What Will Be This Year’s Marshmallow Cannon?

Earlier today the White House announced that its next Science Fair will take place Monday afternoon, April 22nd.  That morning (11:30 Eastern), you will be able to watch the fair live.  Here’s the official announcement video, with highlights from the 2012 Science Fair.

This will be third Science Fair of this Administration (I think the third ever in the White House, but I can’t confirm that).  Invited participants include winners of the STEM Video Game Challenge and other competitions in science, technology, engineering and mathematics.

NCI To Examine Supposedly Failed Clinical Trials

The National Cancer Institute (NCI) is looking for ‘exceptional responders’ to the clinical trials associated with potential cancer drugs.  Such responders would be patients that responded well to drugs that the bulk of the trial population did not.  The hope is that determining why these responders did so well can provide insight into both the drugs and the specific cancers that they were targeting.

Part of this evaluation program ties into recently passed legislation that could allow drug approval for those substances that show evidence of exceptional responders.  The NCI and the Food and Drug Administration will work together on determining the details of the relevant approval tests by the legislative due date in 2014.

Efforts like these, to extract additional scientific knowledge from experiments, may become more common.  Changes in data analysis capacity make it easier to analyze experimental results, and connect them to personalized medical information (like a patient’s genome).  Outside the scientific perspective, funders seem likely to continue a one-two punch of constraining available resources and expecting greater direct return on their investment in research.  Trying to squeeze scientific blood from experimental turnips will become more appealing expeditious.  I prefer to think of it this way – when you’ve learned all you can from an experiment, how can it really be a failed test?

ProPublica Reminds Us That FDA Still Needs Repairs

The recent judicial rebuke over emergency contraception is just the latest example of the challenges the Food and Drug Administration (FDA) has had in getting its scientific and regulatory houses in order.  The kerfuffle over Plan B is different (but not an isolated incident) in that the interference in agency processes came from outside the FDA, rather than from within.  But the agency has a lot of work to do to deal with the conflicts, delays and struggles over drug and device approvals.  The agency is trying (the Commissioner did publicly disagree with the Secretary over Plan B), but it has a long way to go.

This week’s reporting by ProPublica (H/T Scientific American) focuses on the FDA’s relationships with contract drug testing companies.  The reporters recount how two companies were found to have conducted years of tests that were either unreliable or fraudulent.  As a result over 300 drugs needed to be retested, with at least 140 of those drugs already approved for sale.

None of the drugs were pulled from the shelves, even temporarily.  No public statements were made by the FDA about the retesting, even though the European Medicines Agency pulled seven drugs tested by one of the labs.  The FDA remains tight-lipped on the matter, and ProPublica has been able to identify only five drugs that were approved at least in part due to suspect tests of one of the two companies, Cetero (the other company is MDS Pharma Services).

(ProPublica has a number of other investigations worth looking into, many of which focus on medical and/or scientific topics.)

Clearly the FDA still has many challenges to tackle before it can effectively fulfill its regulatory obligations.  The bigger problem, as I see it, is an institutional culture that accepts glacially-paced efforts to correct errors, coupled with a complete lack of interest in informing the public.  I don’t envy Commissioner Hamburg’s task in trying to tame the agency.  I wish her the best of luck.

UK Parliament Committee Offers Suggestions For The Commercialisation Valley Of Death

Last Month the House of Commons Select Committee on Science and Technology released a report on research commercialization.  Titled Bridging the valley of death: improving the commercialisation of research the report presupposes a familiarity with U.K. research and commercial practices far beyond my experience.  For instance, the competitive environment for small and medium enterprises in the U.K. appears to be qualitatively different from the environment in the U.S.  However, the recommendations and other portions of the report have lessons that I think can be learned from by those within and without the U.K.

First was another reminder of how old and outdated cognitive models still dominate policy thinking.  From page 9:

“14. The Science and Technology Policy Research Unit (SPRU) at the University of Sussex, and Exeter Business School (EBS) expressed concern that the Government’s strategy for growth “still retains an implicit discredited linear model in many places” mentioning specifically the Knowledge Transfer Partnerships (KTPs). Others who criticised the idea that there was a single ‘valley of death’ tended to argue that the concept encouraged people to think that innovation was linear, and that financial obstacles were only found in one place.”

While other groups who provided testimony echoed the concerns of SPRU and EBS, testimony from others still in the sway of the linear model suggests David Edgerton is doing Sisyphean work.

Second was both the absence of and need for coherent strategies for innovation, as well as the need for broad thinking about the innovation ecosystem.  In this report such a need manifests in a call for an innovation agency (or rather the adjustment of an existing agency to more fully embrace that mission).

An added bonus I found is the beta of Gateway to Research – a product of the Research Councils UK (RCUK)  It appears to be a one-stop shop for the information each of the seven research councils has on the projects they fund.  It currently goes back to 2006, and there are data issues (which you can examine at the website).  RCUK is working to have the Gateway ready for alpha later in the year.

So Will Someone File A Scientific Integrity Complaint Against Secretary Sebelius?

In late 2011 Health and Human Services Secretary Kathleen Sebelius overruled the judgment of the Commissioner of the Food and Drug Administration (FDA) to prevent the availability of emergency contraception over the counter for girls under 17 without a prescription.  The decision was the culmination of a review ordered by a federal judge in 2009 in part to counter political interference in a scientific review of emergency contraception.  The Secretary attempted to provide scientific justification for her decision, which included concerns that the studies used in the review did not cover all ages that could possibly be provided access if the drugs were made available over-the-counter.  As I noted shortly after the decision, she made her decision a fight over science.  That reflected my lack of knowledge of the ongoing case.

Last week the federal judge that ordered the review issued another order chastising the Department for its decision.  As it did back in 2011, the Obama Administration stands by Secretary Sebelius and her decision.

The judge essentially concluded that the kinds of political interference that prompted the first review – connected to a previous administration – persisted into the current administration.  From page 11 of the Order:

“In my 2009 opinion, I traced the evidence demonstrating that the conduct of the FDA was influenced by the Bush White House, acting through the Office of the Commissioner of the FDA, and I held that this kind of political interference called into serious question the legitimacy of the FDA’s decision. In the present circumstances, the political interference came directly from the Secretary of Health and Human Services, a member of the President’s Cabinet.”

The case that he is dealing with is a Citizen Petition (filed in 2001, with the lawsuit following in 2005) to have the FDA “make all levonorgestrel-based emergency contraception, including Plan B, available for over-the-counter sales without age or point of sale restrictions.”

The judge has ruled that the FDA must make levonorgestrel-based emergency contraception available over-the-counter without a doctor’s prescription or point-of-sale or age restrictions.  The agency has 30 days from the date of the order (April 4) to comply.

Weekend Update Corner: Confirmations, Court Date, STOCK and Walport

Four updates addressing recent developments in ongoing stories:

Several of the Obama Administration’s recent agency nominations have moved forward in the confirmation process.  Energy Secretary nominee Ernest Moniz testified at his confirmation hearing last week.  In a nice contrast to recent Cabinet-level confirmation hearings, there was little drama.  Gina McCarthy’s recent confirmation hearing to become the next head of the Environmental Protection Administration (EPA) was not so genteel.  Given that both McCarthy and Moniz come to their agency’s top jobs with prior agency experience, I believe the difference can be attributed to the relatively hostile reaction the EPA generates in many quarter. The Senate confirmed new Secretary of the Interior Sally Jewell last Wednesday.  Still no official word on the next nominee to be Director of the National Science Foundation.

The Supreme Court will hear arguments this week in the Myriad Genetics case.  It will be limited to whether the genes at issue in the case would be patentable.  I would not expect an opinion before the end of June.

The Mineral Bills Are Coming Back

Many bills take years to finally work their way through Congress – if they ever get there.  The perennial subjects I’ve focused on here include medical isotope production, increased open access for research publications and helium supplies.

Another topic involves critical minerals, often called rare earth minerals (though not actually rare).  This year’s first bill comes from Representative Lanborn of Colorado.  Perhaps reflecting a lowered sense of expectations, the bill focuses on increasing the nation’s understanding of the extent of its mineral resources.  It is notably different from the one critical mineral bill that passed the House last year, so I can’t predict an automatic passage.  But I suspect that has much more to do with the persistent inability of Congress to pass much more than wind than any specifics of this bill.

So, Will Congress Cut NASA’s Budget Over China?

Yes, it’s a provocative title.  But I’ll show in a few lines that it’s not without precedent.

Representative Frank Wolf has written a letter to NASA (H/T ScienceInsider) over the planned attendance of Chinese officials at a conference held at a NASA facility.  The problem is that the participation of Chinese officials in the conference needs to be cleared by Congress.  This is due to a federal law Wolf wrote barring Chinese citizens from visiting NASA facilities.  While there is a provision allowing for a waiver, that process had to be completed two weeks prior to the event.  That deadline was last week.

No word yet as to what NASA’s official response will be.  Representative Wolf has requested a thorough review of all NASA facility visits since the law went into effect.  This suggests that even if this pending visit is resolved to his satisfaction, he may find other objectionable activity.

This is not the first time Representative Wolf has objected to Chinese participation in activities with federal agencies.  In 2011 Rep. Wolf objected to Chinese participation in meetings with Office of Science and Technology Policy personnel.  This led to a dramatic reduction in the office’s budget.  While Wolf may try to trim the NASA budget if he finds more apparent violations of the law, the agency does have some Congressional allies.  It may not suffer in the same way OSTP did (those budget cuts were nearly restored in subsequent years).

Brain and Brain! What Is BRAIN?

Those who get the allusion in the title, the program in question still stinks.

Announced at the beginning of April as one of the Obama Administration’s Grand Challenges, BRAIN (Brain Research through Advancing Innovative Neurotechnologies) is a new multidisciplinary, multi-agency program with roughly $100 million in the President’s recently announced budget for Fiscal Year 2014.  (Must note here the chronic failures of Congress in passing budgets make this funding far from a sure thing.)

Besides the federal research component (roughly $100 million from the National Institutes of Health, the Defense Advanced Research Projects Agency/DARPA, and the National Science Foundation) BRAIN will engage several non-governmental organizations to add over $100 million in additional research support.  The NGOs are the Salk Institute for Biological Sciences, the Kavli Foundation, the Howard Hughes Medical Institute and the Allen Institute for Brain Science.  The funding is anticipated to persist over a ten-year period.  So if the federal budget continues to be dysfunctional, there will still be some engagement in BRAIN.

Advisory Bodies Have BRAIN On Their Minds

Both the President’s Council of Advisers on Science and Technology (PCAST) and the Presidential Commission for the Study of Bioethical Issues will meet in 3 weeks.  Given recent developments, it seems likely they will both have a topic in common.

The Commission is scheduled to meet in Washington on April 30.  No agenda is available as of the day of this posting, but the Federal Register notice for the meeting indicated that incidental findings would be a focus.  Incidental findings have been on the Commission’s agenda for a while.  They represent data found from research and experiments that were beyond the scope of the research.  Typically this is an ethical challenge because informed consent of human subjects involved in such research is typically focused on the designed purposes of the research.

However, at the beginning of this month the President notified the Commission that he will formally request their input on the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) program.  This is a new cross-agency (National Science Foundation, National Institutes of Health, Defense Advanced Research Projects Administration/DARPA) program intended to increase our understanding of how the brain functions; how we think, learn and remember.  The Commission will be asked to evaluate the ethical, legal and societal implications of the program and related developments in neuroscience.  Comparisons to the Human Genome Project have already been made.

Also interested in BRAIN is PCAST.  During the public session (there have always been non-public sessions of PCAST meetings, they just started acknowledging it in print) of its May 3rd meeting (draft agenda), PCAST will hear from the DARPA director and the National Science Foundation Assistant Director for Biological Sciences.  PCAST has held discussions on neuroscience before.  It is possible that PCAST may pursue a report on this topic, but that likely won’t be clear until at least after the upcoming meeting.  The other part of the public session (aside from the usual public comment session) will focus on the impact of technological advances on productivity and employment.