The analogies with room temperature superconductors and antigravity suggest that bromantane is some kind of super drug. But the only thing the author bases this on is the summary of a study in russian that the author can't even read.
Believe it or not there is a respectable number of scientists, physicists no less, who make a living doing nothing but bringing 80 year old Soviet Science to the west. Every so often they get the front pages of nature for essentially finding anti-gravity: http://www.nature.com/news/2008/012345/full/news.2008.1185.h... Or you find actually build computer architectures and languages which American theoretical computer…
I have great appreciation for russian technology, but aren't those exaggeration ?
If setun , the ternary computer was so efficient - how is ithat today we use binary machines(and that in general the russians didn't have a moore's law ) ?
I'm more worried about the fact that more and more drugs are reclassified as prescription only. Right now, I can only get green tea or alcohol without a prescription for anxiety - not exactly the best choices.
No Adderall, Xanax or Provigil for me either - the only things I can get right now are Tofranil from a friend (which is technically illegal) and racetams from eBay.
Over-prescription is the problem of the prescribers' and their incentives, not FDA. FDA opens the tap, prescribers put the water in the cup and give to patients. Patients do not access the water directly. Your concern is better directed to American Medical Association (AMA). If you think you can find helpful chemicals on your own, you are either very confident to use your own body as a guinea pig or suffering from ht…
The FDA specifically on-label approved ritalin for kids, hormone replacement therapy, and statins for people with high cholesterol but no signs of heart disease. Your faith in regulation is misplaced. If you take FDA approval and a doctor's recommendation as proof a prescription is safe you are misguided. (The AMA is a lobbying organization to which about 15% of doctors belong and is irrelevant here.) There is no rel…
I may not be as well-informed as you, but I don't see a problem on those on-label uses you mentioned.
If you want to evaluate the safety of a prescription, I hope you have the right degree for that. Things can look safe on one paper and not safe on another. Or your condition may warrant a risk of greater side effect with the upside of better efficacy. It's true that doctors and FDA can make mistakes, but they are the best people you have.
Uh oh... Didn't know that your AMA is such a place. Do you have a association that represents all prescribers? Prescribing habits should be looked over by them.
It's important to look at the FDA's job in terms of diminishing returns, or maybe as a classification problem. You have some number of drugs coming in, some of which are helpful and some of which are harmful. But you don't have any perfect means of figuring out whether a drug is good or bad. If you start from no screening it's very easy to stop a lot of bad drugs without stopping many good drugs, but as you apply tig…
You have to keep in mind the history of the FDA. When kids were being born around the world with flippers instead of arms and legs because of thalidomide, that wasn't happening in the US because of the FDA. Incidents like that breed cautiousness. The pendulum swings back and forth. A decade ago, the FDA got hammered for being too cautious. Then Vioxx happened and they got hammered for being to lenient. I think the FD…
Thalidomide was very effective in treating morning sickness, it "just" wasn't safe. Why does the danger of thalidomide justify giving the FDA extensive powers to regulate the effectiveness of treatments?
I'm more worried about the fact that more and more drugs are reclassified as prescription only. Right now, I can only get green tea or alcohol without a prescription for anxiety - not exactly the best choices. No Adderall, Xanax or Provigil for me either - the only things I can get right now are Tofranil from a friend (which is technically illegal) and racetams from eBay.
I think the problem here is that the predictive value of the "pretty good evidential" support and success in a future (acceptable to the FDA) clinical trial isn't as high as you might think.
Admittedly it's for a different indication, but the Medivation experience with dimebon, which is a drug used in Russia as an antihistamine for decades, which had "pretty good evidential support" that the drug might work for Alzheimer's disease is, unfortunately, more likely to be par for the course.
There must be some ambiguity in the article, because GP's reading looks plausible to me. For example, "You can’t have one set of elements in Russia and another in the US, everyone would work together and compare notes. At the very least one side would have the common decency to at least steal from the other. No way anything like this could possibly go on. But as far as I can tell this is exactly the state of modern p…
Look at the first sentence of the post. Or the beginning of the paragraph you just quoted. Elements being different in different countries is clearly marked as an absurd example .
Okay, I agree, he's being sarcastic. Sorry, I'm obviously too tired to contribute to this discussion.
You're right that the solution shouldn't be automatic US approval for any drug used in Russia. It's reasonable to have standards for drug testing and require that any drug used in the US is tested to those standards. The problem isn't (only) that US drug standards are strict. The problem is that the financial burden of testing a new drug, which is significant, lies solely on the manufacturer, who can only recoup thos…
> One obvious solution would be a government program whose mission is to identify promising treatments for which private incentives don't line up, and shepherd them through the approval process by funding clinical trials and so on You already have this. It's called Orphan Drugs in the US. http://en.wikipedia.org/wiki/Orphan_drug > a free-market variant, in which the government just auctions off US patent rights for f…
Cool, I wasn't familiar with the Orphan Drug program. From the Wiki page it looks like it's focused on development of new drugs for rare diseases, for which the market is inherently small and thus impossible to do large clinical trials, etc. That's similar to but not quite the same as the problem here, where a drug already exists and the market is potentially quite large, but the lack of patent protection prevents any one company from funding its approval. Do you know if the Orphan Drug Act specifically designates some government body with the mandate and funding to study and approve pre-existing foreign drugs? If not, maybe that could be a useful extension.
You have to keep in mind the history of the FDA. When kids were being born around the world with flippers instead of arms and legs because of thalidomide, that wasn't happening in the US because of the FDA. Incidents like that breed cautiousness. The pendulum swings back and forth. A decade ago, the FDA got hammered for being too cautious. Then Vioxx happened and they got hammered for being to lenient. I think the FD…
Thalidomide was very effective in treating morning sickness, it "just" wasn't safe. Why does the danger of thalidomide justify giving the FDA extensive powers to regulate the effectiveness of treatments?
> Why does the danger of thalidomide justify giving the FDA extensive powers to regulate the effectiveness of treatments?
... because it wasn't safe for use by pregnant women? Am I not understanding part of what you're saying?
I wouldn't consider that to be truly "effective" when the side-effects are quite serious. And by the nature of the medication, all pregnant women taking the drug are necessarily at risk of these side effects.