Dark Remedy: The Impact of Thalidomide and Its Revival as a Vital Medicine

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 drug for 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 lucky is 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 secrets they had earlier hidden, including all of the free samples given to physicians and pharmacists to be handed out like rock candy during Christmas. S

I bought this remarkable book last year and have recommended it to several people. I know next to nothing about medicine, so it came as a revelation. When I was a child in the 1960s, this mysterious horror always lurked in the distance, terrifying but incomprehensible. Like nuclear fallout or the mercury poisoning of Minamata, thalidomide was an important symbol of Frankenstein technology, but I didn't read a proper study of the nightmare until I read 'Dark Remedy' last year. Like many adolescents of my generation, I also enjoyed 'thalidomide jokes'. We thought these were very funny. At the time, I had no understanding of the terrible death and misery the drug inflicted on thousands of children. Despite the suffering it caused, thalidomide has undergone an amazing 'second act'. Almost unbelievably, the Frankenstein monster has been reborn to do some good. In the 1960s, researches discovered that it could cure the lesions caused by an autoimmune disease called ENL. A decade later, it was found to be very effective for curing the lesions caused by leprosy (Hansen's disease); in fact, it was the only cure. In the 1980s, it was found to be extremely good for treating some of the symptoms of AIDS. It is now used to treat as many as 130 disorders. Who could have imagined that the drug that caused the worst medical disaster of the 1950s could be used to ameliorate the worst medical disaster of the 1980s? 'Dark Remedy' should be read be everyone who is interested in science and health.

As outlined above, this book details the history of thalidomide, including its discovery, introduction into society, harmful effects, withdrawal, and eventual rebirth as a useful medication. It is very interesting and keeps your attention throughout the entire book. I am a physician and learned very much from this book, including some information about the FDA, and even about what thalidomide is used for today. I would say that you should read this book if you have any interest in medical history told in a narrative fashion. It will educate you on a tragic event in history and the amazing effects of medications upon human beings. Great, great, great book!

This short book is a compelling drama, complete with innocent victims, dark villians and compassionate and dedicated heros. But it is no simple account in black and white. Rather it is a textured retelling of the profound human tragedy of Tahlidomide, it's impact on the phamaceutical industry, the FDA's regulatory role, and the pursuit of scientific insight.It will come as a surprise to many laypeople that Thalidomide, notorious for the extreme birth defects it caused when it burst upon the consciousness of the world in the early 1960s, is now used for the treatment of dozens of conditions. This book details the painful story of Thalidomide's devastation; the greed and indifference of it's corporate promoters; the dilligence and dedication of a handful of doctors who helped curtail it's spread, the tortured legal struggle of it's victims, and the difficult and collaborative process by which scientists discovered it's secrets and are putting it to use to relieve suffering.The history is recounted on a human scale, making the drama real to the reader. The science, as complex as it is - including molecular structures and the mechanisms of DNA - is articulated in a way that makes it accessible even to the layperson.I highly recommend it.

Anyone who could pay attention to newspapers in the 1960s remembers the stories of thalidomide. Thousands of women took this super-safe sedative, or morning sickness suppressant, and found that their children were born with grotesquely stunted limbs like flippers, or perhaps no arms or legs at all. The dismal story of how thalidomide was invented, marketed, and withdrawn is a big part of the fascinating account in _Dark Remedy: The Impact of Thalidomide and its Revival as a Vital Medicine_ (Perseus Publishing), by Trent Stephens and Rock Brynner, but as the title implies, the story is not all gloom. The initial part of the story is simply shocking, with the German drug manufacturer displaying incompetence and selfishness throughout the product's development, testing, and distribution. When problems emerged, the company did a cover up, hired a detective to keep tabs on the doctors and patients who were complaining, and kept selling the drug.The United States was a huge potential market for thalidomide. A subsidy of Vick Chemical Company (makers of Vicks VapoRub) was set to release it in the US in 1961. The company was sure it would get quick approval from the Food and Drug Administration, because at the time there was no requirement to show that the drug worked, it was up to the FDA to find any data to show any dangers, and pharmaceutical representatives did favors for FDA officials. The FDA, and the company, did not reckon on young FDA staffer Dr. Frances Kelsey, who was appalled by the sloppiness of the application. The story of the drug company's recklessness is shocking, but Dr. Kelsey's refusal to bow to heavy pressure, from both the company and her superiors in the FDA, is one of the inspiring parts of the book. She got a civilian service medal from President Kennedy, and it was due to her unflagging refusal to compromise that thalidomide didn't make it to American shelves.Dismaying and astonishing are the stories of how the drug got approved elsewhere, and how the makers attempted to absolve themselves of any financial responsibility to the victims. But those are only part of the thalidomide story. The other part is that thalidomide is back. Results published in 1965 showed that thalidomide has an enormous capacity to relieve the pain of leprosy. This is important for lepers, of course, but there is not a huge population of lepers these days. More recently and more importantly, thalidomide has been used for HIV; it was found that it was good for the wasting of the illness and the mouth ulcers. From these results have grown the research that shows that thalidomide can be useful for victims of cancer (especially multiple myeloma) and autoimmune diseases such as lupus. Current research on the drug (and author Stephens has done some of it) has pursued just how thalidomide caused its extraordinary birth defects, so that the drug company now making it could work on an analogue drug that has all the good effects and none of the bir