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Posted by duddy   April 25, 2022   2086 views

The thalidomide ordeal that started in the 1950s is a tragic case of what happens when key players in the scientific community dismiss or ignore widespread correlations among two or more coinciding events. In the mid-century, a German pharmaceutical company named Chemie Grunenthal discovered and developed a synthetic sedative called thalidomide that was used to treat sleeplessness, and reduce morning sickness and nausea commonly experienced by pregnant women. While most countries around the world embraced and sold the product for a short period of time, including Canada, the United States’ Food and Drug Administration at the time, which was headed by a Canadian-born medical doctor named Dr. Kelsey, refused to approve its use in the country. Arguably, Dr. Kelsey had done her due-diligence, learning that the German company hadn’t conducted enough research on its safety towards pregnant women, and whether the drug could be passed through the placental barrier and harm a fetus in the womb. The only research the company had conducted was on 1,500 pregnant rats that were treated with the drug, and none produced abnormal offspring (2, Page 280).

A famous article that triggered the suspicion of Dr. Kelsey was from an editorial published in December of 1960 by the British Medical Journal entitled "Is Thalidomide to Blame"? In the article, a fellow doctor writes:

I feel that four cases which have occurred in my practice recently are worthy of mention, as they may correspond to the experience of other practitioners. They all presented in more or less the same way-each patient complaining of: (1) Marked paraesthesia affecting first the feet and subsequently the hands. (2) Coldness of the extremities and marked pallor of the toes and fingers on exposure to even moderately cold conditions. (3) Occasional slight ataxia. (4) Nocturnal cramp in the leg muscles. … It seemed to me to be significant that each patient had been receiving thalidomide ("distaval") in a dose of 100 mg. at night. [1]

Prior to this, thalidomide was generally regarded as being free of toxic effects. Historically, the drug entered the Canadian market in late 1959, even though it wasn’t approved to be sold until April of 1961. The drugs were given as samples for doctors to distribute, and many of the unfortunate early recipients were their wives. Nine months later, three children across Canada were born with shortened, seal-like limbs – characteristic of thalidomide exposure (see below). In all cases, those women had used thalidomide early in their pregnancy. After more and more cases were documented world-wide, Germany and Britain – the drug’s earliest adopters – stopped selling it completely. However, it took Canada three full months longer than Germany to pull it off its market, thus leading to the poorest record of deformities.

One of the main reasons for this delay was that Canadian medical experts at the time considered what was being observed as a case of correlation, rather than causation. Many doctors publicly stated that "thalidomide is not yet proven conclusively to be the fetus-harming agent" and that "evidence against the drug is only statistical". Doctors rationalized that "thousands of women have taken thalidomide in their early pregnancies and delivered normal babies. It could turn out that these women with the damaged babies were all using some other product not yet suspected". In Edmonton, the University of Alberta's professor of obstetrics cautioned that the thalidomide hasn't yet been pinpointed as the sole cause. (2, Page 279)

What these experts failed to recognize was that when circumstantial evidence is strong, as was the case with thalidomide-use and babies born with shortened limbs, two correlating events should be taken more seriously. Given that shortened limbs is extremely rare, its sudden occurrence and spike around the globe should have prompted a more thorough investigation, yet the experts continued to "trust the science", and not their common sense. Many of today's politicians use this phrase as a punchline to silence the opposition (e.g. Canadian Prime Minister Justin Trudeau); anyone who dares to question scientific findings are looked upon as heretics. Look no further than those that object to taking the COVID-19 mRNA vaccine. Many people, including doctors and academics worldwide have legitimate concerns about the newness of the technology, present in the vaccine, though are met with strong criticism and resistance. Had it not been for Dr. Kelsey's strong stance on questioning the science, thousands of American lives would have been permanently damaged. Hopefully, we can learn from history by not rushing the science, be open to questioning all motives, and by trusting one's conscience as much as another person's expert opinion.

Source [1]

[2] Hearings, Volume 4. United States Congress. Senate. Committee on Government Operations. 87th Congress. 1962.

pharmaceutical industry teratogen thalidomide COVID vaccines
Posted in Research
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