The Body Hunters (2 page)

The business of experimentation in developing countries intensifies the pressure to crack open these markets for the sales of new brand-name drugs too, by adding the quid pro quo demands of
local clinicians and government officials proffering their patients as experimental fodder. Pfizer, Eli Lilly, GlaxoSmithKline, and other drug giants jostle at the borders of India, Brazil, Russia, and China, foreseeing huge markets for their cholesterol-lowering, antidepressant, and erectile-dsyfunction-alleviating blockbusters. The industry's philosophy of equating medical innovation with “new products” is especially pernicious in places where simpler solutions have yet to be attempted. While innovative approaches to the health dilemmas posed by the lack of clean water and safe food, for example, are needed, the answer does not lie in new brand-name drugs. And even when new products are indeed what are most needed, from new malaria drugs to cures for sleeping sickness, those that aid the poorest are generally of little interest to drug companies, which commit themselves to the financial needs of their investors. The more likely result will be a drug-marinated class of rich alongside a meds-famished poor. In that case, brand-name drug sales in poor countries will worsen inequality, not correct it. And as has been well documented, inequality itself worsens the health of the have-nots even more.

Finally, we need to open up the debate over the very idea of using human bodies as experimental matter. For some, performing the work of an experimental test subject is the same as, say, taking a job in a factory. But for many others, industry trials in poor countries offer an impossible choice—be experimented on or die for lack of medicine—that undermines human rights. In the streets of Lagos and the halls of international AIDS conferences, people from developing countries are condemning Western scientists' use of them as guinea pigs. The body hunters disregard the growing outcry at their peril.

On a dull October day in 2003 a clutch of physicians and scientists meet in a windowless conference room in the basement of a Washington, DC, hotel. John Wurzlemann, MD, flashes a photograph of modern-day Poland on a white screen to a handful of his colleagues. A generic urban scene, with glittering steel-and-glass buildings encircled by cement sidewalks appears. Wurzlemann, a rumpled, soft-spoken man, grins ruefully. “Most of Poland does not look like this,” he notes, in a deep scratchy voice. “Most of it looks like how it looked in 1939,” during the Nazi and Soviet invasions. “My father went to Poland ten years ago, and he said nothing had changed since the 1930s. Everything just got older.”

And sicker. Just how sick Eastern Europeans have become was the topic of Wurzlemann's late-afternoon lecture that day. Broke, malnourished, and fatally enamored of cigarettes, Eastern Europeans were dropping dead in scores, he told the crowd. While in the United States deaths from cardiovascular disease had been falling steadily since the 1960s, in Eastern Europe cardiovascular disease had mushroomed to epidemic proportions and killed people far more rapidly.
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Wurzlemann was nothing if not blunt. “Disease for disease,” he said, “they are more likely to die.”

Wurzlemann moved quickly through his PowerPoint presentation, offering up a deluge of discomfiting facts and figures. “Hungary has the highest rate of cervical cancer mortality. . . . Breast cancer rates are higher. . . . Cancer mortality among men in Poland is the highest in Eastern Europe. . . . Suicide rates are a lot higher.”

He paused briefly for a slide showing a map of Europe, which had blood-red marks indicating the death rate from all causes. “What it shows,” Wurzlemann said, as the audience gazed on silently, “is that as you go east, people die in increasing waves.” Indeed, it looked as if a bottle of red ink had been spilled over the map of Russia. The stain had spread over all of Eastern Europe too, but France, Italy, and Spain were nearly pristine, marred by a scant few speckles. National borders marked the difference between life and death, drawn in whispery black lines.

The Eastern Europeans were ailing not only because their air was polluted, their food less abundant, and their water dirtier, Wurzlemann said. The amount of money the Polish government coughed up to provide health care to each of its citizens was about one-fourth the sum typical in Western Europe. Such paltry investments typified the region. As a result, preventive techniques, early diagnostic methods, and medical treatments that had transformed killer diseases into manageable chronic illnesses and better in the West were as rare as those shiny skyscrapers. Wurzlemann didn't mention it, but the same could be said for much of the rest of the world too, where well over half of humanity has been brutally left behind in the quest for good health and longevity.

Wurzlemann took a deep breath and turned to his expectant audience. He himself had enjoyed the benefits of the West's good health, wealth, and education, although two generations before him had hailed from ailing Poland and Russia. He grinned and softly muttered, almost to himself: “It is really upsetting, frankly.” Then he briskly returned to his presentation and its scripted points.
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The speakers who followed Wurzlemann offered their own tales of woe from Latin America, Asia, and South Africa. Ordinarily, a group of physicians confronted with such information would respond with any number of suggestions aimed at alleviating the burden of misery. Might more health care training help? Cheaper
drugs? More research into disease etiology? Better diagnostic techniques? But neither Wurzlemann nor the other speakers had traveled to Washington, DC, that day to persuade their colleagues to help the impoverished sick of the developing world, at least not in the standard way that doctors generally try to help patients.

They had gathered because multinational drug companies like Pfizer, Eli Lilly, and Merck had a business problem. Industry labs were bursting with spanking new compounds and insight into which human tissues to aim them at, courtesy of new techniques first pioneered by genetic engineers and biotechnologists in the 1970s. “There are more investigational new drugs, more experimental treatments today . . . than ever before,” former Food and Drug Administration commissioner Mark McClellan exulted before a meeting of industry researchers in 2003.
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But just as the biotech revolution took off, the pipeline turning those new compounds into sellable products had started to clog. Proving new drugs worked in humans, as required by the FDA, had become a spectacularly complex, expensive, and time-consuming endeavor, a constant cause for complaints from industry analysts and investigators. Clinical trials were a “vast canyon” that eviscerated new drugs; a veritable “valley of death,” they said.
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“Large trials have become the norm,” bemoaned another. “All professionals taking part are now reconciled to the idea that such trials will take forever and will cost the earth.”
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According to CenterWatch, a publisher specializing in the clinical research industry, in order to launch a single drug a company has to convince more than 4,000 patients to undergo 141 medical procedures each in more than 65 separate trials. First come the small Phase 1 studies that test a new drug's safety; then the slightly larger Phase 2 studies that look for hints of effectiveness, and finally the extensive Phase 3 studies that aim to prove a drug's effectiveness with statistical certainty. More than 100,000 people have to be enticed to call in for initial screenings for such trials, as only a fraction show up for their appointments, and of these only a fraction would be medically eligible.
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With the
expense of finding and retaining a single test subject for a clinical trial running to at least $1,500, and with some 90 percent of the drugs entering clinical trials failing to garner FDA approval anyway, minimizing the cost and length of clinical trials had become crucial to corporate salubrity.
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And yet, in the United States at least, enlisting sufficient numbers of trial volunteers is difficult, to say the least. Back in 1954, Americans offered their children as human guinea pigs by the millions for Jonas Salk's experimental polio vaccine. When the results of that massive trial were released, radio announcers blasted the news. Church bells clanged. Traffic snarled as drivers jumped out of their cars to shout with joy.
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But not long after, the hastily approved vaccine infected 220 children with polio, and public trust in clinical experimentation started to deflate.
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Revelations of unethical trials followed—exposés of the government-sponsored Tuskegee Syphilis Study in the early 1970s proved a historical nadir—and disillusionment hardened into dislike. Today, although Americans buy on average more than ten prescriptions every year, less than one in twenty are willing to take part in the clinical trials that separate the dangerous drugs from the lifesaving ones.
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Less than 4 percent of cancer patients, who generally have the most to gain from new experimental treatments, volunteer for experimental drug trials, a rate industry insiders deride as “appallingly low.” Many people with cancer “simply didn't want to move from their homes to the clinical center for the time—sometimes weeks—necessary to participate in a trial,” noted industry journal
Scrip
. Others, particularly elderly patients, felt that “cancer may be a sign they have lived long enough.”
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Even trials for what would turn out to be breakthrough cancer drugs like Genentech's breast-cancer drug Herceptin almost withered and died for lack of willing subjects. “Every year tens of millions of women die from breast cancer, and they couldn't get a hundred subjects for a trial,” clinical research exec Dennis DeRosia recalls bitterly.
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The unmentioned reality is that cancer patients are hardly irrational in judging new drugs unworthy of their trouble. Despite the huge amount of investment in cancer research, “success has largely eluded us,” admitted industry scientist David Horrobin. “The few outstanding successes in rare cancers cannot hide the overall failure.”
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For many other conditions, useful drugs are already in adequate abundance. Americans might be convinced to try a new brand-name drug after absorbing a vigorous marketing campaign touting it as the second coming, but when it is a lowly, unapproved experimental medicine, why should they bother? Most patients were uninterested in testing out Pfizer and Eyetech's new eye-disease drug Macugen, for example, because there were already many other drugs available and Macugen had to be injected directly into their eyes. Besides, there were at least two other trials for the same kind of drug, with different delivery systems, going on at the same time.
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So scarce have willing subjects become in the West, Horrobin wrote in a 2003
Lancet
paper, that some drug companies have taken to aggressively recruiting more subjects than they need, a preemptive strike against rivals on the hunt for warm bodies to fill their test clinics.
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Today, industry investigators can count on failing to find sufficient numbers of willing test subjects on time in four out of five of their clinical trials, and the financial strain of hunting for increasingly disinclined test subjects threatens to render the entire industry moribund. While the annual cost of drug development remains mired in controversy, undisputed is the fact that the price tag has zoomed steadily upward since at least 1980, while the output of new FDA-approved drugs has remained essentially stationary. And every day a new drug remains locked in development bleeds companies of up to $1 million in potential sales income.
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Western medicine has relied on human and animal experimentation since ancient times. It was by dissecting the bodies of criminals and the poor, for example, that Greek physicians discovered
the nervous system in 300
B.C
.
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But it was only after the rigorous experimental design called the controlled clinical trial emerged in the 1940s and was codified into U.S. law in 1962 that the global hunt for experimental bodies began in earnest. After a brief period of testing experimental drugs on the U.S. prison population, a practice which ended when ethical scrutiny of trials was stepped up in the 1970s, most drug companies partnered with university hospitals and academic doctors to conduct trials. University doctors were the best experts to call on: reputed to be beyond reproach ethically, they had the patients at their fingertips, the know-how to design and conduct scientifically sound trials, and enough perceived independence to lend weight and credence to the findings.

But over the course of the 1980s and 1990s, the drug market skyrocketed. By 1989, for example, drug companies were angling to launch more than three times more drugs on the market than they had back in 1970. Impatient drugmakers started to get tired of their ponderous academic partners. “Pharmaceutical firms are frustrated with academic medical centers,” University of California's Thomas Bodenheimer noted in an influential 2000
New England Journal of Medicine
paper. “Slow review of industry proposals . . . delays the starting dates of trials.” Academic hospitals “have a bad reputation,” according to Greg Fromell, who works at a company specializing in running drug trials for the industry. They “overpromise and underdeliver.”
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By the late 1990s, the flow of cash from drug companies to academic medical centers had slowed to a trickle, the stream diverted to a new breed of faster, more aggressive drug trial entrepreneurs. New outfits like Quintiles Transnational and Covance call themselves “contract research organizations” (CRO). For a fee they take a drug company's blueprints for a clinical trial and promptly deliver patients, investigators, and results in return.
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“At Quintiles,” the company's Web site says, “we know it's all about results. That's what you want. And that's what you'll get, on schedule or maybe
even a little ahead of it.” Some CROs even insert trial results into FDA applications and splice them into prestigious journal articles on behalf of their industry clients.
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