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Dr. Frank Young: making a difference.

Upon his FDA rests' the safety of products accounting for 25 cents of every dollar consumers spend.

One day last year I found myself on a podium shared by Dr. Frank Young, commissioner of the FDA. We were both speaking on the subject of AIDS, and something akin to love at first sight occurred as I listened to this accomplished raconteur respond to a question about transmission of the dreaded virus.

But you never say never," he cautioned the audience when asked about the possibility of catching a disease from some unlikely method of infection. It reminded him of when he was a medical student and a patient came in with a neck lesion that resembled a syphilis cancre. Yet the back, of the neck was not a place a man would ever be exposed to the Treponema pallidum, a bacterium which burrows in and causes syphilis. Or so the doctors thought. (Syphilis, being sexually transmitted disease, is expected to cause those pesky chancres in areas that touch the genitalia. Everyone knows that the little serpentine-like syphilis spirochetes can burrow through a woman's uterus right into her developing baby but can't live. more than seconds outside their warm moist environment.).

So the teaching physicians continued to ruminate about what could be causing this patient's strange outbreak, Tests were run and numerous possibilities ruled out. And than, in the quiet of a private interview with the patient, our then young Dr. Young, curious medical sleuth that he is, was able to get to the: bottom of this medical mystery, The patient confess 'ed that at night he like to play piggyback with his girlfriend--he would hoist her up on his shoulders with her legs on either side of his neck. Holding her feet in front of him, he would dance about the room. A little imagination could explain how the chancre might have appeared in this most unlikely place. Cavorting in this position had put a sexually transmitted eruption on the back of his neck. Lab ' tests found evidence of the T. pallidum and proved that, our budding Sherlock Holmes: had scored again in his early medical detective efforts.

"You never say never," he repeated, and probably not one person in the audience will ever forget the scientific message he brought home to us. "Hundreds of shared podiums blur in my memory, but Frank Young's earnest teaching and subtle humor will never be forgotten. The audience that day, mostly clergymen attending an annual Congress on the Bible, applauded his masterly presentation. He won our hearts with his lack of pretense and his willingness to poke fun at himself as a means of making a point. Nothing mattered except that the truth be expressed honestly and scientifically.

After the session, I was determined to learn more about this scientist of rare wit, great curiosity, and firm grounding in Biblical literature. We compared calendars and arranged to spend a morning together at FDA headquarters in Rockville, Maryland. During that visit I was delighted to note that quick wit is as much a part of the private Frank Young as his public persona. It's been said that a senscts of humor is a sign of intellgence. We can all hope that this adage holds true in the case of Dr. Young. Lives will be saved and lives will be lost on the basis of the judgments he makes. The agency he leads regulates not only food and drugs, but also radiological and medical devices, human vaccines, veterinary drugs, and even cosmetics.

And if this man needs the wisdom of Solomon, he has researched that too. As we shared thoughts on the awesome medical issues that face the country he quoted I Kings 3:9: "Give therefore thy servant an understanding heart to judge thy people, that I may discern between good and bad." The verse has special meaning to him, he explained, because he took his job "because there is a need to discern between what's good and what's bad."

What's good and what's bad? The questions are tough, and the answers complex, Dr. Young admits. Should AIDS patients be permitted to use drugs without FDA approval? Or will AIDS patients then be prey to exploitation and be subjected to remedies that could harm?

Should blood banks and hospitals be denied the use of a test to eliminate HTLV-I from the blood supply just because the FDA hasn't assured itself that the test is it perfect one?

Should irradiation of food be permitted to prevent salmonella infections?

Acutane is good for acne, but it causes birth defects if taken during pregnancy: what if a prescription is given to a teenager who unintentionally or unknowingly is pregnant?

What should be done about aspirin educational materials and Reye's syndrome?

What about the cost of tamper-proof packaging?

Should cereal companies and other food processors be permitted to advertise health claims on their packages?

Gay-rights pickets carry placards and shout, "Test drugs, not people!" The commissioner must represent everyone, listen to all arguments, make decisions, and direct the speed with which new drugs are reviewed and approved. (AIDS drugs get a 1AA-speedy-priority' )

Dr. Young's position has been called a "hot seat," so hot that it was occupied by five men in the seven years prior to his appointment.

"Did you seek this job or did the job seek you?" I asked him in the privacy of his adequate but spartanly furnished office on Fishers Road,

"I don't know how I got it," he confessed.

"You were just called?"

"I got a call when I was dean of the school of medicine and dentistry at Rochester University," he said. "It was a difficult time because I was planning for the Capital Campaign at Rochester, and we had just remodeled our house. But then I remembered something told to me by my pathology chairman, Dr. Alan Moritz, when I was a young pathology resident. He said, 'Someday it will be your responsibility, because you have been given so much support by the U.S. Public Health Service in the development of your career, to go forward to defend this for the next generation.' The concept of public service was very deep in him. Since that time, I had always thought that sometime I would want to be of service to the government. As my pathology chairman had said, I had been given a lot when I was first trained-I was supported by a public-health fellowship, I got my training in graduate studies and my training in research, and then I had research grants all my life."

The call for government service initially came from Schuyler Baab, and the message was striaghtforward. The post at the FDA was open. Would he be interested in it? "I said, 'No, I don't think so. I'm very happy here.' He said, 'Would you come down and talk?' So I came down, and I met with Schuyler Baab, and George Siguler. They showed me the FDA and said, 'Well, what .do you think?' I said, 'There are problems here, and I'd attack it this way if I were to ever do it. But I don't want to take the job. I'm very happy in my job.' About a week later a follow-up call came, and they said, 'Would you be interested in coming down to speak with the secretary? We're very interested.' And I said, 'No, l really can't mislead Mrs, [Margaret] Heckler. I really don't think I would take the position.'

"I had never met Mrs. Heckler before. And I didn't think I'd take the job, but they kept saying, 'We really want you to come.' So finally I said, 'If you'd like, I'll meet with her, but it's got to be under no pretense, because I'm not going to take' the job.' So they 'said, 'Well, she's going up to New York City-would you meet with her there?'

"So I met with her. I'd done enough homework to, know that the acting commissioner was very, very good, and when I met with her I said, 'Well, Madame Secretary, you've got a wonderful acting commissioner. He's a good man.' She replied, 'We want you.'

"And now I'm getting more and more interested in the idea and I said, 'Well, if you'd like me to come, what I'd like to do is develop an action plan. If you really want me to come, I want you to know that I am interested in making the changes that we discussed.'"

"And what were the changes?" I asked.

"They're now known as Action Plan Phase I," he explained. "We did the Action Plan because this was our way to overcome the criticism that had been leveled at the FDA."

That the FDA staff had become known as medical policemen was no secret. Deservedly or not, manufacturers ridiculed FDA field men for "chasing toothpicks" while, they lamented, applications for new drug approvals were choked by the red tape in this organization. More than 7,000 employees come under Dr. Young's direction.

The tone of Dr. Young's leadership was set within a year or so after his swearing-in ceremony"We must act with deliberate haste in getting approval on drugs for AIDS and other urgent and disastrous diseases," he said. Proof of his determination to pick up the pace in fighting AIDS came with the FDA's quick but thorough evaluation of the ELISA and Western blot tests. AZT was given the fastest drug, approval in the agency's history-107 days. If past policy had been the "slow but sure" variety, Dr. Young prefer"fast but sure" variation.

Despite his earlier reservations, Dr. Young clearly enjoys every minute of the job now. His enthusiasm for the post and the gratification in seeing opportunity to improve the-FDA knows no bounds. More than four years after assuming, th"hot seat," his cool management style has prevailed.

He has tiptoed carefully through the minefields of AIDS dilemnias, quickly winning the respect of the majority of members of the Presidential AIDS Commission. The FDA responded promptly to the AIDS ComMission's concerns about the safety of the blood suply. Dr. Young has won acclaim for not being afraid of making a few waves. "He dares to take some chances in that agency," said one Washington sage who respects Dr. Young's courage.

It also took some bravery for Dr.. Young to, report the FDA's preliminary results of its investigation for the first 192 blood banks inspected. A shocking 12 percent had violated thcts agency's regulations. Fourteen Red Cross centers were cited for violations, and many have recalled products. In response to these problems, the Red Cross has signed an agreement with the FDA outlining steps it will take to eliminate the problems.

"It's embarrassing, but 'I'm glad thats FDA officials came in and pointed it out to us," a blood banker said, His remarks were echoed throughout the country among those who were concerned about blood-banking hazards.

Although Young's professional career has been varied-he's an expert-on gene splitting a former professor of microbiology, and an editor of a medicaljournal--it's as though he's been preparing for this, current assignment all his life. "I've been through the experience of literally having people dying before my eyes while they're waiting for medicine to be approved that could save them," he said.

"In science, especially when dealing with a lifethreatening disease, you must keep an open mind, be compassionate, but not disguise the truth," he told us. He cited a story to illustrate his point. "When I was directing the medical center at the University of Rochester in New York, people occasionally would come to me who had a spouse or child suffering from, some untreatable disease or who were themselves desperately ill. They'd ask my help in obtaining some promising but still experimental treatment. Sometimes they had heard that the treatment usually a new drug-was being tested at the National Institutes of Health in Bethesda, Maryland. 'But I don't have the money to move myself and my family there," they'd say. 'If I can't get this treatment, there's no other hope, Dr. Young, is there anything you can do?'

"I'd have to try to explain that the controlled clinical trials such as, were being done at NIH were necessary, even though they took precious time. If they proved successful, in another year or two the drug could be approved by FDA and I could obtain it for them. 'But, Dr. Young,' they'd reply, 'my wife will be dead in six months.'

"The memory of such anguish and hopelessness still haunts me," Dr. Young explained, "and I think of this experience often as I deal with the urgency of finding a treatment and Cure for cancer and for AIDS."

Shortly after Dr. Young assumed his job, his mother died of cancer, and he -too was diagnosed as having cancer-a malignant melanoma behind his ear. It was removed and the prognosis was positive. "The survival index is very good-94 to 97 percent-but I can identify with people who have gotten frightening diagnoses," he says.

An evnt that occurred in this same time frame and continues to have a lasting effect on-him youngest son, Jonathan, was injured during a highschool wrestling match. Thats youth experienced total. paralysis and two broken vertebrae, and his heart stopped beating for 40 seconds.

"I sensed myself fading away," Jon recalled much. later. The comeback fight was long and difficult, but. today Jon attends college, has occasional physicaltherapy sessions, and hopes to regain more use of his left hand and leg, His courage, was recognized in 1987, when he was given a Victory of the' Human, Spirit Award at a celebration for which First Lady Nancy Reagan was the honorary chairman.

Certainly part of the reason Dr.. Young has' successfully weathered his share, of tragedies bag keen toe support of his wife, Leanne. When I asked him how they met, he beamed. "I noticed this very attractive blonde nurse while I was on my surgery clerkship at Upstate Medical School," he said. He speaks lovingly of her and their fast-pacects Courtshivp. They met in Fegruary, they had their 'first date in. March, he took her home to meet his mother in April, and he proposed two months later. On October 20, they'll celebrate their 33rd wedding anniversary.

"We had the first four children in 5 1/2 years." he noted"She stopped her nursing career right away, and she's been a full-time wife ever since. Actually, she says she's a very well-kept, woman." Part of her role as wife of this busy public servant has been to understand his long hours, at the office and his even longer hours at his desk at home. If he expects a great deal of commitment from his staff at the FDA, he sets a good example with his own dedication. He frets that so much needs to be done, and that it must be done expeditiously.

"There is such a degree of desperation, and people are going to die that I'm not going to be the commissioner that robs them of hope," Dr. Young. says, ne said his agency wa "walking a fine line" by allowing some quantities of drugs for Aids and other diseases to enter the United States from overseas even though they have not been proved safe and effective by FDA standards. Dr. Young defended instituting-changes that would give patients. with lose greater. freedom to try experimental new drugs that just might save their lives.

When a colleague asked Dr. Young whether pressure from the Wall Street Journmal influenced him to give a fast FDA approval to the heart drug TPA, he said: "No, I want you to know that it was my father, Frank Young, Sr., because my father died of his first and only coronary, and I just close my eyes and see him lying next to the couch on the living-room floor when I came in. There were police cars outside with their red lights flashing. He was 45 when he died, What drove TPA approval was my vow to do whatever I could and. as much as possible for heart disease. Lower cholesterol less salt, and now TPA."

TPA is a new product of biotechnology that dissolves clots in coronary arteries. If administered within three hours after the onset of pain, it can reduce. the damage to the heart. Dr. Young's area in research has been in microbiology and genetics and the exciting work that led to cloning techniques. Understandably, he takes great pride in the fact. that the FDA his already approved many products of this new biotechnology.

AIDS put Dr. Young at the eye of thats hurricane. With help from several formal testimonies from Dr. Young and, members of his staff, the Presidential Commission on the, HIV Epidemic recommended:

"The Food and Drug Administration, in an effort to ensure that the nation's blood supply is never contaminated, should define a mechanism that quickly identifies a new threat to the safety of the blood supply and implements procedures that will abrogate that threat.

"As soon as is practically possible, but no later than July 1, 1989, agencies which license and certify health care facilities should make a condition for licensure, a program to notify all recipients of blood or blood products since 1977 of their possible exposure to HIV."

The project recommended by the AIDS Commission that most pleased the commissioner was our suggestion that a Presidential Award for Excellence be presented to the FDA scientist who represented the greatest achievement toward the public good. Comparable to the Nobel prize, this award would be an annual event with a presentation by the President to recognize the dedication of many of the persevering public servants. Lowpaid and unable to "moonlight" as can their counterparts in industry or other branches of the government, these men and women as well as their families sacrifice income to make a difference. Because millions of dollars are involved in decisions the FDA makes about when or if they will approve a new product, the FDA personnel are not permitted to "consult" for industry.

Dr. Young's face beamed when we delivered a prototype of the handsome award with the presidential seal. Dr. Young stated that he has continually been impressed with the quality and dedication of the FDA employees . Of particular help have been the three men who served as Deputy Commissioner-Dr. Mark Novitch, Mr. John Norris, and Mr. James Benson-and his chief of staff, Mr. Joe Levitt. The commission's official report to the President read:

"To inspire pride in the Food and Drug Administration (FDA), an annual Presidential Award for Excellence could be bestowed on dedicated FDA scientists who creatively and expeditiously approve lifesaving products and discover ways to protect society from unforseen health hazards."

-recommendation 4-71, p. 53,

Report of The Presidential

Commission on the

Human Immunodeficiency

Virus Epidemic

June 1988

Dr. Young's daughter Debbie must have a good understanding of her father's challenge. For his birthday, she printed out and shellacked a hanging for his office wall of the lyrics from Man of LaMancha:

To dream the impossible dream,

to fight the unbeatable foe,

to bear with unbearable sorrow,

to run where the brave dare not go.

This is my quest, to follow that star,

no matter how hopeless, no matter

how far;

to fight for the right without question

or pause,

to be willing to march into hell for a

heavenly cause!

And the world will be better for this;

that one man, scorned and covered

with scars,

still strove with his last ounce of


to reach the unreachable stars.
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Copyright 1989 Gale, Cengage Learning. All rights reserved.

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Title Annotation:commissioner of the Food and Drug Administration
Author:SerVaas, Cory
Publication:Saturday Evening Post
Article Type:Biography
Date:Jan 1, 1989
Previous Article:The thyroid mystery.
Next Article:50th anniversary of the FDA.

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