Wednesday, August 1, 2012

Follow up on the FDA


THE NY TIMES
By ERIC LICHTBLAU and SCOTT SHANE
July 31, 2012

WASHINGTON — As he often did, Dr. Robert C. Smith was hammering away at his bosses at the Food and Drug Administration in the most caustic of terms at a meeting to address his concerns about the approval of medical devices.
With seven fellow scientists seated behind him in support, Dr. Smith charged that managers “are not following the law, not following the science, not following F.D.A. core values,” according to notes of the 2008 session. He glared at a supervisor, who sat fuming in front of him.
Dr. Smith — radiologist, lawyer, litigant and the man now at the center of a spying scandal at the F.D.A. — is in some ways typical of that peculiar Washington phenomenon known as the whistle-blower: He pressed charges of government abuse, battled with his bosses, and ultimately was shown the door amid lawsuits and investigations.
But he took his role to an extreme, according to former colleagues, scorning negotiations, making enemies of critics and papering Washington with complaints, which helped sow chaos at the agency. One co-worker compared his efforts to “a mutiny.”
This month, F.D.A. officials came under fire from Congress after disclosures that they had begun a surveillance operation monitoring the e-mail of Dr. Smith and four other employees as they wrote to their lawyers, lawmakers and even President Obama. Dr. Smith’s scorched-earth tactics had so unnerved managers that they, too, resorted to extreme measures, and the monitors ended up producing a sort of enemies list of 21 agency critics, including Congressional officials, academics and journalists.
Some 80,000 pages of documents intercepted in the spy operation — many of them e-mails from Dr. Smith seeking help from scientists, politicians, reporters, academics and others — detail his campaign to expose what he claimed were harmful practices at the F.D.A. The documents, accidentally posted online by an F.D.A. contractor, reveal a four-year process of estrangement between Dr. Smith and his bosses.