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New Book Question's Trustworthiness of FDA

Author: Terence Mix, Attorney at Law

Published: 2013-01-02

Synopsis:

The FDA lacks any criteria for determining what safety actions to take and when to take them once a drug is on the market.

Main Digest

The book probes deeply into the multiple problems inherent in the current system of testing and monitoring of drugs in the U.S. and offers solutions and precautions that could save thousands of lives and billions of dollars in healthcare costs.

U.S FDA - The United States Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), medical devices, electromagnetic radiation emitting devices (ERED), vaccines, bio-pharmaceuticals, blood transfusions, veterinary products, and cosmetics.

The FDA lacks any criteria for determining what safety actions to take and when to take them once a drug is on the market. "Those are not my words," says Terence Mix, author of the new book, "AMERICAN GUINEA PIG: Everything That's Wrong with the FDA and How to Avoid Becoming One of Its Victims." "In fact, it's a conclusion that was reached by the United States Government Accountability Office (GAO) in March 2006 following a 16-month investigation requested by Congress," he adds. Among its many findings, the GAO report also points to lack of effective communication between the two primary offices overseeing the safety of drugs, and in some instances one office even outright rejecting the safety recommendations of the other.

Recently winning Honorable Mention awards at both the New England Book Festival and London Book Festival, Mix's book highlights a number of facts that may shock many of its readers. "Most people seem to think that it is the FDA that either tests or directly oversees the testing of drugs," says Mix. "But unfortunately that is not the case. It is the drug company that designs the study, hand-picks the doctors participating in it, gathers the records, compiles the data and then spoon-feeds everything to the FDA, including its conclusions about the results." Mix laments about the abuses of our system that have been going on for decades and have been documented through civil litigation and whistle-blower lawsuits. "Along with the fox-guarding-the-henhouse problem," he adds, "the current method of testing drugs is infested with multiple conflicts of interest - and that extends even into the FDA."

Mix points to the enormity of this problem, explaining that on average about 230,000 Americans die as a consequence of adverse reactions to prescription and over-the-counter drugs every year - 105,000 of them taking the drug as specified by the drug company. "It's the third leading cause of death in the U.S., behind only heart disease and cancer," says Mix, who also points to annual healthcare costs of $200 billion for the treatment of drug reactions.

America Guinea Pig probes deeply into the multiple problems inherent in the current system of testing and monitoring of drugs by following the premarket and post-market history of 10 different drugs and the tragedy they unloaded upon an unsuspecting public. Few consumers of drug products - about three quarters of our population - realize that drug companies provide 55% of the budget of the drug division of the FDA, Mix points out. "The drug industry and its regulator are joined at the hip," he says, "and the top brass at the FDA view their association more as a partnership. This is why there is so much foot-dragging when it comes to removing a drug from the market or adding a stronger warning."

By way of example, American Guinea Pig cites the history of Cylert, which was removed from the American market in 2005, six years after it was withdrawn in Canada and eight years after it was dropped in Great Britain.

"One of the goals of the book," Mix explains, "is to wake up Congress and point to changes in the law that could save 100,000 lives and cut $100 billion in healthcare costs. And that's every year," he adds. The other is to equip every reader with the information and the tools needed to reduce the risk of becoming another statistic. This is where Mix feels the book will have its greatest value. As one reader posted on Amazon.com, "This book is eye-opening. It's extremely well written and explains a complicated subject matter in a very coherent manner. It sheds light on the troublesome relationship between the FDA and big pharma companies--an issue too many people are unfamiliar with. If you use prescription pharmaceuticals, this book is a must read." - Website: www.americanguineapig.com

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