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[e-drug] New information on the 1960s thalidomide case

E-DRUG: New information on the 1960s thalidomide case
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Dear E-drug Colleagues,

Below is new information on how Grunenthal (in Germany) knew of
thalidomide's harmful effects on foetuses before the medicine was banned
in 1961. This evidence dismantles the long-held belief that birth
defects were an "unforeseeable tragedy" and that Grunenthal's
"actions were consistent with the state of scientific knowledge and
prevailing standards of the 1950s". 

As the article suggests, this was a conscious effort to cover-up  essential 
information for 50 years. The article includes two links to court documents and 
important correspondence leading up to the 1961 ban. Thalidomide victims may 
see justice but Grunenthal is vociferously defending lawsuits.

regards

João

Dr. João L. Carapinha
BPharm, MM P&DM, PhD (Law and Public Policy)
www.twitter.com/joaocarapinha


***
The 50-year global cover-up

http://www.canberratimes.com.au/national/the-50year-global-coverup-20120725-22r5c.html

SECRET files reveal the German maker of thalidomide ignored and
covered up repeated warnings that its drug could damage unborn babies.

The Age has obtained excerpts of never-before-published files from the
archives of pharmaceutical giant Grunenthal which detail explicit
warnings the company received about its drug's potential to harm
foetuses well before it was withdrawn from sale in late 1961.

http://images.theage.com.au/file/2012/07/25/3486637/thalid1.pdf?rand=1343218296209

http://images.theage.com.au/file/2012/07/25/3486947/thalid2.pdf?rand=1343218286415

An estimated 10,000 babies worldwide - including hundreds in Australia
- were born in the late 1950s and 1960s with severe physical
deformities because their mothers had taken thalidomide drugs, which
were marketed as a safe sedative and remedy for morning sickness.

The Grunenthal files expose a 50-year global cover-up and demolish the
company's long-held position that the scandal was unforeseeable
tragedy and that its ''actions were consistent with the state of
scientific knowledge and prevailing standards of the 1950s''.

The files reveal that for at least two years before the drug was
banned in late 1961, German medical professionals had told Grunenthal
staff of concerns that children's deformities were caused by women
taking thalidomide during pregnancy.

Between 1959 and 1961 - while the drug was still being marketed as
safe - Grunenthal employees and their families began having deformed
babies.

In one company file, it is noted that ''eight families, which, as
dependants of the Chemie Grunenthal Company, during the years between
1959 until 1961, had had deformed children''.

Rather than act on the internal warnings, Grunenthal simply told
concerned doctors there was no information to suggest the drug was
unsafe.

The Grunenthal documents have come to light after they were lodged in
the Victorian Supreme Court by Slater & Gordon lawyer Michael
Magazanik in support of a compensation claim by Melbourne thalidomide
victim Lynette Rowe.

Ms Rowe, in a case led by prominent plaintiff lawyer Peter Gordon,
last week secured a multimillion-dollar payout from UK company Diageo,
which bought thalidomide distributor Distillers in 1997.

Diageo is considering settlements with up to 130 other thalidomide
victims in Australia and New Zealand. But Grunenthal continues to deny
any culpability and is aggressively defending lawsuits.

The Grunenthal files include a statement by German pharmacist
Friedrich Koch revealing that he wrote to the firm in late 1960,
having spoken to a mother who took Contergan - a brand name for
thalidomide - during pregnancy and whose child was born with internal
injuries.

''After my discussions with (a patient), I felt compelled to write a
letter to the company Grunenthal on 24 November 1960. In this letter …
I inquired whether a child could develop injuries if the mother had
taken Contergan regularly during pregnancy.

''The thought that medication might possibly affect a foetus … did not
seem absurd to me, but rather worth investigating,'' Mr Koch wrote.

Grunenthal wrote back to Mr Koch enthusiastically giving the drug the
all clear. ''Based on the contents of the letter, I was then able to
tell the parents that according to the company, their babies injuries
were not caused by the mother taking Contergan during pregnancy,'' Mr
Koch's statement says.

''Naturally I presumed that the scientists in Stolberg [Germany] had
already looked into the problem of their Contergan breaking through
the foetus or that they would at least look into it after receiving my
letter.''

A year before Grunenthal assured Mr Koch the drug was safe, the firm
was contacted by a German medical practitioner, Dr K, with similar
concerns.

Dr K's statement reads: ''I can recall with certainty that I made a
possible connection between Contergan and my son's deformities as
early as 1959.

''In the same year, my wife and I had discussed this problem with
[Grunenthal employee] Dr Mannheim at various times … He always
explained that he just could not imagine thalidomide causing these
types of injuries … I established at least a further two malformations
during 1959 which I also connected to Contergan.''

Several files reveal Grunenthal was receiving an increasing number of
queries about the drug's potential to harm babies at the same time it
was telling the public it was safe.

An internal document dated February 1961 - almost a year before
thalidomide was banned - poses a question about its potential to
effect the foetus. Another document includes a reference to Grunenthal
being told that thalidomide was ''known as an abortive drug''.

A March 1961 document says animal testing might shed light on the
effect of thalidomide on a foetus while also acknowledging that the
company had no idea what this impact could be. ''[We have] no
experiences ourselves

regarding [thalidomide] and pregnancy,'' the March 1961 memo states.

Around this time, Grunenthal sales representatives wrote confidential
memos to the firm about what doctors had told them about possible
impacts of the drug. A February 1961 letter from a doctor working in
sales for Grunenthal states that his ''main objective'' in responding
to such concerns was ''once again … to generate general interest and
cause confusion''.

An April 1961 memo from another Grunenthal sales representative deals
with the drug's potential to cause nerve injury, finding that in one
medical ward there were ''20 clear Contergan [thalidomide] allergies
and 2 cases of polyneuritis''.

''On the psychiatric wards with huge use of 271 [thalidomide] no side
effects at all (maybe the idiots are happy when they are tingling!),''
the sales representative noted.

Another file reveals that in the months before July 1961, a German
doctor quizzed Grunenthal about the potentially harmful effects of the
drug during his wife's second pregnancy, given she had previously
miscarried after taking Contergan.

The doctor's wife gave birth to a severely deformed child in July 1961
and he immediately suspected ''the potentially harmful effect of
Contergan on the child''.

In mid-1961, a Grunenthal doctor told a fellow employee ''that in
regard to Contergan, significantly more severe injuries than those
already known were to be anticipated in his opinion''.

Yet another company doctor also confidentially flagged concerns,
telling a Grunenthal meeting that the firm ''needed to investigate the
diaplacental transfer of [thalidomide] by way of animal test to
determine the possibility of damage to the foetus."

According to one of Mr Magazanik's affidavits, ''by May 1961,
Grunenthal knew that its own medically trained staff had 'a very real
fear of [thalidomide] side effects' and were refusing to use
thalidomide drugs within their own families.''

By late 1961, when United States regulators had refused to licence
thalidomide due to safety concerns, Grunenthal's internal files reveal
a growing acknowledgment inside the company that there may be a
serious problem with its drug.

In September 1961, the company wrote to a medical expert querying if
it could draw on his expertise on the ''effects of medication on the
foetus''.

But no tests were done in the last six months of 1961, despite further
concern expressed to Grunenthal that their drug might be harming or
killing babies.

It wasn't until November 1961 that the company finally moved to ban
the drug after getting now well-known reports by Dr Widikund Lenz and
Australian obstetrician William McBride about the links between the
epidemic of birth defects and thalidomide.

The company at this time began formulating its position that it was
not to blame.

But privately, Grunenthal's own lawyers had their doubts about aspects
of the company's behaviour, including its response to hundreds of
reports of nerve damage caused by thalidomide which prompted them to
warn it was facing ''a dangerous and uncomfortable situation so
injurious to the reputation of the organisation''.


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