By Justin Blum
July 19 (Bloomberg) -- The ``FDA Centennial Anthem'' won't be mistaken for ``The Star-Spangled Banner'': In the lyrics, no rockets are glaring red, and bombs aren't bursting in air. Instead, goods are made effective, safe and pure.
Workers at the U.S. Food and Drug Administration are singing a new, 126-word ode marking the regulatory agency's centennial. The hymn is performed by an employee chorus at awards ceremonies, picnics and commemorative events. ``Now in this proud hour, a vibrant vision thrives,'' one line goes.
Not everyone is singing along. While the FDA has roots in the Progressive Era of Theodore Roosevelt, the four stanzas of lofty sentiments ignore more recent FDA setbacks, such as its handling of Vioxx, a drug pulled from the market after it was linked to heart attacks, say agency critics.
``It reads like it's out of a 1950s grammar school textbook where everything is just wonderful,'' says Michael Jacobson, executive director of the Center for Science in the Public Interest, a Washington-based advocacy group critical of the FDA's oversight of food. ``It's a little disconnected from the reality of today's FDA.''
One of the agency's sharpest critics, Sidney Wolfe, director of the Public Citizen Health Research Group, describes the lyrics as ``ridiculous'' and ``degenerate.'' ``There's nothing in there, of course, about regulation,'' says Wolfe, whose Washington-based group monitors the FDA's drug oversight. ``Don't they have any kind of self-consciousness?''
Gerald Harris, the author of the hymn, says it celebrates history and isn't intended to comment on politics or polish the agency's image. Harris, a 60-year-old engineer, works in FDA laboratories in Rockville, Maryland, where he helps devise ways to test medical ultrasound equipment for safety and efficacy.
Expressing Feelings
``I just got to thinking about trying to express my feelings about my job with some words and music,'' says Harris, who has worked at the FDA for 35 years. His anthem is sung by an employee chorus -- numbering two dozen at a June 30 performance -- and sometimes accompanied by a wind ensemble.
In 1814, a pen, the back of a letter and the tune from an old British drinking song sufficed for Francis Scott Key to write ``Defence of Fort M'Henry''--which, re-titled, became the U.S. national anthem in 1931. By contrast, Harris used high-tech gear.
For weeks, Harris sat in the corner of his basement, sometimes staying up until midnight after a full day of work. He used an electric keyboard hooked up to his computer to compose the anthem. He didn't call the result ``Defense of the FDA,'' although he might have.
``One century past, a people's hope fulfilled,'' the anthem begins. ``By an act conceived for safe medicine and food / Protecting rights that our founding fathers willed / To life and Liberty, to happiness pursued.''
`It Was Fantastic!'
Harris beams when he watches fellow employees perform his anthem. He and his wife, Linda, were in the audience on June 30 when the chorus sang at a centennial celebration. The attendees included Health and Human Services Secretary Michael Leavitt.
``It was fantastic!'' the bespectacled Harris said after the singing ended. ``I was really pretty filled with emotion that this was all happening.''
Harris, who earned degrees in electrical engineering and bioengineering, says his only formal training in music writing came in adult education classes in Montgomery County, Maryland, where he lives. He has taken up composing as a hobby, working with a group that writes music for amateur performers. Last year, a colleague asked him to compose music for the centennial.
Gaining Groupies
The FDA posted his lyrics -- and an essay by Harris with annotations -- on the agency Web site. FDA Acting Commissioner Andrew von Eschenbach pulled Harris aside and thanked him. ``The first time I heard it, I was stunned,'' von Eschenbach says in an interview. He hadn't known that Harris wrote music. ``You don't associate people in these different contexts,'' he says.
Now Harris has groupies. After the June 30 performance, members of the chorus surrounded him, seeking his autograph on copies of the anthem.
``We really enjoyed it,'' says Deborah Price, an FDA analyst and chorus member who has performed the anthem half a dozen times. ``We don't get much money but we can find happiness in these songs.''
The FDA's critics at nonprofit agencies and in Congress find something else: More reason to scorn the agency and the oversight of President George W. Bush.
``On drug safety -- as on so many other issues -- this administration's response to serious problems is to sing a happy tune,'' says U.S. Senator Edward Kennedy, a Democrat from Massachusetts, in a statement. ``FDA has real needs that must be met to allow it to safeguard public health -- better resources, more authority, and a commitment to science over ideology.''
Defending the Anthem
FDA spokeswoman Susan Bro defends the anthem as an accurate reflection of the agency's work.
``The Centennial Anthem not only reflects Dr. Harris's long- held beliefs but also resonates with FDA colleagues as a strikingly accurate portrayal of both the expertise and personal dedication everyone brings to their FDA work,'' Bro says.
Congress created the FDA, in 1906, partly because Upton Sinclair had just shocked people with ``The Jungle,'' a novel exposing filth in meatpacking plants. First seen as a crusader for consumer safety, the agency is now under fire for its handling of drugs such as the painkiller Vioxx and Plan B, a contraceptive that works as much as 72 hours after intercourse.
Drug Withdrawn
Whitehouse Station, New Jersey-based Merck & Co., the maker of Vioxx, withdrew it from the market in September 2004 after studies linked the drug to cardiovascular ills.
Some members of Congress also fault the agency for delaying non-prescription sales of Plan B tablets, made by Woodcliff Lake, New Jersey-based Barr Pharmaceuticals Inc. Critics say the FDA is appeasing people who fear that easier access to Plan B would foster premarital sex.
The FDA over the decades gained responsibilities extending to such products as cosmetics and animal feed, as the anthem recalls: ``For food, vaccines, drugs, devices, blood and more / They strove to see these goods effective, safe, and pure.''
Anthems grew out of the nationalism of the late 18th century, says Geoffrey Nunberg, a linguist at University of California at Berkeley, who says the FDA anthem resembles many a school song.
``It might be the Food and Drug Administration; it might be Grover Cleveland High School in 1,200 American towns,'' he says.
To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net.
Last Updated: July 19, 2006 12:36 EDT
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