Dark Remedy: The Impact Of Thalidomide And Its Revival As A Vital Medicine [Hardcover]

Trent Stephens (Author), Rock Brynner (Author)

Book Description

Publication Date: January 9, 2001

A remarkable medicine is now available that can successfully treat millions of people with multiple myeloma, brain tumors and other cancers, arthritis, lupus, Crohn's disease, multiple sclerosis, leprosy, tuberculosis, and AIDS. It's thalidomide-a drug with a chilling history. In the 1950s, this "safe" sedative was all the rage in Europe. Then one baby was born without ears, another with stunted limbs, then another with no limbs at all. In all, ten thousand severely deformed babies were born before thalidomide was banned. But two years ago, this brutal toxin was approved by the FDA. How did the most infamous drug of all time become one of the major players in modern medicine?In this irresistible medical detective story, Trent Stephens and Rock Brynner recount the history of thalidomide, a fascinating tale filled with villains and heroes, and bring us up to the present day, as scientists-Stephens among them-work to create and test an alternative drug that captures thalidomide's curative properties without its cruel side effects. The chronicle of a tragic chapter in the history of public health, Dark Remedy ends with great promise, as we put thalidomide to work for us, in the treatment of over a hundred diseases.

Editorial Reviews

Amazon.com Review

Twentieth-century science is too complex for any one reader's apprehension, so we look for stories that help us grasp its enormity. The jubilant discovery, demonization, and subsequent rehabilitation of thalidomide offers a wide-ranging outline of public attitudes toward science following World War II, and the authors of Dark Remedy: The Impact of Thalidomide and Its Revival As a Vital Medicine tell the story well. Historian Rock Brynner and embryologist Trent Stephens--who may have finally determined the drug's mechanism of action in 1998--treat us to both a devastating indictment of the under-regulated pharmaceutical industry of the 1950s and a penetrating study of thalidomide's reintroduction into mainstream medicine through the black market. The powerful anti-inflammatory properties of the drug make it a popular choice for treating arthritis, leprosy, some cancers, AIDS, MS, and many other debilitating illnesses, but it has only recently won grudging approval. Though the its tone can be acidic (in one instance referring to the "Utopian prosthetics custom-designed for the deformities caused by Utopian medicine"), the book is, for the most part, fair to the corporations that caused and then ignored the epidemic of birth defects, the victims who understandably tried to prevent the drug's revival, and the regulators who were too often bound by short-sighted legislation to do their jobs. The heroes and villains are larger than life, the stories and the science are equally compelling, and Dark Remedy ultimately combines the best elements of journalism and myth. --Rob Lightner

From Publishers Weekly

Thalidomide, the drug notorious for causing deformities in infants during the late 1950s and early '60s, has been back in the news--amazingly, it has been found useful in treating a range of diseases from cancer and leprosy to AIDS. Combining Stephens's expertise as a scientist researching thalidomide and novelist and historian Brynner's (The Doomsday Report) firsthand experience as a thalidomide recipient (he was given the drug to treat t a rare inflammatory disease), this compelling tale documents the history of a drug originally offered as a "safe" alternative to barbiturates (which were used by suicides). Very soon, it came to be linked to nerve damage in adults and to "flipper-like" limbs in babies born to women who took the drug. An arduous legal battle ensued, and the authors nicely highlight such figures as the FDA's Frances Kelsey, who fought successfully against the drug being approved for use in the U.S., and pediatrician Widukind Lenz, who linked thalidomide to the birth defects. In particular, however, the authors successfully convey the necessity of placing an "absolute commitment to truth" ahead of all other considerations when testing, prescribing or selling a drug. "The monster was never thalidomide itself," they claim of the drug that sparked FDA reform. While this moving account offers a chilling glimpse of how the profit motive can negatively affect many lives, it also includes a straightforward presentation of Stephens's pioneering research with thalidomide--research that he hopes will contribute to developing a truly safe alternative. (Feb.)Forecast: Brynner is the late actor Yul Brynner's son. That will undoubtedly help bring publicity to this title, which will draw a wide range of readers interested in the ethics and science of medical research.

Copyright 2001 Cahners Business Information, Inc.

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Product Details

• Hardcover: 208 pages
• Publisher: Basic Books; 1St Edition edition (January 9, 2001)
• Language: English
• ISBN-10: 0738204048
• ISBN-13: 978-0738204048
• Product Dimensions: 8.4 x 5.5 x 0.9 inches
• Shipping Weight: 10.4 ounces
• Average Customer Review: 4.7 out of 5 stars  See all reviews (10 customer reviews)
• Amazon Best Sellers Rank: #1,986,567 in Books (See Top 100 in Books)

Customer Reviews

Most Helpful Customer Reviews

15 of 15 people found the following review helpful:

5.0 out of 5 stars Thalidomide Reborn, March 7, 2001

By 

R. Hardy "Rob Hardy" (Columbus, Mississippi USA) - See all my reviews
(TOP 100 REVIEWER)    (HALL OF FAME REVIEWER)    (REAL NAME)   

This review is from: Dark Remedy: The Impact Of Thalidomide And Its Revival As A Vital Medicine (Hardcover)

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 birth deformities. In fact, such a drug is undergoing trials. Thalidomide, this excellent history and scientific explanation shows, has ruined lives, but it has also caused needed changes in drug approval processes, and still has potential for diminishing suffering.

10 of 10 people found the following review helpful:

5.0 out of 5 stars How the FDA acquired its power in our modern era, February 20, 2008

By 

Guy F. Airey "The Chemist" (San Antonio, TX USA) - See all my reviews

This review is from: 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 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. 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!

6 of 7 people found the following review helpful:

4.0 out of 5 stars The Truth About Teratogens, January 17, 2001

By A Customer

This review is from: Dark Remedy: The Impact Of Thalidomide And Its Revival As A Vital Medicine (Hardcover)

This book is a terrifying and fascinating thriller that weaves a seductive mystery about the history about one of the best known teratogens: Thalidomide. This book explores one of the first incidents that prompted the National Birth Defects Prevention Study, a program which seeks to identify anomaly inducing substances. It also outlines events that prompted the FDA to be considerably more discerning about the level of testing that goes into approving these drugs. 'Dark Remedy' brings a drug with a dark past back into the limelight as a drug with vast potential to change lives for the better. Well written and easy to read this book avoids medical jargon making it a perfect chioce for the layperson seeking to educate themselves about this tragedy. Although these children suffered, two things redeem the situation