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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."
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.
I think this is where an overhaul to the patent system could come in handy. The original patent system was supposed to encourage the sharing of information. However it has been twisted and twisted until it discourages the sharing of information.
Think Deeply.
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 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.
Brought to you by Team SPAM! where we believe: "Information in the noise!"
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 available back then. I still remember many of the feelings I had when I learned, so I have a little bit of an idea what your family is going through. My condolences :-(
I'd rather be flying
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.
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.
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.
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.