Following World War II, the post-war devastation and the shortage
of drugs such as penicillin, built up a high demand for the development of new,
alternative drugs. This period, termed the “golden-age” of medicine, was one in
which there was great fervour for the fabrication of novel medical treatments,
though with a lack of acute attention to detail (Daemmrich, 2015).
With the emergence of antipsychotic pharmaceutical products
in 1954, there occurred a principal therapeutic shift away from the treatment
of infection, and towards the management of psychological disorders (Daemmrich,
2015).
German pharmaceutical company Grünenthal, which was founded one year
after the war in 1946, stumbled upon a sedative in their search for a new
synthetic antibiotic in 1954. Animal testing of this new molecule revealed its
sedative and hypnotic properties, and henceforth thalidomide was produced
(Freckelton, 2015).
Results of the testing, revealing low noxious levels and no
adverse effects in mice, were released in 1956 (Daemmrich, 2015). Following the
animal testing, thalidomide was trialled on kids, mothers of infants, and healthy
adults suffering from anxiety, insomnia, and psychological disorders. The subjects provided overall positive
feedback, reporting no withdrawal symptoms, as was common with other
anti-anxiety drugs at the time (Daemmrich, 2015). However, the trialling of new
drugs during this period was not especially thorough, and randomised controlled
trials (RTCs) were not yet common practice, seeing as the first proper RTCs
were performed only six years previously in 1950 by Richard Doll who had wanted
to change the preceding common principle of doctor’s intuition (Bradley, 2012).
Hence, thalidomide had not been tested on any pregnant animals or women, and
there were no thorough follow-up examinations of the subjects.
Thalidomide was thus put on the market in 1957 as an
anti-anxiety, stress-reducing, and anti-insomnia drug. With high stress levels
following the war, thalidomide quickly became Germany’s number one tranquilizer
(Daemmrich, 2015). During this era, it was common to treat women for anxiety
conditions with sedatives and during the late 50s and early 60s there was a
greater appreciation for authority. Therefore, there grew a widespread acceptance
of unquestioned treatment ordered by physicians as they, with their “incommunicable
knowledge”, knew what was best (Freckelton, 2015), (Bradley, 2012). There was
no discussion about the drug itself, its administration, or the effectiveness
of it. Women simply accepted the drug without even necessarily knowing what
they were taking.
Back then, morning sickness amongst pregnant women was
believed to be due to the materialisation of the mother’s anxiety about the
pregnancy, and that hence sedation would relax the mother enough to alleviate
the nausea (Daemmrich, 2015). Thalidomide therefore began to be prescribed to
women suffering from morning sickness in 1959 as Grünenthal publicized thalidomide as
completely safe for pregnant women (Daemmrich, 2015).
The same year, accounts that thalidomide was toxic began to
arise with numerous people experiencing damage to their nervous system due to peripheral
neuritis (Williams, 2012). Despite this, Grünenthal managed to conceal these findings, paying
off physicians and forcing journalists into silence as they kept making money. As
well as this, it took four months before thalidomide was taken off the market
following the discovery that it had teratogenic effects, causing countless deformities,
in 1961. It was later discovered that Grünenthal had known about the drug
causing substantial nerve injury, and that prior to its release, a boy with no
ears had been born to the spouse of an employee of the company which had been ignored.
The poor
testing, covering up of harmful effects, and other wrongdoings on Grünenthal’s behalf could partly be explained by their
employment of several, both wanted and convicted, Nazi criminals in the
immediate post-war years (Williams, 2012). For example, one employee was Heinz
Baumkötter, a
principal concentration-camp doctor; and the head of pathology when thalidomide was on the market was
Martin Staemmler, a major advocate of the Nazi “racial hygiene” program
(Williams, 2012). Another Nazi follower, who worked alongside Hitler’s private doctor
that was hired by Grünenthal, was Hans
Berger-Prinz. Berger-Prinz was head of the defence in the 1968 trial in which
the company was accused of “negligent manslaughter and causing grievous bodily
harm, deformity, and sickness through the selling of Contergan, the German
brand name for thalidomide” (Williams, 2012). A key character in the trial was Heinrich Mückter,
the man accredited with the manufacture of thalidomide. Mückter had also worked on vaccines
against typhoid during the war, injecting concentration camp prisoners with the
disease.
The most famous of the Nazi workers however was
Grünenthal’s chairman of the advisory committee, Otto Ambros. Ambros is
notorious for having been one of the creators of Sarin, being adversary to Hitler,
and most of all, for being charged with mass murder and enslavement at
Nuremberg. Being chairman of Grünenthal’s advisory committee and having
experience in suppressing all his past transgressions, Ambros was most likely a
great help when it came to concealing the truth of thalidomide’s detrimental effects
and keeping all the bad press and trials under tabs (Williams, 2012).
Thalidomide was the first instance in which medicine succeeded
legal constraints in the absence of a complete assessment of its safety for use
in expectant and breastfeeding women (Mandal, 2015). The devastation that the thalidomide
scandal brought about in the 60s highlighted the consequences of haphazard and
unethical testing. It emphasized the need for the standardisation of RCTs when
testing new drugs. Following 1961, medicine
governing authorities became more stringent and required that any new medicine
be screened for the potential to hurt the growing foetus, and by the early 70s companies were
required to obtain a reliable evidence base for any novel treatments (Mandal,
2015), (Bradley, 2012).
References:
Bradley, J. (2012, November 16). From ‘trust us, we’re doctors’ to the
rise of evidence-based medicine. Retrieved October 27, 2016, from
https://theconversation.com/from-trust-us-were-doctors-to-the-rise-of-evidence-based-medicine-10608
Daemmrich, A. (2016, December 7). Remind me again, what is thalidomide
and how did it cause so much harm? Retrieved October 25, 2016, from
https://theconversation.com/remind-me-again-what-is-thalidomide-and-how-did-it-cause-so-much-harm-46847
Freckelton, I. (2015, December 9). Nazis, lies and spying private detectives: how thalidomide’s maker avoided justice. Retrieved October 25, 2016, from https://theconversation.com/nazis-lies-and-spying-private-detectives-how-thalidomides-maker-avoided-justice-51730
Mandal, A. (2015, January 11). History of Thalidomide. Retrieved
October 23, 2016, from http://www.news-medical.net/health/History-of-Thalidomide.aspx
Williams, R. (2012, October 9). The Nazis and Thalidomide: The
Worst Drug Scandal of all Time. Retrieved October 24, 2016, from http://www.newsweek.com/nazis-and-thalidomide-worst-drug-scandal-all-time-64655
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