FDA Could Delay Adult Stem Cell Breakthroughs 261
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.'"
FTC != FDA (Score:5, Informative)
Heh.
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Re:Non-Story (Score:5, Informative)
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" [ft.com] an entire sham scientific journal printed to order by Elsevier, for Merck.
Re:Totally offtopic (Score:4, Informative)
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.
Re:Why is this a gov decision? (Score:5, Informative)
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.
Re:Why is this a gov decision? (Score:2, Informative)
The answer to that question lies partly in the sordid little tale of elixer sulfanilamide [wikipedia.org]. To make a long story short, Massengill wanted to produce a liquid version of a one of its drugs and one of their chemists discovered that it would dissolve nicely in diethylene glycol. Aside from being a handy solvent, diethylene glycol is sweet tasting, so it made a perfect base for a liquid medicine. The only downside was the fact that it's poison. The FDA tracked the stuff down and managed to prevent most of it from being distributed, but not before over a hundred people were killed by it. Hundreds, maybe thousands of lives were saved by the actions of the FDA. It's not clear whether the Massengill chemist knew did not know about the toxic effects, or if he was aware of some toxicity, but didn't realize quite how bad it could be. In any case, he ended up committing suicide. As for Massengill, they naturally asserted that the results were unforseeable and denied any responsibility. Massengill paid a small fine for labeling the product an 'elixir' even though it contained no alcohol (diethylene glycol is technically an alcohol as I understand it, but I believe it has to be ethyl alcohol to qualify). In fact, that mis-labeling was the only thing that gave the FDA any authority to seize the drug and prevent it's distribution. If it hadn't been for that, the FDA would have been legally been powerless to do anything.
After that, congress passed the 1938 Food, Drug, and Cosmetic Act, which set the FDA upon its current course. Without that act, and subsequent ones in the same vein, the FDA would be what you prefer. In that case, if someone sold Sulfanilamide in liquid form without any mis-labeling, the FDA would come along and check it and say, yep, it contains Sulfanilamide, just like the label says, sure it's dissolved in FREAKING POISON, but there's nothing we can do about that. Wouldn't that be great? Not that I'm saying that the FDA is perfect. It's a massive bureaucracy and I'm sure there are plenty of cases where it does more harm than good. Without it in its current form, however, drug companies would be killing us off like crazy. I mean, have you seen some of the crap they try to (and sometimes do) pull even with the FDA? The magical era you imagine, back when the FDA didn't interfere and the worst you had to worry about in your medicine was that it contained inert ingredients like chalk is a fantasy. The reality is that even big, respected drug companies did wildly irresponsible things with peoples health.
Interestingly enough, something similar happened recently with cough medicine made with Chinese Diethlyene Glycol. Lots of people died, etc. Now the Chinese do have their own version of the FDA, although it obviously isn't as hands on as the US FDA, plus, it apparently doesn't involve itself in products meant for export. One of the interesting things is that even the pre-1938 duties of the FDA would apply, since the reason it happened is because of mis-labeling. Specifically, diethylene glycol from China keeps getting labeled as glycerine and sold for export. There was another major incident where this happened a decade ago, and lots of minor incidents in other products like toothpaste. It happens because of greed and laziness. It's cheaper and easier to buy inexplicably inexpensive barrels of "glycerin", not test them in any way (not that it should be difficult, the difference in viscosity and the fact that glycerin is odorless and diethylene glycol has a fairly intensely sweet odor should be a dead giveaway to anyone who's actually worked with glycerin), and throw it into childrens medicine. Frankly, the simplest explanation is that the sellers and buyers know what's going on, but just hope that no-one will die, but if they do, hopefully no-one will tie it to the tainted product, but if they do, it was the other guys fault, it was a mis-labeling problem, it was a translation error, well you see, what happened, it's a funny story... It's crap. It should be stamped on, and the people responsible should be chewed to pieces. For that to happen, there has to be someone with teeth to do the chewing, for better or for worse, in the US, that's the FDA.
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Re:need some clarity here... (Score:3, Informative)
The idea that in the age of intellectual property, if your not inline with the US gov policy, you will be given a demonstration of US might.
Fined into bankruptcy.
The DIA and CIA where hints at the long deep connections with Big Pharma.
No upstart is going to win the race to the next generation of medical treatments.
If the USA cannot or will not invest in basic science, move to a part of the world where 'biology' is not a dirty word.
Re:Non-Story (Score:4, Informative)
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.
Re:When one realizes (Score:4, Informative)
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.
Re:drats (Score:3, Informative)