Below are responses to the most frequently asked questions to learn more about animal research about non-animal research and the questionable scientific merit of experimentation on animals.

Would drugs be safe without first being tested on animals?

Drugs would be safer than they are now if the animal testing phase was eliminated. Many studies have shown that animals predict correctly for humans only 5-25% of the time.

When researchers administer potentially useful substances to animals, they get plenty of feedback on the substances’ effectiveness in the species tested. However, results nearly always differ dramatically between species, and there are no reliable methods of predicting a human reaction.

In fact, 92% of new drugs fail in clinical trials, after they have passed all the safety tests in animals. Many drugs that reach the market are later withdrawn or relabelled because of serious side effects. Reliance on animal data allows companies to avoid the expense of bigger and better clinical trials.

In addition, substances that could save many human lives are not approved because they are harmful to animals. For example, morphine excites cats, cortisone causes birth defects in mice, penicillin kills guinea pigs and hamsters and aspirin poisons cats. If the results of tests on animals had been relied upon, we would not have penicillin or digitalis (a drug used by heart patients, but which was withheld from the market for years because it was found to raise blood pressure in dogs). We would also be without aspirin (which causes fetal deformities in rats and is toxic to some animals) and chloroform (once a common anesthetic but not used initially because it was toxic to dogs). Certain steroids, adrenaline, insulin and some antibiotics are also toxic to many animals, but medically beneficial to humans.

More than 10,000 people die every year in Canada because of adverse drug reactions (making it the fourth leading cause of death in Canada). For example, the arthritis drug Vioxx was withdrawn in 2004 because it caused up to 320,000 heart attacks and strokes – as many as 140,000 of which were fatal. Animal testing failed to predict these tragedies, which could have been reduced or prevented altogether by modern, human-based tests using DNA chips, human tissues and micro-dose studies where volunteers are monitored with PET and other scanners.

If we don’t use animals, what will we use?

This statement falsely assumes that animal experiments have been responsible for medical advances in the past. However, the real benchmarks of medical progress have relied on the following non-animal methodologies — as will future developments:

• In vitro (test tube) research has been instrumental in many of the great discoveries – of antibiotics, for example, and the structure of DNA, as well as all the vaccines we have today, including polio and meningitis.
• Epidemiology (population research) revealed that folic acid deficiency causes birth defects; that smoking causes lung cancer; and that lead damages children’s brains.
• Post-mortem studies are responsible for much of our modern medical knowledge – including the repair of congenital heart defects in babies.
• Genetic research has elucidated how certain genes are responsible for some diseases. DNA chips allow doctors to prescribe the right drug for specific patients, thus reducing serious side effects of chemotherapy, for example.
• Clinical studies of patients have given us most of our current treatments and cures – including our treatments of lazy eye and the knowledge that HIV transmission from mother to baby can be prevented.
• Human tissue is vital in the study of human disease and drug testing.
• Computer modelling is now very sophisticated, with virtual human organs and virtual metabolism programmes which predict drug effects in humans far more accurately than animals can.
• Advances in technology are largely responsible for the high standard of medical care we receive today, including MRI and PET scanners, ultrasound, laser surgery, cochlear implants, laparascopic surgery, artificial organs, pacemakers and even surgery to correct spina bifida in the womb.
• Human stem cells have already treated children with leukemia and promise to deliver great benefits in the future.

What are some superior non-animal methods?

Many scientifically reliable research methods exist which are superior to using animals to learn about human disease or predict the safety of new drugs. They include:

• Microdosing is a new method of obtaining human metabolism data, which enables potential new drugs to be tested safely in humans at an earlier stage. Microdosing relies on the ultrasensitivity of accelerator mass spectrometry (AMS), one of the most sensitive measuring devices ever invented. Currently, 40% of drugs fail in Phase I clinical trials, which take up to 18 months and cost $5-9 million. Microdosing could screen out drugs destined to fail earlier, faster and cheaper; microdosing takes only 4–6 months and costs $500,000 per drug. It’s accuracy at predicting human metabolism is unsurpassed. EU and US regulators have endorsed the use of microdosing to improve the speed and safety of drug development.
• DNA chips enable the study of pharmacogenetics, which, in turn, enables the practice of personalised medicine. This is the concept that since each person is genetically unique, medicines should be designed for individuals, rather than our current ‘one-drug-fits-all” approach. DNA chips are glass slides the size of a postage stamp, studded with an array of genes or fragments of DNA. A sample of DNA tagged with fluorescent dyes is exposed to a new drug, and then washed over the chip. When the genes on the chip match the DNA in the sample, they stick together and the colours reveal which genes have been activated or suppressed by the experimental drug.
• Microfluidics chips are tiny but have etched onto them a series of tiny chambers, each containing a sample of tissue from different parts of the body. The compartments are linked by microchannels through which a blood substitute flows. The test drug is added to the blood substitute and circulates around the device; thus mimicking what goes on in the body on a micro scale. Sensors in the chip feed back information for computer analysis.
• Human tissue has provided us with a plethora of information on HIV, Alzheimer’s and Parkinson’s. New drugs can also be tested in human tissues, ethically obtained with fully informed consent, before they are given to volunteers in microdose studies.
• Computer modelling with virtual human organs and metabolism programmes can now predict drug effects in humans more accurately than animals tests can. Computers can be used to design the molecular structure of drugs to target specific receptors. For example, the protease inhibitors for patients with HIV were designed by computer and tested in human tissue cultures and computer models, bypassing animal tests due to the urgent need for a treatment. In 1997, Roche Pharmaceuticals had a new heart drug approved on the strength of data from a virtual heart because the animal data was inconclusive. Research teams around the world are working on a ‘virtual human’, which is designed to predict drug metabolism and metabolite interaction with any given organ – information that animal models will never be able to provide. Scientists can simulate experiments in silico (on computer) in minutes that could take months or years to do in the lab or clinic.
• Epidemiology studies lifestyle factors in populations to find correlations that might be significant. Epidemiology linked smoking to cancer; high cholesterol to heart disease; and folic acid deficiency in pregnancy to spina bifida. Large new projects promise to find many more such associations.
• Stem cell research offers potential promise of treatment for a wide variety of diseases. Human stem cells have already been used successfully to treat some leukemias, as well as improving outcomes for heart attack patients and for some patients suffering from Parkinson’s disease. Donated adult stem cells and umbilical cord stem cells can be engineered to provide an ethical source of human stem cells for research.
• New imaging technologies such as magnetoencephalography (MEG), magnetic resonance imaging (MRI), functional MRI (fMRI), magnetic resonance spectroscopy (MRS), positron emission tomography (PET), single-photon emission computed tomography (SPECT), event-related optical signals (EROS) and transcranial magnetic stimulation (TMS) are offering a view of the human body – in particular, the brain – that cannot be gained by studying animals.
• Post-marketing drug surveillance could help to identify unexpected side effects of new drugs much sooner; thus reducing the burden of adverse drug reactions.
• Clinical research has been and will remain the bedrock of medical practice, but many medical treatments have never been studied for efficacy. Large clinical studies are needed to establish whether current practice is actually the best. For example, some long-established practices have been shown to be more harmful than helpful, eg. hormone replacement therapy for preventing heart disease and corticosteroids for reducing brain injury.
• Prevention is always more effective than cure. It is estimated that 80% of all cancers and heart disease – our two biggest killers – could be prevented. Funding further research into establishing preventive factors would be money well spent.

Replacing the animal model is not about finding a one-to-one replacement for every current use of animals: that would be futile since the way animals are currently used is ineffective. We need to use research techniques that are genuinely effective; such as those described above. Only by devoting our resources to human specific research can we be confident that we are doing our utmost to ease human suffering from disease.

What about the argument that animal experimentation is indispensable as our only model of intact metabolic systems?

This assertion suggests that in Vitro research methodologies, though valuable, cannot predict what will happen in a whole living system, which is true. But history has proven that results in lab animals are even more inadequate – predicting results solely for the animal tested, not humans.

Given that metabolic processes differ greatly between species, information garnered in animal experiments has no predictive value and is wholly unscientific when applied to humans. Very often substances that have proven effective in animals demonstrate no curative value for humans, sometimes even causing harm.

By using in vitro research and new technology we can simulate the living intact human far better than a lab animal can. All drugs must eventually be tested on humans. These “clinical phases” of drug testing, as they are called, submit human volunteers to what are at first very incremental dosages, monitor their reactions, and slowly increase dosage.

Clinical testing and subsequent non-animal methods, such as epidemiology and post-marketing drug surveillance, provide what lab animals cannot – 100% accurate measures of the human metabolic processes.

Why does animal experimentation continue?

Many factors perpetuate animal experimentation, the most obvious of which is momentum. The tradition is so deeply ingrained that the whole system is based on it. “Technological lock-in” and “status quo bias” are powerful factors here.

Another factor is that many researchers are far removed from patient care and really believe that by experimenting on animals they are helping to cure human disease. Also, they attract grant money based on how many papers they publish in the scientific literature. It is much easier and faster to publish papers using animals than by doing human-based research.

Pharmaceutical companies continue to do animal tests because regulators require them and because they provide liability protection in court when drugs injure or kill people, despite the fact that the animal tests themselves are scientifically worthless.

Animal tests became mandatory following the thalidomide tragedy in the 1960s – ironically, since they failed to prevent that disaster. Since then, both regulators and pharmaceutical companies have become very familiar with animal tests and readily accept them when they tick all the necessary boxes. As a reviewer for the US FDA (the world’s major drug regulator), Dr Anita O’Connor, acknowledged: “Most of the animal tests we accept have never been validated. They evolved over the past 20 years and the FDA is comfortable with them.”

Sadly, the regulatory system has not really changed since thalidomide. Vioxx (2004) was the biggest drug recall in history, leaving many tens of thousands of deaths in its wake.

Aren’t the 3Rs (“Reduce, Refine and Replace”) the best way to phase out animal experiments?

The 3Rs (“Reduce, Refine and Replace”) are based on the assumption that experiments on animals, though unpalatable, are scientifically valid, leading to cures and treatments for human disease. Proponents of the 3Rs advocate reducing, refining and replacing animal experiments with “alternatives”. The principle has merit in theory – though not in practice – from an animal welfare perspective. However, it makes no scientific sense because if a practice does not work, there is little point in reducing or refining it. The 3Rs have unfortunately become a smokescreen, which allows the continuation of animal experiments to seem acceptable – as long as the 3Rs are applied. The industry could not have devised a better PR campaign.

Those who endorse the 3Rs and alternatives promote the ‘necessary evil’ view of animal experiments. They maintain that each type of experiment – of which there are millions – is, regrettably, necessary until it can be replaced by an alternative. This perpetuates both the practice and the myth that sustains it. Animal experimenters claim that each and every experiment must be assessed on a case-by-case basis for scientific validity and justification. However, science tells us otherwise:

• Applying knowledge gained from animals to humans harms humans most of the time
• Intractable differences between species mean that animals cannot “predict’ how the human body will respond to a disease or a drug. Their use violates the most fundamental principle of biology: evolution. Therefore the “animal model” paradigm should be rejected as unscientific.

The 3Rs serve to deflect attention and debate away from the very real issue of the scientific validity of animal experimentation. While appearing to focus attention on concern for the welfare of laboratory animals, those promoting the 3Rs avoid entering into dialogue on the justification of using animals as models of human disease. The scientific literature of the last 100 years or so reveals sufficient evidence to demonstrate that using animal data in medical research is misleading and often dangerous.

Science already has a wealth of superior (not ‘alternative’) human-based methods at its disposal. They are responsible for the medical care we enjoy today and are the only way to prevent, cure and treat human illness – yet many are starved of funds while animal experimentation is highly funded. The animal experiment lobby maintains that animal experimentation is an expensive business – it is. But it is not just costing society enormous sums of money, it is costing us far more in terms of human health.

Society need not fear that abandoning animal experimentation would mean giving up medical progress. On the contrary, it would ensure greater safety for patients and volunteers in clinical trials and a higher probability of finding cures for human illness. For more information, please see Medical Research for the 21st Century (Greek & Greek, Trafford 2004).

Didn’t the polio vaccine come from animal experimentation?

Animal experimentation actually delayed this much-needed vaccine throughout the first half of the 20th century.

When polio first appeared around 1835, it rapidly paralysed and killed its victims. In 1908, a virus was suspected and scientists began working on a vaccine. Note: In developing vaccines, it’s crucial to determine how the infection enters the body. Luckily, pathologists discovered the polio virus in human intestines as early as 1912, suggesting entrance through the digestive tract.

Meanwhile, researchers successfully infected monkeys with polio. But because monkeys contract polio nasally rather than orally, this “triumph” only postponed the development of an effective vaccine for decades. Incredibly, the scientists working on the vaccine chose to ignore the human digestive data in favour of the monkey data!

It is true that a “vaccine” was derived from animal experimentation. But manufactured from monkey tissue, this “cure” resulted in six human deaths and 12 cases of paralysis. It was abandoned. Further animal experimentation led to the development of a nasal treatment, which only caused permanent olfactory damage to the children tested.

In 1941, Dr. Albert Sabin studied human autopsies to finally disprove the nasal theory. He found the virus confined to the gastrointestinal tract, as had been documented nearly 30 years earlier.

Sabin later denounced the monkey model blunder:

“… prevention was long delayed by the erroneous conception of the nature of the human disease based on misleading experimental models of the disease in monkeys.”

Finally, in 1949, Nobel Prize winner John Enders paved the way for a vaccine by growing the virus in tissue cultures. Though the vaccine could have been produced from human tissue, convention prevailed and manufacturers opted to use monkey tissue instead. Containing the live virus, the animal based vaccine infected 204 people with polio and resulted in 11 documented deaths. It also resulted in at least one virus (SV40) jumping the species barrier and infecting humans.

Because of that, the polio Vaccine is now grown in human diploid-cell culture rather than animal tissue,

Weren’t lab animals responsible for the discovery of diabetes and development of insulin?

Pro-animal experiment contingencies always cite the development of insulin as support for continued animal testing, asserting that insulin harvested from slaughterhouses saved the lives of many diabetics. This is true. But the use of animals in the search for the cause of diabetes has been overwhelmingly counterproductive.

Diabetes affects in excess of 125 million people worldwide and is a leading cause of blindness, amputation, kidney failure and premature death. Physicians in the late 18th century first linked the disease with characteristic changes in the pancreas seen at autopsy. As this was difficult to reproduce in animals, many scientists disputed the pancreas’ role in the disease. When they removed the pancreas from dogs, cats, and pigs, the animals became diabetic. But their symptoms led researchers to conjecture that diabetes was a liver disease, throwing diabetes research off track for decades. In 1922, outraged scientists spoke out against the animal experiments that many were claiming had proven the existence of insulin. They pointed out that human autopsy had in fact shown the pancreas to be the vital organ in diabetes, and that in vitro research had isolated insulin – not animal experiments.

Scientists later modified the in vitro process they had used to isolate insulin, successfully mass-producing pig and cattle insulin reaped in slaughterhouses. This animal-derived insulin indeed saved lives, but not without complications. It also created allergic reactions and exposed patients to serious health risks. Had they recognised these dangers, scientists would have hastened to develop human insulin.

Insulin is only a treatment for diabetes, not a cure. The exact biochemical process through which insulin regulates blood sugar is yet to be discovered. If the funds devoted to studies had gone to human research, would we still have this disease?

How will we combat AIDS without animal experimentation?

Over the last 20 years, billions have been spent fruitlessly trying to infect animals with AIDS. Given the inability to produce an adequate animal model, it is foolish to assume that animal experimentation will lead us to a cure. Many in the AIDS community – with their lives on the line – actively demonstrate against animal experiments as a waste of precious time and money.

Blood from those infected with HIV remains our most illuminating research material to date. Humans who do not progress from HIV to AIDS offer excellent insight to possible ways of countermanding the disease.

Through epidemiology and in vitro research, scientists have already isolated the human gene believed responsible for their immunity. Though proponents of animal testing claim AZT and other preventative medications for AIDS were developed through animal research, existing human data and computers were in fact responsible.

AIDS kills humans at the cellular level, so that is where it needs to be studied. Mindlessly investing valuable research funding in animal experiments only keeps AIDS patients ill.

Aidsvax was tested on 8,000 high-risk volunteers because it protected chimpanzees from HIV infection. Unfortunately for the volunteers, it afforded them no protection whatsoever.

If not with animals, how can we ever hope to cure cancer?

Cancer is the number one cause of death in Canada. One major reason we have not yet stemmed mortality from cancer is this: animal cancer is not the same as human cancer.

Cancer is not one disease. It is many. In humans, there are over 200 different forms of cancer afflicting different organs, tissues, and cells. Though comparable animal organs, tissues, and cells may become cancerous, the cancers are newer identical to human carcinomas.

Given substances are not necessarily carcinogenic to all species. Studies show that 46% of chemicals found to be carcinogenic in rats were not carcinogenic in mice. If species as closely related as mice to rats do not even contract cancer similarly, it’s not surprising that 19 out of 20 compounds that are safe for humans caused cancer in animals.

The US National Cancer Institute treated mice growing 48 different “human” cancers with a dozen different drugs proven successful in humans, and in 30 of the cases, the drugs were useless in mice. Almost two-thirds of the mouse models were wrong. Animal experimentation is not scientific because it is not predictive.

The US National Cancer Institute also undertook a 25 year screening programme, testing 40,000 plant species on animals for anti-tumor activity. Out of the outrageously expensive research, many positive results surfaced in animal models, but not a single benefit emerged for humans. As a result, the NCI now uses human cancer cells for cytotoxic screening.

Dr. Richard Klausner, as director of the US National Cancer Institute, plainly states:“The history of cancer research has been a history of curing cancer in the mouse… We have cured mice of cancer for decades – and it simply didn’t work in humans.”

Have primates been better models for human disease?

The major experimental use of primates is for safety testing of medicines, yet primates’ track record at predicting drugs’ dangerous side effects is abysmal. Many drugs that were safe for primates have gone on to injure or kill people. For example, the arthritis drug Vioxx, which was withdrawn in 2004, killed up to 140,000 people after being “proved safe” in primates.

The second major use of primates is for brain research, however the most dramatic differences between humans and other primates are in the brain. Human brains can now be studied non-invasively using remarkable high-tech scanners. These enable the conscious brain to be observed while engaged in a variety of cognitive tasks of which monkeys are not even capable. In fact, everything we know about neurological diseases such as Alzheimer’s and Parkinson’s has been learned from studying patients, their families and their tissues. Hundreds of drugs for stroke have been developed and tested in primates and other animals, yet all of them have failed and even harmed patients in trials.

While primates are used extensively in infectious disease research, even chimpanzees, our closest living relative, are immune to the human AIDS virus, Hepatitis B and C, malaria and many other serious human pathogens. It is futile to study infections in animals that do not contract them in any similar way. Indeed, the US government redirected $10 million of AIDS research funding away from chimpanzee studies after concluding they are a “deficient model”. Eighty AIDS vaccines have failed in human trials following success in primates. Again, everything we know about HIV and AIDS has been learned by studying people, through epidemiology and in vitro research on human blood cells. In the French blood scandal in the 1980s, thousands of people contracted HIV through contaminated blood – given to patients because it was safe in chimps. The polio vaccine was delayed for decades by the erroneous conception of the nature of the human disease based on misleading experimental models of the disease in monkeys’ according to Albert Sabin MD, the vaccine’s inventor.

Adapted from the booklet ‘Safer Medicines Campaign’, which can be downloaded by clicking the image below.