Healthy Skepticism Library item: 16988
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Publication type: news
Martin D
James L. Goddard, Crusading F.D.A. Leader, Dies at 86
The New York Times 2010 Jan 2
http://www.nytimes.com/2010/01/02/health/02goddard.html
Full text:
Dr. James L. Goddard, who as a brash, crusading commissioner of the Food and Drug Administration in the 1960s helped revolutionize the federal government’s methods of evaluating drugs, died Dec. 18 in Laguna Woods, Calif. He was 86.
His son, Bruce, said the cause was a brain hemorrhage.
From 1966 to 1968, Dr. Goddard, serving under President Lyndon B. Johnson, strove to put the F.D.A. on a sounder scientific footing to better serve the consumer. He cracked down on exaggerated drug advertising and delayed approval of new drug applications until manufacturers had backed them up with more laboratory and clinical testing. And he campaigned to take ineffective drugs off the market.
The New York Times Magazine called him “a wild-eyed crusader with a battle-ax flailing boldly.”
Several months after he assumed leadership of the agency, Dr. Goddard spoke to pharmaceutical executives and suggested that many were dishonest in their applications for new drugs. He threatened that the industry might be “altered beyond your present fear.”
“If this sounds alarming,” he said, “it is because, frankly, I am alarmed.”
Historians and journalists say the effect was to push the F.D.A. into a new era.
“James Goddard marks the demarcation between the old F.D.A. – that had no MDs, no strong standards of evidence and largely subservient relations with the pharmaceutical industry – and the new F.D.A. that was headed by an energetic doctor, enforced strong standards of evidence and became an advocate for the public’s health,” said one journalist, Philip J. Hilts.
Mr. Hilts, author of “Protecting America’s Health: The F.D.A., Business and One Hundred Years of Regulation” (University of North Carolina, 2003), called Dr. Goddard one of the three or four best commissioners in the history of the agency.
Fran Hawthorne, author of “Inside the F.D.A.: The Business and Politics Behind the Drugs We Take and the Food We Eat” (Wiley, 2005) said in an interview Thursday that before Dr. Goddard, the first physician to lead the agency in a generation, the F.D.A. was “small and toothless.” Ms. Hawthorne said he “brought the F.D.A. into the modern age.”
In one instance Dr. Goddard wrote and put into effect legislation calling for drugs to be tested for efficacy as well as for safety. The law, enacted by Congress in 1962, mandated scientific testing of all new drugs to see if they worked, as well as testing of drugs introduced before 1962 for both safety and efficacy. He contracted the National Academy of Sciences to review 4,000 already-introduced drugs.
Dr. Goddard banned 250 antibiotic preparations, particularly throat lozenges, from the market because drug makers had not proved their effectiveness. He started an investigation of possible criminal violations in the testing of new drugs.
He also longed to test drugs against one another to make sure that any new drug functioned better than ones already approved. For political and economic reasons, Mr. Hilts said, the proposal never gained traction.
James Lee Goddard was born on April 24, 1923 in Alliance, Ohio, served in the Army during World War II and completed his medical degree at George Washington University in 1949. After a brief stint in private medical practice, he joined the Public Health Service in 1951, interrupting this work to earn a master’s degree in public health from Harvard in 1955.
In the latter half of the 1950s, he studied automobile safety for New York State and the federal government, doing research that helped buttress the push for mandatory seatbelts. He moved on to the Federal Aviation Agency, where as medical director he did research that resulted in the compulsory retirement age of 60 for pilots.
In 1962, he was named assistant surgeon general and chief of the Communicable Disease Center (now the Centers for Disease Control and Prevention) in Atlanta. At 39, he was its youngest chief ever.
In August 1965, John W. Gardner, secretary of health, education and welfare, set up an advisory committee to reorganize the F.D.A., where morale was low. He decided that Dr. Goddard should lead the way. Dr. Goddard accepted, even though he had made it clear that he wanted to be surgeon general.
Dr. Goddard quickly buoyed the agency, Science magazine said in June 1966. “He has apparently created a spirit not unlike that of the early days of the Peace Corps or the poverty program,” the magazine wrote, “drawing on people who recognize the hardships but want to be in on the fight.”
Drug industry executives complained to the White House about Dr. Goddard’s aggressive approach. His penchant for offhand remarks offended many and helped him with almost no one. He garnered substantial publicity by saying alcohol was probably more dangerous than marijuana.
Vice President Hubert H. Humphrey, a former pharmacist, was upset when Dr. Goddard remarked that the corner drugstore was probably a fading institution. When pharmacists offered $100,000 to the Democrats’ 1968 campaign with the suggestion that Dr. Goddard was expendable, Humphrey and President Johnson were receptive, Mr. Hilts said.
Dr. Goddard joined the pharmaceutical industry as an executive, then as a consultant. From 1970 to 1972, he directed the Ford Foundation’s family planning program in India.
Dr. Goddard’s first marriage, to Mildred Miller, ended in divorce. His wife, Marjorie, died before him. In addition to his son, he is survived by his daughters Margaret Goddard and Tricia Mikle; his stepdaughter, the singer-guitarist Bonnie Raitt; his stepson, David Raitt; eight grandchildren and three great-grandchildren.
Dr. Goddard’s brash style showed itself at the Federal Aviation Agency after he learned that no flying qualifications were required for hot-air balloon pilots. He applied for and got a license, and even made a few balloon flights. The F.A.A. soon set qualifications for balloonists.
