Tuesday, May 22, 2007

PharmaGossip: Distaval - dont forget history

PharmaGossip: Distaval - dont forget history

Here is the review of a book that summarizes the Nazi link to Thalidomide! Please read the link above, then the book review for the back story. Thanks PharmaGossip for this link from bad medicine to Nazism. Sounds just about right to me.

Dark Remedy: The Impact of Thalidomide and Its Revival as a Vital Medicine
November 15, 2001

from Medscape General Medicine [TM]
Reviewed by: Richard J. Powell, DM, FRCP

With Dark Remedy: The Impact of Thalidomide and Its Revival as a Vital Medicine, American authors embryologist Trent Stephens and historian Rock Brynner have cleverly and meticulously crafted a chronicle of 40 years of thalidomide into a thoroughly readable and coherent story. They are to be commended on their detailed research into historical background and efforts to distil the more contemporaneous immunologic ramifications of thalidomide use for the nonspecialist reader. In fact, the book reads almost like a novel, although accuracy has been maintained throughout.

The drug, which was initially promoted as a sedative without side effects, became history's greatest medical tragedy as the development of irreversible nerve damage (neuropathy) and the reports of birth defects were ignored for the sake of monetary gain.

The story begins in Germany, chronicling the employment of ex-Nazi officers in the management of a production company and how their philosophies manifestly influenced subsequent marketing strategies. Thalidomide was "a drug in search of a disease." The authors note, "the only thing thalidomide seemed to have going for it was that researchers could not find a dose high enough to kill a lab rat."

The plot then moves to Israel in 1965, where thalidomide's beneficial effects in leprosy were discovered and subsequently confirmed in a large international World Health Organization study. These studies highlighted the need for the molecular definition of the anti-inflammatory/immunologic properties of thalidomide. It is, however, only in the last decade that some -- although not all -- of the answers have been forthcoming.

The book subsequently focuses on debates within the US Food and Drug Administration and describes the process that successfully prevented the drug from being licensed in the United States with compelling accounts from the individuals responsible for blocking approval.

Indeed, thalidomide beautifully exemplifies the issue of drug risk benefit ratios: as a sedative with a significant side effect profile, the drug was denied a licence, yet approximately 30 years later it has been given a special licence to allow its limited albeit appropriate use in life-threatening conditions when other drugs have been tried and failed. This special licence overcame the need for thalidomide to be illegally smuggled into the United States during the early and mid 1990s.

Especially noteworthy is the 12th chapter, "One Patient's Account," which graphically extols the benefit of thalidomide in an inflammatory condition and is almost worthy of the title "A twist in the tail." Woe betide the reviewer who discloses the secret disclosed therein.

This book is written by 2 worthy Americans and one must allow them a certain partisanship. However, to a British reviewer, the tributes to immunologist Gilla Kaplan, PhD, whose work on the capacity of thalidomide to inhibit tumor necrosis factor-alpha in connection with AIDS research, seemed overstated. Similarly, there is no mention of the UK policy on thalidomide that has allowed its use on a "named patient" basis since 1968; the UK guideline on the use and prescribing of thalidomide in 1994 was largely imitated by the System for Thalidomide Education and Prescribing Safety (STEPS) program in America.

Finally, not surprisingly, the authors struggle to explain the complicated immunologic processes involved in the actions of thalidomide and end up producing a rather indigestible account of the science.

Despite these reservations, I recommend this book not only to those with a specific interest in thalidomide but also as a very informative read for general audiences.

Richard J. Powell, DM, FRCP, is a Consultant and Senior Lecturer in Clinical Immunology at University Hospital, Queens Medical Centre, Nottingham, United Kingdom.
Medscape General Medicine 3(4), 2001. © 2001 Medscape Portals, Inc

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