Thursday, November 01, 2007

Washington News You Should Know About

I have been absent as of late, largely because I have been a bit under the weather with bronchitis which has rendered me pretty sick. However, I have remained on top of issues that should be of interest to people in the diabetes community.

Most notable were two news stories from this morning's Washington Post. The first story was regarding a debate over whether the results of government-funded NIH research should be made freely available to the public, which had potential to make a big step toward resolution as members of a House and Senate conference committee met to finalize the 2008 Department of Health and Human Services appropriations bill.

While it sounds like common sense, believe it or not, today, not all research paid for by U.S. citizens is accessible to them. A two-year-old National Institutes of Health policy encourages, but does not require, NIH-funded scientists to publish in open-access journals. The current NIH Public Access Policy, which was first implemented in 2005, is a strictly voluntary measure and has resulted in a deposit rate of less than 5% by individual investigators, so the policy has largely failed. While there are many small not-for-profit societies who publish journals, the overwhelming majority of biomedical journals are now published by international giants - Elsevier, Wiley/Blackwell, Wolters Kluwer, which are for-profit publishing companies, not groups of scientists and/or doctors.

As the Post noted, the basic idea is that consumers should not have to buy expensive scientific journal subscriptions, or be subject to costly per-page charges for non-subscribers in order to see the results of research we have already paid for with our taxes. Rather, we should be able to access this information on the Internet for free because we have paid for this research. The new rule would enable scientists to publish anywhere they want, although the scientist(s) receiving NIH funding would be required to place a copy of the final version of the paper into PubMed Central, a government database that is free to anyone, and those articles would be available 12 months after the publication of the article in the medical or scientific journal. A number of years ago, scientific papers were published in common scientific journals of the day, but were not copyrighted and could be freely copied. That has changed in the past 30 years especially, and today, the publishers essentially own the article (largely because most journals require authors to sign the rights over to the journal) content, a sweet deal -- if you're a journal publisher. But taxpayers aren't getting their money's worth when the research remains locked away in publisher's databases who claim they own the rights to the content we paid for. Advocates assert that open access will speed innovation by making it easier for the results to be shared and enable others to build on those findings.

Director Elias A. Zerhouni said "Congress recognizes that, in the Internet age, unimpeded access to publicly funded research results is essential for the advancement of science and public health."

Not surprisingly, this legislation has gained widespread bi-partisan support in both the U.S. House of Representatives and the U.S. Senate. But the danger is that President George W. Bush may veto the bill. With both Senate and House appropriation committee chairmen in favor of the legislation, under normal circumstances, the language requiring the change would normally be virtually assured. But the Post reports that Capital Hill watchers say that given President Bush's threat to veto the bill for budgetary reasons and the likelihood of a continuing resolution (which would not have the new language) it might be too soon for the open-access movement to publish a victory paper.

The other article related to the U.S. Food and Drug Administration (FDA). Although the volume of prescription drugs and drug ingredients coming into the country from foreign manufacturers in developing nations (notably India and China) has exploded in recent years, the FDA's budget for foreign inspections has not kept pace and will actually be lower in 2008 than it was in 2002, according to Congressional investigators. The article says that means foreign drug and drug ingredient makers are inspected on average once every 8-12 years, while American-based manufacturers must be inspected at least once every 2 years.

I won't elaborate much further on that other than to say that the FDA's user fees for non-U.S. based manufacturers should be increased significantly to pay for inspections. Although I hate the user-fee system, but if we're going to have one in place, then we should make sure those costs are equitably distributed so we can have sufficient inspections. Enough said.

5 comments:

BetterCell said...

Many of the chemical companys in China are supplying various ingredients that go into the making of Generic Drugs here in the U.S.
There have been a significant amount of these chemical companies that have been supplying contaminated or lower bio-active ingredients to these Generic Manufacturers of Pharmaceuticals.
Since they
are always looking at the "bottom line" to save and make as much money as possible. This risk means more contaminated products and chemicals from China since the FDA is only able to check on no more than 7% of what is coming in from other countries(China).
The situation is too dangerous for the Consumer who is limited to Drug Plans that only cover Generics.
In this case, Savings does not equal/mean Safety.

Scott said...

True, and I think Indian companies have a generally better safety record than their Chinese counterparts, although I think both countries have a long way to go; in the interim, our regulators need to step up to the challenge with more regulation and inspections. The user fees must start to examine content orient, today they do not do so.

BetterCell said...

Out-Sourcing and Free-Trade have destroyed the safety of our Pharmaceutical Industry and our Food Industry as well because we are getting everything from "over there" rather than here, which at one time was the rule and how things were done. When that was in place, there were "Safe Drugs" and "Safe Food" that were free of Contaminants, E-Coli and were better regulated/inspected.

Chrissie in Belgium said...

Just wanted to say I am glad you are feeling better Scott!

Anonymous said...

Scott--

While I am for public disclosure of all publicly-financed research data/studies, I cynically question how valuable these tools may be. (The up-side of such publication--besides informing the public--might allow scientists to circumvent reinventing the wheel as they enter a previously-explored pathway.) The downside might be the "legitimacy" of the information provided by journal publication.

Aubrey Blumsohn (at scientific-misconduct.blogspot.com) wrote an article titled: Elsevier, IBM, Academic freedom and pubic health where he shows how the integrity of many of our "auspicious" medical journals has been eroded. This may not speak exactly to your issue, but it is a good read, and if nothing else, shines light on some of the shady dealings between industry and the prestigious medical journals.
http://scientific-misconduct.blogspot.com/2007/10/elsevier-ibm-academic-freedom-and.html