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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.
Deleted
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.
The medical industry has not been about 'saving lives' since penicillin was created. While Im sure people who get into the industry are there for saving lives, but the people calling the shots are more concerned with money. Its hard to imagine how far we could go if everyone had the same data.
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
It's not the scientists, drug companies, or lack of collaboration that's the problem - it's the FDA. They are far too restrictive about what is approved, and approval takes much longer than it should. An expedient and more reasonable policy of approving drugs (if approval should be necessary at all) would save a LOT of lives.
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.
Pure restriction of the sharing of information and data is not good for profits. Restriction to auditable conduits on the other hand is. The profitability of a given conduit varies.
We need to trade the FDA approval people with the Patent Office approval people.
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!
You would be able to by clean, pharma-grade K from a legitimate source.
In 2004 according to the CDER there were 36 NDAs. Of course looking at the CDER calendar of approvals it looks like acutally there were 74 approvals for last year. Call me skeptical; but this article seems the like a poorly researched regurgitaged press release. Probably written by whoever is backing Prof. Poko's research.
Read between the lines.
The US government plans continued cuts in basic research funding.
Maybe Wikipedia can help with this crisis in information sharing?
Helping out humanity is one more reason to share data. Kindness with compassion is another.
He who knows best knows how little he knows. - Thomas Jefferson
Here's the reality for the clinician wanting to be involved in translational research
Many of the research MD's that I know fall into two camps.
1) Superstars
2) Interested but no money/time
The superstars are the guys that run this place - they have reached a level of scientific and medical fame that gives them the resources to run a clinical practice and operate a research lab by remote control. Not to denigrate them at all all - the ones that I know really deserve the superstar status that they have earned. There are only a few of these guys...
Ok - then there is everyone else.
Some of the researchers in group two are good to talk with and scientifically clued in but run into a huge catch 22. Good physicans or specialists are 'haymakers' for the medical school/ research institution. They are scheduled for surgery, rotations, etc. 60-80 hours a week and are paid very, very well for their efforts. However, if you're sewing your first patient up at 6:30am having arrived at 4:00am or find yourself in the clinic at 11:00pm, the possibility of having time to organize your thoughts, write a grant, order supplies, or administer a lab is next to hopeless in my opinion.
So what do they do? They ask the head of department for some relief time to write a grant, that will pay for more relief time so they can write a real grant to do translational reserach. HOD generally says no way - budgets are too tight, we're short staffed, etc. Nevermind that, at a research institution, part of the promotion scheme is research - most MD's that I talk to say this is an easily ignored part of the job description.
Those that are fortunate enough to write a grant for some relief time frequently migrate toward strict clinical rather than basic or translational research since they can hire a statistician and generate publications from clinical data that they have collected over the years. There is no barrier like trying to get a wet lab running. This has been the outcome for a number of clinicians that have come to my lab interested about a basic research question - we never get a project to the lab.
If we need translational medicine then we need to change the culture of the medical/industrial complex.
I was bored at work today and was poking around Wikipedia when I found this article on HIV vaccines and people are doing some pretty interesting and imaginative stuff. However the article also notes that worldwide HIV research gets about $650 million annually. IE about 1/200th of what the US spends each year on the war in Iraq....
Monstar L
Oh my god!!! Seriously, are all the old ones becoming obsolete or something?
As a matter of fact... some are. We're gradually losing the antibiotics arms-race with the germs as resistant strains to the best we come up with keep popping up. We only have a few drugs left that still kill the worst multi-drug-resistant strains.
In these cases, we do indeed need new drugs because the old ones are obsolete.
Your point about the business model is valid, though. Outside of the drug resistance issue, in many cases, the "new" drugs are simply minor modifications to the formula of old drugs released near the end of a patent to give them more patent control. The end of a patent means the appearance of commoditized generics and price competition with a much thinner profit margin, so they market the crap out of their slightly-modified version (say, a time release formula, or something) to convince people it's better than the form of the drug available as a generic.
Crisis in liturature causes Tom Sawyer to lose his way... (okay, this is kind of OT, but meant as a joke regarding the title, which is kind of silly when you think about it.)
Friends don't help friends install M$ junk.
While it is certainly true that there's a lack of feedback between clinic and lab, there are reasons.
First off, confidentiality regulations make the exchange of useful data a complex task. It requires careful planning, auditing for compliance, and some very special arrangements on how it's handled. Compliance makes it not for the faint of heart (or faint of wallet).
But the article misses the greater point: namely that basic and fundamental research on the etiology of disease is difficult and expensive (especially when people are involved). Basic research is necessary for everyone, but impractical for companies (in and of itself, it's not going to get you a product). Dropping public funding for basic research coupled by rules that allows publicly funded researchers and institutions to patent or commercially exploit findings rather than disseminate them has more or less gutted the last bastion of basic research: academia and non-profits.
You need money to do research, you don't get money for basic stuff anymore, you need something that will draw an investor. So, you skip on to another interesting project that might bring companies a-knockin'.
About the time I got out of graduate school, the commercialization of academic research was really starting to take hold. It took only a few years to effectively bury anything that might look like basic research for the good of all.
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 $5K that has only a 500 dollar reimbursement level. Oh, without breaking the non-disclosure agreement, let me say it would be worth your 15K to have the treatment even if it was out-of-pocket. In mass-market mode the cost of that device would plummet to peanuts over 5 years.
Obviously I am very frustrated that I can't deliver, for mostly artificial reasons
You can never have too much information. A search engine could fix your problem if all the publishers were not such greed heads about other people's work. The bastards won't even share abstracts. The problem I see is a lack of sharing not too much of it.
Friends don't help friends install M$ junk.
The only thing that's surprising is that it took so long for a media outlet to catch on. This has been a long-developing problem.
Businesses tend to cut research and development departments first, particularly if the stock isn't performing according to 'expectations'. It's easier and cheaper to focus on what you have, and improvments of that, than to develop new. In the long-term, it's counterproductive, but long-term thinking isn't encouraged in most corporate environments today.
It's also tough to attract and keep people in the field. Working in a basic research lab usually equates to lousy pay and zero stability. You're paid way less than most people with equivalent expertise in other fields, and you basically go "grant-to-grant," and if a grant doesn't come through, you're out. If you want something more stable (or as stable as anything gets, these days), you move to a different field.
Then there's the setting of priorities. Companies will fund things that are likely show a quick result, not something that will take time and may not pan out. If there's political pressure, then various governmental agencies try to 'fill the gap' for the translataional development phase, but that pulls money out of basic research. Private groups try to fund basic research, but again, they have their constituency to worry about. Add in the intellectual property concerns. You have universities and research labs worrying about patents and licensing fees. You have private companies not willing to pay for a "might be something". The end result is that there isn't as much money for basic research, and where it is, is in specific areas, the government is trying to do development, and business is just cherry-picking. Researchers aren't allowed to communicate effectively, since that might compromise a patent or a license. This leads to a lot of holes in the process. It's really a mess, and there's no nice easy solution. I'd love to hear of one though!
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.
Yeah, like Thalidomide. Approved overseas, where it caused thousands of babies to be born with very severe birth defects. Not approved in the US, because of the slow FDA process.
Be careful what you wish for.
Sean
FDA regulations prevent deaths, but at enormous costs. It now costs $500M - $1B to bring a new drug to market.
Thus, no drug can be developed unless there is a $1 - $2B / year market for it.
Thus, "me too" drugs, microbes developing resistance to the too-few broad-spectrum antibiotics that the drug companies can afford to develop and market, complete avoidance of any therapies that can't be patented, e.g. reovirus treatments for cancers and the many drugs contained in herbs, and the very slow adoption of "off-label" uses of new drugs, e.g. artemisinin for cancer.
The effect of the FDA's regulations is to very greatly reduce the numbers of new medicines, and the numbers of medicines available to us in the US. There are 500+ major drugs available to Europeans that are NOT available to us here.
This causes many more deaths than are avoided by the FDA regulations in the first place -- after all, liability for product safety is a much stronger force than any FDA sanction that can be placed on the company.
The FDA is completely obsolete: it can easily be replaced with a database that records all clinical information on any new drug.
Then, we go back to the common-sense approach to drug testing: test it in vitro, in animal studies, on the most-desparate patients, less-desparate, etc.
Yes, this will kill actively kill people, as compared to the current FDA-mandated testing approach. OTOH, look at the progress in AIDS drugs, where political pressure allowed short-cutting the FDA's process, and compare it to progress against any cancer (which kills 100s 0f times more people, but has no political lobby).
You can't program for an open environment. Regulations are programs. Regulations and other programs for open systems nearly always have perverse effects, as it is much easier to screw up a rain forest than it is to improve it.
Lew
Not to mention how many of those pay-per-view journals cost WAY too much to read a single article or subscribe to. I could see it back in the olden days when they were very limited run dead tree versions only, but ON THE WEB? You think the **AAs are out to lunch on pricing, sheesh.
Anyway, when it comes to "new and improved" drugs, I really don't care. Until it's illegal for an FDA or USDA or FCC (pick an agency, it don't matter) "government servant" doofus to get a retirement check, then turn around go to work for the industry they were just "regulating", the system is broken and highly suspect for collusion, bribery, payoffs, whatever.. It's no different from elected congress critters doing that, or retired dot mil going into military arms sales. Too much "we'll take care of you after so called 'retirement'" nonsense going on. And when their corporate profit system spends MORE on advertising and marketing and "investors profits" are more important than actually healing people, being WORTH of their government granted incorporation charters, I don't care about how much of a "hassle" it is to them or what they SAY it costs, because, frankly, I don't believe them, I think they cook the books just like the energy companies do.
That has been tried by previous generations going back to our prehuman ancestors, we are the survivors of the successful experimenters. No thanks, I want my drugs tested, and I don't intend to test them on myself first.
Seriously. Aren't there any countries with advanced-enough industrial infrastructure and less regulatory crap?
You wouldn't have to move *everything*. Just move the trials there and start selling to them. People outside the US get sick too, and a lot of them have the money to pay for their treatment.
How socialized is the health system in Chile?
I love that phrase: knockout mouse. Makes me think of some Bugs Bunny-style mouse wearing a tight sweater & lipstick.
http://reason.com/9505/SASHA.may.html/
Hey I know he was a spoiler and a can be a downer, but violence solves nothing man.
OSGGFG - Open Source Gamers Guide to Free Games
Moderators asleep again? Or just "testing" drugs??
http://reason.com/9505/SASHA.may.html
(there was an extra slash)
New bench to bedside program? It's called the Medical Scientist Training Program, and it was started at the University of Chicago in 1969... Nothing new here.
The difference is that you can sue a drug company if they sell you dangerous or inefficient drugs. This and brand power should be enough to keep them very honest, though some accidents will - and should - always happen.
Drugs have costs and benefits, with the costs being side effects and the benefits their healing power. I'm so sick of discussion of them pretending there are only costs.
But is the slowdown of new drugs really a crisis? Maybe the Big Pharma just needs to downsize, and put those scientists to work somewhere else.
At least the researchers are working directly with the patients and their doctors with a focus on therapy instead of just more research. Look as the succes of the Lorenzo's oil to reverse ALD--It took twenty more years for the research to catch up with the fact that it worked and saved thousands of kids from developing into terminal quadriplegics just with adding a certain unsaturated oil to their diet. By the way, Lorenzo's Oil was a great movie documenting the success of the process to focus on results and therapies instead of pure research.