Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat
by Fran Hawthorne
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Book Summary Information
Author: Fran HawthorneEdition: Hardcover
Audio: English (Original Language); English (Unknown); English (Published)
Published: 2005-02-25
ISBN: 0471610917
Number of pages: 338
Publisher: Wiley
Book Reviews of Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat
Book Review: Everything you want to know about the FDA.
Summary: 5 Stars
This is one of the most thorough investigative books I have ever read on such a narrow topic. The author covers the history, and political and regulatory issues of the FDA in far more detail than I expected. Her in depth investigative style reminds me of Sylvia Nasar in A Beautiful Mind: The Life of Mathematical Genius and Nobel Laureate John Nash.
From the author's investigation I derived the FDA does the very best of an impossible situation. This is because its constituents have irreconcilable contradictory objectives. Big Pharma wants fast and efficient drug approvals. Consumers want safe drugs in all circumstances. Congress wants a cheap regulatory process (fiscal efficiency).
I also realize that despite their best efforts the FDA can't keep us safe. This is true for several reasons. The FDA does not control how doctors prescribe drugs. When they prescribe a drug for something else than its main purpose (off-label use), the FDA has no say on that. We are on our own. Also, supplements are not regulated by the FDA. You buy a supplement from China that has some lead in it. You do so at your own risk. Also, the FDA clinical trials will not catch side effects that occur less than 1% of the time. So, they approve drugs that are perfectly safe for 99% of the population but can turn out to be lethal to 1%. That's what happened with Vioxx. It passed all the rigorous clinical trials. But, when the population at large took it a very small percentage suffered dire cardiovascular implications. So, expect nasty headlines and drug recalls to continue because there is no explicit alternative to their occurrences.
No matter how you look at it, the FDA is under a huge amount of political pressure. Unlike the Federal Reserve they are not an independent branch of government. Their livelihood (Budget) is almost solely dependent on the goodwill of Congress. And, Big Pharma lobbies Congress to death. Thus, the FDA is always under huge pressure to do the right thing by its boss, Congress, who in turn does the right thing by its customer-constituent Big Pharma. Exacerbating those conflicts of interests even more, now a good part of the FDA's budget is financed by fees approved by Congress it earns directly from Big Pharma. This is the exact same conflict of interest that caused the housing and credit crisis. Moody's and S&P gave AAA ratings to mortgage securities that should have been rated BB at best in part because the rating agencies are paid by the security issuers. Fortunately, consumer groups and related liabilities mount a counter pressure to Big Pharma that forces the FDA to maintain its proper balancing act.
The author taught me a bunch of things I did not know about this whole business. Some are downright funny. I always wondered about drug advertising on TV. Remember when we were bombarded by drug TV commercials and the commercial did not even tell you what the drug was for. It just told you to ask your doctor about a specific drug. We probably all thought this was really absurd. Now I know it was at the time the FDA's effort to regulate what pharmaceutical companies could say in TV commercials about drug ads. For the FDA it was a way of saying `No' without having the full power to say no. I don't think the FDA thought Big Pharma would take their word for it and produce commercials without saying what their product was for but they did!
In any case, if you want to know everything there is to know about the FDA I strongly recommend this book.
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