Murray L. Aitken

There's nothing like a product withdrawal to put the pharmaceutical industry under the microscope. Following Merck's decision to withdraw Vioxx from the market, a flurry of reports in the US media suggested a need to re-examine and overhaul everything from the drug approval process, to direct-to-consumer advertising, to the way pharma handles R&D. Our challenge as an industry is to use the Vioxx case as a catalyst for making thoughtful improvements to our current practices—improvements that build on the many things we are doing right.

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:

• People are indisputably enjoying longer, more productive lives thanks to pharmacotherapy.
• Such success has lulled many into believing that approved medications are risk-free. In reality, no drug is absolutely safe or without side effects.
• Physicians are expected to understand and manage the risks associated with prescription medications.
• Mechanisms exist to monitor and track adverse events and to bring such information to the attention of the relevant regulatory bodies.

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 solution to identifying and managing the risks inherent in pharmaceuticals will most certainly involve:

• The application of new tools that will enable the pharmaceutical product development process to keep pace with the research discovery process. In its March 2004 paper "Challenge and Opportunity on the Critical Path to New Medical Products," FDA envisions a new product development toolkit. including computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques.
• Facilitating and accelerating the flow of clinical information among physicians, patients, manufacturers, and regulatory bodies concerned with product safety. Accessing and analyzing the anecdotal information on how drugs perform in the "real world" that thousands of physicians are privy to in their daily practices.
• Increasing efforts to give physicians and patients the clinical information they need to make informed treatment decisions.

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.