Appointment Heading For The Exits

While the confirmation challenges continue, at least one high-level science and technology appointee is stepping down.  Margaret Hamburg, Commissioner of the Food and Drug Administration, will step down at the end of next month (H/T ScienceInsider).  Even with slightly less than two years remaining in the Obama Administration, there is a chance Dr. Hamburg’s successor may not be confirmed before a new President is sworn in.  (I am encouraged by indications that a nominee has already been identified.)

Hamburg’s tenure is one of the longest in the agency’s history.  When she took over, the agency was struggling, with ethical challenges over drug approvals.  The agency is currently in the middle of regulatory changes for food safety oversight and medical device approvals, and it has not been perfect.  There were complaints over the agency’s inaction over compounding pharmacies (which are not presently regulated by the FDA), and Hamburg was overruled by Health and Human Services Secretary Sebelius over Plan B emergency contraception (though the courts eventually sided with the FDA).

NSF Changes Transparency And Accountability Procedures

The National Science Foundation (NSF) announced in early December changes to its accountability and transparency procedures.  Based on some of the changes, it would appear that the move is also in response (see the third paragraph) to the Republican congressional efforts to explicitly connect individual grants to ‘the national interest.’

The changes are focused on how projects are described in grant proposals and abstracts.  While that may appear superficial, it’s worth remembering that most policymakers and members of the public will only encounter brief descriptions of scientific projects.  Like an abstract.

So, effective December 26, the NSF Proposal and Awards Policies and Procedures Guide was updated to reflect the following (quoting from the press release):

“Should a proposal be recommended for award, the PI may be contacted by the NSF Program Officer for assistance in preparation of the public award abstract and its title. An NSF award abstract, with its title, is an NSF document that describes the project and justifies the expenditure of Federal funds.”

“The guidelines for program officers in the Proposal and Award Manual now state that a nontechnical project description must explain the project’s significance and importance and “serve as a public justification for NSF funding by articulating how the project serves the national interest, as stated by NSF’s mission: to promote the progress of science; to advance the national health, prosperity and welfare; or to secure the national defense.” The titles and abstracts of NSF’s awards are made public on NSF.gov.”

What would be lovely to see is the commencement of a research program to assess how these new requirements are implemented, and how views of titles and abstracts change (if they do).  Will these new requirements be handled in the same way the ‘broader impacts’ requirements have been?  Will Congressional efforts to micromanage grant approvals make use of this information?

NIH IRB Proposal Reflects Proposed Common Rule Changes

The National Institutes of Health (NIH) has issued a request for comments on a draft policy concerning Institutional Review Boards (IRB).  The NIH proposes allowing multi-site research studies to use a single IRB for approval.  The idea is that concentrating the human subjects review approval to one IRB would reduce the administrative burden.  It is even possible that a single IRB review for multi-site research might increase protections by focusing the oversight to a single body.

Comments are accepted on the policy through January 29, 2015.

This draft policy reflects changes proposed in 2011 when the Department of Health and Human Services proposed changes to the Common Rule – the suite of regulations on oversight of human subjects research.  IRB approval is just one facet of those changes, so maybe there are additional policy proposals coming.  Even in today’s dysfunctional environment, 3 years is a long time to wait.

Clinical Trials Data May Get More Transparent

The Department of Health and Human Services (HHS), the parent department of the National Institutes of Health (NIH), has issued proposed rules concerning the transparency of clinical trials data (H/T Nature News, ScienceInsider).  The proposed rules should be published in the Federal Register soon, and with the 90 day comment period, submissions will likely be due around February 19.  NIH also released a Draft Policy, and is asking for comments by February 19.

The proposed rules are quite lengthy (over 400 pages); so lengthy that it might be folly to consider the NIH Draft Policy as an effective summary.  The main purpose of both is to increase the amount of data that is reported and available to the public (through ClinicalTrials.gov).  Adverse effects and negative results would be disclosed under these proposed policies.

However, as NIH Director Collins explains in a blog post, the NIH policy goes further than the HHS proposed rules.  The policy would apply to all clinical intervention trials that NIH funds (not just drugs), while the HHS rules are focused on summary data of certain clinical trials for drugs and therapies.

While an intention behind both policies is to close reporting loopholes, it’s not clear how effective the new policies will be in addressing the significant under-reporting of clinical trials data.  Ideally more results will be submitted to ClinicalTrials.gov and more results will be made available faster than they currently are.  But reporting on these policies suggests that the amount of data still not reporting is quite large, and these new policies may make only a dent.

The Non-Technical Challenges Facing The Truckbed Reactor

Lockheed Martin made some noise on Wednesday with its announcement that it had made a breakthrough in nuclear fusion reactors.  Specifically, it claimed advances in developing a compact reactor.  Based on size reductions achieved through new magnetic confinement techniques, the company will be able to develop a prototype reactor within five years that could power about 80,000 homes and fit in the back of a truck.

The announced advancements are relatively thin on details, suggesting that the promised advancements are currently theoretical.  Even if those gains can be demonstrated, a radical shrinkage in the size of fusion reactors could upend the regulation of nuclear reactors.  Smaller reactors will make it easier for non-governmental parties to build and use them (though deep pockets may well be required).  While the matters of waste, radioactivity, and weapons proliferation are different for fusion reactors than their fission cousins, they still need to be managed.  If there’s the slightest chance that Lockheed is not overstating its case, I think it’s worth having a conversation about how to regulate smaller fusion reactors.  Better to have rules before the technology is mature than after.

Kamen’s Arm Gets A Hand From The FDA

The Food and Drug Administration (FDA) is responsible for approving medical devices (among other things).  Which is why that agency had to review Luke, one of the many items Dean Kamen and his company (DEKA Research and Development) have developed that have transformative potential.  I’ve posted here about Kamen’s water purification technology, and most of you have likely heard of the Segway, which he developed as well.  Luke is the nickname for the DEKA Arm, which is funded by the Department of Defense.  DEKA is working with Next Step Bionics and Prosthetics and biodesigns, inc. to develop the project, which has been in the works since at least 2007, based on this TED talk.

The FDA approval means that the arm, which can translate electrical systems from the body into movement, can be commercialized.  It can be configured for those with limb loss at the shoulder or at the middle of the upper or lower arm (but not at the wrist or the elbow).  Luke represents advances in dexterity and precision that should allow users to do much more than is currently possible with similar prosthetics.

While the arm can now be marketed, it is far from certain that the devices will achieve widespread use.  Certainly the military, which helped fund the research behind Luke, could be in a position to make sure veterans and service members can obtain the arms.  But will insurance companies and medical professionals take to the device at numbers that would make the devices a commonplace for those missing their arms.

As for the increase in the cyborg population, I for one welcome our future part-robotic overlords. </Simpsons>

 

For Now You’ll Still Have To Spike The Punch Bowl With A Flask

Palcohol is one of those products that might sound like a good idea at first blush.  Further thought may cause you to change your mind.  It’s freeze-dried alcohol.  It will be offered in six flavors, and the product is going through the approval process at the Alcohol Tobacco Tax and Trade Bureau.

The reason it attracted attention this week is that the Bureau issued approved labels for the product and then indicated the labels had been issued in error.  The company believes that everything should be resolved once some changes are made on the labels.

The potential for abuse of this product seems pretty high (it will be pretty easy to overserve, and drinking won’t be the only way to consume it), so I would not be surprised to see some jurisdictions attempt to bar sale of the product, even after it is completely approved by the Bureau.  Whenever that ends up happening.