We must urge the media, the medical community, legislators, regulatory bodies, and the public not to overreact. To put the drug safety issue into perspective, we must remind other stakeholders that:
Over the past several decades, the industry and regulatory agencies have worked together to speed safe, innovative products to market and to educate physicians, pharmacists, and patients about treatment options. Much of this progress stands to be lost if public criticism drives rash policy decisions. A higher safety standard—without a corresponding breakthrough in the means to identify and manage risk—would slow the clinical development and approval process to a glacial pace. Most likely, clinical trials would be extended by several years, and the FDA process for reviewing drug applications would be protracted. Physicians would be less involved in determining the risk/benefit ratio of treatments—and would have fewer treatment options. And the information flow from manufacturers to patients would be more restricted. It is hard to see who would be served by such a scenario.The attention garnered by the Vioxx withdrawal could, however, result in some positive changes for the industry and society as a whole if we keep the right goal in mind. The essential question we must ask as an industry is, "How can we identify side effects earlier and more thoroughly as we move from laboratory to medicine cabinet?"
The solution to identifying and managing the risks inherent in pharmaceuticals will most certainly involve:
FDA, for its part, is already acting. Within a few weeks of the Vioxx withdrawal, the agency announced that, among other things, it would research how more can be learned about the side effects of drugs in actual use, conduct workshops on drug safety and risk management, and publish its promised risk-management guidelines by the end of 2004.
Now is the time for the industry to provide real and visible leadership in finding faster and more comprehensive ways to identify and manage the risk associated with its products. The consequences of not doing so could ultimately slow the pace of innovation and the advancement of health. That would be the most painful and dangerous of all side effects in the Vioxx withdrawal.
Not-so-golden oldies? "No organization primarily focuses on monitoring effects of older drugs. Yet it is well recognized that old drugs, used poorly, are responsible for most public health damage caused by [adverse drug reactions]."; Brian Stroma, JAMB, December 17, 2004.
Murray L. Aitken is senior vice-president for corporate strategy at IMS.