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Crisis in Science Prompts Sharing of Data
Carl Bialik from the WSJ writes "'The crisis in "translational science," or turning basic discoveries into therapies, has been brewing for years, but it hit a depressing nadir in 2005, when just 20 new drugs won approval from the Food and Drug Administration,' Sharon Begley writes in the Wall Street Journal. Concerned researchers and foundations are pushing for more sharing of data between basic scientists and clinical investigators, and Stanford is launching a program to train doctoral students in bench-to-bedside research."
So, what, the 'success' of science is now judged by how many drugs are rushed through FDA certification without proper testing?
Or is there a real crisis here that the article doesn't do anything to elucidate?
By restricting the sharing of information and data, the maximum profit potential can be extracted from it.
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Creates barriers to entry.
Consolidates power into large multi-nationals.
Preserves the status quo.
Does not change the fundamental fact the individual must remain responsible.
The FDA cannot make you safe.
We would probably be just as unsafe as we are now, but with more choices, faster time to market, and with smaller companies participating.
If we had had an FDA for computers we would never have had a PC revolution start in some stoner's garage.
Oh yes, I would much rather have 5000 new drugs, that might have adverse side effects and will kill me...than to have 10 new drugs that have had a bunch of research done...
Science is run by corporations now. Non-commercial scientific research has been getting the gas pipe for years. Corporate scientists are more than willing to take all the data the silly hippy scientists are willing to give them for free. They're not so willing to share their data in return, because their shareholders will string them up.
This is what you get with that cushy research job at the biotech company, folks. Now it can start biting you in the ass, just like your greed has bankrupted the rest of us.
It's almost like crazy patents are stifling innovation...Who'da thunk it?
Seriously, as long as you have to pay, and pay, and pay just for the methods to work with x or y type of gene so that you can SEE what your drugs are doing, you're not going to be zipping along at record pace. And, as ridiculous as IP law has become, I can't imagine you'd be comfortable bouncing ideas off your peers at other labs...I mean, the point of that is to see if they have a solution, but if they have a solution, then they'll probably throw a cup of hot coffee in your face and run down to the patent office.
What did they think was going to happen when they started this crap?
ad logicam Claiming a proposition is false because it was presented as the conclusion of a fallacious argument.
Oh my god!!! Seriously, are all the old ones becoming obsolete or something? Isn't that where the pharmaceutical companies should be making most of their money? Or is there such a premium on "new" drugs that they can't stay profitable without them? If that is the case, it sounds to me like there are some pretty unsustainable business models out there. You really can't dictate innovation... unless of course, someone starts designing new diseases so you can then trot out the cure to them as a new product...
I'd rather be flying
Making a knockout mouse may be a more physiological model but it's still a far cry from really working on human disease. It may be more sophisticated than cells in a dish but it's still basic research.
What does this author have against basic research anyways .. the tone of the article is really negative:
It has a pile of discoveries to show for it -- but no cure.
Discoveries, after all, are supposed to be good for something besides filling science journals.
No kidding! But how can anyone even begin to take a rational approach to medicine without basic research? There is a place for excellent basic research, just as there is a place for truly clinically oriented research.
Rushing it not a good idea. Proper testing is necessary. What you are proposing could cost a greater number of lives.
If we wonder why there are less and less drugs getting approval, we need to look at what researchers and universities are doing with the science the American taxpayer pays for.
Since 1980, universities and individual researchers have had the right to patent IP paid for by public funds. This was obstensibly done to "facilitate the exploitation of government-funded research results by transferring ownership from the government to universities and other contractors who could then license the IP to firms."
However, it is clear how this would have a chilling effect on basic research. Surely cooperation has suffered at the expense of competition. Patents have been a disaster for software, where synthesis of many ideas are important to create products. It is probably similar for the biological sciences.
These researchers are funded by public money. Their results need to be used for the public benefit, and shared publicly.
There's only one case where I agree with you, and that's when a drug has been tested extensively internationally and there's solid clinical data there to back it up. If a drug's been used in Europe, Asia, or Australia for years with no major incidences of serious side effects, then YES, it should be fast-tracked for approval. If the data's there internationally to show the drug's safe, why should the US researchers need to replicate years and years of European data and navigate that red tape?
And you would know it was clean, pharma-grade, and legitimate because the guy in the trenchcoat said so?
The government has two powers that no Consumer Reports or other private watchdog has: The power to compel, and the power to punish.
Take Vioxx, for instance. Thanks to the government's power to compel the release of evidence, we now know that Merck knew about the drug's dangerous side effects for some time, and chose to not notify consumers of the risk in order to keep from scaring them away and keep their sales up. Libertarians like to dream that they could set up companies to do the same thing, but no watchdog company would ever have been able to walk into Merck and demand copies of incriminating internal memos and succeed.
The FDA may be corrupt and useless, but I don't believe a world without it where companies could do whatever they want without at least a facade of obeying some regulations would be a better one than where we are now.
If I have been able to see further than others, it is because I bought a pair of binoculars.
when just 20 new drugs won approval from the Food and Drug Administration
Crisis? Seems like they are getting their act together. It takes TIME to really know what these drugs do, and I for one am not happy with so many drugs get released and are then pulled a few years later due to some life threatening side effect.
Horns are really just a broken halo.