The public's misperception of risk is one of the most important places to begin to educate the public and restore trust and confidence. The public believes largely that drugs should be free from side effects. This naïve and misinformed perception crosses over into the public's view of clinical research. Whenever an adverse side effect is reported, the public tends to conclude—with the assistance of the media and overzealous politicians— that federal oversight is lax and that manufacturers have violated a sacred trust.

Today, public perceptions about the risk associated with marketed and investigational medical therapies are shaped significantly by journalists facing deadlines, politicians seeking reelection, companies trying to promote consumption, and doctors who have neither the tools nor the time to adequately converse on the subject. The critical question that consumers are not being taught to ask is: What level of risk is tolerable and acceptable. The answer depends, of course, on the benefits of taking that treatment.

Numerous polls show that the public does not understand the true risk of taking any medication, be it a drug that has been on the market for decades, a new prescription or an OTC treatment. Conceptually, the public concedes that all drugs have side effects, but no one thinks these effects will happen to them.

Mainstream media outlets serve up a mostly lopsided view of new therapies, exaggerating their benefits upon commercial release and emphasizing their negative characteristics when less common side effects occur. What initially gets reported about a drug is incomplete. The story hooks on one clinical trial finding that may represent marginal clinical improvement.

Kenneth A. Getz MBA

Also, the media takes great pleasure in reporting drug withdrawals. They are headline grabbers. Yet the public—particularly in the United States—does not realize how rare drug withdrawals actually are. A study conducted by the Tufts Center for the Study of Drug Development a few years ago concluded that the number of drugs withdrawn from the market is smaller in the United States than in any other country.

With respect to clinical trials, the public has virtually no context with which to understand risk—and study volunteers are not much better. They tend to have very limited understanding of it. A CenterWatch survey conducted years ago, for example, found that following informed consent form review, the majority (89%) understood the logistical expectations of the study, but more than one-third claimed they did not understand that it carried additional risk compared to that posed by a standard treatment.

Given the small amount of time available to educate volunteers considering participation in a trial, there seems to be a major opportunity to teach the public and patient communities how to think realistically about medical treatment risk.

Assessing risk

Although the premise of zero-risk is flawed, FDA and the EMEA appear bound by it. Industry professionals describe these agencies as obsessed with unrealistic safety expectations and safety monitoring that adds time and cost to drug development and commercialization. They point to the rising complexity of Phase I and II protocols as evidence of sponsors looking to gather more safety data to satisfy agency requirements. Industry professionals also point to agencies becoming more skittish and reluctant to approve therapies, as evidenced by delayed decisions around the introduction of treatments that had the same safety profile as similar drugs approved historically.

Zero-risk tolerance is also seen in the growth of postmarketing safety surveillance efforts. Three out of four new drug approvals in the United States and EU have postmarketing commitments. And more than half of these commitments require gathering additional safety data. Several postapproval surveillance initiatives have also been established. The FDA's MedWatch program encourages public and professional input on adverse events. It also publishes a quarterly Web-based Drug Safety Newsletter to provide postmarketing information to health care professionals and stimulate additional adverse event reporting. The Sentinel Initiative represents a cooperative effort to monitor medical product safety by creating linkages between existing electronic databases run by private health insurance plans and government agencies. The Basal Adverse Events Report represents another cross-agency effort intended also to be an industry reporting tool.

Balanced education

Recent and highly visible product withdrawals are no doubt comforting to the vast majority of Americans who are hopeful FDA errs on the side of caution. But has that caution come at the price of articulating the true risk–benefit equation? A more reasonable "balanced risk" perspective would recognize risks but weigh them against potential gains for the drug's targeted patient population.

There are isolated examples of patient advocacy groups that have done an admirable job of educating disease sufferers that all treatments come with the risk of adverse events as well as the potential to improve and extend the quality of life. The Parkinson's Disease and Cystic Fibrosis foundations, for example, have developed comprehensive communications designed to set more realistic patient expectations about therapeutic risk. But comparable efforts on a broader scale are nowhere to be found.

Physicians widely cite DTC advertising as a critical improvement area to reduce overuse of newly approved drugs and, consequently, any of the risks associated with them. Doctors don't have time to make a compelling counter argument when patients show up at their office demanding a drug, so they prescribe it even if an older, perfectly acceptable alternative already exists.

Disapproving fingers inevitably point to the beleaguered FDA, whether the topic is misleading drug ads, me-too drugs, or access to compassionate use therapies still in the testing stage. But the agency doesn't have the budget, legislative power, or corporate influence to enact change of this sort.

FDA may have the wherewithal, in cooperation with industry and the NIH, to provide more consistent and standardized public information about risks and benefits. The FDA already has a Risk Communication Advisory Committee to assist the agency with targeting and translating safety messages for the public.

The Center for Information and Study on Clinical Research Participation (CISCRP) is developing educational initiatives to inform the public about the risks and benefits of all medical therapies. Clearly these initiatives would need to include all stakeholders, including health care professionals, insurers, payers, politicians, and the media. Investment analysts might also benefit by a balanced education about risk–benefit profiles.

It's important that public education and outreach efforts come from a variety of sources in order to touch people through a wide variety of distribution channels: from television, radio, and newspapers to magazines.

Integral players

Consumers are integral players in risk–benefit decision making. It is too important for these decisions to be left to regulators, ethics committees, sponsors, and investigators. Product labeling and black-box warnings are fine, but people lean more on communication from their doctor or information of uneven quality gleaned from the Internet.

The public have a high degree of trust in their physicians, nurses, and pharmacists, but those same professionals may be overwhelmed by the amount and range of information about medical product safety. So many people rely on the opinions of seemingly well informed friends and colleagues.

Public education and outreach are essential to setting realistic expectations about medical treatment risk. With the support of informed practitioners, public servants, and the media, a realistic and educated public forms the foundation from which clinical research professionals can restore trust and confidence.

Kenneth A. Getz MBA, is a Senior Research Fellow at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, email: kenneth.getz@tufts.edu