WASHINGTON _ Charges of McCarthyism have beenleveled against House Commerce OversightInvestigations Subcommittee Chairman Joe Barton (R-Texas) in his investigation into alleged FDA abuses ofpower.

Ranking Democrat Henry Waxman (D-Calif.) Tuesdayobjected to Barton refusing to share evidence with him,comparing him with Sen. McCarthy who often opened hishearings by saying "we have the evidence." During the1950s, McCarthy held a series of hearings that vilifiedseveral government and private citizens over their allegedassociation with the Communist Party.

The McCarthyism label also was applied to Barton'sproceedings by Sidney Wolfe, director of the HealthResearch Group, who objected to Barton's questioning ofFDA Commissioner David Kessler as to whether the twohad lunched together. "It is unfortunate and deplorablethat a member of Congress, groping for straws, wouldstoop to tactics quite reminiscent of the late Sen. JosephMcCarthy in order to try to establish some sort of cabalinvolving the FDA and me," Wolfe said. "Asking Dr.Kessler `do you know and have you even had lunch withSidney Wolfe' is the sort of probing which should havevanished long ago."

Wolfe's Health Research Group, in Washington, oftenhas prodded the FDA for approving drugs too quickly andnot being rigorous enough in its reviews.

Tuesday's hearing by Barton's subcommittee was thefourth in an ongoing series to investigate whether theFDA has intimidated drug and device manufacturers andhas failed to be responsive to companies whenconducting product reviews. While the hearings began asan exploration of whether the FDA needlessly slowedapprovals and retaliated against manufacturers whocomplained of these slow tactics, they have deterioratedinto partisan squabbling and parliamentary maneuvering.A full hour at the hearing was consumed by a debatebetween Barton and Waxman over whether a documentshould have been entered into the hearing record.

Compared to previous appearances before thesubcommittee last month (see BioWorld Today, Nov. 16,1995, p. 1), Kessler appeared to stand up to thequestioning more than he had in the past. He repeatedlyobjected to inferences posed by several Republicans thatthe agency was engaged in illegal or unethical activities.

"At the last hearing the statement was made four timesthat a grand jury failed to indict Houston physicianBurzynski [despite FDA-initiated investigations]. Thosewere strong words about the FDA. We did not participatein those [grand jury] procedures. We did not haveknowledge of that process," Kessler said.

Stanislaw Burzynski last week was indicted for criminalcontempt, mail fraud and sending an unapproved drugthrough interstate commerce.

"In fact, yesterday [Monday] U.S. attorney Michael Clarkstated in open court that the subcommittee had receivederroneous information that the grand jury had failed toindict the physician on previous occasions. It is importantthat we keep to the facts," Kessler said.

All grand jury proceedings are closed to the public and norecord is kept of indictments that are not handed down.

When pressed by Barton to document the FDA's role inthe criminal investigation of Burzynski, Kessler resisted,saying that "prudence demands that I not comment whencriminal proceedings are under way."

Kessler summed up his and Barton's ideologicaldifferences when he remarked, "the five cases underinvestigation have a common public policy issue. Thequestion is whether we will have a market-based[regulatory scheme] that operates on the buy beware,caveat emptor, principle or if the American people havethe right to drugs and devices that are safe and effective."n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.