Advisory panels' objectivity questioned

Washington -- From warnings or guidance on prescription drug labels to advice on treating cancer survivors, health information flows from federal health advisory committees. But the debate over the credibility of these directives is gaining attention.

Some argue that physicians and other scientists who serve on the committees often have such close ties to industry that findings are skewed. Others contend that these players in the research and practice fields provide the expertise required. Representatives from both sides of the issue assembled July 24 in Washington, D.C., for a discussion hosted by the Center for Science in the Public Interest.

Advisory committees are plentiful in the federal government. The Food and Drug Administration has dozens that grapple with such high-profile topics as the dangers posed by popular arthritis drugs and antidepressants. The National Academies rely on hundreds of committees to produce reports on such topics as childhood obesity or health literacy.

In such instances, the panels' work impacts the day-to-day care of patients.

Consider a panel's conclusions carefully, cautioned Steven E. Nissen, MD, president of the American College of Cardiology and former chair of an FDA advisory panel. As an insider, Dr. Nissen has strong feelings on the need for impartiality in research. For example, he decided five years ago to refrain from accepting industry funding for his research. He advises physicians to turn to practice guidelines drafted by professional societies for clinical advice. "They usually do a pretty good job of weighing the evidence," he said. But with an Institute of Medicine report, for example, "unless you know the players, it's hard to judge whether a report is good."

Determining whether players have ties to industry isn't always easy. And just how far agencies should go when establishing criteria for committee membership is generating discussion. A bill has been introduced in Congress that would ban FDA scientists with links to a company from entering into decisions on company products.

Dr. Nissen, who participated in the July 24 debate, detailed his own position. "I think physicians who serve on speakers' bureaus or paid company advisory boards should be excluded. However, I do not think that serving on an independent steering committee or data safety monitoring board for a randomized clinical trial should be grounds for recusal."

Strong advisory panels are important to counterbalance efforts to manipulate the FDA for political purposes, Dr. Nissen said, pointing to the controversial fate of over-the-counter availability for the Plan B contraceptive as an example. "Unfortunately, under relentless and inappropriate administration political influence, the FDA rejected approval."

The AMA also has expressed concern that politics could subsume science and adopted policy at its Annual Meeting urging the FDA to prioritize the science behind its decisions.

Dr. Nissen pointed to an imbalance in power between the FDA and the products it monitors as another problem. The agency now relies too heavily on the "user fees" from the pharmaceutical industry rather than money from Congress, he said. "As a consequence, the FDA is financially indebted to the companies it must regulate."

Agency actions

Scott Gottlieb, MD, FDA deputy commissioner for medical and scientific affairs, defended the agency's drug review policy, calling it the most open in the world.

He also unveiled an agency proposal designed to provide greater clarity for procedures used when granting waivers to allow advisory panel members with ties to a product under discussion to continue to participate. Currently, Dr. Gottlieb said, the FDA examines each case of potential conflict of interest and determines whether it could have an impact on a panel member's impartiality. Often ownership of a large amount of stock in a company will result in recusal.

The agency also will attempt to codify its waiver decisions, which is expected to provide greater consistency to the process, Dr. Gottlieb said.

But barring all potential panelists with possible ties to a product or drug under discussion could be difficult, he noted, because the agency doesn't know which issues or products will come before its standing committees.

"We believe we need thought leaders, people who are heavily immersed in clinical trials and heavily engaged in the practice of medicine," Dr. Gottlieb said. "If lack of private-sector work becomes the primary criterion for serving on a committee, it would represent a giant step backwards."

The FDA isn't the only agency that recruits outside scientists for advisory committees. The National Academies -- which include IOM, the National Academy of Sciences and the National Research Council -- do the same.

According to a CSPI report released July 24, one of every five scientists appointed to a national academies panel had direct financial ties to companies or industry groups with a stake in the outcome of the study on which they were working. About half of the 21 panels examined were found to have some scientists with identifiable biases who were not offset by scientists with alternative viewpoints.

Although CSPI did not question the academy reports' quality, it concluded, "The NAS needs to be more transparent and work harder to find scientists without conflicts of interest."

E. William Colglazier, PhD, executive officer of the National Academies of Science and National Research Council, called the study "wrong and misleading," and said the academies carefully screen for potential conflicts and impose a rigorous peer review.