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Events, Science, Science Policy, Stanford News, Technology

The challenge – and opportunity – of regulating new ideas in science and technology

The challenge – and opportunity – of regulating new ideas in science and technology

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Innovation in science and technology holds promise to improve our lives. But disruptive business models, do-it-yourself medical devices, and open platforms also introduce corporate and personal risks. How can the public stay safe from unknown consequences as a company’s product or service matures? In a recent panel co-sponsored by Stanford’s Rock Center for Corporate Governance and Center for Law and the Biosciences, experts in law, business, and ethics discussed what happens when science and technology outrun the law.

Talk of drones, app-based car services, and music-sharing technologies teased out key issues currently disrupting legal paradigms. But biomedical science took center stage. “Health is more regulated than any other [area]” said panelist Hank Greely, JD, the Deane F. and Kate Edelman Johnson Professor of Law and director of the Center for Law and the Biosciences. He characterized the FDA’s processes as useful in slowing innovation in the health space but noted that rigorous pre-market regulation “won’t work in most parts of the economy.”

What happens when regulation is beyond reach? Greely noted that even if the FDA could limit an entrepreneurial company, it couldn’t conquer the DIY market. He referenced a procedure known as transcranial direct current stimulation, which, by applying electrodes to the head, can feel like “Adderall through a wire” or alter a person’s mood according to placement. A transmitting device is so simple to make, Greely said, “the hardest part will be finding an open Radio Shack.”

Moderator Dan Siciliano, JD, faculty director of the Rock Center and professor of the practice of law, asked the panelists which under-regulated technologies they found frightening. Vapor cigarettes, answered Eleanor Lacey, JD, for luring youth through fruit flavors and targeting them through advertising channels prohibited for regular cigarettes. (As previously reported on Scope, the FDA announced last spring that it would regulate the sale, but not marketing, of e-cigarettes.)

Lacey, vice president, general counsel and secretary of SurveyMonkey, discussed regulation issues involving health information that is transmitted on the company’s platform, where users own their data. She pointed to instances of users creating surveys on which respondents shared HIPAA-protected information, admitted suicidal thoughts, or confessed to crimes. The company cooperates with law enforcement in a very narrow set of sensitive situations but also upholds neutrality of the user-owned space and the user right to control the content: “You don’t want us to be able to shut it down,” Lacey said.

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In the News, Medical Education, Research, Science, Science Policy, Stanford News

A conversation with John Ioannidis, “the superhero poised to save” medical research

A conversation with John Ioannidis, "the superhero poised to save" medical research

ioannidis at deskI always relish a good Q&A. As a writer, I know how hard it is to craft questions that elicit insights into a person — or his or her work. That’s why I jumped at the opportunity to spotlight a recently published Vox interview with John Ioannidis, MD, DSc, director of the Meta-Research Innovation Center at Stanford.

Ioannidis is blunt, and prolific, with his criticisms of science.

Among his concerns: Researchers usually publish only results that show statistical significance, failing to share numerous experiments that didn’t work out, which would also be illustrative. Many studies aren’t reproducible: Sometimes due to a lack of data, other times just due to shoddy procedures. Researchers “spin” data to please their funders.  And in universities, scientists are compelled to publish, a system that favors quantity over quality. Peer review has gaps. And the list goes on and on.

What, then, to do?

Here’s Ioannidis (referred to by the writer as “the superhero poised to save” medical research) in the Q&A:

Maybe what we need is to change the incentive and reward system in a way that would reward the best methods and practices. Currently, we reward the wrong things: people who submit grant proposals and publish papers that make extravagant claims. That’s not what science is about. If we align our incentive and rewards in a way that gives credibility to good methods and science, maybe this is the way to make progress.

One problem is education, he says:

Most scientists in biomedicine and other fields are mostly studying subject matter topics; they learn about the subject matter rather than methods. I think that several institutions are slowly recognizing the need to shift back to methods and how to make a scientist better equipped in study design, understanding biases, in realizing the machinery of research rather than the technical machinery.

There’s much more in the piece, including a glimpse of Ioannidis’ “love numbers” system.

Previously: Shake up research rewards to improve accuracy, says Stanford’s John Ioannidis, John Ioannidis discusses the popularity of his paper examining the reliability of scientific research and “U.S. effect” leads to publication of biased research, says Stanford’s John Ioannidis 
Photo, which originally appeared in STANFORD Magazine, by Robyn Tworney

Cancer, Chronic Disease, Clinical Trials, Science Policy

A look at crowdfunding clinical trials

A look at crowdfunding clinical trials

1024px-Assorted_United_States_coins I’ve been able to watch the crowdfunding phenomenon up close: My husband is a Kickstarter addict, and he, like millions of others, funds projects that speak to his passions and social priorities. In recent years, some non-profits have applied the crowdfunding model to clinical trials (something he hasn’t funded yet), and others may follow suit as federal-funding dollars dries up. Last week, Nature Medicine published an article that describes the first few years of those efforts and the questions they bring up.

As outlined in the piece, critics argue that the system unfairly penalizes those that may not have a large online social network to use to publicize their funding efforts, while proponents say it makes it possible for donors to connect more directly with the research and it increases transparency of research funding. As one source explains:

“One key thing is tangibility,” says Catherine Ferguson, Innovation Project Lead at Cancer Research UK, “It’s an inherent part of crowdfunding that isn’t inherent in regular funding.” Whether it’s a particular type of cancer or a particular therapy, crowdfunding allows for a “more direct relationship with both the researcher and the research,” she adds, emphasizing that this directed approach is good for maintaining relationships with donors.

Cancer Research UK, which we’ve written about before, was one of the early advocates of clinical trial crowdfunding. It recently concluded it first effort to crowdfund a clinical trial to study a vaccine for Epstein-Barr virus in cancer patients. The group fell far short of their goal, raising only six percent of the £40,000 ($61,000) goal on their Indiegogo campaign, so it returned the funds to donors. Again, from the article:

The organization chose a so-called fixed-funding model, in which they chose a goal amount but kept none of the funds that were raised if the goal wasn’t met. “It felt disingenuous to keep some of the money but not make the research happen,” said Ferguson. “We really wanted to emphasize that the money was for a specific project and if the project couldn’t be fully funded, then why keep the money?” Because the campaign wasn’t successful, the funds raised were returned to those who pledged the money, but Ferguson said that many of the donors reached out to make contributions to the organizations anyway.

Other organizations are using slightly different models, and the coming months, or maybe years, will reveal whether any are able to successfully fund clinical trials through this new avenue.

Previously: New crowdfunding sites apply Kickstarter model to health and medicineCan crowdfunding boost public support and financing for scientific research? and Crowdsourcing the identification of cancer cells
Photo by Elembis

Global Health, In the News, Public Health, Research, Science Policy

Gates Foundation makes bold moves toward open access publication of grantee research

Gates Foundation makes bold moves toward open access publication of grantee research

Bill and Melinda GatesLast week, the Gates Foundation announced that it will now require all grantees to make the results of their research publicly accessible immediately. Researchers will only be able to publish their research in scientific journals that make the published papers accessible via open access – which rules out publishing in many prominent journals such as Science and Nature.

Inside Higher Education detailed the new policy:

The sweeping open access policy, which signals the foundation’s full-throated approval for the public availability of research, will go into effect Jan. 1, 2015, and cover all new projects made possible with funding from the foundation. The foundation will ease grant recipients into the policy, allowing them to embargo their work for 12 months, but come 2017, “All publications shall be available immediately upon their publication, without any embargo period.”

“We believe that our new open access policy is very much in alignment with the open access movement which has gained momentum in recent years, championed by the NIH, PLoS, Research Councils UK, Wellcome Trust, the U.S. government and most recently the WHO,” a spokeswoman for the foundation said in an email. “The publishing world is changing rapidly as well, with many prestigious peer-reviewed journals adopting services to support open access. We believe that now is the right time to join the leading funding institutions by requiring the open access publication of our funded research.”

But the Gates Foundation policy goes further than other funding instutions. Once the papers are available publicly, they must be licensed so that others can use that data freely, even for commercial purposes. A news article in Nature explains the change:

The Gates Foundation’s policy has a second, more onerous twist which appears to put it directly in conflict with many non-OA journals now, rather than in 2017. Once made open, papers must be published under a license that legally allows unrestricted re-use — including for commercial purposes. This might include ‘mining’ the text with computer software to draw conclusions and mix it with other work, distributing translations of the text, or selling republished versions.  In the parlance of Creative Commons, a non-profit organization based in Mountain View, California, this is the CC-BY licence (where BY indicates that credit must be given to the author of the original work).

This demand goes further than any other funding agency has dared. The UK’s Wellcome Trust, for example, demands a CC-BY license when it is paying for a paper’s publication — but does not require it for the archived version of a manuscript published in a paywalled journal. Indeed, many researchers actively dislike the thought of allowing such liberal re-use of their work, surveys have suggested. But Gates Foundation spokeswoman Amy Enright says that “author-archived articles (even those made available after a 12-month delay) will need to be available after the 12 month period on terms and conditions equivalent to those in a CC-BY license.”

The Gates Foundation has funded approximately $32 billion in research since its inception in 2000 and funds about $900 million in global health funds annually. That’s a smaller impact than, say the U.S. National Institutes of Health, which funds about $30 billion in health research. But it does represent nearly 3,000 papers published in 2012 and 2013. Only 30 percent of those were published in open access journals.

Previously: Teen cancer researcher Jack Andraka discusses open access in science, stagnation in medicineExploring the “dark side of open access”, White House to highlight Stanford professors as “Champions of Change”Stanford neurosurgeon launches new open-source medical journal built on a crowdsourcing modelDiscussing the benefits of open access in science and How open access publishing benefits patients
Photo of Bill and Melinda Gates by Kjetil Ree

NIH, Research, Science Policy, Stanford News

Shake up research rewards to improve accuracy, says Stanford's John Ioannidis

Shake up research rewards to improve accuracy, says Stanford's John Ioannidis

currencyLab animals such as mice and rats can be trained to press a particular lever or to exhibit a certain behavior to get a coveted food treat. Ironically the research scientists who carefully record the animals’ behavior really aren’t all that different. Like mice in a maze, researchers in this country are rewarded for specific achievements, such as authoring highly cited papers in big name journals or overseeing large labs pursuing multiple projects. These rewards come in the form of promotions, government grants and prestige among a researcher’s peers.

Unfortunately, the achievements do little to ensure that the resulting research findings are accurate. Stanford study-design expert John Ioannidis, MD, DSci, has repeatedly pointed out serious flaws in much published research (in 2005 he published what was to be one of the most highly-accessed and most highly-cited papers ever in the biomedical field “Why most published research findings are false”).”

Today, Ioannidis published another paper in PLoS Medicine titled “How to make more published research true.” He explores many topics that could be addressed to improve the reproducibility and accuracy of research. But the section that I found most interesting was one in which he argues for innovative, perhaps even disruptive changes to the scientific reward system. He writes:

 The current system does not reward replication—it often even penalizes people who want to rigorously replicate previous work, and it pushes investigators to claim that their work is highly novel and significant. Sharing (data, protocols, analysis codes, etc.) is not incentivized or requested, with some notable exceptions. With lack of supportive resources and with competition (‘‘competitors will steal my data, my ideas, and eventually my funding”) sharing becomes even disincentivized. Other aspects of scientific citizenship, such as high-quality peer review, are not valued.

Instead he proposes a system in which simply publishing a paper has no merit unless the study’s findings are subsequently replicated by other groups. If the results of the paper are successfully translated into clinical applications that benefit patients, additional “currency” units would be awarded. (In the example of the mice in the maze, the currency would be given in the form of yummy food pellets. For researchers, it would be the tangible and intangible benefits accrued by those considered to be successful researchers). In contrast, the publication of a paper that was subsequently refuted or retracted would result in a reduction of currency units for the authors. Peer review and contributions to the training and education of others would also be rewarded.

The concept is really intriguing, and some ideas would really turn the research enterprise in this country on its head. What if a researcher were penalized (fewer pellets for you!) for achieving an administrative position of power… UNLESS he or she also increased the flow of reliable, reproducible research? As described in the manuscript:

[In this case] obtaining grants, awards, or other powers are considered negatively unless one delivers more good-quality science in proportion. Resources and power are seen as opportunities, and researchers need to match their output to the opportunities that they have been offered—the more opportunities, the more the expected (replicated and, hopefully, even translated) output. Academic ranks have no value in this model and may even be eliminated: researchers simply have to maintain a non-negative balance of output versus opportunities. In this deliberately provocative scenario, investigators would be loath to obtain grants or become powerful (in the current sense), because this would be seen as a burden. The potential side effects might be to discourage ambitious grant applications and leadership.

Ioannidis, who co-directs with Steven Goodman, MD, MHS, PhD, the new  Meta-Research Innovation Center at Stanford, or METRICS, is quick to acknowledge that these types of changes would take time, and that the side effects of at least some of them would likely make them impractical or even harmful to the research process. But, he argues, this type of radical thinking might be just what’s needed to shake up the status quo and allow new, useful ideas to rise to the surface.

Previously: Scientists preferentially cite successful studies, new research shows, Re-analyses of clinical trial results rare, but necessary, say Stanford researchers  and John Ioannidis discusses the popularity of his paper examining the reliability of scientific research
Photo by Images Money

Big data, Bioengineering, NIH, Research, Science Policy, Stanford News

$23 million in NIH grants to Stanford for two new big-data-crunching biomedical centers

$23 million in NIH grants to Stanford for two new big-data-crunching biomedical centers

More than $23 million in grants from the National Institutes of Health – courtesy of the NIH’s Big Data to Knowledge (BD2K) initiative – have launched two Stanford-housed centers of excellence bent on enhancing scientists’ capacity to compare, contrast and combine study results in order to draw more accurate conclusions, develop superior medical therapies and understand human behaviors.

Huge volumes of biomedical data – some of it from carefully controlled laboratory studies, increasing amounts of it in the form of electronic health records, and a building torrent of data from wearable sensors – languish in isolated locations and, even when researchers can get their hands on them, are about as comparable as oranges and orangutans. These gigantic banks of data, all too often, go unused or at least underused.

But maybe not for long. “The proliferation of devices monitoring human activity, including mobile phones and an ever-growing array of wearable sensors, is generating unprecedented quantities of data describing human movement, behaviors and health,” says movement-disorders expert Scott Delp, PhD, director of the new National Center for Mobility Data Integration to Insight, also known as the Mobilize Center. “With the insights gained from subjecting these massive amounts of data to  state-of-the-art analytical techniques, we hope to enhance mobility across a broad segment of the population,” Delp told me.

Directing the second grant recipient, the Center for Expanded Data and Retrieval (or CEDAR), is Stanford’s Mark Musen, MD, PhD, a world-class biomedical-computation authority. As I wrote in an online story:

[CEDAR] will address the need to standardize descriptions of diverse biomedical laboratory studies and create metadata templates for detailing the content and context of those studies. Metadata consists of descriptions of how, when and by whom a particular set of data was collected; what the study was about; how the data are formatted; and what previous or subsequent studies along similar lines have been undertaken.

The ultimate goal is to concoct a way to translate the banter of oranges and orangutans, artichokes and aardvarks now residing in a global zoo (or is it a garden?) of diverse databases into one big happy family speaking the same universal language, for the benefit of all.

Previously: NIH associate director for data science on the importance of “data to the biomedicine enterprise”, Miniature wireless device aids pain studies and Stanford bioengineers aim to better understand, treat movement disorders

Health Costs, Health Policy, In the News, NIH, Public Health, Science Policy

Research investment needed now, say top scientists

Top scientists made the case for continued investment in basic science and engineering earlier this week by unveiling a new report, “Restoring the Foundation: The Vital Role of Research in Preserving the American Dream” by the American Academy of Arts and Sciences.

Here’s why this is important: Federal investment is needed to power innovation engines like Stanford’s School of Medicine, and if that money gets funneled to roads, the military, Medicare, or any of a variety of other uses, fewer jobs, and fewer discoveries, could result. From the report:

Unless basic research becomes a higher government priority than it has been in recent decades, the potential for fundamental scientific breakthroughs and future technological advances will be severely constrained.

Compounding this problem, few mechanisms currently exist at the federal level to enable policy-makers and the research community to set long-term priorities in science and engi­neering research, bring about necessary reforms of policies that impede progress, or facilitate stronger cooperation among the many funders and performers of research…

Stanford President John Hennessy, PhD; biochemist Peter S. Kim, PhD; and physicist (and former U.S. Secretary of Energy) Steven Chu, PhD, are among the scientific rock-stars who co-authored the report.

For an excellent piece on the political debate surrounding the report’s release, check out the coverage in Science here. NPR also recently aired a series that colorfully illustrates the effects of research cutbacks, including a piece on a patient suffering from ALS, and a profile of several underemployed scientists.

Becky Bach is a former park ranger who now spends her time writing or practicing yoga. She’s a science writing intern in the Office of Communications and Public Affairs. 

Previously: More attention, funding needed for headache care, “Bold and game-changing” federal report calls for $4.5 billion in brain-research funding, Federal investments in research and higher education key to U.S. maintaining innovation edge

Podcasts, Public Safety, Science, Science Policy, Stanford News

The risks of tinkering with dangerous pathogens

The risks of tinkering with dangerous pathogens

In an effort to understand new and rare infectious diseases, researchers often use recombinant DNA technology to create novel strains in the lab. In 2012, researchers did just that, creating strains of the H5N1 influenza virus that were transmissible between mammals, setting off a debate about the ethics of creating viruses that were potentially more dangerous than those that occurred naturally.

Earlier this year, in July, a group called the Cambridge Working Group convened to continue discussing these questions. David Relman, MD, a biosecurity expert at Stanford, is a member of the group and spoke to Paul Costello about the risks and benefits of lab-created pathogens. Highlights of their conversation are in a piece in the most recent issue of Inside Stanford Medicine, where Relman notes:

My greatest fear is that someone will create a highly contagious and highly pathogenic infectious agent that does not currently exist in nature, publish its genetic blueprint, allow it to escape the laboratory by accident, or else enable a malevolent person or persons to synthesize the agent with the intention of releasing it in a deliberate manner. Although these may be unlikely scenarios, they could have catastrophic consequences, which is why I and others feel that we need to sensitize everyone to these possibilities and decide how to manage these risks ahead of time. I want to be clear: I am not opposed to laboratory work on dangerous pathogens, especially if they are known to exist in nature. Rather, I am opposed to high-risk experiments and, in particular, those that seek to create novel, dangerous pathogens that cannot be justified by well-founded expectations of near-term, critical benefits for public health — benefits that clearly outweigh the risks, and benefits that cannot be achieved through other means.

But not all researchers advocate the same level of caution. A few weeks after the Cambridge Working Group formed, another group called Scientists for Science to advocate in favor of using recombinant versions of pathogens in order to understand them better. Relman says that the two groups are probably not as far apart as they appear. He says he fully supports studying disease-causing bacteria, but:

The place where we may disagree is on whether we are willing to acknowledge that there may be experiments — probably few and far between — that perhaps ought not to be undertaken because of an unusual degree of risk. Just because a scientist can think up an experiment doesn’t mean it should be performed.

Relman elaborates on these topics in the 1:2:1 podcast with Costello above.

Previously:  How-to manual for making bioweapons found on captured Islamic State computer, Microbial mushroom cloud: How real is the threat of bioterrorism? (Very) and Stanford bioterrorism expert comments on new review of anthrax case

Applied Biotechnology, Bioengineering, Science, Science Policy, Stanford News

Stanford microscope inventor invited to first White House Maker Faire

Stanford microscope inventor invited to first White House Maker Faire

Foldscope-adams-squareLast week assistant professor of bioengineering Manu Prakash, PhD, received a call he couldn’t refuse — an invitation to attend the first-ever White House Maker Faire, to show attendees how to build a 50-cent microscope out of laser-cut paper, plastic tape and a tiny glass bead.

At today’s event, Prakash will also demonstrate how he turned a toy music box into a $5 programmable microfluidic chemistry set that can be used for applications as diverse as testing water quality and science fair projects.

Maker Faires, started by Make magazine in 2006, are gatherings where do-it-yourself enthusiasts show off their homemade projects and teach others how to make things using new technologies such as 3D printers, laser cutters, and desktop machine tools.

President Obama is hosting the first-ever White House Maker Faire to celebrate our “Nation of Makers” and to help empower America’s students and entrepreneurs to invent the future.

Prakash, who grew up in the mega-cities of India without a refrigerator, is a leader in the frugal maker movement. At Stanford, he works with students from bioengineering, medicine, and Bio-X to reengineer expensive, complex health-related devices to make them better, faster and cheaper.

His team also focuses on developing affordable science tools to inspire global innovation. To that end, Prakash recently launched an educational initiative called the “10,000 Microscopes Project,” where build-your-own-microscope kits will be shipped to the first 10,000 people who pledge to share their microscope images and experiments in a free, online microscopy manual.

“I’m so happy that the White House is looking at ways to celebrate scientific curiosity and invention,” Prakash told me. “Many children around the world have never used a microscope, even in developed countries like the United States. A universal program providing a microscope for every child could foster deep interest in science at an early age.”

For more information on the White House Maker Faire and today’s National Day of Making, or to watch the event live, visit www.whitehouse.gov/makerfaire or follow #NationofMakers on Twitter.

Previously: The pied piper of cool science tools, Music box inspires a chemistry set for kids and scientists in developing countries, Free DIY microscope kits to citizen scientists with inspiring project ideas and Stanford bioengineer develops a 50-cent paper microscope
Photo, of Quinn Monahan trying out a paper microscope, by Amy Adams
Photo in featured entry box by Manu Prakash

In the News, Neuroscience, Research, Science Policy

"Bold and game-changing" federal report calls for $4.5 billion in brain-research funding

"Bold and game-changing" federal report calls for $4.5 billion in brain-research funding

Collins and ObamaSome news today about the federal BRAIN Initiative – a major research plan aimed at revolutionizing our understanding of the human brain. (Stanford neurologist William Newsome, PhD, is co-chair of the initiative.) Francis Collins, MD, PhD, director of the National Institutes of Health, today heard and accepted a working group’s recommendations for the initiative’s budget and long-term scientific vision.

As outlined in an NIH release:

The report drafted by the ACD BRAIN Working Group maps out a sustained commitment of $4.5 billion in new federal funding over 10 years beginning in fiscal year 2016 to achieve seven primary goals. NIH already announced an investment of $40 million in fiscal year 2014 and President Obama has made a request for $100 million for NIH’s component of the initiative in his fiscal year 2015 budget.

The NIH efforts on the BRAIN Initiative will seek to map the circuits of the brain, measure the fluctuating patterns of electrical and chemical activity flowing within those circuits, and understand how their interplay creates our unique cognitive and behavioral capabilities.

Collins called the recommendations “bold and game changing” and noted, “As the Human Genome Project did with precision medicine, the BRAIN Initiative promises to transform the way we prevent and treat devastating brain diseases and disorders while also spurring economic development.”

Previously: NIH announces focus of funding for BRAIN initiative, BRAIN Initiative and the Human Brain Project: Aiming to understand how the brain works, Brain’s gain: Stanford neuroscientist discusses two major new initiatives, Co-leader of Obama’s BRAIN Initiative to direct Stanford’s interdisciplinary neuroscience institute, Experts weigh in on the new BRAIN Initiative and A federal push to further brain research
Photo, of April 2013 announcement of BRAIN Initiative, from the National Institutes of Health

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