PREGNANT Australian women were used as human guinea pigs for the morning sickness drug thalidomide in trials that had devastating effects on some of their unborn babies.
Never-before published files reveal the 1960 Australian trials were the first tests of thalidomide drug Distaval on pregnant women anywhere in the world.
The files, 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 foetuses.
A September 1962 letter written by a Distillers executive confirms that “no tests were carried out in pregnant animals before Distaval was marketed”.
Documents show trials of Distaval on pregnant women were conducted by obstetricians at Sydney’s Crown Street Women’s and Royal Prince Alfred hospitals from as early as May 1960. Other hospitals in Melbourne and Adelaide also conducted trials, although it is not known whether pregnant women received the drug.
A July 1960 Distillers memo records the receipt of ‘‘an urgent telegram from the Royal Melbourne Hospital requesting supplies of Distaval’’ and boasts of ‘‘further success with Royal Prince Alfred’’ in Sydney.
Distaval was also being sold by pharmacists to the public from August 1960, with promotional material highlighting its ‘‘exceptional safety’’.
In 1961, malformed babies were born in Australia as a result of the trials, over-the-counter sales 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.
Twice between April and July 1961, Sydney obstetrician William McBride — who was involved in the trials — contacted Distillers to warn that women who had taken Distaval had produced malformed or dead babies. ‘‘I have had four deaths at birth in the last eight weeks. One baby has been born with 6 fingers, one with fingers joined together [and] one with malformed toes,’’ Dr McBride told a senior Distillers executive in early July 1961.
Despite Dr McBride’s warnings, Distillers kept promoting the drug to GPs and as late as November 1961 tried to have it included on Australia’s Pharmaceutical Benefits Scheme.
In a October 9, 1961 letter, a senior Australian executive of Distillers, W.G. Poole, advised a colleague that although Distaval had been rejected for inclusion on the PBS, ‘‘we are going to try and tackle the matter in another way’’.
‘‘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,’’ Mr 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,’’ he wrote.
Months after Dr McBride’s 1961 warnings, Distillers’ medical department was still advising sales staff that although the drug ‘‘almost certainly does cross the placental barrier... no adverse effects on the foetus have been noted’’.
The revelations are contained in affidavit material lodged in the Victorian Supreme Court by Slater & Gordon lawyer Michael Magazanik as part of a compensation claim brought by Melbourne thalidomide victim Lynette Rowe.
In his affidavit, Mr Magazanik alleged: ‘‘In effect, the Distillers defendants had chosen pregnant Australian women, rather than laboratory animals, as experimental subjects.’’
British firm Diageo, which bought Distillers in 1997, last week announced a multimillion-dollar settlement with Ms Rowe, paving the way for other potential deals for the 130 surviving thalidomide victims in Australia and New Zealand.
Lawyer Peter Gordon, who led Ms Rowe’s lawsuit, yesterday said he was ‘‘really impressed’’ by Diageo’s response to a problem it inherited when it bought Distillers. ‘‘In my 33 years of running these sorts of cases, Diageo has taken a more compassionate view than any company I have dealt with,’’ he said.
The files expose Distillers’ failure to conduct any tests on thalidomide’s effect on the reproductive system before it encouraged Distaval’s use in pregnant Australian women, even though its senior medical staff knew it was highly likely to cross the placental barrier from mother to foetus.
In a March 1960 letter, Distillers researcher D.M. Burley wrote: ‘‘I should imagine that Distaval does cross the placental barrier, but its effects on the foetus [have] not so far been detectable.’’
Other documents from 1960 show Distillers was aware that the US Food and Drug Administration was questioning the US distributor of thalidomide about the lack of testing on animals.
Distillers and the German creator of thalidomide, pharmaceutical firm Grunenthal, only began testing the drug on pregnant animals after they received multiple reports of dead and deformed babies.
The files show that in a series of August 1962 tests, Distillers reported malformations in the offspring of rabbits given thalidomide and ‘‘a high incidence of still births’’ in kittens born to cats given the drug.
Distillers also appears to have misled the Australian government in 1962 about when it omitted Dr McBride’s July 1961 warning from a letter to the director-general of the Health Department outlining the chronology of its knowledge of thalidomide’s ill-effects.
The files reveal the contemptuous attitude of some Distillers executives towards senior Australian health officials assessing its bid for listing on the PBS.
In a March 1961 memo to Distillers in London, Mr Poole said Australian officials were ‘‘susceptible to gratification of one kind or another... I know that this idea will seem almost impossible to anyone who has dealt with senior civil servants in England but, unfortunately, the same level of honesty simply does not apply out here in a number of cases’’.
The company also sought to conceal from Australian health officials and the general public its knowledge of thalidomide’s tendency to cause nerve injuries The company was aware of hundreds of cases overseas in which thalidomide had caused severe nerve damage.
‘‘The peripheral neuritis question has not so far caused any trouble. It appears to be a thing which only happens very infrequently and, whilst we have advised our representatives of the position, we have told them to do no more than answer honestly a direct question from a doctor. I see no good purpose in us deliberately raising the matter,’’ Mr Poole wrote to colleagues in March 1961 as the company tried to get the drug listed on the PBS.
Later in 1961, when the company realised it could no longer conceal thalidomide’s propensity to harm unborn babies and damage nerves in adults, Distillers executives moved to stop over-the-counter sales and make the drug prescription only in a bid to avoid legal action.
Another file from March 1962 shows Distillers drafted self-congratulatory letters for Australian doctors to submit to medical journals calling for the limited reintroduction of thalidomide — despite its clear link to dead and deformed babies.
‘‘Dear Sir, I have been following with interest the correspondence,’’ the draft letter began.
‘‘While applauding the company who marketed Distaval (thalidomide) for their concern over the welfare of patients for whom it may be prescribed, I wonder whether they are justified in completely depriving doctors of the use of the drug by withdrawing it from the market,’’ it stated.
Another file from the same month shows that Distillers had concluded no financial assistance would be offered to thalidomide victims.
‘‘We have, of course, debated whether, notwithstanding absence of any liability, the company should do anything for those who appear, as a result of the Distaval, to have suffered so tragically,’’ it stated.
‘‘I cannot go into all the many factors which have had to be taken into account in considering this aspect, but the [conclusion] we have reached is that the company should not make any offer of financial assistance.’’