Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation

Rating:
Summary: Only The friendly side of the FDA
Review: As with many institutions, the FDA servers a perceived needed purpose. This book is a history of why the agency was needed and its design. It is filled with horror stories and how the FDA came to the rescue. Some of these stories even scared me as I recognized the products and or brands. The chapter "Capitalism in Crisis" reads more like a political statement against capitalism than a "FDA is out to help" statement.
What they do not say is that the FDA is the Government to the point that they can carry guns and badges. Now with the fast pace of drugs and device invention the FDA is needed more than ever. The other side of the coin is that thy have become an unwatched agency that can and does set its own rules to how a business can do their job down to describing the data field that are to be stored in their computer. Their regulations read like a phone book of conflicting statements (with no recourse). And you can be shut down on a whim if you do not follow the regulations as interpreted by their agent as they are the law.
The book contains an excellent set of notes. They are divided in to chapters. And there is a fair index. For people that like pictures there are eight pages of monochrome photographs.
The author has written several articles on medicine for various periodicals.

Rating:
Summary: Fascinating look inside the FDA
Review: Hilts has written a masterful account of the history of the FDA. It is an amazing tale of the health protections we now take for granted. The FDA as we know it is a relatively modern creation. Just 50 years ago the basic safety of our drugs was in question since no efficacy and safety testing was in place. There was no such thing as clinicial trials. Hilts takes us through the evolution of the FDA from a shoestring operation to its massive size today.

What is evident is that the FDA, flaws and all, still is the only barrier between the public and sometimes ethically challenged businesses. Often criticized as slow and anti-business it is clear that the FDA has tried to do what is right most of the time. At times the book reads like a novel when describing instances of deadly foods or drugs being sold to the public. For those who criticize the FDA, it is well worth reading to establish the historical context. It is clear Mr. Hilts is no friend of industry and this must be noted in reviewing his book. Sometimes only the worst of American business is noted, with little credit to the life saving miracle drugs produced by industry. That said Mr. Hilts book should be read by all those who deal with the FDA.

Rating:
Summary: A Much Better Book
Review: Hilts is a journalist so perhaps he can be forgiven for writing such a biased book, although to give him credit, he does not seem to even try to hide his bias, which makes the book a kind of comedy.
A much better (and thinner) book on the FDA is written by a former FDA regulator and a M.D., To America's Health, by Henery Miller.

Rating:
Summary: History or Propaganda?
Review: I came across this book when it was assigned to me in one of my MBA classes, and I thought it would be very interesting to finally read about how the FDA was created. I have a strong interest in the pharmaceutical industry and the agencies that regulate it, and the idea of a definitive 'history of the FDA' really appealed to me. From the very start, it was obvious that this book had an extrememly liberal slant, to the point that any good practices seen in the industry, or good companies within it, were completely obscured. However, I kept an open mind, and figured that the basic facts were still in order. However, I just got to the chapters regarding the Reagan years, which are perhaps the furthest back my memory goes. I was appalled by the vitriol the author spewed against all conservatives, and the conservative ideology, calling all conservatives a group of "white men" who were bound by "their anger against minorities, government, and established elites". Leaders such as Ronald Reagan were desribed as having an ideology that was "a bundle of fears and dislikes", and an "anger that holds together the radical conservatives". Now, I don't mean to say that the author isn't entitled to his opinion, but the degree to which he carries these extreme beliefs into a book that is described as a history is disturbing. I now doubt everything I've read so far, and will be looking for an unbiased account in order to get the TRUE story.

Rating:
Summary: Great intro to public health regulation
Review: Sorry the other reviewer didn't like this, but as an FDA employee when Reagan would not allow the regulation of unpasturized cheese, where the listeria bacteria consumed in it caused the deaths of dozens of babies and pregnant women (pro-life?), I have to agree with the author. That cheese example is just the beginning; it doesn't include the dozens children who died after it was clear that aspirin use in children with fever caused the deadly Reye syndrome and the administration refused to allow FDA to put warning instructions on the label. It does not include the dozens of children who were poisoned by pills in easy-opening containers (iron pills look like candy and overdoses not treated promptly are irreversibly fatal). This book does name courageous industry people as well as public servants. It can open your eyes to the critical role the government played in assuring the availability of penicillin during WWII and vaccines today. It is the history of germs and cures in the US in a plain-spoken format. However, if Karl Rove is your hero and you've forgotten about Iran Contra, guns for hostages, ketchup as a vegetable in school lunches, a recommendation to wear hats for global warming, and how much you paid for the savings and loan scandals (over $1 TRILLION according to conservative estimates) ... have I left anything out?... then your neo-con heart will surely break.

Rating:
Summary: Excellent History of FDA
Review: This is an excellent, well researched history of the U.S. Food and Drug Administration and the modern pharmaceutical industry. Hilts does a good job of explaining the complex and technical new drug approval process for the general public. The author builds a solid case for well controlled clinical trials as a necessity for approving new drugs and biologics that are both safe and effective. He documents the history of pharmaceutical disasters from Elixer of Sulfanilimide and Thalidomide, to Rezulin.

Although the book focuses on the regulation of drugs, there is also a good overview of important developments in medical devices and food, including the battles over food labeling and silicone-filled breast implants. Hilts gives a fascinating account of political efforts to curb the agency including dirty tricks during the Nixon administration and more current deregulation efforts by conservatives in Congress. The author is a journalist who has worked for the Washington Post and New York Times. It is well written and easy to read. The book is a must for understanding the FDA.