It's time to test the testers

Over-reliance on the accuracy of animal testing is dangerously
misleading and puts human life at risk, writes Kathy Archibald

Friday May 5, 2006

In her article People power, Sophie Petit-Zeman falsely equates
the whole of medical research with animal experimentation and
misrepresents animal testing opponents as "anti-science".

As a geneticist who has worked in pharmaceutical development,
I share the conviction that medical research is vital. I have
medicines and surgery to thank for saving my life many times
but I am grateful to the doctors and patients who went before
me: not to animals.

All of our current drugs and treatments were discovered through
astute observation of patients, pioneering self-experimentation,
ingenuity and advances in technology. Aspirin, the world's most
common medicine, owes nothing to animals: nor do antibiotics,
anaesthetics, Aids drugs, antidepressants - the list goes on.

How is the public supposed to judge whether animal research
is essential when all they hear are unsubstantiated claims like:
"Some of the major advances in the last century would have
been impossible without animal research". The Advertising
Standards Authority recently ruled that this assertion, made
by the Association of Medical Research Charities, was
misleading and should not be repeated, yet it is the very
mantra of pro-vivisectionists.

This issue must be judged on facts. Take drug testing: the
evidence to date shows that animal tests predict fewer
side-effects than a coin toss. This is why nine out of 10
drugs that pass animal tests fail in human trials; injuring and
sometimes killing the volunteers.

The recent drug trial fiasco in London provides stark new
evidence of the futility of testing new drugs for safety in
animals: the six unfortunate men were reassured that
TGN1412 was safe because it was safe in monkeys.

Further examples abound of drug catastrophes where many
people have been killed despite extensive "proof" from
animal tests that the drug was safe. Arthritis drug Vioxx,
withdrawn from the global market in 2004, appeared safe
and even beneficial to the heart in animal tests, but caused
as many as 320,000 heart attacks and strokes in people - as
many as 140,000 of them fatal. The associate safety director
of the US Food and Drug Administration (FDA) described
it as the "single greatest drug-safety catastrophe in the
history of the world."

Side effects of prescription medicines - all tested for safety
on animals before they can be administered to humans - are
now the fourth biggest killer in the western world.

Animal tests are failing to protect us and the government is
failing to learn from disaster after disaster. Maybe this time,
because false reassurances of safety in monkeys were so
clearly responsible for the TGN1412 calamity, the call for
scrutiny of animal tests will be heeded at last. Even the
Handbook of Laboratory Animal Science admits that
"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."

Animal research misleads in other ways too; hampering our
understanding of human disease. Former director of the US
National Cancer Institute (NCI) Richard Klausner lamented:
"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."

The NCI also believes we have lost cures for cancer because
they were ineffective in mice. Cigarette smoke, asbestos,
arsenic and benzene are all safe to ingest, according to animal
studies. Conversely, of 20 compounds known not to cause
cancer in humans, 19 do cause cancer in rodents. Seven
hundred drugs to treat strokes have been found safe and
effective in animal studies. Of the 150 tried so far on patients
in clinical trials, not a single one is safe and effective. Thirty
Aids vaccines have likewise failed in clinical trials after
successful studies in primates.

There is no getting away from the fact that people have to
be the ultimate guinea pigs for testing new treatments.
Clearly, the health and safety of research volunteers and
patients should be paramount and the best pre-clinical
safeguards should be in place to protect them.

New drugs go through three basic testing phases: in vitro
(test-tube) and in silico (computer) modelling; animal
testing; and, finally, human trials. Before a drug is tested
in humans, there should be persuasive evidence that it is
safe and effective. No method - animal, human or test-tube,
can predict the reactions of every patient with 100% accuracy.

Reactions differ between sexes, ages and ethnic groups,
which is why clinical trials should be more representative
of the general population. We are all different, but not as
different from each other as we are from animals.
Non-animal methods are not completely fail-safe, but do
offer more security.

Currently, 92% of new drugs fail in clinical trials. This
means that volunteers in the trials suffer unexpected side
effects, which can be serious and even fatal. According
to Drug Discovery World in 2002, this is largely because
"the animal data were poor predictors of efficacy in the
human subject."

It has been known among scientists and the pharmaceutical
industry for decades that animal testing is scientifically
unreliable. As long ago as 1962 The Lancet commented:
"We must face the fact that the most careful tests of a new
drug's effects on animals may tell us little of its effect in
humans." In 1964 James Gallagher, the medical director of
Lederle Laboratories, admitted: "Animal studies are done
for legal reasons and not for scientific reasons. The
predictive value of such studies for man is often meaningless."

So, pharmaceutical companies conduct animal tests simply
to satisfy government regulators. Crucially, animal data
provides liability protection when drugs kill or injure people
- and has allowed pharmaceutical companies to avoid the
expense of conducting clinical trials as extensively as they
should.

In 1984, Professors Lawrence, McLean and Weatherall
observed: "The methods of assessing toxicity in animals
are largely empirical and unvalidated ... It is urgently
necessary to know whether the tests as in fact conducted
have sufficient predictive value to be justifiable, or whether
they are a colossal waste of resources to no good purpose..."

Since then, evidence has mounted that animal tests are
inadequate for the task they are supposed to perform but -
incredibly - this has never been systematically investigated.
In light of recent drug disasters, the only responsible course
of action is to evaluate animal testing scientifically, in an
independent and transparent manner.

· Kathy Archibald is the director of Europeans for Medical
Progress, a patient safety group that is calling for an
evaluation of animal testing. Add your support here.
http://www.curedisease.net/edmform.shtml

http://education.guardian.co.uk/higher/comment/story/0,,1767632,00.html

Special report: The business of research
http://education.guardian.co.uk/businessofresearch/0,,481464,00.html