THE BODY HUNTERS
Testing New Drugs on theWorld’s Poorest Patients
by Sonia Shah
The New Press, New York, London.
Reviewed by Margaret Setter

The Body Hunters is a story of enormous complexity about the struggle to reform and bring under social control the giant corporations who control the pharmaceutical industry. A slim volume of only 176 pages, it is augmented by no less than 52 pages of footnotes. Most are easily accessed on the Web and offer a magnificent resource for anyone interested in the socio-political aspects of the pharmaceutical industry.

In his foreword, John le Carre refers to the book as “an act of courage on the part of its author and its publishers for lifting the veil on the darker side of the pharmaceutical industry”.

According to the World Health Organization, just over three hundred drugs are essential for public health; yet over nine thousand drugs are available on the US market. These drugs are mainly used to control the diseases of affluence, for example to lower blood cholesterol levels. Billions of dollars are spent each year to promote fast foods to an ever-increasing number of overweight Americans. Nearly two out of every three Americans are overweight or obese, an epidemic that has implications for heart disease, cancer, diabetes and a wide range of serious health problems related to tobacco and alcohol consumption.

Americans also suffer a high rate of social alienation, individualized as “anxiety-depression syndrome”. This condition requires a social response but clinical research is an industry, not a social service. It is undertaken to obtain the data necessary to win the approval of the Food and Drug Administration, without which no drug can be sold on the US market.

Prozac, Eli Lilly’s antidepressant drug was just one of many antidepressant drugs, marketed to millions whether or not it was needed, making them feel better by numbing their pain, while leaving untouched the real reason for their unhappiness.

The reason this situation prevails is because the US market is clogged with me-too drugs developed mainly to maintain the high rates of profit of the giant companies.

Multinational drug companies like Pfizer, Eli Lilly, and Merck, have a business problem arising from new techniques first pioneered by genetic engineers and biotechnologists in the 1970s. Safety campaigns by citizens ensured that for the past thirty years or so, Americans have been the beneficiaries of laws that protect their interests when participating in clinical trials of new drugs.

For example, the notion of giving a placebo to very sick people participating in a trial is forbidden by the Hippocratic oath, US legislation, and the voluntary Helsinki Agreement to which the US is a signatory. Physicians are bound by law to align their interests with those of their patients. The patient’s welfare must always take precedent over and above the outcomes of the studies.

Giving a placebo to a sick person is ethical only when a scientist cannot tell whether a drug will work any better than the placebo, a state of confusion described as “equipoise”. If the investigator does know, he is ethically obligated to administer the active substance. There is an inherent conflict of interest in clinical trials. Here the physician-investigator’s first commitment is to the data, not the patient.

Le Carre puts it this way. “The corporations outsource their clinical trials to countries where sick people are so poor they are ready to sign up to anything, whether or not they can read what is on the consent form. This process is accelerating due to the pressures on the profit-driven industry, competition between corporations acting as the driving force to cut costs and beat rivals to be the first to release new drugs on the market.

In 2004, as estimated by the FDA, drug companies seeking FDA approval for their new products were launching over sixteen hundred new trials overseas every year, but not in Western Europe and Japan. It is the broken, impoverished countries of Eastern Europe; Latin America, Russia, India, South Africa and other African countries that are currently the theatre for testing drugs designed for patients in the rich world, whose health problems bear little resemblance to those prevailing in poor countries.

Foreign (for example US) clinical researchers, in attempting to justify a wealthy western researcher taking advantage of the global poor, often run the risk of slipping into unconscious fatalist and racist attitudes. As one clinical observer observed: “The real world is exceedingly painful”. Shah elaborates: “The ill health of the developing world which is now proving valuable for Western science to mine, is something mournful perhaps, but as static and irreversible as the setting sun”. The fallacy of this claim is exposed in the following paragraphs based on recent history.

ZAMBIA: A CASE STUDY.

In 1964, the British colonialist government withdrew from Zambia, leaving behind clapped out copper mines and only minimal infrastructure. “African Socialist” polices were applied by President Kenneth Kaunda, including free education and health care. The copper mines were rehabilitated and put into production once more. Within a few years, the diseases of poverty had been largely overcome, and for a time Zambia enjoyed the highest standard of living in sub-Saharan Africa.

This situation could not last. In the early 1970s the Arab oil crisis sent petroleum prices sky-high, while copper prices plummeted. Zambia was obliged to apply for a loan from the World Bank, which meant submitting to economic rationalist policies and conditions. Over time Zambians were forced to dismantle their welfare state including government subsidies to farmers. Tens of thousands of government workers were retrenched.

By 2003 two hundred thousand Zambians required immediate antiretroviral therapy for AIDS, one in five Zambians faced death by starvation, and life expectancy had fallen to thirty-five years. Every day, at the University Teaching Hospital in Lusaka, thirty children perished, suffering the effects of lack of nutritious food, untreated water teeming with a host of pathogen, with untreated HIV further weakening the children’s ability to fight off the parasites. No help was forthcoming from the west.

On the contrary, western medical researchers; epidemiologists, virologists, and gastroenterologists flocked to the University Teaching Hospital, focused on what was described as “paediatric patients”. It is heartbreaking to read Shah’s account of thousands of parents “clutching tiny bundles: Their shrunken, malnourished babies and toddlers, whose innards it seemed, were seeping out”. One hundred out of fifteen hundred infants of desperate applicants were chosen to be part of the study. They were divided into two main groups; each divided again between those who were HIV positive, and those who were not.

Twenty-five children, those who were HIV free, were given an experimental drug, nitazoxanide (Alinia). Fourteen improved. The remaining eleven were given a second, three-day course and improved. “The drug had, “arguably” saved their lives.

Another twenty-two children, also free of HIV, their bodies wasted with cryptosporidium, were given a placebo. They received only the fluids and vitamins given to all the children. Four died.

Of the HIV infected children twenty-five were given a short, three-day course of the drug. Five perished. Another twenty-four HIV infected children got placebos. Four died.

Crypto may have ceased being a serious problem for AIDS patients in the USA, but a market for Alinia could still be found with handfuls of Americans, mainly children, who caught the bug from swimming pools. When otherwise healthy individuals become infected Crypto is a self-limiting disease, and usually clears up within a fortnight. One must question whether the price paid by the 13 starving Zambian children who died as a result of the experiments was worth it.

Shah speculates on how the surviving children and the relatives of the dead felt at the end of the experiment. Did they know, as their doctors must have, that better cures were available with antiretroviral therapy and other drugs? Was it made clear to them that the trial was designed to launch a drug in another, wealthier, society?

More studies followed in Peru, Egypt and Mali. In the mid 1990s it was discovered that slamming HIV with multiple antiretroviral drugs beat back many of the opportunistic infections, such cryptosporidium, which plague HIV positive patients.

SURROGATE END POINTS: WE ARE ALL LOSERS

In 1985 a long running government study on cardiovascular risk, known as the Framingham Report, found a correlation between low levels of serum cholesterol and increased longevity. Instead of conducting a public education campaign about the perils of diets based on high fat foods and sedentary lifestyles, Merck seized the opportunity to promote high cholesterol as America’s leading health adversary, with its drug, Mevacor (Lovastatin), touted as the cure. By 1991 sales had topped $1billion per year. Mevacor was a stunning testament to the power of marketing when better diets and more exercise would have conferred broader health benefits and would have been cheaper and safer as well.

During the 1990s saturation marketing by the drug corporations had Americans clamouring for new drugs, most of which accommodated rather than corrected for unhealthy lifestyles. The New Right, industry lobbyists, conservative economists, had the public excoriating the FDA for its tardiness in approving these new so-called wonder drugs. In 1991 the FDA capitulated by announcing that henceforth, new drugs would not need to demonstrate they cured disease and improved people’s lives. For example a drug developed for cardiovascular disease would not have to prove it reduced mortality from heart disease, it would simply have to prove the drug lowered cholesterol levels. Rather than show a new anti-cancer or AIDS drug extended patients’ lives, they could prove instead that the drug shrank tumours of increased the white blood cell count. “Flexibility” was the buzzword, rather than helping patients in their struggle with illness.

Shah claims society is responsible because it is by “our tacit approval” that this exploitation continues. Paradoxically, as individuals we are not personally to blame, although that does not relieve us of the ethical responsibility to act. But there is currently no mechanism we can apply to change the system in any far-reaching, effective manner, no final answers. All we can hope for at present are options that may or may not lead us to achieve the critical mass required to discipline the worst aspects of corporate abuse.

She suggests a few, tentative steps that might be taken. First, it is necessary to combat the idea that the exploitation and human rights violations so much a part of medical and pharmaceutical research, are simply side effects. That involves dispelling the myth that researchers conduct clinical research in poor countries for altruistic reasons. The real reason is because someone has agreed to finance it.

Clinical research is an industry, not a social service; it is undertaken for the data. If so, those people who participate in such trials should get access to study drugs after the trial ends. (That may not be such a good idea, given that many trials take up to several years to complete).

We must hold science accountable “when it renders little more than interesting papers and “me-too” drugs. (A me-too drug is a device that allows a corporation to continue to reap higher prices accruing to a patented drug by altering the molecule slightly. This prevents the drug from being reclassified as a cheaper “generic).

“Achieving this kind of accountability will be no easy task. It would require an Act of Congress and the drug companies would enlist patient groups in fighting it tooth and nail”. What we can do, as consumers, is to support nonprofit outfits aimed at public health, and I would add, each one can choose to adopt a healthy, vegan lifestyle, cultivate positive human relationships, and above all, encourage others to get active.

INTERESTING WEBSITES.

(1) http://www.cspinet.org/integrity/index.html et al
(2) http://www.infoplease.com/ipa/A0762136.html Human rights violations of African-American sharecroppers (Tuskegee experiments)