Author name: Sonia Shah

August 17, 2006 Exposing prisoners to experimental drugs would be allowed only after the completion of early toxicity testing. This will hardly restrain drugmakers because they don’t need prisoners for early toxicity testing anyway. Students and homeless people line up in droves for the $200 daily fee, plus room and board, on offer at the industry test clinics. It’s “money for doing almost nothing,” as one test subject, a former law student, told me. The bottleneck for drugmakers is in recruiting warm bodies for late-phase trials that establish a new product’s effectiveness with statistical certainty. These “Phase 3″ trials can require tens of thousands of patients to complete, and most drug-saturated Americans are reluctant to take part. Eighty percent of trials fail to meet recruitment deadlines, bleeding drugmakers of $1 million a day while their blockbuster wanna bes remain locked up in development. To solve the dilemma, many drugmakers have rushed overseas, to places like India and Poland, where sick, desperate patients are abundant. Now, if the institute’s recommendations hold sway, they’ll be able to access the 7 million souls captive to the US correctional system as well. The institute’s proposed caveat — that prisoner experiments include subjects from outside prison walls as well — will make little practical difference in such trials. Few, if any, drugmakers would want to restrict these huge trials to prisoners anyway. The institute also recommends that prisoners help oversee prison experiments. Unfortunately, often in resource-constrained environments, most everyone has an interest in the resources that well-funded research can bring in. “It generates quite a bit of hard-earned money,” one clinical investigator in South Africa explained to me. According to the institute, prisoners shouldn’t be deprived of this by a “myopic” obsession with informed consent. The rationale, according to the institute, is that “access to research may be critical to improve the health of prisoners and the conditions in which they live.” This is a bit fuzzy. Research breakthroughs alone don’t change conditions, as anyone who has seen stockpiles of vaccines rotting in tropical warehouses can tell you. Change requires the implementation of research, which most researchers are neither responsible for nor interested in. Sadly, there’s no guarantee that helpful research on prisoners will be promptly — or ever — applied to improve prison conditions. In fact, the institute can scarcely ensure that research on prisoners offers the “potential benefit” that their proposed regulations call for. Pediatric trials are supposed to offer “potential benefit” to children. Why, then, do clinical-trials registries list just one trial on pediatric AIDS (a fatal disease for which few pediatric formulations of needed medicines are available), compared with no fewer than 70 on high blood pressure in children? These experiments are not designed for their potential benefit to children, although drugmakers effectively argue that some subset of children will benefit from them. Rather, children are rounded up for such trials because blood-pressure drugs bring in $25 billion a year for drug companies, and testing these primarily adult medications on children extends drugmakers’ brand-name patents by several lucrative months. Since 2000, Food and Drug Administration officials and drug executives have led a movement to restrict the rights of human subjects in medical research: from making substandard care to the poor acceptable, to gutting strict curbs on the use of placebos. The institute’s stance seems part of the trend. But once the experimenters are given the keys to the lockup, the choice for the imprisoned will be stark. Behind bars, “death at random is a way of life,” according to one prisoner who spoke to government advisers prior to bans in the 1970s. “The only place in this prison that people don’t die is in the research unit,” he said. “Just what is it that you think you are protecting us from?” For this prisoner, at least, the choice was clear: Be experimented upon or die.

February 17, 2006 News flash: “Too much contemplation gets in the way of good decision-making”! (Greg Miller, Science, February 17,2006). “Thinking too hard about complex decisions…may lead to worse choices”! (Newsday, February 17, 2006). “New advice for anyone who is struggling to make a difficult decision: Stop thinking about it”! (Boston Globe, February 17, 2006) Dimwits everywhere rejoice! A new study in today’s Science magazine says that thinking too much is bad for you. I think not. I admit I was intrigued by these new findings. But the spin is all wrong. Psychologists at the University of Amsterdam studied different ways people make decisions about things like buying shampoo or a new car. Some of their subjects evaluated all the relevant information—price,size, what have you—and then made a decision. Others evaluated all the relevant information, then killed sometime distracting themselves, and then made their decision.When faced with only a few variables, surrounding the choice to buy shampoo,for example, the first method worked better (judged subjectively as well as objectively). But when faced with a larger array of variables, surrounding buying a house or car, the second method worked better. Why? Because, the researchers say, the second method allows the brain to do some unconscious processing, which is probably better than the conscious mind at synthesizing complex variables. To me this study underlined how important it is for people to have downtime—time away from rapid-fire, always-on computer and television screens, instant messaging, cell phones, deadlines, one damn just-in-time thing after another. The need for contemplation! For relaxation! For all the things that allow one to descend below conscious thought into (hopefully) deeper levels of processing. Say, like…sleep! Music! Literature! And so the spin that the press is putting on it—”Stop thinking!”—is all wrong. What the study suggests is: Think Deeper. But it is suggestive that the “stop thinking” angle has such appeal. What does it mean? Nothing good, I’m afraid. Seems like yet another sign of a society in decline, one that elects cowboys as presidents and considers contemplation suspicious.

January 16, 2006 As the Times series has amply shown, our health suffers when we rely on fast foods and sugary drinks to sustain ourselves. But in places where malnourishment and poverty are rampant, the ramifications are even more profound. In Western countries the transition from hardscrabble malnourishment to today’s drive-through, fast-food cornucopia occurred over centuries, with the happy result that our societies were able to control infectious diseases spread by hunger and poverty before facing the maladies of richly calorific diets, including diabetes, obesity and heart disease. As anyone who has seen the KFCs and Pizza Huts sprouting along the alleys of Mumbai and Cape Town knows, in developing countries, no such time lag exists. What experts call the “nutrition transition” is taking place within a single generation. According to recent research, malnourished mothers tend to bear babies predisposed to storing excess energy as fat. This is a useful adaptive advantage in communities where calories are often scarce, enabling babies to survive nutritional deficits. But when such babies grow up to consume Western-style diets chock-full of fatty, sugary foods, that benefit turns into a deadly curse, leading them to gain disease-causing extra fat much more rapidly than they would have otherwise. And so, hot on the heels of the multinational soft drink and fast food companies in poor countries has been an epidemic of chronic disease.Today, four of out five people who die of chronic, noncommunicable diseases such as diabetes and heart disease perish not in New York or California but in developing countries, according to the World Health Organization. More Indians and Chinese suffer cardiovascular disease than Americans, Japanese, and Europeans put together. Diabetes and coronary heart disease are epidemic in India, which is home to the greatest concentration of Type II diabetes sufferers in the world. In some areas of Africa, as many as one in five has diabetes. Nearly 20 million Africans suffer from hypertension. Worse, while diabetes in rich countries is primarily a condition of the elderly, in developing countries the disease strikes those in the prime of life, aged forty-five to sixty-five, slashing their average life expectancy by ten to fifteen years. For developing countries barely treading water amid the flood of malnutrition, HIV infection, malaria, and tuberculosis, “the public health implications of this phenomenon are staggering,” the WHO has noted, “and are already becoming apparent.” The era of strings-attached IMF and World Bank loans, which forced the dismantling of many indebted countries’ public-health infrastructures, is partly to blame. Global trade agreements forged throughout the 1990s eased the entry of soda makers and fast-food companies into the emerging markets of the developing world. As we start to address the deadly legacy of hyper-marketed fast foods and sodas here at home, we should remember that the problem does not end at the corner Burger King. We’ve spread the problem beyond our borders, where its effect is likely to be much worse.