Newly uncovered documents reveal that pregnant Australian women were used as guinea pigs for the morning sickness drug thalidomide in a series of clinical tests some 50 years ago that left a number of children with substantial birth defects.
The 1960 Australian trials were the first for the thalidomide drug Distaval on pregnant women anywhere in the world, The Age, an Australian daily newspaper, reported recently.
The files, which came from thalidomide distributor Distillers Company (Biochemicals), “show Australian women were given Distaval before any tests had been done on pregnant laboratory animals to determine the effect of thalidomide on fetuses,” the paper said.
A letter written by a Distillers executive from September 1962 confirmed that “no tests were carried out in pregnant before Distaval was marketed.”
According to the documents, trials of the medication were conducted by obstetricians at Sydney’s Crown Street Women’s and Royal Prince Alfred hospitals beginning as early as May 1960. Hospitals in Melbourne and Adelaide conducted trials as well, but it isn’t clear pregnant women there received Distaval.
Additional records tell more of the story.
Some wanted it distributed more widely
A Distillers memo dated July 1960 records the receipt of “an urgent telegram from the Royal Melbourne Hospital requesting supplies of Distaval.” It also mentions “further success (of drug testing) with Royal Prince Alfred” in Sydney.
Records also show that the dangerous drug was being sold to the public beginning around August 1960; it was marketed with materials boasting of the drug’s “exceptional safety.”
Later, in 1961, deformed babies were being born to women who had taken the drug, as well as over-the-counter and prescription sales.
“Several Distillers employees in the UK, Australia and New Zealand were among those whose children were severely damaged by the drug, company records show,” the paper said.
Sydney obstetrician William McBride, who was involved in the trials, contacted its distributor twice between April and July 1961, to warn that women who had taken the drug had given birth to malformed or dead infants.
“I have had four deaths at birth in the last eight week,” he wrote. “One baby has been born with six fingers, one with fingers joined together (and) one with malformed toes.
Despite the warnings; however, Distillers continued promoting the drug to pharmacists and, as late as November 1961, attempted to have it placed on Australia’s Pharmaceutical Benefits Scheme – a public health tool.
It was rejected but its advocates vowed to press forward. One of Distiller’s executives, W.G. Poole, advised a colleague after the drug was rejected for inclusion on the PBS that “we are going to try and tackle the matter another way.”
At least the company stepped up
“Distaval has been accepted by the psychiatric and mental hospitals in NSW as the hypnotic of choice and is being used in almost every mental hospital in the state,” Poole wrote. “We have excellent contacts with the senior medical officers in these hospitals and we are going to approach them to see if [they]… will… make an approach to the government.”
News of the trials and the resultant ill-effects caused by Distaval came to light in an affidavit from Victorian Supreme Court by Slater & Gordon lawyer Michael Magazanik as part of a compensation claim brought by Melbourne thalidomide victim Lynette Rowe, the paper said.
“In effect, the Distillers defendants had chosen pregnant Australian women, rather than laboratory animals, as experimental subjects,” the affidavit said.
Diageo, a British firm that bought Distillers in 1997, recently announced a multi-million dollar settlement with Rowe; the case will now pave the way for about 130 surviving victims of the Distaval trials in Australia and New Zealand.
Despite the horrible after-affects, Diageo’s actions were at least honorable, Rowe’s attorney said.
“In my 33 years of running these sorts of cases, Diageo has taken a more compassionate view than any company I have dealt with,” said lawyer Peter Gordon.
J. D. Heyes
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