FDA the Boss of Pills (Pills and You) by Joyce L. Griffith

There were few details about the author available but it is evident from her books that she has a sister who is a pharmacist. On this background alone one might not expect to get too excited about a book discussing an enigmatic and emotive subject such as the food and drug administration of the United States of America. In her own words “This book sums up what you’d probably like to know about the Food and Drug Administration, the government-authorized organization in charge of all pills produced and sold in the US.”

The author is to be congratulated on getting a well informed and proper balance into a discussion of the FDA. All too often it is easy to take a very polarized view of the regulator. This short and informative book is a useful introduction to the world behind the pharmacist’s counter and lets us understand that there are conflicting agendas and difficult decisions to be made.

Griffith discusses the case of Brittany Murphy as an introductory example. Of course we know of several other high priority cases in recent years of the rich and famous dying young because, in part at least, a number of medications were taken over a period of time. These are tragedies for the individual and their loved ones and the emotion is taken higher by the realization that the outcome could have been avoided.

The role of the FDA and the role of the manufacturer and the role of the physician were covered extremely well. The problems of rare side effects were also discussed and this is a struggle that will continue for future generations. At its very heart the rare side effect issue talks to the hardest issue of all to understand that a drug can be marketed without knowing each and every possible side effect. The fact that a side effect is rare does nothing to help you if you are the unlucky one. This, however, will only be resolved through continuous efforts of the industry and the regulators.

 What was missing from “Boss of Pills” was the role and responsibility of the end user. You and I have a tremendous responsibility for our own lives and welfare. This is not a political discussion about the size of the nanny state, and this is not a question about the morality of businesses who sell goods that to one extent or other can cause harm. It is true that pharmaceuticals are recalled if a problem is found; this same is true of cars. Cover ups or missed opportunities or systematic failures to deal rapidly with problems occur in many industries whether regulated or not. The problem with pharmaceuticals and our health is the basic misconception that marketed drugs are safe. Safe in this context we take to mean on their own and in combination in all situations and in all people. Unfortunately this is not the case. There are too many variables and too many opportunities for the unexpected to arise. We like to blame a person or an entity when calamity arises. If only we could take on board the lessons of the famous tragedies that we should be vigilant about our own lives and strive constantly to support our own education about the risks the world poses to us.

This really is an excellent book and would be a splendid introduction to the very tough world of pharmaceutical development and regulatory science.

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