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FDA Could Delay Adult Stem Cell Breakthroughs
destinyland writes "A Colorado medical advocate says, 'The FDA contends that if one cultures stem cells at all...then it's a prescription drug,' in arguing that revolutionary new treatments could be delayed by 20 years — even using cells extracted from your own body. According to the FDA, even therapies that simply re-inject your body's adult stem cells could be prohibited without five years of clinical trials and millions of dollars of research. How useful are cultured stem cells? 'In animal models, they routinely cure diabetes.'"
Heh.
But we just might want them telling drug companies that, yes, they do actually have to test for safety and efficacy before they start selling the stuff...
The private sector has the virtue of (mostly) being extremely responsive to competitive incentives. This is good when those incentives drive development. This is bad when those incentives drive obfuscation, misdirection, and the burial of inconvenient data. Consider the twisted tale of the "Australasian Journal of Bone and Joint Medicine" an entire sham scientific journal printed to order by Elsevier, for Merck.
Those are trade terms...
An animal model is a well characterized and well understood animal, often a very specific line of a given species, used as a model for a disease. You can't know that the results you're seeing are mappable to what would happen in a human if you haven't characterized your model yet. For example, to model a respiratory virus you need an animal that can be infected by it and exhibits similar pathology to humans. Chimps are not a good model for HIV as they don't develop AIDS, as another example.
Animal experimentation would apply to all sorts of things that might not be considered animal models.
The FDA simultaneously enforces standards of ethics and cleanliness that help prevent outbreaks of disease, which affect all of us, and outbreaks of rampant idiocy and ill-advised release of powerful and untested medications.
Without them, we wouldn't ever see salmonella coming. We wouldn't know if any cattle stock had been infected with salmonella, we wouldn't know if the drugs we're buying do what they say they're doing.
They still do what they were originally deigned to do: ensure that we get what we pay for, without the unwelcome side effects that cutting costs brings.
To clarify THAT, one hypothesis is that there are stem cells in tumors. This makes it tough to treat tumors, as the cells you really need to get are the stem cells seeding the tumor, but they tend to be missed by a lot of chemotherapy drugs as they may be slower-dividing, as stem cells may be in other contexts.
There are some cancers that may arise from normal populations of stem cells as well, but no one is saying all cancerous cells came from a population of stem cells. No one is saying all cancers have stem cells keeping them going either.
Note that's all theory, some of it may be outdated, some or all of it may have been disproven. I'm not too up to date, and stem cell biology moves really fast compared to most other fields in bio.
Some doctors and all pharmaceutical companies and hospitals do not want to cure you with a blue pill. Their whole existence in life is to maximize their profits, to do otherwise is not in the interest of their share holders.
As a physician, let me ask: What are you talking about? What are these diseases that you speak of that can be easily cured with a pill that the pharmaceutical companies don't want to make?
Heart disease is the most common cause of death in this country. Why? Usually, it's because of lifestyle issues: no exercise, eating poorly, smoking, etc.
The most common cancer that kills people? Lung cancer. Want to decrease the risk of lung cancer? Stop smoking.