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."

Comments

I'm not sure I understand...

[minginqunt]

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?

Re:I'm not sure I understand...

[IAmTheDave]

This is a tough egg to crack because everything revolves around money. Research requires money, and unless there is measured output, money invested is considered lost by the enterprises that supply said money.

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.

Why would the business people want that?

[Colin Smith]

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

Re:Why would the business people want that?

[recycledpork]

Actually I think that pretty much every economic theory would suggest that trading and sharing actually benefits all parties involved. I realize that you are being sarcastic, but maybe if people would actually apply the knowledge humans have acquired instead of just doing business as usual we would all be better off.

Re:Why would the business people want that?

[TubeSteak]

Pharma companies consider failed clinical trials to be trade secrets.

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.

FDA regulation by design

[Anonymous Coward]

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.

Re:FDA regulation by design

[Waffle Iron]

Your approach to drug deregulation was tried in the 19th century, and it was an abysmal failure. Most drugs on the market were ineffective, dangerous, or even lethal.

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?

When you make science commercial...

[analog_line]

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.

only 20 new drugs?

[Analog Squirrel]

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...

Patents and IP are a problem

[MojoRilla]

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.