The National Science Foundation finally put up a web presence for its part in the BRAIN initiative. Announced a little over a year ago, the BRAIN initiative is a multi-agency program that is also a public-private partnership with various companies and foundations. The focus of the initiative is to develop tools and foundational knowledge for researchers to get a better picture of the activities in the brain.
Until recently the only federal agency involved with the initiative with a website on it was the National Institutes of Health. I have yet to find a similar portal for the Defense Advanced Research Projects Agency (DARPA), though there is this press release. But the National Science Foundation has finally opened a web presence for its part of the initiative (H/T SSTI). Arguably it’s website is the most public-facing of the three agencies, but the bar is set quite low in that regard.
What would be nice, but is not likely to come, is some government-wide site that provides a broad picture of the activities in this initiative. Each agency can speak effectively to its particular function within the larger project. But with three agencies dealing with $200 million (the President has asked for double that money for the next budget), and private entities also involved, looking at the NIH and NSF websites can’t help but present an incomplete picture of what’s going on. And that makes the promotion of this initiative, and of whatever results emerge from it, all the harder to explain – to funders and to the public.
The American College of Medical Genetics and Genomics (ACMG) has changed its mind on the subject of incidental findings (H/T ScienceInsider). Such findings are things found that were beyond the scope or focus of a particular test or procedure. A little over a year ago ACMG issued recommendations on incidental or secondary findings. While there was some disagreement on what they meant, a particular issue with the recommendations was that patients should be notified of the findings, whether they wanted to know them or not.
The latest report changes that policy to allow for patients to opt out of such notification, specifically at the point where genomic sequencing may be ordered. This changes the tenor of the initial recommendations, which encouraged labs to actively look for particular mutations. It’s certainly easier to facilitate an opt-out option if it’s done before the findings can be established.
No word yet on how much the report on incidental findings from The Presidential Commission for the Study of Bioethical Issues influenced this change. But I’m not surprised to see a significant push against the initial policy, as it could be reasonably seen as coercive. Here’s to the willingness of organizations to change their collective minds.
The President’s Council of Advisors on Science and Technology (PCAST) will meet again next Friday, April 4, in Washington. The public session is scheduled, per the current agenda, to run from 9:30 a.m. Eastern until noon. As is customary the meeting will be webcast, and an archive will be available through the meetings page of the PCAST website.
This morning meeting will focus on two report and one panel that science policy stakeholders should find of particular interest. As part of the President’s review of big data, privacy and the economy, PCAST was asked to conduct “a study to explore in-depth the technological dimensions of the intersection of big data and privacy.” The subject was a theme in the January 2014 meeting, and the report will be discussed at this one. Another report, focused on anitmicrobial resistance, will also be discussed.
The 10:45 panel is titled “Analytical Techniques to Improve Public Policy Decision Making.” Panelists come from a variety of fields – sociology, computing, digital advertising and bioinformatics. I don’t know if this panel is intended to inform the big data report or if it’s focused on a completely separate project. Perhaps we can all find out on April 4.
The President’s Fiscal Year 2015 (which starts on October 1, but likely won’t get funded until next February) budget rollout includes doubling support for the BRAIN (Brain Research though Advancing Innovative Neurotechnologies) Initiative. The $100 million multi-agency (National Institutes of Health, Defense Advanced Research Projects Agency and National Science Foundation) public-private effort will have some of its first funding awards later this year.
A compatible project in Europe, the Human Brain Project, recently announced a dramatic expansion of its consortium. While not providing funding support at a comparable level, the HBP just added 32 research organizations from 13 countries. It’s focus is on developing a model for brain function, while BRAIN is focused more on imaging and controlling brain activity. As you might suspect, there are already informal collaborations between HBP and BRAIN supported institutions. The two projects opted to make it official just recently. But it’s not publicly official, as there are still some wrinkles to be worked out. Chief among them are the differences in medical ethics and data sharing practices and regulations between the European Union and the U.S.
The National Institute of Mental Health (NIMH), one of the National Institutes of Health (NIH), is changing its criteria for funding clinical trials. Director Thomas Insel explained the decision in a blog post late in February (H/T Nature News). It’s a shift in focus that resonates – at least for me – with the NIMH decision last year to not use the DSM-V in how it organizes research on mental illness.
For clinical trials moving forward, NIMH will require that the proposed treatment being tried is not the sole purpose of the trial. The trial must also generate knowledge about the mechanisms underlying the relevant disorder. In other words, it will not be enough for a trial to see whether a drug has the desired outcome (usually controlling symptoms). The trial would also have to increase the knowledge base around the underlying condition. This shift in focus will accompany a set of new standards for efficiency, transparency and reporting. Insel and others at NIMH have looked at current Institute trials and found them wanting.
“Recent performance in our clinical trials program is not acceptable: recruitment is too slow, registration in public databases is not consistent, and reporting takes too long to meet the needs of the public for better treatments. To respond to the public concern that “time matters,” we will be establishing new requirements for timelines, trial registration, publication, and data sharing.”
The new criteria will apply to all new applications of trials, effective immediately. The transition will not be easy, but the prospect of being able to do more than just treat the symptoms of psychological conditions is enough to make the Institute act.
Yesterday genome sequencing innovator J. Craig Venter announced his latest venture, Human Longevity, Inc. (HLI). The company has $70 million in startup funding to promote healthy aging through genomics and cell-therapy based therapeutics and diagnostics.
The first phase of this effort is to construct a large genome-sequencing center. When at full capacity, the center would be able to sequence 40,000 sequences per year, with a possible increase to 100,000 sequences per year. With the machines HLI has purchased, the company anticipates the cost per genome to be around $1,000.
The company will focus its efforts on several diseases: cancer, diabetes, obesity, dementia, heart and liver diseases. It’s established partnerships with several universities and research institutes to sequence the genomes of consenting clinical patients (though ScienceInsider’s report suggests patients will have to speak up if they don’t want to participate).
While the company is interested in making genomic sequencing cheaper, they are operating in a big industrial fashion that seems unlikely to pass along any improvements to the individual. That is, HLI is not likely to become a genomic equivalent to 23andMe. While that probably means the company will handle its interactions with the Food and Drug Administration much better than 23andMe, the proprietary aspect of HLI’s business models don’t leave much room for those who contribute their genomic data to benefit from their contributions. So the $1,000 genome sequence really won’t be the price for the person on the street.
A Food and Drug Administration advisory panel provided some filler for the 24-hour news channels this week. The reason: discussion of mitochondrial replacement as a means of in-vitro fertilization (IVF). It involves a ‘donor’ cell which has its nucleus removed to receive the nucleus of the mother (it bears some resemblance to somatic-cell nuclear transfer, except there is an additional DNA source involved). This method could be used for situations where the mother has mitochondrial defects that could be passed on to the offspring.
The method gets the superficial cable news attention because the resulting offspring would have DNA from all three donors. While the Presidential Commission for the study of Bioethical Issues has not weighed in (it doesn’t meet again until June), the FDA panel discussed the state of science and research on the technique, as well as the design requirements for early-phase clinical trials. Researchers have produced monkeys via this IVF technique, but panel members were reluctant to recommend human trials at this time.
Over on the other side of the Atlantic, the U.K. is further along in regulating the technique. The appropriate advisory bodies started assessing mitochondrial replacement in 2011, and the government announced last year that it was working on regulations. It issued a consultation on Thursday for the draft regulations (questions of interest are on pages 27-28). Responses will be accepted until May 21.
Here are some recent items of note.
Open Access: Both Science and The Royal Society have announced plans to establish open access journals. Science Advances will be financed through author charges, aim for rapid publication, and use an editorial model comparable to that of scientific societies. Royal Society Open Science will be the first broad-based journal from the Society, focusing on the full range of science and maths. It follows a similar financing model to Science Advances (gold open access), that some in the UK have criticized as not encouraging the development of institutional repositories.
Petitions: Two recent responses to petitions at the We The People website considered science-related topics. The Administration responded to a petition concerning net neutrality and another on access to clinical trials and compassionate use. While the net neutrality response was characterized as a reassertion of government policy, the White House demurred on making a statement on the second matter to avoid interfering in the determinations of an independent government agency.
Science Raps: Tom McFadden has been busy. His third rap video release this month focuses on metals, and comes from students at the Nueva School.
Physics Caucus: The Congressional Physics Caucus will likely have fewer members in the next Congress. Representative Rush Holt of New Jersey announced he will not seek re-election this fall. When he leaves in early January 2015, he will have served 16 years. He holds a Ph.D. in physics from New York University, and was assistant director of the Princeton Plasma Physics Laboratory at the time he was elected to Congress. Representative Bill Foster is the other current member of the Physics Caucus. Best wishes to Representative Holt in his next endeavor, whatever that might be (I’d wager that Franklin’s List is planning to get him involved).
The Food and Drug Administration (FDA) is going to study whether or not drug advertisements on television need to be changed. There are concerns that the current model, where all of the drug’s side effects are supposed to be listed, is giving a realistic picture of the benefits and harms of the advertised drug.
(FWIW, it certainly provides an easy, if sometimes lazy, vehicle for comedy.)
The Federal Register notice describes the possible study, and explains what the FDA hopes to accomplish. The idea is to examine the effects on consumer understanding of providing different levels of risk information in a direct-to-consumer advertisement (while the request is specific to television, I have to think any changes would influence other advertising).
“Our hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks. We will also investigate other questions such as whether overall drug risk and benefit perceptions are affected by these changes.”
As the FDA is at the study phase of this particular regulatory process, it will be months before we have a different form of commercial for comedians to mock.
More music to share today.
Hot on the heels of the Brahe/Kepler fight, Tom McFadden has dropped the last in the series of Brahe’s B.A.T.T.L.E.S. This time two diseases fight it out for lethal supremacy. See how the black plague and the yellow fever try to one-up each other in this video. The choice of song to repurpose is quite apt.
While Tom’s current video project is now over, he continues to work in science education. You can follow his efforts on his website.
I stumbled upon Gia Mora’s one-woman show, Einstein’s Girl, thanks to a promotional email. The show uses advanced physics and mathematics as a way to explore relationships. Mora gets into much more detail about the why behind the piece on her blog, and she comes to science from the perspective of an interested non-scientist (she’s on the board of the SoCal Science Cafe). You can sample some of the songs from the show and the album before diving into it completely.
Finally, Francis Collins, National Institutes of Health Director, can’t help breaking into song. He did so at the end of his appearance on The Diane Rehm Show yesterday. Whether or not you think he should keep bringing the guitar with him, I think you have to respect his tenacity.