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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."
By restricting the sharing of information and data, the maximum profit potential can be extracted from it.
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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.
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.
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.
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.
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?
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
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.