Pulitzer Prize-winning journalist Saul Friedman (bio) writes the twice-monthly Reflections column for Time Goes By in which he comments on news, politics and social issues from his perspective as one of the younger members of the greatest generation. His other column, Gray Matters, formerly published in Newsday, appears each Saturday.
My years in daily journalism enabled me to meet the best and the worst: A quiet, unassuming young woman in my Cape Town writing class had her own story to tell; she had been imprisoned and tortured by the South African regime she fought and now she wanted to be a political reporter in her newly freed country.
Some years earlier, a Houston detective who was a friend, lectured school kids (including mine) on the evils of drugs, then killed himself a few yards from my office at police headquarters because he too turned out to be a drug dealer.
No wonder reporters become cynics; the evil that men do lives after them the good is too often buried with them. Recently I was reminded of a couple of memorable encounters in one of my last years in daily reporting, 1995, when I met, interviewed and wrote about a devil and a true saint.
Satan, in this case, was personified by Newton Leroy (Newt) Gingrich, who was then the new speaker of the House of Representatives. The saint was (and is) Dr. Frances Kathleen Oldham Kelsey, a senior pharmacologist for the U.S. Food and Drug Administration, who was still working at age 80 when I met her.
As far as I know, Gingrich and Dr. Kelsey have never met. But in a manner of speaking, their paths crossed in early 1995, which is how I came to meet them both that year.
Gingrich’s blustering and boisterous Republicans had taken over the Congress and were shaking up Washington with their notorious “Contract for America.” Dr. Kelsey, who had been given a medal by President John F. Kennedy in 1963, still came to work daily at her cluttered desk in Washington’s suburbs, reviewing applications for new prescription drugs, protecting the safety of the millions who use medicines. Indeed, because of people like Dr. Kelsey, the U.S. brands approved by the FDA are the most trusted.
For those who don’t know or have forgotten who she is, Dr. Kelsey, a Canadian born M.D., had gotten her training in the Thirties as a researcher in pharmacology at the University of Chicago. Her boss, E.M.K. Geiling, had hired her thinking Frances was a man. She accepted the job without telling him the truth.
She distinguished herself assisting him in discovering, on contract with the FDA, that a popular drug, Elixir Sulfanilamide, had caused 107 deaths because of an ingredient, diethylene glycol, a solvent now used as anti-freeze. Two years later, in 1938, the Congress passed the landmark Federal Food, Drug and Cosmetic Act. It would not be the last time that Kelsey would have a profound effect on our food and drug laws. Kelsey won her PhD as a result of her work and had developed an interest in drugs that caused congenital malformations.
Fast forward to 1960 after she obtained her M.D. and married a colleague, Dr. Fremont Ellis Kelsey, (they have two daughters). That year Frances came to work at the FDA as one of a few physicians reviewing drugs and one of her first assignments was to consider the application of a drug maker William S. Merrill to license a drug called Kevadon, whose generic name was thalidomide.
The drug, developed in Germany, was a popular and best-selling sedative or tranquilizer, depending on the dosage, because it relieved nausea and other discomforts of pregnancy during the first trimester.
It was widely used in Canada, 20 European countries and Africa, but not in the largest market, the U.S. You can imagine the pressure she was under from Merrill, which had millions of dollars at stake. Some of her bosses pressed Kelsey for a decision. But she persisted in seeking additional information to explain a curious British study that documented nervous system side effects and possible birth defects.
By the spring of 1962, she was reading reports from Europe, in the technical literature not widely circulated in the States, that many of the thousands of mothers who had taken thalidomide were reporting horribly deformed babies – born with flippers, but no arms or legs. The impatient drug maker, William S. Merrill, mimimized these reports and gave away some thalidomide pills as a promotion, which added pressure on Kelsey (and resulted in ten deformed children).
Enter a Washington Post reporter, Morton Mintz, who by way of another reporter got a tip from an aide to the late Senator Estes Kefauver (D, Tenn.) that Kelsey had been fighting a battle to keep the drug off the American market. Kefauver had been trying to strengthen the FDA and thalidomide seemed a perfect example of the law’s weakness.
In July 1962, after interviewing Kelsey and pinning down what was happening to thousands of children outside the U.S., Mintz broke his story, a lengthy piece that began
“This is the story of how the skepticism and stubbornness of a government physician prevented what could have been an appalling American tragedy, the birth of hundreds or indeed thousands of armless and legless children.”
Dr. Kelsey, he wrote, “saw her duty in sternly simple terms and she carried it out, living the while with insinuations that she was a bureaucratic nitpicker, unreasonable and even...stupid.”
As a result of the story, Kelsey’s work and the ghastly photographs of deformed children (there were relatively few in the U.S.), the Congress passed a series of amendments to the Food and Drug and Cosmetics Act in 1962 requiring that drugs must be effective as well as safe, which meant extensive testing.
Kelsey, as I mentioned, was awarded the Distinguished Civilian Service Medal in August, 1963, become a legend at the FDA and one of the most honored civil servants.
But as you would expect, the drug manufacturers, now called the Pharmaceutical Manufacturers and Research Association, were unhappy with those Kefauver amendments, charging that prolonged testing was too costly and kept needed, if risky, drugs from the market for too long.
During the deregulation campaigns of the Reagan and first Bush administrations, the size and budgets of the FDA suffered by as much as 30 percent. Reagan claimed that delays in drug approvals were “needlessly killing Americans.” But the agency persisted and Democratic congresses resisted attempts to dilute the laws.
But after Republicans took control of the Congress in 1994, Newt Gingrich declared war on the agency calling it the “number one job killer in the U.S.” And, with his customary hyperbole, he called the agency’s head, Dr. David Kessler “a bully and a thug.”
Kessler’s crime? Trying to label tobacco a substance to be regulated. As Mother Jones magazine reported, “a powerful bloc of critics in the drug industry has joined hands with the Republican Congress...to overhaul the FDA.”
Indeed, Gingrich formed an organization headed by a crony, the Progress & Freedom Foundation, which proposed placing the responsibility for the testing and review of drugs in the hands of private firms, including the drug companies. FDA spokesman Jim O’Hara charged that what
“...this proposes is the dismantling of many of the safeguards that protect the public from drugs and devices that are unsafe or just don’t work. This is a proposal that says public health and safety are commodities for the market place.”
The Progress & Freedom Foundation, supported by contributions of drug manufacturers, also sought to limit the liability for drug companies if their products killed patients.
As a Newsday reporter assigned to cover the new Congress and Gingrich, I remembered the work of Dr. Kelsey on thalidomide and, to my surprise, she was still on the job. O’Hara arranged an interview so I could ask her about the latest attacks on her agency and the drug industry’s attempt to take over what she’s been doing for 57 years – carefully, with occasional nitpicking, reviewing the efficacy and safety of the drugs we give to ourselves and our children.
Kelsey, then the director of the FDA Office of Scientific Investigations, was publicity shy. But when I saw her, she was moved to speak out.
“The drugs today are not castor oil,” she said. “I’ve lived through days when we didn’t have the advantage of today’s regulations and look what happened. Now drugs have gotten far more complex and, yes, dangerous. There is margin of safety. Let’s not go backwards. We’ve seen enough tragedy.”
An industry lobbyist told me at the time that many drug manufacturers don’t want the responsibility for reviewing and approving drugs for that meant giving up the safety seal of approval they get from an FDA license. Other industry lobbyists sought to repeal the Kefauver amendments and leave the question of efficacy to the doctor and the patient. Kelsey told me,
“In a perfect world, that might work if doctors knew what they were doing and patients knew what they were getting. But drugs and genetic engineering compounds are becoming increasingly complex.”
William Schultz, then the FDA’s deputy commissioner added,
“All drugs carry some degree of risk. We are prepared to take the risks, as we do with the horrible side effects of chemotherapy, if the drugs are also effective. But if the risks outweigh the effectiveness and the FDA cannot require efficacy, then there can only be confusion about what drugs to take. And a very vulnerable population will be open to fraud.”
As things turned out, the FDA stepped up its approval process and gave industry some responsibility for reviewing some if its products. But the Kefauver amendments, the direct result of Kelsey’s work on thalidomide, survived while Gingrich’s Contract for American mostly fell flat. In fact Gingrich, has flashed like a ragged meteor trailing a dust cloud in the firmament, but if you examine his careers, his real accomplishments are rather minor. For Gingrich is a destroyer, not a builder.
Just four years into his tenure, Gingrich lost the speakership and his House seat after he forced a shutdown of the government ostensibly in a budget clash with then President Clinton. But according to a close ally, Gingrich was angry that he had been given a back seat on Clinton’s Air Force One.
In any event, the shutdown helped Democrats win seats in the House and contributed to Clinton’s re-election in 1996. Gingrich was fined for repeated ethics violations, the first speaker so punished, and in 1998 he resigned and his revolution went with him.
Now, with Barack Obama in the White House, Newt Gingrich has done little that might be called constructive. He has made a career out of saying almost anything to destroy the presidency and the federal government, which pays him a pension. In 1995 after the Oklahoma City federal building was bombed, I confronted Gingrich in Atlanta with a question: Might his constant anti-federal government rhetoric have contributed to the mindset of the bombers. I don’t remember his outraged denials, but he protested too much.
Personally, Gingrich has what might be called a checkered past and present. He boasted to me one day that he was a Vietnam War draft dodger. He divorced his first wife, while she was ill with cancer. And left his second wife, Marianne, for a blonde aide. Callista, his third wife.
Despite his obvious personality flaws, he is given an audience if not credibility. Some friends say this one-time history professor has gone too far, off the deep end. His trademark is speaking for the sake of shock and awe, saying almost anything no matter how foul and far out to get attention.
It’s the advice he gave Republicans long ago. Use incendiary language, he urged. And in the past months he has followed and often led the right-wing nuts lower and lower into the political depths, the underworld. And why not? That’s where Satan lives.
As for the saint, I’m pleased to report that Dr. Kelsey, who retired six years ago at age 90, has just received the first “Kelsey award” for outstanding service to her agency and the American people.
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