Dogs have been everything we’ve ever needed them to be, including volunteers for clinical trials of drugs meant for both people and pooches. Sadly, these furry test subjects are sometimes euthanised at the end of these experiments, because it’s deemed the only way to get the accurate test results scientists are looking for. But the Food and Drug Administration is set to start a small — and safe! — study of dogs that might change that way of thinking.
One type of research that dogs are often euthanised for is the study of new antiparasitic drugs. Dogs are artificially infected with parasites, then given drugs to treat them. Because some of the molecules used in these drugs only affect the gut, and aren’t systemically absorbed by the body and bloodstream, it can be hard to confirm that the drug actually worked. So scientists will euthanize the dogs to physically examine their bodies for parasites.
These studies are often used as the gold standard by the FDA for approving new or generic drugs claimed to be at least as effective and safe as existing drugs (in this context, the studies are testing what scientists call a drug’s bioequivalence).
But the new planned study, according to a proposal released by the agency Friday, will see whether alternative methods of drug detection that simply rely on blood tests, can gauge a drug’s bioequivalence as accurately as the more gruesome method.
The study, as currently planned, will recruit 29 dogs. Before the experiment even begins, the dogs will be raised to be especially comfortable around people. Eventually they’ll move into the research facility, where the staff will spend time and play with them four to five times a day. Three months into the living arrangement, the dogs will be split off into three groups, with each group receiving a different type of pill. The pills will be made of a pair of common antiparasitic drugs, one that works locally and one that’s absorbed into the bloodstream. Over the course of nine months, the dogs will have their blood regularly taken and studied.
Because these drugs are so well-studied, we already know how they affect a dog’s body. Based on that data, the FDA’s scientists have created a model that basically uses the level of drug absorption in the blood from one drug (the widely absorbed one) to predict how the other drug (absorbed locally) is working. So it’s hoped this experiment will show that this model can be accurate in the real world, and how to better refine it if needs to be.
If successful, the FDA would then promote the model to be used by drug companies hoping to get approval for their generic drugs, greatly reducing the number of dogs that are both used in live trials and sadly euthanised.
“While we understand that in certain situations the use of animals in research is needed, we’re committed to exploring ways to help FDA scientists and product developers reduce reliance on this practice. This proposed study is a big part of that effort,” FDA chief Scott Gottlieb said in a statement announcing the study.
In recent years, as a part of a global movement to replace, reduce, and refine the use of animals in research, scientists have started to create their own computer modelling programs to take the place of animals, a method also known as “in silico” testing. Other have created less invasive diagnostic tests or even begun to rely on human-like organs in the lab that are lined onto microchips — methods that the FDA is reportedly using more often in its work.
The FDA will allow the public and interested parties to offer comment and suggestions on their proposal for the next 60 days, after which the study will likely begin to get underway. As for the brave dogs that would be used in this study, the FDA says they’ll be retired from their lab duties permanently after the experiment, and be given for adoption as pets.
[FDA]