The story of the scientist who prevented a huge tragedy

This story reads like a movie script, but while it’s hard to believe, it actually happened. The protagonist of this feat, Frances O. Kelsey, is a Canadian-American scientist, who managed to resist pressure from a pharmaceutical corporation and saved thousands of children from physical disability. In addition to her proof of courage, she reminds us how far the consequences of our decisions can be.

At the awesome.club we believe that some stories are so sensational that they must always be remembered so that humanity does not repeat the same mistakes.

Frances dreamed of becoming a scientist since childhood (which was not easy for a woman at that time), and at the age of 21 she received a degree in pharmacology.

In 1960, she was hired by the Food and Drug Administration, the FDA (the US government agency responsible for regulating food, drugs, cosmetics, etc.), and one of her first assignments was to research a substance called thalidomide, a tranquilizer prescribed for pregnant women that was already marketed in several countries and would be launched in the USA.

The researcher suggested that, before release on the American market, more studies should be carried out on the risks of the drug, as we will show below.

Thalidomide was synthesized for the first time in the middle of the 20th century, in the course of research by the company Chemie Grünenthal, which produced antibiotics.

Even in the case of an overdose, thalidomide did not kill the animals used as guinea pigs. From this, it was concluded that the drug was safe and the manufacturer sent free samples to doctors in Germany and Switzerland. The drug, as we said, had a significant sedative (soothing) effect.

A harmless, innocuous sedative that, as later noted, also relieved insomnia and morning sickness. It felt like a dream come true! Under different names (more than 37!), Thalidomide started to be sold in 46 countries in Europe, Scandinavia, Asia, Africa and South America. A year later, a large-scale advertising campaign was launched claiming to be “the best and safest cure for pregnant and lactating women” and this despite the fact that neither the manufacturer nor the distributors had researched the product’s effects on unborn babies.

The few reports that existed about the side effects of this medication (for example, neuritis) were denied and silenced.

“Distaval (thalidomide) is not a barbiturate or a sedative, it also works as a sleeping pill. It is a safe painkiller that provides healthy sleep.”

In September 1960, thalidomide arrived in the United States. The Richardson-Merrell company submitted it to the FDA for examination under the name of kevadon.

Approval just seemed like a formality. However, Frances rejected the request and surprised everyone, claiming, as we said, that more studies were needed.

What was the scientist’s concern?

Safety studies of the drug produced strange results and an absolute absence of toxicity was observed. But what if the bodies of the animals used in the experiment simply couldn’t absorb the drug? Nobody had verified this possibility. On the contrary, when the first experiment showed that the guinea pigs hardly calmed down when taking thalidomide, the scientists changed the test conditions to obtain the expected result. The desire to quickly bring the drug to market was very strong. However, Frances found the safety evidence inadequate. Richardson-Merrell, the company that would produce the drug, was aware of the risk of developing neuritis with the use of this drug, but did not mention this fact in the report submitted to the FDA. In February 1961 there were more such reports. No tests were carried out on the effect of the drug on developing fetuses, despite the fact that, at that time, they already knew about the permeability of the placental barrier. Frances decided to evaluate some indications that thalidomide caused paralysis of the peripheral nerves and assumed that the damage to the embryos could be even greater.

Frances requested more information, and as a result, the conflict began. She received responses from the US manufacturer, Merrell, waited 60 days, and made new requests. She was pressured, they tried to manipulate her through her bosses, she was scolded for her alleged incompetence, in addition to complaining about her bureaucracy. Frances insisted that the safety evidence was not conclusive and believed that Merrell needed to do more research.

“At Richardson-Merrell they were very indignant,” said Frances. “They were disappointed because Christmas is the peak season for sedatives and sleeping pills. They kept calling me and visiting me saying: We want to see this drug on the market before December, because that’s when sales increase.🇧🇷

But it held firm until late 1961, when scientists in Germany and Australia found a link between thalidomide and numerous cases of malformations in children born after their mothers took the drug during pregnancy. Only under pressure from the press, the company Chemie Grünenthal (which had developed the drug first) began to withdraw the medicine from the market, notifying its American partners of what had happened.

To appreciate how difficult it was for this woman to make such a decision, it is necessary to consider several facts.

At that time, thalidomide was sold in over 40 countries. An aggressive marketing campaign was carried out. It seemed that permission to sell in the United States was just a formality. The requirement of American laws to approve the product was the safety of the medication. In addition, tests had already been carried out: Richardson-Merrell managed to distribute more than 2.5 million pills using therapists and most doctors found it effective and useful, which was confirmed in their reports. In the warehouses of the pharmacies there were already tons of the medicine “Kevadon” ready to be sold. At that time, Frances had been working at the FDA for about a month, and this was one of her first assignments. You can imagine how much it cost her to endure countless accusations of incompetence. The pressure was enormous.

On August 8, 1962, President John F. Kennedy presented Frances with the Outstanding Civil Service Award, the highest non-military award in the United States. She became the second woman in history to receive such a distinction. The tragedy of thalidomide forced many countries to review and tighten their licensing policy for many drugs. For example, requirements were added to provide evidence of a drug’s effectiveness, and careful monitoring was implemented for both patients and physicians. In total, according to rough estimates, in the 6 years that the drug was on the market, approximately 12,000 children were born with abnormalities because of the “harmless tranquilizer” that their mothers took. About 40% of them died before their first birthday. To understand how difficult life was for the survivors, just look at the photos of the most famous victims: the star of a German documentary, Niko von Glazov, and Germany’s bass-baritone Thomas Quasthoff.

Chemie Grünenthal and its partners were sued by victims in several countries. The first accusations began to arrive in 1961, but the lawsuits lasted for decades. In most cases, the results were paid in compensation to the victims’ families and special relief funds were created. Frances O. Kelsey worked for most of her long life. She retired at age 90 and returned to her native Canada. In addition to the award received in 1962, she won many others (including one named after her, intended for FDA personnel). Frances died in August 2015, aged 101, less than 24 hours after receiving the Order of Canada by the Lieutenant Governor of Ontario.

But thalidomide, curiously, “came back into action” in the late 1990s, when it proved to be effective in the treatment of serious diseases, such as leprosy and some malignant tumors insensitive to chemotherapy. Of course, now it is prescribed under the strictest control and only when a woman is not pregnant.

Have you ever had to make a very difficult decision in your life? Has anyone pressured you to do the opposite? How did this happen? Tell us in the comments section below.