Jurors and FDA scientists lack confidence in agency, surveys say.

Perceptions of the FDA--from both inside and outside the agency--are less favorable than they once were, according to recent surveys.

The results of a Union of Concerned Scientists (UCS) survey of FDA scientists reveal a grim perspective of the agency's integrity. Out of nearly 1,000 respondents, 18 percent agreed with the statement, "I have been asked, for nonscientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document." Sixty percent said they knew of cases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal, or modification of FDA determinations or actions."

One respondent from the agency's Center for Drug Evaluation and Research noted, "Scientific discourse is strongly discouraged when it may jeopardize an approval."

Twenty percent said they "have been asked explicitly by FDA decision-makers to provide incomplete, inaccurate, or misleading information to the public, regulated industry, media, or elected/senior government officials." Only 51 percent said the agency is acting effectively to protect public health.

A few of the questions overlapped with those asked in a 2002 survey conducted by the Department of Health and Human Services Office of the Inspector General, and the UCS compared them. The comparison showed, for example, that 19 percent of the 2002 respondents said they were "not at all confident" that the FDA adequately monitored the postmarket safety of drugs, whereas 29 percent of the 2006 respondents were not at all confident. (Voices of Scientists at FDA, July 20, 2006, www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.html (last updated July 28, 2006).)

The public also appears to be more skeptical of the FDA. The legal consulting firm Zagnoli McEvoy Foley found that the agency's "halo effect" has worn off in recent years, according to research it conducted between 2003 and 2006.

The firm conducted an online survey of 404 jury-eligible Americans this year to assess their attitudes about the pharmaceutical industry and the FDA. Less than one-third had a positive perception of the agency. (Eric Finkelstein, Jurors' View of FDA Has Soured in Recent Years, Nat'l L.J. 6 (July 10, 2006).) (A spokesperson for the firm declined to provide the survey report but noted that the National Law Journal article summarizes the most relevant results.)

Jurors and mock jurors the firm questioned in 2003 and early 2004 consistently showed their trust in the FDA by saying, for example, that"a drug can be trusted if FDA approves of it." But by 2005, many said the FDA does not adequately protect Americans from defective drugs. The researchers attributed this change to a loss of confidence in the federal government in general, as well as a growing number of drug-related lawsuits.

Karen Barth Menzies, a Los Angeles lawyer who represents injured plaintiffs in cases against pharmaceutical companies, noted that the companies' direct-to-consumer advertising, the view that they are profit-driven, and the FDA's high-profile problems contribute to negative public perception of the industry and its regulating agency.

"There is still a significant majority" who think that the FDA is simply short-staffed and can't do its job, she said, but more people are becoming skeptical of the "improper influence of the pharmaceutical companies."

In May, a Wall Street Journal Online/Harris Interactive poll also reflected this decline. Of 2,371 people surveyed, 58 percent said they thought the FDA does a fair or poor job ensuring the safety and efficacy of new prescription drugs, and 36 percent said it did a good or excellent job. Two years earlier, 37 percent said fair or poor, and 56 percent said good or excellent. (Americans Growing Less Confident in FDA's Job on Safety, Poll Shows, Wall. St. J. Online, http://online.wsj.com/article/SB114831296787359612.html (May 24, 2006).)

How might the public's increasing awareness of the FDA's shortcomings affect pharmaceutical litigation? Menzies said that in the past, when jurors tended to trust the agency, lawyers "let the FDA stay on the sidelines." Now, lawyers are likely to approach juries differently, she said.

"We will still have to take proper steps to educate the jury," but they will be a "more open-minded audience" when presented with evidence, she said.

Menzies also noted that the FDA's role in some cases has become more prominent. In the past, "it was unheard of to get a deposition of an FDA official," but such depositions are now common, she said. In the Vioxx litigation, for example, the plaintiffs deposed FDA whistleblower David Graham.

Forty percent of the UCS survey respondents said they could not publicly express "concerns about public health without fear of retaliation." That study will make it easier to convince jurors that "those at the rank-and-file level are trying to do their jobs, but the politically connected officials are precluding them," Menzies said.

Echoing that sentiment is a report released in June by Rep. Henry Waxman (D-Cal.), which said that "FDA headquarters officials routinely reject the enforcement recommendations of career field staff."

Explaining this problem to jurors is "like revealing that they can't trust their doctors," Menzies explained. "Nobody wants to believe that." But now, she said, "we don't have to make the entire FDA the bad guys."