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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."
2,000,000 patents were discovered in science last year!
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.
I've been working on clinical research for a long time now. The issue isn't quantity, it is quality. I can quickly produce a database of a couple million patients for you, but it would be crap data. When I verify the data, I get far less (around 300k). But, I've just hit a problem that I see in clinical research. If, for example, I refuse to consider a person with a blood pressure below 70/30, I have just skewed the results. On the other hand, if I accept typos from the millions of medical clerks who, in my opinion, are not required to understand basic spelling or typing techniques, I skew the data. There is no way to get truly valid results. I just get estimates and comment on trends. I let the doctors make assumptions about the trends. It could be that a new employee is typing in the weights and she keeps hitting '2' instead of '1' - then suddenly the patients started weighing more. A doctor will attribute the weight gain to McDonalds. I'm sorry, but there's no real point here. I just wanted to explain a bit of what is really going on in these clinical research areas.
The previous comment is purposely vague and generalized, but all of the facts are completely true.
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
If we are having a lack of new drugs and everything is being patented, are patents still constitutional?
Work bio at MMWD
It could be that research has cooled because of the large number of lawsuits being thrown at them. Why spend all the money developing a new drug, when any possible profits will be eaten up by numerous lawsuits, and the resulting high price will be used as justification for allowing a company in a third world nation to steal the design and sell a cheap copy.
Who would win this election: Andrew Weiner vs Andrew Weiner's weiner.
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.
2,000,000 patents were discovered in science last year!
Patents are not discoved! They are a God Given Intellectual Property Right, enshrined in the constitution and one of the fundamental Rights of Man*.
**The fact that corporations are not technically men has no bearing on their applicabilty to corporations. Dissenters will be dealth with.
May the Maths Be with you!
Oh my god!!! Seriously, are all the old ones becoming obsolete or something?
As a matter of fact... some are. We're gradually losing the antibiotics arms-race with the germs as resistant strains to the best we come up with keep popping up. We only have a few drugs left that still kill the worst multi-drug-resistant strains.
In these cases, we do indeed need new drugs because the old ones are obsolete.
Your point about the business model is valid, though. Outside of the drug resistance issue, in many cases, the "new" drugs are simply minor modifications to the formula of old drugs released near the end of a patent to give them more patent control. The end of a patent means the appearance of commoditized generics and price competition with a much thinner profit margin, so they market the crap out of their slightly-modified version (say, a time release formula, or something) to convince people it's better than the form of the drug available as a generic.
HIV is easy to prevent, from a medical standpoint. Condoms and abstinance can irradicate it. The only barriers to stopping the spread of HIV are political and social.
That said, HIV is totally politicized, and is actually grossly over-funded compared with many other diseases.
Diarrhoea kills 4.2 times as many children as HIV, but you don't see Susan Saradon wearing a brown ribbon at the Oscars. Diarrhoea can be cured with a US$0.10 packet of rehydration salts and some clean water. A few million bucks could save all of those kids, including the logisitcal costs.
But Diarrhoea isn't a popular cause with the lefty crowd (or the righty crowd for that matter). Why? Because actors and politicians actually know nothing about public health, and are only interested in causes that promote their own images. HIV is a good "image" issue because a number of famous people have contracted it. There's little chance of anyone from Hollywood dying from Diarrhoea unless they're marooned in Ecuador on an Eco-toursim trip.
First, let me say I am a primary stakeholder. I am a Chief Medical Officer in a medical device company with a device that shows spectacular clinical activity.
Well, the patent holders in the arena have damnable method patents on all the key parts, and haven't done squat in the arena for better part of 20 years. And it's an almost impossible logjam of non-collaboration. So once again, irrational patents rear their ugly head. And we won't talk about patents on naturally occuring proteins, not a new man-made drug, but a protein made from recombinant methods of naturally occuring DNA. I urge everyone to take a look at the patent on BMP-7 -- 1996 -- almost certain to reverse major tubulointerstitial damage in the kidneys, languishing on the vine as a result of the patent. (Hey, OrthoBiotech -- how many more years before you pull the trigger?) While the inventor deserves a Nobel for the clinical identification, he does not deserve a patent. He didn't invent BMP-7. Nature did. He noticed what it does and proved it beyond clinical doubt.
While the device-side of the FDA is a reasonable 2-3 years for approval at low cost (though still mostly useless and an extra-step) the drug-side is totally criminal in its existence. We are approaching 1.2 billion dollars to get a drug thru the process and it is absurd. Every time the FDA expands its regulatory web, fewer drugs and devices make it to market. It's a huge resistor sitting across the current of medical creation.
I don't need either patents or anything else to protect my market. It's hard enough to make science into clinical treatment that anyone who can do it and compete with me is welcome. What I need is the damn artificial stakeholders to be de-empowered by the elimination of method patents, elimination of patents on naturally-occuring proteins, elimination of obvious patents on combined therapy.
I also need the huge regulatory web that dictates patient selection and over-restricts my patient base to go away. One would think that multifactorial statistical analysis was a forgotten or unknown art listening to FDA regulators. And the damnable meaningless questions, the endless drivel the FDA requires to prove safety. There is no such thing as safety -- negatives can't be proved. I can only prove harm. My device has a 3% mild complication rate and what looks like an 80% remission rate against diseases that are uniformly fatal. Why the hell do I have to jump thru a zillion hoops to get to a damn feasibility trial with people dying like flies? In a country based on freedom, we have no health freedom.
And there is no such animal as an FDA scientist. Even those with Ph.D.'s in the sciences are bureaucrats. They are interested that their precious questions on their forms are answered not that the device/drug works or simplifying things to get something to market. Well, the cost of those forms are tens of millions of dollars of work, most of which is NOT essential to making the damn thing happen clinically. And the hubris -- we at the FDA guarantee safety -- what bs -- how many have died from Vioxx -- how many have died waitng for beta-blockers to show up -- how many drugs with good but not great clinical activity never made it due to regulatory cost?
And the socialism of medicine -- with CMS/HCFA dictating reimbursement, fer cryin out loud, why should anyone go into business when they can't get a real market price on anything. There are great devices just sitting in the wings which don't come into the market because overall reimbursement is peanuts relative to value. Noone is going to deliver to market a device with a treatment price of $15K, a direct cost of $5K that has only a 500 dollar reimbursement level. Oh, without breaking the non-disclosure agreement, let me say it would be worth your 15K to have the treatment even if it was out-of-pocket. In mass-market mode the cost of that device would plummet to peanuts over 5 years.
Obviously I am very frustrated that I can't deliver, for mostly artificial reasons
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?
My dad's an immunologist working for a private firm developing cancer drugs. I asked him about the whole patent issue, and he said, "When we come out with a new product, we WILL get sued." That's just how the industry is now.
What's worse, he says, is that even straightforward research involves a lot of legal hurdles. You can't just do your research, produce your chemicals, etc. in the most straightforward way, because it might get you sued for patent infringement down the road. Everything takes longer because of these legal hurdles. And nobody working in private industry publishes in scientific journals, because they'd lose out on patents and screw over their company.
Of course, my dad has his name on a bunch of patents himself. I'm sure his company is just as anal about protecting their own patents as everyone else. So really, the only people who get a net benefit from the current situation are... the patent lawyers.
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.
Sure.
.govs. Get CE mark. Live happy and rich -- but not in France.
China. So much for any freedom.
Europe. Sell soul to a dozen
Caribean Union. Not too bad.
Brazil. Not too bad again.
Singapore. Hmmm. Rich pseudo-capitalist country with a mostly free reign. Ok. Definite winner.
South Korea. Top of the line -- oops N. Korea and nukes... might be worth the risk tho.
Mexico. Pay off one of 32 ruling families. Make zillions. Ok. Definite winner if one can afford bribes.