Review of Dark Remedy: The Impact of Thalidomide and Its Revival as a Vital Medicine (Paperback)

Dark Remedy by Brynner and Stephens is a rather scary tale of how one person,Dr. Frances Kelsey, may have just saved the people of the United States from a very trajic event in the 1960-61 era. Being a new FDA employee back then, she simply refused to permit its (ie, thalidomide)acceptance for the US (FDA approval) market,and by doing so,prevented one of the worst nightmares that could have occurred in American medical history. Many other countries had already approved the drugfor use,and by doing so,suffered consequences most of us are well aware of to this date. For that one fact alone, she certainly deserved the medal given by President Kennedy and many thanks from every American. The book also shows how bullish a pharmaceutical company can be. In 1958,it boldly went through the William Merrill company,so to set up the manufacturing process,as the drug called "Kevadon" back then. We are all very fortunate,that she (Kelsay)had the will and inner guidance not to cave in to all of the pressures of lobbyists of other countries and just say "no."Their approval (other countries,I mean)earlier of this so-called"super safe" sedative caused some of the most grotesque limb malformations imaginable to people-- that totally trusted the medical community at the time. The makers of this product clearly knew the dangers,but in the interest of greed and money,openly chose to ignore the findings. Essentially,doctors and pharmacists were lied to in accepting their literature presented to our FDA.The authors state that metabolism of this product by our bodies generate over 100 byproducts,each capable of doing this or that,and I am not quite sure this is true.However, there is the attempt now to bring the drug back to the FDA for approval for use in "certain" other types of trajic disease states,such as MS or HIV.I can assure you, I have spoken to both CDER and the FDA,and this will happen ONLY if this product verifies properly every sentence they write in the literature and-- proves out as such in every milligram of discovery is verified.Whether Dr. Kelsay was just stubborn, wise, or luckyis irrevalent now,as she IS the person who, ultimately gave the FDA the power that it has today.An event like this often, is the defining moment of such governmental entities. However, the FDA is not without comflicts of interest as you will find out. The voting methods used on products even today,sometimes seem to contradict rationale on both sides of some of the issues troubling approval of certain medicinal products and devices.Rock Brynner and Trent Stephens do an excellent job of keeping the book on task,and full of suspense, describing the tasks done by the pharmaceutical firm to cover all of the little nasty secretsthey had earlier hidden,including all of the free samples given to physicians and pharmaciststo be handed out like rock candy during Christmas.Some texts I have read try to make a point that only one stereochemical form of the drug is bad, this is not important. The body often will transform between isoforms (R and S),so this is moot to me.If you needed to pick a choice of this trajic story,and the heroic job done by one person to whom we as Americans should be indebted,it is this one.This book is a winner!



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