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     Winter 2006

  
   Inside the FDA
    The Business and Politics Behind the Drugs We Take and the Food We Eat
    By Fran Hawthorne
    John Wiley & Sons, Inc., Hoboken, NJ: 2005, 338 pp. (with Notes and Index)

   Fran Hawthorne, science and business writer for major magazines and newspapers, starts off her
   look at the FDA by describing the travails of a small, start-up biotech firm's attempts to gain approval of a
   new protein agent called Oncophage to treat cancer. The money, the paperwork, the clinical trials, the
   meetings with government scientists and outside consultants not to mention the enormous amount of
   data that must be submitted all lead to a sense of wonder how any new drug or biologic agent ever
   gets to market. Every time our intrepid investigators and company officers think they are home free,
   the FDA ants more: another study, another way of presenting data, and on and on.

   Yet drugs slip through and must eventually be recalled or given "black box" package insert warnings
   after they are taken by millions and found to cause harm. Think of Vioxx, Baycol, Propulsid, several anti-
   arrhythmics and SSRI type nti-depressants, Rezulin, Pondimin, Redux, and Duract. The list is long and
   considerable patient harm has resulted from these and other recalled drugs.

   The history of food and drug regulation in the United States from colonial times to the present represents
   a fascinating social history and offers insight into the roles of scientists, corporations, consumers and
   the politicians. From the time of the 1906 Food and Drug Act, precipitated by Upton Sinclair's The Jungle,
   there has been a struggle among these groups. The book spends a chapter on this history, summarizing
   landmark events: Dr. Harvey Wiley, the first commissioner after the 1938 revision of the laws establishing
   the agency outside the Agriculture Department, the post-war growth of the pharmaceutical industry and
   the numerous new drugs coming to market, the thalidomide scare and the heroic role of Dr. Frances
   Kelsey in preventing tragedy here, Senator Kefauver and the then new concept that drugs should be
   effective as well as safe before admission to the market, public and political controversy over birth
   control pills and later RU-486, the abortion pill, commissioner David Kessler's attempts to regulate
   tobacco that ultimately failed, and the AIDS crisis and the failure of leadership by the Reagan
   administration and the FDA.

   The author points out that the FDA must compete with numerous agencies, especially the Department
   of Agriculture (from which the FDA was separated in 1940) for regulatory prowess. The latter has a much
   larger budget and significantly more congressional clout. She points out how the various federal agencies
   responsible for some aspect of food and drug regulation keep bumping up against each other...a
   bureaucratic turf war run amok. Take a cheese pizza...FDA's responsibility unless someone adds
   pepperoni, then it's Agriculture. Similar joint or overlapping responsibilities are rife with other government
   agencies: DEA, FTC, EPA, CDC and NIH along with numerous state health departments and, oh yes,
   Congress with its political and budgetary control. Consider the political contretemps over getting the
   morning after pill from prescription to over-the-counter status.

   Hawthorne then takes us through the details of the process of development of a new drug and the
   "truckloads of paper" it takes to get final approval. Some milestones include the search for a new drug
   a concept by the pharmaceutical company or biotech that may influence a disease, the animal studies,
   the investigational new drug (IND) application to the agency (often accompanied by pre-conferences) to
   design the three part clinical trials (phase I, II and III) with actual patients, and finally, if the drug shows
   promise as safe and effective, the new drug application (NDA) which, if approved, leads to marketing of
   the drug to the public. The theme is "how fast" and "how careful" the FDA should be in approving a new
   drug. There is invariably a tension between the time and money (often hundreds of millions of dollars over
   5-10 years) it takes to bring a new drug to market and the degree of care in evaluation by the agency.
   Newer developments such as the role of the advisory committees of outside experts, pharmaceutical
   company financing of the approval process and the "fast-track" for drugs that are deemed critical
   (there is no effective treatment for the disease already on the market) are explored. It should be
   remembered that the FDA is a hierarchical bureaucracy with all that term implies for budgetary priorities
   and political and public pressures.

   One of the better features of the book is the author's account of the approval process for specific
   drugs and their subsequent fate: the return of thalidomide as an adjunct treatment for AIDs and cancer;
   Rezulin, the diabetes drug that was taken off the market after patients began dying from liver failure; the
   strange story of Lotronox, a drug for irritable bowel syndrome, recalled when several deaths were linked
   to it and then re-released with modified instructions for use; Accutane, the acne drug that could cause
   birth defects. Nor is the food component of the FDA left out. The bacterial contaminations of juice and
   hamburger by E. coli O157:H7 and the mad pursuit of mad cow disease make for interesting reading.

   The author completes her examination by citing problems and predictions for the future: frivolous and
   me-too drugs; the cost of medicines and generics vs. brand name drugs; the FDA's role in combating
   terrorism; the trend toward designer and life-style drugs to modify appearance, longevity, sexual
   performance as well as mood and intellect; and of course the roles of politics and consumer advocacy
   groups in shaping the course of future pharmaceuticals.

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