Friday, January 3, 2014

What-I-Will-Call-ics Anonymous: Some Current Trends in Science and, Especially, Technology Studies, Part 3

This is the third in a series of three posts, which examine some current trends in science and technology studies, focusing especially on the latter.

In the last post, I described what I see as some of the key current trends in technology studies. These trends fit a general pattern I described in the first post, where younger scholars are moving away from a certain mode of theorizing focused on jargon-creation and moving both towards a different notion of theory, a more traditional one perhaps, and towards valuing deep empirical research. In this final post, I will do two things. First, I will show that shift I have described holds for other locales in science and technology studies as well and is not simply an idiosyncratic phenomenon in the study of technology. Second, I will conclude by suggesting both that we have to pitch a certain mental model of what constitutes exciting thought and that we must more actively foster the development of this new intellectual movement. 

I should have said this earlier, but I want to emphasize that the views in these posts are solely my own and do not represent the thoughts of my blog teammates. In fact, if experience holds, Hank and Lukas will be swooping in at any moment to give me a good beating. I wouldn't have it any other way. 

Thursday, January 2, 2014

What-I-Will-Call-ics Anonymous: Some Current Trends in Science and, Especially, Technology Studies, Part 2

This is the second of three posts on current trends in science and technology studies, focusing especially on the latter. 

In the last post, I tried to describe a shift currently underway in science and technology studies. Part of my claim there was that, if the shift is happening, then some people might be looking in the wrong direction for exciting developments. This misdirection of perception—and outmoded criteria of excellence—could lead one to worry about "intellectual vitality." But our fretful colleagues should chill. There is great and exciting work being done today; it's just not being done where the worried ones are looking. In this post, I outline what I see as the most promising trends in technology studies today. 

Wednesday, January 1, 2014

What-I-Will-Call-ics Anonymous: Some Current Trends in Science and, Especially, Technology Studies

In the spirit of New Year's Day, as people are setting resolutions, pondering the fresh and the new, thinking about what this year will bring (and fighting off hangovers), I wanted to put up this series of posts, which consider some current trends in science and technology studies and even suggest some paths for the future. I will be publishing three posts over the next three days. 

First, I should probably give some context for what I've written here. And I should also give a warning. The posts in this series are long, as my posts usually are, but in this case, I feel less ashamed. This series is really an essay on the state of a field, and its form fits that ambition. So, as for the context . . . 

Saturday, December 14, 2013

The Problem of the One and the Many in Gun Control

Over the past several months, I've become obsessed by what you might describe as the problem of the one and the many. It surfaces for any collective in which the interests of individuals diverge from those of the whole. I'm currently writing an essay about the way this problem manifested itself in debates at the turn of the 20th century about the evolution of multi-cellularity or super-organisms like insect societies. I also wrote a post on this blog recently arguing that people's misgivings about the Affordable Care Act ought to be seen as a manifestation of the same problem. Today, on the one-year anniversary of the tragic Sandy Hook school shooting, I would like to suggest that current debates about gun control can be seen in the same light.

Friday, December 13, 2013

Can Contributors Change Journals?

We asked Melinda Baldwin, who specializes in the history of scientific journals, to offer some thoughts on Randy Schekman's recent editorial in the Guardian. Melinda is currently finishing a book, Making Nature: The History of a Scientific Journal, to be published by the University of Chicago Press. You can learn more about her work here.

On Tuesday, Nobel Prize-winning biologist Randy Schekman made a startling announcement: he intends to boycott three top scientific journals—Science, Nature, and Cell—that published much of his Nobel-winning research. According to Schekman, these “luxury journals” are “damaging” and “distorting” science. As researchers, funding bodies, and tenure committees have focused on brand names and impact factors, the quality of papers—and of science—has declined. 

Top Journals Science, Nature, and Cell (Image Source)
Schekman’s editorial naturally sparked my interest—I am currently finishing a book about the history of Nature—and made me think about journal prestige in the twenty-first century. The three “luxury journals” certainly don’t lament their status as the world’s most sought-after scientific publications. In Nature’s case, this level of prestige is (as I argue in my book) partly the result of a conscious effort by several Nature editors to attract interesting papers and make Nature a desirable place to publish new research.* But it is also bottom-up: for decades, researchers have chosen to publish in Nature, and it is this role of contributors I want to explore today.  

Thursday, December 5, 2013

Epimemetics and the "Selfish Gene"

"Die, Selfish Gene, Die."

That's the title of a controversial new article by David Dobbs. In it, he argues that the "selfish gene" (coined by Richard Dawkins in 1976) represents an outdated gene-centric approach to evolution. Instead, he says we need to focus on things like gene expression and genetic accommodation — things the "selfish gene" covers up and under-emphasizes.

Dobbs has been criticized for his biology (e.g. here and here and especially here), and he's responded in an interesting way: "my challenge," he writes in a follow-up post, "was less to an [sic] technical account of nature than to a metaphor and story used to describe those technicalities." He's against the "selfish gene" not for what it represents, but for its power as a "selfish meme."

Comments on a post by the Editor-in-Chief of io9

While some have pointed out that Dobbs is having it both ways — and, to a certain extent, Dobbs acknowledges this — I want to take seriously his claim that what matters is less the selfish gene itself (or The Selfish Gene the book) and more the "selfish gene" the meme. Below, I'll suggest why "meme" is an inappropriate way to frame the issue, and how history might provide another path.

Friday, November 29, 2013

Consuming the Self: One Critique of 23andMe

Last week, the FDA sent a letter to Ann Wojcicki — the CEO of direct-to-consumer (DTC) genetic testing company 23andMe — ordering them to stop marketing their Personal Genome Service (PGS), which the FDA defines as a "medical device" subject to specific forms of regulation. 

According to Forbes, Wojcicki and her company have flouted regulatory red-tape despite both efforts by the FDA to work with them and 23andMe's own  statement that their "relationship with the FDA remains critically important." As a result, the FDA ordered it to stop selling $99 PGS kits. 

Historians have noted different aspects of the story, both here at AmericanScience (here and here) and elsewhere (e.g. here and here). I want to take a slightly different tack, one rooted in Sanford Kwinter's response to an address made by Wojcicki at Harvard in 2012. Here is Kwinter: 


There's a lot to note about Kwinter's position, which he calls “a position that is perhaps far too rarely put on the record today." It's one of resistance and radical critique, far removed from the usual stance of the historian today. Here, I'd like to explore its implications for our current moment.

Wednesday, November 27, 2013

What’s better than a holiday card? “Possibly the worst FDA letter of all time.”

Building on Lukas's post here yesterday on the FDA's warning letter to 23andMe, I asked Dr. Margaret Curnutte, a postdoctoral fellow at Baylor School of Medicine, to write a guest post on the topic. Maggie wrote her dissertation on the business and politics of direct-to-consumer genetic testing and has continued to follow the next generation genome sequencing industry closely.

Holiday greetings from the Food and Drug Administration (FDA) came a little early this year for direct-to-consumer (DTC) genetic testing firm, 23andMe. All seemed to be quiet since 2010 when 23andMe and a handful of other DTC firms came under the scrutiny of Congress and FDA. The ebb of critique had subsided so much that it became unfashionable at academic meetings to mention anything DTC. And now FDA’s most recent letter to Ms. Wojcicki, 23andMe’s CEO and co-founder, has put the company back in the spotlight. Time to write another chapter in the DTC saga.
Seasons Greetings from the FDA!
     In its recent letter FDA informed the firm that its Personal Genome Service (PGS) is without marketing clearance and in violation of the Federal Food, Drug and Cosmetic Act. To translate, back in 2010 FDA had sent a similarly friendly letter to tell the company that its service was a medical device under said law. This meant that depending on how the device was classified (i.e. Class I, II, or III) it was subject to premarket (in practice post-market) approval. This sort of approval seems to present an existential crisis, but it looked like 23andMe had been trying to work through this “premarket” approval while continuing to be fully operational. Then on November 22, 2013 FDA asked the firm to immediately discontinue marketing of PGS. The major concerns have been and continue to be about the analytical and clinical validity of the service, meaning its accuracy and reliability.

Tuesday, November 26, 2013

Science, Regulation, and the Epistemology of Big Data

The internet has been abuzz with the FDA's decision to order the personalized genomics firm 23andMe to stop selling their DNA Analysis Service. You can get a good overview of the dispute between the company and the regulatory agency here. What I'd like to do here is to explore a fascinating epistemic question that lies at the heart of this kerfuffle.

One thing that has made 23andMe such a high-profile company is its innovative business model.  It can, and I believe should, be seen as a manifestation of a much larger cultural move that is often labeled big data.  The company is making a financial bet on the idea that DNA sequences are not so different from hypertext in that both can be analyzed computationally using efficient search algorithms.  It is not so surprising, then, to learn that the company's co-founder and CEO, Anne Wojcicki, is married to Sergey Brin, one of the co-founders of Google.  And indeed, Google ranks among 23andMe's biggest corporate backers, having invested close to $4 million into the startup.

The company's main selling point is that it has built a vast database of genome sequences, which it has annotated with metadata gathered both from customer surveys and the published literature.  Its business model, then, is not so different from that of Google, except that the data it trades in are of a different sort.  Rather than compiling an ever larger database of email, instant messages, and search histories to more powerfully target advertising, it collects sequence and meta-data to produce ever more powerful assessments of what your DNA says about who you are, where you come from, and what (health risks) might lie in your future. The more people order the company's "spit test" (pictured above), the bigger the database becomes, and the more detailed and accurate its statistical assessment of your genetic risk factors will be.

In its official warning letter, the FDA made a number of interesting points, but let me just take on two of these in particular.

The first is broadly ontological, and it concerns the question of whether 23andMe falls under the agency's regulatory purview. In order to claim the authority to regulate its business practices, the FDA argues that 23andMe constitutes a medical device manufacturer.  This is somewhat surprising, since the spit test merely purports to reveal the information already encoded in your genome.  As such, it is rather different from interventionist machines like endoscopes and other things we normally think of as medical devices.  Does the FDA's letter therefore imply that anyone offering to look at your back and check for moles, say, is also peddling a medical device?

The answer is "no."  The reason, regulators claim, is that 23andMe does more than just sequence its customer's DNA.  It also interprets those sequences, using its vast database to provide you with a statistical assessment of your risk factor for developing certain diseases.

And it is precisely these interpretations that has the FDA worried. This is because, in theory at least, these interpretations could be riddled with false positives or negatives. Imagine, for example, mistakenly being told you have a 75% chance of developing breast cancer. This might prompt you to have a preventative and, in this case, wholly unnecessary mastectomy. Or imagine the alternative: erroneously being told you have a low risk factor for developing breast cancer. This might cause you to forgo routine checkups, with potentially disastrous consequences.

The real problem, according to the FDA, is that 23andMe does not have any solid evidence that it's statistical analysis are, well, statistically sound.  As the FDA's letter to Wojcicki states, "even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses."

What's at root in the disagreement here might be more than meets the eye.  Although I cannot say so with certainty, I have a strong suspicion that what the FDA is really objecting to here is the use of big data techniques in biomedicine. Traditionally, if a company wants to bring a certain pharmaceutical or medical device to market, it is expected to conduct extensive clinical trials. In so doing, there might not be an expectation that every aspect of the drug or device's mechanism of action is fully known. However, there would at least be clinical or experimental data to support its safety and efficacy.

But these are precisely the kinds of data that big data will not produce. That is, big data companies like Google and 23andMe are in the business of data analysis, not data production. They expect their users to generate the data themselves.  All that they do is to devise techniques (algorithms) with which to draw conclusions from those data.

If I'm right, there is a fundamental epistemic rift between the FDA and 23andMe. What's at stake in this rift, moreover, is no less than the question of whether big data approaches can legitimately be exported from scientific research and internet marketing to clinical medicine!

Friday, November 15, 2013

Science in the Streets

Science in the Streets:
A free public engagement event from the History of Science Society
Thursday, Nov 21, 3-6 pm, Boston Convention & Exhibition Center

[I have asked Conevery Bolton Valencius, who teaches at UMass Boston, to write a guest post about an event she is helping to organize at this year's HSS.  Many readers of this blog are interested in popular science & science popularization, and I urge everyone to join us for what promises to be a fascinating discussion!]

Current newspaper headlines make clear how anti-science and science-illiterate many Americans are, at least about some political issues.  But there are effective and interesting efforts going on all around to engage people in the workings and the wonderings of science.  Further, historians of science are doing a lot of that work – and sometimes have particular insight about what is new or very old about rhythms of scientific skepticism or scientific enthusiasm. 

At next week’s annual conference of the History of Science Society, we’ll explore some of the most exciting current efforts to engage the public in scientific research and scientific education – and we’ll reflect on how historians of science are contributing to those efforts.

The HSS conference opens with Science in the Streets, a free, all-ages public event at Boston Convention & Exhibition Center (on the Silver Line!), Room 253C on Thursday, November 21, 2013 from 3-6pm.

To find out more, continue reading after the jump.