i’m sure they all have off shore accounts
I’m encouraged the GOP can actually win this if they keep passing bills to open select agencies ...
We’re asking the wrong question about people who are affected by the ‘shutdown’.
We should, in every case not involving justice and defense, ask if the Fed govt should be involved in that arena in the first place.
This article is difficult to comment on. Beginning with the opening statements about the FDA, and through the discussion about the stem cell treatment, the author does not seem very knowledgeable about the FDA’s function, or medical science.
I shudder to think what kinds of drugs would be sold for medicinal purposes if the FDA were not there to require that drug companies have to demonstrate efficacy and safety in order to be allowed to sell the drugs. I read horror stories of countries that do not have or enforce such regulatory mechanisms, where people die because they took something that some quack assured them would be curative. I just saw one yesterday, where some children in South America died from taking a counterfeit cough syrup. The idea that without the FDA, people would be able to decide for themselves what drugs would be safe and effective is not one that has ever been demonstrated in practice.
As for the company trying to get around the FDA approval process by using cells from patient’s own bodies—well, the hypothesis is sound, but where are their safety and efficacy studies? I looked at some articles on Google; I did not any mention of safety/efficacy studies, nor of any quality control protocols used before injecting the cells back into patients. The original cell samples may have come from the patients, but cells in culture, especially when subjected to selective pressures like drugs or hormones used in cell culture, can change drastically and unpredictably from their original genotype/phenotype. I would be extremely worried about alterations in the growth control mechanisms of these cells, since injecting cells with disregulated growth pathways can be disastrous for the patient receiving them. I’m going to have to agree with the FDA on this one—once the cells have been grown and manipulated in a lab, they are no longer an integral part of the patient’s cell population. Anyone wanting to inject such cells into patients really does need to demonstrate safety and efficacy before doing so.