WHAT MAKES DAVID KESSLER RUN?

Throughout 1991, the Food and Drug Administration found itself under severe pressure to impose a moratorium on the sale of silicone breast implants. Liberal interest groups like Public Citizen and the National Women’s Health Network insisted that the implants resulted in connective tissue disease. The media added to the pressure with tales of implant disease and rupture so disturbing that at least one woman tried unsuccessfully to remove hers with a razor blade. There was, however, one problem with a moratorium: There was no scientific justification for it. Or so an FDA advisory panel concluded in November 1991.

On January 3, 1992, a dissenting member of the panel met with FDA commissioner David Kessler. Dr. Norman Anderson, a professor at Johns Hopkins, was a true believer in the need for a moratorium, if not an outright ban. He gave Kessler a mound of documents obtained through a plaintiffs’ attorney and under court-ordered seal that alleged scientific fraud and manufacturing violations by Dow Corning, the leading producer of implants. Anderson delivered a not-too-subtle threat to Kessler: Unless a moratorium was imposed he would make a scheduled appearance that night on Nightline and blast the FDA.

Well, Anderson made his Nightline appearance — during which he said nothing critical of Kessler or his agency. And three days later, Kessler stunned colleagues by keeping his end of the bargain with Anderson. “Today, I am requesting a moratorium on the further use of all silicone gel breast implants,” Kessler said, acknowledging, “I have gotten documents, literally handed to me on Friday, that I reviewed for the first time.” In April 1992 Kessler rejected a second FDA panel’s recommendation against a moratorium and announced more sweeping restrictions on the availability of silicone implants.

Kessler’s reversal had immediate and devastating repercussions. It prompted a litigation explosion. In the two years after Kessler’s April 1992 announcement, roughly 16,000 lawsuits were filed by women with breast implants. More than 1,000 lawyers were involved. Their most visible target: Dow Corning, which collapsed under the weight of lawsuits and declared bankruptcy in May 1995.

David Kessler, it turns out, was wrong about breast implants. We know because he says so. Three months after Dow Corning’s demise, Kessler made an extraordinary concession before a congressional subcommittee: “Silicone gel implants do not cause a large increase in traditional connective tissue disease,” he said. Two weeks later, he made the same concession on Nightline: “There’s not a large risk,” he said.

In other words, Kessler acknowledged his moratorium was in error, a conclusion also borne out by numerous highly respected studies released over the past year. Yet with a few notable exceptions — such as an October 1995 60 Minutes segment — Kessler’s blunder has gone practically unnoticed in the media. On the contrary, the press still treats him adoringly.

How has David Kessler gotten away with one of the costliest regulatory mistakes in decades with so little criticism and virtually no accountability? It’s very simple: This graduate of law school, medical school, and business school has proved himself an amazingly resourceful political animal. Washington has never seen an official as publicity-conscious and politically sensitive as Kessler in a highly technical post. Even Surgeon General C. Everett Koop, a notorious publicity hound, couldn’t come close.

Kessler knows how Washington works. He rewards allies and punishes what few critics emerge. From his behind-the-scenes maneuvering to get the top FDA job in 1990 at age 39 to his habit of concentrating on high-profile issues at the expense of more important but less flashy FDA matters, Kessler has demonstrated time and again that his first priority is as much public adulation as it is public health. And he has done so by portraying himself as a disinterested, nonideological civil servant, even as he runs the FDA like a liberal activist’s dream.

Kessler’s life is a case study in how an exceedingly bright young man can link his talent with his ambition to achieve a rapid rise through Washington politics. He graduated magna cum laude from Amherst College in 1973 and then earned a law degree from the University of Chicago and an M.D. from Harvard — all by the age of 28. In 1981, while serving his residency in pediatrics at Johns Hopkins Hospital in Baltimore, Kessler began volunteering on the Senate’s Labor and Human Resources Committee staff. His stint there would prove invaluable: The committee chairman, Sen. Orrin Hatch, a conservative Republican from Utah, was extremely taken with him and would later describe Kessler as “one of the brightest, most decent men I know.” Equally important, the experience opened Kessler’s eyes to Washington’s ways. ‘s a doctor, I’m supposed to say that my most important training was my medical internship,” said Kessler in a 1991 New York Times Magazine profile, “but frankly, my years on Capitol Hill were the most important. That’s what taught me how this town works.” (Kessler refused to be interviewed for this piece.)

From 1982 until taking the FDA job eight years later, Kessler held senior positions at the Montefiore Medical Center, the hospital of the Albert Einstein College of Medicine in the Bronx. But this wasn’t his real passion, as he was simultaneously earning an advanced professional certificate from New York University’s business school and teaching food and drug law at Columbia. “I didn’t want to just sit there and run a hospital,” he later told the Washington Post. Indeed, Kessler had already begun cultivating friends who would come through for him during his campaign for the FDA job.

Kessler is fond of portraying himself as a simple public servant called upon by two presidents, Bush and Clinton. But this self-portrait is at odds with the facts. When then-FDA boss Frank Young resigned in November 1989, Kessler mounted a full-court press for the vacant position. Among those he lobbied were Peter Barton Hutt, a former FDA general counsel, and Charlie Edwards, a former FDA commissioner, both of whom wielded considerable influence in food-and-drug circles. Kessler also returned to his old boss Hatch, who went to bat for him with senior Bush administration officials. Ron Kaufman, a high-level political aide in the Bush White House, recalls that Hatch used to engage in “two kinds of lobbying — pro forma and real. For Kessler, his lobbying was real.”

But Kessler didn’t impress Health and Human Services secretary Louis Sullivan, who oversaw the FDA. After a disappointing session with Sullivan, Kessler returned to Hatch, who persuaded Sullivan to grant Kessler another audience. After that meeting, Sullivan left it to the White House to choose between Kessler and someone else.

But the White House botched its vetting. Bush’s personnel chief, Chase Untermeyer, never interviewed Kessler, leaving only C. Boyden Gray’s office of White House counsel to do a cursory background check. A preoccupied Gray asked Christopher DeMuth, president of the American Enterprise Institute and a regulatory expert, to check out Kessler. DeMuth had never heard of him but turned up a 1977 article from the University of Chicago Law Review in which Kessler questioned the merits of some anti-cancer regulations. So DeMuth called back a few days later to say Kessler seemed acceptable — a terrible irony, considering that DeMuth’s think tank has been engaged in combat against Kessler ever since. The formal nomination was issued soon thereafter and sailed through the Senate on a voice vote. Kessler never had to undergo a formal confirmation hearing.

During the Bush years, Kessler succeeded in alienating numerous administration officials because of his anti-business approach, his grandstanding, and his refusal to work with White House officials on FDA reform. After the 1992 election some of Kessler’s enemies in the administration mounted a quiet campaign to guarantee he would be forced out of office before Bush left the White House. (Alone among political appointees in the administration, Kessler had refused to submit a letter of resignation, as he and everybody else had been asked to do.) The effort intensified when Bush officials discovered in December that Kessler had begun correspondence with the president of the French pharmaceutical company Roussel Uclaf encouraging him to submit the necessary paperwork so RU-486 (the “abortion pill”) could be distributed in the United States.

But Kessler survived: In the final days of the Bush presidency, the Clinton transition team sent the White House a list of people it wanted kept on, and Kessler was on the list. The genteel outgoing president acceded to the request, a decision Bush has told friends he now deeply regrets.

So how did Kessler get on this prized list? He denies having done anything to orchestrate his being held over by the Clinton administration, but this is open to question. Bush offcials suspected at the time that he was working surreptitiously with the Clintons even before the election, but they had no hard evidence. FDA officials recall that one of Kessler’s senior policy aides, Michael Taylor, labored before and after the election to boost Kessler’s status with Clinton officials. Kessler himself tried, without success, to have a pre-election dinner with Al Gore but later persuaded influential Democrats like Sen. Ted Kennedy and Rep. Henry Waxman to lobby the Clinton administration on his behalf.

During the Bush-Clinton transition, Sidney Wolfe of the Naderite group Public Citizen pressed Gore to keep Kessler as commissioner. And three months after Clinton was inaugurated, Kessler ingratiated himself with his new boss, HHS secretary Donna Shalala, by announcing that the FDA would approve one of her pet projects, the female condom, despite its whopping 26 percent failure rate. For the Clinton administration, the decision to keep Kessler was the path of least resistance. Because Bush had never fired him, Kessler never had to be renominated and thus the new administration was spared a round of testy confirmation hearings.

Almost from the moment he arrived at the FDA’s Rockville, Md., headquarters in December 1990, it was clear that Kessler had grand designs for the agency. Sometimes they were symbolic — Kessler shed 50 pounds from his beefy frame soon after becoming commissioner — while others had real consequences, such as hiring 100 additional enforcement officials. His quasi-religious sense of mission shone through in a May 1993 speech: “We gave [FDA employees] a cause in which to believe. We gave them a place where, once again, the good guys could win.”

Yet what kind of leader has Kessler been to his “good guys”? He has taken to relying on his five deputy commissioners to do the lion’s share of his work, and his fondness for working from his Bethesda home has only exacerbated the sense of isolation felt by many senior FDA staffers not in Kessler’s inner circle. The head of the Center for Devices and Radiological Health, Bruce Burlington, conceded in an April 1995 meeting with congressional staffers that he had never seen Kessler set foot in his facility.

Kessler’s dependence on a small group of advisers is troubling primarily because of the backgrounds of those within the inner circle. Sidney Wolfe, the head of Public Citizen, maintains a close relationship with Kessler, and his Luddite perspective has infected FDA personnel decisions. Kessler’s policy chief, William Schultz, previously worked for both Public Citizen and Rep. Henry Waxman, while Mary Pendergast, one of Kessler’s closest aides, is married to a senior Public Citizen staffer, David Wadeck.

Others around Kessler share the Public Citizen/Naderite worldview. The head of legislative affairs, Diane Thompson, is the former chief of staff for Sen. Barbara Mikulski, a liberal Democrat from Maryland, while Kessler’s special assistant for policy, Mitch Zeller, previously worked for New York representative Ted Weiss, easily the most left-wing member of the House before his death. Another special assistant, Jerold Mande, was a legislative assistant to Sen. Al Gore, while the chief public relations spokesman, Jim O’Hara, is married to Marla Romash, who served as a spokeswoman for Gore.

Despite these obviously leftish credentials, Kessler tried after the 1994 election to persuade conservative Republicans he was one of them. In his first meeting with Texas congressman Joe Barton, one of the chief FDA reformers, Kessler immediately began trying to find common ground by talking about the work he had done for Orrin Hatch.

Kessler may not have won Republicans over, but his campaigns on issues ranging from breast implants and tobacco to orange juice and nutritional supplements have resulted in what can only be called his lionization in the mainstream media. Kessler has done so much television that he has a full-time TV adviser named Sharan Kuperman on the FDA payroll.

There’s just one problem, according to many who have worked with him: The actions Kessler takes are motivated as much by his own ego as they are by any genuine health concerns. Kessler’s original supporter, Hatch, now says that Kessler has become “more interested in publicity for the FDA than in the day- to-day hard work.” This same charge is made by former FDA staffers, who routinely describe Kessler as an “egomaniac.” They recall meetings with Kessler in which an equal or greater amount of attention was devoted to how the press would “play” their efforts as to whether the efforts were worthwhile (“I’ve got to call Phil on this” was a frequent refrain, referring to one of Kessler’s favorite reporters, Phil Hilts, of the New York Times) .

The first indication that public relations would trump public health at Kessler’s FDA came four months after Kessler became commissioner. Procter & Gamble had been targeted because FDA officials claimed the company’s Citrus Hill “Fresh Choice” orange juice wasn’t truly “fresh.” The day after negotiations between the FDA and P&G broke down, Kessler ordered agency officials, working alongside federal marshals, to seize 12,000 gallons of the orange juice at a warehouse in Hopkins, Minn. Though there was no issue of public health at stake, the seizure was a hit: The Washington Post ran the story on the front page, network news covered it, and Jay Leno talked about it on the Tonight Show. The Washington Post wrote a fawning profile a month later, claiming that Kessler “seems to want to be effective, not visible, to be a strategist, not a self promoter.”

Kessler’s relations with the press are easy to follow: He punishes those who are critical of the agency by shunning their interview requests, while rewarding reporters he likes with access, leaks, and in one instance a job. Herbert Burkholz wrote a 5,300-word paean to Kessler for the New York Times Magazine in June 1991, which concluded with the words: “Can any one person really turn the FDA around? Listening to Kessler, it is easy to believe that if anyone can do it, he can.” Three years later, Burkholz wrote a pro Kessler book. Today, he is employed by the FDA as a Kessler speechwriter.

What happens when someone has the temerity to publicly criticize the FDA? When Carl Feldbaum, president of the Biotechnology Industry Organization, wrote in the Washington Post last year about the FDA’s slow drug-approval rate, at least three companies belonging to the organization were called by FDA employees with explicit instructions to have the organization back off its calls for reform. But none of the companies wanted its name publicized, fearing retaliation. Indeed, nearly every individual I spoke with who had business before the agency refused to speak for the record, saying he feared swift and severe reprisals for comments critical of Kessler or the FDA.

Kessler’s dealings with an ex-staffer, Jim Phillips, underscore his fanatical devotion to good press. After leaving the FDA in July 1994, Phillips went public with some of his gripes in an interview with a trade newsletter. Kessler responded by calling Phillips at home and shouting at him, “I can’t believe you would do this to me!” and “I made a mistake in bringing you to the FDA!” Two weeks later, Kessler tried, but failed, to get Phillips to come back to the agency — presumably in order to silence him. Kessler’s pursuit of Phillips has continued: Last year, Kessler ordered at least two FDA officials to record and transcribe voice-mail messages left by Phillips and had the transcripts of these messages turned over to Joe Barton, with copies sent to two Democratic congressmen, John Dingell and Ron Wyden (now a senator).

What does the future hold for David Kessler? In the short term, he will continue his high-profile offensive against tobacco; his quest to have nicotine declared a drug will bring tobacco under his regulatory thumb. Kessler’s longer-term plans will be dictated by what happens in November. Bob Dole has privately promised to fire Kessler if he becomes president, but with Clinton in the White House there’s every reason to believe Kessler will stay at the FDA and press on. For David Kessler, an unelected civil servant with no defined term of duty, has come to Washington to save you, and if in the process he harms industry, impedes the release of life-saving drugs and medical equipment, and terrorizes health-care providers and manufacturers, what does he care? He’ll always get good press.

By Matthew Rees