Once upon a time, the medication BoTox (made by a company called Allergan) was tested for its potency, on a batch by batch basis, in living animals. This medication, which is really a protein derived from bacteria, has many important therapeutic purposes. For example, it has been shown to be very effective in the treatment of chronic migraine headaches – a condition that can have disabling effects on those who suffer from it. It is used to treat disorders in which people sweat profusely (hyperhidrosis) or have overactive bladders, both of which affect people’s qualities of life by impairing normal social functioning. It has also been used in the treatment of motor disorders like spasticity and dystonia, preventing the irregular and disruptive involuntary movements that are found in these disorders, thereby reducing the physical pain that is so often a consequence of them. Of course, it has also been used for aesthetic reasons, an arguably less compelling medical use.
Because the potency of individual batches of BoTox produced vary, the Food and Drug Administration (FDA) in the United States required Allergan to test each batch on live animals. For each batch, studies were conducted in which the amount of BoTox that was required to produce a specific toxic effect was evaluated in live animals, and the dose was adjusted to ensure that the potency of the drug across batches could be accounted for (roughly, if the batch was half as potent, this can be accounted for by giving twice the dose, ensuring that clinical effects were stable over time). This testing involved a lot of animals, mostly mice.
However, earlier this summer, the FDA changed its mind. It was approached by an organization that had – at considerable expense – developed a test that could determine BoTox potency just as well as the animal tests – but without involving live animals. The test is conducted on cells in a dish.
The organization spent millions of dollars to develop the test and to petition the FDA to consider this replacement for live animal use based upon its empirical results. They were successful.
Who was this organization? Was it the Humane Society of the United States? Perhaps it was People for the Ethical Treatment of Animals, or the Physicians Committee for Responsible Medicine?
It was none of these. Indeed, since none of these organizations spend their operating budgets on the laboratory research that is required to develop alternatives to live animal studies, it couldn’t have been any of them.
So, who accomplished this? It was Allergan itself. Biomedical researchers at the company who used animals in their tests became determined to find a model system that could replace living animals, and they didn’t stop until they found one. They did this though it came at a huge expense to the company. They were committed to producing medicines that people need and to use the fewest animals in the process, and they accomplished that. As the Allergen press release notes, there have been several attempts, using a variety of methods, over the past two decades to develop a replacement for the LD50 test, but until now all these have fallen short. A report from a 2008 scientific workshop convened by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program Interagency Program for the Evaluation of Alternative Toxicological Methods (NICEATM) provides a good overview of many of the challenges involved in delevoling a replacement for the LD50 test, and the different approaches used to address them.
As always, the alternatives that exist for animal use in biomedical science came from the very scientists who are otherwise roundly criticized by the anti-animal research movement. Maybe the irony is lost on organizations like PCRM, HSUS and PeTA, but not on us. At UCLA, our administration has instituted a funding program that provides seed funding to scientists to promote work on refinement, reduction and replacement. What have the leading anti-research groups done? Nothing, but complain. Perhaps instead of criticizing scientists, these organizations should join with us in attempting to discover alternatives and reduce animal use.