"Completely harmless": thalidomide, and the official who said no

Series: How minds are moved · The official line vs what people lived · 3 of 7

When a German children’s doctor, Widukind Lenz, went back to the mothers of babies born with missing or shortened limbs and asked what they had taken in early pregnancy, about one in five said Contergan. He asked again, more carefully. This time about half said yes. Many explained that they had not mentioned it the first time because it seemed too obviously harmless to be worth talking about. That is how well the reassurance had worked: even the victims did not suspect the pill. More than 10,000 babies are estimated to have been born damaged by thalidomide in 46 countries. In the United States, the official count was 17.

The difference had a name: Frances Oldham Kelsey.

Contents · 9 sections

TL;DR #

• Thalidomide was sold from 1957 as a sleeping pill so safe you could not overdose on it. In West Germany it was over the counter, nicknamed “Germany’s babysitter”.
• In Britain, Distillers’ promotional material said it could be given “with complete safety” to pregnant women. Nobody had tested that.
• When doctors reported nerve damage, the German maker denied having such reports, according to the later criminal investigation and journalists who read the files.
• At the US FDA, a newly hired medical officer, Frances Kelsey, kept asking the American licensee for evidence it did not have, despite heavy pressure. The drug was never approved in the US.
• But about 2.5 million tablets had already been handed to American doctors as “investigational” samples. The law changed in October 1962.

What it is #

In the book I am writing, SHTF vs STFU, this chapter is called “Completely Harmless”, because those words, or close versions of them, were the core of the official line. Thalidomide is a clean example of a specific persuasion pattern: reassurance that runs ahead of the evidence.

Grünenthal, a young West German company, launched Contergan on 1 October 1957 with what was a huge campaign for its time: about 50 journal adverts, some 200,000 letters to doctors and 50,000 circulars to pharmacists. The message everywhere: non-toxic, completely safe. Under licence it was sold in dozens of countries under different names: Distaval in Britain, Softenon in Belgium, Kevadon and Talimol in Canada, Isomin in Japan. A doctor who heard about a problem with one name often did not know it was the same chemical as another.

How it works #

Start from a true fact and stretch it. Thalidomide really was very hard to overdose on. Rats survived huge doses. In an age when barbiturate sleeping-pill overdoses killed people regularly, that was a real advantage. The persuasion stretched “you cannot overdose on it” into “it is harmless”, and then into “it is harmless for anyone”, including the unborn. The first was tested. The last was not.

Make the advert about trust, not chemistry. One Distaval advert showed a small child reaching for a bottle on a medicine shelf: even if a child got hold of it, it could not hurt itself. That image speaks to parents, not pharmacologists.

Manage the bad news. When pharmacists and neurologists reported tingling, numbness and nerve damage in long-term users from 1959, what Grünenthal did was laid out in the West German criminal investigation and in reporting, such as Multinational Monitor in 1987, by journalists who read the company’s files. A doctor who asked was told no such effects had come to the company’s attention, when at least three reports had. A paper linking the drug to nerve damage was delayed. Internally, the sales side worried about the drug becoming prescription-only. The company has always maintained that it acted according to the scientific standards of its time.

Blame the messenger. When Lenz telephoned the company in November 1961 and asked it to withdraw the drug, it refused at first. On Sunday 26 November the newspaper Welt am Sonntag published his warning. The next day the drug was withdrawn in West Germany. The company blamed, as one historian put it, “the sensationalism of the press”.

The official who said no #

In 1960 the US Food and Drug Administration hired a Canadian-born doctor and pharmacologist, Frances Oldham Kelsey. One of her first files was an application from the American firm Richardson-Merrell to sell thalidomide as Kevadon.

The law of 1938 gave reviewers sixty days; if the FDA did nothing, a drug was approved automatically. Kelsey found the safety data thin, with nothing at all on pregnancy. She asked for more. The company sent paperwork, not the evidence. She asked again. Then she read reports in the British Medical Journal about nerve damage from Distaval and asked why the company had not told her.

What happened next is the part that matters for this series. Richardson-Merrell’s representatives phoned and visited her and her superiors again and again. She was called a bureaucrat who was holding things up. She did not move. On 30 November 1961 the company told the FDA about the German withdrawal. In March 1962 it withdrew its application. On 15 July 1962 the Washington Post ran a front-page story calling her a heroine, and on 7 August 1962 President Kennedy gave her the highest award for a federal civilian employee.

What people lived #

Kelsey stopped the approval. She could not stop the samples. The 1938 law let companies send unapproved drugs to doctors for “investigational” use, with no requirement to tell patients. Richardson-Merrell had already shipped about 2.5 million tablets to more than a thousand doctors. Around 20,000 Americans took them, some hundreds of them pregnant. Many doctors kept no proper records. The official count of affected American births is 17; the real number may be higher.

In Britain, the women remember what their doctors said. In oral histories collected by the Wellcome Collection, one recalls being told: “Oh, it won’t harm you, you’ll be fine”, and adds, “And I believed him, as you do, doctors them days.” Afterwards many mothers felt guilty for the rest of their lives, for something that was never their fault.

The drug did not leave the world in a day. Canada kept it in pharmacies until March 1962. Japan waited months longer. In Spain, according to victims’ groups, it stayed on sale into the mid-1960s, and the government only acknowledged in 2007 that it had been sold there. East Germany, by contrast, never approved it.

What the record shows, and what it does not #

• The West German criminal trial that began in 1968 ended in 1970 with no verdict, after Grünenthal agreed to pay 100 million Deutsche Mark into a foundation. Nobody was convicted.
• In Britain, the Sunday Times was blocked by a court from publishing an article on how the drug was tested and sold. In 1979 the European Court of Human Rights ruled that the ban violated freedom of expression.
• Grünenthal apologised publicly for the first time on 31 August 2012, more than fifty years later. Survivors said the apology was for the silence, not for the pill.
• The October 1962 Kefauver-Harris Amendments required proof of both safety and effectiveness before sale, and informed consent in trials.

There is one thing I want to be careful about. Whether the danger to the unborn could have been foreseen in 1957 is still argued. Harold Kalter, a historian of birth-defect science whose book is in my library, notes that the standard rat tests of the time might well have missed it, because rodents are hardly affected. The Nobel laureate Ernst Chain said it “could not have been foreseen”. Kalter is just as clear on the other point: when doctors reported harms, the company ignored and denied them “until they could no longer dismiss the truth”. The first question is contested. The second is documented.

And a second caution. William McBride, the Sydney obstetrician praised as one of the discoverers of the danger, was struck off in 1993 for falsifying data in later research on another drug. A voice that was right once is not right forever. Each claim has to be checked on its own.

How to notice it #

• “Completely” anything. Absolute words like completely safe, no side effects, totally harmless are sales language, not science.
• Ask what was tested. “Safe” for whom? Tested on which group, for how long?
• One true strength stretched. A real advantage (hard to overdose) used to cover an untested area (pregnancy).
• Several names, one substance. Check the active ingredient, not the brand.
• Denial of reports. If a maker says it has “no reports” of a problem that doctors are discussing, look for independent reporting systems.
• The press is blamed. “Sensationalism” is sometimes true, and sometimes the last line of defence.

Frequently asked questions #

Was thalidomide tested at all before it was sold? #

Yes, on animals and in some patients, mostly for sedation and toxicity. It was not tested in pregnancy, and there was no law in West Germany requiring that. The claim of safety in pregnancy was made without that evidence.

What exactly did Frances Kelsey do? #

She refused to accept an incomplete application, kept requesting specific safety data, and did not give way under repeated pressure. The drug was never approved in the US. She did not, and could not, stop the “investigational” samples already distributed.

Is thalidomide still used? #

Yes, under strict controls, for a complication of leprosy and for multiple myeloma. In Brazil, where it is used against leprosy, a study of births between 2005 and 2010 found new cases of thalidomide damage.

Could the harm have been predicted? #

That is contested. Some historians say standard tests of the time would have missed it. What is not contested is that the claim of safety in pregnancy was never tested before it was made.

The lesson #

The most dangerous sentence in this story is not a lie. It is a reassurance that went one step further than the evidence. The mothers who did not even mention the pill to Lenz show how far that kind of reassurance can travel. And the one country that mostly escaped did so because a single official in her first year kept asking a boring question: where is the data? It is a question anyone can ask, about anything sold as completely safe.