Sharon Begley article on Evolutionary Psychology

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

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

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

Rising Health Care Costs in America

It is unarguable that health care costs in America have been rising to the point of being out of control. When looked at as a percentage of GDP, cost per capita, or total spending, the amount that the U.S. is spending on health care each year is increasing far faster than the rate of inflation.  What is less obvious, however, is the cause of these cost increases. Three recent articles offer three distinct theories for the causes of the escalation.

In The Value of Medical Spending in the United States, 1960-2000, David Cutler attests that the “increased use of medical therapies has led to increased medical costs” (Cutler, 2006). Cutler uses  cost-benefit analysis to compare gains in life expectancy against costs incurred, concluding that “although medical spending has increased substantially during the past 40 years, the money spent has provided good value” (Cutler, 2006). Conversely, Gerard Anderson, in It’s the Prices, Stupid: Why The United States is So Different From Other Countries, writes that the U.S does not provide more services than other countries, but suggests that “the difference in spending is mostly attributable to higher prices of goods and services” (Anderson, 2003). Another viewpoint expressed in No Reverse Gear, by Paul Ginsburg, identifies advances in medical technology, and American’s demanding attitude towards such products, as the primary driver of health care costs. Ginsburg cites the “supplier-induced-demand” as a force involved in creating a system that bypasses traditional economic models for a more cost-blind one.

In these three propositions, I believe that a very important aspect of rising health care costs in America is only barely touched on, which is the culture of America itself. While it seems straightforward to assign the increase in costs to a simple mathematical equation of increase in price and increase in quantity of services, it is interesting to investigate why these increases are occurring. There is a natural trend towards growth in many areas of the economy, but rarely do we see such unsustainable demand for goods and services. Victor Fuchs and Zeke Emanuel label this phenomenon The Perfect Storm of Overutilization,  blaming the combined factors of a “physician culture emphasizing thoroughness”; a marketplace that allows for third-party payments, direct-to-consumer advertising, and utilization incentives for physicians; and the simple fact that “US culture emphasizes the new and the fancy; old and plain is equated with deprivation” (Fuchs, 2008).

If we are to “fix” the health care cost problem, it cannot be a simple restructuring of goods and services offered, nor can it be a solution only involving refinancing. These solutions would be stop-gap measures that would not truly address the root of the problem: America’s tendency to want the newest, shiniest thing. In what has been dubbed the “technological benefit of the doubt,” Americans have a propensity to trust new, and often expensive, technologies, regardless of actual increases in effectiveness in treating a disease. We see an exampled of this phenomenon when drug companies come out with new versions of their old products. For example, Claritin, Claritin-D, and Claritin Clear all have similar rates of effectiveness at treating allergies, yet each is increasingly expensive. The market provides a demand for newer medicine, and so the company supplies. It seems as though the words “new” and “improved” are forever linked, albeit sometimes inaccurately, in our collective consciousness.

To decrease costs, we would have to truly reevaluate the way Americans perceive medical care. “Thoroughness” would need to have a new meaning, one that does not include utilizing every available technology, but only those technologies whose costs are justified by the expected clinical benefit. A cultural revolution, which is undoubtedly much more difficult to achieve than one purely economic, would need to come about before America truly accepted any radical changes to the healthcare it obtains.

- Libby Greismann

Patients, Researchers File Suit to Invalidate Patents on Breast Cancer Genes

The ACLU filed suit Tuesday in the Southern District of New York seeking to invalidate patents on the BRCA1 and BRCA2 genes.

The complaint alleges violation of Article I, section 8, clause 8 of the Constitution (the “patent” clause), the First Amendment, the Fourteenth Amendment, and 35 U.S.C. section 101 (patent subject matter eligibility).

The complaint can be accessed at http://www.aclu.org/images/asset_upload_file939_39568.pdf.

With recent decisions from the Federal Circuit limiting the types of inventions that are eligible for patent protection, the time may seem ripe for this test.  The question, however, is whether challenging patents like these will ultimately advance innovation.  Perhaps limiting the enforceability of such patents might better address some of the more troubling aspects they raise.

–Brenda Simon

Virtue, or virtuoso

I went solo to see the Soloist last night.  It was a pretty good movie, but it had a lot going for it from the get-go, as far as my film-preferences go: mental illness, neglected urban decay, wordy nerds, and a love of music that borders on idolatry.   What I didn’t expect for it to include was something else that gets me going: medical ethics.  First, a little background.  Then, I will get back to the movie.  Don’t worry, no spoilers.

One of the crowning tenets of modern medical ethics is that individuals should not be forced to undergo treatments, and they should be adequately informed about the risks of various therapies before they agree to sign-on.  I think we can all agree that, in general, informed consent is an ethical concept.

In response to research atrocities of the last century and the paternalistic notion that a doctor “knows best,” the right of an individual to direct her health care decision-making has been enshrined not just in medical ethics, but also in the common law of tort.  Individuals who are treated without giving their voluntary informed consent can sue under negligence doctrines, and in some states under fraud.

Despite being a cornerstone principle in bioethics, the limits of obtaining informed consent have been recognized.  Children are not able to give informed consent, though there is a growing movement to allow adolescents to have their opinions taken into account alongside their parents’ assent.  Patients who lack capacity (meaning they are not capable of making specific medical treatment decisions) cannot provide informed consent.  And in some cases, because you are of a class of people so vulnerable and so routinely abused by society, we assume that your ability to consent is compromised.  And in some cases, it probably is.  This thinking, however motivated it is by protecting the best interests of the subject and deterring those who seek to exploit the poor, perpetuates a system where some people’s wishes are deemed per se illegitimate (though we often couch the discussion of informed consent in thoughts of duress or coercion).  While I understand the roots of this thinking, and its proper default of erring on the side of protecting the vulnerable, I do suggest that on occasion we challenge its application.  To assume that under no circumstances could a poor mother in India voluntarily consent to be paid $100 in return for participating in a low-risk clinical trial is condescending and denying the very agency we want to respect.  It’s a perverted return to a type of paternalism that assumes informed consent means “you would choose what I would choose.”

But the pendulum swings both ways.  On the opposite side do we have perhaps too much deference for an individual’s ability to direct her care?  In cases where patients are mentally ill, stricken with schizophrenia and not taking any medication, would it be ethical to force them to take anti-psychotic drugs, if just for a little while, so they could get a window on to what their world might be if they chose to continue with meds?  Of course traditional theorists of bioethics answer a resounding, “no.”  But this is the question Steve Lopez’s character (played by the gifted Robert Downey, Jr) asks for a moment in the Soloist.  He met Nathaniel Anthony Ayers, a homeless man who once attended Julliard, on the streets of LA.  Lopez is a journalist at the LA Times, and at first just wanted to write a column about Ayers, describing how one could go from cellist prodigy to living on Skid Row.

Along the way Lopez decides that Ayers may have schizophrenia, based upon his confusing speech patterns and his altered(?) sense of reality.  But of course Lopez cannot diagnose Ayers and neither can we.  Instead, Lopez asks the volunteers at an LA community clinic to provide Ayers with mental health care.  Lopez asks why the clinic cannot force Lopez to take meds.  The clinic coordinator speaks from the cynicism that only a fallen optimist could possess.  He instructs Lopez that they could only force Ayers to take his medication if he were a danger to himself or others.   To this, Lopez poses a (paraphrased) hypothetical: “what if I called the police and said that Nathaniel had threatened me?  He would then get 14 days of mandatory treatment where he could see how his life could be, free from mental illness…wouldn’t you want to be a part of that?”  As Lopez contemplates Ayers’ life on the rough streets of Skid Row, he asks, “Is arm-twisting him to take medication more humane than leaving him here?”   Incidentally, under California law, Lopez could be held civilly liable if he lied to the police about Ayers’ risk to himself or others…

Of course, Lopez assumes that anti-psychotics would likely help Ayers, and they very well may not.  It’s also possible that Ayers has already tried to stick with various treatments, and the negative side effects were just too much for him.   Or, Ayers has a history of coerced treatments, where he has been tied down, given electro-convulsive therapy or received so many meds at such high doses that he was left snowed and unable to appreciate Beethoven.  This is of course not the kind of treatment supported by the APA, and it’s obviously possible to have well regulated, moderate doses of anti-psychoatics prescribed that don’t leave people snowed.  We do not know what treatment Ayers has experienced before Lopez enters his life with his journalistic lens.  But it is interesting that if someone, as a result of mental disorder, were considered an imminent threat to himself or society, he could be involuntarily committed for some time under various state laws.  For example, in California, a 5150 hold would allow such a person to be restrained in a health care facility, without his consent, for 72 hours while he is evaluated and treated.  Why is our focus on the immediate threat, and not on someone who is slowly and predictably killing himself?  Perhaps this is because the statutes were often written to prevent battery, homicide, or suicide.   In an ideal world the state would help people be the “best” version of themselves, and keep track of our deleterious behaviors over time – but this is unrealistic.  The state cannot protect you from many things that fall short of the criminal code, even those self-destructive things that would together amount to the same outcome, albeit more slowly.  But is it just about what’s practical, or is there something else motivating the distinction over forced treatment when the danger is imminent?

I guess I’m wondering why it is that we’re so inconsistent with our principle of informed consent.   In some cases we may be overly deferential and in others – overly paternalistic and dismissive.   Our informed consent behavior, as codified in state statutes and court cases, does not track cognitive capacity or SES/vulnerability very neatly.  Perhaps the difference is that with the mentally ill, we are forcing them to take something that might not work, rather than letting the juggernaut of the status quo do its work.  But don’t we forcefully treat thirteen year olds, who might actually be better able than those with schizophrenia to understand and articulate their wishes?

Maximizing informed consent is something for which to strive.  But can we ever do as good of a job as we hope/think we are doing?  What if, on the margins, informed consent is just a channeling device, making us feel better about our substitute judgment of what is in the individual’s best interests?  And when we cannot presume to know what is in the best interests of someone’s brain that is so foreign to us – either because it’s so poor, so third-world, so mentally ill or disordered –  we stick with the false safety of the status quo?   — Teneille

Low-Salt Legislation in NYC

A recent New York Times article reported that Michael Bloomberg, the mayor of New York City, has announced that the city is starting a “nationwide initiative to pressure the food industry and restaurant chains to cut salt intake by half over the next decade.” The city has published data that this public policy experiment will lower health costs and prevent 150,000 premature deaths every year.

But where exactly is this data coming from? There is a strong following in the medical world for the anti-salt campaign, citing salty diets as a direct contributor to high blood pressure, and the associated heart problems. The logic, then, is that altering the public’s diet will reduce the number of morbidities and mortalities such as strokes and heart attacks. But the studies that suggest this connection may not be the most reliable works on which to base a complete overhaul of New York’s eating habits. In fact, most of the notable drop in blood pressure associated with a decrease in salty foods is observed in patients already suffering from hypertension. Furthermore, conflicting studies have reported a rise in blood pressure in response to less salt, or, more commonly, no change at all.

Without conclusive data to back his claims, it seems that Bloomberg is unethically engaging his citizens in a research experiment that may in fact be harmful to their health. The Times article cites studies that report numerous consequences of lowering salt intake, including anhedonia, a symptom of depression, an increased rate of hospitalization, and even death. What these conflicting reports tell us is that the effects of salt intake must be studied further, in a controlled and safe environment, and not with the heavy hand of sweeping legislation.

Enrolling an entire city in a giant experiment raises quite a few issues from a bioethical standpoint. Where are the consent forms? The IRB approval? Acknowledgement of risks and side effects? How about voluntary enrollment? As in all research, the experimenter cannot possibly be sure that the effects he predicts will come about. When an entire city is involved, it then becomes much more important to ensure safety and ethicality of such endeavors. In the 1990’s, there was a nationwide sweep to reduce the intake of fats, before clinical trials yielded any conclusive data. Interestingly, what we saw was an increase in the rate of obesity, as people were eating more “low-fat” foods that contained harmful ingredients, and switching their calorie intake to carbohydrates. It’s very possible that this anti-salt campaign will end in a similar story. If Bloomberg chooses to promote this venture as a public health policy, and not as a legislative experiment, it must be firmly founded in conclusive empirical data.

While it is indeed likely that the mayor has the people of New York’s best interests in mind, I do not think that an ill-informed and indiscriminate legislation is best serving their needs. An awareness program about the possible effects of salt on blood pressure, or dietary guidelines that promote healthy eating habits, would be a safe first step, until science can definitively declare salt as dangerous. As a final thought, I wonder whatever happened to letting people make their own choices about food. What’s next, issuing a warning label on pints of Ben and Jerry’s? Come on, Bloomberg. Take a page from Marie Antoinette, and “Let Them Eat Salt!”

- Libby Greismann

Update on Indian BEOS case: Accused released on bail

We wrote in December about the murder trial in India that relied heavily on Brain Electrical Oscillations Signature (BEOS) test to prove that Aditi Sharma had “experiential knowledge” of the poisoning of her former fiance, Udit Bharati.  Aditi and her husband, Pravin Khandelwal, were sentenced to life in prison. The original opinion, which we believe contains many serious flaws, is available at the original post.

We recently learned, courtesy of some research by Rajat Rana (thanks to Vinita Kailasanath!), that Aditi and Pravin have been granted bail by the Bombay High Court (documents: Aditi’s bail order and Pravin’s bail order).  Pravin’s sentence was suspended on the grounds that there was no real evidence to tie him to the case as a conspirator. Aditi was released based on the fact that the evidence of her possessing the arsenic-laced prasad was not compelling, and indeed “the possibility of plantation cannot not be ruled out” (sic). The BEOS evidence is not mentioned in either brief.

Watch this space for further news and a complete analysis.

- Emily Murphy

More on No Lie MRI case

David Washburn at the Voice of San Diego has reported on the No Lie MRI case, with some choice quotes from the CEO of No Lie MRI, Joel Huizenga.

We hope to learn more details about the case and the offered evidence soon, so watch this space.  In the meantime, for background reading on fMRI-based lie detection, Hank Greely and Judy Illes published a comprehensive review in the American Journal of Law and Medicine (2007, vol 33, pp. 377-431).

- Emily Murphy

Non-Prescription Usage of ADHD Meds at One University

I recently was sent a fascinating article on “enhancement” uses of Adderall, Ritalin, and Dexedrine on the campus of one college. The article is

Alan D. DeSantis, Elizabeth A. Webb, and Seth M. Noar, Illicit Use of Prescription ADHD Medications on a College Campus: A Multimethodological Approach, Journal of American College Health 57:315-323 (Nov.-Dec. 2008).

I have not, yet, found a free version of the article that I can link to, but I highly recommend it.

The article discusses a two-pronged look at the use at a large university of ADHD medications by students who did not have a prescription for the medications. The study used two approaches. First, it surveyed 1800 students; then it conducted follow-up interviews with 175 students.

34 percent of the surveyed students reported using an ADHD medication without their own prescription. (Four percent of the surveyed students reported that they had prescriptions for such medications and were excluded from the survey.) The rate of use increased from 18% in the freshman year to 55% by the senior year. 39% of the male subjects used the drugs compared with 30% of the female subjects. 48% of the “Greek” students (fraternity or sorority members) used the drugs compared with 23% of non-Greek students.

Of those who had used the drugs without a prescription, 72% said they did so to stay awake to study, 66% said they did to concentrate on their work, 36% said they used them to help memorize things, 22% said it was to stay awake and have fun, and 12% said it was to make work more interesting. Seven percent said it was for the high and 5 percent for appetite suppression. (People could give more than one reason, so the percentages total far more than 100%.)

There have been other surveys of college student use of these medications, with a range of results. (This survey’s results are at the upper end for usage.) What made this article particularly interesting to me were the quotations from the interviews, as students talked about their motives for using the drugs, their acquisition of the drugs, and their perception of the results. Students found it very easy to get access to the drugs, particularly in libraries or in fraternity or sorority houses. Over ninety percent said they got the drugs from friends or significant others. Fifteen percent got the drugs for free; those who paid spent from $3 to $10 per pill, but people reported that those selling the pills did not do it for the money but as a service to their friends. The sellers were students with ADHD drug prescriptions whose prescriptions were based on daily use but who used the drug much less frequently. As one student reported, “It is easier than beer to get.”

Although there is little, if any, good evidence about the effects of these drugs on the performance of people who do not have ADHD, the students reported strong belief in their efficacy. And they reported a general lack of guilt, in part because it was being used for studying rather than getting high.

I have helped write an article about the use of drugs for cognitive enhancement. (Henry Greely, Barbara Sahakian, John Harris, Ronald Kessler, Michael Gazzaniga, Philip Campbell, Martha Farah; Towards Responsible Use of Cognitive-Enhancing Drugs by the Healthy, Nature 456:702-05 (Dec. 11, 2008)) Adderall, Ritalin, and Dexedrine are not harmless drugs and their widespread use, without prescription, has worrisome health implications. But the DeSantis article does help make the point that such uses are common. “The first thing that became evident during the course of our interviews was how prevalent the use and casual discussion of stimulants were on the college campus.” What, if anything, to do about illegal use of cognitive-enhancing drugs is a complex question, but that use is certainly both real and substantial.

- Hank Greely

Request to admit No Lie MRI report in California case is withdrawn

The Center for Law and Biosciences received this very gracious (and unnecessary!) thank you letter today from the dependent’s counsel, Gary Seiser.  I speak on behalf of Emily, Hank and myself when I say it was a pleasure assisting you, Gary.  We are very happy with the outcome. To see the background on this case that has been made public, see Emily’s blog entry here and the Wired article covering the story, here.     — Teneille

______

Professor Henry “Hank” Greely
Director, Center for Law and the Biosciences
Stanford Law School

March 25, 2009

Dear Hank:

I wanted to thank you for agreeing to co-counsel the evidentiary hearing on the admissibility of fMRI for lie detection, and for all the help you gave me in preparing for the hearing.

I also wanted to thank Emily Murphy, Ph.D., and Teneille Brown, J.D., both at Stanford, for all they did for me.  As someone who had never heard of fMRI, let alone fMRI for lie detection, their almost daily explanations, suggestions, and help were invaluable.

Three others also deserve thanks.  Anthony Wagner, Ph.D., at Stanford gave me a broader understanding of fMRI.  Rich Haier, Ph.D., at UC Irvine was extremely helpful answering questions and providing me with material.  And Andy Kozel, M.D., of the University of Texas Southwestern, for agreeing to talk with me and to share his latest articles; his openness and honesty were very welcome.

Special mention should go to Marcus Raichle, M.D., of Washington University in St. Louis, for agreeing to take time out of his very busy schedule to fly to San Diego and testify that use of fMRI for lie detection is not yet generally accepted by the relevant scientific community as reliable, especially for real world, high-stakes situations involving individuals.  Talking with a senior scientist of his stature and knowing he would be our witness was an honor.

I could not have adequately prepared for this evidentiary hearing on admissibility without all of you.  Now I understand both the great potential of fMRI for lie detection, and the many hurdles yet to be overcome before it is ready for the courtroom.  It has definitely been a learning experience.

As you know, this week the proponents of the evidence withdrew their request to have it admitted, thus ending the issue in our case.  I won’t speculate on why they did that.  I will only say I was confident that with all the help I had received, you assisting as co-counsel, and Marc Raichle on the stand, we would have prevailed.  In a way, we did.

As you understand, the confidential nature of our proceedings prevents me from saying more at this time, but please know the help from all of you in the legal and scientific communities was greatly appreciated.

Sincerely,

Gary Seiser

Gary C. Seiser, Senior Deputy
Office of County Counsel
Juvenile Dependency Division
4955 Mercury Street
San Diego, CA  92111-1703

Certified Child Welfare Law Specialist (CWLS)
National Association of Counsel for Children
Accredited by the State Bar of California
Board of Legal Specialization