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‘Tis the Season – Some Thoughts on Fat

Part way through the holiday season either definitely is, or definitely is not, a good time to think about obesity. Between family feasts, work-related parties, New Year’s Eve, and cold (well, cold for California) weather, calories always seem to pack in more tightly this time year – leading to the clothes fitting more tightly.

And, in the interests of full (plus size?) disclosure, I must note that, if only I could grow a decent beard, I could be a great Santa Claus. I’ve got the hair color; the “ho, ho, ho” abilities; and the body-mass index for it. This personal, and non-financial, conflict of interest has kept from writing or speaking about the subject, though not from thinking variously shaded thoughts about it over the years. A couple of recent articles, of very different types, have led me to share just a few of those thoughts in this blog post.

In its December 15, 2012 issue, the Economist, to which I have subscribed for over 30 years, did a long “special report” entitled “Obesity” (here). (It may be worthy of note that this was in the issue immediately before its overstuffed, end-of-the-year, holiday “double issue” – “do you want fries with that?”) The report reviewed some of the science of obesity, its (very limited) treatments, its epidemiology, its physical and financial costs (though not the psychological or social ones), the roles of food companies, and some of the plausible policy options for dealing with obesity. The comparative perspectives were particularly interesting to me – the problem is much broader (pun intended) than the “flyover” parts of the United States with Mexico, the Persian Gulf, and even China experiencing their own obesity epidemics.

The Economist’s special reports are usually on things like Mexico, France, the World Economy, Technology and Geography, India, Judaism, London, natural gas, and the Arctic – those being the topics for its other special reports in the second half of 2012. The attention paid to this topic was striking . . . so was the shortage of easy solutions.

So I want to talk a bit about science and the causes of obesity, the limitations of some currently trendy policy interventions, and some final thoughts on how this seems to me likely to play out in the long run.

Obesities and Their Causes

First, there is, and long has been, a lot more of pseudo-science or popular science about obesity than real understanding. One thing should be clear, but seems almost never to be acknowledged: if viewed through a medical lens, “obesity” is the name for a symptom, not for a single condition with a single cause. “Hepatitis” is the medical term for inflammation of the liver, derived from the Greek word for liver. It was a diagnosis, but the term is now used, with appropriate modifiers, for several different kinds of liver problems, with different infectious or environmental causes. Most researchers now think that what we call “schizophrenia” or “autism” are actually several (if not many) different disorders, with different causes and different possible treatments. Even cancers of particular organ systems, like lung or breast cancer, are subdividing into more and more types of malignant cells, sometimes being classified based on nothing more than different cell surface receptors on their membranes. But which receptors a tumor’s cells carry may determine the proper treatment, and the patient’s life or death.

It will be shocking if “obesity” turns out to be one thing, let alone one thing sharing as its only cause in any meaningful way “eating too much.” Age of onset, location of fat deposits (“apple shapes” versus “pear shapes”), ease of contracting, ease of treating, effects on health – these and many other things will vary among fat people. Some few will even have a straightforward physiological cause, such as an endocrine disorder, a serious genetic condition whose symptoms include obesity, or even some tumors. For most people, though, the cause is likely to be some complex combination of genetic predispositions, environmental (mainly diet) triggers, and psychological traits. Maybe the best way to think about it is that “obesity” will prove to be one health condition the same way “cancer” is one health condition – there will be key defining characteristics in common (too much fat, on the one hand; cells proliferating out of control, on the other), but many different causes, preventive measures, and treatments.

Science journalist Gary Taubes has a nice “World View” column in the December 13, 2012 issue of Nature, entitled “Treat Obesity as Physiology, Not Physics,” (here). Taubes has written frequently on obesity, including a book, Why We Get Fat. I first noticed his writing in this area when he wrote a scathing evisceration of the idea that the percentage of calories in our diet coming from fat had anything to do with obesity, tracing the idea to (literally, and solely) two lawyers working on a Senate committee staff in the 1970s.

Taubes, as his Nature piece sets out, has come to believe that American thinking on obesity has been fixated since the end of World War II on an “energy balance” view of obesity, based on the idea of

University of Michigan physician Louis New­burgh, that obese individuals had a “perverted appetite” that failed to match the calories that they consumed with their bodies’ metabolic needs. “All obese persons are alike in one fundamental respect,” Newburgh insisted, “they literally overeat.” This paradigm of energy balance/overeating/gluttony/sloth became the conventional, unquestioned explanation for why we get fat.

Instead, Taubes believes that an earlier European tradition that identified obesity with hormonal dysfunctions was more accurate. Taubes’s own view is that having a diet high in easily digestible (high glycemic index) and sweet (high fructose) carbohydrates causes higher insulin levels, which in turn causes most obesity, and the current epidemic. He recognizes that this is a hypothesis, not the proven truth, but, through the Nutrition Science Initiative, which he co-founded, is pushing to have this, and the opposing “energy balance” theory rigorously tested.

I certainly don’t know which, if either, of those two theories is “right” – or “how right” either is – but it is striking how little rigorous evidence we have about why and how people get fat. Part of that, of course, is because really controlled trials are hard. People get fat over a long period time and controlling, or even measuring, exactly what they eat and do during that time is very hard. (Especially since people, much more than mice and rats, cheat and lie when it comes to food.) Although the energy balance hypothesis has led to simple advice (“eat less, exercise more”), its success in stemming the tide of obesity is, clearly, beyond underwhelming.

Four Policy Interventions

The worries about obesity, in the context of limited evidence about its causes or cures, have led to some proposed interventions that seem, to me, likely to be, at best, useless but harmless and, at worst, largely useless but quite harmful indeed. I will talk about four such interventions here: redeeming “food deserts,” restricting junk food, regulating advertising and disclosures, and increasing sanctions on the obese.

Some people seem to think that the problem with obesity, especially in poor and minority communities, is the lack of access to farmers’ markets, Whole Foods Markets, and their equivalents. “If only the poor could buy reasonably priced kale,” they (don’t quite) say, “obesity would melt away.” Good luck with that. I think getting more food choices into poor neighborhoods at reasonable prices would be a good thing (especially that “reasonable prices” part), but I have to believe (without, I’ll admit, any rigorous evidence) that most people – poor or rich – prefer calorie, salt, and sugar stuffed foods to “wholesome” foods because most people enjoy the former more than the latter. How much is taste, how much is “fullness,” how much is habit is hard to know, but it is more than the lack of easy to buy fresh fruits and vegetables. (By the way, my wife makes a kale recipe we love – it is sautéed in bacon grease and served with crumbled bacon and white beans.) The same is true of school lunches. Put squash in that cafeteria line – even really tasty squash – up against french fries and I think I can predict which one will usually win. I don’t believe better availability of more “good” food wouldn’t help some people lose weight – just very, very few people. It won’t dent the obesity problem.

Similarly, restricting junk food (or trying to restrict junk food) seems to me similarly unlikely to have much effect. Whether it is zoning against fast food restaurants or banning soft drinks of more than 16 ounces, increasing the hassle of getting lots of very high calorie (or very low nutrient) food probably will make some differences. Some people might eat less; some might eat the same total amount but in less frequent trips (gorging or hording), some might even stop buying chili cheese curly fries at the drive-through and instead buy the ingredients at Safeway and make them at home. Better for the wallet, not for the waistline. Again, I am not saying this will make no difference; banning cigarette vending machines probably was a (small) factor in reducing smoking. I just don’t think it will do much – and its political costs will be substantial.

Regulating information about food is a third approach. One could try, for example, to ban advertisements for McDonalds on children’s cartoon shows. Or, as we have done to some extent, one could try to force companies to “speak” through requirements that they disclose nutritional information about their food. Whether either advertising limitations or disclosure requirements would be very effective seems doubtful. Again, they might cause small changes, but I think only small ones. Disclosure could help truly motivated dieters, for example, diet more effectively. But even if these methods were effective, are they feasible? The politics would be tricky but not necessarily impossible, particularly as companies want to look like they are being responsible (heck, most of them probably even really do want to act responsibly, as long as profits aren’t affected).

But, to mention a third publication I recently read, the Commercial Speech Doctrine might prove a substantial barrier. Conservative judges and justices have been regularly expanding the free speech rights of businesses to make money without annoying government interference. (See, for example, an earlier CLB blog post on a Second Circuit case finding that a criminal conviction for illegal off-label promotion of pharmaceuticals violated the First Amendment, here.) Tamara R. Piety and Samantha Graff, in The New First Amendment and its Implications for Combating Obesity Through Regulation of Advertising, available through SSRN here, focus on possible First Amendment barriers to regulating advertising of “junk food” to children. They see cause for concern.

A fourth strategy is to increase the sanctions on being fat in order to discourage it more. Some want fat taxes in health coverage, increasing the costs for health coverage for the overweight (or decreasing it for the not-overweight, which is almost the same thing). Others think social stigma may be worthwhile, the way that turning smokers into “outdoors only” lepers did (I suspect) help reduce smoking. There are three problems with this approach.

One is that it would be hard to increase the costs of being fat in much of America. The employment discrimination, the nasty comments (or the strongly approving comments for any apparent loss of a pound or three), the social (including romantic) barriers – most people who are overweight pay a high price for it, which is why about half the adults in the country will be on a diet at some point in the year. (Of course, some American cultures, particularly some minority cultures, do not have the same stigma on being fat – I’d love to see an anthropologist try to understand those cultural views and their possible oppositional relationship to the dominant culture’s preference for thinness.)

The second is that those diets rarely work because, for most people who are overweight, losing weight, and keeping it off, is somewhere between hard and impossible. Increasing the price paid for being overweight will lead to some people losing weight and a few keeping substantial weight off for the long term. But it will mainly make more people miserable as they try, and fail, to diet.

The third problem, of course, is that it makes people miserable. Pain and suffering as incentives to “better” behavior have a long history and sometimes they make sense. But that’s only plausible, I think, when the expected benefits substantially outweigh (too many inadvertent puns on this topic) the costs. Given points one and two, that seems unlikely here.

The Long Run

I see two possible long run scenarios.

In the first, society slowly and gradually adjusts. It comes to grips with the new environmental reality – nearly unlimited amounts of very attractive but very fattening food – and has its culture change (“changes its culture” seems far too active in this context) to deal with that reality.

In the 1700s England (and particularly London) had an epidemic of gin. For the first time, hard liquor was available to the masses and the masses liked it . . . way too much. Government interventions came and went but over about thirty or forty years, the epidemic receded to an endemic. Maybe the people most vulnerable died out, maybe people less vulnerable learned to be more careful, maybe social sanctions helped. Alcoholism remained, I’d guess at a higher level than before, but it was not tearing the culture apart. (One might argue that the pathological alcohol culture that Prohibition introduced into the US took 30 or 40 years post-repeal to moderate.)

Similar, though somewhat quicker processes seem to work with modern drugs of abuse. Heroin or crack epidemics burn through a place, and then burn out – or, at least, burn down to a smaller, controllable fire instead of a raging inferno.

Smoking is, of course, another possible example. Mean annual consumption of cigarettes by American adults went from 50 person in 1900, to about 300 in 1920; 1,000 in 1930; close to 2,000 in 1940; 3,000 in 1950; plateauing around 4,000 between 1960 and 1970, before beginning a slow decline to today’s figure of about 1,200. But about 20 percent of the adult population still smokes. That percentage has fallen by half in forty years, but it is still over 40 million American adults. How much of the smoking fall was caused by a realization of the health effects, by higher taxes, by advertising limitations, by bans on smoking in public places, by concerns about secondhand smoke, by cultural shifts, or simply by smokers dying off at a higher rate? Who knows – but the cigarette epidemic, like the gin epidemic of the 18th century, is receding, but still doing damage.

Controlling obesity will be harder than controlling smoking. Food is harder to control than tobacco – one can’t stop cold turkey. And the second hand effects are less tangible. The slow “natural” decline of the obesity epidemic would likely be slow indeed

So what’s the other scenario? Deus ex machina – or, perhaps better, better body weights through science. I think our greatest hope has to be in understanding the mechanisms that lead to obesity better and then learn to prevent and treat it better. Puritans might scoff at the idea of tasty low calorie french fries – “they should eat their brussels sprouts and like it!” – but that, or safe and effective appetite suppressing or metabolism increasing pills, or even surgical interventions with fewer and milder side effects are probably the best hope. Limiting the harm that comes to people from obesity-encouraging eating habits will be hard – changing those eating habits is likely to be much harder. Letting people eat their cake but not pay a weight price for it will not appeal to those who oppose cake (or support will power), but I suspect it will be the only thing that has a good chance of working in less than half a century.

Where is that research going on? Pharmaceutical companies have had very limited success with weight loss remedies; research continues but investment is not high. Food companies have had some successes with lower calorie foods in some contexts; I don’t know what their investment is like. There is no National Institute of Weight and no American Obesity Association to promote basic scientific research. Federal research is surely being done – the NIH claims to spend over $800 million a year on research “to reduce the prevalence of obesity and its health consequences.” How much of that includes say, research on diseases associated with obesity, like diabetes or stroke, is not clear. But if this is really an important policy problem, spending even the claimed not quite 3 percent of the NIH budget on it seems too little.

This blog post has now gone on about the length of a scientific article, so it is only right that it end with the stereotypical last words of scientific articles: “further research is required.”

Hank Greely

The uncertain future of pre-natal diagnostic method patents

Prashant Reddy Thikkavarapu

The field of medical diagnostics has travelled a long distance over the last century. Starting with Roentgen’s discovery of clinical X-rays in the November of 1885 to the revolutionary Human Genome project which was completed in 2003, healthcare has witnessed nothing short of a revolution in the manner in which medical illnesses have been diagnosed and treated. A key beneficiary of these advances has been pregnant mothers, who now have a range of inventive diagnostics tools designed to test their foetuses with minimal risk to either the mother or the unborn child.

Like most other technologies, investment into researching new pre-natal diagnostic tools, depends on the degree of protection these tools will receive under patent law. Investors need to be assured protection for their investment. The decision of the Supreme Court in Mayo v. Prometheus (2012) which has made it difficult to patent diagnostic method patents has slowly begun to take its toll, especially with regard to pre-natal diagnostics.

In Mayo the Supreme Court had to walk a fine line between S. 101 & S. 102. While 101 deals with patentable subject matter, 102 lays down the criteria for determining the patentability of a subject matter found to qualify as patentable subject matter under S.101. Traditionally, the U.S. Supreme Court has given S. 101 a very broad interpretation and has gone far enough to say that anything under the Sun is patentable save for the laws of nature. This limited exception makes it particularly difficult to claim patents for diagnostic methods since most discoveries in this field are basically discoveries of laws of nature. More often than not this analysis straddles both S. 101 & S. 102, especially when Courts are trying to determine whether the claimed invention is adding anything to the laws of nature.

In a recent opinion, dated November 20th 2012, the CAFC applied the Mayo precedent, for the very first time, to invalidate US Patent No. 6,573,103 in the case of PerkinElmer Inc. v. Intema Ltd. The patent in question claimed screening methods which would help diagnose the risk of fetal Down’s syndrome by contrasting particular markers from the first and second trimesters of pregnancy along with the differences in ultra-sound scans.

Yet another series of lawsuits regarding pre-natal diagnostics tools to diagnose Down’s syndrome, involves Sequenom’s patent no. 6,258,540. This patent diagnoses the existence of Down’s syndrome by analysing foetal DNA in the mother’s blood. Heralded as a path-breaking diagnostic tool, there is considerable pending litigation over this patent involving several parties. At least one such lawsuit filed by Ariosa Diagnostics Inc. against Sequenom, seeks to invalidate the ‘540 patent on the basis of the Mayo precedent.

Patent law is not the only area of uncertainty when it comes to diagnostic method patents. The code of ethics prescribed by the American Medical Association (AMA) continues to prohibit physicians from patenting medical procedures and methods. The AMA has previously climbed down from its prohibition against its members patenting medicines, surgical instruments and it remains to be seen whether it will climb down from its opposition to patenting of medical procedures.

Irrespective of the opposition to the Supreme Court’s decision in Mayo and the position of the AMA, policymakers have to eventually start dealing with the issue of incentivizing innovation in the medical diagnostics field in a post- Mayo world, else we risk investors either pulling out of the field or more tragically, postponing the public disclosure of path-breaking discoveries until they can figure out a way to translate such discoveries into patentable subject matter.

Prashant Reddy Thikkavarapu is an LLM student at Stanford Law School and one of our four student fellows this year at the Center for Law and the Biosciences

Sexual Orientation Change Efforts, California Law, and Cognitive Liberty?

A three-judge panel of the Ninth Circuit Court of Appeals just granted a temporary injunction pending appeal in the case of Pickup v. Brown,* a challenge to the constitutionality of a new California statute barring licensed health practitioners from providing the treatments defined as “sexual orientation change efforts” to minors. This is a quite interesting case, for lots of reasons – First Amendment speech rights of health care providers, the varying roles of parents, states, and minors over how children are raised, statutory regulation of medical practices, sexual orientation and the Constitution, and others. But one of the others that may get overlooked is that the case may be a bit of an imperfect test drive for arguments about “cognitive liberty.”

As I was finishing this post, I came across another post on these cases from NYU law professor Arthur Leonard, which goes into the legal issues in more detail than I do. I recommend it. What follows is supposed to be just enough background to let you understand the case, but it did get a bit long. Some of you may want to skip down to the “Cognitive Liberty” heading.

The Statute and the Cases

The Ninth Circuit has set up a page with links to downloadable copies of the relevant documents here. (This is a nice touch by the Court – part of a section of the Court’s home page that has links to documents about five cases of particular media and public interest.) The Appellant’s emergency motion for a temporary injunction pending appeal is probably the best document to start with because it contains two, conflicting, lower court decisions about this statute, plus the language of the statute itself.

Here’s the background. Earlier this fall the California Legislation, and Governor Jerry Brown signed, SB 1172, a statute that added three new sections, 865, 865.1, and 865.2, to the California Business and Professions Code.

The latter two sections are the operative parts:

865.1. Under no circumstances shall a mental health provider engage in sexual orientation change efforts with a patient under 18 years of age.

865.2. Any sexual orientation change efforts attempted on a patient under 18 years of age by a mental health provider shall be considered unprofessional conduct and shall subject a mental health provider to discipline by the licensing entity for that mental health provider.

The first section provides definitions, of mental health provider (a broad swath of licensed health care providers or trainees) and of “sexual orientation change efforts” (”SOCE”). It defines the latter as

“any practices by mental health providers that seek to change an individual’s sexual orientation. This includes efforts to change behaviors or gender expressions, or to eliminate or reduce sexual or romantic attractions or feelings toward individuals of the same sex.”

The section goes on to exclude from that definition “psychotherapies that: (A) provide acceptance, support, and understanding of clients or the facilitation of clients’ coping, social support, and identity exploration and development, including sexual orientation-neutral interventions to prevent or address unlawful conduct or unsafe sexual practices; and (B) do not seek to change sexual orientation.” (emphasis added).

Apparently the bill had been pushed heavily by Equality California, a non-profit advocacy group that became an intervenor-defendant in the Pickup case. The draft bill allowed past patients to sue providers for harm caused by prior SOCE treatment, but that was eliminated in the legislature. Initially, the California Psychological Association (CPA), California Association for Licensed Professional Clinic Counselors, California Psychiatric Association, and California Association of Marriage and Family Therapists (CAMFT) opposed the bill, although eventually the CPA and the CAMFT supported it and the others withdrew their opposition to it (but apparently did not support it). Governor Brown signed the bill on September 29, 2012, making it apparently the first legislation of its kind in the United States. The Act is to go into effect on January 1, 2013.

At least two suits were filed to block the Act. The Pickup case was filed on October 4 in the Eastern District of California. Its plaintiffs were four mental health professionals who provided SOCE treatment, two organizations whose members provided SOCE treatment, and two sets of parents (Jack and Jane Does 1 and 2) on behalf of two minor patients (John Doe 1 and 2) of two of the plaintiffs. This case was assigned to Judge Kimberley Mueller, who held a hearing on the plaintiffs request for a preliminary injunction against the statute on November 30 and issued an order denying that request on December 4.

At the same time, and in the same district court, two other affected licensed mental health professionals plus a person who “was involved in sexual orientation efforts commonly called ‘SOCE’” as an adult in 2011 and 201” and “had been planning on becoming a therapist specifically to work with individuals having same-sex attractions and to help men like himself.” This suit, Welch v. Brown, was also filed in the Eastern District of California and (for some reason) was assigned to a different judge, William B. Shubb. This case was filed on October 1. I cannot tell when this preliminary injunction motion hearing was held, but Judge Shubb granted the motion on December 3.

Both judges sit in the same courthouse in Sacramento. I do not know why the two suits weren’t consolidated and assigned to one judge – it is not common to see the same legal issue decided by two judges in the same district court in different ways. The plaintiffs in the second case did file a notice of related case, arguing that the two should not be considered “related” because they had different plaintiffs, some different defendants, and some different legal theories, including the state law theories in Pickup. (Seems unconvincing to me, but I’m a long way removed from district court practice.)

Judge Shubb’s opinion for his plaintiffs focused on their First Amendment rights. He found that the statute attempted to regulate speech, that it was not viewpoint neutral, and that it would have to survive strict scrutiny to be upheld. Without having seen any compelling state interests that the statute was narrowly drawn to serve, he concluded the plaintiffs were likely to succeed and granted the preliminary injunction. He did not reach his plaintiffs’ other claims, including those based on the right to privacy, on the Free Exercise and Establishment clauses, or on the vagueness and overbreadth under the First Amendment Neither did he allow these professional plaintiffs to represent the interests of patients and their parents, or, for that matter, any professionals other than themselves. His injunction applies to only these three plaintiffs.

Judge Mueller, on the other hand, held that the ban was a regulation of conduct – providing a specific “treatment” and not of “speech.” “[W]hat SB 1172 proscribes is actions designed to effect a difference, not recommendations or mere discussions of SOCE.” She further held that the conduct involved was not the kind of expressive conduct that is sometimes treated as speech for purposes of the First Amendment, like wearing a black armband or burning a flag. She thus judged the statute under the “reasonable relationship” test and held the legislature’s findings about the lack of safety and efficacy of SOCE were sufficient to uphold it – or, at least, to lead to a conclusion at the preliminary injunction stage, that the plaintiffs had not shown that they are likely to succeed on the merits on that claim.

Judge Mueller, unlike Judge Shubb, then had to analyze her plaintiffs’ claims about parental rights and, in a lengthy discussion, held that the statute did not violate those constitutional rights. Her plaintiffs had alleged several California constitutional violations in their complaint but had not made them part of the motion for a preliminary injunction.

Her opinion also refers, several times, to a possible role for people who are not licensed mental health providers covered by the statute. Nothing in the statute, she points out, prevents parents from seeking “SOCE or its equivalent through religious institutions or other unlicensed providers.” (I must say it seems a bit odd to me to say that banning licensed professionals from doing something is o.k. because unlicensed laypeople can still provide it - not crazy, but a bit odd.)

As noted (far) above, the plaintiffs appealed in Pickup (I don’t know whether the defendants have appealed in Welch. The three-judge panel, made up of Judges Goodwin, Leavey, and M. Smith, granted the Pickup plaintiffs’ request for a temporary injunction pending that appeal; I’m guessing the case will be argued in the spring of 2013.

This Case and Cognitive Liberty

SO . . . this is an interesting case, made more interesting by some federal court precedents on medical practice and the First Amendment. In one, Conant v. Walters, the Ninth Circuit enjoined the federal government from revoking a physician’s Drug Enforcement Administration license on the ground that he had recommended a patient use marijuana for medical purposes. In another, Wollschlaeger v. Farmer, a federal district court enjoined a Florida statute that forbade physicians to ask patients about gun ownership or to record any information about gun ownership in patients’ charts.

I’m not a First Amendment specialist and I don’t want to be one. I thought Judge Mueller’s position on the difference between a treatment and speech made sense, even if it is a “talk treatment”, but I could be wrong – particularly as the courts keep expanding the freedom of commercial speakers. I’m also not an expert on the constitutional law about parents and children, but I know enough about it to have very little confidence in anyone’s prediction of how the issue would get resolved here.

So I don’t know what the Ninth Circuit (or the Supreme Court) is likely to do with this case. I suspect (no surprise) that the standard of review will be crucial. The legislature’s findings that SOCE (all SOCE?) is neither safe nor effective should stand up to rational relationship review, but not, I suspect, much more serious inquiry.

But what most interests me about this case is its possible connection to “cognitive liberty.” The term “cognitive liberty” may have been coined over a decade ago by Wrye Sententia and Richard Glen Boire, the founders of the Center for Cognitive Liberty and Ethics. Today it is coming into wider use as people interested in neuroethics wonder what protections exist, or should exist, for people who want to keep their brains (cognitive portions and others) free from undesired interventions - or open to desired interventions. Nita Farahany, in particular, has been writing about some aspects of cognitive liberty and the Bill of Rights, such as the application of the Privilege Against Self-Incrimination to neuroimaging technologies. (See her excellent Stanford Law Review article, Incriminating Thoughts.) The accelerating pace of human neuroscience, and concomitant human neurotechnologies, is making these kinds of issues seem more and more relevant.

I have written a couple of articles about one potential issue around cognitive liberty – the use of neuroscience to “treat” people for things that aren’t diseases: H. T. Greely, Direct Brain Interventions to “Treat” Disfavored Human Behaviors: Ethical and Social Issues, Clinical Pharmacology and Therapeutics 91(2):1-3 (Feb. 2012), here but not free, alas, and Henry T. Greely, Neuroscience and Criminal Justice: Not Responsibility but Treatment, U. Kan. L. Rev. 56:1103-1138 (2008), available here as PDF. These articles mainly talk about hypothetical situations, involving speculative coercive neuroscience-based “treatments” for, say, criminal behaviors (though “chemical castration,” which they did discuss, is not hypothetical.) They also briefly raised questions, though, about restricting the power of people to choose such internventions, about the limited ability of children to consent, and about possible “treatments” for sexual orientation.

Unlike most of the situations I discussed in those articles, the Pickup case is not about a frankly coercive decision, by a court, a legislature, or anyone else, to impose an intervention, but about a decision to prohibit licensed providers from providing an intervention to a consenting person. (Of course, the degree of voluntariness to a consent when even a, say, 17 year old has said, consistent with his parents’ wishes, that he “seeks” SOCE, is certainly questionable.)

This case is also not about fancy neuroimaging, transcranial magnetic resonance, deep brain stimulation, or psychosurgery. The case, as framed by the plaintiffs, is about “talk therapy” (although the statute does ban more tangible interventions as well).

At its core, though, the case is about a medical or quasi-medical intervention that people (and their parents) want to use to change how their brains work – and not in a way that can be stigmatized as a “drug of abuse.”

There is no FDA review for “talk therapy” or other treatments not involving new drugs, biologics, or devices. A FDA finding that a treatment is “safe and effective” might give a state legislature less leeway.

Cases involving minors – even older teenaged minors – present special issues. Having an adult seek a prohibited intervention (note that the California statute doesn’t apply to adults) could make a difference.

And any issues in the U.S. involving sex, reproduction, or sexual orientation get special treatment. Challenges to a law prohibiting, say, a treatment that leads to cognitive enhancement could well be treated differently.

But it could also be the case that future cases about neuroscience based interventions in people’s brains – forced or forbidden – could be affected, for better or for worse, by the result in Pickup v. Brown.

Hank Greely


* Seriously, when you’ve got four named plaintiffs, two institutional plaintiffs, two each Jack, John, and Jane Doe defendants, and a case involving sex, why order your plaintiffs so that the caption is “Pickup v. Brown”? Or should I be thinking “pickup trucks”?

Psychiatry, Disease Definitions, and the War on Drugs

The lines we’ve drawn to distinguish the sick from the well, and legitimate treatment from drug “abuse,” are blurring beyond discernment. Earlier this month members of the American Psychiatric Association approved a new manual that re-defines many mental illnesses, prompting howls that the group has alchemized ordinary unpleasant behaviors and emotions into diseases. Critics claim the newly-minted “disruptive mood dysregulation disorder” turns kids who throw tantrums into mental patients, while changes to the definition of depression transform sadness due to the death of a loved one into a symptom of a disordered mind.

While this angst is understandable, it’s surprising we continue to take these disease definitions so seriously. Read the rest of this entry »

Not Law and the Biosciences - but not Rocket Science Either

Friday, July 20, 2012, Aurora, Colorado

Sunday, August 5, 2012, Oak Creek, Wisconsin

Tuesday, December 11, 2012, Clackamas Mall, Clackamas, Oregon

Friday, December 14, 2012, Sandy Hook Elementary School, Newtown, Connecticut.

Tomorrow, two weeks from now, two months from now . . . your home town or mine? Probably not, but almost certainly some Americans’ home towns - we’ve seen at least four of these mass shootings in just the last 5 months.

Trying to stop or even reducing the number of mass shootings in a country that already has hundreds of millions of guns and billions of rounds of ammunition in private hands would not be easy. But if, for political reasons (bolstered by some newly successful constitutional arguments), we rule out the regulation of guns and ammunition, it seems likely to go from very difficult to beyond impossible.

Gun lovers will continue to deny that too many guns and too much ammo is a problem. Some will continue to mouth that the problem is too few. If only those second graders had been carrying - or, at least, their teachers. They will cry that this tragedy is being inappropriately politicized. Maybe a few of them will have qualms, maybe not.

But the rest of us – those not infatuated with automatic weapons and daydreams of using them to repel invasions from Russia, China, or Washington, D.C. - must not let gun politics continue as usual. We must say “enough” and start working, thoughtfully and carefully, to come up with effective ways to prevent, or at least limit, these shootings. If we never start, we can never have any success - that’s not bioscience, or rocket science.

Our lack of any policy response to these killings, though understandable in terms of short term politics, is, in a broader sense, just plain crazy. So maybe there is some kind of “biosciences” in it after all.

Hank Greely

How not to run a drug study: The University of Minnesota puts on a clinic

At Scientific American, Dr. Judy Stone is using a notorious case of research misconduct at the University of Minnesota (where I studied bioethics) to walk through the requirements of ethical research on human subjects and the many ways they can be violated. It can be difficult to keep up with the research scandals at Minnesota’s Psychiatry Department over the years, so for the sake of clarity: this is the one involving Dan Markingson, a young man who killed himself while participating in an industry-funded clinical trial of Seroquel (the “CAFE” study). Read the rest of this entry »

Amgen Buys DeCODE - Reflections Backwards, Forwards, and on DTC Genomics

Earlier this week, U.S. biotech giant Amgen announced it was buying DeCODE Genetics for $415 million, thus apparently ending that company’s “interesting” 16 year ride. See this article in Genome Web Daily (access requires free registration). Read the rest of this entry »

A Minor Update on the Sherley Human Embryonic Stem Cell Case

The long-running saga of Sherley v. Sebelius – the challenge by two adult stem cell researchers (and initially others) to federal funding for hESC research, founded mainly on the Dickey-Wicker amendment - may finally be nearing an end. When the case was last seen, the DC Circuit, acting through a quite conservative panel of three judges, had ruled against the plaintiffs, upholding the district court’s grant of summary judgment for the government. The opinions were split in somewhat odd and interesting ways (see the discussion in my most recent - and ninth - blog post on this case, from August 30, 2012, here). As that post pointed out, the plaintiffs could then seek rehearing en banc from the entire DC Circuit or file a petition for certiorari, asking the U.S. Supreme Court to review their case. Read the rest of this entry »

A Constitutional right to sell the date rape drug to 8 year-olds

In 1993, the FDA approved a drug called Neurontin for use – in doses of up to 1800 mg per day – as an add-on (or “adjunctive”) therapy for partial complex seizures. Doesn’t sound like a blockbuster drug, does it?

Well, you’d be surprised. Parke-Davis earned more than $3 billion in Neurontin sales in 2004 alone. How did they do it? Let’s listen in on a motivational speech a Parke-Davis executive gave to the company’s marketing managers: Read the rest of this entry »

2013 CLB Workshop Series

Beginning in January, CLB will host its annual Workshop Series. The Workshop brings leading law professors and other academics from throughout the U.S. to present papers of interest to Stanford students, faculty, and members of the community. In previous years, the the Workshop has covered a variety of topics at the intersection of law and the biosciences, including bio-patents, DNA privacy, reproductive rights, science policy, bioethics, health insurance, neuro-law, and others.

The 2013 CLB Workshop Series will be hosted here, at Stanford Law School, and begin on January 8, 2013. All talks run from 4:15 p.m. to 6:15 p.m.; rooms will be posted closer to the talks’ dates. The Workshop is open to all students, faculty, and members of the Stanford community.

2013 CLB Workshop Series Schedule

January 8, Peter Lee (UC Davis)
“Transcending the Tacit Dimension: Patents, Relationships, and Organizational Integration in Technology Transfer”

January 15, Robert P. Merges (UC Berkeley)
“Patents and Drugs for the Developing World”

January 22, Patrick Lin (Cal Poly San Luis Obispo)
“Do Bio-Enhancements Violate the Laws of War?”

January 29, Andrea Roth (UC Berkeley)
“Modern Times: Rethinking Legal Sufficiency in an Era of Truth Machines”

February 5, Alex Capron (USC)
“Rethinking Informed Consent for Research”

February 7, Nita Farahany (Duke)
“On Cognitive Liberty”

February 19, Susan M. Wolf (Minnesota)
“Return of Results and Incidental Findings to Research Participants: A Fundamental Challenge to Health Law and Bioethics”

February 26, Carl Elliot (Minnesota)
“Fear and Loathing in Medical Research”

March 5, R. Alta Charo (Wisconsin)
“Faster, Safer, Better? Alternative Approaches to Drug Development”