Several high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know (...) it? Concerns are growing about the potential for industry sponsors to suppress negative results from clinical trials research. Scientists, medical journal editors, legislators, and the public have called for greater transparency in the conduct of clinical trials and the drug approval process. (shrink)

Several high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know (...) it? Concerns are growing about the potential for industry sponsors to suppress negative results from clinical trials research. Scientists, medical journal editors, legislators, and the public have called for greater transparency in the conduct of clinical trials and the drug approval process. (shrink)

Increasing reports of financial entanglements involving scientist and industry have led some to question the neutrality of research results. In December 2003, a story in the Los Angeles Times shocked readers by exposing several cases of NIH scientists embroiled in serious financial conflicts of interest.1 It was revealed, for example, that senior NIH official Stephen Katz was a paid consultant to Schering AG, a German pharmaceutical company with which he was involved in conducting clinical trials. In a similar case, John (...) Gallin, director of the NIH's Clinical Center, was discovered to have co-authored an article on a company's gene-transfer technology, while being paid as a consultant to a subsidiary of the same company. Jeffrey Schlom, director of the National Cancer Institute's Laboratory of Tumor Immunology and Biology, helped direct NIH-funded studies examining wider use for a particular cancer drug while serving as a consultant whose highest-paying client was looking to genetically engineer that drug. (shrink)

Concern over research integrity at the NIH led to the adoption of strict conflict of interest rules in 2005. An outcry from NIH scientists followed. This paper analyzes the legal and ethical issues raised by the new rules, and suggests potential areas for modification.