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FDA's David Kessler offers to protect us from greedy corporations and unscrupulous business people. But who protects us from ambitious, media-wise, grasping bureaucrats? Just call me "Doe" By Peter Brimelow and Leslie Spencer "WE ARE SLIPPING BACK tO the turn of the century, when snake oil salesmen roamed about." U.S. Food & Drug Administration Commissioner David Kessler, 42, waves his arms to emphasize the point. "Never has there been a systematic evaluation of vi- tamins," he booms dramatically at the packed congressional hearing room. "The marketplace is awash in unsub- stantiated claims. It is time to do what needs to be done." "In the end, I'm a doc," Kessler once told People magazine in one of his frequent interviews. (FoItBES did not get one. After Kessler's press of- fice questioned us pointedly about our other sources, we were told he was too busy. ) But this man who likes to present himself as friendly young Doc Kessler might be more realistically described as "the quintessential D.C. chame- leon"-as Kim Pearson of Food & Drug Insider Report quips-with an intense drive to control. Behind Kess- ler's campaign to increase FDA vitamin health claim regulation: a Napoleonic lack of faith in markets and in people's ability to take care of themselves. With the Clinton Administration's plans to put politics in command of the health care business, the record of Kessler and the FDA de- mand closer scrutiny (see following story). Kessler's political drives were evident early. After entering Harvard Universi- ty Medical School, he spent two years at University of Chicago Law School, and finished his law degree at Harvard simultaneously with his M.D. (Hold the yuppie envy. This seemingly superhuman feat is not un- precedented among those seeking public or business careers and is sniffed at by doctors concerned with professional standards. ) Chicago Law Professor Richard Epstein recalls Kessler vividly: "He was a good student, but not an analyt- ical star by any means. You knew he wasn't going to spend his life poking around people's openings." Indeed he wasn't. Kessler fulfilled his pediatrics residency in a Baltimore hospital at night, devoting days to work on food and drug legislation as a Capitol Hill staffer for Senator Orrin Hatch, a job the conservative Repub- lican gave him as a favor to Edward Kennedy. President Bush named Kessler FDA Commissioner in 1990. Kessler's ambition showed most nakedly in his campaign to be retained by Clinton in the FDA post. In a stunning act of treachery, Kessler spoke before the Food & Drug Law Institute in December, after Bush had lost the election but before he left office, openly deriding the deregula- tion espoused by the man who ap- pointed him. In a blatant bid for reappointment, he proclaimed: "What a significant portion of the electorate indicated is that it is weary of a government that is dictated by special interests." Kessler even refused to return the formal request for resignation sent to 108 Forbes  November 22, 1993

• Dr. David Kessler, Food & Drug Commissioner in the Bush and Clinton administrations Napoleonic chameleon? him and all other political appointees, according to former senior Bush offi- cials. (Kessler denies this.) "A messenger had to be sent to pick it up. But he kept working furiously behind the scenes to keep his job.... Even during the campaign he tried to schedule dinner with Al Gore," insists one Bush Health & Human Services official (who like others declined to speak on the record, claiming to fear Kessler's vindictiveness). He thinks that Kessler was desperate to be re- tained, not reappointed, because he knew he could not survive another congressional approval process. Too many Republicans felt betrayed. Clinton took the bait and asked for Kessler's retention. Bush spinelessly agreed. Forbes  November 22, 1993 Kessler's campaign for continued employment by a liberal Democratic Administration was apparently long calculated. Back in 1990 he picked Mary Pendergast from the FDA gener- al counsel's office as senior adviser. Pendergast is married to David Vla- deck, close colleague of Sidney Wolfe, Ralph Nader's health guru at Public Citizen. Another key Kessler appoint- 109

FDA ment: Mike Taylor, a relative of Tip- per Gore. Kessler's regular meetings with Public Citizen's Wolfe reportedly be- came an embarrassment to the Bush Administration. And Mar,v Pender- gast had to be forced by industry and White House pressure to "recuse" herself from the FDA's breast implant crackdown because of a potential con- flict of interest-Public Citizen sells breast implant litigation kits to plain- tiffs' lawyers. Immediately after the election, sources say, Kessler started encourag- ing U.S. testing of the French abor- tion pill RU-486 (see following storv). Previously, he had argued strenuously against it on health grounds. (Kessler denies this, too. ) And despite that law degree, Kessler seems to be indifferent to constitutional problems posed by congressional encroachments. Last year, for example, Representative John Dingell(D-Mich. ) shocked ob- servers when he moved his staffer Claudia Beville into the FDA for sever- al months while investigating FDA management of the medical device industry. She snooped in files and interrogated FDA officials. FDA aide Mike Taylor Gore kin, Kessler appointee. "If the executive branch wanted to resist, they would have compelling separation-of-powers arguments, and 200 years of precedent," argues for- mer U.S. Attorney Stephen Mark- man. But Kessler apparently had no intention of resisting powerful congressmen. Notable Kessler cam aigns:  ange juice. In 1991, prompted by complaints from two competing orange juice makers, David Kessler ordered U.S. marshals into a Minne- sota warehouse to seize 2,000 cases of Procter & Gamble's Citrus Hill Fresh Choice orange juice. FDA claims P&G had ignored orders to delete the word "fresh" from the label of this recon- stituted juice. But this trivial com- plaint was not about health. It was about showing the iron fist. "This had nothing to do with orange juice. And it had nothing to do with fresh," Kessler was repeatedly quoted as say- ing at the time. A lieutenant, Kenneth Feather, told the press: "We want to say to these companies that you don't know when or how we'll strike. We want to eliminate predictability."  Breast irrzqlants. Last year Kessler denied a woman's right to choose silicone breast implants by practically .driving them from the market. He alleged health hazard. But former Surgeon General Everett Koop re- portedly startled the 3,000 plastic sur- geons at a recent annual convention 'Yvith the observation that the FDA ;'investigation (of breast implants) ~"smelled to high heaven ... there is inore than meets the eve." What didn't meet the eye: feminist politics and the influence of Naderite Sidney Wolfe. The policy Kessler im- posed on private practitioners-to al- low reconstructive implants for mas- tectomy patients but not for cosmetic purposes-is obviously irrational in pure health terms. And Kessler's crackdown has devas- tated the entire medical device indus- t~r _ nly 12 new heart valves, high- tech surgical instruments and the like were approved last year, compared with 47 in 1990. Venture capitalists have turned away. Companies have started building plants overseas.  Vitamin store raids._In the F[)~'s campaign to restrict health claims made by the vitamin industry, the agency raided 35 homes and hcalth food stores in seven states this vear It claims the target is prescription drugs being sold illegally. But in mans raids it seized nonprescription vitamins There have been allegations that Fn.~ officials threatened further seizures if store owners talked to the press  Restri_ctin health informario~~ Kessle~~ah s-3ramaucallv increaird` re strictions on prescription drug ad% cr tising to consumers and doctors, part of a drive to centralize information in the FDA's hands. "Drugs approved for one form ot cancer often turn out to help anc~th er," says Emory Professor Paul Ru bin. "Doctors used to learn about this through industry seminars, mail- ings ... these things have been great lv reduced under Kessler. Secondarv uses are not illegal, but the FDA sA on't let companies tell you about them- unless it has approved them." But even Napoleon was defeated eventuallv. There are signs that Kess- ler's grandstanding has gone too far, even for the Clinton Administration. Says one former White House staffer in touch with Clinton officials: "He's grating already." Maybe Kessler should be looking for new openings. ~ 110 Forbes • November 22, 1993 I