“These Mobile Apps Are Subject to FDA’s “Enforcement Discretion.” Whaaa?”

Tuesday, September 24, 2013 Reblog: Pharma Marketing Blog

“We pick only the finest bugs!” (roaches wikimedia)


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“An ELSI Program for the BRAIN Initiative?”

Posted by Pete Shanks on August 29th, 2013 Reblog Biopolitical Times:

quotes listed:

“People who are developing the technologies are not thinking of ethics, they are engineers.” — Henry S. Richardson, Kennedy Institute of Ethics

“We need to find ways to engage with social media and educate the public … that we did not have when the genome ELSI program began. … It’s probably going to require a 20-year-old to figure out how to do it.” — Thomas Murray, Hastings Center

“Working scientists and clinicians need to engage with the public directly, and at this point, there is no incentive to do so.” — Anjan Chatterjee, University of Pennsylvania


“Even more worrying, as noted in a comment, is that the representative from the Defense Advanced Research Projects Agency (DARPA) “stated that some of the brain research at DARPA would be classified for security reasons.” Now there’s a loophole …

The ethical issues are becoming pressing. On Tuesday, August 27th, researchers at the University of Washington claimed to have achieved a “Vulcan mind meld” — electrical signals in one human’s brain caused another human’s hand to move. (Yes, of course there is video.) It’s a stunt that builds on previous work with rats and monkeys, it hasn’t been peer-reviewed, the goal is to assist paralyzed people, and the data transmitted are “only simple brain signals, not thoughts, and cannot be used on anyone unknowingly.” But it’s an early signal of what is coming.

The Ethical, Legal and Social Implications (ELSI) program of the Human Genome Project, analyzed last week by Thomas Murray, who helped design it, is still controversial. Some biologists (usually off the record) see it as a waste of money and time; some ethicists see it as a convenient cover for researchers (“watchdog or lap dog?” [pdf]). But it did establish the concept of integrating such discussions into the research process. So far, the Presidential Commission is essentially discussing how to discuss the issues in relation to the BRAIN Initiative. A properly funded ELSI program seems like a good idea. “


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From the Dept. of (probably won’t work) genetic hygiene

At the End of the Slippery Slope: Margaret Atwood’s MaddAddam Trilogy
Posted by George Estreich, Biopolitical Times guest contributor on September 24th, 2013

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“HAM-D’ing It Up”

Reblog-Psych Practice

discorse on checklists

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” Breaking News – FDA Issues Final Guidance on Mobile Medical Applications”

September 23, 2013 • by pzettler Reblog from
The Stanford Center for Law and Biosciences:

“FDA will focus on regulating the subset of apps that pose the greatest risks to patients: (1) apps that are used as accessories to already-regulated medical devices, e.g., an app that alters the function or settings of an infusion pump, and; (2) apps that transform a mobile platform into an already-regulated medical device, e.g., an app that uses an attachment to a smartphone to measure blood glucose levels.”

I’m not certain about neurotech and the FDA Medical Device Exemptions:

or if this would be enforced?

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“A Serbian Sokal? Authors spoof pub with Ron Jeremy and Michael Jackson references”

A shameless reblog from Retraction Watch:
“What do porn star Ron Jeremy, Max Weber and Michael Jackson have in common? Very little — except the three names appear in the list of references for a recent hoax paper by a group of Serbian academics who, fed up with the poor state of their country’s research output, scammed a Romanian magazine by publishing a completely fabricated article.

The paper is replete with transparent gimmicks — obvious, that is, had anyone at the publication been paying attention — including a reference to the scholarship of Jackson, Weber, Jeremy and citations to new studies by Bernoulli and Laplace, both dead more than 180 years (Weber died in 1920). They also throw in references to the “Journal of Modern Illogical Studies,” which to the best of our knowledge does not and never has existed (although perhaps it should), and to a researcher named, dubiously, “A.S. Hole.” And, we hasten to add, the noted Kazakh polymath B. Sagdiyev, otherwise known as Borat.

The paper, “Evaluation of transformative hermeneutic heuristics for processing random data,” by Dragan Djuric, Boris Delibasic and Stevica Radisic, appeared in the magazine Metalurgia International, according to the website In Serbia, which reported on the story. The authors, from the University of Belgrade and the Health Center ‘Stari Grad’, appear on the manuscript in false wigs and mustaches.

Here’s the abstract from the article, in all its glorious meaninglessness:

The improved understanding and proper application of simulation models for various domains, from e-government to e-learning is an appropriate riddle. In this significant paper, we increasingly understand how randomized heuristic algorithms could be unexpectedly applied to the intuitive processing of random data in a novel way. While such a claim might seem counterintuitive, it is supported by prior relevant work in this thriving field. We describe a robust conceptual tool for solving this promising challenge using transformative hermeneutic heuristics for processing random data. Accordingly, the main focus of our work is, obviously, the evaluation of such methodology on an encouraging and intriguing subject of finding in which ways people in an insufficiently developed country see the aid provided by European Community. This illustrative case clearly demonstrates our profound approach, and, thusly, is a compelling foundation for future improvements of the methodology. In fact, the main contribution of our work is that we argue that although a random process might carry a slight risk of being insufficiently relevant for the problem at hand, the solution to any such conundrum could be surely looked for in a multidisciplinary approach

If this sounds like the work of Alan Sokal, it should. The Serbians tip their wigs to Sokal, whose 1996 mock paper Social Text, “Transgressing the boundaries: towards a transformative hermeneutics of quantum gravity,” caused the journal substantial chagrin.

A litany of previous work supports our use of self-learning archetypes [8]. Our heuristics is broadly related to work in the fieldof hermeneutics by Sokal [Error! Reference source not found.], but we view it from a new perspective: random theory. [6]

We highly recommend reading the article, whose endless inside jokes make it effectively an infinite jest. In it you can find gems like this modest contextualization:

Our work has been inspired and directly founded on various astonishing research by intellectual giants in various interesting fields of social science and practically conducted and supported by the advances in multiple technical disciplines, thus giving this work a veritable multidisciplinary aura. We place our work in context with the prior work in several multidisciplinary areas.

Or this circular figure caption:

The decision tree model proposed in this paper is shown in Figure 7. It clearly presents the proposed model, which might be useful to EU analysts, but also to theorists who might judge the validity of this model using the new proposed heuristics.

Or this:

As we will soon see, the goals of this section are manifold. Our evaluation could represent a valuable research contribution in and of itself. The first experimental results came from 2500 trial runs, and were not reproducible. The next batch of results come from only 50 trial runs, and were not reproducible. Continuing with this rationale,the many discontinuities in the graphs point to improved precision introduced with our decision tree algorithms. Such a hypothesis at first glance seems unexpected but fell in line with our expectations. As hypothesized, the final run was sufficiently consistent, which shows the useful convergence of our heuristics. Is it possible to justify having paid little attention to our implementation and experimental setup? Yes, but only in theory. Our evaluation strives to make these points clear.

According to In Serbia, the Romanian magazine

which is otherwise full of Serbian authors, published it in its entirety, without a single correction.”

appropriate music of mirth:

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Steam OS

“Thousands of games, millions of users. Everything you love about Steam.
Available soon as a free operating system designed for the TV and the living room.”

Sometimes evolution takes extra steps:

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