Biopower in the Era of Biotech – lareviewofbooks
Posted: September 7, 2017 at 7:44 pm
SEPTEMBER 7, 2017
TWO TRENDS are on the rise, and one is about to make the other worse.
The first is epitomized in a July 2017 report in The Economist on the United Statess urban-rural divide, which noted that deaths of despair suicide, heart disease, and drug overdoses are increasing in the southeastern corner of West Virginia. Life expectancy for men is now 16.5 years lower than in neighboring Arlington. Christian H. Coopers moving essay in Nautilus entitled Why Poverty Is Like a Disease, Karin Goodwins journalism in the Guardian, and James Bloodworths op-ed in New Scientist have piled on additional accounts of how chronic stress and loss of a sense of control can be our undoing.
Meanwhile, in the second trend, biotechs rise, ever more powerful tools are being developed for in vitro fertilization, and for anti-aging and cancer technologies. Some of the latter run to six figures, which means some insurance companies may not cover them.
As economist Thomas Piketty noted in 2014, and so many have since Trumps election, the United States is embroiled in an intensifying era of class struggle, which expresses itself not only in differential impacts on health as pegged to class, but also in the growing unlikelihood that the rural poor, and indeed the poor in general, can securely provide for their children, no doubt a factor in the declining fertility rate. At the same time, the commercialization of science steadily escalates, along with its corollary: the commercialization of human life. Many life scientists hope to start a company and strike it rich. Many have. Entrepreneurial scientists now count themselves among the wealthiest of Americans, and, as the market so freely allows, some of them build their careers on the development and sale of biotech solutions. Offering a route to positive eugenics, longer life, and interventions into deadly diseases, these life-saving and life-enhancing technologies will assuredly widen the public health gap.
First, consider birth. In December 2015, I attended a meeting at the National Academy of Sciences in which a member of the American Society of Reproductive Medicine stood up to proclaim that parents have a right to use the gene-editing tool CRISPR-Cas9 and in vitro, or IVF, technologies to have a genetically connected child. These technologies could be used, he explained, to repair the code for deleterious genes that run in certain families or improve older parents chances of a birth. Bioethicist Hille Haker argued that there is a difference between a negative right, which is a freedom from harm or tyranny, and a full positive right, which is a freedom to access potential benefits. Having a healthy child is a negative right, according to Haker, meaning a right you have unless someone (such as the Chinese government) takes it away, but not a full positive right. If it were a full positive right, society would be hidebound in debt to pay for each of its citizens to have children, applying genetic tests and in vitro techniques as needed. Almost no one would contend that society has such a responsibility, she argued. You may disagree with me, but as an ethicist I put the consequential assessment in terms of rights and obligations, Haker said. There is no right to a genetically related child, it is a high value, not a right.
In August, Shoukhrat Mitalipov, at the Oregon Health & Science University in Portland,controversially became the first scientist in the United States to use the gene modification system CRISPR to alter a human embryo. He modified the gene MYBPC3; when mutated in a single copy of that gene, it can increase your risk for a rare heart condition. Forty-two of the 58 embryos he altered, or 72 percent, had two mutation-free copies of the gene in every cell, and, most importantly, there were no unintended mutations. This study suggests that any technical limitations will soon be overcome, which will then open up a landslide of ethical questions related to equity. Keep in mind that many of us carry a genetic variant that predicts risk for a serious condition. Will insurance companies pay for these gene modifications, and to what extent? Or will the wealthy alone be able to afford to modify their embryos?
This past winter, the National Academy of Sciences and National Academy of Medicine published a report entitled Human Genome Editing: Science, Ethics, and Governance that signals support for gene editing to the heritable, or germline, code, but only in cases where no safer options are available. In her book, A Crack in Creation, Jennifer Doudna, one of the inventors of CRISPR-Cas9, also signaled her openness to CRISPR-ized babies through gene modification.
Already, insurance coverage of in vitro fertilization varies widely by state, and now gene modification techniques may further challenge the concept of what is medically necessary. A mutated APP gene can predict early-onset Alzheimers. A mutated BRCA gene can predict breast or ovarian cancer. A disrupted PCSK9 can lower LDL cholesterol. The Food and Drug Administration actually thinks of CRISPR as a drug rather than a device, so in the United States, CRISPR must pass through a regulatory process for each target it modifies, even in an embryo. For some single-gene or Mendelian diseases such as Tay-Sachs and cystic fibrosis, or the immune disorders NEMO or X-SCID, CRISPR technology could be a fairly straightforward new treatment modality in vitro. Keep in mind, however, that generating an embryo without a heritable mutation can, in the vast majority of cases, already be accomplished by screening embryos before implantation. This raises the question of when CRISPR would be indispensable. In fact, genetic variants in BRCA, which tend to run in high-risk families, are nested in complex so-called epistatic relationships involving the interaction of multiple genetic variants. It would be impossible to know whether altering that single gene reduces cancer in a family in future generations. And if it did, would poor families be able to afford it? Probably not.
Marcy Darnovsky, director of the Center for Genetics and Society in Berkeley, California,and her team have counted as many as 45 countries that ban germline modification. The United States is not one of them, and instead it handles germline editing in vitro much as it does stem cell research by prohibiting funding to scientists to do this research and prohibiting funding to the FDA to review applications for clinical trials of CRISPR babies. We can be sure that entrepreneurial scientists who stand to cash in on such technologies are working to alter such policies. Using gene-editing techniques in a test tube is arguably safer than using gene modification techniques on a living person in a test tube, youre modifying a clump of 64 cells or fewer, rather than trillions of cells, and eliminating the risk of an immune reaction. But those test tube techniques still require genetic diagnostics to know something about a familys risk, not to mention requiring the capital outlay to pay for expensive genetic diagnosis and IVF treatments in short, not particularly realistic or affordable for most of us.
Ultimately, none of this would help living people who develop a disease such as cancer. New technologies such as genetically engineered T-cells combined with CRISPR will enable doctors to coax the bodys immune system into fighting cancer,the first of which wasapprovedonAugust 30, which Novartis will sell in the U.S. for$475,000, a drug price that is nine times the median income in the United States. This means that high-cost medicines will create wealthy scientists and just as surely will exacerbate the health divide. This may be the reality if the Trump administration repeals the Affordable Care Act, but it may also be the reality in a single-payer system such as the National Health Service in Britain, which isnt prepared to pay for these high-priced medicines either. Indeed, oncologist and author Siddhartha Mukherjee warned this summer at the annual American Society of Clinical Oncology meeting about dividing the world into the rich who can afford personalized cancer treatment and the poor who cannot. If health insurance is unequal or inadequate, the only solution may be to use the power of the state to regulate the cost of cancer drugs. A drug price fairness initiative is in fact already on the ballot in Ohio; and transparency laws, established in Vermont, are clarifying their cost. We may have to cap them by executive order.
In the 1970s, Michel Foucault developed the influential notions of biopower and biopolitics, which gave power its access even to the body. In his words, biopolitics is the endeavour, begun in the eighteenth century, to rationalize problems presented to governmental practice by the phenomena characteristic of a group of living human beings constituted as a population: health, sanitation, birth rate, longevity, race. He defines biopower as the techniques for achieving the subjugation of bodies and the control of populations. But even Foucault had yet to conceive of how new biotechnologies could be leveraged. The industrial revolution of the human genome initiates an era in which social divisions are amplified by means of genomics technologies.
Foucault was wrong about some things, such as health and mental illness being solely the result of social forces. But he may have been only partially wrong. As neuroscientist Robert Sapolsky and so many others have noted, stress is distributed unequally across the social spectrum. Hierarchies of wealth and power institutionalize certain forms of stress, including chronic forms, and, according to a spate of recent research, social hierarchies are then embedded in body chemistry through social imprinting. If this research holds up, then it seems clear that we cant undo the damages accrued by years of poverty or poor social status by giving more funding to wealthy scientists. Theres been a clear shift to funding genetics research into mental illness, but the fact is that this research supports the drug-maker model, which then mostly benefits those who control and sell those drugs. It supports their careers through generous amounts of public funding. It does not support the disenfranchised who may need more than drug-based interventions.
The philosopher Nick Bostrom defines transhumanism as the doctrine that
holds that current human nature is improvable through the use of applied science and other rational methods, which may make it possible to increase human health-span, extend our intellectual and physical capacities, and give us increased control over our own mental states and moods.
This not-so-subtle movement includes efforts by the National Institute of Mental Health to monetize the field of psychiatry by basing research on a molecular biomarker or gene target that can be pursued as a diagnostic test or drug target, an agenda that is, in fact, now in retreat because so few reliable biomarkers or targets have actually been discovered. Clinical biomarkers and biochemical transformations have failed to make a dent in suicide rates, not to mention in the incident rates or prognosis of serious psychiatric ills. The most promising discovery coming out of research into psychiatric drugs in recent years may be a street drug called ketamine, or Special K, a worldly knowledge that experts have expropriated from regular folks.
As for the budding life-extension industry, it is built around over-the-counter drugs, such as nicotinamide mononucleotide (NMN), and the development of new drugs to degrade proteins that build up in brains and are associated with age-related diseases such as Alzheimers and Parkinsons disease. In 2013, the Time magazine cover story Can Google Solve Death? became part of the transhumanist spectacle when it noted that, for CEO Larry Page, solving cancer may not be a big enough task. The article introduced life extension company Calico, which is currently working on ways to degrade proteins that build up in the brain and are correlated with age-related diseases. But insurers may not have an incentive to pay for life-extension techniques that add bonus years, since insurance is more costly when we are older. As a result, these pursuits only contribute to the trope that life extension is a luxury pursued by wealthy Silicon Valley entrepreneurs stymied by their own loss of control. The most potent real news is precisely the connection between income and longevity. In short: The fact that such studies have led to no major societal shifts in how we value life suggests that the longevity that drug makers pursue as a financial prospect is solely about extending life for the wealthy.
An urgent question, therefore, is the following: Are our scientific institutions working on behalf of the public and fairness, and so of distributive justice, or are they working for commercial interests? And another disturbing question: Are these interests being normalized before we can even debate them? The fact that scientists themselves like to appeal to economic interests when asking for public funding should offer one clue. And of course it doesnt help that scientists want to sell us stuff.
In the famous 1971 Chomsky-Foucault Debate, Foucault argued that those who take up social justice causes are in fact doing so only because they want to take power. Chomsky demurred:
I think its too hasty to characterize our existing systems of justice as merely systems of class oppression [] they also embody a kind of groping towards the true humanly valuable concepts of justice and decency and love and kindness and sympathy, which I think are real.
Of course, institutions can be applied to advance justice and fairness, or be exploited for special interests. If authority is broadly distributed and innate to the wellsprings of the mind, then institutions are an extension of principles that reside within us and should seek to ensure access and fairness. But if scientists are working toward selling biotech solutions at the highest price the market will allow, then scientific institutions may be exploited for power and profit and thats just capitalism.
The irony is that we may need the state to ensure fair access to medicines we fund, and to prohibit genetic enhancement or reproductive advantages if all of us cant afford or access them. This is no small problem. Political scientist Francis Fukuyama called transhumanism the worlds most dangerous idea, suggesting that the commercialization of biotech would create increasing unfairness. In his book Our Posthuman Future, he qualifies his original end of history thesis, arguing that human genetic engineering and in vitro fertilization might perpetuate social divisions, putting liberal democracy at risk. If there is one imperial power left on the world stage, Fukuyama argues, it is biotech. What should we do in response to biotechnology that in the future will mix great potential benefits with threats that are either physical and overt or spiritual and subtle? he asks. The answer is obvious: We should use the power of the state to regulate it.
Here are some recommendations: the price of biologic medicines (gene and cell therapies) should be fixed or capped that is, if the public is expected to subsidize their cost through National Institutes of Health funding. If that sounds too much like socialism, then we need to stop socializing the costs and risks of drug development through NIH funding. A second point: The federal legislators and the FDA should have strong regulatory control over the creation of gene modifications to the heritable code of newborns. For the moment, they are able to constrain those enterprises as mentioned earlier, the FDA regulates gene modifications as a drug, and any specific target must pass through an extensive regulatory process. Once approved, then some sort of public insurance must make them accessible to everyone, or else biotech will assuredly exacerbate social and economic inequality, thus affecting the Freedom Index in the United States.
Scientists are readily using taxpayer funding to advance their own economic interests, thereby institutionalizing power and wealth. Indeed, many managerial scientists count themselves among the wealthiest Americans with annual salaries in the six and seven figures. If the state has a role, it is to live up to the ideals which we are groping towards, the concepts of justice and decency, rather than the current reality of scientific institutions seeding biotech startups. The fact is that scientists are increasingly testing public trust. Whether they should continue to receive tax-exempt funding ought to depend on whether they are working toward fair and equal access to medicine, lest by the time science funding reaches a commercial shelf, life is simply up for sale.
Jim Kozubek is the author ofModern Prometheus: Editing the Human Genome withCrispr-Cas9,published by the Cambridge University Press.
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Biopower in the Era of Biotech - lareviewofbooks
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