Public Access to NIH Funded Research Gains Momentum
Here's a typical scenario: a researcher writes a grant application to do a study; if the grand is awarded, the grant pays the researcher to do the study; once the study is complete the researcher writes a paper which gets published in a peer reviewed journal. Frequently it is the US government who provides the funds for research, enriching our knowledge in addition to the researcher and their institution. Then the journals get to profit by copyrighting and publishing the resulting research.
Lots of government funded research is available at little or no cost through government web sites or the Government Printing Office. For some reason, much medical and scientific research is only available for a price through private publishers, professional or scientific societies. For US taxpayers, it's like paying twice for the same thing – once in taxes that funds the grant, and again to read the results. This has been an issue for some time, and it looks like things are heating up.
[..] the battle lines shifted last month when a National Institutes
of Health report revealed that a compromise policy enacted last spring
– in which NIH-funded scientists were encouraged but not required to
post their findings on the Internet — has been a flop. Less than 4
percent filled out the online form to make their results available for
public viewing.
Now a key federal advisory committee has
recommended that scientists who receive NIH grants be required to post
their results within six months of publication. And the Senate is
considering legislation that would mandate such disclosures for an even
broader array of federally funded scientists.
Before the Internet, the only way to provide research results was to make journals free; that's a bad idea. Scientific journals generate needed revenue for societies and publishers. And when government funded results are available individually on web sites at no charge, people will still subscribe to and buy journals and magazines. Why? Because they are the easiest and most convenient way to read the articles – easier on the eyes, more conveniently delivered, stored and carried from place to place; you can even make notes on them.
Members of the ACC are not going to cancel their journals so they can spend hours at their computers reading papers. But students will have greater access. Those of us in industry will benefit, as will the industry – how many of you pop for th $12 to $30 for any of the journal articles I post about? I didn't think so.
Forbes Questions FDA Recalls
Forbes zeros in on one of health care's conuundrums, recalling potentially unsafe medical devices. While Forbes says, “Recalls aren't what they used to be,” they offer no proof of backsliding or laxness on the part of the FDA or medical device manufacturers.
drug-infusion pumps, four times in the year issuing warnings of serious
flaws to doctors and hospitals. Seven people may have died as a result
of problems with the pumps, says Baxter. In October the Food & Drug
Administration seized 6,000 Colleagues from company warehouses in
northern Illinois. Yet the pumps remain in wide use with the blessing
of the FDA: 80,000 times a day patients in hospitals and nursing homes
get their drugs infused through what could be a faulty Colleague.
The word “recall” does have one meaning in a regulatory sense, and another in common usage. A regulatory recall entails formal verified customer notification of a problem and corrective action. The corrective action can entail staff training, product testing, defective parts replacement, software upgrades, and or component redesign and replacement. The corrective action may accompany the recall notification or follow some time later. Ironically, not all recalls are a result of an unsafe product. Vendors may be forced to issue a product recall if they have strayed outside of regulatory boundaries and thus creating “nonconforming” and thus “adulterated.” For example, if a company determines that their device labeling is inconsistent with the intended use statement in their 510(k), their product instantly becomes adulterated and subject to recall.
As the Forbes article points out, rarely are devices yanked from service – especially ubiquitous devices like IV pumps. Sometimes, as in the case of implanted defibrillators and pacemakers, risks inherent in replacing the device could present a bigger safety risk than leaving a recalled device in place.
to mean a product is dangerous and needs to be taken out of service.
But medical devices have become so prevalent and complex that it’s
impossible and impractical to remove them all. Last year the FDA
recalled 87,000 Medtronic
(nyse:
MDT –
news
–
people
) defibrillators and 28,000 Guidant
(nyse:
GDT –
news
–
people
) pacemakers but didn’t require they be exhumed from people’s chests.
You can get the latest info on the Colleague pump recall here.
Of course what Baxter needs is not an upgraded Colleague pump, but a completely new device – and one that incorporates connectivity.
