THE THALIDOMIDE TRAGEDY:
Another example of animal research misleading science
by John Lesso
Thalidomide, the nightmare drug responsible for over 10,000 human birth
deformities, has again reared its ugly head with the appearance of its
dreadful effects being passed on to the children of victims. This latest
threat of the possibility of further litigation against the makers of
thalidomide has once again rallied industry-beholden animal researchers to
the drug's defence with laboratory data "disproving" the clinical
findings.
As reported in the British Sunday Mirror, the babies of six young men who
were born deformed because of thalidomide have also been born with
malformed
limbs. Two of the babies have almost identical deformities to their
fathers.
Obstetrician Dr William McBride, who first warned against thalidomide in
1961, has called on doctors to study children of victims and report back
to
determine the scale of the tragedy.1 He says there are second generation
victims in Germany, Japan and Bolivia as well as Britain.2
Despite the clinical evidence to the contrary, British health authorities
such as the Medical Research Council maintain that the vast bulk of
evidence
from laboratory and animal tests is against thalidomide having any genetic
effects.2 There is no doubt that results from animal experiments will play
a
major part in the drug's defence, as it has done from when thalidomide's
horrible effects first started appearing back in the early 1960's. In
fact,
thalidomide apologists still adhere to the defence that the thalidomide
tragedy could not have been predicted, mainly because the drug had not
been
tested specifically for birth defects before being marketed, as at the
time
it wasn't required by law. This convinced most, including health activists
campaigning for thalidomide's victims.
Thalidomide campaigners argue that the thalidomide tragedy is not an
example
of an animal-tested drug that proved disastrous for humans, but of the
dishonesty and sharp practices of the pharmaceutical industry. This view
is
based upon the fact that the animal tests carried out by the inventor of
the
drug, the West German pharmaceutical company Chemie Grunenthal, were very
superficial and incomplete, and their clinical trials were hastily done
and
questionable.3 Also, prior to the introduction of thalidomide, Grunenthal
did not carry out animal tests specifically to demonstrate teratogenic
(malformation causing) effects.4 There is also no evidence that any of the
drug licensees did either. However it soon will become evident that the
human birth deformities caused by thalidomide was the result of misleading
results from animal experimentation as well as the dishonesty and ruthless
behaviour of drug companies.
In 1957, soon after the launching of Contergan (thalidomide) in West
Germany, came reports of peripheral neuritis that revealed thalidomide's
toxic effects on the nervous system of the user.5 This is a serious
illness
which may occur anywhere in the body. For example, it may begin with a
prickly feeling in the toes, followed by a sensation of numbness and cold.
The numbness spreads often above the ankles, and eventually is followed by
severe muscular cramps, weakness of limbs, and a lack of co-ordination.
Some
of these symptoms improve or disappear when the cause is removed, but much
of the damage is irreversible.6
Peripheral neuritis does not itself point to reproductive damage, but many
scientists would take such an assault on the nervous system as grounds for
general suspicion.7 One such scientist, McCredie, reported that the limbs
of
children with thalidomide malformations show changes analogous to those
which can occur in the adult as a consequence of pathological alterations
to
peripheral nerves.8 Such a suspicion was suggestive enough to cause Dr
Frances Kelsey, the Medical Officer of the Food and Drug Administration,
to
reject the drug firm's application to market Kevadon (thalidomide) in the
United States, because among other reasons, she wasn't satisfied that the
drug would be safe to take during pregnancy. Her handwritten note on the
original memorandum reads: "This was based on peripheral neuritis symptoms
in adults."9
The original animal tests by Chemie Grunenthal did not show indications of
this unexpected and serious side-effect.10 Furthermore, in several
European
countries, including England and Sweden, the licensees of thalidomide
carried out their own animal tests, independently from the German firm,
and
came to the same results as Chemie Grunenthal.11 If the tests had
predicted
peripheral neuritis and if the firms had acted upon the results in a
responsible manner, the drug would not have been released in the first
place
and a major disaster would have been avoided.
Unfortunately this wasn't the case: "an estimated 10,000 children - but
probably many more - were born throughout the world as phocomelics,
deformed, some with fin-like hands grown directly on the shoulders; with
stunted or missing limbs; deformed eyes and ears; ingrown genitals;
absence
of a lung; a great many of them still-born or dying shortly after birth;
parents under shock, mothers gone insane, some driven to infanticide."12
(Hans Ruesch, medical historian.)
And to illustrate just how neglectfully the firms behaved, consider the
fact
that despite thousands of cases of peripheral neuritis and that a growing
number of cases of deformities were being reported, the drug firms
resisted
moves to withdraw their products. Besides, their resumed animal tests
could
not duplicate the deformities, so they saw no reason to remove the drug.
Only when the evidence was overwhelming did Chemie Grunenthal finally take
Contergan off the market.13 Also, in other countries around the world,
including Brazil, Italy, Japan, Sweden and Canada, drugs containing
thalidomide were not withdrawn till a year or longer after Grunenthal's
withdrawal of the drug.14
As a consequence to the thalidomide tragedy there has been a marked
upsurge
in the number of animals used in testing of new drugs. Also drugs are now
specifically tested on pregnant animals to supposedly safeguard against
possible teratogenic effects on the human foetus. Vivisector's claim that
if
such tests were carried out prior to thalidomide's release, birth
deformities in humans would have been discovered. This is of course sheer
nonsense. "In pregnant animals, differences in the physiological
structure,
function and biochemistry of the placenta aggravate the usual differences
in
metabolism, excretion, distribution and absorption that exist between
species and make reliable predictions impossible."15 (Dr Robert Sharpe,
former senior research chemist.)
In fact when the link between human foetal abnormalities and thalidomide
was
established (through clinical observation), the world-wide explosion of
animal testing, using a large range of species, proved it very difficult
to
duplicate the abnormalities.16 Writing in his book, Drugs As Teratogens,
J.L. Schardein observes: "In approximately 10 strains of rats, 15 strains
of
mice, 11 breeds of rabbit, 2 breeds of dogs, 3 strains of hamsters, 8
species of primates and other such varied species as cats, armadillos,
guinea pigs, swine and ferrets in which thalidomide has been tested,
teratogenic effects have been induced only occasionally."17 Eventually
only
after administrating high doses of thalidomide to certain species of
rabbit
(New Zealand White) and primates could similar abnormalities be found.
However researchers pointed out that malformations, like cancer, could
occur
when practically any substance, including sugar and salt, is given in
excessive doses.16
All this simply reaffirms what many doctors and scientists have been
warning
for a number of decades - animal experimentation misleads science and any
similarity to the human situation is merely coincidence and cannot be
verified until the experiment is repeated on humans. Experimenting on
animals is like playing roulette.18
The massively increased use of test animals following the thalidomide
tragedy only served to dupe the public, encouraging people to keep
consuming
animal-tested drugs. Consequently malformations are increasing. Over
twenty
years later, on July 19, 1983, a headline in the New York Times revealed:
"Physical and Mental Disabilities in Newborns Doubled in 25 Years". More
recently, the March of Dimes Birth Defects Foundation, an organisation
responsible for monitoring birth defects, reveals that every year more
than
a quarter million babies (1 in 12) are born with birth defects in the
United
States.
In West Germany's authoritative medical journal Munchner Medizinische
Wochenschrift, 1969, Dr W.Chr. Muller, of the nation's First
Gynaecological
University Clinic, reported that an extensive survey by German doctors had
revealed that "for 61% of all malformed children born alive and 88% of all
stillborn children, the intake of various drugs had to be held
responsible."19
While drug companies continue to be allowed to release their products on
the
basis of phoney, alibi animal experiments, is there any wonder why
humanity
continues to suffer drug-induced problems of such magnitude.
John Lesso is coordinator of the Campaign Against Fraudulent Medical
Research (CAFMR). Write to: POI Box 234, Lawson NSW 2783. Phone/fax: (047)
58 6822. Email: cafmr.pnc.com.au URL: www.pnc.com.au/~cafmr
Subscription to CAFMR is $18 per year.
References
1."Thalidomide Dad's Tragedy", Sunday Mirror, London, July 3, 1994.
2. "Thalidomide horrors show up in the children of victims", Gold Coast
Bulletin, Australia, April 26, 1995.
3. Sjostrom, H., and Nilsson, R., Thalidomide and the Power of the Drug
Companies, Penguin Books, 1972, p.191.
4. ibid., p. 189.
5. Sharpe, R., The Cruel Deception: The Use of Animals in Medical
Research,
Thorsons Publishing Group, Wellingborough, England, 1988, pp.105-6.
6. The Sunday Times Insight Team, Suffer The Children: The Story of
Thalidomide, Andre Deutsch, London, 1979, p.32.
7. ibid., pp.62-3.
8. McCredie, J., "Thalidomide and Congenital Charcot's Joints", Lancet,
1973, vol. 2, p.1058-61.
9. The Sunday Times Insight Team, Suffer the Children, p.79.
10. Sharpe, R., The Cruel Deception, p.106.
11. Ruesch, H., Slaughter of the Innocent, Civitas Publ., New York, 1986,
p.360.
12. Ruesch, H., Slaughter of the Innocent, pp.360-1.
13. ibid., p.361.
14. Sjostrom, H., et al, Thalidomide and the Power of the Drug Companies,
pp.131-48.
15. Sharpe, R., The Cruel Deception, p.107.
16. Ruesch, H., Slaughter of the Innocent, p.361.
17. Reproduced in Drugs and Pregnancy - Human Teratogenesis and Related
Problems, Hawkins, D.F. (Ed.), Churchill Livingston, 1983.
18. Croce, P.,"That's why I am against vivisection" in CIVIS International
Foundation Report, Ruesch, H. (Ed.), CIVIS, Massagno, Switzerland, Autumn
1989, Nr 7, p.1.
19. Muller, W., Munchner Medizinische Wochenschrift, 1969, No. 34, repr.
in
Ruesch, H., Slaughter of the Innocent, p.365.
