By Kristen Perosino
Congress is currently considering important legislation to improve drug and medical device safety and strengthen scientific integrity at the Food and Drug Administration (FDA). Both the House (H.R. 2900) and Senate (S. 1082) versions contain provisions that should be adopted in the final bill to better protect public health. One such provision is Title V Section 501 of the Senate bill regarding the right of FDA scientists to publish their research. This language, which amends the Federal Food, Drug, and Cosmetic Act, adds the following wording to the policy on the review and clearance of scientific articles published by FDA employees:
(a) Definition- In this section, the term ‘article’ means a paper, poster, abstract, book, book chapter, or other published writing.
(b) Policies- The Secretary, through the Commissioner of Food and Drugs, shall establish and make publicly available clear written policies to implement this section and govern the timely submission, review, clearance, and disclaimer requirements for articles.
(c) Timing of Submission for Review- If an officer or employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug Administration is required by the policies established under subsection (b) to submit an article to the supervisor of such officer or employee, or to some other official of the Food and Drug Administration, for review and clearance before such officer or employee may seek to publish or present such an article at a conference, such officer or employee shall submit such article for such review and clearance not less than 30 days before submitting the article for publication or presentation.
(d) Timing for Review and Clearance- The supervisor or other reviewing official shall review such article and provide written clearance, or written clearance on the condition of specified changes being made, to such officer or employee not later than 30 days after such officer or employee submitted such article for review.
(e) Non-Timely Review- If, 31 days after such submission under subsection (c), the supervisor or other reviewing official has not cleared or has not reviewed such article and provided written clearance, such officer or employee may consider such article not to have been cleared and may submit the article for publication or presentation with an appropriate disclaimer as specified in the policies established under subsection (b).
Information sharing is an essential component in science. FDA scientists should be able to conduct research and publish findings without fear of retribution. However, a recent survey of FDA scientists suggests that the FDA does not presently offer this open environment. Thirty-six percent of the scientists surveyed felt that they could not express any concerns about public health within the FDA without fear of retaliation. Forty percent reported that they could not express these concerns publicly without the same reservations. The atmosphere within the agency doesn’t appear to have changed much since Dr. David Graham, a 20 year veteran FDA scientist, released his 2004 testimony detailing his experience inside the FDA. After conducting a large, three-year epidemiologic study, Dr. Graham and other scientists concluded that high-dose Vioxx significantly increased the risk of heart attacks and sudden death. The study was labeled by senior management at the Office of Drug Safety as “a scientific rumor.” Moreover, the scientists received pressure from these senior managers to change their conclusions. Dr. Graham describes his attempt to publish the results of the Vioxx study:
Finally, we wrote a manuscript for publication in a peer-reviewed medical journal. Senior managers in the Office of Drug Safety have not granted clearance for its publication, even though it was accepted for publication in a very prestigious journal after rigorous peer review by that journal. Until it is cleared, our data and conclusions will not see the light of day in the scientific forum they deserve and have earned, and serious students of drug safety and drug regulation will be denied the opportunity to consider and openly debate the issues we raise in that paper.
How many thousands of lives could have been saved had Dr. Graham and his peers been able to publish their research? In an agency responsible for protecting public health, any suppression (or distortion) of science can have dangerous consequences. We have already seen evidence of this in the Vioxx tragedy, regarded as the greatest drug safety catastrophe to date, and also in the highly publicized safety problems surrounding Ketek and Avandia. With public confidence in the FDA fading, it is clear that federal efforts are needed to ensure that sound science is brought back to the forefront of decision making at the FDA. Therefore, scientists should be not only allowed, but encouraged to share scientific results with colleagues as well as the public. The right of FDA employees to be able to publish in scientific journals or speak at scientific forums must be clearly established and protected.
Part of the FDA’s mission is to advance public health by “helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” FDA scientists are expected to provide this data. They should be able to do so without constraints, in order for the public to make truly informed decisions about their health and wellbeing.
Kristen Perosino works for the Project on Scientific Knowledge and Public Policy and is an MPH candidate at George Washington University’s School of Public Health.