Bitter Pills: Inside the Hazardous World of Legal Drugs

I didn't know about Stephen Fried and "Bitter Pills," much less quinolone antibiotics, until I myself was, like Mr. Fried's wife, "Floxed," just a few weeks ago. I began my search for information on reactions to quinolones after four days of gatifloxacin (brandname Tequin) left me with tingling and weak arms and legs, difficulty swallowing and breathing, visual disturbances, headaches, dizziness, and more. I seriously thought I had a stroke or Guillain Barre syndrome or rapid onset multiple sclerosis, I was so sick. Let me say that first, Stephen Fried's book is an excellent overview of the circumstances of adverse drug reactions to quinolone antibiotics. And with the increased visibility and use of Cipro, and the ease with which doctors dispense heavy-hitting antibiotics like Levaquin and Tequin, I'm sure I'm not going to be the last person to suffer a reaction and end up being "Floxed" and needing the information and reassurance provided by this book.But it is also much much more. It's an expose of the pharmaceutical industry's fast and loose way of dealing with drugs, drug safety and the American public. This is not a rant -- it's an impeccably researched and detailed presentation of the intricacies involved in drug approvals and tracking of adverse reactions that exposes the limitations of the system, and the dangers those limitations present to us as patients and consumers. As a patient advocate and spokesperson for thyroid and autoimmune disease patients, I know all too well the feeling of being held hostage to big pharmaceutical companies at the expense of my health and wellness. Stephen Fried has finally exposed and explained -- clearly and without rancor -- how the drug industry really works, and his book, including the excellent appendix on how to contact pharmaceutical companies, report adverse reactions, protect yourself against bad drugs, and generally protect yourself as a consumer -- is must-reading for every empowered patient or health consumer.I highly recommend this book to doctors, patients, and anyone who prescribes or takes prescription drugs.

"Bitter Pills" is the real-life version of "Strong Medicine" by Arthur Hailey. With a very personal beginning resulting from his wife's near death and slow recovery from taking ONE PILL (Floxin), author Fried went on to find whether there were other victims (many), and why the drug was approved in the first place. Interviews in profusion show why the FDA has its problems. Examples are given of the tendency of drug companies to defend their drugs at any cost regardless of evidence. The end of the book contains addresses of many drug companies, organizations to whom to report adverse drug reactions, and a sample form to send to the FDA. Well thought-out advice for patients (or their helpmates) to investigate drugs are given. A number of other good books on the subject are listed. Fried is to be congratulated for doing a very accurate job with a minimum number of accusations. I did not find a single technical error in the entire book, and I have about 12 years exploratory drug development and teaching about it as a professor of medicinal chemistry. Even Fried may not have realized how many drugs not discussed in his book shorten life, because they are tested and accepted based on surrogate endpoints for short periods. This may not be so bad for antibiotics that are taken for two weeks, but can be very destructive for drugs intended to be taken for 20-40 years.

This book begins as a personal story. One day journalist Stephen Fried was forced to rush his wife, novelist Diane Ayres, to an emergency room, when she suffered a severe seizure. She turned out to be suffering an adverse reaction to an antibiotic, Floxin, which she had been instructed to take for a minor urinary infection. "Bitter Pills" grew out of Fried's attempts to understand what had happened to his wife.Fried, and his readers, soon discover that Diane Ayres' case was not unique, or even rare. Floxin is only one of legions of prescription drugs which can cause severe adverse reactions, which cause at least 45,000 deaths per year in the US (some estimates go as high as 200,000). It is a tribute to Fried's excellence as a reporter that he is able go beyond his dramatic personal story to give a comprehensive picture of what he calls " the hazardous world of legal drugs."Fried reviews the history of drug regulation in the US, and ably documents the shortcomings of the current regulatory system, as well as the inordinate influence drug companies have on the process. Two of the many specific "hazards" he identifies are the desperate need for doctors to have an independent, reliable source of information on the drugs they prescribe (almost all the informatin they currently have comes from drug manufacturers), and the equally crying need for an effective system for reporting and cataloging adverse drug reactions.I put this book down very impressed with Fried as both a reporter and a writer. He has clearly immersed himself in an important issue long enough, and deeply enough, that he has mastered it. He has then turned around to convey the complex issues involved to readers very effectively and without losing their interest. I look forward to work of similar excellence from Fried in the future.

I read this book at least a year ago but am still impressed by the story and the thoroughness of the author. I found it especially chilling because it is something I can imagine happening to me. Like Fried's wife, Diane, I too suffered a mild closed-head injury from an automobile accident as a child. Also like Diane, this injury has never given me problems and so I have never had reason to worry the subject - never considering it might have repercussions, certainly not when it comes time to fill a prescription. The most chilling part is that I can easily imagine a physician doing exactly what Diane's physician did - reading (or glancing at) the bland official Floxin contraindications as Fried has presented them, and deciding the antibiotic will be just fine!Fried's investigation into the drug-approval process was fascinating reading. By looking at one antibiotic in depth, he captured a lot of specific information that can no doubt be applied to the general case of pharmaceutical approval.The appendix to the book suggests how to read a drug insert and is a wonderful bonus - practical information you can use any time you deal with your MD or go to the pharmacy.

Five cheers! Have you ever taken a prescription drug? Has your doctor ever given you free samples and said, "Let's try this; it's new." Fried takes his wife's severe neuropsychiatric reaction to a new antibiotic as the jumping off point for a spell-binding review of the US drug approval process. I have some first-hand knowledge of the process, and found the book to be right on target (with a quibble over his account of his own emergency department visit). The book is especially timely this year, given the recent withdrawals of dexfenfluramine, fenfluramine, mibefradil, and bromfenac from the market,the growing realization of the dangers of troglitazone, and the push to force the FDA to move more quickly on drug approvals. Mr. Fried is to be commended for this stellar piece of work! We all send regards to his wife, Diane.