Posted by Jessica Cussins on August 7th, 2014
The notoriety of the Tuskegee syphilis study is unparalleled in the field of bioethics. Last week marked the 42nd anniversary of the horrific experiment’s termination, and many people took the opportunity to recall Tuskegee and examine its relevance to the treatment of human research subjects today.
Half a century ago, what the US Public Health Service did in Tuskegee was considered acceptable medical practice. Its researchers willingly endangered the lives of hundreds of African American men in rural Alabama, leading them to believe that they were being treated for “bad blood.” They could have been treated for the syphilis they actually had, since penicillin had become an available treatment by then.
But in the name of improving scientific understanding of the disease, all relevant information and treatment were purposefully kept from them. They were unknowing participants in a 40-year-long medical study to test the natural progression of syphilis and the full extent of its toll on black bodies.
Wives and children of the men contracted the disease, and numerous people died, but it was not until there was a leak to the press in 1972 that the study finally came to an end.
According to Alexander Cockburn in Whiteout: The CIA, Drugs, and the Press, “the lead researchers remained unapologetic.” Dr. John Heller, the Director of the Public Health Service's Division of Venereal Diseases, said, “For the most part, doctors and civil servants simply did their job. Some merely followed orders, others worked for the glory of science.”
Anyone familiar with the twentieth century’s record of other medical experimentation horrors will recognize this sentiment. In many ways, Tuskegee is just one among many examples of how easy it is for good people to believe they are doing good science. It also demonstrates that it can take decades before those in power will see, or say, otherwise.
That day finally did come for the Tuskegee experiment, and one of its legacies is the Belmont Report, which lays out fundamental principles for safeguarding human research subjects. These include protecting the autonomy of all people and treating them with honesty and respect; following the philosophy of “do no harm” in order to minimize potential risks; and ensuring that procedures are non-exploitative.
Despite the history of grave abuses in medical research, the notion of objective science never quite seems to go away. Twitter users talked about the danger of this in a great discussion thread on the day of the Tuskegee anniversary:
“myths of objectivity and value-free science are not only false but also harmful”
“We inadvertently reinforce the erroneous idea that policies tht arent explicitly detrimental must not b harmful at all”
“Science in and of itself is not an inherently noble value or cause. Applying #bioethics allows what we do to be noble”
A common thread throughout the discussion was the need for more work to ensure that people of color and other vulnerable communities are not exploited in medical experiments. In other words, we need to hone our historical perspective, but we also need to open our eyes and see what is happening all around us, right now, even though we tend to think that “now we know better.”
But do we? A report by Carl Elliott published late last month details the extent to which the pharmaceutical industry routinely tests new drugs on people who are homeless or mentally ill. Companies are well aware that many people in these situations will comply with a lot, for very little in compensation. Elliott uncovered accounts of people starting to take addictive drugs just to qualify for a particular study; of drug study recruiters approaching residents right outside a homeless shelter; of negligent care in what became a fatal incident.
Elliott points out a troublesome trend that has taken place since Tuskegee [bold added for emphasis],
Not long ago, such offers would have been considered unethical. Paying any volunteer was seen as problematic, even more so if the subjects were poor, uninsured, and compromised by illness. Payment, it was argued, might tempt vulnerable subjects to risk their health. As trials have moved into the private sector, this ethical calculus has changed.
In the 1970s, after a series of notorious research abuses, legislators pushed for a central federal agency with the power to protect human research subjects. The medical research establishment fought this idea, however, and when the National Research Act was passed in 1974 a very different alternative followed: a patchwork system of small ethics committees known as Institutional Review Boards. The boards were originally located in hospitals and medical schools, but clinical research has since moved into the private sector. Many are now for-profit companies that review studies in exchange for a fee.
With ethics now being determined on a case by case basis, often in a setting ripe with conflicts of interest, and utterly opaque due to companies’ view that clinical trials are commercial secrets, is it any wonder that lack of trust is widespread, especially among vulnerable communities?
This is not a problem of ignorance.
On the contrary, how could anyone who is paying attention trust our current for-profit patchwork system to ensure that medical experiments are undertaken in an ethical and just way?
Previously on Biopolitical Times:
North Carolina and Genetics: From Sterilization to Research Subjects
Posted by Victoria Massie, Biopolitical Times guest contributor on August 7th, 2014
|Elaine Riddick is one of North Carolina's sterilization survivors|
Willis Lynch says the nurse asked him to sing her a song as she slipped the mask over his face. It was the serenade of lifetime, but it would be years before Lynch learned that this song slipped him into cutting the ties that could bind him to a future generation of his making.
In 1947, at the age of 14, Lynch was one of an estimated 76,000 people who were forcibly sterilized through the state of North Carolina’s selective sterilization program, which ran from 1929 to 1974. It was a program that, according to pamphlets, aimed to protect the broader state’s citizenry from the burdens imposed by those it identified as “moron,” “feebleminded,” “(mental) defectives,” and/or “a person of little intelligence.”
These categories allowed the state to codify and target the sterilization of those who did not fit its profile of an ideal citizen: the poor, people of color, people with disabilities, and even victims of rape who became pregnant. The assumption was that all citizens had a duty to protect the parenting of “a healthy, normal baby,” and that those targeted for sterilization should voluntarily give up their reproductive rights.
In reality, people often found themselves forced to choose between being released from state institutions and receiving welfare benefits, or losing their right and their ability to have children. Under the sterilization program, voluntary surrender was a cover for an insidious ultimatum. In other words, North Carolina – like more than 30 other states with laws allowing eugenic sterilization – found it more efficient to deny the possibility of future generations to certain people, rather than attend to the structural, socioeconomic and political issues that make poverty, racism and rape not only possible but normal.
North Carolina’s history of sterilization has come to the surface this summer as the state began accepting claims from those who were involuntarily sterilized. This step toward offering compensation to victims and their families made North Carolina the first state in the country to do so.
And yet in spite of this major symbolic victory, Lynch’s all-too familiar song lingers, harmonized now to the tune of Kannapolis citizenry turned into human research subjects in the name of bio-banking.
“Sequenced in the U.S.A.”
Located on the outskirts of Charlotte, Kannapolis was a town once known as the largest towel manufacturer in the world. Most of those who lived in Kannapolis depended on Cannon Mill as the linchpin of the local economy. But a little over a decade ago, the town experienced the largest single layoff in the state’s history as the mill’s doors were permanently closed.
Since then, Kannapolis has become a hub for biotech research and innovation, in part due to a billion-dollar investment by Los Angeles real estate magnate and businessman David H. Murdock. According to a revealing article in The Pacific Standard called “Sequenced in the U.S.A.: A Desperate Town Hands Over Its DNA,” Murcock “stepped in to transform Kannapolis into a $1 billion mecca for biotechnology and life sciences research,” building a 350-acre research complex on the site of the demolished Cannon Mills.
The town’s former blue-collar laborers aren’t the kind of people who will find jobs at Murdoch’s high-tech institute. But they now find themselves bombarded with “opportunities” to provide urine and blood samples for its research efforts, including one called the MURDOCK Study. At schools, churches, and health care facilities, there is a very high likelihood that recruiters will be waiting under a tent to collect local biological material so that researchers can connect family histories to genetic sequences in the pursuit of personalized medicine.
But despite the fact that the local raw material may help biotech ventures make billions of dollars, guess how participants are compensated: a $10 gift card to WalMart.
The argument can be made that participants are at least getting some form of compensation for their contributions to the study, and some told the Pacific Standard that they are taking part in the study “for the good of their grandchildren and future generations.” But questions remain.
Can one consider consent to be informed when Kannapolites are being invited to relinquish their biological material for use in a future that has yet to come and may never come to pass, that cannot be predicted, and that is only as speculative as the venture capital supporting the biotech industry? Shouldn’t we be given pause by the legacy of Henrietta Lacks, an African American woman whose cells were taken without her consent to produce the first known human immortal cell line for medical research?
According to international consensus, research subjects are to be expected to know the “nature, duration, and purpose” of experiments in which they take part. The MURDOCK study has no temporal end in sight, and the nature of the projected research has yet to be made clear. The assumed public good may turn out to be one that much of the public cannot share.
Despite assurances by researchers that participants can withdraw from the study at any time, once blood and urine is taken, the material and information is out of their control. Participants are informed that they can make no claims to the benefits of the commercial products that may be made possible by the biological materials and information they provide.
The state of North Carolina once promoted eugenic sterilization as a technique to protect the public. Today, it hosts private-public a biotech industry effort to build lucrative biobank-based ventures. Are there similarities to which we should be paying attention?
Victoria Massie is currently a graduate student at UC Berkeley, pursuing a Ph.D. in Sociocultural Anthropology with a designated emphasis in Science & Technology Studies. Her research examines the transnational circulation of genetic ancestry testing information by African-Americans, particularly between (but not exclusive to) the United States, Cameroon, and Sierra Leone. She is also a poet, and a summer intern at the Center for Genetics and Society.
Posted in Bioethics
, Biopolitics, Parties & Pundits
, Biotech & Pharma
, Human Rights
, Personal genomics
, Reproductive Justice, Health & Rights
, Sequencing & Genomics
, The States
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More Heart-Wrenching Chapters in the Baby Gammy Story
Posted by Jessica Cussins on August 7th, 2014
Headlines around the world have broadcast the heart-wrenching story of the Australian couple who took home their healthy baby daughter and left her twin brother with his Thai surrogate mother after learning that he had Down syndrome. Thousands of news articles have been written since the news was first reported last week, and conflicting versions of what happened have not yet been fully resolved. By all accounts, the story of baby Gammy has gotten more shocking every day.
After several days of media attention, the Australian commissioning parents were identified. Shortly thereafter, court documents were discovered revealing that the babies’ father has been convicted of 22 child sex offences in Australia, including offenses against a girl who was seven years old and two more under thirteen.
And now, the couple seems to have vanished. Child protection services tried to find them without luck, and their dog was taken away from their empty house by animal protection officers.
Apparently no formal contract was ever signed between the commissioning parents, the surrogacy agency, and Pattaramon Chanbua, the woman they paid to carry and deliver their babies. The head of the unidentified Bangkok fertility clinic could now face jail time. More shockingly, 21–year-old Chanbua, who has been caring for Gammy since he was born, could also face jail time for her involvement with commercial surrogacy, despite claiming that she never knew commercial surrogacy is illegal in Thailand because she saw so many websites offering it online.
Thankfully, Gammy is in good hands for now. More than $230,000 has been raised via GoFundMe by the organization Hands Across the Water for the life-saving health care Chanbua would not have been able to afford on her own.
If there is any silver lining in this heart-wrenching debacle, it is that it is now clearer than ever that regulation and oversight of cross-border surrogacy is sorely needed to prevent more cases of neglect and harm to women and children.
Previously on Biopolitical Times:
Data Yearning to Become Expensive Information
Posted by Pete Shanks on August 6th, 2014
Several initiatives have surfaced recently that hope to move genomics more effectively toward medical applications. They are trying to link genomic and phenotypic data, establish baselines for health, and use computational techniques to move the science forward. Some seem more promising than others; even discounting for self-promotion, Craig Venter may be leading the pack.
The highest-profile and clearly most political announcement was made in the UK by Prime Minister David Cameron on August 1. It firms up the proposals for Genomics England, which plans to sequence 100,000 genomes — 40,000 from patients suffering from cancer and other rare diseases; 35,000 from their relatives; and 25,000 from the cancer cells themselves.
The broad outlines of this are not new, and were cogently critiqued by Helen Wallace of GeneWatch UK a couple of months ago, on grounds of effectiveness (dubious) and privacy (very worrying, and addressed even by The Observer). Commercial exploitation is also a concern. The project is a partnership between the government, the Wellcome Trust, and Illumina, which will perform the sequencing. Cameron is pushing it hard:
This agreement will see the UK lead the world in genetic research within years. As our plan becomes a reality, I believe we will be able to transform how devastating diseases are diagnosed and treated in the NHS and across the world.
In the US, there has been a more surprising, though much smaller-scale, development: The embattled direct-to-consumer testing company 23andMe has scored a $1.4 million grant from the National Institutes of Health. It’s pin money to the Googleplex, of course, but some kind of validation. This will help them refine web-based surveys, collect phenotypic data, dip the company’s toes into whole-genome screening, and accomplish the:
Enablement of external non-23andMe researchers to access aggregate de-identified data from the 23andMe database to further accelerate the pace of human genetic research.
Back at the mothership, Google X (the “semi-secret" research arm that works on everything from self-driving cars to Glass) has had another bright idea: They will work out what is normal for humans. The Baseline Study is in its early days but involves "70-to-100 experts from fields including physiology, biochemistry, optics, imaging and molecular biology.” They’ll study 175 (and, later, more) people in great detail (partly using wearable devices, including glucose-monitoring contact lenses), and of course they are being, that is, will be, careful:
Baseline will be monitored by institutional review boards, which oversee all medical research involving humans. Once the full study gets going, boards run by the medical schools at Duke University and Stanford University will control how the information is used.
The genomics research establishment is somewhat skeptical, it seems. Yaniv Erlich of the Whitehead Lab at MIT tweeted:
Breaking: Google moonshot study (that does exactly what has been done in genomics for years)
Daniel MacArthur, who has been working in the field for a long time, and is currently based at Harvard, the Broad Institute and Massachusetts General Hospital, took an even less charitable view in several tweets, including:
Late to this, but calling this Google study a moonshot just absurdly devalues that term …
I confidently expect Google to be AT LEAST as successful in life sciences as they have been in social media
Ouch. For more nuanced commentary, see George Dvorsky at io9 and Kenrick Vezina at the Genetic Literacy Project, among others.
But Craig Venter is ahead of them all, at least in his own analysis. And he has hired one of Google’s hot shots, Frank Ochs, who basically made Google Translate work. According to MIT Technology Review:
Venter says that he’s sequenced 500 people’s genomes so far, and that volunteers are starting to also undergo a battery of tests measuring their strength, brain size, how much blood their hearts pump, and, says Venter, “just about everything that can be measured about a person, without cutting them open.” This information will be fed into a database that can be used to discover links between genes and these traits, as well as disease.
That’s only the start. The goal is a million human genomes sequenced by the end of the decade. Venter remains absolutely committed to the DNA-programming view of humanity, but appropriately humble about the lack of advances over the last decade or so:
I’ve had my genome for 15 years, and there’s not much I can learn because there are not that many others to compare it to.
That is going to change.
Previously on Biopolitical Times: