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Authors: Scott Carney

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Biotech giants Genentech and Cirus thought that refined cyclopamine might be able to stop prostate cancer in its tracks. Both companies denied running clinical trials in India and stated that any use of the compound on pregnant women would be dangerous. However, I was able to find drug suppliers in Mumbai and Delhi willing to sell it to me over the phone. While my follow-ups over the next few weeks provided little additional information on the case of the one-eyed baby, they raised the specter of the Letrozole experiments that had happened only a few hundred miles away.

“Third world lives are worth much less than European lives. That is what colonialism was all about,” said Srirupa Prasad, a visiting professor of medical history at the University of Wisconsin–Madison.

The situation in China is potentially even more dangerous, as the government stands to make a tidy profit off the lack of medical care. The starkest examples come from Henan Province, where impoverished farmers are habitual targets for red marketers. They have both been harvested for their tissue and then used as unwitting test subjects.

Starting in the 1990s the head of Henan Provincial Department of Health set up a biotech company that paid for blood collection. The setup was similar to the days of professional donation in India, except that blood donors had no ability to bargain up the price of blood. The lab separated the blood into components and sold them on the national (and possibly international) markets. Anthropologist Ann S. Anagnost wrote that the biotech industry had transformed blood into a marketable commodity in its own right.
22
It is traded in a similar way to gold. Middlemen and brokers collect blood on their own and funnel it back to the cash-paying corporation without regard to how it was obtained. Anagnost writes that the military even helps to coordinate the efforts.

In a scene similar to the blood pirates in Gorakhpur, India, the only thing that mattered was the quantity of blood, not the collection processes. To save money on collection, untrained techs reused needles between patients and spread the HIV virus throughout the donor pools. Soon Henan had one of the highest rates of AIDS in all of China. After years of unsafe protocols, the government eventually stopped paying for blood, but the damage was already done.

In 2002, however, biotech investors turned the blood-collection-induced AIDS epidemic into an opportunity for clinical research. They began to scout through the former blood donors for test subjects on whom they could test an experimental AIDS treatment. A pilot study in 2003 conducted by California-based Viral Genetics took on thirty-four treatment-naive subjects in Henan who were in the final stages of the disease. Their condition was so far advanced that traditional antiretrovirals would not be effective. The hope was that an experimental drug called VGV-1 could restore the effectiveness of the older generation of drugs and give AIDS patients a slightly longer prognosis. They were ideal candidates because the government had never given them treatment for their HIV.

The clinical trial was the first chance that most of the former blood donors had to seek medical attention at all. When the trial started they were not offered any information about the risks or even about how the drug might help their prognosis (it wouldn’t). With the help of an international network of activists the group managed to get word to the institutional review board in America responsible for green-lighting trial designs. The board responded that the trial might have needed some cosmetic changes in its informed consent policies.

But anthropologist Melinda Cooper notes that the board too narrowly focused on consent rather than on the almost systematic exploitation of people who were perennial victims of medical deceit. Never mind the contractual issues, she writes; the clinical laborers had “nothing else to sell but exposure itself.”
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AT A DEEPER LEVEL
, the Henan drug trial demonstrates how test subjects don’t share in the benefits of pharmaceutical research. As unequal partners in drug development, they neither earn a market rate for their contributions to research, nor have access to the patented drug once it is approved.

If the new drug developed in Henan eventually led to FDA approval, then it would be highly unlikely that the drug would even be available in Chinese markets in the patients’ lifetime. As with kidneys, eggs, and every other red market, the flesh of trial subjects can only move upward through the social hierarchy. Most benefits that pharmaceutical companies derive from outsourcing clinical trials are never reciprocated downward and back into the community. The poor and destitute bear the risk of testing drugs, but only the affluent receive their potential benefits. According to a 2006 study by Ernst and Young, at most only 10 percent of China’s population, the percentage of people with health insurance, would ever be able to afford patented drugs.
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There’s a double standard when it comes to valuing human bodies. During research people enrolled in clinical trials are altruistic volunteers helping the state of science. After the drug trial their contributions are forgotten—participants are unable to share in either the financial rewards of a patented medication or the benefits of a new therapy. Though test subjects bear the entire physical risk in drug development, companies that go on to make billions on drug sales fail to recognize that it takes more than flesh to make a drug—it takes the minds and bodies of real people.

 

 

A three-dimensional printer at the laboratory of Organovo in California. The machine uses an ink made out of stem cells to print out human tissue. This printer could one day produce artificial organs that could be used to stop the spread of illegal markets in human tissue. However, the technology still has serious challenges to overcome.

 

A
T A FERTILITY
clinic in Cyprus the rakish embryologist Savvas Koundouros waves his hand in the air as if he were erasing my questions before they even left my mouth. He is in the business of human eggs, yes, but there’s a lot more to the reproduction industry than just making babies. With his voice low and heavy with cigarette smoke, he grabs my notebook and starts jotting down notes.

“The real story here is stem cells. Soon I’ll have developed a new procedure to create embryonic stem cells without ever having to use a human egg.” His finger, apparently restless, thrusts upward into the air as he explains that he is developing a method to create embryonic stem cells out of other tissues. One day, he says, the research will circumvent the legal ban on embryonic stem cell research in the United States that restricted scientists to just a few select lines of genetic material lucky enough to be grandfathered in before President George W. Bush banned new lines. The dearth of new material was one of the most important stumbling points for clinical progress. President Obama reversed the order in 2009, but roadblocks to the research seem to keep coming up, by way of federal court injunctions and protests by religious activists.

For decades embryonic stem cell research has been the controversial battleground in the fight between forward-thinking scientists who see stem cells as the building blocks for an extremely beneficial branch of medicine and religious groups opposed to research on embryos on the principle that it kills a potential human life. So far, the only way to develop new stem cell lines requires destroying embryos.

However, Koundouros says that his lab will be able to sidestep the religious objections and not destroy eggs at all. He will simply mature them from bone marrow or skin tissue. With the science for research purposes basically the same he would have solved a sticky political argument with a technological solution. And, he says excitedly, scientists can then get on with ushering in a new era of medicine. Perhaps with the advances laboratories might be able to regrow whole organs, repair damaged tissue, and possibly extend life forever. The potential is endless.

Soon my notebook overflows with crisscrossing lines and circles that represent eggs, strands of DNA, and the unlimited healing potential locked inside our own bodies. It takes patience and timing to finally yank the paper away from him and find some space to make my own notes on the subject. But it doesn’t take long for my pen to slow down on the page and fall flat. It wasn’t his fault, but I just couldn’t match his enthusiasm on the subject. It was the same story I’d heard dozens of times before. Stem cells might be the future, but the hurdles to medical breakthroughs are more than simply regulatory.

We’ve been on the verge of a scientific revolution for decades. It seems like every few months one scientist or another predicts that in the near future like salamanders we will regrow lost limbs. Or a magazine will tout that a lab is on the verge of a breakthrough that will allow us to grow fresh and genetically perfect organs in bioreactors, or that computer technology will one day allow us to download our brains onto a hard drive to continue on in a virtual rendition of our real-life selves. Failing that, there are already companies that offer a service to cryogenically freeze our bodies so that we have a chance to wait for regenerative medicine to catch up and cure the problem of death. More than anything else, though, as a society we’ve pinned our hopes on various iterations of stem cell treatments to pave the way to the future of medicine.

THE WORLD FIRST HEARD
about stem cells in 1963 when Ernest Armstrong McCulloch and James Till, two Toronto-based cellular scientists, showed that these root cells can transform into any other cell in the body. These so-called pluripotent stem cells could be a key to repairing or replacing any damaged human tissue. For more than a generation we have been patiently waiting for a time when our own bodies could be treated as renewable resources. Stem cells and regenerative medicine might allow us a chance to untether our inner selves, what I have called a soul, from the meat that lets us wander through the world. We’re no longer stuck with the bodies that we are born with. It’s immortality within reach.

Our faith in science to deliver miracle cures probably came along in 1928 when Alexander Fleming, a Scottish pharmacologist who kept an untidy workspace, left Petri dishes of common bacteria in his lab over a long weekend. When he returned, he discovered that an opportunistic fungus had colonized and killed the bacteria—inadvertently leading to the discovery of penicillin and the first revolution of modern medicine. Within a few years hospital wards could fight off infections that had until then routinely killed people after surgery, the bubonic plague was almost completely eradicated, and killers like strep throat, tuberculosis, and syphilis were stopped in their tracks. Most of us can’t remember a time when a sore throat meant all-but-certain death. But for people living at that time antibiotics were like gifts from God. Ambrosia.

Humanity’s elation can be broken down into numbers. In the Middle Ages a human life span rarely exceeded twenty-five years. By 1900, a child born in the United States could expect to live about forty-seven years. A child born today should make it to the age of seventy-eight. The discovery of antibiotics along with safe blood transfusions, public health improvements, and hospital care that reduces infant mortality have added almost thirty years to life expectancies in the developed world. The eminent science writer Jonathan Weiner boils it down this way: “During the twentieth century we gained . . . about as much time as our species had gained before in the whole struggle of existence.”
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In his book
Long for this World,
Weiner profiles Aubrey de Grey, a futurist and immortalist who is certain that regenerative medicine heralds another leap in life spans that will let us live forever. De Grey sees death as simply another medical condition begging to be solved. As medicine improves to a point where all maladies are treatable, death will merely be a problem for the uninsured.

De Grey and his disciples are outliers in the scientific community, but faith in medical science to cure our ailments is simply human. With almost a hundred years of medical miracles it is difficult to conceive that men in lab coats won’t come up with consistently better treatments for our sicknesses. Where we used to pray to God for longer and healthier lives, now we pray to scientists to develop cures for the things that could kill us.

The problem with living in the age of miracle cures is that we expect them to keep coming. Sometimes small advances make the next leap forward seem tantalizingly close. Artificial versions of complex organs have been in the pipeline for more than half a century. The first artificial kidney, known now as the humble dialysis machine, was invented in 1946. The first implantation of an artificial heart in a human patient took place in 1969.

Biologically based approaches are also gaining momentum. With the help of bioreactors and hardy cell lines it is possible to grow human skin for transplants in a laboratory. Burn victims facing the prospect of harvesting skin from their own bodies for transplant have never been happier (for men, the largest swath of available skin is often the scrotum).

These modest gains are all that is keeping a nagging question at bay: What if medical science is reaching a plateau? In the twentieth century, antibiotics seemed to solve the problem of infection, however in the last thirty years resistant strains of bacteria have evolved to make most of the old first-line treatments ineffective. Staph infections caused by antibiotic-immune bacteria are quickly becoming the top killers in hospitals. Gene therapy hit a dead end when a patient died during a clinical trial. With only a few exceptions FDA-approved stem cell therapies are still decades away. In many ways, it feels like we are going back to where we started from.

As far as pharmaceutical development goes, other than antibiotics, there have been no unequivocal cures in drug development in the last century. Tested against placebos, most improvements are only fractionally more effective than therapies we had at the beginning of the twentieth century. There is no pill that can cure cancer. It takes huge regimens of debilitating drugs to maintain HIV as a chronic illness. Some drugs, like the anti-inflammatory treatment Vioxx, actually increased the chance of heart attacks and had to be recalled. Profitable antidepressants like Prozac have been linked to patient suicides and in many cases are no better at alleviating depression than plain sugar pills. Every year the FDA issues hundreds of recalls for drugs and devices that it had once approved. Despite all the activity, it isn’t clear that medicine is marching forward; it might just be marching sideways.

There is one major caveat in this. While miracle cures in stem cells and drug development haven’t kept pace with technical development in robotics or the Internet, revolutionary changes in surgical techniques and medical imaging come every few years. In the twentieth century the science of cutting, stitching, and rerouting different bodily systems has made the equivalent of a quantum leap.

In the 1800s surgery was a death sentence. If you didn’t die from blood loss on the table, then more often than not an infection would overwhelm you during recovery. At the time the most common operations involved limb amputations. In those cases success wasn’t determined as much by the skill of the surgeon or his knowledge of anatomy, but by the speed at which the doctor was able to hack through human flesh and cauterize the wound. The most famous surgeon at the time, Robert Liston, could amputate a limb in two and a half minutes.

Today operating rooms are nerve centers of high-tech innovation and, more important, success. Killers of yore—from brain aneurysms to gunshot wounds, compound fractures, heart attacks, and tumors—all stand a good chance of survival with a timely ER visit. Kidney transplants now only take a matter of hours. Hip replacements are commonplace and keyhole surgeries leave virtually no scars. We live in the golden age of the operating room.

This discrepancy between surgical innovation and stagnation in pharmaceutical development and regenerative medicine lies at the heart of the insatiable demand for human tissue in red markets around the world. Drug development and regenerative medicine have not proceeded along surgery’s logarithmic curve. Drug breakthroughs have been few and far between and yet patients demand them immediately. Patients want stem cells to fix our broken kidneys and ailing hearts. Unable to find the cures they want in regenerative medicine, patients must opt for surgical fixes.

It may be every person’s right to expect protection against the bubonic plague, surgery for burst appendixes, and alleviation from pain, but the issue is much more complex when treatments depend on harvesting tissue or health from another person.

ANTHROPOLOGIST CATHERINE WALDBY
, who coined the term
clinical labor
to describe the work of human guinea pigs, as mentioned in the clinical trials chapter, writes that markets for human tissue illustrate “the impossibility of regulating the fantasy of a regenerative body, bound up as it is with the desire for a mastery over time and fear of death, through the rationality of market forces.”
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Even if the promise of regenerative medicine is technically possible in some far-flung future, there is no reason to expect it within our lifetime. In the developed world we invest great amounts of material resources, treasure, and hope into extending life a few years at a time with surgical and medicinal interventions. To some degree it even works. A new kidney can bring a person off a dialysis machine for a handful of years. The recipient of a donor heart has about a 50 percent chance of living ten more years. It’s not immortality, but it’s significant. Meanwhile, in many cases even if the transplant is covered by insurance or government aid, patients spend exorbitant sums of money, and even bankrupt themselves and their families paying for expensive antirejection drug regimens.

The medical industry makes it too easy to confuse buying power with a right to stave off death. Without a transplant, organ failure is a fatal condition. But rather than come to terms with the eventuality of death, entering into hospice care, and preparing loved ones for the inevitable, legal and illegal markets sell hope of more life. As I’ve written, a woman who is unable to conceive because of a medical condition can instead explore the possibility of a domestic adoption, or doctors and social workers can provide her with a wide array of medical options to bring biological offspring into the world.

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