June 16, 2008 – The July-August issue of Public Health Reports includes two pieces from staff of the Project on Scientific Knowledge and Public Policy (SKAPP): an article by Susan Wood and Kristen Perosino, “Increasing Transparency at the FDA: The Impact of the FDA Amendments Act of 2007,” and a letter to the editor from David Michaels and Celeste Monforton in response to a letter about their article “Beryllium’s Public Relations Problem: Protecting Workers When There Is No Safe Exposure Level,” which appeared in the journal’s January-February issue.

Wood and Perosino examine the provisions of the FDA Amendments Act that address the approval decision-making process and financial conflicts of interest; increased access to data flowing from clinical studies; and publication of scientific research by FDA scientists. They conclude, “The 2007 legislation, with its provisions for conflicts, transparency, and scientific freedom, may have begun to restore confidence in and capability of the FDA”; however, they note that “the impact depends on the implementation of these provisions, the resources available to the FDA to fully carry them out, and the will of FDA leadership.”

In the Letters to the Editor section of the journal, Brush Welllman’s Marc Kolanz advances his company’s interpretation of the events and evidence Michaels and Monforton laid out in “Beryllium’s Public Relations Problem,” which criticized the beryllium industry for attempting to slow the adoption of more protective beryllium exposure limits. In their response, Michaels and Monforton note that “Kolanz’s letter [to PHR] is an excellent example of our article’s primary message---that Brush has waged a concerted campaign over many years to refute the scientific evidence of the health hazards associated with beryllium exposure.”

For example, Michaels and Monforton refute Kolanz’s claim that Brush Wellman did not hire Hill and Knowlton, the public relations firm that pioneered the tobacco industry’s strategy of creating doubt to avoid regulation:

Kolanz unequivocally asserts that Brush “did not hire Hill and Knowlton (H&K) nor implement their proposal.” The evidence we have for our reporting of Brush’s relationship with H&K is an invoice sent by the public relations firm to Brush (with accompanying note), the H&K public relations program proposal, an internal Brush memo talking about materials needed for the H&K initiative, a letter from Brush to H&K providing “supporting information for the PR program,” a series of letters developed by H&K for Brush to send to its customers reassuring them of the safety of beryllium, and copies of letters sent by Brush Wellman that include much of the text provided by H&K (with copies sent to H&K).

Because many of the documents used by Michaels and Monforton to respond to Kolanz’s claims have not been publicly available, they are posted on the SKAPP website so that readers can decide for themselves how these historical records should be interpreted.