Rousing and readable: sure to brings smiles at the FDA and howls of protest from industry lobbyists.

PROTECTING AMERICA’S HEALTH

THE FDA, BUSINESS, AND ONE HUNDRED YEARS OF REGULATION

Chicanery, greed, politics, battles won and lost: welcome to the Food and Drug Administration.

New York Times science reporter Hilts (Memory’s Ghost, 1998, etc.) has no doubts about the need for an independent FDA to protect the public’s health, and he has no qualms about identifying the forces that have attempted to thwart its mission. From passage of the Food and Drug Act of 1906, shortly after Upton Sinclair’s The Jungle aroused public outrage over the meatpacking industry, to passage of the Kefauver-Harris amendments in 1962, spurred by furor over the thalidomide disaster, Hilts shows how commerce, politics, and events have shaped the evolving role of the FDA. Born in the Progressive Era as the US Department of Agriculture’s Bureau of Chemistry but hobbled by minimal budgets and authority, the FDA had little effectiveness until the Food, Drug, and Cosmetic Act of 1938, sparked by public concern over children’s deaths caused by sulfanilamide, gave it the job of checking drugs before they went to market. Hilts examines the growth of the giant pharmaceutical industry, the rise of a conservative movement opposed to government regulation, and the policies and styles of FDA commissioners. He shows how controlled scientific studies became the standard for determining a drug’s safety and effectiveness and how the often-beleaguered agency’s professionalism was established. Among the many battles he recounts were those over package-insert information, nutrition labeling on processed foods, silicone breast implants, development of AIDS drugs, and recall of drugs hazardous to health but profitable to pharmaceutical companies. Common sense, says Hilts, demands that businesses, whose first job is profits, be countered by a regulatory agency whose first job is public safety. As imperfect as the FDA is, he states, duly noting the payoff scandals of the late 1980s, its work remains essential.

Rousing and readable: sure to brings smiles at the FDA and howls of protest from industry lobbyists.

Pub Date: April 2, 2003

ISBN: 0-375-40466-X

Page Count: 352

Publisher: Knopf

Review Posted Online: May 20, 2010

Kirkus Reviews Issue: March 1, 2003

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Authoritative and, most helpfully, accessible.

HEALING OUR VILLAGE

A SELF-CARE GUIDE TO DIABETES CONTROL

Self-help guide for diabetes sufferers, mostly in question-and-answer format, with an emphasis on helping racial and ethnic minority diabetics.

Coleman is a pharmacist with a doctorate in her specialty, Gavin a Ph.D. and M.D. Aside from acknowledgments and a foreword signed by Gavin alone, their voices and expertise are indistinguishable, offering lucid, simple solutions for diabetes patients. Gavin relates watching his great-grandmother endure debilitating pain as a result of diabetes while he visited her as a youngster. He remembers hearing adults mention that sugar killed her, and he wondered how something that tasted sweet could cause so much harm. As an adult, he realized that his great-grandmother's affliction could be controlled through treatment. The authors focus on Type 2 diabetes, the most common form in minority populations. An estimated 18.2 million Americans are diabetic, with perhaps 5 million unaware of their situation. About 11 percent of U.S. diabetics are African-American, and about 8 percent are Latino. The question-and-answer format begins with an overview section about diabetes, with an emphasis on risk factors. Section Two covers management of the disease, including nutrition, exercise, blood-testing, oral medications and insulin use. In addition, the authors continually recommend smoking cessation, as well as instructing patients on the readiness of self-treatment. Section Three explains the complications—high blood pressure, high cholesterol and heart disease—that could arise if the condition remains untreated or treated ineffectively. The questions in all of the sections are worded simply, and the answers are usually free of medical jargon. Though the sudden shifts in tone and voice are occasionally jarring, the writing remains clear enough to distill the facts. The real downside here, though: patronizing, laughable illustrations that degrade the overall product.

Authoritative and, most helpfully, accessible.

Pub Date: Jan. 31, 2004

ISBN: 0-9746948-0-0

Page Count: -

Publisher: N/A

Review Posted Online: May 27, 2010

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There's a clear and intelligent gadfly at work here, offering much food for thought through his outrage.

CANCER-GATE

HOW TO WIN THE LOSING CANCER WAR

An astute—and sadly revealing—collection of articles from the past 15 years covering a wide number of topics related to the state of cancer research in the United States.

While it's true that Epstein—a physician and professor of occupational and environmental medicine at the University of Illinois College of Medicine—is clearly distressed by the current situation regarding our nation's approach to seeking cures and causes of cancer, this is far from a screed or conspiracy theory. He and a small number of contributors explain clearly why they feel the cancer fight has been stymied from the beginning. Epstein suggests the elimination of two impediments immediately: blaming the victim and putting the emphasis on diagnosis and treatment instead of prevention. He further suggests that there ought to be a distance between research institutions and those who fund the research. Since that likely means state intervention, he would like to see that ideologically biased individuals are not put in positions of power, dispersing funds (as happened under the Reagan administration, with its closed-door sessions with industry executives); too often the economic and political strings are held by those with a conflict of interest, such as the makers of products with suspicions of carcinogenic properties, or those with a vested interest in selling drugs to cancer patients. He also suggests that groups like the American Cancer Society stop spending three-quarters of their massive annual outlay on administrative costs, and start working more closely with environmental and occupational groups. Finally, he addresses the potential threats from pre-menopausal mammography, and the food industry's use of growth hormones.

There's a clear and intelligent gadfly at work here, offering much food for thought through his outrage.

Pub Date: Feb. 28, 2005

ISBN: 0-89503-310-0

Page Count: -

Publisher: N/A

Review Posted Online: May 23, 2010

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