Alicia Mundy's First WSJ Page One Story: 'Lobbying Drove FDA Process'

Alicia Mundy, who has specialized in probing the links between FDA policy and lobbying efforts by drug-makers and other health care companies, delivered her first front page story on the subject in Friday's The Wall Street Journal.

Ms. Mundy, who joined the Journal in March 2008, penned the 2,500-word investigative story, Political Lobbying Drove FDA Process, in which she pours over internal FDA documents to report that "The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections" by FDA scientists.

The article focuses on Menaflex, made by New Jersey-based ReGen Biologics Inc., and quotes former FDA Commissioner Andrew von Eschenbach saying "we fumbled that process" when the agency agreed to fast-track approval of the product that is used to repair a torn meniscus in the knee.  Mr. von Eschenbach was in charge of the government regulator at the time it allowed ReGen to skip past standard clinical trials on its path to approval.  The FDA approved Menaflex on December 20th.

To support her reporting, Ms. Mundy cites "emails reviewed by the Journal," although she doesn't make clear how she obtained access to the internal FDA communications.  This is similar to a story Ms. Mundy wrote on January 14th, Glaxo's Emails on Avandia Reveal Concern, in which she notes that Senator Chuck Grassley of Iowa was preparing a report "containing excerpts from Glaxo documents."  In her Page One story, Ms. Mundy also mentions that Sen. Grassley "is also looking into the Menaflex approval process" -- making the Senator's office a leading candidate as the source of her materials.

Two other supportive sources Ms. Mundy cites are Jay Mabrey, the chief of orthopedic surgery at Baylor University Medical Center, who served as chairman of the FDA advisory committee weighing Menaflex; and Larry Kessler, who now heads the Health Services Department at the University of Washington, but who was previously with the FDA and directed the laboratory that reviewed Menaflex. 

Dr. Kessler told Ms. Mundy the Menaflex approval "shows the FDA at its worst."

Ms. Mundy's past reporting has been controversial leading one critic affiliated with the Center for Medicine in the Public Interest to accuse her last year of her own conflicts-of-interest, having worked at as a New America Foundation Fellow prior to joining the Journal and written an article for the "far left" American Prospect magazine.  Additional details are available in Ms. Mundy's Health.NewsBio.

Ms. Mundy is the author of Dispensing With The Truth, which alleges a deliberate deception by Wyeth-Ayerst (a division of American Home Products) pertaining to the risks of the diet drug, fen-phen.

Jared A. Favole, who covers the FDA for Dow Jones Newswires, is credited at the bottom of Ms. Mundy's front page story for having contributed reporting to it.

To order Ms. Mundy's full Health.NewsBios dossier, phone 866-NEWS-070, x.2.  It is available, like that of dozens of other influential health journalists, for $69.95.

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Alicia Mundy, who has specialized in probing the links between FDA policy and lobbying efforts by drug-makers and other health care companies, delivered her first front page story on the subject in Friday's The Wall Street Journal. Ms. Mundy, who joined the Journal in March 2008, penned the 2,500-word investigative story, Political Lobbying Drove FDA Process, in which she pours over internal FDA documents to report that The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by FDA scientists. The article focuses on Menaflex, made by New Jersey-based ReGen Biologics...

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