Book Review: Inside the FDA

In March of 1932, socialite and millionaire playboy Eben M. Byers died of a horrible and mysterious disease, his body corroded until his bones began to shatter apart. Strikingly handsome in his youth, by the time of his death a series of last ditch operations had eliminated the lower part of his face and reduced him to a distorted shadow of his former self. His bizarre death was the result of his addiction to a quack cure, radium-laced water. This deadly nostrum was not under the feeble authority of the FDA, whose jurisdiction did not extend to radioactive substances, these being classified at the time as "natural elements."

K. John Morrow, Jr.

Byers' death ignited a storm of outrage, and on this basis of the highly publicized event, the agency vigorously campaigned for a sweeping expansion of its powers. With the institution of new regulations, the radioactive patent medicine industry collapsed overnight.

This bit of early FDA history illustrates a point that Fran Hawthorne discusses at length in her up-to-the-minute description (John Wiley and Sons, copyright 2005) of the agency entrusted, as she describes, with protecting the American people from virtually every questionable substance, food additive, medicine, or medical device to which they may be exposed. That is, the FDA is a cobbled together agency, built over the years by reaction to calamities and emergencies, rather than through an ordered process of considerate legislation. And, as Hawthorne shows us, the FDA, always a target of political pressure, has lately been deeply embroiled in controversies that go to the heart of what we consider our humanity; issues of stem cell research, abortion, birth control, catastrophic illness and the end of life.

INSIDE THE FDA

Hawthorne leads the reader through the complex history of the agency from its origins at the turn of the 20th century, through the sleazy era of patent medicines to the thalidomide tragedy, the struggles of FDA head David Kessler over tobacco regulation, and to the recent recalls of Rezulin and Zoloft. She treats her subject with understanding and respect, and the many interviews are a fascinating look inside the agency.

Repeatedly within the narrative the reader sees the complex interface between science, personal emotion, and political demands. Hawthorne recounts the hearings over the reintroduction of thalidomide, when it was found in the late '80s to be an effective treatment against leprosy and certain forms of cancer.

In John W. Jackson's opinion, (chairman of Celegen, maker of thalidomide) the turning point came when a thalidomide victim took his turn at the microphone. "He was sitting in his wheel chair, and he gave a very impassioned speech — 'Who am I to deny these people the chance?' There were tears in the eyes of several people on the advisory committee. I felt the same way," Jackson said, as he dabbed his eyes six years later.

So the FDA, more than any other governmental agency, is moved by the pressure of emotional argument, at the same time trying to use the strongest science available to fulfill its charge of protecting the public's health and safety.

The book finishes with consideration of the invasion of drug advertising into the marketplace, frivolous and perhaps dangerous drugs, and the challenges that we can anticipate in the future for the FDA.

There is one shortcoming that I found in the book — there are no photographs of the heroes and villains that have carried on this epic battle for the hearts, minds, bodies, and pocketbooks of the American people. It would have been instructive to see images of this rogues' gallery that has profoundly influenced every aspect of our lives.

Aside from this minor grousing, I would recommend this fine book to anyone who wants to know more about the FDA.

K. John Morrow, Jr. Department of Research and Development, Meridian Bioscience, Inc. 3471 River Hills Drive, Cincinnati, OH 45144 Ph 513-271-3700 x 398, JMorrow@meridianbioscience.com.