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In our current culture, the phrase "government bureaucrat" is often used as an epithet, but Frances Kelsey-who died on August 7 at age 101-was a career government bureaucrat who was also a genuine American heroine.
In the early 1960s, Kelsey, a doctor and research scientist with the federal Food and Drug Administration, almost singlehandedly took on the pharmaceutical industry. She stood up to the manufacturer of a dangerous medicine-thalidomide-and saved tens of thousands of babies from birth deformities.
If you are in your 40s or 50s, Kelsey, working quietly in her FDA office, may have saved your life, by making sure that your doctor didn't prescribe thalidomide to your mother.
Kelsey's battle with the makers of thalidomide is an inspiring tale of how one individual's expertise and courage protected the public against the greedy drug companies.
Equally important, Kelsey's stance inspired Congress to revise the rules for approving new drugs protecting hundreds of millions of Americans, then and now, from unsafe medicines. In doing so, she helped restore the public's faith in government's ability to protect people from reckless corporations who would knowingly put dangerous products on the market.
In the annals of science, Kelsey is considered the patron saint of drug safety. A highly-trained scientist, she recognized that science could be misused by corporations who put profits over public safety. But until a sympathetic newspaper reporter described her battle with the drug companies, she worked in relative anonymity.
After World War II, American business embarked on a crusade to persuade Americans that science and technology could save humankind from the threats of disease, war, and hunger, and could make society more efficient and productive and life easier. DuPont, for example, promoted its products through the popular slogan "Better living through chemistry."
Americans were thrilled by advances in modern medicine that created "miracle drugs" like penicillin, the polio vaccine, and others that helped wipe out many diseases. But our love affair with medicine had a serious downside. Many Americans, as well as Europeans, got hooked on sleeping pills and tranquilizers. One out of seven Americans took them regularly.
Thalidomide was first introduced in Germany in 1957 by Chemie Grunenthal, a drug company. It was considered safe enough to be sold as a sleeping pill without a prescription. Then doctors began giving it to their pregnant patients suffering from morning sickness.
By 1960, the company was marketing thalidomide in 46 countries, but not the United States. Its sales were almost on a par with aspirin.
In 1960, Richardson-Merrell Pharmaceuticals applied for FDA approval to market thalidomide in the United States under the brand name Kevadon. At the time, pharmaceutical companies were required to show that their drugs were safe, but could sell drugs 60 days after they submitted requests to the FDA, so long as the agency didn't object, which it rarely did, because it mostly relied on the manufacturers for information.
At the time, the FDA did not require scientific clinical trials. Drug laws back then allowed companies to send new drugs to doctors for "research purposes," so Richardson-Merrell distributed thalidomide tablets to more than 1,000 doctors who gave them to about 20,000 patients. Approximately 3,760 of them were women of childbearing age, including at least 207 who were pregnant. The doctors were not required to track their patients to find out if the drug was working or having any harmful side effects.
Assuming that the Kevadon application was a slam-dunk, the FDA assigned it to Kelsey, who had just arrived at the agency a month earlier. Born on Vancouver Island, British Columbia in 1914, she had earned her bachelor and Master of Science degrees in pharmacology from McGill University, and her Ph.D. in pharmacology as well as a medical degree from the University of Chicago. She taught pharmacology at the University of Chicago and the University of South Dakota and worked as a general practitioner from 1957 to 1960, when she moved to Washington to work for the FDA. She was one of only seven full-time physicians reviewing drug applications.
Kelsey's power to approve or deny the company's application was the result of the 1938 Food, Drug and Cosmetic Act. In late 1937, hundreds of children were poisoned and died after being given the antibiotic, Sulfanilamide, a medicine used for strep throat that was dissolved in a toxic solvent to make it easier for children to take. The pharmaceutical industry vigorously opposed the law, claiming it would be economic disaster for the drug makers and pharmacies. But despite that powerful opposition, the law passed after the scandal came to light and outraged the public.
Kelsey, who as a graduate student had helped with the Sulfanilamide investigation, quickly figured out that there was something fishy about Richardson-Merrell's Kevadon application. She had seen a British study that linked thalidomide to significant neurological side effects. She discovered that many of the company's claims that the drug was safe were not backed up with evidence.
Kelsey asked the company for additional information. She demanded that Richardson-Merrell contact the physicians who were given Kevadon samples, but the company didn't comply. She then asked the company for the names of patients who had been given the samples, but the drug company didn't provide the list. Instead, Richardson-Merrell harassed Kelsey with constant phone calls, went behind her back to talk with her superior and threatened to file a lawsuit. They called Kelsey a stubborn and unreasonable bureaucrat.
Kelsey refused to back down. She conducted further research and discovered that some of the documents used to "prove" thalidomide's safety were falsified. She discovered that some European doctors reported that a growing number of children were being born without limbs or with flipper-like arms and legs, but Chemie Grunenthal denied that there was any connection between these deformities and the drug.
Richardson-Merrell viewed Kevadon as a big money maker and was in a hurry to get FDA approval. Its Kevadon supply was already in its warehouses. It had already given the samples to 1,000 American doctors for alleged "research" purposes. Its marketing campaign was ready to go. In fact, assuming that the FDA would rubber-stamp its application, Richardson-Merrell had already created a marketing brochure for its salespeople claiming that it had ". . . firmly established the safety, dosage and usefulness of Kevadon by both foreign and U.S. laboratory and clinical studies."
But thanks to Kelsey, the company never got to use those brochures. She recommended that the FDA deny the company's application.
Her concerns were vindicated when it came to light that at least 10,000 children in Europe, Australia, Japan, and Canada were born with abnormally short limbs and in some cases without any legs, arms, or hips. Thanks to Kelsey, the United States was spared this tragedy, with fewer than 50 cases of thalidomide-related birth defects, due to the samples the company provided doctors, who then gave the drug to their patients.
But Kelsey did more than stop one drug company from marketing a dangerous drug to the public. She was also the catalyst for a major change in federal drug safety laws.
Senator Estes Kefauver, a Democrat from Tennessee, had been trying for years to pass legislation to strengthen federal regulation of drug approvals, but industry lobbying had thwarted any progress. Then, on July 15, 1962, The Washington Post published a front-page article by reporter Morton Mintz, "Heroine of FDA Keeps Bad Drug Off Market," exposing Kelsey's role in preventing a thalidomide epidemic.
Kelsey didn't enjoy the spotlight and she always reminded reporters and others that she worked as part of team, giving credit to her pharmacologist Oyam Jiro and her chemist Lee Geismar, as well as her superiors at the FDA. But she reluctantly agreed to testify before Congress and speak to women's groups and on college campuses.
In 1962, President John F. Kennedy presented Kelsey with the Distinguished Civilian Service Medal, the highest honor available to civilian government employees. At the White House ceremony, Kennedy said, "Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States."
Public Domain
The publicity surrounding Kelsey was useful to the Kennedy administration and members of Congress, especially Kefauver, who had been trying to pass stronger regulations on pharmaceutical companies.
Kelsey's celebrity strengthened Kefauver's hand. The drug companies opposed Kefauver's efforts to strengthen government rules and FDA authority. They claimed that new pretesting requirements would harm patients by keeping drugs off the market; that publicizing the side effects of drugs was unnecessary because it was really the physicians' responsibility to warn their patients; and that increased regulation of drugs would give government control over our lives.
But as the horrible effects of thalidomide on newborns became public, the industry opposition was overwhelmed by public demands for more government regulation and safer drugs.
Congress soon enacted the Kefauver-Harris Drug Amendments Act in 1962-giving the FDA more authority to demand that drug makers prove their products were not only safe, but also effective before receiving approval to market them in the United States. The law mandated that drug manufacturers maintain records of adverse events linked to drugs and promptly report these to the FDA. It required that advertisements of medications include information about their side effects.
In 1962, a Gallup national survey found that Kelsey was one of the ten "most admired women in the world." That year, the FDA established a new division to test and regulate new drugs and put Kelsey in charge. She later became director of the FDA's Office of Scientific Investigations. She helped revise medical-testing regulations that protected consumers and challenged conflicts of interest between doctors and drug companies. The "revolving door" between government agencies and the businesses they regulate has long been a way of way of life, but Kelsey never went to work for the drug industry. She worked at the FDA for 45 years, retiring in 2005 at 90 years old.
In 2010, the FDA initiated the Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health. Fittingly, it selected the 96-year old Kelsey as the first recipient.
Around the same time that Kelsey was battling the drug companies, another woman scientist, Rachel Carson, was taking on the chemical industry. Her bestselling book, Silent Spring, published in 1962, carefully documented the dangers of pesticides and herbicides. In that book, Carson, a biologist who spent many years working for the U.S. Bureau of Fisheries (now the U.S. Fish and Wildlife Service), revealed the long-term presence of toxic chemicals in water and on land and its threat to animals, the habitat, and humans, including DDT in breast milk. She accused the chemical industry of intentionally spreading misinformation and government officials of uncritically accepting industry's claims. Her book, and her Congressional testimony, helped spark the modern environmental movement, which pushed Congress to establish the Environmental Protection Agency in 1970. Two years later, the federal government banned the use of DDT. Unlike Kelsey, Carson, who died in 1964, never saw the changes that her work had inspired.
Cynicism, even hostility, toward government has escalated since Kelsey and Carson became celebrity scientists.
Especially since the start of the Ronald Reagan era in the 1980s, conservatives have been on a crusade to shrink the size of government-particularly the agencies and policies designed to make business act more responsibly toward consumers, workers, and the environment.
Reagan's most famous statement-"Government is not a solution to our problem. Government is the problem"-has become the unofficial slogan for the recent resurgence of right-wing extremism. Corporate lobbyist Grover Norquist, president of the conservative group, Americans for Tax Reform, once famously said that he wanted to reduce the size of government to the point "where we can drown it in the bathtub." Fox News, Rush Limbaugh, Glenn Beck, the Tea Party, and propaganda outfits like the Cato Institute and the Heritage Foundation all share this antipathy toward government-especially taxes and regulations.
Today's corporate lobbyists-like Richardson-Merrell Pharmaceuticals a half century ago-never claim that they want to weaken government to increase profits for shareholders. They, and their political and media allies, argue, instead, that government standards are a "burden," that they are "arbitrary," that they snag companies in "bureaucratic red tape," that they deny consumers "choice" in the marketplace and that they "kill jobs." They attack "overzealous" regulators who, they claim, thwart innovation.
These words are consistently echoed by the Chamber of Commerce, industry lobbyists, right-wing think tank propagandists, and their allies in Congress, especially (but not only) Republicans who do the bidding for drug and food companies, the mining, chemical, and oil industries, and other business interests. The FDA, because of its broad authority over many industries, is one of their favorite targets.
For example, former House Speaker Newt Gingrich was a long-time foe of the FDA. As a presidential candidate and corporate influence peddler, he's continued his attacks. Last year he called the FDA "an obsolete bureaucracy with obsolete rules that do more harm than good." Representative Fred Upton, a Republican from Michigan, who chairs the House Energy and Commerce Committee and is a major recipient of drug industry campaign contributions, recently sponsored a bill he claimed would "accelerate new cures and keep America as the innovation capital of the world," but which consumer groups said would put consumers and patients at risk by requiring the FDA to speed up the approval of certain drugs and lower safety standards. Representative Darrell Issa, a Republican from California, chair of the House Committee on Oversight and Government Reform and a major corporate ally, has called the FDA a "broken bureaucracy." Representative Joe Pitts, a Republican from Pennsylvania, who chairs the House Energy Subcommittee on Health, has attacked the FDA for "needless bureaucratic barriers that hurt patients and jobs."
There are many voices today-among elected officials like Elizabeth Warren, and activists in the consumer, environmental, and labor movements-calling for stronger regulations on banks and other corporations. But few Americans today could identify a career public servant-a "government bureaucrat" like Frances Kelsey-whom they admire.
In fact, there are tens of thousands of people like Kelsey working today in government offices and labs around the country, quietly protecting Americans from products that could kill or injure them if their manufacturers were allowed to make and market them. They work as researchers and inspectors for the FDA, the Occupational Safety and Health Administration, the Federal Aeronautics Administration, the Environmental Protection Agency, the National Transportation Safety Administration, the Centers for Disease Control, the Consumer Product Safety Commission and other federal agencies, as well as in state and local government. Every day, they save lives.
In the 1960s, for millions of Americans, Kelsey was the public face of government and an inspiring figure. If we want to restore American's faith in government, we need to identify and extol the work of the many government bureaucrats today who stand in Kelsey's shoes.
