Body Politic

Published on The Nation (http://www.thenation.com)

 

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How Our Genetic Maps Are Being Sold to the Highest Bidder

Patricia J. Williams | June 6, 2012

Who owns our bodies? One of the weirder cases exploring this bioethical question involved South Carolinian John Wood, whose leg was amputated after an airplane crash in 2004. Wanting to be buried “whole” eventually, he had the leg embalmed and placed it in a storage unit with other belongings. But he fell behind on the rental fees, and the contents of the unit were sold to one Shannon Whisnant, who found the leg carefully wrapped and nestled inside a barbecue smoker. Whisnant called the police, who traced it back to Wood. Wood insisted the leg be returned given his sincere belief that, detached or not, it was part of him. Whisnant, however, claimed that he was the purchaser-for-value and hoped to put the leg on display and charge a hefty price for the viewing. “Halloween’s just around the corner,” he explained.

The ghoulishness of this situation should not obscure the legal issues at stake: should a commodity interest in the contents of the storage unit trump the sacrosanctity of corporeal integrity? Are discarded body parts “alienable”? Or do they fall in the realm of what we deem constitutionally “inalienable”? A devastating disease.

What about DNA? Suppose we assumed that Wood’s genetic makeup included cells that were resistant to AIDS. Do Wood or Whisnant have any proprietary claim to profits to be derived from the extraction, culture and sale of those cells? Could Whisnant not only display the leg but also publish Woods’s entire genome as part of his Halloween show? Could the police officer to whom Whisnant brought the leg do a DNA test, retain the sample, patent a method of assaying the extracted data and ultimately market a pharmaceutical byproduct to patients at $5,000 a dose? We all leave a trail of hair and hangnails wherever we go—under what circumstances should that material be regarded as discarded and thus open for exploitation by finders-as-keepers?

At the end of May the personal genetics company 23andMe announced that it had procured its first patent, for “Polymorphisms Associated With Parkinson’s Disease.” Patents create exclusionary rights in knowledge; they prohibit non–patent holders from using that knowledge without permission or the payment of royalties. 23andMe’s patent stems from massive aggregations of data culled from customers who have paid considerable money for information about their genetic predispositions for various health risks. While 23andMe’s consumer contract says that no “research” on submitted spit samples shall be done without consent, many customers seem not to realize that “research” is defined as purely “academic”—which is to say, work published in “peer-reviewed scientific journals.” The contract then distinguishes “research” from “research and development (R&D)” of commercial products—for which no consent is needed.

When announcing news of the patent, CEO Anne Wojcicki declared that she wants “discoveries to move from the realm of academic publishing to the world of impacting lives by preventing, treating or curing disease.” But it is precisely in academic publishing that new ideas are most apt to be freely shared and tested; Wojcicki seemingly wants to dislodge discoveries “from” academia “to” the gated community of patent law—simultaneously designating patent law as the exclusive geography of disease prevention, treatment and cure. As she explains, “Often the only way a company will even think about pursuing a drug lead is if they have assurance that they can recoup their investment.”

Wojcicki frequently expresses her desire to heal and to broadly share the knowledge gained through data mining. Readers may know that she is married to Google co-founder Sergey Brin, whose family history of Parkinson’s disease places him at risk. But that backstory, compelling though it may be, is not reflected in the business model either of them pursues—nor should anyone expect it to be. As with any for-profit corporate head, their fiduciary duty is to make money. The realization of any wider, or public, interest in healthcare will not come from the private corporate sphere by itself.

The patent system, as well as our corporatized system of R&D, assures that the real wealth of data-aggregating businesses will come not from analyzing individual spit samples but from the far greater asset of bundling customers’ genetic, lifestyle and family history for commercial exploitation. In 2010, when classes at Stanford and Berkeley held “spit parties” to analyze students’ genetic material, I wrote in these pages that “we should be more thoughtful about the ends for which our bodies are being mined. The redemptive thrill of being co-creators of some medical miracle must be measured against the possibility that we are rendering fungible that which most profoundly distinguishes us and…enabling a commodity exchange in which important aspects of our identities will be sold to the highest bidder.”

I hope 23andMe will consider how better to channel its discoveries into nonprofit, low-cost treatment for all—or for its “direct consumers,” at the very least. It’s hardly a new ethical challenge. Consider The Immortal Life of Henrietta Lacks, by Rebecca Skloot. Lacks was a poor black woman who suffered from a unique form of cervical cancer, to which she succumbed in 1951. While she was at Johns Hopkins, her doctor removed some of her cancer cells, cultured them in a petri dish and distributed them for research purposes. It was the first “immortal” human cell line, and it has been the foundation for billions of dollars’ worth of medical and pharmaceutical discoveries. Neither Lacks nor her family was informed of the removal of her cells or the profit derived from them. When Skloot located Lacks’s children and grandchildren, she found a family still poor and without healthcare. Skloot’s response was to set up a nonprofit foundation that provides emergency healthcare and medical scholarships to those in need. Donations may be made by visiting henriettalacksfoundation.org [1].

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Source URL: http://www.thenation.com/article/168261/how-our-genetic-maps-are-being-sold-highest-bidder

Links:
[1] http://henriettalacksfoundation.org

Marvels, Madness, Medicine

by Patricia J. Williams

Released: 7 Oct 2010

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In the January 2011 issue of the Journal of Policy History, Susan Reverby, a historian at Wellesley College, will publish a paper detailing a particularly sordid moment in American history. From 1946 to ’48, the Public Health Service, with the assent of some Guatemalan officials, engaged in medical experiments on 700 Guatemalan soldiers, prisoners, mental patients and children. The documents Reverby discovered show that doctors intentionally sickened many of their subjects with syphilis, either by injecting infected fluids into their spines and under their skin or by supplying them with afflicted prostitutes.

Of course, this horrendous project arose from “the best of intentions” — to improve serological testing for the disease and to measure the degree to which penicillin and other medicines could act prophylactically. The US military was also interested in finding STD protections for soldiers that might be simpler and less painful than those available at the time. Ultimately, the observations in Guatemala were inconclusive because it proved harder than anticipated to infect sufficient numbers to constitute an adequate data set.

The doctor in charge of the two-year project was John Cutler, an assistant surgeon general who, in his later years, was a “beloved” professor at the University of Pittsburgh School of Public Health. It was in his archives that Reverby found notes and photographs documenting the existence of the project. Even before this revelation, however, Dr. Cutler’s long-term legacy was one of infamy: He was one of the main researchers in the Public Health Service’s Tuskegee Syphilis Study, in which black sharecroppers went purposely untreated from the 1930s to 1972, when the project finally was exposed. In 1944, moreover, Dr. Cutler directed a study in which gonorrhea was injected into prison “volunteers” at the state penitentiary in Terre Haute, Indiana. And in 1953, after returning from Guatemala, he resumed his experiments with syphilis injections, this time with prisoners in Sing Sing prison in New York.

Dr. Cutler’s experiments, while horrific, were not unique. Nonconsensual medical experiments were a prominent feature of South Africa’s apartheid regime. In America, we know about the military’s experimentation with atomic radiation on unwitting soldiers and patients from the 1950s to the ’70s and experiments with LSD in the ’70s. In the ’90s New York City foster children were used to test the effects of certain unlicensed drugs for AIDS. And let’s not forget all the “tests” done at Guantánamo Bay.

It’s important to understand how we repeatedly deceive ourselves into appalling forms of corruption by wrapping ourselves in the language of high standards. Reverby cites a telling quote from the 1967 autobiography of virologist Thomas Rivers: “I tested out live yellow fever vaccine right on my ward in the Rockefeller Hospital. It was no secret, and I assure you that the people in the New York City Department of Health knew it was being done…. Unless the law winks occasionally, you have no progress in medicine.” Rationalization has ever been thus: It’s humanitarian in the long run. We confuse, in other words, motives and means.

The United States Holocaust Memorial Museum posits three contexts in which nonconsensual medical experimentation took place in Nazi Germany: first, in military organizations, premised on rationalizations of security, exigency and defense; second, in the hunt for new pharmaceuticals and treatment methods; third, in conjunction with ideologies of racial, ethnic or religious superiority in which “common sense” dictates that some humans are less valuable than others and can be sacrificed for the “greater good.” The moral lesson of the Guatemalan experiment ought to spur public conversation and review of all these areas. My list of topics would include:

1. Despite more encompassing interpretations of the Biologic and Toxin Weapons Convention, we are increasingly converting academic research facilities into biodefense containment labs. A 2004 American Journal of Public Health article points to “inadequately characterized risks,” as well as concern that the program is informed by a “political rather than health agenda.”

2. The weakened condition of the FDA means that many drugs have been inadequately vetted before coming to market. The scandals involving Vioxx and Avandia are great failed experiments inflicted on a trusting, unsuspecting public.

3. Pharmaceutical companies and venture capitalists are investing in miracle drugs and testing by seeking out very poor people as “volunteers” in exchange for “medical treatment” or for token amounts of money that are dwarfed by the health risks involved.

4. Our consent procedures must be scrupulously overseen and updated, particularly where “volunteers” are used in places like prisons, mental health institutions, foster care or orphanage settings or on populations living under oppressive regimes. (As Reverby points out, Guatemala in the ’40s was essentially run by the United Fruit Company.)

5. Germ line therapy and genetic manipulation will increasingly implicate future generations. We must ask ourselves if our present zeal for “transhuman,” “gen-rich,” “enhanced” versions of ourselves is but a vast experiment in narcissism.

Scientific revolution always tempts us with blinding hubris. How else could Dr. Cutler engage in experimentation at the same time as and of the very sort for which the United States was prosecuting Germans in Nuremberg? So while President Obama and Secretary of State Hilary Clinton issue formal apologies to the people of Guatemala, we must interrogate our own freighted contemporary moment — of economic desperation, of rising nativism, of promises of hellfire to come, of soaring incarceration rates. These are divisions that have never been exploited to any good or decent end.

Patricia J. Williams, a professor of law at Columbia University and a member of the State Bar of California, writes The Nation column “Diary of a Mad Law Professor.” Her books includeThe Rooster’s Egg (1995) and Seeing a Color-Blind Future: The Paradox of Race (1997).

Copyright © 2010 The Nation — distributed by Agence Global

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Released: 07 October 2010

 

bring your genes to cal….

Published on The Nation (http://www.thenation.com)

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Freshmen Specimen

Patricia J. Williams | September 9, 2010

The school year at the University of California, Berkeley, began with a swab. In a program called Bring Your Genes to Cal, 5,500 incoming freshmen were asked to provide samples of their saliva in an experiment designed to bring the student body together in the same manner that reading To Kill a Mockingbird might have in the past. The more than 700 students who responded had their DNA analyzed in Berkeley’s (uncertified) labs, assessed for susceptibility to alcoholism, lactose intolerance and relative metabolism of folic acid. The exercise provoked an international debate about the ethics of the assignment. Ultimately, the California Department of Public Health barred the university from dispensing individual profiles on the grounds that genetic analysis is correlative only and is neither necessarily predictive nor diagnostic at this point. A collective comparison of the class’s genetic data was permitted, however, and circulated in “anonymized” form at orientation.

There are several reasons that Berkeley’s undertaking should give us pause. The first and most obvious is that of privacy: this information reveals more than we can yet interpret at the singular, embodied level of human identity. DNA decoding will become infinitely more precise in the near future, and with that growing precision in familial tracking and biological identification, “anonymizing” results by removing names and Social Security numbers will mean less and less.

Second, Who owns, or ought to own, these data? Although the Berkeley experiment is framed as an exploration of a vast genetic commons, this information is the subject of intense commercial speculation. And the degree to which specific gene sequences may be patented is quite contested in the law. Should you, as the biological vessel of a particularly exploitable bit of genetic material, receive any remuneration? Are your genes to be valued, in purely pecuniary terms, as akin to a deposit of oil beneath your land? Once genes are patented, can rival researchers be barred from working on the same material?

Another problem with Berkeley’s DNA swabbing is that it perpetuates the assumption that DNA analysis is as good as or the same as personalized medicine. Despite large gaps in understanding and the astonishing absence of standards, the results of genetic research are often held as being far more definitive than yet shown. The mere phrase “genetic correlation” is heard as a 100 percent infallible guarantee of whatever follows. This assumption is often implicit in the advertising of some direct-to-consumer companies like Navigenics and 23andMe. Indeed, both companies were hired to analyze the results of a medical school class’s “spit party” at Stanford University recently.

On July 22, however, the Government Accountability Office issued a report that advised consumers of the scientific uncertainty of individual results, in which assessments of risk varied widely from company to company. The GAO also found “10 egregious examples of deceptive marketing, including claims made by four companies that a consumer’s DNA could be used to create a personalized supplement to cure diseases. Two of these companies further stated that their supplements could ‘repair damaged DNA’ or cure disease, even though experts confirmed there is no scientific basis for such claims…. Two other companies asserted that they could predict in which sports children would excel based on DNA analysis, claims that an expert characterized as ‘complete garbage.’ Further, two companies told GAO’s fictitious consumer that she could secretly test her fiance’s DNA to ‘surprise’ him with test results—though this practice is restricted in 33 states. Perhaps most disturbing, one company told a donor that an above average risk prediction for breast cancer meant she was ‘in the high risk of pretty much getting’ the disease, a statement that experts found to be ‘horrifying’ because it implies the test is diagnostic.”

This is not to say that genetic testing shows nothing at all, but the results inform only at the aggregate level or as a set of probabilities. This explicitly aggregate data collection has been the subject of yet another controversial program, called Gopher Kids, conducted by the University of Minnesota at the annual state fair. At a booth adorned with balloons and a cute animal mascot, researchers offered free T-shirts and amusement park rides to parents and children willing to submit saliva swabs and answer a lengthy questionnaire about lifestyle. The university advertises participation as altruistic, a contribution to public health and human knowledge. The problem with this is that, again, the law is not settled about whether our genetic makeup is more the property of the excavating mind of the scientist or the individual property of a particular identified body.

Finally, there is the question of motive. Spit parties are boosted as ways to get to know one another in the social realm—as though it were a collective séance or a big, slimy Ouija board. But the real reasons that so many companies market swabbing kits is not entirely altruistic: there is huge money to be made in expanding the data sets as broadly as possible. The predictive probabilities involved in reading genes for disease or physique or ancestry can become more precise only by sifting through data of whole populations and then correlating frequencies of particular conditions with particular genetic clusterings. This, it is thought, will be very valuable in devising and marketing pharmaceuticals, as well as in forensic identification technologies.

As we enter the genomic era, we should be more thoughtful about the ends for which our bodies are being mined. The redemptive thrill of being co-creators of some medical miracle must be measured against the possibility that we are rendering fungible that which most profoundly distinguishes us and, in the name of a gift, enabling a commodity exchange in which important aspects of our identities will be sold to the highest bidder.

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Source URL: http://www.thenation.com/article/154596/freshmen-specimen

Hidden Assets

The Hidden Cost of DNA Banking

Diary of a Mad Law Professor

by PATRICIA J. WILLIAMS

This article appeared in the April 12, 2010 edition of The Nation.

March 25, 2010

In March 2009, Lily Haskell was arrested while attending an antiwar demonstration. Within hours she was released. Although she was not charged with any crime, her arrest alone was sufficient for her to be required to submit a DNA sample. The ACLU of Northern California filed a lawsuit on her behalf, challenging the constitutionality of the statute mandating police to retrieve and retain DNA from anyone arrested for a felony. As Michael Risher, Haskell’s attorney, asserted, the statute subjects innocent Californians to “a lifetime of genetic surveillance” with no judicial oversight, simply because they might have wandered into the field of suspicion of a single police officer.

The collection of DNA has mushroomed in the past five years. California has the third-largest forensic DNA database of any government entity in the world (behind Britain and the US government). All three collect DNA from arrestees regardless of guilt. All three have databases highly skewed by race and class. In Britain 42 percent of black men have had their DNA sampled and stored. Until recently, however, forensic DNA samples were retained only from convicted felons who had committed violent or sexual offenses. With very little oversight or consistency, local rules for collection in criminal cases have expanded haphazardly, often including anyone who is arrested even mistakenly. People may challenge the retention of their DNA and sue to have it expunged, but that process can take years.On March 6 of this year President Obama appeared on America’s Most Wanted to announce support for taking DNA from all arrestees, for banking that data and for keeping it without restriction even if there is no subsequent conviction. Undoubtedly it would have been much more controversial if he’d advocated DNA collection for all citizens, but his proposal seems to have slipped under the radar when framed as “only” for arrestees. By this metric “innocence” becomes a matter of degree, with certain people less innocent than others, marked by suspicion, kept on file, looked at first, disproportionately subject to the vicissitudes of laboratory and storage error. And even if mistakes are rare, it is exceedingly hard to persuade anyone of that if you are tossed in with a category the public deems inherently suspicious.

Obama and John Walsh, the host of America’s Most Wanted, endorsed the patently false idea that DNA is no different from fingerprinting. DNA samples can potentially reveal data about all kinds of other aspects of the self, including probabilities for certain health conditions, and can potentially implicate close family members. Employers and insurance companies are already hungering for DNA analysis that may allow them to refuse jobs or coverage to those with the mere hint of genetic predisposition to certain medical conditions (never mind pre-existing conditions).

In addition to the invasion of privacy, we must also weigh the possibility of technical mistakes. As a report from the National Research Council observes, “There is no uniformity in the certification of forensic practitioners, or in the accreditation of crime laboratories.” That measure of human error is never conveyed in narratives touting the perfect infallibility of DNA evidence.

Furthermore, while DNA has been vaunted as a revolutionary tool of exoneration–in ruling out suspects, in other words–it is much less precise as a mechanism of positive identification when dealing with “cold hits,” that is, attempting to match DNA fragments from a crime scene against samples stored in massive databases. Bioethicist Erin Murphy clarifies the point by comparing DNA typing to blood typing: “Imagine a murder scene at which police find a blood sample certain to belong to the killer. Crime scene technicians…show that it is type O. Later, the police find and draw blood from two suspects. One suspect is type AB; the other is type O. We can, with unreserved confidence, say that the first suspect is not the killer; but regarding the second suspect, we can only say that she is included within the class of people that includes the killer. The probability that she is the actual killer turns on how many other people have that blood type, along with any other evidence that we might be able to adduce.”

Finally, we risk sacrificing the American credo of free will: that we endeavor and achieve even when such accomplishment may be against otherwise calculated odds. DNA, for example, is being collected privately from those who submit samples for genetic ancestry tracking or from young professionals who pay thousands to outfits like 23andMe in exchange for overly deterministic pronouncements about “the gene for” this or that. This collection and storage of DNA by private means is thoroughly unregulated. The Genetic Information Nondiscrimination Act of 2008 prohibits insurers and employers from using genetic prediction in hiring or coverage, but the act is easy to circumvent. For example, every time we dispose of a coffee cup or a hangnail, that “garbage” is open to the exploitation of others, including police. Few who contract with genetic ancestry tracking or “personalized medicine” companies realize that their profit is derived both from consumers and from reselling their samples out the back door, in supposedly “anonymized” form, to research institutions and insurance companies. “Anonymized” means that names, addresses, Social Security numbers and birth dates are kept confidential. But less than 1 percent of the information that the human genome contains has been reliably decoded. The day is surely not far away when names and Social Security numbers will be quaintly unnecessary in pinpointing identity.

We are at the very beginning of a scientific revolution that will no doubt profoundly unsettle certain notions of privacy and bodily integrity. The rampant, unreflective “bio-prospecting” occurring in public law-enforcement agencies and at private-sector data-mining companies should give us pause.

Metalinguistics of The Health Debate

Reverse Nazism and the War on Universal Healthcare

Diary of a Mad Law Professor

by PATRICIA J. WILLIAMS

This article appeared in the September 14, 2009 edition of The Nation.

August 26, 2009

The spinmeisters of the right have done quite a job with what used to be straightforward English etymology. Thanks to Rush Limbaugh and Fox News, “integration” was inverted to mean “takeover” and “colorblindness” is code for abandoning the advances of the civil rights movement, which itself is synonymous with an “industry” of exclusion. It’s no surprise, then, that whenever a piece of progressive legislation comes to the table, the same manipulations come into play from right-wing pundits who shamelessly profess their desire to see the Obama presidency fail. Thus it is that America’s Affordable Health Choices Act of 2009 is being turned upside down as the neat equivalent of Germany’s Bankrupting Forced Death Act of 1939.

If you are watching the healthcare town-hall ruckuses with only common dictionary meanings in your head, you will be struck by the protesters’ general incoherence and outright nonsense, bearing no rational connection to the actual draft of the healthcare bill. As Representative Barney Frank demanded of one constituent who likened the bill to Nazism, “On what planet do you spend most of your time?”

But if you listen as though deciphering pig Latin and realize that this demographic is speaking from a well-managed, near-hypnotic looking-glass world where every word from the mouth of a Democrat (or a liberal, or a Latina, or a Canadian) is a lie, a betrayal… then it all makes sense. Their world truly has been turned inside out, by the election, by the economy, by the precarious conditions that threaten us all. But for those whose sense of identity has been premised on a raced, masculinist, conservative Christian hierarchy of American power, the world must seem even more emotionally terrifying than any actual facts would indicate.

So reversal is key to understanding what’s going on. It’s not just “lies”; it’s the expressive angst of people whose felt power relations have been turned upside down. It’s not factually accurate, but this is how they feel. Obama is Hitler! Health insurance for all means euthanasia for me! “My” country is suddenly “their” country.

Of course, there are special interests who profit from the magnification of these fears. Betsy McCaughey, a former shill for a medical instruments company, is the original source of the “death panel” rumors. From the beginning, big pharmaceutical and insurance companies, with an almost inconceivable amount of money to spend, have been muddying the waters. Think about the recent revelation that Merck secretly financed the publication of a fake medical journal that was designed to look objective but merely touted the supposed benefits of its products–and included “paid advertisements” for the company’s drugs. What is truth in such a corrupt hall of mirrors?

But what does the bill actually say? A quick summary of the most contentious point: the act would provide reimbursement if you seek medical counseling about end-of-life decisions. This option allows you to plan what you would like to have done in the case of catastrophic or terminal illness–nothing forced about it. All extraordinary measures will continue to be used to resuscitate someone whose wishes are unknown: feeding tube, intubation, cracking ribs to defibrillate, whatever it takes. By contrast, it is private, profit-motivated insurance companies–which deny coverage based on pre-existing conditions and restrict one’s choice of doctor, medical treatments and length of hospital stays (based on actuarial tables)–that bear the greatest resemblance to a mulching euthanasia machine. When nearly 50 million US citizens live without any health coverage, how on earth could a purely voluntary public option be considered throwing people under the bus?

Let me acknowledge the genuine ideological and moral misgivings behind some of the protests. Many libertarians hate anything the government does, no matter how monopolistic or quasi-governmental the power of pharmaceutical and insurance companies. But they are a minority and not generally the bloc using the language of reversal and code. Similarly, there are those with genuine moral or religious qualms: “prolifers” who, if they believe that life begins at the molecular moment of conception, could also think that any end-of-life consultation is against God’s will. This would be the same line of reasoning followed by those who wanted Congress to keep Terri Schiavo on life support no matter what. While I can certainly respect that as a belief, it is clearly even more of a minority position than libertarianism. In addition, it requires strong-armed government intrusion over the wishes of patients or family; and it is totally unsustainable as national public policy.

All of this is complicated but surely, with a bit of listening, comprehensible to the average citizen. So how do we connect the reality of our dismal life-expectancy and health-cost statistics to the hysterical sobbing of people who come to town-hall meetings furious that “the insurance companies won’t be able to make a profit”? Much of the epic woe is not about healthcare or public options. It’s about roiling resentments that need to be dressed up as something else, the coded mummery of Halloween monsters hybridized into new chimeras of hate. It’s about fear that precious resources are being transferred to “alien” others. Fear that the gains of others are ill-gotten, leaving the lonely patriot survivalist as victim, “thrown away,” trash. In these fiery monologues, even our president is figured as conspiratorially alien-birthed, from a galaxy far, far away, who’s just pretending to be one of “us.”

This morning I saw a picture of President Obama dressed as Hitler, complete with little mustache, tacked high on a tree trunk. At first it seemed jaw-droppingly ridiculous, sociopathically paranoid. But if the rule of reversal is what’s encoded in that image, all people of good will must worry that what’s really at stake for some of our gun-toting, demagogic fellow citizens is nothing less than America’s very own Weimar moment.

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