Over the last several months, I have been exploring the origins of pharmaceutical malfeasance. Thalidomide, the drug given to pregnant women to prevent morning sickness, stands as one example, in a long line of examples, of the complete lack of scruples associated with this industry. Here is a snippet of what I am working on.
Origins of Thalidomide
Thalidomide, developed by German chemists in 1953, was originally marketed as a non-toxic, non-addictive, sedative beginning in 1957. Just like DDT, thalidomide was regarded as being completely safe precisely and solely because of its exceptionally high lethal dose in mice (5000mg/kg of weight). No other safety assessments were reported, at least before the drug was marketed and distributed globally. With such a high degree of non-lethality, the marketing of this drug was intense. It was a wonder drug, if there ever was one, to be used for multiple illnesses from the simple sedative to a flu medication.
Soon after its release, it was discovered that thalidomide was also an anti-emetic. This opened the door to a whole new market: pregnant women. Even though tests of reproductive safety using animals were well established by the mid-1940s, the manufacturers of thalidomide claimed in court documents and in a public apology decades later to have not understood the necessity for these tests.
Thus, with no other safety tests or parameters, just the initial toxicology testing to determine lethality in a single, non-pregnant strain of mice, thalidomide was marketed for use during pregnancy. In much the same way that pharmaceuticals are marketed today, letters were sent to 40,000 physicians touting thalidomide’s benefits:
“In pregnancy and during the lactation period the female organism is under great strain. Sleeplessness, unrest, and tension are constant complaints. The administration of a sedative and a hypnotic that will hurt neither mother nor child is often necessary.” – Chemie Grunenthal, Letter to doctors (1958).
Along with those letters, free samples were given to physicians to distribute to their pregnant and non-pregnant patients alike. Uptake was immediate and unquestioning. Before it was recalled, thalidomide would be distributed by 14 different companies, in 46 countries, under 39 brand names. Two of the more popular names included Contergan and Distaval.
Evidence uncovered from court documents shows that the company knew about the birth defects well before marketing it to pregnant women, as a wife of a company worker given thalidomide gave birth to a daughter without ears in December 1956. Other documents show that the labeling for the drug, as late as 1961, was clearly demarked, not for pregnant women.
“We were shown a packaging unit for Contergan-Thalidomide with the sticker NOT FOR PREGNANT WOMEN. The management knew about the intrauterine effect of the preparation at the latest by mid-October. The decision to carry on selling the preparation was without any doubt motivated by profit-making and criminal in my view”. Dr. Günter von Waldeyer-Hartz, October 1961.
As women given thalidomide during pregnancy began delivering children with missing or malformed limbs, the connections to the drug were recognized, and once again, denied by the drug company. Four months before the drug was removed from the market, two physicians, one from Australia and the other from Germany, published reports of the devastating effects of the drug on fetal development. By November 1961, when the drug was finally removed from most markets (it remained available in Spain until 1965), some 100,000 women and their children had suffered catastrophic consequences, which included some 20,000 children born with serious birth defects across Europe. This was in addition to the estimated millions of people prescribed this drug for non-pregnancy-related issues that would develop intractable nerve damage and other serious side effects.
Though it has been widely believed that moms in the US escaped the horrors of thalidomide owing to the efforts of the FDA’s rejection of the thalidomide application, recent court documents show that a drug maker in the US distributed some 2.5 million doses of thalidomide via 1200 physicians to 20,000 women under the auspices of a ‘clinical trial’; a clinical trial in which the physicians were encouraged not to collect data. Ultimately, of course, the FDA denied their application, and thalidomide was never officially used in the US.
In 1967-68, key Grunenthal employees were brought to trial and continued to maintain their ignorance, arguing that the ‘thousands of abnormal births were an act of God’. Through expert political and legal maneuvering, the courts agreed, the defendants were set free and granted immunity from further criminal prosecution. Non-disclosure was forced upon the families who had been injured. Over the next several decades, there were dozens of court cases against the manufacturer but there was never an admission of guilt. There never is. The ignorance argument offers well-worn cover for chemical manufacturers worldwide and the legal system supports this argument.
In 2012, 50 years after the thalidomide tragedy, the company offered a public apology, but again, there was no admission of guilt or even a sincere acknowledgment of their responsibility in the tragedy.
“Grunenthal has acted 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. We regret that the teratogenic potential of thalidomide could not be detected by the tests that we and others carried out before it was marketed.”
Without admission of guilt and with enough time passed, thalidomide has once again entered the space of pharmaceutical wonder drug. This time in the field of cancer. The nervous system effects that proved so obviously deleterious to the developing fetus, and though less obvious, but still present in adults who used this drug, are now thoroughly forgotten or ignored.
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This article was published originally on October 7, 2019.