Onco'Zine

Introduction

The history of thalidomide shows a dark past. When the drug launched in 1957 it was found to act as a tranquilizer and painkiller. The drugs was originally marketed as drug for the treatment of insomnia, coughs, colds and headaches. Doctors also found that thalidomide was an effective antiemetic which had an inhibitory effect on morning sickness. As a result, thousands of pregnant women took the drug to relieve their symptoms. Despite the fact the drug had never been tested on pregnant mammals and was chemically similar to drugs known to harm embryos, the launch of the drug was supported by aggressive marketing campaigns.

Then, in the early 1960's the Australian obstetrician William McBride and the German pediatrician Widukind Lenz suspected a link between an increase in numerous devastating cases of birth defects and thalidomide.

Within a year after the link was confirmed, Grünenthal, the German pharmaceutical company based in Stolberg near Aachen, marketing the drug, and their representatives around the world, took the drug off the market.

Around the same time regulatory authorities banned the drug from markets worldwide.

New beginnings
Following thalidomide tragedy, Jacob Sheskin, a Professor at the Hebrew University of Jerusalem at Hadassah University Hospital and the chief staff and manager of Hansen Leper Hospital in Jerusalem, noted that the drug offered treatment related benefits to patients with erythema nodosum leprosum or ENL, a painful complication of leprosy, in an attempt to relieve pain in spite of the ban.

From the 1970s Grünenthal supplied thalidomide tablets to support leprosy hospitals around the world in the management of ENL. The drug was distributed by agreement with the World Health Organization (WHO). National health authorities strictly monitored the distribution. Grünenthal continued to make the drug available for humanitarian reasons only until June 2003.

Cancer
In 1998, U.S. based Celgene Corporation (now part of Bristol Meyers Squibb/BMS) received approval from the U.S. Food and Drug Administration (FDA) to market thalidomide in the treatment of erythema nodosum leprosum or ENL.

Today, the drug, is being marketed by Celgene under the brand name Thalomid for the treatment of acute treatment of the cutaneous manifestations of moderate to severe ENL, and, in combination with dexamethasone, for the treatment of patients with newly diagnosed multiple myeloma.

To prevent harm to unborn life, the FDA required Celgene the development of a stringent - mandatory - program to place to monitor - and prevent - us of the drug by pregnant women. The program called System for Thalidomide Education and Prescribing Safety or S.T.E.P.S. limits the prescription and dispensing rights of the drug only to authorized prescribers and pharmacies, requires a registry of all patients prescribed the drug. The program also provides extensive patient education about the risks associated with the drug and includes periodic pregnancy tests for women who are prescribed it.

The origin of a tragedy
There are numerous conflicting historical and anecdotal accounts about the origin of thalidomide. Some accounts claim that the drug was developed by Swiss pharmaceutical giant Ciba (now part of Novartis), others claim that the drug was developed by researchers working for Grünenthal.

According to data published in a report by Martin Johnson, director of The Thalidomide Trust in the United Kingdom, the drug was developed at the end of World War II in Nazi Germany, more than 10 years before Grünenthal secured a patent in 1954, as an antidote to nerve gases such as Sarin.

Martin discovered that a Heinrich Muckter, a former Nazi doctor, was paid large bonuses before thalidomide tragedy broke. According to Martin's report, following the launch of the thalidomide, Grünenthal paid Muckter nearly 22 times his annual executive salary.

Otto Ambros, who became an advisor for the British pharmaceutical company The Distillers Company (Biochemicals) Ltd, a subsidiary of Distillers Co. Ltd., was another convicted Nazis war criminal linked to Grünenthal and thalidomide. Distillers marketed thalidomide under the brand name Distavel in the United Kingdom, Australia and New Zealand.

Conflicting reports suggest that the drug was first synthesized in 1949 by British scientists at the University of Nottingham.

In this Onco'Zine Dossier our editors review various aspects of the history and development of thalidomide.

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Last Page update: October 29, 2020
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