On 24 September 1972, The Sunday Times carried an
article entitled "Our Thalidomide Children: A Cause for National
Shame" : this examined the settlement proposals then under consideration,
describing them as "grotesquely out of proportion to the injuries
suffered", criticised various aspects of English law on the recovery and
assessment of damages in personal injury cases, complained of the delay that
had elapsed since the births and appealed to Distillers to make a more generous
offer. The article contained the following passage:
"... the thalidomide children shame
Distillers ... there are times when to insist on the letter of the law is as
exposed to criticism as infringement of another’s legal rights. The figure in
the proposed settlement is to be £ 3.25 million, spread over 10 years. This
does not shine as a beacon against pre-tax profits last year of £ 64.8 million
and company assets worth £ 421 million. Without in any way surrendering on
negligence, Distillers could and should think again."
A footnote to the article announced that "in
a future article The Sunday Times would trace how the tragedy occurred".
On 17 November 1972, the Divisional Court of the Queen’s Bench Division granted
the Attorney-General’s application for an injunction restraining publication of
this future article on the ground that it would constitute contempt of court
(see paragraphs 17 to 35 below for a summary of the draft article and
particulars of the contempt proceedings).
Luckily, the
“The newspaper then decided to fight the
injunction on its investigation into the origins and testing of the drug. The
case went right through the British legal system and up to the European Court
of Human Rights, which decided that the injunction violated the right of
‘freedom of expression’. The full story of thalidomide could eventually be told
in 1976, revealing that both Grünenthal (the maker) and Distillers had not met
the basic testing requirements of the time.”
How
strange for the “untouchable" British Courts.
But
why did Distillers with such a big business in Whisky and Gin decided to go
into Pharmacy, you may ask. Watching the
Harold Evans’ film finally gave me a clue.
It was all to do with Huxley and his Brave New World.
One
member of the board volunteered that he had read Brave New World in which
Aldous Huxley predicted that sedative pills would soon replace alcohol and
religion as ‘the opiate of the masses’.
The board of Distillers sat up and the rest is history, saddest history
of modern Medicine.
Thalidomide & Morality.
A
certain Australian doctor, Dr. McBride has often been quoted as being the first
to report the abnormalities associated with thalidomide taking and its effect
on foetal development. In fact his
reputation rested on a short letter to the Lancet in the early 60s asking if
anyone else had noticed the problems he had observed in the babies of mothers
who'd taken thalidomide for their nausea during pregnancy.
This
was the first published notification of concern but the reality was indeed that
a midwife at his hospital,
They
were mostly, if not all, Dr McBride's patients and the only thing Sister
Sparrow could put it down to was that Dr McBride had started prescribing
thalidomide as an anti-nausea drug when the other obstetricians hadn't.
Dr.
McBride did eventually got the Australian Order for this letter but was struck
off the Medical Register for falsifying data on the research of another drug .
The link
Dr.
Widukind Lenz of
In
one of his lectures, Lenz described dramatically how he was confronted with
this event:
In June 1961, 1 was consulted by the
parents of a child who had been born with short arms and only three fingers on
each hand. Shortly before, I had received inquiries about two similar cases and
had replied that I was not aware of this specific type of malformation
syndrome, but it seemed most likely to me to be due to a new mutation of a
dominant gene. Shortly thereafter, however, further similar cases were born and
other doctors reported similar observations. Hence, it seemed more and more
unlikely that these cases were all due to new mutations of a gene that
previously mutated extremely rarely.
Lenz
started to systematically and thoroughly ask the parents about details of the
gestational history. On November 11,
1961, a date he remembered well, he first began to suspect that the sedative
Contergan (thalidomide) could be the cause of this ‘new’ malformation syndrome.
Three days later, his suspicion turned
into certainty and he communicated these observations to the manufacturer —
Grünenthal — and recommended withdrawal of the agent. Only two weeks later, the company withdrew the
drug from the market.
Dr.
Widukind Lenz’s father, Fritz A Lenz was a German geneticist, member of the
Nazi Party and influential specialist in eugenics in Nazi Germany.
Research
into this subject throws up surprises.
Non approval
In 1960,
The
application for New Drug Approval (NDA) was by drug manufacturer
Richardson-Merrell’s NDA for Kevadon—the
Before
the days of the Internet: Kelsey read about a paper was published in the BMJ[1] on December 31, 1960 of 4 patients suffering from
symptoms of peripheral neuritis. This
raised an even bigger red flag for Kelsey: “the peripheral neuritis did not
seem the sort of side effect that should come from a simple sleeping pill.” Not only were there pharmacological problems,
but Kelsey found the clinical trials to be woefully insufficient in that the
physician reports were too few and they were based largely on physician
testimonials rather than sound scientific study. She rejected the application.
She asked
for more information from Merrell, who responded with another application
merely stating that thalidomide was at least safer than barbiturates. Kelsey then sent a letter directly to Merrell
saying that she suspected they knew of the neurological toxicity that led to
nerve inflammation but chose not to disclose it in their application. Merrell grew increasingly upset that Kelsey
would not pass their drug, which had been used in over 40 other countries at
this point.
If
neurological toxicity developed in adults who took thalidomide, Kelsey
wondered: What was happening to the foetus of a pregnant woman who took the
drug? In her training she has studied
what happened to drugs crossing the placenta barrier. Her concern hit on what would be the most
dangerous effect of thalidomide in other countries.
The withdrawal
On
November 15, 1961, Dr. Widukind Lenz[2] called Chemie Grünenthal to share his suspicions
regarding the drug and the link to limb malformations in newborns. He spoke to
Dr. Mückter, Grünenthal’s medical director, and urged him to take the drug off
the market immediately. Lenz now had 14 cases of babies born with deformities
which he strongly believed were directly connected to Thalidomide. Mückter
vehemently refused to withdraw the drug. Luckily Lenz wouldn’t be put off and
went public with his suspicions. It was only after the press got hold of the
story that Grünenthal decided to withdraw the drug, on November 27, 1961. But by then over 10,000 infants all over the
world were affected, and countless others died in-utero.
Despite
this withdrawal, Merrell did not withdraw the application on their own until
April of 1962. But by then the drug had
already been distributed to “more than 1200 physicians, about 15,000-20,000
patients—of whom over 600 were pregnant,” according to Swan. In the
A darker past
It has
since emerged that the “first” case of foetal defect was born on Christmas Day,
1956 to an employee of Grünenthal.
In the
In November
1944, Fritz ter Meer, sent a memo to Karl Brandt, the SS General who ran
Hitler’s euthanasia programme, explaining that a drug numbered 4589 (with the
same chemical formula as Thalidomide) had “been tested and was ready for use.”
Correspondence
was discovered that dealt with the sale of one hundred and fifty female
prisoners for experimental purposes, “… With a view to the planned experiments
with a new sleep-inducing drug we would appreciate it if you could place a
number of prisoners at our disposal…”
There are
hints that some
It is now
widely believed that this preparation was the forerunner for the preparation
that was to become known the world over as Thalidomide.
President
Kennedy awarded Kelsey the President’s Award for Distinguished Federal Civilian
Service, making her the second woman to receive such a high civilian honour.
In her
memoir, Kelsey says that the honour did not belong just to her. “I thought that
I was accepting the medal on behalf of a lot of different federal workers,” she
writes. “This was really a team effort.” She was quickly promoted to chief of
the investigational drug branch in 1963, and four years later, she became
director of the Office of Scientific investigation—a position she held for 40
years until she retired at the age of 90. She lived until the age of 101, and
passed away in 2015.
There is
hope still.
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