First, a few days ago the following broadcast was made on the US National Public Radio network.
Public Access to NIH Research (broadcast Friday, April 11th, 2008)
This week, rules went into effect that say that reports of research funded by the National Institutes of Health, the major medical research funding agency in the United States, must be made freely available after a maximum of one year. A publication based on NIH-funded work is now required to be deposited in a public database. The law says that "The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law."
More information and the Audio of the program is available from the following URL.
The details of the US approach can be found here:
Exactly the same should be happening in Australia. All publications that are funded more than 50% by the National Health and Medical Research Council – and other Government bodies like the Australian Research Council – should be freely available after a reasonable but not lengthy period – no more than 12 months at the outside in my view.
The best thing would be to create a fully searchable freely available Australian National Academic Repository and insist on contributions to the repository for the funding – with a few exceptions for areas such as national security etc.
What a great idea.
Second, very recently we had this published.
WellPoint developing drug safety monitoring system
Tue Apr 15, 2008 4:25am EDT
By Bill Berkrot
NEW YORK (Reuters) - Health insurer WellPoint Inc said on Tuesday it is developing a system that will use its 35 million-member database to monitor and help to more quickly identify potential safety problems of approved medicines.
WellPoint's Safety Sentinel System, being developed in collaboration with U.S. health regulators and other government and academic institutions, should in theory be able to uncover health risks that might crop up once drugs are being used by the general population more quickly than the FDA, doctors or drugmakers.
"When we see a signal within our claims data that suggests there may be an issue, we can very quickly work with our provider community to figure out if in fact it's real," Marcus Wilson, president of WellPoint's HealthCore unit, which is developing the system, said in an interview.
Merck & Co withdrew its widely used pain drug Vioxx in 2004 -- after more than five years on the market -- after a study showed it doubled the risk of heart attack and stroke. Had the WellPoint system been in place, it might have picked up the heart risk years earlier, Wilson said.
In a simulated test of the system using data WellPoint had available after Vioxx was first approved comparing patients on Vioxx with those taking other similar pain drugs, "we were able to see a clear separation in number of heart attacks and strokes within six months," Wilson said.
There is no reason the Therapeutic Goods Administration and Medicare Australia could not get the necessary approvals to do exactly the same thing in Australia.
Again, they just need to get on with it! We would all be safer if they did.