I was just reading about the animal testing for stem-cell research in fighting Parkinson's disease. It shows a lot of promise, but it got me thinking about certain groups that oppose animal testing, and their logic (or lack thereof).
One of the big arguments used against animal testing is that Thalidomide was not found to cause birth defects during the testing process. That is completely true. Usually, the argument continues that the reason Thalidomide was approved by the FDA was because the animals used in testing were so dissimilar to humans that the animal testing indicated that Thalidomide was perfectly safe when used to prevent 'morning sickness.' Let's examine that claim.
First of all, Thalidomide was not developed as a 'morning sickness' pill. It was developed as a sleeping aid. It was tested as such.
Secondly, as far as the animals being too dissimilar to human beings, after the animal testing is completed, there is at least one round of 'human trials' before a drug can be brought to market (in both the US and the UK). So why didn't the UK human trials result in birth defects? Because they never tested it on pregnant women (or animals, for that matter). Some women who were prescribed Thalidomide became pregnant and continued to take the drug (after all, they didn't know that they shouldn't). Part of the problem was that Thalidomide really was an effective 'morning sickness' pill. When women found out that they were pregnant, and hadn't suffered from the usual nausea in the AM, word got around. Now, I don't pretend to know what British law says on the subject, but in the US, if a product has been tested safe, and then it is determined that said product is also effective in treating other ailments, it does not have to go through clinical trials again. Most of the time, this is reasonable. Minoxidil was a blood-pressure medicine that was also found to be effective, in some instances, for treating male-pattern baldness. In the case of Thalidomide, this was not reasonable. As it turns out, the pill cured 'morning sickness' by radically altering the developmental cycle of the fetus--causing birth defects. After word got around that these birth defects were happening, the researchers went back and test it on pregnant animals. Guess what happened? Birth defects.
Thirdly, The FDA did not approve it. There were two reasons for this: 1) the clinical trials indicated that although the drug caused no side effects in animals, it also did not make them sleepy (the fact that a drug was being marketed that had undergone animal testing but did not have the desired effect on animals raised a red flag), and 2) it had not been tested on pregnant subjects . The UK National Health Services approved it, as did the equivalent agencies in several other European countries.
For what it's worth, it was not actually FDA policy at the time to insist on pharmaceutical testing using pregnant subjects, but the doctor that was assigned to the Thalidomide case, Dr. Frances Oldham Kelsey, had studied Quinine in the 40's (Quinine is a drug used to treat malaria that has also been known to cause birth defects when taken by pregnant women). FDA policy changed on October 10th, 1962, when President Kennedy signed a bill extending the powers of the FDA and requiring more rigorous testing--thanks to Thalidomide.
I believe in animal testing--at least, as a precursor to human testing. I do think that sometimes lab animals get mistreated, and I think that is wrong. I mean, think about it, if you're testing to see if Rhyzomapan is safe, but then you're mistreating the lab animals, and they all die; is Rhyzomapan the problem, or is it just the way the animals are being treated?
No comments:
Post a Comment