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In his book, "Cruel Deception" Dr Robert Sharpe describes, analyzes and offers a his critique of animal-based medical research. He provides examples to support his thesis: 1) the differences between other animals and humans produce results of questionable value, 2) the results are in some cases are dangerously misleading, 3) the results have often delayed and hampered advances in various diseases, 4) alternative research methods and preventive medicine provide many benefits and provide the best chance for future advances, and 5) that animal experiments thrive "through a conspiracy of secrecy and deception" which is pursued to protect enormous financial interests.
Examples of above five sections listed below:
1) Examples of animal tests and experiments have been criticized by scientists as having results of questionable value:
1a) In Ohio in January, 1974, the FDA sued the producers of Beacon Castile Shampoo with Lanolin after a young girl suffered eye damage when the shampoo got into her eye. The Ohio Court ruled in favor of the company and said that the FDA had "failed to show that the results of tests on rabbits' eyes (the Draize Test) can be extrapolated to humans."
1b) In a section titled "Scientists and the Draize Test", B Ballantyne*, D W Swanston* criticized: ". . . There are structural and biochemical differences between human eye and that of animals. . . . Extreme caution is required in extrapolating results. Typical example is application of corticosteroids. . . ." Muir, Flower, Van Abbe*: "Predictive reliability of Draize has been questioned and its use of living animals has been criticized." Kemp, Meredith, Gamble, Frost*: "The rabbit eye is structurally and physiologically different from the human eye." Coulston, Serrone*: "Important areas where it is difficult to extrapolate animal data to man is eye and skin." Swanston*: "No single animal species has been found to model exactly for the human eye anatomically or in response to irritation." In 1971 twenty-five labs tested 12 chemicals of known irritancy. Extreme variation between labs was found. "The rabbit eye procedures should not be recommended as standard procedures. . . ."
1c)Chapter 4, "Keep Taking the Tablets." Sharpe writes "According to British statistics, most animals are used to develop new drugs and appliances (1,586,075 or 51 per cent of the total in 1986), yet the vast majority clearly suffer and die to test products for which there is no real medical need."
1d) Over a 25-year period, the US' National Cancer Institute screened 40,000 species of plants for antitumor activity and, as a result, several proved sufficiently safe and effective on the basis of animal tests to be included in human trials. However, all of these were either ineffective in treating human cancer or too exotic to consider for general use.
1e) Sharpe quotes scientists critical of the LD50: D. Lorke*, Institute of Toxicology, Bayer AG, Germany: ". . . if LD50 could be measured exactly . . . barely be of practical importance . . . extrapolation from animals to man is hardly possible." Dr Sharratt*, British Petroleum, on LD50: "As index of acute toxicity, this is valueless." Assoc. of British Pharmaceutical Industry*: ". . . as far as new medicines are concerned, no need for LD50 . . . regulatory authorities are moving away from reliance on it." G Zbinden* and M Flury-Roversi*, Institute of Toxicology, Zurich: "For selection of doses in subacute and chronic toxicity experiments, LD50 cannot provide consistent and reliable results."
1f) Sharpe quotes three critics of animal testing for birth defects: Dr Peter Lewis, Hammersmith Hosp., London: " . . . teratogenicity tests are virtually useless scientifically." D F Hawkins, Hammersmith Hospital: "Great majority of perinatal toxicology studies are intended to convey medical legal protection to pharmaceutical houses and political protection, rather than produce information that might be of value in human therapeutics." R W Smithells: "Extensive animal reproductive studies . . . are more in the nature of a public relations excercise than serious contribution to drug safety."
1g) Sharpe states: "In a survey of 600 patients with chronic stable angina, surgery made no difference to survival but did reduce the severity of the symptoms, whilst another study found no evidence of increased life-expectancy except in patients with severe obstruction of the left main heart artery."
Section 2. Examples of disastrous consequences stemming from drugs that were deemed safe by animal tests include:
2a) OTA Report from World Magazine, 8/21/82: ". . . drugs and medical procedures cause between 2,000-12,000 cancer deaths each year in the United States."
2b) "A staggering 120,366 patients were discharged from or died in UK hospitals during 1977 after suffering the harmful effects of drug treatment." "Between 1964 and 1972 over 10,000 male volunteers were recruited to take part in a World Health Organization trial using the drug clofibrate. The outcome was alarming. Those receiving clofibrate did indeed suffer fewer mild, non-fatal heart attacks but the overall death rate turned out to be 37 per cent higher than those not taking the drug. . . . Adverse effects of drugs are known to be grossly underreported yet during 1977 Government figures show that 120,366 patients were discharged from or died in hospitals in the UK after suffering the side-effects of medicinal products. . . . In the United States, an estimate has been given of one in seven hospital beds taken up by patients under treatment for adverse reactions caused by drugs."
2c) Sharpe cites numerous drug disasters: "According an OTA (Office of Technical Assessment), drugs and medical procedures cause between 2,000 and 12,000 cancer deaths every year in the US. Examples include adenocarcinoma of the vagina in young women whose mothers had taken stilboestrol* during pregnancy, brain tumors from drugs to prevent rejection of kidney transplants and endometrical cancer after estrogen replacement therapy, particularly in women aged 45-74. Of all childhood cancers in Western Europe and North America in the 1950s and 1960s, 5-10 per cent were caused by x-rays used for diagnosis during the mother's pregnancy. Ironically many anticancer drugs themselves can cause the disease. . . . Opren* did indeed modify the disease process--but only in laboratory rats. By the time human trials had disproved the animal data, it was too late. Opren turned out to be highly toxic with 3,500 reports of harmful effects including 61 deaths in Britain alone. . . . The drug Eraldin*, marketed by ICI in the 1970s for the treatment of heart conditions, was found to cause serious eye damage, including blindness, and there were 23 deaths. Eraldin was thoroughly tested and yet animal experiments gave no hint of the tragedy to come. . . . Several other arthritis drugs, including Alclofenac*, Ibufenac*, Flosint*, Osmosin* and Zomax*, have also been withdrawn after unexpected, often fatal side-effects. . . . Prolonged tests in rats had shown 'excellent tolerability' and Flosint '. . . was also well tolerated in the dog and monkey in medium-term toxicity tests.' Furthermore the tests showed '. . . no signs of toxicity in both these species in long term tests.'" "Zelmid* was approved but a year later the Committee on Safety of Medicines had received over 300 reports of adverse reactions. Of these, 60 were serious, including convulsions, liver damage, neuropathies and eight cases of Guillain-Barre syndrome that had never been previously arisen as a drug side-effect. There were seven deaths. In September 1983 Zelmid was withdrawn yet the original tests in rats and dogs had shown no evidence of toxicity at five times the human dose. . . . Even if the drug [thalidomide*] had been tested on pregnant rats, the animals so often used to look for foetal damage, no malformations would have been found. . . . Thalidomide does not cause birth defects in rats or in many other species. . . . By 1966 there were 14 separate publications describing the effects of thalidomide on pregnant mice. . . . McBride's experiments with mice when attempting to confirm his suspicions about the drug, had also been negative. . . . Only in certain types of rabbit and primate could thalidomide's notorious effects be seen. So if thalidomide taught us anything it should have been that different species can react very differently. . . . ICI's heart drug Eraldin, which caused deaths and severe eye problems including blindness, was widely prescribed right up to the time it was withdrawn in the mid-seventies, despite frequent warnings. . . . Major tranquilizers* create their own problems too. They are a major cause of parkinsonism and a related group of symptoms called tardive dyskinesias where patients lose control of their muscles."
Section 3. Examples of advances delayed due to misleading animal experiments include: Dr Irwin Bross, former Biostatics Director, Roswell Park Memorial Institute for Cancer Research, Buffalo, NY, cites evidence that conflicting animal results have often delayed and hampered advances in the war on cancer, and have not produced a single substantial advance in prevention and treatment of human cancer. Current chemotherapeutic agents of value were found in clinical tests rather than in animal studies. "The scientific tradition that medical hypotheses must be "proven" in the lab has had unfortunate consequences . . . research with the animal model of polio resulted in a misunderstanding of the mechanism of infection. This delayed the development of the tissue culture, which was critical to the discovery of a vaccine." Bross quotes Drewitt and Kani, psychologists: "development of behavioral therapy might have been more rapid if more relevant research had been carried out on human volunteers rather than on animals . . . importance of imagery might have been defined earlier."
Section 4. Alternatives to Animals.
4a) Dr Robert Sharpe points out carcinogens are largely identified by epidemiology rather than animal experiments. He explains that the cancer death rate has continued to rise and we should be concentrating on prevention, not cures. International Agency for Research in Cancer: ". . . 80-90 per cent of human cancer is determined environmentally and thus theoretically avoidable" (C S Muir and D M Parkin, BMJ, 5-6, 1/5/85).
4b) "Professors N R Farnsworth and J M Pezzuto of University of Illinois College of Pharmacy argue that sufficient in vitro techniques now exist so that almost any useful drug* effect can be predicted without using animals." ". . . enlightened researchers are now suggesting the use of human cancer* cells and tissues . . . as a means of not only testing drugs but for understanding the nature of the disease itself. . . . several substances rejected by animal experiments have proved highly active against human tumours."
4c) In the UK, surgical skill is obtained by work with human bodies* in the dissecting rooms, then by observation* of senior surgeons, and finally taking over* under close supervision. Scientists, University of Bradford, use a Biovideograph instrument, developed by bioscience, as an alternative to animals for teaching pharmacology and physiology.
4d) ". . . The ICI laboratory used over 12,000 mice a year to test less than 1,000 compounds for antiviral activity but, by 1977, as their dependence on tissue culture systems grew, over 22,000 substances were tested and the number of mice used had fallen to about 2,000."
4e) Sharpe states: "In any case, despite experiments on animals, of those agents known to cause cancer in people, the great majority were first identified by observation of human populations while for several human carcinogens -- for instance arsenic, benzene and alcohol -- animal tests are persistently negative."
4f) ". . . vaccine* can be safely produced from cultures of human cells. . . . Other scientists, referring to the 'severe occular lesions' seen in such tests, have now suggested an alternative approach using isolated eyes* taken from animals killed for food. Whilst the test still depends on animal tissue, it does avoid the pain and suffering experienced by living animals and could be improved still further by relying on human tissue from eye banks**. Rapid screening of drugs against the AIDS* virus can also be carried out in the test tube**. . . . Today many viral vaccines such as polio, rubella, rabies, measles and smallpox can all be produced from human cells*. . . . Other biological products such as hormones* and anti-tumour antibiotics* can be measured more accurately by high performance liquid chromatography (hplc**), a sensitive nonanimal technique that divides a substance into its constituent parts for precise analysis."
4g) Sharpe states: "In a survey of 600 patients with chronic stable angina, surgery made no difference to survival but did reduce the severity of the symptoms, whilst another study found no evidence of increased life-expectancy except in patients with severe obstruction of the left main heart artery." According to the British Medical Journal: "The control of coronary heart disease necessarily depends on prevention, since treatment so often comes too late. Mass medication is potentially dangerous, and it would be better if risk factors could be controlled by changing habits." According to World Medicine: "In 1968 American men had one of the highest death rates from coronary heart disease, but thanks to a 56 per cent reduction in the consumption of animal fats, and a comparable rise in vegetable oils, American death rates fell by 21 per cent over the next 10 years."
Section 5. Information on Defenders.
Author states bribery of physicians and government officials plays role in irrational drug promotion and use in Third World. Chloramphenicol, can cause fatal blood disease, restricted in industrial countries, only six of thirty brands gave warning in Indonesia.
OTHER SOURCES: Congressional Record, 4/30/80, Vol 126, #68, p101, Senate. by Dr Robert Sharpe. Sharpe quotes scientists critical of the LD50: D Lorke*, Inst. of Toxicology, Bayer AG, Germany: ". . . if LD50 could be measured exactly . . . barely be of practical importance . . . extrapolation from animals to man is hardly possible." Dr Sharratt*, British Petroleum, on LD50: "As index of acute toxicity, this is valueless." Assoc. of British Pharmaceutical Industry*: "...as far as new medicines are concerned, no need for LD50 . . . regulatory authorities are moving away from reliance on it." G Zbinden* and M Flury-Roversi*, Institute of Toxicology, Zurich: "For selection of doses in subacute and chronic toxicity experiments, LD50 cannot provide consistent and reliable results." AFAAR - American Fund for Alternatives to Animal Research, 2/1/89, "Book review," by Macdonald Daly. Daly reviews The Cruel Deception: The Use of Animals in Medical Research by Robert Sharpe. The review, originally published in Animals' Agenda magazine, reveals that Sharpe advocates an "essential only" drugs policy such as the system in Norway where there are only 1,900 licensed formulations (compared to UK's l8,000). Sharpe argues that research on animals will not rid people of degenerative conditions such as heart disease or cancer. Epidemiological surveys revealed the mainly dietary and environmental origins of the illnesses of affluent societies. Daly notes that some quotes used by Sharpe are taken out of context and "are unrepresentative of their authors' general positions." In a note to "Members and Friends," AFAAR lauds Sharpe's book for valuable and new information, but criticizes Sharpe's documentation for including "some incorrect documentation which could weaken credibility for the fully established statements."
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