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.

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.

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.

“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.”

Here are some hints at their other agency priorities, which suggest a more active FDA than we have been used to:

“We intend to work closely with the Centers for Disease Control and Prevention (CDC) to identify priority areas for joint action — such as the response to infectious-disease emergencies and outbreaks of foodborne illnesses and the development of safety systems to prevent lethal overdoses and drug interactions.”

“We look forward to working with the National Institutes of Health, the pharmaceutical and biotechnology industries, academic medical centers, and research universities to accelerate the development of cures.”

…

“To make important new treatments available to patients, the FDA should collaborate with the Centers for Medicare and Medicaid Services [...] as well as with industry and patient and consumer groups to explore ways of shortening the time from approval to reimbursement. One emerging opportunity is the area of personalized medicine, in which the agency should work with scientific leaders on novel approaches to treating illness.”

“In the domain of food safety, a public health approach starts with the use of data to identify the riskiest parts of an enormous and complex system. The FDA should partner with the Department of Agriculture and other federal agencies, states, and other authorities to establish a modern food-safety system focused on prevention of contamination. Working with Congress to modernize food-safety laws, the FDA must strive to build safeguards into every step of the production and distribution process.”

…

“The CDC and the FDA should also work closely to identify areas of potential progress in nutrition. A laissez-faire approach to nutritional claims can lead to more confusion than understanding. Working with industry and others, the FDA can support efforts to educate the public about nutrition and promote more healthful foods.”

“Globalization intensifies all the challenges the agency faces. With more than 200,000 companies from around the world selling food, cosmetics, or medical products in the United States, a public health framework provides the only viable way of protecting the American public. To anticipate the next import crisis like that involving contaminated heparin, the agency should assess imported products for their potential to cause significant problems.”

The whole article is worth reading, as it includes the Commissioner and Deputy Commissioner’s perspective on public communication of FDA matters.

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.

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.

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.

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.

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.

Expanding the Scope of the Regulation & Disclosure of Interests – Should institutions currently not covered by the regulations now be subject to them, and should all financial interests, direct and indirect, be disclosed?

Definition of Significant Financial Interest - Should the current exemptions and minimums for reporting financial interests be changed?  Are there certain financial interests that should be reported regardless of amount?

Identification and Management of Conflicts by Institutions – Currently institutions must appoint individuals to monitor potential conflicts, and determine steps to take in order to eliminate or reduce such conflicts.  The NIH is interested in several possible adjustments to these regulations.

Assuring Institutional Compliance – The NIH is interested in comments about additional enforcement options, as well as whether or not to require independent reviews or regular conflicts of interest training.

Requiring Institutions to Supply Additional Information to the PHS - Pretty straightforward.

Institutional Conflicts of Interest – Reflecting the move in the research community to address institutional conflicts of interest, here the NIH is seeking comment on whether regulations for these conflicts are required and what they might be.

Comments are due by July 7.

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.

I have my doubts that the bill will go anywhere.  The bill isn’t cheap, and Specter’s former colleagues might feel like blocking any of his bills for his defection.  While translational research could use some additional support, it is unclear that the independent research board and $2 billion per year is the best way for addressing the problem.  And while few at the NIH would object to a permanent $10 billion boost to the agency’s baseline, there would be growing pains that I doubt the agency is in a good position to handle.  That may be proven wrong if NIH handles the stimulus funding well.