The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Safe Medical Devices for Children
Then, in June 2001, FDA required the manufacturer to collect additional information to compare premarket and postmarket patient populations, examine types and rates of adverse events during premarket and postmarket periods, and determine compliance rates for patient follow-up (FDA, 2001m).7 The committee requested and received a copy of the letter directing this study.
In December 2003, based on information received after market approval, FDA issued a public health notification for physicians with information about long-term mortality risks with the stent (Feigal, 2003). The data used for the public health notification were also used in a paper authored by FDA staff and an academic physician that was published on the website of the Journal of Vascular Surgery. Subsequently, as recounted in a July 2004 story in the Wall Street Journal, the article was removed from the website after objections and reference to legal action from the manufacturer of the device. The article was later withdrawn completely by FDA on grounds that the conclusions went beyond the public health notification (Mathews and Burton, 2004; see also Cronenwett and Seeger, 2004; Greenfield, 2004). According to the newspaper article and a statement by the surgery journal’s editors (Cronenwett and Seeger, 2004), the company argued that the article relied on data that were confidential and proprietary and could not be used without company permission.8 Like other recent incidents involving physician and public access to information from clinical studies involving antidepressant use with children and other drugs, this incident raises questions about the lack of public information about the results of postmarket commitment studies and the appropriate boundaries
Two months earlier, in April 2001, FDA had issued a public health notification discussing problems with this device and one other (Feigal, 2001a). The notification stated that one device had been the subject of a voluntary production suspension and recall after the company revealed that it had failed to report many device malfunctions and adverse events (including severe vessel damage) and that an internal audit revealed problems with complaint handling, manufacturing quality systems, documentation procedures, and staff training. With respect to the other device, FDA described concerns about serious adverse events (e.g., aneurysm rupture, device migration) and reported that it was working with the manufacturer to collect additional data.
The editors of the surgery journal expressed extreme disappointment that they were prevented from publishing an article with “data that we believe are important to readers” and that they viewed as “identical to the data in … other public documents” (Cronenwett and Seeger, 2004, p. 210). In a letter to the editors, the lead clinical investigator for the stent trials—who was highly critical of FDA’s 2003 public health notification—called for publication of the article so that clinicians could judge whether it provided support for the agency’s conclusions (Zarins and Bloch, 2004). The committee understands that the sponsor has expressed interest in an independent evaluation of the information it submitted to FDA but that it is still discussing the matter with FDA.