CHAPTER ONE
A Question of Intent
A Great American Battle With a Deadly Industry
By DAVID KESSLER
PublicAffairs
When I was appointed commissioner of the Food and Drug Administration in October 1990, the newspapers said that I had been preparing for the job my whole life. There was some truth to that. I was trained both as a doctor and a lawyer, I had taught food and drug law, and I was running a teaching hospital in the Bronx. Reporters liked to add that I had also worked on Capitol Hill, though I had been only a part-time volunteer during my pediatric residency.
With encouragement from me, friends and colleagues began mentioning my name as a possible candidate to lead the FDA. My campaign for the job took a big step forward when I was summoned to see Louis Sullivan, President Bush's secretary of Health and Human Services, under whose authority the agency fell. Dr. Sullivan greeted me graciously, though he was always reserved and formal, and he escorted me into his spacious front office overlooking Independence Avenue. The dome of the Capitol dominated his view. The former president of Morehouse School of Medicine, Sullivan had come out of the same world of academic medicine as I had; there was every reason for me to feel at ease.
We walked together to his private dining room, where Sullivan asked, "What would you do with the agency?"
"Enforce the law," I said. It rang flat, even in my own ears. Sullivan did not react, but I felt a wave of panic, a catecholamine surge, wash over me. I had never experienced anything like it before. My back muscles went into spasm. I was afraid to pick up a fork, lest the secretary notice my shaking hands. I was the medical director of Albert Einstein Hospital in the Bronx, but here, in this setting, I was an unknown. Sullivan wanted to know what I would do if I had responsibility for an 8,000-person agency with a $600 million budget that regulated one quarter of every dollar Americans spent—from the food they eat to the drugs they take to the cosmetics they wear. For someone who had supposedly spent decades preparing for the job, I did not have a very articulate answer.
Early on, I knew that I wanted to work in Washington. I also knew that I would become a doctor; I had known that from childhood. Deciding to go to law school was harder for me, but I knew that legal skills would somehow prove useful.
In 1975, I took a leave from Harvard Medical School to attend the University of Chicago Law School. Paulette, whom I had married the previous summer, had already completed her first year of law school. She has a gift for argument, and on the exams in classes we took together, she always earned a higher score. We had met years earlier, on the porch of the three-story wooden Victorian house where she lived at Smith College.
At the time I was a student at Amherst College, immersed in a study of renal cancer in frogs and the viruses associated with it, and I needed an unending supply of amphibians with tumors. To find study animals, I traveled to large frog farms where I put on thigh-high wading boots and squeezed the bellies of thousands of animals, looking for masses. To others, it might have seemed routine, but nothing about science has ever been routine to me, not then and not now. In science it often seemed that the longer the road, the greater the reward, at least often enough to turn the dullest assignment into an adventure.
The evening Paulette and I stood talking, the trunk of my Oldsmobile was filled with croaking frogs, hundreds of specimens in plastic bins. She accepted my invitation to take a look, but I could not tell by the expression on her face whether she was impressed or repelled. It was the last time I saw her at a loss for words.
My fascination with frogs could be traced back to Oscar Schotté, one of the world's great developmental biologists and one of my most important early influences. I had been named an Independent Scholar during my junior year at Amherst, which exempted me from traditional classroom requirements and left me free to devise my own course of study. Although well past retirement age, Schotté, a professor emeritus, singled out one student each year to whom he served as mentor. Beginning in 1971 I spent two years in his laboratory, sometimes working through the night. My responsibility in those years was not to study a set curriculum in a predetermined sequence, but to learn the art of inquiry and investigation. I thrived in that unregimented environment.
Whatever else he taught me about science, Schotté also helped me understand that meticulous attention to detail and patience are as important to problem solving as a grand vision. In those years I also learned the importance of focusing fully on a task and sticking with it until it was done.
Schotté introduced me to his closest friend at Amherst, the great American historian Henry Steele Commager. Schotté and I agreed that Commager's class on the American Enlightenment was the one formal course I would take as an Independent Scholar.
Never afraid to take a stand, no matter how unpopular, Commager had opposed the Vietnam War as early as 1964, just as in the 1950s he had been one of the academic world's sharpest critics of Senator Joseph McCarthy. But he counseled patience in an impatient era. He cautioned us to examine carefully the long-term consequences of actions intended to remedy the immediate problems of the world, and he emphasized that important things in life are never achieved quickly, but rather through what he called "the long pull." He remains in my mind a model of citizenship, a man whose devotion to scholarship was combined with his commitment to public responsibility.
Schotté and Commager: one a scientist, the other a humanist. These were the models whose faces I saw before me as I began the journey that would take me from my private world to a very public life.
Although my first performance felt like a disaster, Louis Sullivan called me back for a second interview months later. We had barely begun talking when Michael Calhoun, the secretary's chief of staff, strode into the room. Slightly balding trim and strong, Calhoun held himself erect and looked every inch a member of the Praetorian Guard. He was as direct as his boss was courteous. Without pausing to make small talk, he interrupted out conversation. "There is only one question. One issue. Are you going to be loyal to the secretary or are you going to be loyal to Hatch?"
The question surprised me. Calhoun was referring to my first experience in Washington almost a decade earlier, when I was a volunteer on the staff of Senator Orrin Hatch's Committee on Labor and Human Resources, the Senate's health committee. Since then I had not had much contact with Hatch. But shortly before my meeting with Sullivan and Calhoun, I had seen the senator at a dinner to raise funds for medical education in South Africa. I half expected one of his aides to whisper in his ear, "That's David Kessler, he used to work for you." Instead, Hatch greeted me with a bear hug. "Remember Uncle Orrin when you're commissioner of FDA," he said affectionately.
My early experience within the Beltway had been something of a proving ground for me. To make it to Washington back then, I had to be persistent. In college I wrote Republican Senator Jacob Javits of New York, offering to volunteer as a summer intern in his office, but I got nowhere. Later, with medical and legal degrees in hand, I tried again when Senator Ted Kennedy chaired the health committee. Still no results. Finally, when the Senate passed into Republican hands, I was welcomed. It was sheer luck—the committee was in a period of transition that had left it short-staffed. At the time I cared little about which political side I worked for.
I began in the spring of 1981, working at the Dirksen Senate Office Building where space was at such a premium that I was not given a desk. Squeezed into a tiny ground-floor office with several colleagues, I made do instead with a small telephone stand. One day the staff director rushed in, clutching a stack of papers.
"Who knows something about the FDA?" he demanded. "We need someone to work on some legislation."
I spoke up. The interest in cancer that I had developed under Oscar Schotté's tutelage had remained with me during law school. There I wrote for the University of Chicago law review, analyzing a controversial section of the law that dictated how the FDA should regulate cancer-causing chemicals in food.
"Okay, this is yours," he said, tossing the papers at me. In that instant I became the committee's resident FDA expert.
Now, as Calhoun interviewed me for the job of commissioner of the FDA, I realized my early ties to Capitol Hill could count against me in a different political circle. I tried to allay his fears. "Look, I know Hatch," I said. "I don't have to earn my stripes with him. I can say things to him that someone coming in fresh could not." Calhoun seemed unconvinced.
The FDA was an organization in trouble and most people in Washington knew it. In truth, the agency had been under stress since its inception. Although it was launched as a scientific agency, science had often clashed with the realities of politics. Harvey Wiley, a visionary public servant, fought for passage of the Federal Food and Drugs Act of 1906, one of the nation's first consumer protection laws. He was immediately opposed by a powerful lobby. Lawyers for the industries that would be subject to its authority—canning, drugs, and whiskey—came before Congress to plead for exemptions, claiming that the law was too harsh and would ruin their businesses. Wiley prevailed and became head of the Bureau of Chemistry, the FDA's predecessor.
In the decades that followed, the nation's food and drug laws were toughened considerably—in 1938, under the Federal Food, Drug, and Cosmetic Act, for the first time drugs had to be proved safe before they could be sold, and in 1962, manufacturers were required to establish that they were effective as well. Over the years, the range of products under the FDA's jurisdiction grew exponentially and the scientific challenges became more complex. But the resources with which to shape an appropriate response did not keep pace.
By 1990 virtually no one was happy with the FDA. Weakened by years of ideological intervention, especially during the Reagan era, from 1981 through 1988, the agency had become a political whipping boy. Much of its authority had been diluted by the Office of Management and Budget, which was used by the White House to pursue an aggressive and dangerous deregulatory agenda. The FDA was underfunded, understaffed, and demoralized. It lacked basic enforcement powers—it could not subpoena witnesses and documents, embargo unsafe or questionable food and drugs, assess civil penalties for most violations, or destroy unsafe imports. There was such confusion in the marketplace that even some of the industries the FDA policed wanted its authority restored. But real as doubts about the FDA's capacity to protect the American food and drug supply were, they were not what brought me back to Washington. It was fraud and scandal.
The scandal began with an informant, a private investigator, and an attorney. The attorney, Val Miller, who represented one of the nation's largest generic drug manufacturers, believed something was radically wrong at the agency. His client had been steadily winning approvals for many of its new products until 1986, when those approvals dropped off precipitously The following year he found out why.
At the Holiday Inn in Rockville, Maryland, the Washington suburb that is also headquarters to the FDA, Miller had lunch with an FDA chemist who had left the agency a few months earlier. The nervous woman expressed concern about what was going on in her former office. Millet kept pushing gently for information, and the story began to unfold.
The chemist reported that some drug companies were delivering generous gifts—a fur coat, an expensive VCR—to her boss, Charles Chang. Not coincidentally, Chang had taken away certain drug applications that the chemist was reviewing and had reassigned them to someone else. Currently, Chang was running three reviewers. Two were slow and methodical, while the third was able to clear a swift 200 approvals a year. The drug makers who paid off Chang had their applications read by the speedy reviewer.
Miller checked out the informant and decided she was credible. Nothing gave him any reason to think she was either an attention seeker or a disgruntled employee. He decided to hire a private investigator, who later became known to federal prosecutors as "Trash Cover" because of his careful scrutiny of Chang's garbage. Twice a week during a six-week period in 1987, Chang's trash produced a piece of a photograph. It was apparent that the pieces were being carefully cut up and then discarded.
But Chang wasn't careful enough. Slowly, Trash Cover was able to put together the pieces of the photograph. It was a picture of Chang with two men, one the president of a generic drug company, the other a consultant to the industry. They were standing in front of a Hong Kong tourist attraction. This was the beginning of what came to be known as the generic drug scandal, which eventually led to the conviction of forty-two people and ten companies on charges of fraud or corruption. Charles Chang went to jail.
Although FDA Commissioner Frank Young was not implicated in the generic drug scandal, he had been slow to respond to hints about it. I met Young at about this time, when I invited him to give a lecture to the class I co-taught on food and drug law at Columbia University's law school. From the vantage point of the Morningside Heights campus that day, I realized that something was wrong. Within minutes of his arrival, Young thumped on his chest.
"I'm in body armor," he said.
According to Young, the FBI in New York had picked up a threat on his life. An HIV-infected man had allegedly paid five hundred dollars to have Young assassinated. Young asked my co-teacher, Hal Edgar, to identify an escape route from the lecture hall, and he warned Hal that for his own safety, he should not stand too close.
"Vortex," Young said repeatedly as he lectured our class. "FDA is in the vortex." I had never heard anyone use that word so many times.
But it was not bullets that should have worried Young. After a series of missteps and misjudgments at the FDA, the Department of Health and Human Services, of which the FDA is a part, began to view the agency as more of a problem than an asset. Young's most notorious decision had been the embargo he placed on all fruit imported from Chile, largely on the basis of a single anonymous threat; the scare proved unfounded. The generic drug scandal was the crushing blow. Young was asked to resign in 1989, and a search for a new commissioner was launched.
At the same time, the Bush administration decided to create a blue-ribbon advisory committee to examine the FDA's problems and to recommend solutions. Charlie Edwards, who had headed the agency in the early 1970s, was put in charge. My academic articles on food and drug law and my time with Orrin Hatch helped bring me to Edwards's attention, and I was asked to become a member of his advisory committee.
By then, the reputation, as well as the abilities, of the world's premier food and drug safety agency had sunk to historic lows. In its final report, the Edwards Committee described "grave resource limitations" that imposed "sometimes staggering burdens on the Agency." The committee also expressed "doubts about the FDA's current capacity to conduct effective law enforcement," or to fulfill its many other statutory obligations.
What was unclear was how much any one leader could change things. An old story told by FDA field inspectors captured the sentiment within the agency. "The FDA is like one of those giant clowns carried in the New Orleans Mardi Gras parade," it went. "The body, moving under cover, is the agency itself. The head, called the commissioner, is pelted with rocks until the clown fall over. But the body picks up another head and keeps doing its business."
I received a call from the White House personnel office in late October 1990 to say that the President was going to nominate me as FDA commissioner. As I hung up I stared out the window of my Bronx hospital office, overlooking a barbed wire-enclosed subway yard, and for a moment I felt triumphant. That uncomplicated feeling did not last long. Within days I received a letter from a congressman asking in no uncertain terms that I turn a set of FDA documents over to his committee; on the bottom, he had written, "Welcome to Washington and good luck."
On learning of my nomination, Michael Calhoun told a high-level staffer in the legislative affairs office of the Department of Health and Human Services to "encapsulate" me. When the Senate Committee on Labor and Human Resources, which was preparing for my confirmation hearings, asked me to respond to a list of questions, the Department tried to insist on writing the answers for me. Assuming it was my views that the senators wanted to hear, I refused.
"This is my confirmation," I said. "I'll answer the questions."
Everyone believed the congressional vote to approve my nomination would have to wait until after the holidays when the new legislative session began. But a sense of urgency took hold, as Congress and the White House decided that the FDA had gone long enough without a commissioner. There was a push past formalities, and in the end I was confirmed in a record eight days. Never again would I have it so easy in Congress.
I was thirty-nine years old, and I was supposed to clean up an agency in crisis. The giant clown in the Mardi Gras parade had picked up a new head.
(C) 2001 David Kessler All rights reserved. ISBN: 1-891620-80-0