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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."
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.
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.
Did you even read the article summary, much less TFA?
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.
[Fuck Beta]
o0t!
Well, we certainly need new anti-biotics. Then again, sometimes new drugs replace old ones because they produce fewer side effects; sometimes new drugs treat new problems; and sometimes new drugs are just pushed to replace an old one because the patents on the old ones ran out so that it's become a commodity produced by generic manufacturers, wiping out any possibility of monopoly profits.
Of course it helps if the manufacturing process is slightly different for the generic formulation to help cut costs (and increase margins) and that the process difference affects the product, leading to more side effects.
Laissez lire, et laissez danser; ces deux amusements ne feront jamais de mal au monde. - Voltaire
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.
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 do need seperate trials unless all trials are conducted in exactly the same way. This is feasible for a short while but eventually the basis for the tests has to change and then you need to retest all drugs to again assess their relative efficacy.
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 clinical data as to its effects. At overdose levels it does not aliviate pain as much as other drugs (morphine). Note that I am not trying to say it is the best or worst pain relief for any individual with any arbitrary complaint. It is less harmfull to MOST patients then morphine or heroin but is less effective at pain relief. Stomach ulcers can be exacerbated by it so if you are suffering pain from ulcers you probably should not use asperin. Heroin is far more effective at relieving pain but its long and short term side effects are not pleasent (Asprin and Heroin were first synthesised at about the same time by one man (Felix Hoffmann)). The company, Bayers, that Hoffmann was working for shelved Asprin in favor of Heroin as they thought it more effective. Time has shown that Heroin is significantly more effective at relieving pain for most people. However it also is addictive and has no known benifical side effects.
So yes, over time, some idea of the relative effectivness of a drug can be determined (in a vauge way). But still a drug should be chosen based on the condition of the patient not on some abstract relative performance.
I do agree that the results of the FDA tests should be public domain.