What links a Basil Fawlty filming location with the town of Rennes in France?
This sounds like the start of a joke, but sadly it is anything but. The scene where Sybil Fawlty goes to hospital was filmed at Northwick Park Hospital in London. Northwick Park is where in 2006, 6 healthy young men developed symptoms of major organ failure shortly after taking the new drug TGN1412 in a clinical trial.
Rennes is the scene of the latest clinical trial disaster. I offer my sincerest sympathies to the families of the 5 men so horribly affected in France. One man is reported to be brain dead and the others may suffer permanent damage. A true tragedy.
While there are some differences between the Northwick Six and the Rennes Five, what they share in common is that before they reached this clinical trials stage they were comprehensively tested on animals in laboratories. And were found to be safe and effective. What does this tell us?
The Drug Trials Process
Before a drug is tested on humans, it goes through laboratory and animal testing. Medicines are also tested for toxicity before being given to people* MHRA
Then there are four phases of drug testing in humans. The volunteers in both these shocking cases were involved in Phase 1
Phase I – studies, on a small number of healthy volunteers, to understand what effects a new medicine has on human subjects – what happens to the compound in the body from the time it is swallowed or injected until it is excreted. Study participants are monitored for side effects. Medicines & Healthcare products Regulatory Agency
*Interesting to note that MHRA do not specify that toxicity testing is on animals. But it is. While people obviously have a vague awareness that ‘laboratory animals’ are used to test drugs (the phrase ‘laboratory animals’ is helpful in distancing them from how people normally relate to animals like pet cats and dogs in their immediate sphere) if you were to tell your neighbour, for instance, that someone was routinely administering poison to a dog, your neighbour would be shocked beyond measure and rush to call the RSPCA.
There are certain differences between the Northwick Six and the Rennes Five in the details of the way the respective drugs were administered, but what they have in common is that before they could reach the clinical trials stage they were comprehensively tested on animals in laboratories. And were found to be safe and effective. What does this tell us?
How It All Began
Drug testing in animals began with the Diethylene glycol tragedy in 1937 when many people died after taking sulfa drugs to which it had been added. When it was fed to animals it was found that they too were sensitive to the chemical. And animal testing was born. NAVS
Each year inside British laboratories, around 4 million animals are experimented on. Every 8 seconds, one animal dies. Cats, dogs, #rats, #mice, #guineapigs, #rabbits, #primates and other animals are used to test new products, to study human disease and in the development of new drugs. Animal Aid
In the US the testing of just one substance alone, be it a potential drug or toxic chemical, can involve using up to 800 animals and cost over $6 million. NEAVS
The UK government is supposedly committed to the Three Rs but millions of animals continue to suffer. The Three Rs are:
- Replacement: methods which avoid or replace the use of animals in research
- Reduction: use of methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.
- Refinement: use of methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals used. More information
In spite of the unthinkable suffering of animals in their millions,
the existing approaches to safety testing in the preclinical phases of drug development are not reliable enough to identify potential toxic liabilities for humans. In addition, regulatory agencies and the pharmaceutical industry understand that the present “gold standard” of animal testing is not the answer, as rodent testing is about 50 percent predictive of human toxicology. A study which examined six drugs already known to cause certain side effects in humans, determined that animals correctly predicted 22 side effects, but incorrectly identified 48 side effects that did not occur in humans, and missed 20 side effects that did occur in humans. This means that the animal models were incorrect 68 out of 90 times (76% of the time) NAVS
Animals respond differently and unpredictably. Animal-based (in vivo) toxicity testing, which causes severe suffering, distress, and death for the animals used, is typically performed without anesthesia or analgesics and is of questionable, if any, scientific value. Dr. Gerhard Zbinden, one of the world’s leading toxicologists, once described a standard in vivo test as little more than “a ritual mass execution of animals.” NEAVS
Animal Aid spells it out in plain English
[animal] experiments are bad science… : they do not produce information that can be reliably applied to people.
Yesterday we were reminded of this horrible truth.