ASA Non-broadcast Adjudication: Europeans for Medical Advancement

Complaint

The Association of Medical Research Charities and Research Defence Society Ltd objected to a leaflet, for a pressure group opposed to medical research on animals, that was headed "Our children's health - too important to gamble with? We think so ...". The text continued "Reliance on animal experimentation amounts to gambling with our children's health. Time and time again, misleading results from animal experimentation have proved tragic or fatal when applied to children and babies. And there are much better options!" Under the sub-heading "Cancer", the leaflet claimed "Treatment of childhood leukaemia has also improved dramatically, thanks entirely to ingenious research on cell and tissue cultures - not to animal experiments ... The biggest obstacle in the search for cures for cancer and many other diseases of childhood is our irrational dependence on animal experimentation, which has cost far too many thousands of lives." Below that, the leaflet listed medical research methods that did not involve animals, with comments on how those methods had been or could be applied, and claimed "... children (and adults) are dying every day because precious funding is wasted on studying animals ...". The back of the leaflet claimed "Europeans For Medical Advancement seeks to advance the knowledge necessary to prevent and cure human disease. We support mainstream science-based medical research and medical care. We oppose animal experimentation because it directly harms humans and because it diverts funds from useful research methods."

The Association of Medical Research Charities challenged the claims:

1. "Treatment of childhood leukaemia has also improved dramatically, thanks entirely to ingenious research on cell and tissue cultures - not to animal experiments" and

2. "The biggest obstacle in the search for cures for cancer and many other diseases of childhood is our irrational dependence on animal experimentation, which has cost far too many thousands of lives".

Research Defence Society Ltd challenged the claims:

3. "Time and time again, misleading results from animal experimentation have proved tragic or fatal when applied to children and babies";

4. "... children (and adults) are dying every day because precious funding is wasted on studying animals ..." and

5. "We oppose animal experimentation because it directly harms humans and because it diverts funds from useful research methods", because they believed the implication that animal experimentation directly harmed humans was misleading.

CAP Code (Edition 11)

Adjudication

1. Complaint upheld

Europeans for Medical Advancement (EMA) explained why they believed the improvements that had been made in the treatment of childhood leukaemia did not depend on animal research, citing examples from the 1940s and 1950s. They quoted Dr Alexander Haddow, who stated in an interview in the British Medical Journal in 1950 that the effect of urethane on leukaemia in humans might not have been discovered if researchers had investigated animal leukaemia alone. They asserted that the leukaemia treatment Glivec had been discovered entirely through in vitro (test tube) research.

We considered that the claim implied recent improvements in the treatment of childhood leukaemia had been achieved entirely without animal research. We considered that readers were unlikely to regard the research conducted in the 1940s and 1950s to be recent improvements. We noted Glivec was a recent treatment for chronic myeloid leukaemia, which principally affected adults and was a rare form of leukaemia in children. We also noted animal research had been carried out in the course of the development of Glivec. We concluded that the advertisers had not shown that recent improvements in the treatment of childhood leukaemia had been achieved entirely without animal research and told them to amend the claim.

2. Complaint upheld

EMA quoted from The Handbook of Laboratory Animal Science, which stated "Uncritical reliance on the results of animal tests can be dangerously misleading and has cost the health and lives of tens of thousands of humans". They said substances that caused cancer in one species might not cause the same kind of cancer in another species. They said substances that had been found to treat cancer in animals safely and effectively had later been found to be too toxic or ineffective to be used in humans. They said one cancer research institute now used human cancer cell lines to screen cytotoxic drugs, to ensure it did not research substances that could not be used to treat cancer in humans. They sent 19 quotations, from newspapers and scientific journals, that supported their view that animal models were inadequate for the study of human cancer, including quotations from the Director of the US National Cancer Institute. They gave 50 examples in which they believed the use of animal research had directly or indirectly harmed humans.

EMA said a 10-year study begun by the United States Food and Drug Administration (FDA) in 1976 found that 52% of the new medications included in the study were recalled or relabelled because of side-effects that had not been discovered by tests on animals; they asserted that another study, of six drugs, had found that animal testing had correctly predicted 22 known side-effects, failed to predict another 20 side-effects and wrongly predicted 48-side effects. They also asserted that recent research had found that one in five new drugs was relabelled or recalled because of serious adverse reactions, despite testing on animals. They argued that animal testing harmed humans, because resources were wasted testing therapies that were not effective for humans and because patients were harmed by unpredicted adverse reactions. They drew attention to relevant chapters from the books "Golden Geese and Sacred Cows" and "Specious Science", by the founders of EMA.

We accepted EMA had shown the results of animal research often did not help to accurately predict the effects of substances on humans; some substances had adverse effects on humans but not animals, and vice versa. We acknowledged that some people had died because animal tests had not identified dangers to humans. We considered, however, that researchers did not rely on animal tests to accurately predict side effects in humans: adverse effects on humans were identified in clinical trials and animal tests were used to predict side effects only to the extent that research would not proceed to clinical trial if animal tests suggested that the substance was likely to be toxic. We noted much of the evidence, particularly the 50 examples, concerned substances that had also been tested on isolated cells and tissues and on humans in clinical trials; animal tests might well have failed to predict adverse side-effects that resulted from the widespread use of those substances, but so had those other techniques.

Although the claim appeared in a strongly-worded campaigning leaflet, it was presented as fact, not opinion. We considered that, while the very large amount of evidence presented by the advertisers demonstrated short-comings of animal research, it reflected only one side of a hotly debated issue; it did not, for example, cover cases where animal testing had proved useful in the development of treatments. We considered that citing specific cases where animal tests had proved misleading or unhelpful did not, in itself, show that the general approach was misconceived, as implied by the claim.

We considered that EMA were entitled to express their opinion about animal testing, but that they had not shown that animal research was "the biggest obstacle in the search for cures ...", given the many other obstacles faced by researchers developing treatments. Moreover, proving it had "cost far too many thousands of lives" would require them to demonstrate the overall net effect of animal testing was many thousands of deaths; an almost impossible task that we considered they had not met. We concluded that the claim was too strongly worded and told EMA to present it as opinion, not fact; we urged them to consult the CAP Copy Advice team for help doing that.

3., 4. & 5. Complaint upheld

EMA referred us to the evidence they had submitted in response to Complaint 2, including the quote from the Handbook of Laboratory Animal Science that "uncritical reliance on the results of animal tests can be dangerously misleading and has cost the health and lives of tens of thousands". In addition, they provided further examples that they believed illustrated how people had been harmed because of animal experimentation.

We noted the further examples consisted of quotes from a variety of sources, including news media and medical journals, that discussed the limitations of animal testing or the inadequacy of funding for clinical research.

We again noted the claims were presented as fact not opinion and acknowledged the very large amount of evidence presented by EMA that assessed the short-comings of animal research. We considered that the claims were very strongly worded: they went further than asserting the failure of animal research to, for example, accurately predict adverse side-effects, instead implying animal research had been shown, "time and time again", to have been solely responsible for tragic or fatal consequences to children, babies and adults and had indirectly caused deaths through the diversion of funds from alternative research methods.

We noted the quote from the Handbook referred to uncritical reliance on animal tests; it did not refer to the validity of animal research per se. We again accepted EMA had shown the results of animal research often did not help to accurately predict the effects of substances on humans and acknowledged that some people had died because animal tests had not identified dangers to humans, although we considered that the failure of animal tests to identify dangers was not the sole cause of death in those cases.

We noted the evidence for the diversion of funds consisted of evidence that less money was available for clinical research than might be available if animal research were disbanded. We considered that that evidence supported EMA's opinion that animal testing was a contributory factor affecting the level of funding available for human-based research, but not the presentation as fact of the funding situation having caused deaths. We also noted the claim referred to the diversion of funding from all other research methods, not just clinical research, and considered that the advertisers had not sent evidence to show that funds were diverted from other research methods into animal testing.

We considered that EMA had not proved the results of animal tests had been shown "time and time again" to have been solely responsible for tragic or fatal consequences to children, babies and adults or had indirectly caused deaths through the diversion of funds from alternative research methods.

We told EMA to amend the claims and again urged them to consult the CAP Copy Advice team.

The leaflet breached CAP Code clauses 3.1 and 3.2 (Substantiation) and 7.1 (Truthfulness).