Stanford Center for Law & the Biosciences Blog

Militarized Neurotechnology: Incapacitating chemical agents

September 3, 2009 · 6 Comments

Two recent pieces in Nature, an opinion and an editorial, discuss how non-lethal neuroactive chemical agents have been used by military forces (e.g. fentanyl-induced unconsciousness) and speculate about the potential development of more non-lethal weaponized chemicals (drug-induced lack of aggression, oxytocin-induced trust). Although using these chemical agents is prohibited by the Chemical Weapons Convention, an exception allows their use by law enforcement, for example, in domestic riot control (which may or may not include intrastate military actions).

The author of the opinion article is strongly opposed to allowing the military to use non-lethal chemical agents (including incapacitating agents that result in unconsciousness, like fentanyl), and recommends removing the exception for law enforcement. Some people, however, would like to see the CWC be amended to include a new exception permitting incapacitating agents to be used in warfare, which  increasingly takes place in population-dense areas where using lethal force could put civilians’ lives at risk.   The divergent views on policy regarding incapacitating neuroactive chemicals leads me to ask, what about these chemicals makes them more alarming than other weapons?  An understanding about why incapacitating chemical agents are uniquely worrisome should inform how they will be regulated.

Is it that they are difficult to defend against and therefore more effective? Is this a problem even though these weapons create non-lethal alternatives in otherwise deadly situations? Or is our real concern that, by incapacitating, they facilitate brutality toward a defenseless prisoner? If so, then the conversation should be about illegal soldier/police abuse, not the chemical agents themselves. Or is there something inherently unacceptable about militarized neuroactive chemical agents? Is acceptability determined by the intended effect (temporary unconsciousness)? By the mechanism (manipulating the brain)? By the amount of pain (fentanyl was developed as an anesthetic, so likely none)? By the size of its therapeutic index and how safe it is (when used to end a siege in a Moscow theater, fentanyl-derived gas killed 124 of the over 750 hostages)?

Should the Chemical Weapons Convention be amended to prohibit the use of incapacitating chemical agents by law enforcement?  Or to permit their use by the military?  Does permitting them in either context place us at the tip of a too steep slope of biological weapons with more prolonged and devastating effects (attacking fertility or the immune system)?  Or does it save lives?

Comments, thoughts, or answers welcome!

- Kelly Lowenberg

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Why Everyone’s Afraid of the Big, Bad Socialist (and why it’s a sheep in wolves’ clothing)

September 1, 2009 · Leave a Comment

If you want to destroy a program, call it “socialist.”  Unfortunately, most people who invoke this term of late have no idea what it means.  For those defacing pictures of Obama to make him look like Hitler, Socialism is not Nazism.  Hitler was a fascist – meaning that he crushed opposition, symbols of power and race were paramount, and the nation was exalted above the people. Socialism, on the other hand, merely means that the government manages the production or distribution of certain goods.  For the love of God, please stop conflating socialism with the Nazis or communists. Socialism may be ugly in its extreme, but there is nothing ugly about many stripes of socialism.

Public education is socialist.  The preservation of streams and clean air is socialist.  Public libraries are socialist.  Requiring car insurance is socialist.  Disaster relief is socialist.  Medicare is socialist

If Medicare is a federal program overseeing health benefits for those over 65, then why does it stir up hysteria when the government suggests a similar option for the rest of us who are under 65?   Probably because lobbyists have done a great job of confusing the issues.  They are making it seem like the government will take away your insurance and replace it with sub-standard care.  This is a misconception. The president’s current plan does not limit choice, it expands it.  If you are under-insured, the plan merely provides another option similar to what members of Congress have.  There would be no “death panel” that decides whether you receive care.   Rather, you would be given information on options and risks of intubation and feeding tubes, and YOU would decide what to do.  Incidentally, we have data that indicate that people who receive end-of-life counseling are not less likely to get care; in fact, it improves quality of life and attitude.

We also have data on health care reform.  It all points in the same direction.  We need to cut costs.  We need to insure more people and divorce employment from insurance.  We need to stop incentivizing the liberal ordering of unnecessary tests.  We need to realize that for every dollar we spend on futile measures, we are taking away resources from effective prevention and treatment. 

When it comes to highly politicized issues, we almost never have access to the kind of data that we have here.  For starters, we know that Americans pay twice as much as other industrialized nations and we have far worse outcomes.  We rank in the bottom percentiles on life expectancy and infant mortality, and we have roughly two times the rate of heart disease, stroke, and diabetes. Apparently, more is less.

But insurance company lobbyists would have you believe that the status quo is amazing and no one wants change.  In order to get a sense of the true health care climate, what we really need to do is chat with those who are sick.  They will tell you that they spend their Saturdays fighting insurance companies to pay for claims. They are forced into bankruptcy due to cancer and they’re kicked out of their homes despite having a lifetime of good credit.  We need to stop listening to corn-fed cattle, herded to the townhall meetings by insurance lobbyists who are hoping to create a real-life episode of the Simpsons – complete with the mob psychology. Maybe if they confuse us enough we will shoot ourselves in the foot and squash important change.  

But why is change so unattractive?  Are we dragging our feet because we believe that only other people get sick, and if they do, it’s their fault? Are we naively wedded to the American ideal that we don’t need the government to help us out of problems (unless, of course we are “too big to fail,” then please send the government checks.  Sincerely, Corporate America.)  Surely, now more than ever, we realize that none of us is immune from losing our jobs and insurance. 

Health care is a public good – like libraries, education, and the environment.  Should the free market provide education, while poor kids slip through the cracks?  Should capitalism decide how much of our forests to destroy?  Of course not. We need to stop invoking socialism as an automatic conversation stopper.  Widespread socialism can be wasteful.  But in some cases, socialism is not only moral, it’s critical to the sustainability of our society.  — Teneille Brown

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fMRI and Lying – An Interesting, Different Approach

August 31, 2009 · Leave a Comment

The number of published, peer-reviewed articles exploring the use of fMRI as a lie detector is now around 20 and at least two companies continue to sell fMRI-based lie detection services in the United States (in my much-repeated view, very prematurely).  A new article, though, uses fMRI in a different and interesting way to explore lying.

Josh Greene and Joseph Paxton have just published a paper in the Proceedings of the National Academy of Sciences looking cleverly at some of the processes involved in one kind of lying.  Greene and Paxton, Patterns of Neural Activity Associated with Honest and Dishonest Moral Decisions, PNAS 106:12506-12511 (July 28, 2009).

http://www.pnas.org/content/106/30/12506.full?sid=5e3b601b-662c-424d-aa90-1696fc469431

Greene and Paxton enrolled subjects in what they thought was a study of paranormal abilities to predict the future.  They were asked, while in a scanner, to predict the outcome of computer-generated, random coin flips.  Some of the time the subjects had to record their prediction in advance (the “no opportunity” condition), other times they just reported whether their prediction was correct after they were told the “true” result (the “opportunity” condition).   Each trial was a gamble of $3, 4, 5, 6, or 7 – a correct guess won that amount, an incorrect guess lost that amount.

They got useful data from 35 subjects, each of whom had 70 repetitions under the “opportunity” condition.  Fourteen of them were classed by the investigators as “honest” in the opportunity condition because they were right about 50% of the time.  Fourteen were classified as “dishonest” -  they were “right” 69 percent of the time or more, which should have happened fewer than one time in a thousand.  (The investigators do not accept their own cover story about paranormal ability!) Seven, who were right “too much” but not enormously too much, were classified as ambiguous.

The investigators talk about two models for honesty – “will” and “grace” (thus, perhaps, betraying that at least one of them watched television during the 1998-2006 run of Will and Grace).  The “will” model assumed one’s brain has to work harder to overcome the temptation to cheat.  The “grace” model assumes that some people never even considered cheating and that the cheaters’ brains would have to work harder.

The investigators looked at reaction time and found that the honest group had no significant response time differences in the opportunity and no opportunity conditions or between their wins and losses.   The dishonest group took longer in its opportunity condition “losses” than in its “wins” – took longer to decide to be honest.  It also took longer in its opportunity condition losses than the honest group did.

The fMRI data showed that the dishonest group had greater activation in the dorsolateral prefrontal cortex when it had opportunity “wins” (when it could have cheated to win) than with no opportunity wins.  It also showed more activation in the control network (anterior cingulate cortex, dorsolateral prefrontal cortex, and ventrolateral prefrontal cortex) when it had opportunity “losses” (decided not to cheat) than when it had no opportunity losses.  The honest group showed no differences.

So – at least in this kind of trial, honesty might be a matter of not thinking about cheating, not of controlling an impulse to cheat:  grace, not will.  The article has a much richer discussion of its findings than this poor summary, including a good summary of the limitations of the experiment and I recommend it.  It is particularly noteworthy among the fMRI-based lie detection tests in one way – it is based on “real” lies, situations where the research participant, on his or her own, decides to lie without being instructed to do so (and, in fact, has been at least implicitly instructed to tell the truth).  As such, it may tell us more about at least some kinds of lying than the usual experimental approaches.

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Treating Heroin Addiction With Heroin?

August 28, 2009 · 2 Comments

A study published in the August 20, 2009 issue of The New England Journal of Medicine and reported in The New York Times may challenge our conception of how to best treat opioid addiction. The study, conducted in Canada and led by Dr. Martin Schechter, shows promising results for using the active ingredient in heroin, diacetylmorphine, to treat people addicted to opioids, who do not respond to methadone treatment.  Currently no prescriptions can be written for heroin in the U.S.  Heroin is included in Schedule I of the Controlled Substances Act based on its high potential for abuse, the lack of any accepted medical use in the U.S., and the lack of accepted safety for use of the drug under medical supervision. Research on the efficacy of heroin maintenance treatment in reducing opioid dependence may call the basis of that classification into question.

Participants in the study, all of who had previously been unsuccessful in methadone treatment programs, were assigned to either take oral methadone (n=111) or injectable diacetylmorphine (n=115).  Another 25 subjects were given injectable hydromorphone (n=25) in order to verify the self-reported rates of heroin use through urine analysis. Both the participants and the investigators were aware of whether the assigned treatment was methadone or diacetylmorphine.  The assignment of the injectable treatments, however, was double-blind.  The injectables were administered under supervision, and methadone was dispensed at a pharmacy or clinic on a daily basis.

After one year of treatment, the patients receiving diacetylmorphine were more likely than those receiving methadone to have reduced rates of illegal activities including drug use (67% compared to 47.7%, p<.004), and to still be participating in the treatment program (87.8% compared to 54.1%, p<.001).  The diacetylmorphine group also showed “greater improvements with respect to medical and psychiatric status, economic status, employment situation, and family and social relations.” 

Interestingly, the investigators “observed similar outcomes” from the two injectables, but did not have enough power to compare the conditions.  They note that if hydromorphone is as effective as diacetylmorphine, then it may be easier to employ as a treatment, avoiding the many hurdles associated with prescribing the active ingredient in heroin.  

During the trial, diacetylmorphine was associated with a higher incidence of serious adverse events, raising questions about the safety of the drug.  Twenty-four of the 29 serious adverse events that were related to a study drug, occurred in the diacetylmorphine group (most commonly seizures and overdoses).  The investigators suggest that the drug should only be administered under close medical supervision, so the patient can be treated promptly in event of a seizure or overdose, as was the case in this study.

Based on the data, patients in both the methadone and the diacetylmorphine treatments improved.  The more dramatic improvement in the diacetylmorphine group among these participants indicates that using this drug may be an effective treatment for patients who are unresponsive to methadone treatment, and who would otherwise, having exhausted their medical options, exit the healthcare system and, likely, wind up entering the criminal justice system.

Although the clinical evidence is the first of its kind gathered in North America, European researchers have previously found similar results with heroin maintenance programs, and some countries have applied those findings.  According to Dr. Virginia Berridge’s editorial in the same issue of NEJM, doctors in Switzerland and the Netherlands have already begun prescribing heroin.

Berridge gives a thoughtful analysis of how attitudes about drugs and maintenance treatment depend on context: who the are people using them, the needs of the medical profession, whether the drug was first used as a “medical” drug or a “killer” drug, and how we define treatment and recovery.  Berridge’s editorial is an informative companion to the diacetylmorphine and methadone comparison study, pointing out that policy on treating drug addiction often depends as much on the political and social context as it does on scientific evidence.

- Kelly Lowenberg

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Eulogy for John Barton

August 25, 2009 · Leave a Comment

I was asked by John’s family to speak at his memorial service on August 16.  Because of his important role in, among many other things, law and the biosciences, especially with regard to intellectual property issues, I thought it might be worthwhile to post here my comments on him.  They focus primarily on his role at Stanford Law School, but do (I hope) give some idea of the breadth and importance of his work and of the fundamental goodness of the man.  He is missed.

* * *

John H. Barton and Stanford Law School

One of the worst things about growing older is the ever increasing number of memorial services.  Sometimes, they do serve as celebrations of lives that had come, through old age or a long struggle with disease, to a natural completeness.  This death, though, was different.  It was tragically premature.  John was in great physical and mental shape and his inquiring spirit was always young.  His family and friends, his colleagues, and all the people around the world who have benefited from his work have been cheated of many more good years of John Barton.

But as John would have been the first to note, life is always uncertain and he had a good run.  It wouldn’t have been like him to complain – a little wistful disappointment, perhaps, but no complaints.  And so, we too should focus on our gratitude for having had so much of John, for so long, to celebrate.

This is particularly true for Stanford Law School.  John arrived at the law school as a first year student in September 1965, almost 44 years ago.  I want to spend the next few minutes telling those of you not from the law school a little bit about what he has meant to us.

John was not our typical law student, a hot shot just out of an elite undergraduate school.  In 1958 he graduated magnum cum laude from Marquette University with joint degrees in physics and in philosophy, an early sign of the breadth of his interests.  The next year, while serving in the Navy, he married Julie and they started their family.  After three years in the Navy, he went to work for a top-secret defense electronics firm.  (I doubt that discrete John ever told anyone what he did there).  As a result, he did not start law school until he was nearing 30, with a wife and four children.  (The fifth made his appearance during Christmas break, John’s second year.)

In 1965 Stanford Law School was in the middle of its steep ascent, from a good regional school, to a very good national school, to one of the world’s top law schools.  In spite of his family obligations and thirty hours a week of paying work throughout law school, John was a spectacular law student.  Our colleague John Merryman remembers John Barton as his student in first year Property. It was, John Merryman says, “the first time I realized the school was getting so good that some of the students were smarter than the faculty.”  He even had first year student John Barton teach one of his class sessions.

After graduating in 1968 (in a rare lapse, only second in his class), John spent one year working for a leading Washington D.C. law firm, Wilmer Cutler and Pickering.  (Those were the days when the largest law firm near Palo Alto had fewer than 20 lawyers.)  But after only a year we pulled him back to the law school. He started teaching in the fall of 1969 and won our teaching award, voted by the students, his very first year.  He was part of  our faculty for the next 40 years.

It’s not quite clear how old the Stanford Law School is – it depends on when you start counting, which may in turn depend on when the Development Office thinks it useful to declare an anniversary – but I estimate that John was at the law school with about half of the students the school has ever had and with about 80 percent of our living alumni.  He taught several thousand Stanford law students, helping them with everything from first year contract law to courses he helped to create, like international business transactions, law in radically different cultures, intellectual property as a business asset, and biotechnology law and policy.  Our colleague, Buzz Thompson was his student in the mid-1970s.  He remembers that John “was the epitome of the absent minded professor.  In those days of chalk, by the end of class, John would be covered by chalk dust — on the front of his shirt and jacket, on his side, on the seat of his pants.  But his lectures were consistently brilliant — packed with interesting and valuable insights.”

John was a particularly important teacher for our foreign graduate students.  The law school has long offered masters and doctoral degrees to lawyers from other countries.  These students, particularly in the doctoral program, can be difficult to teach.  Although they are all very intelligent, they come from many diverse cultures and bring with them vastly different levels of knowledge of the American legal system or American legal thinking – and of scholarly written English.  Even in his retirement, John always took foreign students.  He worked, hard, with them to improve their analysis and insights – and their written English.  He was truly tireless in that role and was greatly appreciated, and loved, for it – and, as a result, he helped populate and improve law faculties around the world.  We’ve gotten several emails from his former international students.  Here’s a sample, from Professor Yahong Li at the University of Hong Kong:

“I have been strongly influenced by his broad knowledge of law, technologies and society, his intellectual curiosity, his work ethic, his kindness, and his love for mankind.  I feel so fortunate to have had the opportunity to be his student, and he will live in my heart as a great mentor forever.”

John retired from the Law School in 2002, which meant that he stopped teaching – except, of course, for all the times when he was brought back to teach courses we needed, to supervise international students who otherwise would have fallen through the cracks, or to deliver guest lectures for colleagues, like me, bent on exploiting him.  In spite of these continuing teaching obligations, retirement increased, not diminished, his research and policy work.

Although I haven’t mentioned it yet, John was always first and foremost a scholar – not an ivory tower scholar but one who wanted to help make policy, with the dirty hands and the occasional scar to prove it.  John’s work covered a very broad range but three aspects of it are especially noteworthy. First, he was interested in how science and law intersected, including but not limited to intellectual property.  Second, he was interested in the whole world, not just the United States.  And third, he was interested in concrete problems, where solutions would make the world a better place.  In the first two, he was a decade or two ahead of his time – forty years ago he picked out fields that had not yet begun their enormous growth in importance to law schools.  In the third, he was timeless.

John’s first topic as an academic was nuclear weapons control.  He then became interested in agriculture – the Green Revolution and its possible successors.  And eventually he came to focus on human health, particularly but not solely through vaccines.  To all of these he brought an engagement with the science along with a deep knowledge and interest in the legal tools that shaped these problems and their possible solutions – public international law, trade law, environmental law, antitrust law, and, increasingly, intellectual property law.  He mastered these legal fields not just because they were fascinating but, primarily, because they were important for people’s lives, including the lives of billions of people who did not know they existed – and whose existence these areas of law often slighted

And so he fought for more food, better drugs, better vaccines, but he did it by working with all sides:  governments, non-governmental organizations, and multi-national corporations.  He idealized none of them, he demonized none of them – he recognized that all were crucial pieces of solutions.  I think John may have been happiest, in recent years, about his role several years ago as chair of the Commission on Intellectual Property Rights and Developing Countries.  It was extraordinary that the British government, which created this commission, should reach out to an American scholar to chair it, but then John was an extraordinary American scholar.

John’s bibliography shows nearly a hundred books, chapters, articles, and other writings.  Very few appear in law reviews, the standard home for our trade’s work.  He wrote and worked with hundreds of collaborators.  Few were law professors or even lawyers.   John was thoroughly interdisciplinary before interdisciplinary was cool – when it was unconventional and even a bit odd.  If that ever bothered him, or worried him, he never showed it.  He did work he thought was important, in the ways that it could best be done, whether or not that fit into the traditional mold of a law school, or law professor.  That mold ultimately changed, in part because John helped break it.

I’ve talked about what John did – what he taught and wrote, but a large part of John’s importance to the law school came from how he was.

Our dean, Larry Kramer, said this about John:

“To me, the most remarkable thing about John was his selflessness and good will.  He never pushed or sought anything for himself and he was always willing to extend himself for others.  He pitched in and just did what needed to be done—without complaint, without needing or seeking recognition.  Even in retirement, he was as active and engaged a colleague as anyone.  And always modest, soft-spoken, and gentle.”

Paul Goldstein calls him “that rarest of beings in the legal academy: a truly humble man.”

And Miguel Mendez recalls “the warm and respectful manner in which he treated everyone: faculty, staff, and students.”

Miguel’s words remind me of a scene from Pygmalion (and My Fair Lady).  Eliza accuses Higgens – Professor Higgins, note – of rudeness.  She holds up Colonel Pickering, who treats a flower girl like a duchess.  Higgins defends himself by saying he treats everyone the same; he treats a duchess like a flower girl.  John treated everyone equally well – with attention, concern, and respect – from the eccentric questioner at a talk to the newest and most clueless student, staff member . . . or colleague.

Pat Adan, who served as John’s assistant in recent years, told me the staff’s general feeling about John:  “Always a gentlemen, never a complaint, always courteous if something needed fixing, he was grateful for anything you did for him.”

Respect, courtesy, and gentleness were certainly important parts of John’s character.  But of his many virtues, the one that strikes me most powerfully was his integrity.  John did what he thought was right, whether or not it was popular or good for his career.  He never even seemed to think about doing anything else – he never seemed to be tempted, because doing anything other than the right thing never seemed to occur to him as an option.

There is a saying so old that it is in Latin:  De mortuis nil nisi bonum dicendum est – speak nothing but good of the dead.  As I realized what a long list of John’s virtues I would have, it occurred to me, as an academic matter, to try to find some failings.  There must have been some – I’m sure humble John would have treated us to a long list – but the best I could come up with was that he wasn’t great at telling jokes . . . although he was very good at laughing at them.

I want to end with a personal word.  To me, John was more than a colleague.  He was a friend, a mentor, a support, and a model of what one could do with an academic life.  I miss him, and I owe him.

And so does all of Stanford Law School – its faculty, alumni, students, and staff for the last 40 years.  We are, individually and collectively, in his debt.  It is comforting, though, to think that John will live on as part of the continuing fabric of the Law School, influencing, as an indelible part of the institution, the lives of countless more students, staff, and colleagues.

We are all worse for his too early death; we are all better for the life he lived so well.  We will miss him.

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Professor John Barton is dead

August 12, 2009 · 1 Comment

Stanford Law Professor John H. Barton died on August 3, 2009, nearly three weeks after a bicycle accident had put him into a coma.  John was 72 years old and had retired from Stanford Law School in 2002, but he remained an active presence at the School.  He was still excitedly working on new and continuing projects, mainly aimed at improving health in the developing world.

John graduated with from Marquette University in 1958 with degrees in philosophy and in physics. After three years of service in the US Navy, he worked for several years as an engineer.  In 1965 – married, with children – he became a 1L at Stanford Law School and had a brilliant student career.  After law school he worked as an associate for one year with the firm then known as Wilmer, Cutler, and Pickering before joining the Stanford Law School faculty in 1969.  Until last week, he never left.

From the beginning of his career John was fascinated by the intersections of science, law, and society.  He worked on nuclear weapons control, environmental problems, and human health, almost always with an international field of vision.  From his earliest faculty days through his death, he did not care whether he was doing traditional law professor work – he worked with scientists, lawyers, policy-makers, and anyone else in his effort to make the world a better place.

John was a man of integrity so great that I’m not sure he ever noticed it – I believe it never occurred him not to do the right thing.  He combined curiosity, intellectual rigor, and compassion better than anyone I have known.  He was a great mentor, a great friend, and a very good man. His friends, Stanford Law School, and the world are all diminished by his too early death, but we are all better as a result of his life.

Hank Greely

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Neuroscience: Is There Anything It Can’t Do? (guest post by Ryan Calo, CIS)

July 15, 2009 · 3 Comments

I almost laughed out loud when I read Jonah Lehrer’s mediation on neuroscience and art (Unlocking the Mysteries of the Artistic Mind, Psychology Today July/August 2009).  The gist is that neuroscience—which has yet entirely to explain how memory works—may be on the verge of unraveling the human response to art.  Great art’s ability to evoke the sublime or challenge expectations amounts, apparently, to a series of readily explicable tricks.

Take cubism, for instance.  It turns out we’re not really responding to Picasso’s bold challenge to sequential representation or some still deeper current of imagination.  Rather, Picasso is using “careful distortion” such as emphasis or exaggeration to “intensify reality.”  Art, in other words, is an optical illusion, and artists the fledgling “neuroscientists” who first figured this out. (Cats apparently introduce a subtle whine to their purring that our brains find it difficult to ignore.  Behold!  Cats are neuroscientists.)

The position Lehrer synthesizes is the modern day equivalent of saying that pushpin is as good as poetry.  It is utterly inadequate as an account of our relationship with visual art.  Even if the allure of Cézanne’s minimal Mona Lisa could be explained through the insight that “[t]he mind delights in filing in blanks,” what of Magritte’s Ceci Nes’t Pas Une Pipe?  Or what about Duchamp’s Mona Lisa?  Does Duchamp exploit the “neural mustache bias”?

Maybe I’m over-reading Lehrer.  Maybe the idea is that neuroscience is to art what physics is to tennis.  Andy Roddick couldn’t tell you much about friction or momentum, but these phenomena sure make it difficult to return his serve.

If so, “neuroaesthetics” confuses mechanism with meaning.  And it probably doesn’t add much even there: everyone knows that certain techniques of art, such as perspective, trick the brain in some way.  Knowing the exact mechanism cannot resolve any central “mystery” of art.

The brain is ridiculously complex and good neuroscientists spend a lot of time learning about it.  This cannot leave much room for the study of art.  Maybe neuroaesthetics should focus on unlocking the nagging mystery of, say, the placebo effect, and leave art its little mustache.

-Ryan Calo

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Book Note: In Pursuit of the Gene by James Schwartz

July 13, 2009 · Leave a Comment

This fascinating science history is subtitled “From Darwin to DNA” and, although the main action ends in the 1930s with only a 14 page epilogue moving from Oswald Avery to the Hap Map, the book does cover a lot of historical territory – and a lot of intriguing personalities.  The book follows the concept of the gene from Darwin’s notion of “pangenesis” through Hermann Muller’s prescient speculations about the physical nature of the gene.  It focuses largely on particular scientists and their work, hitting Francis Galton, W.F.R. Weldon, William Bateson, Hugo de Vries, Gregor Mendel, and Walter Sutton, among others, before reaching Morgan and his fly group, and particularly Hermann Muller.

It is not new to suggest that scientists have personalities, quirks, and feuds, but Schwartz provides at least two nice examples of battles within science, following at length the conflicts between Weldon and Bateson in the early 20th century and the travails of Muller with Morgan and his disciples. Schwartz, for good reason, is so fascinated by Muller that I wonder if there might be a Muller biography in his future, to supplement Elof Carlson’s 1981 book.  (What’s not to be fascinated about with Communist/eugenicist scientist from New York City who worked in both Hitler’s Germany and Stalin’s USSR before working on the Republican side of the Spanish Civil War?)  He clearly focuses much more attention on Muller than on Morgan, Sturdevant, Bridges, and the other members of the original Fly Room and its successors (perhaps as a complement to the way Kohler’s history of the fly room arguably under-discussed Muller).

One of the strongest points of the book, to me, was that Schwartz was willing to go into some detail about the experiments that led scientists to their conclusions.  The discussion of the fly crosses, for example, were clear enough that I really felt I understood what had been done and grasped the excitement caused by the results.

I’ve done a fair amount of unmethodical and unfocused (but interested) reading about the history of genetics and molecular biology.  I have greatly enjoyed some of the biographies, such as Evelyn Keller’s biography of Barbara McClintock or Paul Berg’s study of George Beadle.  And Jim Watson’s The Double Helix is, of course, in a category by itself (although into exactly what category this wonderful book fits remains unclear).  Of the broader histories, Schwartz’s seems to me to belong with Judson’s Eighth Day of Creation and Kohler’s The Lords of the Fly – even though it lacks a clever title.   I recommend it.

- Hank Greely

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Sharon Begley article on Evolutionary Psychology

June 24, 2009 · 3 Comments

Sharon Begley, one of my favorite American science journalists (at least on bioscience topics), just published a 4300 word article in Newsweek on Evolutionary Psychology.  To call it a devastating attack would be about right, I think.  It is a very powerful summary of the scientific  evidence against strong EvoPsych positions.  I have been skeptical about Evolutionary Psychology ever since I first heard of it and found David Buller’s critical book about the field, Adapting Minds, largely persuasive.  This Begley article, though, seems to me the best short critical assessment I have seen.  I strongly recommend it.

http://www.newsweek.com/id/202789

– Hank Greely

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More on the ACLU Suit to Invalidate Myriad’s Patents on Breast Cancer Genes

May 27, 2009 · 2 Comments

Earlier this month, I wrote that the ACLU filed suit on behalf of patients and researchers against Myriad for its patents related to breast cancer.  This suit is particularly interesting as a direct challenge to whether human genes should be the subject of a patent–to many a question that is long overdue.  This question was glossed over after the 1980 case of Diamond v. Chakrabarty, in which the Supreme Court held that a genetically modified bacterium is patentable subject matter.  The likely suspects to challenge such patents, other biotech companies that depended on patents to secure investment, had an interest in not having all patents of this type declared invalid.  Why did the ACLU wait such a long time to bring this suit?  It’s likely that recent decisions addressing the scope of patentable subject matter signaled that the time was ripe to address the issue, perhaps in a way that would result in a narrower interpretation of subject matter eligibility (Bilski, Comiskey, Classen).

The suit raises several questions, though I focus on the following four issues:

1.      Are human genes within the scope of patentable subject matter?  This is the question that follows naturally from the Bilski decision that patent claims must be narrowly tailored to cover a particular application of a fundamental principle, such as a law of nature, rather than preempting the principle itself.  A claim would need to be tied to a machine or be transformative to be patent-eligible.  The method claims at issue are not tied to a particular machine.  One could argue that identifying a gene that corresponds with an increased susceptibility to disease is transformative-it takes biological material and transforms it into information about disease risk.  For the composition of matter claims, isolating DNA would physically transform it, though it’s unclear whether such a transformation would be seen as insignificant extra-solution activity.

2.      Does imposing high costs for patented tests that implicate human health violate the First Amendment or fail to promote progress?   I think this is a hard argument to make, given that this is the essence of the patent bargain.  If you invest and discover something, you can charge what you want for 20 years from your filing date.  We don’t invalidate patents on MRI systems or life-extending pharmaceuticals based on the costs their patent holders decide to charge, though the courts have imposed a reasonable royalty in response to unauthorized use (eBay v. MercExchange) or (rarely) compulsory licensing has been required.

3.      Does allowing a patent that (potentially) excludes others from correlating information violate the First Amendment?  It’s hard to imagine standing would be satisfied here.  I doubt that any patent holder, even Myriad, would bring suit against a doctor for performing a correlation, whether performed mentally or even after disclosing the results to a patient.

4.      Does allowing a patent that prevents a second opinion of a medically relevant test conflict with the First Amendment or fail to promote progress?  The First Amendment argument seems a bit of a stretch, though perhaps preventing a patient from obtaining a second opinion does undermine the purposes of the patent system.  More particularly, it prevents the public from verifying what the patent holder claims to own, which seems to be part of the disclosure requirement of the patent system.

I think these types of patents are becoming less important, in part because of the narrowed scope of patentable subject matter eligibility, the broadened ability to show obviousness, and the likelihood of finding invalidating prior art from the Human Genome Project.  The decreased pace of discovery of single genes that correlate with disease also lessens the significance of this suit.  It’s challenging to get decent empirical evidence on under what circumstances these types of patents ultimately encourage or hinder innovation, but in light of the importance of these discoveries to health, the more prudent approach is to assume that they encourage it.

Other discussions related to this suit:

IPWatchdog:

http://www.ipwatchdog.com/2009/05/14/aclu-files-frivolous-lawsuit-challenging-patents/id=3417/

Holman’s Blog:

http://holmansbiotechipblog.blogspot.com/2009/05/aclu-lawsuit-challenges-patenting-of.html

Patently-O:

http://www.patentlyo.com/patent/2009/05/people-vs-the-brca-patents.html

Patent Docs:

http://www.patentdocs.org/2009/05/association-for-molecular-pathology-et-al-v-us-patent-and-trademark-office.html

Earlier Post:

http://lawandbiosciences.wordpress.com/2009/05/13/patients-researchers-file-suit-to-invalidate-patents-on-breast-cancer-genes/

–Brenda Simon

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