How pharma is improving animal testing - European Medical Journal

How is pharma improving animal testing – and what do activists think?

3 Mins
EMJ GOLD
The pharmaceutical industry has been trying to refine, reduce and replace animal testing for some time, but animal rights activists argue progress is too incremental. Gains have been made, but what is the activists’ case for acceleration?
Words by Isabel O’Brien

If you put animal rights activists in a room with pharmaceutical researchers, you’d expect a few sparks to fly. The use of animals in scientific research has almost halved in the last decade, according to EFPIA, but is it moving fast enough for animal rights campaigners?

“The industry has always seen the welfare of animals as crucial to good science,” argues Kirsty Reid, Director, Science Policy, EFPIA, a body that plays a major role in shaping animal testing regulations and practices. But this view is not widely accepted or understood by animal rights activists such as Jarrod Bailey, Science Director, Animal Free Research UK, who says: “The pharmaceutical industry’s efforts in response to [this issue] has always appeared mixed and quite contradictory.”

While both groups agree that animals should not suffer for the benefit of human health, they have different priorities and goals. Pharma is primarily looking at ways to make trials more humane, whereas campaigners have a razor-sharp focus on eradication. 

Refine, reduce, replace

The ‘Three Rs’ are where the crux of the conflict lies. Standing for ‘refine, reduce and replace’, activists accept the pharma industry is becoming adept at refining and reducing animal testing, but argue it is struggling to truly make gains in replacing the practice entirely.   

“There have been positive, constructive conversations with individuals over the years who’ve been supportive of the Three Rs at the very least, or even replacement altogether,” says Bailey. “But on a more macro level, there have been corporate messaging and position statements that are consistently defensive of animal testing.” 

The industry has always seen the welfare of animals as crucial to good science 

While the EFPIA’s latest report on the industry’s progress is far from ‘defensive’, it certainly focuses on steps to refine and reduce animal testing rather than replacement. For example, the analysis recounts the ways in which researchers can adapt animals living quarters to be more comfortable and stimulating, as well as ways to reduce the number of invasive procedures required to take samples. 

“They may have mitigated some animal suffering at times, but they have also failed to significantly tackle – or may well even have exacerbated – the use of animals in drug development,” critiques Bailey. “This is because pursuing the Three Rs – unless there is a specific effort on replacement – tacitly accepts the premise of using animals and their role as accurate and reliable ‘models’ for human biology.” 

In response to the criticism of the Three Rs, the EFPIA reveals that it plans to use a new philosophy to shape its strategy going forward. Published in 2021 by philosophers David DeGrazia and Tom Beauchamp, ‘The Principles of Animal Research’ has been described as more comprehensive than the Three R methodology, especially as “they consider responsibility for the wellbeing and quality of life of the individual animal”, Reid explains. The six principles encourage researchers to weigh up the individual suffering of an animal against the expected net benefit. Only if the sum adds up can the test go ahead legally.  

Is animal testing effective?

Think of animal testing and its ethics will be the first aspect to jump to mind. Animals are ultimately unable to consent to being enrolled in a trial like humans can, but there is another key motivator for activists and researchers to find alternatives. 

“The reasons the pharmaceutical industry works towards limiting using animals, go beyond being ethically motivated,” explains Reid. “It is also due to an increase in new and evolving technologies, innovations and predictable methods, which, on one hand, aid in eliminating animal suffering and use, and on the other, provide better and more reliable data than animals.”  

What matters for all concerned is that this change happens, and that it happens as quickly as possible 

This is an area where researchers and campaigners agree – up to a point. Both sides accept that animal responses do not perfectly replicate human responses, but while the pharma industry still views these tests as highly scientifically relevant, campaigners like Bailey have a different take. “The evidential weight provided by animal tests of new human drugs is hugely insignificant,” he argues, “this is largely due to species differences in gene complement and gene expression”. The evidence that animal data is affected by the stress of the procedures is also noteworthy, adds Bailey.

Potential substitutes

While the pharma industry accepts the distinct genetic and enzymatic differences between humans and animals, it is somewhat bound by the fact technology has not yet reached the right level of sophistication to be used as a substitute. 

“Applying alternative methods may lead to significant reduction in animals used, however most of these methods are not yet able to fully replicate the complexity and reactions of a living organism, especially for systemic and chronic conditions,” explains Reid. However, there are few examples of advances that could signal more investment on the horizon.

This includes a research project that used a liver-on-a-chip approach (in which liver disease is modelled on an electronic chip) that was able to predict drug-induced liver injury. The inability to predict such injury is “a major single cause of drug failure in clinical trials – much better than poorly predictive animal tests”, argues Bailey. He adds that such in vitro solutions, which allow researchers to replicate the function of living tissues and organs, could save the pharma industry up to $3bn a year. Not a bad saving, but there are many hurdles to overcome first.

So, for now, the pharma industry is focused on reducing the number of redundant animal tests to a minimum. The development of analytical methods to replace animal testing is also a priority, but less advanced. Does this approach cut the mustard for animal right activists? No, but as Bailey notes: “What matters for all concerned is that this change happens, and that it happens as quickly as possible.”  

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