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Bitter Pills: What You Need to Know About the Drugs You Take
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Book Review and Interview With Author Stephen Fried
by Mary J. Shomon
Several weeks ago, I wrote
an article about how I had a particularly bad reaction to an antiobiotic, known as Tequin (gatifloxacin) that left me suffering dizziness, tingling in my hands and knees, pains in my legs, weakness in my arms and legs,difficulty swallowing and breathing, all within four days of starting the drug. After my airway started to swell in reaction to the drug, I was taken off it, and put on tranquilizers to calm down what appears to have been a violent central nervous system reaction to the drug, a member of the fluoroquinolone antibiotic family. The "quinolones" also include the now-famous Cipro (cirpofloxacin), and another popular antibiotic, Levaquin.
In an effort to learn more about this reaction, I came upon a support forum for sufferers of bad reactions to the quinolone antibiotics, the Quinolone Antibiotics Adverse Reaction Forum, and that led me to the amazing book Bitter Pills: Inside the Hazardous World of Legal Drugs, by Stephen M. Fried.
 | The book is an amazing account that starts with Fried's wife nearly dying from taking Floxin, another quinolone antibiotic. The book describes the neurological and mental illness that results from her taking just one of these pills. Fried, an investigative journalist, begins to explore the world of adverse drug reactions, and discovers that his wife is not alone in getting, as Fried labels it, "Floxed."
This launches his more comprehensive expose of the issue of adverse drug reactions, Food and Drug Administration approvals, regulation and oversight of drugs, and the politics and economics that drive the actions of the pharmaceutical industry. In the book, Fried points out that more people die each year from adverse reactions to prescription and over-the-counter drugs than from illegal drug use, and goes on to explain the approvals and monitoring process, and the frightening yet common marketing practices that make drugs a potential danger. |
While hair-raising, the book is required reading for anyone who takes prescription medicines. Thyroid patients in particular will appreciate Fried's discussion of the Betty Dong study of the thyroid drug Synthroid, and how the pharmaecutical company attempted to suppress that research and prevent the public from learning that Synthroid was equivalent to its competitors, not better, as the manufacturer had claimed, and used to justify the drug's higher price.
Fried also provides guidelines on how to protect yourself against the possible dangers of prescription medications, and what to do if you do have an adverse reaction to a drug, in terms of followup with your physician, the FDA and the pharmaceutical manufacturer.
I had an opportunity interview Fried regarding some thoughts about the book and its implications for patients.
Mary Shomon: What do you think is the most important message the typical person who takes prescription medicine should take away from your book?
Stephen Fried: That taking medication safely and effectively is much more complex than what drug company advertising suggests, and that there is a way for consumers to be more informed about the drugs they take, and the machinations of the pharmaceutical industry and the FDA, without having to memorize the Physicians Desk reference.
Mary Shomon: How important do you feel it is that consumers who have adverse drug reactions file an official report with MedWatch?
|  Stephen Fried |
Stephen Fried: It is very important to report adverse drug reactions to the FDA--it is also important to file follow-up reports if you can, because it's important for the agency and drug company to know how long you had symptoms and whether they finally abated. One of the biggest problems with MedWatch reports is incompleteness.
Mary Shomon: While your book touches upon a variety of situations in terms of drug approval processes and adverse reactions, thryoid patients in particular have been frustrated by the saga of the Synthroid research, which you mentioned in your book. This has led to the never-ending class action lawsuit, and now the long, drawn-out and quite political FDA approval process for levothyroxine drugs. Needless to say, there are many patients frustrated with the control that the pharmaceutical companies have over patient and professional groups, frustrated with the FDA's seeming impotence to control huge pharmaceutical companies, and frustrated that the patients seem to be the least concern of all involved. For patients who want to take action, what would you suggest they do? (i.e., given what you know about pharmas and FDA, should they write to legislators? Join Public Citizen? Switch to competing drugs? Start their own patient groups? Complain to HMOS and insurance companies? etc.?)
Stephen Fried: I believe that part of the problem with the regulation of drugs and drug companies is that consumers rarely raise their voices to Washington, except to protest drug pricing. For that reason, legislators only pay attention to pricing issues. drug safety is far more important: most people would be willing to pay a little more if they could buy a little more health and safety. Public Citizen is a fine group that does important lobbying and is able to amplify some of the new safety issues that come up in the literature--but they can sometimes scare people out of taking their meds, which is bad.
I've tried to get the individual patient advocacy groups to pay more attention to drug safety issues. These groups tend to focus primarily on increasing research expenditures for possible cures; I think they should focus some of that attention on making sure that people are using current treatments more safely and effectively.
As for legislation, the most important piece of legislation in drug safety is the bill, which renews every five years, which enables the "user fee" program--which asks drug companies to pay a large fee for their drug applications to be processed, and in exchange the applications have been processed more quickly. Most of the FDA's regulatory budget comes from these fees, and as I've written in my book, the drug companies have refused to allow the fees to be used for postmarketing surveillance--to find out more about drug effects once the drugs are on the market.
The user fee bill, which is called PDUFA, is up for renewal this year, and there seems to be a real chance for the first time that the drug companies can be coerced to letting the user fee money be used for safety surveillance. People should write to their legislators demanding that they don't vote yes for a new PDUFA bill unless the user fee money can be used for postmarketing surveillance. The more money that goes for safety monitoring, the better chance that new safety problems will be caught early and dealt with early. Catching these problems does not, however, mean yanking drugs off the market: it means making sure they are labelled more correctly and advertised more approrpriately.
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