Thursday, April 01, 1999

A Primer on Neuroscience and Public Policy

Brain Policy: How the New Neuroscience Will Change Our Lives and Our Politics

By: Robert Cook-Deegan M.D.

 rev_v1n1cookdeegan_1

The separate worlds of politics and science met and interacted in the Office of Technology Assessment, Congress’s agency for analyzing policy related to science and technology. Starting with its 1984 report on Impacts of Neuroscience, the Office delved into brain research until 1995, when Congress—in an act of self-destructive pique— saw fit to sacrifice the Office on the altar of fiscal austerity. Robert Blank, a political scientist who writes on genetics and reproductive technology, sat from 1987 to 1991 on the Office advisory panel that presided over a series of reports on “new developments in neuroscience”: neurotoxicity (1990), biological rhythms (1991), neural grafting (1990), and the biology of mental disorders (1992).1 Now he has written a primer on selected areas where policy affects neuroscience or where neuroscience influences policy.

Blank sets out to survey “rapid advances in our knowledge of the structure and functions of the central nervous system and its linkages to genetics” and “to examine the impact of this new understanding and its accompanying vast array of applications on human behavior, social institutions, and our perceptions of humanhood.” This is a worthy ambition, but a tall order for a book of 197 pages.

In Brain Policy, Blank consciously bases his approach to the issues on the way that the policy issues of genetics came under academic scrutiny. The scientific research initiative known as the Human Genome Project, which emerged out of genetics a decade ago, spawned parallel studies of the project’s social, legal, and ethical implications. In 1988, when James Watson agreed to direct the Genome Project for the National Institutes of Health (NIH), he announced that it would include these studies. As a result, NIH established its Ethical, Legal, and Social Implications program in 1989, and similar programs took root in other genome research efforts here and abroad. The first initiatives of the Ethical, Legal, and Social Implications program were conferences, surveys of issues, and publication of essay collections, all of which enabled scholars to get their bearings before they found ways to study the issues empirically or seek specialized knowledge on specific subtopics.

Since policy decisions draw heavily on understanding of belief and behavior, both of which arise in the brain, Blank makes a persuasive case that neuroscience merits as much attention to its policy implications as does genetics—and he is surely correct that it has received far less. Blank’s book set out to do for neuroscience what the Ethical, Legal, and Social Implications agenda has done for genetics. It has the value (and the limitations) of a general survey, with serious constraints on depth of analysis and level of detail.

TOURING THE BATTLEFIELD WITHOUT A MAP

Almost any reader of Brain Policy will learn much from Blank’s concise summaries of science and policy issues. He comes to science as a dedicated, competent nonspecialist. His coverage is generally accurate, and his analysis of policy is balanced and fair, although scientists may occasionally cringe at an overly broad generalization and readers may disagree with his conclusions. Brain Policy illustrates by example how neuroscience raises social issues. It could help guide discussion in an undergraduate seminar on social implications of neuroscience or in the many new graduate seminars on ethical implications of science, although it may be necessary to bring the discussion up to date and supplement the book with specialized readings.

Blank begins most chapters with a review of a particular area of brain science, then turns to social, legal, or ethical questions that arise from it. The first chapter covers the basics of brain anatomy and neurochemistry, then turns to the emergence of the concept of brain death and the renascent debate about it in recent years. The next chapter focuses on cognition and memory and examines analogies between mental processes and computer function before turning to philosophical controversies about mind-brain dualism. After the basic scientific overview, the chapter on genetics looks at diagnosis, gene therapy, and the eugenics and nature-nurture debates. A meaty chapter on brain and behavior takes off from earlier consideration of genetics and neurochemistry, discussing violence, addiction, gender differences in brain structure and function, and sexual orientation. This chapter’s final section looks at how knowledge of brain mechanisms influences legal and moral conceptions of free will and responsibility.

Next Blank considers direct interventions into the function or structure of the brain: electroconvulsive shock, electrical stimulation, psychosurgery, and drug treatments for psychosis, depression, and anxiety. After a section on performance-enhancing drugs,  Blank turns to computer simulations and virtual reality (which more properly belong in the previous chapter, since they are sensory experiences, not direct brain interventions). These surveys of the science of intervention pave the way for discussions of the right to refuse treatment and of the use of psychotropic drugs in children. Neural grafting and exposure to toxins that affect brain function (each the subject of an Office of Technology Assessment volume) here get a chapter each. The final chapter of Brain Policy addresses overarching issues and recurring themes.

UNASKED QUESTIONS

At the end of this impressive tour, the reader has glimpsed many battlefields where science meets policy, but has done so without a map or insight into strategy. Many important questions also remain unasked. 

Shouldn’t a book on neuroscience and policy address two decisions that Congress makes every year: how much to spend and through which agencies? 

Shouldn’t a book on neuroscience and policy address two decisions that Congress makes every year: how much to spend and through which agencies? The Office of Technology Assessment’s 1983 survey of federal money for brain research found just over $500 million distributed across five NIH institutes; three institutes subsequently re-united with NIH in 1991 (mental health, drug abuse, and alcohol); the National Science Foundation; the Department of Defense; and four other agencies. Every one of those budgets is subject to annual appropriations, and each appropriation cycle must address questions about how best to advance scientific knowledge and its applications. How much should each federal agency devote to increasing understanding of molecular and cellular function? To studies of disease causation? To databases that codify scientific information? To epidemiology? To understanding behavioral and social factors that affect health? To clinical trials for promising drugs? To developing technologies for diagnosis and screening?  Lying beyond these questions are even more difficult ones about the proper role, in our national system of innovation, of research supported by the government versus by private pharmaceutical, biotechnology, or device-manufacturing firms.

Questions about federal support are tough in any scientific field, but especially so in one like neuroscience, with so many disparate players. There must be policies for scientific research that is supported by different agencies, for different purposes, through different mechanisms, and with different “attitudes.”  Do the agencies cooperate, for example, to erect a common infrastructure of databases, new investigative instruments, and sets of clinical data? Are there areas where projects are apt to be supported by one agency that might not know another is already funding the area? 

America’s health and biomedical research system is immensely productive of new technologies, drugs, surgical procedures, and ways of organizing health care. The system is far less productive of knowledge that might guide decisions about third-party coverage of new services, demonstrate effectiveness in real-world practice (beyond clinical trials to prove efficacy), compare treatments that have different costs, and ensure that new technologies are used appropriately (and care systems are accountable for appropriate use). One thing NIH does not support, for example, is research that could help the Health Care Financing Administration decide what Medicare and Medicaid should (and, more difficult, should not) pay for among all the fruits of NIH’s past research.

Blank does note our relative weakness in technology assessment, which is supposed to guide decisions on adopting and covering new health technologies, but he does not give much attention to the causes of the weakness or possible solutions. Nor does he describe the structure of federal research support that contributes to this weakness— or the pressure groups that have helped to shape that structure.

AN EMPIRE SHAPED BY ADVOCACY

Advocacy for biomedical research may be the single most distinctive feature of U.S. research policy; it affects neuroscience enormously. Because of this advocacy, support for neuroscience is driven in large part by the quest for gains against specific conditions: Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, schizophrenia, mood disorders, epilepsy, stroke, neurological disorders, drug abuse, alcoholism, eye diseases, and developmental disorders. Hundreds of organizations plead passionately for Congress to provide funds that are then channeled through more than a dozen federal agencies. NIH is the neuroscience behemoth, but it is also a confederacy of largely independent institutes, each supported by an external constituency that is usually focused on one or a cluster of diseases. Those who benefit from NIH research—the disease advocates and the scientists whose work is supported by NIH— have an enormous impact on what NIH does, and just as important, what it does not do.

Every new product or service that springs from the mighty American medical research system can become a money maker for someone. Pharmaceutical and biotechnology firms sell drugs; instrument firms sell diagnostic and scientific devices; neurosurgeons perform surgeries; and neurologists and psychiatrists perform procedures, make diagnoses, and administer treatments. These health professional and trade groups dominate the one-seventh of the American economy devoted to health spending, one of our fastest growing sectors. In the past half century, the fraction of disposable income devoted to food has dropped by half; the fraction devoted to health has tripled.

We are obviously much better at saying “yes” to medical technologies than saying “no” This reflects a simple fact of political life that Blank acknowledges but fails to trace to its roots. The decision to say “no” to a new technology primarily benefits taxpayers as a whole by reducing the overall spending on health, but that decision also denies a “yes” to a specific individual with a specific need. 

We are obviously much better at saying “yes” to medical technologies than saying “no.” This reflects a simple fact of political life that Blank acknowledges but fails to trace to its roots. The decision to say “no” to a new technology primarily benefits taxpayers as a whole by reducing the overall spending on health, but that decision also denies a “yes” to a specific individual with a specific need. Thus there are passionate constituencies for saying “yes,” but a far more diffuse, weaker constituency for saying “no.” The Federal Drug Administration (FDA) approval process requires strong evidence of safety and efficacy before saying “yes” to marketing a new drug or device. For producers of these drugs and devices, there is, therefore, a strong financial incentive to provide evidence of efficacy. But there is little incentive to compare costs of treatment alternatives, and and science can fail to address when a benefit is worth the cost. If new services or procedures are not subject to FDA approval, the incentive is weak to gather evidence that could guide coverage and payment decisions.

In short, the stakes for America seem higher when it comes to deciding what science to pursue, what applications to encourage, and what medical practices to reimburse, than when making a decision about many of the issues addressed in Brain Policy. True, Blank’s neural grafting case study does raise questions about these crucial concerns, but in a speculative, future-oriented mode, whereas these same questions are economically significant for diagnostics and drugs right now. A pivotal health policy question of the coming decade, for example, will be who pays for new drugs and who sets the price; this question is looming in the federal Medicare program, where there is active debate about expanding benefits to include outpatient drugs.

Drugs affecting nerve function are a big part of this problem. As consumers and patients, we want the new drugs; as payers we don’t want to pay for them. The pharmaceutical sector opens new markets that represent new treatments—often for conditions that could not previously be treated as effectively. Yet a growth market for Pfizer, Lilly, or Merck busts the family budget, or the budget for health plans that cover drugs. Unfortunately, Brain Policy focuses on social problems and ethical issues about use of drugs, rather than on how they are developed and the respective roles of private and public sectors in that development.

MASTERING THE LITERATURE

Some final remarks on the timing and style of Brain Policy. Its coverage of some topics is several years out of date. The vast majority of references come from 1988-1996, with spillover into 1997. At one point, Blank refers to a 1991 Office of Technology Assessment report as “recent” (as perhaps it was when he wrote that sentence), but the time lag leaves holes. The otherwise excellent discussion of neural grafting and use of fetal tissue in medical research, for example, ends with the lifting in 1993 of the congressional ban on research involving fetal tissue. This omits the re-imposition of bans annually since 1995 through appropriations riders. As in past years, this battle promises to be one of the fiercest over the fiscal 2000 science budget. The outbreak of vigorous debate about human stem cells derived from fetal and embryonic tissues is likewise left out. Since the stem cell controversy ignited only in 1998, missing it is understandable in an academic treatise that must have taken several years to write, but missing four (going on five) annual cycles of appropriations bans on fetal research is less forgivable.

Another limitation may concern teachers. Blank relies heavily on secondary sources. Facts and statistics are often attributed to review articles, news stories in science journals, or synthetic reports like those produced by the Office of Technology Assessment, the Institute of Medicine, or consulting firms. It is not fair to push this criticism too hard, as it is impossible to imagine any one person mastering such a vast literature sufficiently to tether all facts to their primary sources, and a slim volume by a single author is generally better than a multi-authored collection of unconnected essays. That said, however, the most successful books in the Ethical, Legal, and Social Implications genre growing out of the genome project have been just such essay collections: The Code of Codes (Daniel J. Kevles and Leroy Hood, Eds., Harvard University Press, 1993), Genetic Secrets (Mark A. Rothstein, Ed., Yale University Press, 1997), and Are Genes Us? (Carl F. Cranor, Ed., Rutgers University Press, 1994). The closest comparable single-author genome book is Philip Kitcher’s The Lives to Come (Touchstone, 1997), which is far more coherent, tightly argued, and clearly written than Brain Policy. Kitcher no doubt was helped by the greater maturity of the field he surveyed. He entered a village populated by scholars of the Ethical, Legal, and Social Implications program; Blank found only logging roads through a dense forest, but the contrast between the books is nonetheless striking.

Blank has adopted the Office of Technology Assessment’s neutral, dispassionate tone. In most cases, this is a strength; disparate positions are usually well summarized. Blank’s prose is academic, however; most sentences could be shortened by four or five words without changing the meaning. Cells and social organizations “interrelate” and “intercommunicate” when relating and communicating would do. “Preciseness” often does what “precision” was designed to do. Blank and the Georgetown University Press might have gained some readers at the margin by tightening the prose.

In sum, Blank has done yeoman service in distilling an enormous mass of material into a slim volume, and his book deserves to be widely read. He would do well to improve the next edition by providing a map of the domain he surveys, taking care to describe all the salient issues, and getting a good copy editor. Perhaps, instead, he will inspire others to write such a book.  

EXCERPT

From Brain Policy: How the New Neuroscience Will Change Our Lives and Our Politics, by Robert H. Blank. ©1999 Georgetown University Press. Used with permission.

No two areas of medical research have wider implications for the study of the human condition than molecular biology and neuroscience. Although the political ramifications of human genetic research have been well documented and widely analyzed over the past decade, and the social, legal, and ethical dimensions funded as part of the human genome project, there has not been the same systematic scrutiny given neuroscience. In the light of the rapid advances in our knowledge of the structure and functions of the central nervous system (CNS) and its linkages to genetics, it is critical to examine the impact of this new understanding and its accompanying vast array of applications on human behavior, social institutions, and our perceptions of humanhood.

Social scientists who in general have tended to ignore both genetics and neuroscience research must become aware of the developments in the study of the brain and its implications for society in the twenty-first century. As noted by Crick, “there is no scientific study more vital to man than the study of his own brain.”... Although neuroscience may not be the final frontier of humans, the benefits and risks of new areas of intervention in the brain, as in the genome, require heightened attention across the social sciences.  

CONCLUSIONS: THE EMERGENCE OF BRAIN POLICY

As in other areas of biomedicine, new developments in neuroscience will emerge at an accelerating rate over the coming decades. Furthermore, because we are still at the primitive stages of understanding the nervous system, the speed of discovery in neuroscience is likely to outpace that in other areas of medical science. This book has demonstrated that despite the recency of knowledge in neuroscience, the technological fruits of the Decade of the Brain represent merely an impressive start to a more complete understanding of brain function and dysfunction, the genetic and neurological basis of human behavior, and the biochemical foundations of mental disorders. Less impressive to date have been our gains in knowledge of the impact of the environment on the brain.  

The current attention directed toward neuroscience has raised awareness of its importance to all aspects of human life, but it has not yet placed neuroscience high on the policy priorities in health care. This, however, will change. The wide array of new intervention capacities and the tremendous costs of CNS-related health care problems, along with the emergence of the view of the inseparability of the mental and physical dimensions of health, will demand considerably more attention by policy makers in the coming decades. The health benefits of more specific psychotropic drugs, neurogenetic treatments for mental disorders and neurodegenerative diseases, and heightened understanding of brain function in general are significant.

Unfortunately, the emergence of these new intervention techniques comes at a time when health care resources are becoming scarce and competition for funding is tight. Many interventions, particularly medications, are likely to be cost-effective and in fact might lead to cost savings. However, other emergent treatment strategies such as neural grafting and neurogenetic procedures will be very costly on a per case basis. Moreover, because total cost involves frequency of use as well as per case cost, even less expensive procedures can add significantly to overall health care spending when applied to large populations, for example, Alzheimer’s patients.

To date, seldom have even rough estimates been given for prospective innovating procedures such as neural grafting or preimplantation gene therapy. Although this is understandable at this early stage of development, analysis of cumulative costs is crucial before they come into routine use. As noted in Chapter 1, though high cost alone is not a justifiable reason to block or slow diffusion of various neural intervention techniques, as with all medical innovations it must be a factor for consideration. Although the inclusion of economic considerations is alien to our current value system, complete analysis of brain intervention techniques is impossible without such data.  

References

1. Full text OTA reports are available online: http://www.wws.princeton.edu/~ota/ 

http://www.access.gpo.gov/ota/

http://www.ota.nap.edu/

 



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Scientific Advisory Board
Joseph T. Coyle, M.D., Harvard Medical School
Kay Redfield Jamison, Ph.D., The Johns Hopkins University School of Medicine
Pierre J. Magistretti, M.D., Ph.D., University of Lausanne Medical School and Hospital
Robert Malenka, M.D., Ph.D., Stanford University School of Medicine
Bruce S. McEwen, Ph.D., The Rockefeller University
Donald Price, M.D., The Johns Hopkins University School of Medicine

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