not make available unpublished clinical trial data that are not discussed at advisory committee meetings. “The FDA is now somewhat more transparent, but it’s not transparent enough,” said Steven Nissen, MD, chair of the department of cardiovascular medicine at the Cleveland Clinic. “For reasons I can’t understand, it still keeps information secret,” he added. The FDA recently formed an internal Transparency Task Force to develop recommendations for making information about FDA activities and decision making more readily available while protecting confidential information (http: //tinyurl.com/3mazd5q). According to Avorn, this initiative focuses primarily on access to reports of adverse events that are spontaneously provided by physicians and patients after a drug has been approved. “Of greater concern are adverse events identified by drug companies during the clinical trials that they conduct,” he said. “This is more relevant information, but it is also where company ownership of data often comes into conflict with the public’s right to know, and the public often loses that battle.”