“Brain Research Through Advancing Innovative Technologies” will be the subject of over $100 million in federal investment. DARPA will contribute $50 million, NIH $40 million, and NSF $20 million. They will partner with the Allen Institute ($60 million), Kavli Foundation ($4 million), Salk Institute ($28 million), and Howard Hughes Medical Institute ($30 million). It’s not clear what all these dollar figures really mean, but it almost certainly beats a poke in the eye with a sharp stick.
BRAIN is to be led by two prominent neuroscientists: Bill Newsome at Stanford (great scientist, good guy) and Cori Bargmann at Rockefeller University (don’t know her, though know her name).
BRAIN is to have an ethics component, to be handled (initially?) by the President making requests to the President’s Commission for the Study of Bioethical Issues (PCSBI). PCSBI has at least two members were versed in neuroethics and law and neuroscience: Nita Farahany and Jonathan Moreno. In the long run I think any one general bioethics commission won’t prove adequate – I’d prefer “let a hundred flowers bloom,” though that requires water, fertilizer, and (of course) money for those flowers. But this is astart.
Here’s the White House announcement: White House.
Here’s a useful NY TImes article about the project: NYT.
How important this will turn out to be, of course, remains to be seen. It is not a commitment at the level of the Human Genome Project, but there doesn’t seem to be the same kind of target available as there was for the HGP. I’m optimistic – but that’s probably just my brain talking. 
Hank Greely
CORRECTIONS MADE: I not only misspelled Dr. Bargmann’s name, but I placed her at the wrong university in Manhattan – she is at Rockefeller University.
The CLB’s own Jacob Sherkow has a great piece on The Yale Law Journal Online analyzing a little-noticed, but potentially very significant, aspect of the Supreme Court’s recent decision in Mayo v. Prometheus:
The Mayo Court’s novel test for patent eligibility—whether or not an invention involves “well-understood, routine, conventional activity, previously engaged in by researchers in the field”—focuses on how an invention is accomplished rather than what an invention is. That concern with the method of invention poses several normative, statutory, and administrative difficulties. Taken seriously, the “how” requirement will likely have broad effects across all levels of patent practice.
You can find the article here. It’s well worth the read.
As part of CLB’s Supreme Court Law and the Biosciences Oral Argument Reduxes (CLBSCOTUSLABOAR), we have Stanford’s own Mark Lemley discussing oral arguments in last week’s FTC v. Actavis case. You can listen to the interview here:
Mark Lemley on FTC v. Actavis
Prashant Reddy Thikkavarapu, CLB Student Fellow
Following in the footsteps of GSK’s decision to release all clinical trial data (which we blogged about here), Swiss pharmaceutical major Hoffman La’ Roche has announced that it too would make available more clinical trial data.
Unlike GSK which was probably motivated to release more clinical trial data after facing a $ 3 billion dollar fine, Roche’s reason was most likely the criticism it faced for not disclosing data from certain clinical trials regarding the safety and efficacy of Tamiflu or ‘oseltamivir’. Roche had made quite the killing in profits through the sale of its patented ‘oseltamivir’ when the World Health Organization declared a pandemic during the bird-flu crisis and approved Tamiflu as the preferred treatment. As a result of the alert declared by WHO most national governments had stocked up significantly on Tamiflu. There has however been an active campaign since 2009, by the Cochrane Collaboration (a public health group) and the British Medical Journal to access more data on the clinical trials of Tamiflu to examine whether the drug was actually as safe and effective as claimed by Roche. In response to the appeals by this campaign, Roche had agreed in 2009 to provide researchers with more information on the clinical trials but has allegedly not released any information in the last 3 years. Read the rest of this entry »
TUESDAY, APRIL 2, 2013
4:30 PM – 6:00 PM
Stanford Law School, Room 280B
 Dr. Ioannidis is the C.F. Rehnborg Chair in Disease Prevention at Stanford University and is Professor of Medicine and Director of the Stanford Prevention Research Center at Stanford University School of Medicine. His 2005 paper in PLoS Medicine, “Why most Published Research Findings are False,” has been the most-downloaded article in the history of the Public Library of Science and was described by the Boston Globe as an instant cult classic. His work combines skills in clinical research methodology and evidence-based medicine with the challenges of current molecular medicine and genomics.
This talk is free and open to the public. Register here. |
When I hear, “FDA,” I generally think of the government regulator of serious, potentially dangerous drugs: thalidomide, fen-phen, tasmar. I typically don’t think of hand soap. But if you, like millions of others around the world, use certain antibacterial hand soaps, you’re in fact using an FDA regulated “drug.” The problem is that with respect to certain antibacterials, the FDA has never finalized its regulations of those drugs. And due to a rather peculiar procedural loophole, those drugs have entered the market without the FDA determining that they’re either safe or effective. The FDA’s failure to finalize that determination–and the plaintiffs’ standing to challenge it–were precisely the issues presented in Natural Resources Defense Counsel v. FDA, decided by the Second Circuit last week. Read the rest of this entry »
This is a topic that the CLB has followed and, in fact, I am one of about 25 speakers at this TEDx extravaganza at the headquarters of the National Geographic Society in Washington, D.C. The event runs from 8:00 am to 5:00 on Friday, March 15. If you can’t make it to the NGS headquarters, it is being webcast live. Go here for details. The recordings will also be posted on the TEDx site in about three weeks.
Should be fascinating!
Hank Greely
I’ve written previously about an egregious and tragic case of research misconduct at the University of Minnesota involving the death of a young man named Dan Markingson. I’m taking up the subject again today to voice support for a petition calling on Minnesota’s governor to investigate the University’s treatment of Mr. Markingson and its conduct in responding to related allegations of wrongdoing. You can (and should) sign the petition here.
For a fuller recitation of the facts, please see my earlier post. Here is the extremely short version:
Dan Markingson – a vulnerable, psychotic young man – was forced to choose between enrolling in a Pharma-funded drug study or being involuntarily committed (in other words, locked up). A UMN doctor enrolled him in the study despite having just determined that Dan “lack[ed] the capacity to make decisions regarding [his] treatment,” rendering it highly unlikely that Dan could have given valid informed consent to participate. As Dan’s mother, Mary Weiss, observed his mental condition deteriorating, she repeatedly tried to have Dan removed from the trial – at one point asking “Do we have to wait until he kills himself or someone else before anyone does anything?” But the UMN co-investigators in the drug study refused to terminate his participation. Shortly after Ms. Weiss made her desperate plea, Dan Markingson killed himself by cutting his own throat. Read the rest of this entry »
When it comes to whether expert testimony can be admitted in court, the U.S. is a checkerboard map: each jurisdiction either follows the Daubert rule or the Frye rule. In Daubert jurisdictions, expert testimony may only be admitted if it is (1) relevant; (2) reliable; and (3) rooted in the scientific method. What counts as the “scientific method” varies, but this prong typically focuses on whether hypotheses are subject to empirical falsification and the potential error rate of the test proposed. In Frye jurisdictions, expert testimony may only be admitted if it is generally accepted within its own scientific community. The Frye test has long been criticized as essentially allowing junk science in the courtroom–junk science is, after all, generally accepted in the “junk science community”–but Frye jurisdictions have recently combated this by increasingly aligning the “general acceptance” portion of the standard to Daubert’s scientific method prong. Currently, the federal system, and most states, are Daubert jurisdictions, but Frye states remain: California, Florida, Illinois, Kansas, Maryland, Minnesota, New Jersey, New York, Pennsylvania, and Washington.
Most people would assume that, Daubert or Frye, expert testimony concerning DNA evidence is admissible. But this paints “DNA evidence” with too broad of a brush. In fact, there are multiple types of DNA evidence, some of which we’ve profiled on this blog. Needless to say, forensic analysis of different types of DNA evidence come with different falsification methods, error rates, and “acceptance” in the forensic community. The admissibility of at least some types of DNA evidence may, therefore, depend on whether the testimony is sought to be admitted in a Daubert or a Frye jurisdiction. And a recent case out of New York–a Frye state–highlights just this distinction. Read the rest of this entry »
Again, as part of CLB’s weekly winter quarter workshop, our mini-podcast with Susan M. Wolf is now up on our Stanford Talks site. Professor Wolf discusses her recent paper on incidental findings in research with CLB director Hank Greely. You can listen to it here:
Mini-Podcast with Susan M. Wolf
