LOOKING FOR TREASURES IN FDA’S CLOSET

by Anna Wilde Mathews

In the windowless basement conference room of a Food and Drug Administration building, two agency officials rummaged through dusty boxes hunting for valuables.

Before long, they unearthed a Dalkon Shield, the notorious birth-control device tied to several deaths in the early 1970s; a “Waist Whittler” belt for plump women of the 1960s who wanted to trim inches without exercise; and “Acupuncture pants” underwear with a strategically placed magnet that supposedly increased male potency. “It was pre-Viagra,” said Suzanne Junod. “It probably wouldn’t sell today.”

Dr. Junod and her associate, John P. Swann, are historians at the FDA. On this day, they were getting their first look at a collection of vintage medical devices, hoping to catalog them and to pick out a few for public display. Part of a little-known fraternity of historians who work at government agencies, the two provide historical context for FDA regulatory and legal decisions and publish original research about the agency’s past.

They also serve as custodians of the FDA’s collection of historical objects, preserved to provide a window into the evolution of the 98-year-old agency. Because the FDA is where remedies get approved, the scholars find themselves at the center of American medical ingenuity and controversy, from the dangerous early patent medicines to the debate over silicone breast implants.

Not all the issues are so weighty, however. One day recently, as they searched for interesting relics, Drs. Junod and Swann pondered a thumb-sized plastic cylinder and wondered: Why would anyone want to use something called the “Hemorr-Ice?” The package said the gadget was a clinically proven method of treating hemorrhoids through cryotherapy, or cold therapy. “Most people,” Dr. Junod said to her colleague, “would have sat on an ice cube.”

The historians will eventually document and photograph the objects. The most interesting might make it into exhibits, including one planned to honor the FDA’s 100th anniversary in 2006. A number of the devices were confiscated years ago by FDA inspectors as quackery and had been stored by the agency’s center that reviews medical devices.

Many federal agencies have historians to preserve and interpret their pasts, though their purposes and jobs vary widely. At the National Aeronautics and Space Administration, where space buffs hang on every bit of astronaut lore, historians advise moviemakers, release CD recordings of famous missions, and preserve relics viewed by millions of museum visitors.

In other departments the jobs are decidedly less glamorous. R. Dale Grinder, the Transportation Department’s historian, says he hasn’t been consulted by policy makers since the late 1980s—despite his view that officials could sometimes have benefited from knowing “the historical perspective of the deregulation of the airlines and other forms of transportation.”

At the Central Intelligence Agency, chief historian Scott Koch’s office writes the authoritative chronicles. But he can’t talk about them. “Almost all of it is classified,” he said. “It sort of goes with the territory.”

The 44-year-old Dr. Junod, who heads an association of historians working for the federal government, became the FDA’s first professional historian 19 years ago after finishing her doctoral dissertation at Emory University on food-additive regulation. Dr. Swann, 47, whose graduate work at the University of Wisconsin focused on pharmaceutical history, began working for the history office in 1989 after a stint in academia. He got special Drug Enforcement Administration certification so he could handle the controlled substances in the FDA’s collection, including amphetamines and painkillers.

The two historians have a wide range of responsibilities. “We perform the function of an institutional memory,” said Dr. Junod. “Issues that are of interest to consumers re-emerge—vitamins in the 1950s, dietary supplements in the 1990s.”

The historians were asked to provide context for FDA lawyers who faced a Supreme Court challenge to the agency’s authority over pharmacists who make drugs. Dr. Swann came up with some original documents that showed the FDA regulating aspects of the practice of pharmacy “compounding,” at least in a limited way, as early as the 1910s. (The FDA ended up losing the case in 2002 when the Supreme Court struck down a section of a 1997 law, agreeing with the pharmacists’ argument that it violated their First Amendment rights.)

In addition, the historians publish original research. Dr. Junod co-wrote a paper about the approval of the first birth-control pills, comparing how American and British regulators handled the issue. One of Dr. Swann’s published papers looks at how the government determined whether drugs worked before 1962, when efficacy joined safety as a prerequisite for approval. Often, the historians help outside scholars who need FDA records, including a University of Washington professor who wrote a history of Western society’s battle against constipation.

The historians also oversee a collection of 1,500-plus items that are mostly kept in storage facilities near the FDA’s headquarters in Rockville. The stash includes the “Tylenol Twaddler,” a wood contraption invented by FDA staffers for checking bottles during the 1986 crisis in which Tylenol capsules were poisoned with cyanide.

As part of their jobs, the historians track down additions to the collection. One acquisition: An original bottle of a treatment called “Elixir Sulfanilamide” that killed 107 people in the 1930s before the FDA was able to seize all the medicine, which contained a deadly solvent. The bottle turned up when FDA staffers moved out of an old downtown Washington office building.

Occasionally, an old artifact sparks new controversy. After lending a Minnesota museum a “Shoe Fluoroscope,” a machine once used by shoe stores to X-ray customers’ feet, the FDA history office got an irate call from state officials worried about radiation. According to the historians, the issue was resolved when they reassured the regulators that there were no plans to activate the machine.

Combing through the boxes of medical devices recently, Drs. Swann and Junod found several pseudoscientific gadgets, including the Urinometer, the Hemovitameter, and the Precision Nervoscope.

Sometimes, the scholars were stumped about the purpose of a device. When Dr. Swann turned a dial on the sinister-sounding “Electro Sedation Unit,” the plastic box started ticking, but nothing else happened. A flying saucer-shaped device began buzzing when Dr. Junod flipped it on. Holding it against her neck, she said, “It doesn’t feel bad at all.”

They also unearthed the “Bioelectrometer,” a 1960s-era machine studded with dials and gauges that promised to “detect organic pathology, spinal lesions, and toxicity by measuring tissue resistance.” When Dr. Junod plugged it in, a needle on the device jumped. Prying open the breadbox-sized machine, Dr. Junod found only a tiny transistor inside. “It’s like the Wizard of Oz!” exclaimed Dr. Swannn.

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Anna Wilde Mathews is a staff reporter for the Wall Street Journal.