THE THALIDOMIDE TRAGEDY:

Another Example of Animal Research Misleading Science

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 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, whom 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 was not 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 Grünenthal, were very superficial and incomplete, and their clinical trials were hastily done and questionable. (3) Also, prior to the introduction of thalidomide Grünenthal 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 launching 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 that 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 that 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 Grünenthal 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 Grünenthal. (11) If the tests had predicted peripheral neuritis and if the firms 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-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.)

Moreover, to illustrate just how criminally neglectful 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 withdrawal their products. Besides, their resumed animal tests could not duplicate the deformities, so they saw no reason to remove the drug. Only until the evidence was overwhelming did Chemie Grünenthal finally take Contergan off the market. (13) Also, in other countries around the world including Brazil, Italy, Japan, and Sweden and Canada drugs containing thalidomide were not withdrawn until a year or longer after Grünenthal'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. In addition, 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 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, eleven breeds of rabbit, two breeds of dogs, three strains of hamsters, eight species of primates and in 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 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 just 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 a 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 it 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 Münchner Medizinische Wochenschrift, 1969, Dr W.Chr. Müller 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, releasing their products based on phoney, alibi animal experiments is there any wonder why humanity continues to suffer drug-induced problems of such magnitude.

Published in the Spring 1996 issue of the CAFMR Newsletter.

Copyright 1996 by the Campaign Against Fraudulent Medical Research, P.O. Box 234, Lawson NSW 2783, Australia. Phone +61 (0)2-4758-6822. www.pnc.com.au/~cafmr

The above article may be downloaded, copied, printed, or otherwise distributed without seeking permission from CAFMR. However, printed acknowledgement is required when this is done.

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. Sjöström, 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. Sjöström, 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. Müller, W., Münchner Medizinische Wochenschrift, 1969, No. 34, repr. in Ruesch, H., Slaughter of the Innocent, p. 365.