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Crisis in Science Prompts Sharing of Data
Posted by
Zonk
on Fri Jan 20, 2006 10:48 AM
from the varieties-of-mice-that-nature-forgot-to-make dept.
from the varieties-of-mice-that-nature-forgot-to-make dept.
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."
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Can't be true! (Score:2, Funny)
Re:Can't be true! (Score:2)
Not Discovered (Score:5, Funny)
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.
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Re:Can't be true! (Score:3, Insightful)
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.
I'm not sure I understand... (Score:4, Insightful)
Or is there a real crisis here that the article doesn't do anything to elucidate?
Re:I'm not sure I understand... (Score:5, Informative)
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Re:I'm not sure I understand... (Score:3, Insightful)
Re:I'm not sure I understand... (Score:3, Informative)
My example of Asprin does have a strong basis. Asprin has been in use for 107 years. It has been synthesised for 109 years (as a side note, one of its natural forms, willow bark, has been in recoreded use in europe since 1763). This gives a great deal of clinic
Re:I'm not sure I understand... (Score:5, Interesting)
The fields of science affected by patents are worst affected, but all fields of science are today in at least some form of crisis. "Publish or perish", and a bureacratic/accountancy driven push for quantity of publications over quality, has caused an explosion in the number of published articles and an equally dramatic drop in the substance of said articles.
The result is that even in a small sub-field, there are too many publications for an indiviual to keep track of. Actually reading other people's articles takes a lot of time, often only to discover that the reported research is superficial and the time spent understanding the paper was wasted anyway. This results in people not bothering to read the literature, and instead just repeating work some other group has already published. This contributes to the explosion of publications, and thereby keeps the bureacrats happy. But the effect on science is overwhelmingly negative.
An associated effect is that the real interest in the research is often obsfucated in the publication. If it was clear from a cursory reading how superficial the research was, the journal referee's might reject it. And if some other research group can figure out exactly what you did, they might be able to reproduce your work and scoop your future researches.
Fields subject to commercial interests suffer extremely badly from this, to the extent that in drug research, much of the interesting research is never published publically at all.
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Re:I'm not sure I understand... (Score:5, Insightful)
Add on to that that much of the research money comes from private or public for-profit agencies, and you have a real connundrum on your hands.
Unfortunately, pure science and pure investors often clash when it comes to desired outcome. Scientists are often happy to take years and years to develop therapies or make discoveries to be sure that the science itself is rock-solid. However, investors require that their investments - often not all their own money - yields dividends and results in made money.
Until we have some system in place that supports scientific research without requiring an immediate return on ivestment, this crisis will continue unabated.
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Re:I'm not sure I understand... (Score:3, Insightful)
Re:I'm not sure I understand... (Score:5, Informative)
I'm sure the patent flurry isn't helping much either, since the delay in publishing something to make sure that companies (and in today's world, university foundations) can set things up so that they can maximize profits of any derivitives of their work. This process takes much more time than it used to.
I think the interesting part of this is the fact that groups that are actively sponsoring specific diseases are starting to fund these studies from start to finish. I'd love to see more of this. there are hundreds of illnesses and diseases that do not have a large enough number of people who are stricken to justify the cost of developing a drug worth it. by allowing researchers to share data quicker, and better, foundations that are supporting research may just have the power to do everything short of manufacturing the drug. They can't afford to pay for broad testing, however, so they need to rely on more access to other's research so that they can focus on the most promising paths of their own.
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Why would the business people want that? (Score:5, Insightful)
Re:Why would the business people want that? (Score:5, Insightful)
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Re:Why would the business people want that? (Score:5, Insightful)
The FDA is not legally allowed to divulge the results of anythign that's withdrawn from approval.
Basically, if everyone told everyone else about what didn't work, the only companies that would benefit are those developing similar products. First to market usually has a huuuge advantage, which is why no company wants to help its competitors get ahead.
This addresses only one aspect of TFA & what you're saying, but that's how it is. Not that it is a good thing, since undisclosed trials/failures usually equates with undisclosed risks.
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Re:Why would the business people want that? (Score:3, Insightful)
But you are adding a presupposition in your hypothesis. "benefits all parties involved" implies a limited subset of economic theories; those that are intended to benefit societies, such as capitalism, communism, and socialism. This neglects the one we use in the United States; corporatism. Corporatism is essentially tribalism applied to the corporation. Each tribe sees itself
Re:Why would the business people want that? (Score:2, Interesting)
I agree sharing does benifit us all. Unfortunately, drug companies seemed to be focused on maximizing the share price for the investors. In that light, does it make sense for a drug company to own part of a drug or all of a drug? Sharing profits on a drug will affect the company's bottom line. I think share holders and stock analysis would look less favorable on those companies. It's not about how better science can drive the drug industry, it's about how money drives the drug industry.
Re:Why would the business people want that? (Score:3, Interesting)
FDA regulation by design (Score:4, Insightful)
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.
Re:FDA regulation by design (Score:4, Insightful)
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Re:Nothing (Score:3, Insightful)
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 thei
Re:FDA regulation by design (Score:5, Insightful)
Today, this unregulated approach continues with the "herbal remedy" market. Once again, most of these products are ineffective or dangerous.
Where do you get the idea that things would be any different if no approval were needed for real drugs today?
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Wonderful (Score:2, Insightful)
When you make science commercial... (Score:5, Insightful)
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.
Been there/Done that (Score:5, Interesting)
Re:Been there/Done that (Score:3, Interesting)
What about Docs who enroll marginally qualified patients into a study to collect the cash from the drug companies?
Hmmmm. (Score:4, Insightful)
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?
Re:Hmmmm. (Score:3, Informative)
Patents aren't mentioned once.
The problem TFA is talking about has nothing to do with patents and everything to do with research not being converted into useful therapies/products.
Maybe patents are the underlying cause of this, but you don't back up your claim with any facts. And no, the point isn't to see if you have a "solution." A solution to what? This is about basic research.
Re:Hmmmm. (Score:2)
See, they see all world as property of something, someone. Anyone belongs to someone, there should be no free tools, free goods, and specially, no free knowledge. Someone should do money out of it.
Why they think so? Hmmm...what about some ill-based theory that greed is something "healthy"? Don't matter that couple of psyhologists would insist on something in lines about "luck of love" or "felt cold
only 20 new drugs? (Score:4, Insightful)
Re:only 20 new drugs? (Score:2)
As far as the developing Pharmas are concerned - they're all going off-patent without being replaced.
Bingo!
You say that, but these are some of the most profitable companies out there, and have been for decades.
Re:only 20 new drugs? (Score:2)
Re:only 20 new drugs? (Score:3, Insightful)
Anyway, drugs don't cure diseases; they cure *instances* of diseases. If a doctor sets your broken leg, that doesn't mean there won't be any more broken legs in the future. Likewise my taking something for high cholesterol doesn't prevent someone else developing high cholesterol today or 100 years from today. Most drugs being developed today are not aimed at killing pathogens, but at adjusting the patient's own che
Re:only 20 new drugs? (Score:2)
There is ABSOLUTELY a premium on new drugs! One reason is that a minor tweak to an existing drug creates a whole new drug. This can be patented and sold for a premium price. If the drug is only slightly better than an older one, doctors will almost always prescribe the new one.
Also, and more importantly, when old drugs lose their patents, everyone (at least those who are sane) will buy the generic drug. What if Lilly s
obsolete drugs (Score:3, Informative)
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,
Re:only 20 new drugs? (Score:2, Interesting)
Of course they are. I didn't mean to imply that they should simply give up research, just that I don't think it should necesarily be expected that new breakthroughs will come at regular, predictable intervals. I certainly don't think that a healthy business model can be based on that happening.
My baby sister was a cancer survivor at the age of 16... that was nearly 15 years ago, and she too would have had a much easier time if treatments available now were availa
Re:only 20 new drugs? (Score:2, Informative)
Of course it helps if the manufacturing process is slightly different for the generic formulation to help cut costs (and
The problem is the FDA (Score:2)
Re:The problem is the FDA (Score:2, Insightful)
Re:The problem is the FDA (Score:2)
How? How, would reducing safety checks on drugs make them safer? How would decreasing stringency on drug side effects benefit people? This seems counterintuative in the extreme.
Could you please cite a scientific study or something, because it just sounds like male bovine faecal matter to me.
Kind of calls into question patent laws. (Score:5, Interesting)
If we are having a lack of new drugs and everything is being patented, are patents still constitutional?
Slow because... (Score:5, Interesting)
Making mice is translational? (Score:3, Insightful)
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.
Patents and IP are a problem (Score:5, Insightful)
Since 1980, universities and individual researchers have had the right to patent IP paid for by public funds [wipo.int]. 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.
Cutting basic research (Score:2)
The US government plans continued cuts in basic research funding.
Maybe wikipedia can help? :) (Score:2)
Helping out humanity is one more reason to share data. Kindness with compassion is another.
It's a total disaster out here in Med Land (Score:5, Informative)
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
Patents are a big problem. (Score:5, Interesting)
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.
Re:A trade is needed (Score:2)
I think if that happenned, we would very quickly end up with a situation like this [google.com].
Re:Or they could just fund it better (Score:5, Interesting)
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 [who.int], 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.
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