Animal Studies Paint Misleading Picture

27/08/2013

Animal Studies Paint Misleading Picture

Maneka Sanjay Gandhi

(Bihar Times) When I was young, every school had to cut up animals to learn biology. Years later, the education system realized that cutting animals harmed the child. So schools were ordered to stop it.

Zoology dissection has been stopped by order of the UGC. Even medical colleges have realized that cutting animals by undergraduate students makes no sense and are planning to stop it. Pharmacy and dental colleges have already stopped it. In a few years dissection will become a horrible memory.

Now come to the so called research for a great medical breakthrough. India just has one patent. But millions of animals have been killed by so called researchers. In fact, after all the killing and their monthly salary, few even write up the experiments on animals. The premier Medical Journal Lancet says that only 2% of research in India is written up and submitted for review.

Indian researchers are not the only fakers in the field.

Every few days I see some new headline in the paper about a new cure for cancer. When I read the article it says that some breakthrough has been made when testing animals. Months later the “breakthrough” has failed in clinical trials on humans and is abandoned. The researchers get their grants and after a few days another study will start. Lakhs of animals are dead but 90% of the researchers achieve nothing.

And they cannot. Animal testing leads nowhere. Can a test on a human be applicable to a rat? No. So why should medicines that work on rats be applicable to humans?

My scepticism is borne out by an amazing 2010 University of Edinburgh study which has found that published animal trials tend to overestimate the likelihood that a medical treatment will work by about 30% or more.

Researchers suggest that the main cause for this is because negative results during animal trials often go unpublished.

Based on analysis of 525 “breakthrough” studies on strokes including 1,359 experiments and 16 different treatments, researchers found that only about a third of these results were even reproducible in human trials. A major overstatement of efficiency has become par for the course.

Why are researchers telling lies?

Researchers suffer from “Publication Bias”. They know that negative or neutral results are not interesting enough to be published or talked about. However when positive results are obtained from an animal trial they will get published - in journals, review articles, textbooks, courses - leading to fame for the researcher amongst his peers and making his viewpoint the “truth”. But if data is not published because it is negative or differs substantially from published work, then the researcher has to find something else to do.

The Study reported that only 10 publications (2%) printed research that was negative. Only 6 had reports that did not make some significant new claim. 214 experiments apart from the 1359 which found negative findings in the same area were not printed at all.

Non-publication of data raises ethical concerns, first because the animals used have not contributed to the sum of human knowledge, and second because participants in clinical trials may be put at unnecessary risk if efficacy in animals has been overstated. But because the truth is hidden, animal testing continues in the life sciences and medical research. If researchers knew the truth – that a great deal of research fails because of the animal models used – then they would look for alternatives. We may even find the actual cures for diseases like cancer that we are pretending to treat now.

The impact of publication bias in basic research has not previously been quantified. The Edinburgh research has for the first time shown that publication bias is prevalent in reports of laboratory-based research in animal models to the extent that as many as one in seven experiments remain unpublished and reviews of the results of interventions in animals overstate their efficacy by around one third.

Misleading or one sided research data can go on compounding the problem, leading new researchers down the garden path as they attempt to build on already published data. Let me explain it simply:

Ten experiments take place that say colouring a rat’s ears can cure cancer. Nine say that it has no effect on the disease at all. None of these nine experiments are published. But the tenth which says that colouring the ears of a rat MAY have some effect on cancer will be published as a “breakthrough”. New researchers only see this one published article. So they get put in years trying to find out which other ear colours could cure cancer. If they had read the unpublished works they would have abandoned this line of research altogether instead of further unnecessary animal experiments testing poorly founded theories.

Some safeguards are built into the system of information dissemination by making a published article open to review. But it is a hit and miss method with “experts” using review articles to emphasise their own particular perspective and again without digging into the data that has NOT been published.

This is what the Edinburgh researchers say “ If experiments have been conducted but are not available to reviewers, as they are not the same as results from experiments that were published, then reviews, and the resulting expert opinion and public understanding, will be biased. This is the “file drawer problem”: at its most extreme, the 95% of studies that were neutral and reported no significant effects remain in the files of the investigators, while the 5% of experiments that were falsely positive are published, and reviewers conclude—falsely—that the literature represents biological truth.”

If publication bias did not exist, at least one-third of animal-based experiments would have shown different results. In fact the Study says “We think that the present study is more likely to underestimate than to overestimate the effect of publication bias.”

What are the reasons that researchers look for “positive hyped results, no matter what the truth is:

1. First, there is likely to be more enthusiasm amongst scientists, journal editors, and the funders of research for positive rather than for neutral studies.

2. The majority of animal based studies use only a few animals. Neutral studies therefore seldom have the statistical power confidently to exclude an effect that would be considered of biological significance, so they are less likely to be published than are similarly underpowered “positive” studies.

How many animals were killed in those 214 experiments that were never reported? 3,600.

What is the solution to this? A central register of experiments involving animals should be made so that anyone entering the field can access the number of experiments grouped along a broad subject. In England www.clinicaltrials.gov logs all clinical trials before they begin.

The value of animal experiments for predicting the effectiveness of treatment strategies in clinical trials has remained controversial. Animal experiments may contribute to our understanding of mechanisms of disease, but their value in predicting the effectiveness of treatment strategies is extremely limited. Less than 10% even translate into clinical trials on humans. I could give you a list of thousands of medicines that worked in animals and failed in humans.

The purpose of the Edinburgh study was to convince scientists and journals to publish rigorously conducted negative studies as well. If we publish all the times that experiments on animals have failed, we might get researchers to go to the track of serious science instead of wasting time.

To join the animal welfare movement contact gandhim@nic.in

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