Cool Things About Being Retired
INTERESTING STUFF: 22 September 2010

REFLECTIONS: On A Devil and a Saint

SaulFriedman75x75 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.


Category_bug_reflections 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.


At The Elder Storytelling Place today, Johna Ferguson: Part 2 First and Last Boat Ride

Comments

Saul,

Excellent! I have to confess this is the first time I've heard of Dr. Kelsey and her amazing achievements and fascinating career.

Seems we owe a big "thank you" to the doctor.

Newt "The Grinch" Gingrich can go suck an egg for all I care about him. What a jerk.

Wow. I started into this expecting to be informed as usual. Informed I was, but also educated with an incredible array of information in two important areas. Thank you, Mr. Friedman.

Aren't we all just sick of Newt? Some people outstay their welcome, even on hype-TV.

Thank you, Dr. Kelsey, for your courage and determination. Thalidomide was being tested when I was pregnant with my son. I had endured a horrible nine months with my first pregnancy that involved nausea almost from the moment of conception to being in labor. I had lost 20 pounds so you can see how sick I was. My doctor said that the drug would prevent nausea with this pregnancy and urged me to try it. I didn't know that it wasn't on the market yet and took one treatment (I think it was by injection), which, mercifully did not help so I did not continue.

As for Newt, he has made an art of talking fast and sounding so positive that gullible people are impressed. If you sound like you know what you are talking about it sways so many. He is an opportunistic hypocritical fraud.

Thank you for another well informed article.

One of my distant cousins lived near him (same street) and he was not at all popular in their neighborhood.

Well done, Saul. Thank you for the story of Dr. Kelsey. Thank you for showing why government regulation is necessary. Thank you too for juxtaposing Newt Gingrich the destroyer's flaws with Dr. Kelsey the builder's virtues.

I worked for UCSF for over 30 years and was the assistant to the Chief of the Neonatal Intensive Care Nursery. The doctors I worked for were extremely ethical and conscientious about what drugs they used on newborns but they were constantly bombarded by pharmaceutical reps to use the latest fixer-er-upper, regardless of it's efficacy or safety. If those doctors, at the top of the medical ladder came under such relentless pressure to use non-approved drugs, I can only imagine the pressure on other medical personnel. We also saw the FDA gutted by the various Republican administrations and knew that it was only a matter of time before we had another thalidomide tragedy. Thanks for detailing the career of the slime bait that's bedeviled our politics for far too long. It's another tragedy - not medical this time - that he and his ilk are getting louder and more destructive all the time.

Thank you, Saul, for always bringing us the most informative columns.. You are to be commended..I know I appreciate you and I'm certain others look forward to your appearances,too.

I don't care for Gingrich either. I do not like over the top conservatives. I'd prefer Sarah Palin--just kidding. Gingrich has no prayer of getting nominated, Palin does. What a disaster, in my opinion, that would be reminicent of Goldwater back in '64. I voted for Obama--believe it or not--and probably will again. Please don't ask me why :). See, I'm really one of you.

Come on John, you are pandering.

It is easy to understand why journalists are a cynical bunch of folk; for you get to connect the dots of history while it is happening. This was a fascinating article, even though it is unsettling since Gingrich is still around and talking.

Whenever I see Gingrich on TV, I think, "why is that guy still around?" He is a obnoxious, self promoting bore, totally in love with the sound of his own voice. What a contrast between Dr. Kelsey and Gingrich. Thanks, as usual for another informative article. Your insights are much appreciated.

Let's drag out those pictures of those poor deformed babies and use them as an example of what the Republicans believe in. It would make for memorable political ads. Also, does anybody besides me read these stories or listen to the latest TeaPartiers' rants and and think of Nazi Germany? Bring up the Holocaustand people ask "How could the German people let that happen?' Well, we will let it happen if these wolves with their sheep followers get their way. Government and its rules and regulations helps make us a civilized nation. (I'm stressed, can you tell?)

Newt and his ilk invoke God constantly but do nothing to back it up but shout inanities that any sensible person would reject.

This is why my blog is languishing for the moment. I am working hard to help my Congressman in his race to keep the tea party out of Congress.

Thank you for this very informative article. I have trouble with understanding the complexities of politics sometimes. Words like "The Devil" and "Saints" can make me feel overwhelmed with what I'm looking at in trying to comprehend policies. However, I CAN recognize the difference between a builder and a destroyer. In this I have a new way of truly "seeing" what I am "looking at" in politics. I thank you for that.

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