Archive for the ‘Health’ Category

Watch Out for Those Fake Journals

May 2nd, 2009

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The Scientist reports on the efforts of Merck to create a journal that looked like it was peer-reviewed, but only contained summaries or reprints of other research.  Working with the publisher Elsevier, Merck supported the Australasian Journal of Bone and Joint Medicine, a journal that is not indexed in MEDLINE, a major index of biomedical research, nor is there a website for the journal.  The existence of this journal came about during an Australian lawsuit over the recalled Merck drug Vioxx.  You can review two issues online.  According to witnesses in the trial, the preponderance of articles covered in the journal were about Merck products, and some of the review articles were very thinly sourced.  A journal with even moderate review standards and a board with members who are awake and coherent wouldn’t let this pass.

There are two particular concerns here.  This suspect conduct in biomedicine does nothing to help that field combat the issues surrounding conflicts of interest.  Additionally, this misleading activity points out that the lay reader, or even Ph.Ds reading outside their speciality, may not be able to effectively assess the quality or potential biases of journals and research.  Working in policy, it’s much more common to consider the sources of research and give those products effective scrutiny.  Being more open and transparent about the processes behind journal submission, review and publication can help combat the relative ease of others to sneak in low-quality or biased research under the guise of quality journals.

Swine Flu, Technology and Policy

April 27th, 2009

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This is not the first time flu and technology have intersected.  While Google Flu Trends is currently mum on the swine flu, you can track CDC notices via Twitter or its official Swine Flu pageGlobal tweets are also available (H/T Marc Ambinder).

A couple of policy points worth making here.  We currently have an acting director of the Centers for Disease Control, no doubt at least in part due to the continuing absence of a confirmed Secretary of Health and Human Services.  While that might also explain why Homeland Security Secretary Janet Napolitano has been the highest profile government face on this issue, it’s a good argument to try and make sure the transition process can happen more smoothly and more quickly to allow for staff to take positions sooner after January 20 than is currently the case.  Secondly, it would be worthwhile to evaluate the public health response in the U.S. to this flu (especially if it gets worse), and see what changes, if any, need to be made.  $420 million in funds for pandemic flu were removed from the recent funding bills, and it would be nice to know whether that was a good call.

A final point.  It’s relatively early in the process here.  While the cases in the United States have not been as widespread, nor as lethal, as those in Mexico, we simply don’t know enough yet to be sure.  This item from the New York Times explains some of the yet unanswered questions that will help map this particular outbreak.  This post from Effect Measure helps explain what the numbers mean (and don’t mean) and what makes an epidemic, pandemic, and outbreak.

Varmus Interview Discusses NIH Organization, Research Balance

April 26th, 2009

Posted by: admin

Co-Chair of the new President’s Council of Advisers on Science and Technology (PCAST), Dr. Harold Varmus, has a new interview at American Scientist’s website.  The interview covers his work in science and science policy.  Those readers not familiar with biomedical research or the NIH will learn more about how the NIH may not be as disease-centered as coventionally thought.  You will also find some suggestion that PCAST will be a more vital and active advisory body than it’s been before.

Unfortunately, the interviewer asks a question that somehow completely confuses the problem of politicization in science.

Do you think controversial scientific questions, such as the use of human embryonic stem cells, can ever be removed from politics in the United States?

While Varmus appears to accept the premise and say that they can, a careful reading of his response demonstrates how questions involving ethics choices – like the use of human embryonic stem cells – always involve some level of politics.  He speaks of how the U.K. and the U.S. used different forms of regulation to control the use of human embryonic stem cells, and how an effective incorporation of scientific expertise in the political process would allow for effective rules on research to be established and used.

NIH Issues Draft Stem Cell Funding Guidelines, Focuses on Embryos Generated for IVF

April 20th, 2009

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On Friday the National Institutes of Health issued draft guidelines for funding research on stem cells.  This guidelines are in response to the March Executive Order issued by President Obama revising the previous funding constraints on stem cell research.  The guidelines are for extramural research, as internal NIH procedures cover all intramural research.

As is all too common with this issue, things get blurred pretty quickly.  This funding and associated guidelines are for research conducted on the stem cells, and cannot fund the derivation of human embryos.  The Dickey-Wicker Amendment bans such derivation.  The guidelines also restrict NIH funding to embryonic stem cells derived from embryos created for reproductive purposes that would otherwise be discarded.  Research on adult stem cells and induced pluripotent stem cells can *continue* to be funded by NIH dollars.  As it stands, this is not a free-for-all.  From the announcement of the draft guidelines:

NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed under these Guidelines.

As I noted, these are draft guidelines, and comments can be submitted to NIH.  The comment period is 30 days from the publication of a notice of rulemaking in the Federal Register, which should happen this week.  Check back to the NIH link I provided above to find the final date for comments, which should be no later than May 24, along with more specifics about how and where to send your comments.

Robert Cook-Deegan Reviews The Art and Politics of Science

April 12th, 2009

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In the March-April issue of American Scientist, Robert Cook-Deegan reviews the memoir of Harold Varmus, The Art and Politics of Science (H/T Review-a-Day).  Cook-Deegan runs the Center for Genome Ethics, Law and Policy at Duke University, and has written a wonderful review.  I recommended the book earlier this year based on an excerpt. Anyone still not persuaded of the need to read the book, or to follow Varmus as he serves as co-chair of President Obama’s PCAST (President’s Council of Advisers on Science and Technology), will be after reading Cook-Deegan’s review.


GAO Borrows Sting Tactics from Chief Wiggum to Bust For-Profit IRBs

March 27th, 2009

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Nature’s The Great Beyond blog has an interesting, if annoying, entry on a recent Congressional investigation into for-profit Institutional Research Boards (IRBs).  For those readers who haven’t done research involving humans, IRBs sign off on research protocols in human subject research.  Universities and other non-profit research organizations have them, but there are also for-profit IRBs.  As the profit motive in such operations can skew toward generating approvals rather than fulfilling the expected research oversight, a Congressional investigation into these companies makes sense to me.

You can read the specifics – statement from witnesses and Representatives, supporting documents – about the hearing via the House Energy and Commerce Committee’s website.  The really short version – the committee had Government Accountability Office (GAO) investigators set up fake companies with fake products seeking IRB approval.  So far, so good.  The tactics, however, suggest an interest in the eventual Congressional grandstanding had way too much influence over the investigation.   From the blog entry:


NIH Can See the Hard Landing This Time

March 26th, 2009

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ScienceInsider reports that the House Appropriations Committee (the Labor, Health and Education Subcommitee) recently held a hearing on stimulus spending and the National Institutes of Health.  A webcast of the hearing is currently online.

An exchange between the subcommittee chairman, Rep. Jackson (D-IL) and Acting Director Kington noted the potential hard landing after the stimulus funds are spent by NIH and the acceptance rate declines as the budget comes back to Earth.

But hearing chair Jesse Jackson Jr. (D–IL) noted the obvious: The 2-year bolus of money could prove to be “a double-edged sword” if scientists can’t keep going when NIH’s budget drops to normal levels in 2011.

Raynard Kington, NIH acting director, said that because the stimulus-funded grants will lead to new advances and ideas, NIH expects a rise in applications in 2011. As a result, the success rate for grants could “drop several points below what it has been” if NIH does not receive a “substantial” budget increase, Kington said. The success rate is projected to be 21% in 2009, NIH officials say, which is close to the historical low.

Just because the cliff can be seen doesn’t mean it will be avoided.  It just makes it easier.

Comparative Treatment Research Program Part of Stimulus

February 22nd, 2009

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Scientific American’s 60 Second Science Blog reports on a research program in the stimulus package that will compare how different medical treatments address various ailments.  The overall goal appears to be addressing rising health care costs, which explains why some of the opposition to this program comes from those concerned that it will lead to rationed care.  The project will be guided by a 15-member council and will coordinate its work with the Department of Health and Human Services, the National Institutes of Health, and the Agency for Health Care Research and Quality.  Other countries, including England, France and Denmark, conduct similar research, but how their research outcomes affect treatment or health care varies.

Science Agency Guidance on the Stimulus

February 21st, 2009

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While the National Science Foundation will wait until next week to release its guidance on the stimulus funding it is responsible for (in part because the National Science Board will meet on the subject early next week), the National Institutes of Health has released a letter (H/T DrugMonkey) outlining how it will handle its stimulus funding, at least where grants are concerned.  Acting Director Kingston indicated that his organization will focus on the following items:


Senate adds NIH Funding to Stimulus Bill?

February 4th, 2009

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The Scientist is reporting that the Senate has added to the stimulus bill, by amendment, an additional $6.5 billion in funding for the National Institutes of Health (NIH).  Given the apparent rediscovery of reduced government spending by the Republican Party and the continued incompetence of the Congress, it remains to be seen whether this current stimulus bill goes anywhere.  If it does, there are at least two serious issues worth noting: