ippy2 2010 IPPY Book Awards - Gold
ForewordAwardStic 2010 ForeWord Magazine's Book of the Year Awards - Silver
NAUTILUS-SILVER---BESTsmall 2009 Nautilus Book Awards – Silver
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2008 National Best Books Awards - Finalist

Overview 


What if it were possible to eliminate hundreds of thousands of birth defects worldwide every year through the use of a little pill? What if it took no more than pregnant women ingesting a small dietary tablet throughout the first two months of pregnancy? What if this magic pill had escaped detection by the scientific community right up until its discovery less than a year ago?

What if the scientific detective that made the discovery happened to be a trial lawyer?

In a story that reads like a Hollywood script, truth trumps fiction with a revelation that will leave scientists and physicians throughout the world wondering how such an important piece of research could have escaped their detection. Yet as more and more researchers examine the hard evidence presented by Terence Mix in The Price of Ovulation, their conclusions will no doubt fall in line with colleagues who have already scrutinized the hypothesis presented by the attorney and author.

And that discovery did not occur by chance or without many years of research. In fact, in many ways it was a byproduct of two and a half decades of litigation with the manufacturer of a fertility drug – not to mention three more years of reviewing and analyzing hundreds of scientific papers in preparation of this book.

Clomid (clomiphene citrate) is the most widely used fertility drug in the world. Since its introduction in 1967, literally millions of American women have taken the drug to stimulate their ovaries in the hope of conceiving a baby. For many of these women Clomid has been the answer to their prayers. Others have not been so fortunate – and have borne the brunt of a hidden cost.

Although tens of millions of prescriptions have been written for Clomid, over the decades a quiet and little-known debate has raged in the medical and scientific community over the risks to the offspring conceived with the drug. Dozens of published epidemiology studies have linked Clomid – and other fertility drugs – to a wide array of serious and severe birth defects. Up to one out of every ten babies born following the use of Clomid and other fertility drugs will be born with a serious birth defect.

Yet through the efforts of the manufacturer of Clomid to suppress and conceal crucial evidence and information concerning the drug’s risks – coupled with a blatant disregard of that evidence by the FDA – virtually all consuming patients and the majority of their prescribing doctors remain unaware of these risks.

But for the author of The Price of Ovulation, the sad and disturbing history of Clomid has been a major focus of his professional life. Out of that focus grew the book, a compelling narrative about his sacrifices, obstacles, frustrations and efforts to bring this history to the attention of the users of fertility drugs and his ultimate discovery of a means to offset the risk of these birth defects – a means, it turns out, that also applies to a significant percentage of birth defects in naturally-conceived pregnancies.

It all began in June 1970, when a young couple became parents for the very first time. The assisted conception had followed two years of infertility and frustration. But their day of joy quickly turned into a nightmare when their baby boy was delivered without any hands. He had been conceived with Clomid. When their suspicions turned to the drug, the couple sought out legal assistance and ultimately retained the services of the author. At the time, Terence Mix was a young and inexperienced trial attorney. By April 15, 1974, he had become an expert, both in trial skills and knowledge about fertility drugs. That was the day he won the first-ever jury verdict against Clomid and its manufacturer.

For Mix, it was the beginning of a 34-year odyssey to help infants afflicted with severe birth defects and to bring the truth about the risk of malformations to the attention of Clomid users throughout the world. In the process he has unquestionably become the most-experienced trial attorney on Clomid in the country. He has litigated case after case on behalf of malformed infants and built both an impressive legal record and comprehensive knowledge about the truth behind the drug and its risks.

On one level, The Price of Ovulation is an eye-opening expose´ about a previously unrevealed risk of fertility drugs and the actions one manufacturer has taken to conceal that risk. Among its many revelations are documents never before seen by the public or medical community – many even yet to be viewed by the FDA. Its author is perhaps the only outsider to sit within its pharmaceutical plant and personally scan thousands of pages of confidential documents. What’s revealed is a shocking story of what goes on in the pharmaceutical industry and why the country is in desperate need of a remedy for the failings of our designated watchdog. In chilling detail, the book documents how the FDA turned its back on efforts to warn the public of the dangers of Clomid, including those reported by the author.

The timing of this book could not be better. Recent disclosures about the dangers and cover-ups of drugs like Vioxx, as well as statements issued by senior officials at the FDA, such as Dr. David Graham, who acknowledged that it is “virtually impossible” for that agency to currently protect the public from dangerous drugs, make The Price of Ovulation timely reading. At the present time, wide-spread public interest about the potential risks of drugs and the FDA’s woeful lack of measures to protect the users of those drugs runs high. This book brings together all of the problems that the general population still faces, notwithstanding legislation recently passed by Congress.

The ultimate benefit and value of the book, however, is a discovery offered by its author. Every reader contemplating the use of fertility drugs, either as a separate regimen to assist in ovulation or as part of the procedures associated with in vitro fertilization (IVF) and other assisted reproductive technology (ART) methods, will learn of protective measures that can be taken to counter the risk of birth defects otherwise associated with such efforts to achieve pregnancy.

Indeed, this book may well become a must-read for every couple contemplating pregnancy and desiring to minimize the risk of congenital anomalies.