Safer Medicines - putting patient safety first

Putting patient safety first

Frequently Asked Questions

These consider some of the issues relating to the use of animals in biomedical research:

Surely there is evidence that animal research is useful for human medicine?

But animal research must lead to cures for humans?

But I am always hearing about new breakthroughs as a result of animal research

At least animal research must be conducted to the highest scientific standards?

Do animal researchers report their findings fairly?

Would drugs be safe for us if they were not first tested on animals?

Humans are animals, so what’s the problem?

How can we hope to cure cancer without animal research?

How can we know that medicines will not cause birth defects without testing them on animals?

Wasn’t animal research responsible for the polio vaccine and other major medical and scientific advances?

Don’t all doctors support the concept of animal research?

Why does animal research continue?

Aren’t the 3Rs the best way to phase out animal research?

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

  • In vitro (test tube) research has been instrumental in many great scientific and medical advances. For example the discovery of antibiotics, the structure of DNA, and the development of many of the vaccines we use today.
  • Epidemiology (research into the causes of health and illness in populations) has revealed that folic acid deficiency causes birth defects, tobacco smoking causes lung cancer, lead damages children’s brains and social inequality leads to ill-health.
  • Post-mortem studies have been used for centuries to further understanding of the human body and have led to many clinical benefits, including advances in congenital heart disease. Post mortem studies remain an excellent way of studying the effects of a disease on the whole body.
  • Clinical studies: well-designed clinical trials are able to establish whether current practice is actually the best option. Some practices have been shown in clinical trials to cause more harm than benefit, e.g. the use of corticosteroids after brain injury.
  • Human tissue is vital in the study of human disease and drug testing (animal tissue differs from human tissue in crucial ways). Human tissue is used for a range of different purposes, including understanding disease progression, developing diagnostic and screening tests, and testing the effects of drugs. Tissue banks store human tissue for use in research, e.g. tissue from people with certain diseases, or from different parts of the body.
  • Human stem cells: the generation of human induced pluripotent stem cells (iPSC) has been an important breakthrough. iPSC possess the genetic background of individuals so can be used to create disease- or patient-specific models, such as ‘organoids’.
  • Organoids are simplified in vitro versions of organs, capable of modelling some specific function of that organ (Lancaster and Knoblich 2014).
  • Organs on chips are micro physiological systems that enable basic biological processes to be studied and the effects of drugs to be investigated. By identifying safety and efficacy issues earlier in the drug development process they may enable the selection of drug candidates that are more likely to succeed in human clinical trials. The US is making significant investments in organ-on-chip technologies (Marshall et al 2018).
  • In silico (computer) approaches and mathematical modelling are now being used to better understand the complex chain of processes that occur when a chemical enters the human body, allowing a better understanding of how toxicity is expressed in the body. In an in silico ‘drug trial’ the computer model predicted the risk of human drug-induced heart arrhythmias with 89% accuracy, compared with animal studies that showed up to 75% accuracy (Passini et al 2017). In another example, in which the world’s largest machine-readable toxicological database was used to predict the toxicity of new chemicals, it clearly outperformed animal tests (Luechtefeld et al 2018).
  • Imaging technologies: magnetic resonance imaging (MRI), functional MRI (fMRI), positron emission tomography (PET) and other imaging technologies are now able to offer a view of the human body that cannot be gained by studying animals.
  • Microdosing is a process whereby drugs are administered in doses small enough to be safe, but large enough for the cellular response to be studied, enabling potential new drugs to be safely tested in humans. All new drugs are eventually tested on humans but new microdosing techniques can be used to achieve this more safely.
  • Post-marketing drug surveillance is the practice of monitoring drugs after they have been marketed. Potentially this can help to identify any unexpected adverse drug reactions much sooner.
  • Prevention is always more effective than cure. It is estimated for example, that 90% of stroke risk factors are modifiable through lifestyle changes (O’Donnell et al 2016).

Replacing the animal model is not about finding a one-to-one ‘alternative’ to every procedure that involves animals, it is about a completely new approach to research that is committed to using the best and most physiologically relevant research methods for investigating human health and illness.

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