Per the New York Times, the President’s Council on Bioethics has been given its walking papers.  Although the Council’s authority was set to expire September 30, it has been asked to cancel its June meeting, and the members have been told their services are no longer needed.  I have found no indication that the naming of a new council is imminent, but it stands to reason that it should happen soon, at least prior to September 30.

The New York Times article notes that

“The council was disbanded because it was designed by the Bush administration to be “a philosophically leaning advisory group” that favored discussion over developing a shared consensus, said Reid Cherlin, a White House press officer.

“President Obama will appoint a new bioethics commission, one with a new mandate and that “offers practical policy options,” Mr. Cherlin said.”

Aside from the stem cell decision made by President Bush early in his administration, there have been few, if any, policy judgments made that received recommendations from the council.  It has issued several reports on various biomedical issues, but they were often readers on the subject, essay collections, or other documents more suited for background information than policy advice.  This is, of course, the perogative of the President.

Yesterday the National Institutes of Health issued a press release on the Challenge Grant program, which is designed to help spend some of the stimulus money awarded to the agency.  Approximately 20,000 applications were received (H/T The Scientist), which is equal to the number of applications the agency typically receives in a major review round.

How many grants will be rewarded?  According to the press release:

“NIH expects to devote at least $200 million in ARRA funding to Challenge Grants. In addition to the approximately 200 Challenge Grants that will be funded by the NIH Office of the Director, it is likely that more than 200 ARRA-related grants will be funded by NIH Institutes or Centers.”

So, 200 Challenge grants through the Office of the Director, and 200 or more stimulus related grants through other centers.  The acceptance rate is around 1-2 percent.  And this is after Senator Specter’s vote was purchased with a $6.5 billion boost to NIH funding.  It appears that the oversupply of biomedical research grants will keep acceptance rates low regardless of the money thrown at the situation.

In what might be a microcosm of the pending struggle over the nation’s health care system, a radiologist has proposed in Nature magazine that stablizing tumors at a manageable size, rather than eliminating them entirely (H/T 60 Second Science Blog).  This is a significant shift in traditional strategy, which is usually to knock out the cancer – sometimes repeatedly, should it recur.  Put another way, treat the disease as chronic and manage it with smaller doses of chemotherapy, rather than seeking the death strike and risk the potential of resistant cells returning with a vengeance.  Robert Gatenby, the radiologist behind this idea, compares this different strategy to the integrated pest management approach to invasive species, which was accepted by the Agriculture Department as far back as the Nixon Administration (as it happens, the beginning of the War on Cancer can be traced to the Nixon Administration as well).

A parallel with the upcoming debates over the U.S. health care system would be the current emphasis in the United States on treatment and prolonging the last years of life over prevention and other longevity measures.  While it may be an open question in either situation whether or not changing tactics would be more effective, there will be significant resistance to entertaining the idea in either case.

The new Commissioner and Deputy Commissioner of the Food and Drug Administration, Margaret Hamburg and Joshua Sharfstein, outlined their priorities for the FDA in a recent Perspectives article in the New England Journal of Medicine.  Acknowledging the stumbles of the FDA in the last few years, they seem concerned about making sure the FDA is more of a supporter than a hindrance to action in public health and food safety.

“From our vantage point, the recent salmonella outbreak linked to contaminated peanut butter represented far more than a sanitation problem at one troubled facility. It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls. And it exposed the failure of scores of food manufacturers to adequately monitor the safety of ingredients purchased from this facility.”

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From the New England Journal of Medicine we have this review of digitally-enabled public health surveillance.  The recent online activity over the swine flu and Google Flu Trends are only the latest efforts in activity that go back 15 years.  What started with reporting systems has grown to include news aggregation, mashups, and, yes, even the Internet darling of the moment, Twitter.  The authors are concerned, however, that the increasing online capacity for assessment and analysis not displace the work of public health practitioners and clinics.  Put another way, its fine to look up symptoms online, but you should still see a doctor if needed rather than self-diagnosing.  There are other concerns:

Information overload, false reports, lack of specificity of signals, and sensitivity to external forces such as media interest may limit the realization of their potential for public health practice and clinical decision making. Sources such as analyses of search-term use and news media may also face difficulties with verification and follow-up. Though they hold promise, these new technologies require careful evaluation. Ultimately, the Internet provides a powerful communications channel, but it is health care professionals and the public who will best determine how to use this channel for surveillance, prevention, and control of emerging diseases.

Given the title of the NEJM piece – “Digital Disease Detection – Harnessing the Web for Public Health Surveillance” – I think another pair of concerns to add is privacy and security.  If IP addresses can be tracked, which is true with some of these cases, then it is possible to connect particular incidents to particular individuals.  Unless its necessary to communicate with specific individuals, measures should be taken to preserve the anonymity of those whose information supports this public health monitoring.  The security of the databases and other systems using this information need to be strong enough to guard against breaches and inadvertent exposure.

No, the National Institutes of Health are not going up against Merck, GlaxoSmithKline and the other companies of Big Pharma.  They are going to start drug development research on so-called “neglected” diseases (H/T ScienceInsider).  The $24 million program (less than .1 percent of the total NIH budget) to establish a drug development pipeline will trigger a new initiative called Therapeutics for Rare and Neglected Diseases (TRND) coordinated through the NIH Office of Rare Disease Research.  The NIH defines a rare disease as one that affects fewer than 200,000 Americans (less than .067 percent of the population), and estimates there are 6800 rare diseases affecting 25 million Americans (nearly 1 in 10 of us).

I think this is a perfectly reasonable thing for government to take on – fill in the gaps in biomedical development that are not currenlty being addressed by the private sector.  Given the costs of pharmaceutical research, companies often focus on diseases or conditions that affect millions of people.  Government can also make any drugs developed for these diseases available relatively cheaply, as they are not motivated by profit in these endeavors.

That’s an interpretation of this analysis in Cell Stem Cell (no, that’s not a stutter, but a journal title).  In short, there is a significant concern that the consent standards required by the new NIH guidelines (currently under public comment) would preclude using most existing stem cell lines, including those that were accepted under President Bush’s stem cell research guidelines.  Of course, we are talking about federal funding for these stem cell lines; private entities will be free to continue to fund stem cell research.  The new guidelines were drafted in response to President Obama’s Executive Order removing the guidelines of the previous administration.

The issue is the retroactive application of informed consent standards.  For reasons listed in the piece that are primarily legal/judicial in nature, the authors of the analysis consider retroactive regulations to be an unfair infringement, equivalent to an ex post facto law which is specifically proscribed in the Bill of Rights.  From a research perspective, such retroactive regulations are problematic where consent procedures are concerned because it is usually difficult, if not impossible, to conform old consent actions to new consent procedures without violating subject confidentiality (or anonymity), or the validity of the experiments in the research.  As a result, most current NIH grants in this area would have to be stopped.

Given that President Obama’s actions on stem cell research and scientific integrity were issued on the same day, I find it ironic that an effort to preserve one could serve to undercut change in another.  The comment period on the stem cell guidelines should close soon, and we will see whether or not the final regulations will manage to have a chilling effect on stem cell research that could rival the effect following President Bush’s 2001 limitations.  If this is the case, some comfort could be taken in the Obama Executive Order, which allows for the NIH to review and update the guidelines as appropriate.  This ought to be a lesson to those who thought the issue was resolved with the March Executive Order.

Picking up on a post from last month, ScienceInsider and others have reported on a lawsuit that may test the validity of gene patents.  The Public Patent Foundation and the American Civil Liberties Union have filed suit against Myriad Genetics, which is the company owning the patents, and controlling the genetic tests, for the BRCA1 and BRCA2 genes that show a predisposition to breast cancer.  Among the allegations is that the monopoly on these genes and the associated diagnostic tests prevents patients from obtaining a second opinion.  Apparently any examination of these genes requires permission from Myriad Genetics, which seems like an overreach of the traditional conception of the protection afforded patent holders.  The consequences to individuals include the inability to have other scientists assess the results of the tests and the influence of these genes on the potential for cancer.  General effects include a chill on research into these genes, and other consequences addressed by Nobel laureate in Physiology or Medicine Sir John Sulston.

It’s unfortunate that the validity of gene patents is going to be tested in this fashion, as I don’t expect this validity to be shaken.  Perhaps it’s a consequence of the deep pockets necessary to participate in a patent infringement case (on either side), but I think some kind of fair use or research exemption arrived at through an infringment action is a stronger legal claim than infringement of free speech.  Since the state of genetic understanding over the last several years has typically exposed more about what we don’t know that what we do know, to restrict access to genes like BRCA1 and BRCA2 appears to cause more harm than good.

Last Friday the National Institutes of Health issued a request for comment in the Federal Register (H/T ScienceInsider).  They seek comments on whether or not the current policies on conflicts of interest need to be amended.  Comments are due July 7 and can be submitted online, by mail, fax, or in person.  Check the request for specific submission instructions.

The focus of these policies is on research involving human subjects or other research where the Public Health Service may be involved.  There are some specific questions they are seeking comments on, which I’ve summarized after the jump.  Consult the request for comment for additional details.

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Senator Arlen Specter’s recent decision to rejoin the Democratic party (he was a member in the 1960s), attracted a fair amount of attention this week.  What did not was his effort to give yet another boost to National Institutes of Health funding and create another biomedical research agency. Senator Specter wants to reset the baseline of the NIH to $40 billion (roughly the amount of the current NIH budget plus the $10 billion increase from the stimulus bill.  $6.5 billion of that $10 billion was courtesy of the Senator).  In addition to this permanent 1/3 increase in the NIH budget, Specter wants to establish a new agency, the Cures Acceleration Network, to help translational research.  This is research to facilitate converting the knowledge of scientific discoveries into usable cures.  Specter uses the phrase “valley of death” to refer to this kind of research, though readers may be more familiar with that phrase in a more general context of commercializing university research.

The plan can be found on a new website, SpecterForTheCure.com.  The domain name should tip you off that this is a campaign website, you can see the copyright notice for Citizens for Arlen Specter.  Nothing wrong with that, I note it because I have a hard time recalling other instances where research as an issue factored in a campaign for office when an initiative or other measure was not also on the ballot.  Specter will introduce legislation soon, if he hasn’t already, but press reports indicate the new agency would be funded at $2 billion under the legislation, and serve as an independent federal agency, like NASA.  It would be outside the NIH or the Health and Human Services Department.

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