Customer Reviews

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

5 star:		(8)
4 star:		(1)
3 star:		(1)
2 star:		(0)
1 star:		(0)

 

 

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 The dismal story of how thalidomide was invented, marketed, and withdrawn is a big part of the fascinating account in _Dark Remedy: The Impact of Thalidomide and its Revival as a Vital Medicine_ (Perseus Publishing), by Trent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.

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!

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

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.

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!

I would recommend to any one interested in the tragic thalidomide story. This is well written. I wish I had read before. It is a reminder that exposures thought to be safe for the pregnant woman may be quite harmful to the fetus. It is a reminder that there needs to be an alertness by drug companies to the possibility that their product could cause birth defects because they are in a position to be the ones who first detect it and can minmize the numbers of children damages by the prompt removal of the drug.

A well-researched book that covers both sides of the thalidomide story. First used as a sedative with no restrictions until its effects on unborn infants was known, thalidomide is both a deadly poison and a beneficial drug, for some applications. I especially enjoyed the discussion of how the victims of thalidomide supported its reinstatement and how they employed various means to educate and warn potential users of its adverse effects. Other wonderful sub-stories include how thalidomide led to the reform of the FDA via the efforts of one dogged lady and a personal account of someone using the drug to live a normal life.

Dark Remedy is a very informative book on Thalidomide. It is a HOSA (health occupations students of America) reading book, for high school students. I teach that in high school and thought it was a good book for our future healthcare students to read.

Dark Remedy tells of how thalidomide caused the greatest medical disaster in history - but today is enjoying a comeback as a life-saving treatment despite its side effects. Dark Remedy considers how the drug became a nightmare in the 1960s, how it was banned, and how it's receiving new research attention today which may reinstate its use without its side effects. An intriguing medical history.

Dark Remedy is definitely not all it's cracked up to be. I agree that it's a disturbing and informative book chronicling the "life" of thalidomide but I have to admit that I found it pretty boring. Maybe I'm just too young to understand the tragedy that resulted from the use of thalidomide. The truth is that I had never even heard of thalidomide until I read this book. I guess I can't truly grasp the impact that this drug had on the world and that may have contributed to the confusion I experienced while reading Dark Remedy. The only parts of the book that I found interesting were the experiences of the children who were born with phocomelia. That is what I was looking for when I first decided to read this book. I guess I should have looked elsewhere.