Thalidomide’s big lie overshadows corporate apology

By Harold Evans
September 12, 2012

A lie wrapped in an apology is still a lie. It is a big lie, a particularly offensive lie, coming as it does from the German company Chemie Grünenthal responsible for inflicting its notorious drug thalidomide on hundreds of thousands of women in 52 countries. Some 90,000 babies are calculated to have died in spontaneous abortion, but at least 10,000 mothers are known to have given birth to malformed babies between 1958 and 1961; the most damaged survive today as limbless trunks, others whose legs and arms were reduced to digital “flipper” extrusions from the shoulder, and thousands have severe internal injuries as well.

Grünenthal (now GmbH) was a small private company set up after World War Two as an offshoot of an old family firm that made soaps and detergents. Its first pharmaceuticals were produced under foreign license, but thalidomide (which it called Contergan) was its own, a sedative discovered by accident in the spring of 1954 by a 32-year-old chemist and doctor, Heinrich Mückter. To exploit the postwar sleeping-pill boom, Grünenthal marketed it massively from October 1957 as “completely safe,” “completely atoxic,” and free of the unpleasant side effects of barbiturates. The sales department called it “the apple of our eye” because it was so profitable. From 1958 to 1961 they zeroed in on promoting it for use by expectant mothers.

The apology for the tragedy has come from Grünenthal’s new chief executive, Harald Stock, who at the end of last month stood outside the company’s Rhineland offices in the small town of Stolberg to unveil a bronze sculpture of a thalidomide child with foreshortened “flipper” arms. “We ask for forgiveness that for nearly 50 years we didn’t find a way of reaching out to you, human being to human being.”

The emotion and apparent sincerity were appealing, but in the next breath he made forgiveness impossible. “Grünenthal acted,” he said, “in accordance with the state of scientific knowledge and all industry standards for testing new drugs that were relevant and acknowledged in the 1950s and 1960s.” That was flatly untrue, a product of either deep-rooted cynicism, belying his whole apology, or of appalling ignorance. Grünenthal has propagated the big lie for 50 years, retailing the notion that reproductive tests were unnecessary because nobody could possibly have realized in the fifties that a drug could penetrate the placental barrier and reach the fetus. (Stock and the company did not respond to requests for comment on these charges.)

It is 39 years since, as editor of the Sunday Times of London in the early seventies, I was associated with thalidomide investigations. Our survey of the scientific literature, consultations with reputable pharmaceutical companies and independent specialist advice swiftly found that reproductive studies were routinely done in the 1950s, because it was widely recognized that a drug could indeed reach the fetus. The tranquilizers in direct competition with thalidomide were all tested for teratogenic effects and the results published. If reproductive tests had been done on thalidomide, they would not necessarily have shown precisely what deformities would be produced, dependent on the time of ingestion in relation to the development of the fetus, but they would certainly have shown that drugs could endanger unborn children in some way.

We went to see the pharmacologists. An investigative reporter visited the laboratories of Hoffman-LaRoche in New Jersey, producers of Librium, Valium and Mogadon, and checked their records. Reproductive testing had been routine since 1944. So, too, with Lederle, Burroughs Wellcome, Pfizer, SmithKline and ICI in Britain. Dr. G. Edward Paget, director of Inveresk Research Institute, a member of the Medicines Commission and the World Health Organization Expert Committee, and author or joint author of some 48 distinguished publications, said that as a toxicologist, he, and others like him worldwide, were testing drugs on pregnant animals in the fifties. “Any ICI drug likely to be used by pregnant women would have certainly been tested for its effect on pregnant animals.” All this we published in the newspaper and in books.

Grünenthal did no single animal test for effects on reproduction, nor did its licensees in 11 European nations and in 7 African, 17 Asian and 11 countries in the Americas selling thalidomide under different trade names. They were led to believe that Grünenthal had done that. In the United States, some 2.5 million doses were distributed, targeting pregnant women, without evidence from a single reproductive test.

Grünenthal made much of subjecting thalidomide “to the usual battery of investigations,” but even its animal tests for toxicity conducted by Dr. Mückter with associates Kunz and Keller were perfunctory. In 1965, scientists at the University of Stockholm reported: “The number of animal experiments in the toxicity test were far too small; because of this a low frequency of side effects could not be detected, even though these are important for a sedative like thalidomide and very necessary if the substance is to be declared unpoisonous. The conventional toxicological and pharmacological tests are most unsatisfactory. Kunz, Keller and Mückter tried to hoodwink the reader by creating a false impression of the scope of their tests.”

Hoodwinked is strong language for an academic document but mild by comparison with the German trial judges’ summation on Grünenthal testing. “Negligent, misleading, inexcusable, very inadequate by the standards of the day … The overall behaviour publicly shown by the company did not correspond with the standards required of a serious and conscientious producer of pharmaceuticals.”

Deception was the pattern for Chemie Grünenthal. On May 2, 1958, Dr. Augustin Peter Blasiu, who was retained by the company, published the results of using Contergan on 370 patients of whom 160 were nursing (not expectant) mothers: “Side effects were not observed either with mothers or babies.” Grünenthal distorted Dr. Blasiu’s careful report with a cunning promotional letter giving the impression he had tested Contergan on expectant mothers (my italics):

Dear Doctors,

In pregnancy and during birth the female organism is under great stress. Sleeplessness, unrest and tension are constant complaints. The prescription of a sedative and hypnotic that will hurt neither the mother nor child is therefore often necessary.

Blasiu did not see this material before a mass mailing. He condemned the Grünenthal letter as “unfair, irresponsible and misleading.” His anger made no difference.

Stock might merit forgiveness for an occasional oversight, or a clinical mistake, but Grünenthal, hungry for profits from selling millions of pills, would never face up to what it had done. Even before releasing the drug in October of 1957, it knew that one of its employees had given birth to a baby without ears, a red alert it ignored. From the very earliest days, it brushed aside medical complaints in increasing numbers that their wonder sedative caused peripheral neuritis, irreversible damage to the nervous systems of adults. It suppressed or delayed unfavorable reports about this from doctors by pressuring medical journals, it lied to inquiring doctors, it bribed others to write favorable reports when they had done no testing at all. For four months after an Australian obstetrician connected birth defects with thalidomide, the company continued to sell their poison to mothers, and the mothers produced more malformed babies.

The company, in short, covered up a crime against humanity for more than 60 years.

A few months ago I attended a reunion in London of several hundred British victims. I was moved by their bravery, by their ingenuity and resolve in making the best of their handicapped lives, too many of their bodies failing under the strains. I recognize that Grünenthal has made some monetary compensation, though it is not enough to ensure the very worst affected victims everywhere receive appropriate lifetime care, deprived as they increasingly are by loving parents. But money will not buy absolution. The company should come clean. It must at last dedicate itself to exploring and publicizing the origins of the greatest drug disaster. Thalidomide was incubated in ignorance, fueled by haste, propelled by reckless greed, concealed by deceit. “The unclouded face of truth” must no longer suffer wrong.

PHOTOS: Thalidomide victim Tony Melendez is shown in an undated file photo at age 4 while attending a therapy program at the University of California. REUTERS/File Swiss National Councilor Christian Lohr speaks during a debate in the National Council during the spring parliament session in Bern, March 8, 2012. Lohr was born with disabilities due to a drug based on thalidomide. REUTERS/Michael Buholzer

7 comments

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Not quite right to say all this without mentioning governmental betrayal. Whose job is it to protect the public from crooks? Who in government, which agency, which person, signed the “okay” that allowed this “poison” to be sold? And how exactly did that come about? Let’s stop berating crooks, for that will get us nowhere, but let’s begin identifying (and prosecuting) corrupt officials.

Posted by Rinaldo36 | Report as abusive

There are indeed issues with the company for a long time, however just as bad is thee constant negative dehumanizing portrayal of thalidomiders as again evident in this commentary.
“malformed babies between 1958 and 1961; the most damaged survive today as limbless trunks, others whose legs and arms were reduced to digital “flipper” extrusions from the shoulder, and thousands have severe internal injuries as well.”

That very public dehumanizing portrayal of thalidomiders very likely was and is one of the main reasons for many challenges parentd and thalidomiders faced and face.

Cheers
Gregor Wolbring

Posted by Wolbring | Report as abusive

YOu mean the government regulators who are being cut back on? Whose funds are being denied them by congressmen bought by the drug companies? By the obfuscation of companies trying to hide or pad data, or bury it under reams of unimportant information? WHo don’t have the money to pursue legal ramifications and duties to the public?
THOSE government regulators?
It’s not all about government corruption, you know. It’s pure political chicanery.
Take a look at the SEC. Goldman Sachs spends more maintaining and upgrading its tech then the entire SEC budget.
The ATF? If they are lucky, they can get into an inspect a gun store once every seven years.
You think Health officials have it any easier?

==RED

Posted by REDruin | Report as abusive

It’s not the fault of police that criminals commit crimes

Posted by Benny27 | Report as abusive

Sir Harold Evans responds:

Governments have to varying degrees and very slowly tried to fill the compensation gap left by the inadequacy of drug companies’ payments. The real scandal on government inaction into failing to investigate the disaster in 1962 is one I have highlighted many, many times but most recently in My Paper Chase. This abdication of a clear public duty is the reason desperate families were forced to sue the drug makers, and were failed by the legal system – another scandal.

Posted by jledbet | Report as abusive

A powerful and moving article – as is the book, Suffer the Children. Many congratulations to Sir Harold Evans and the Sunday Times Insight Team for their brilliant expose of this terrible tragedy.

There is, however, a major and tragic irony in blaming insufficient animal testing for the disaster: more animal testing would not have prevented the release of thalidomide, since very few species suffer birth defects or other adverse effects in response to the drug. The Office of Health Economics concluded that: “It is unlikely that specific tests in pregnant animals would have given the necessary warning: the right species would probably never have been used.”

This in no way excuses Grünenthal for their catalogue of wrongdoing. But another dreadful legacy of thalidomide is the regulations it spawned: enshrining in law a system of animal testing that would not have averted the thalidomide tragedy and has not averted innumerable tragedies since. Adverse drug reactions are now one of our leading causes of death, and 9 out of 10 new drugs fail in human trials after appearing to be safe and effective in animal tests.

New technologies that could improve drug safety are not being embraced today because governments still demand animal testing, despite its pitiful record.

Please read this excellent short article about thalidomide’s long shadow: http://www.thenational.ae/news/uae-news/ science/when-animals-fail-the-test

Posted by KathyArchibald | Report as abusive

(1) One mother of a child with no arms,said that one night she took 2 pills to induce sleep. It took only 2 pills to malignantly deprive her unborn child of a normal life. “2 small pills = 2 baby’s arms”.

(2) A baby whose mother had taken thalidomide had no arms, no way to attach prosthetic arms , and a deformity of her genito-urinary tract. Seeing only a life in an institution for the child, the distraught mother killed the baby. The jury acquited her due to the circumstances.

Posted by EmmetEarwax | Report as abusive