Friday, September 3, 2010

The Peanut Solution

Maggie Steber for The New York Times
THE WAIT A World Food Program screening center in Port-au-Prince.

By ANDREW RICE
Published: September 2, 2010

Like most tales of great invention, the story of Plumpy’nut begins with a eureka moment, in this case involving a French doctor and a jar of Nutella, and proceeds through the stages of rejection, acceptance, evangelization and mass production. The product may not look like much — a little foil packet filled with a soft, sticky substance — but its advocates are prone to use the language of magic and wonders.

What is Plumpy’nut? Sound it out, and you get the idea: it’s an edible paste made of peanuts, packed with calories and vitamins, that is specially formulated to renourish starving children. Since its widespread introduction five years ago, it has been credited with significantly lowering mortality rates during famines in Africa. Children on a Plumpy’nut regimen add pounds rapidly, often going from a near-death state to relative health in a month. In the world of humanitarian aid, where progress is usually measured in subtle increments of misery, the new product offers a rare satisfaction: swift, visible, fantastic efficacy.

Maggie Steber for The New York Times
Children, eating a peanut paste, at a seaside tent camp in Haiti.

THE FACTORY Partners in Health makes its own peanut-based supplement in Haiti.

Maggie Steber for The New York Times
THE SCALE Loramie Joseph is weighed at a Save the Children center.
Plumpy’nut is also a brand name, however, the registered trademark of Nutriset, a private French company that first manufactured and marketed the paste. It was not the intention of Plumpy’nut’s inventor, a crusading pediatrician named André Briend, to create an industry around Plumpy’nut. Briend, his friends say, was always personally indifferent to money. (Also, apparently, to publicity — he declined repeated requests to be interviewed for this article.) One element of genius in Briend’s recipe was precisely its easy replicability: it could be made by poor people, for poor people, to the benefit of patients and farmers alike. Most of the world’s peanuts are grown in developing countries, where allergies to them are relatively uncommon, and the rest of the concoction is simple to prepare. On a visit to Malawi, Briend whipped up a batch in a blender to prove that Plumpy’nut could be made just about anywhere.

Others, however, quickly realized that the miracle product had more than just moral value. Nutriset has aggressively protected its intellectual property, and the bulk of Plumpy’nut production continues to take place at Nutriset facilities in France. (Unicef, the world’s primary buyer, purchases 90 percent of its supply from that factory, according to a 2009 report prepared for the agency.) Internationally, there has been a vituperative debate over who should control the means of production, with India going so far as to impose sharp restrictions on Plumpy’nut, calling it an unproven colonialist import. Elsewhere, local producers are simply ignoring the patent. In Haiti, two manufacturers are making products similar to Plumpy’nut independently of Nutriset: one is Partners in Health, the charity co-founded by the prominent global-health activist Paul Farmer. Partners in Health harvests peanuts from a 30-acre farm or buys them from a cooperative of 200 smallholders. It’s planning to build a larger factory, but for now the nuts are taken to the main hospital in Cange, where women sort them in straw baskets, roast them over an outside gas burner, run them through a hand grinder and mix all the ingredients into a paste that is poured into reusable plastic canisters. Peanuts in Haiti and throughout the developing world have a high incidence of aflatoxin, a fungus that can sicken children, especially fragile ones. But Partners in Health says the product, which it calls Nourimanba, is safe.

When I visited one of the charity’s outpatient clinics in July, 1-year-old Elorky Decena was silent and listless as a nurse hooked a scale over the clinic’s doorway and put him in an attached harness. A month before, he was found to have severe acute malnutrition, a condition characterized by extreme stunting and wasting that afflicts an estimated 20 million children worldwide. The nurse announced that he had gained more than four pounds on a diet of Nourimanba.

Patents are meant to offer incentives to innovators by giving them a time-limited right to exclusively exploit their ideas for profit. But many say that lifesaving products should be treated by a different set of rules. There has been a long and bitter argument, for instance, over the affordability of patented AIDS drugs in Africa. Critics have made a similar case against Plumpy’nut, which is fairly expensive, costing about $60 per child for a full two-month treatment. “We were concerned because of the way Nutriset was managing their intellectual property,” said Stéphane Doyon, a nutrition specialist with Doctors Without Borders, a medical charity. “We felt that there was the possibility for the creation of a monopoly.”

“Poverty is a business,” Patricia Wolff, a St. Louis pediatrician, said. She founded Meds and Food for Kids, the other local producer of fortified nut paste in Haiti. When I first spoke with her in May, Meds and Food for Kids was struggling to raise money to expand its operations, and Wolff complained mightily about the difficulties she faced because of Nutriset’s market dominance. “There’s money to be made,” she said, “and there are people who have that kind of way of thinking.” Two months later, Wolff made a tentative deal for Meds and Food for Kids to become a Nutriset franchisee. In the end, she said, she couldn’t afford to battle hunger on her own.

In the United States, Plumpy’nut’s sole manufacturer and chief promoter is a 38-year-old mother of four from Barrington, R.I. Navyn Salem doesn’t have a background in medicine or aid work. She first glimpsed the potential of Plumpy’nut three years ago on “60 Minutes.” Since then, Salem has devoted herself to making the product for export to needy nations like Haiti. Though her Providence factory, a joint venture with Nutriset, has all the trappings of a business, selling its wares to relief agencies under the name Edesia Global Nutrition Solutions, the operation is registered as a nonprofit foundation and was established with seed money from Salem and her husband, Paul, a private-equity financier. Dancing along the nebulous line between capitalism and charity, Salem casts herself as a marketer, offering a neatly packaged solution to a tragic and no longer intractable malady. On a Tuesday in May, she brought her message of good news to a Mother’s Day benefit in Midtown Manhattan.

“This is not my ZIP code,” Salem said as she stood in the East Side Social Club, a wood-paneled restaurant, amid a jostling crowd of bejeweled women pinching noontime flutes of Champagne. She met one of the party’s hosts, Lauren Bush, the former model and niece of the most recent ex-president, a couple of years ago at a conference of the Clinton Global Initiative. Now Bush and her mother, Sharon, were selling a specially designed line of teddy bears — a big one called Plumpy and a small one called Nut — to raise money to purchase the product for children in Africa.

When it came time to eat their own meal, a three-course lunch­eon, the party guests found seats at tables set with elaborate centerpieces, made up of stuffed bears and Plumpy’nut packets. As volunteers sold raffle tickets for a Dior handbag, Salem delivered a practiced speech. Earnest and attractive, with wide brown eyes, she told the audience that her father, a member of an Indian merchant family, grew up in Tanzania. “There are over a billion people in our world that are malnourished,” Salem said. “It’s a shocking statistic. The good news is there’s a very simple solution.” And that, she said, was Plumpy’nut. “It’s really revolutionary, because it doesn’t need to be mixed with water or refrigerated,” Salem continued. “And the most miraculous part is, it will transform a child from literally skin and bones to certain survival in just four to six weeks.”

This transformation, seen in before-and-after photos — on one side a sick and wasted child, on the other, a chubby, smiling one — was the promise that captured imaginations far beyond the technocratic community of specialists that originally developed Plumpy’nut. “People love a silver bullet,” says the prominent nutritionist Steve Collins. Salem’s decision to devote a portion of her family’s fortune to the cause was impressive, but she is hardly the only person who was touched by the substance’s potential. At the benefit, many of the attendees said they had seen the same inspiring “60 Minutes” segment, in which Anderson Cooper compared the paste to penicillin, concluding that it “may just be the most important advance ever” in the realm of childhood malnutrition. After Salem spoke, she began squeezing dabs of Plumpy’nut onto plates and passing them around, assuring the partygoers that the brownish goo was surprisingly tasty, with the consistency and sweetness of a cookie filling. Everyone ate it right up.

Plumpy’nut proved so palatable and so valuable that it was only natural that other interests were now trying to take a bite. “You want to hear about the bad stuff?” Salem whispered. There was a lot to talk about. Outside the restaurant, beyond the protective cordon of appreciation, rival factions were fighting over a less innocent — though perhaps no less important — issue: who should profit? Plaintiffs were suing, accusing her partners at Nutriset of anticompetitive practices to protect their position atop a $200 million marketplace. Doctors, foreign-aid organizations and agribusinesses were staking competing claims, each invoking the interests of the world’s most fragile children. “Forget all the politics,” Salem pleads. “I’d like to erase them all.” But try as she might, she can’t wish away the questions of property and law.

Everyone, it seemed, wanted to own a bit of Plumpy’nut.

At the beginning, the problem was devilishly simple: malnutrition was killing millions in poor countries — it’s thought to be responsible for a third of all deaths of children under 5. And yet the global medical community was expending little effort to develop improved treatments. In the early 1990s, the accepted regimen for severe acute malnutrition — a watery mixture fed through a tube — was 30 years old and was unable to prevent the deaths of 20 to 60 percent of patients in hospitals. Frustrated, a small group of doctors began searching for a better way to get nutrients into starving children. One of them was André Briend.

According to legend, Briend hit upon the inspiration for Plumpy’nut one morning at the breakfast table, when, after years of vainly mixing nutrients into cookies, pancakes and yogurt, he opened a jar of Nutella, and the idea came to him: a paste! Like most such stories, this one is not completely true — or rather, it elides many years of false starts, research, scientific collaboration and infighting. The first advance came in the form of F100, a dried high-energy milk that was fortified with a mix of vitamins and minerals that were designed to counter the specific biochemical effects of malnutrition in children. F100 had to be mixed with water, though, which in poor countries was apt to be rife with bacteria. It also tasted unpleasant. As a childhood-nutrition expert attached to a French government institute, Briend came up with the idea of mixing F100 together with peanuts, milk, sugar and oil. The concoction was full of protein and fat, which insulated its nutrients from oxygen and humidity and masked their unappetizing flavor.

The true advance lay not in the formulation, however, but in the way the paste could be put to work. Earlier treatments had to be administered in a hospital setting, which meant a long, expensive stay away from home for both mother and patient, so children were rarely brought in for treatment until they were already extremely weak and susceptible to all the pathogens that lurk in third-world health facilities. What Briend and a few other specialists envisioned was a treatment that could be administered at home, by families instead of doctors. For medical professionals, this required a radical shift in mind-set. Briend searched the world for someone willing to conduct field tests, cautioning that collaborators in his experiments, as he put it in a 2000 message to a malnutrition Listserv, “should be ready to accept a road with trial and errors.”

One doctor who decided to take a risk was Mark Manary, a pediatrician and professor, who was working at a hospital in Malawi. His malnutrition ward was crammed full of dozens of children lying on mats. “It was really an incredible burden,” Manary recalled. “These kids are deathly ill, you’re doing whatever you can for them, and you think you’re on the right track, and then you come in the next morning and four of them have died.” Manary emptied out the ward, sending his patients home with Plumpy’nut. Many malnutrition experts were horrified. “It seemed dangerous to them, and it made them afraid,” said Manary, who recalled that one eminent figure stood up at a conference and said, “You’re killing children.” In fact, when the results were analyzed, it was found that 95 percent of the subjects who received Plumpy’nut at home made a full recovery, a rate far better than that achieved with inpatient treatment.

The Malawi test emboldened Doctors Without Borders, which recognized that treating children outside clinical settings would allow a vastly scaled-up response to humanitarian emergencies. In 2005, it distributed Plumpy’nut to 60,000 children with severe acute malnutrition during a famine in Niger. Ninety percent completely recovered, and only 3 percent died. Within two years, the United Nations endorsed home care with Plumpy’nut as the preferred treatment for severe acute malnutrition. “This is an enormous breakthrough,” said Werner Schultink, chief of nutrition for Unicef. “It has created the opportunity to reach many more children with relatively limited resources.” Nonetheless, Schultink estimates that the product reaches only 10 to 15 percent of those who need it, because of logistical and budgetary constraints.

Briend’s invention may satisfy a need, the hunger of children, but that doesn’t directly correspond to economic demand, which is set by buyers — the donor nations and international agencies that spend billions of dollars on food aid and famine relief. This is the gap Navyn Salem is hoping to fill. Her mission is threefold. First, her plant manufactures Plumpy’nut for sale. Second, she is trying to use publicity and humanitarian appeals to persuade the customer base — the foreign-aid donors — to allocate more money to purchase and distribute the product. Finally, and most ambitiously, she is advocating the use of Plumpy’nut and a number of spinoff products to address a wider array of challenges, including malnutrition prevention. The broadened market, in theory, could be enormous: The World Bank, in a recent report, recommended that aid agencies scale up their spending on such programs, which currently stands at $300 million annually, to $6 billion a year. The U.S. Agency for International Development, which administers the $2.2 billion Food for Peace program, has been examining the usefulness of Plumpy’nut and products similar to it. American food aid must comply with stringent regulations meant to encourage domestic procurement, a requirement Navyn Salem is perfectly placed to meet.

Salem’s interest in philanthropy was intensified after reading a biography of Farmer, the crusading physician, with whom she subsequently traveled to Rwanda, but it took Plumpy’nut to galvanize her thoughts. “We talk about AIDS, tuberculosis and malaria and how detrimental they are, these terrible epidemics, but then I realized that malnutrition was killing more than all of them combined,” Salem said. “And we know how to fix it.” She didn’t know much about famine relief or the insular community of nutritionists who deal with it, but she had a professional background in advertising and marketing, and she wanted to do something that drew on what she saw as her natural entrepreneurial strengths. “I thought, Let’s figure out if we can run a business that saves thousands and thousands of lives,” she said. Salem’s factory, located in an industrial area of Providence just off Interstate 95, cost $2 million to start. In March, right around the time she opened for business, she gave me a tour. The front lobby was decorated with large photos of grinning African children that Salem took on her trips to Rwanda and Tanzania. We donned blue smocks, hairnets and booties and entered the sanitized factory floor, where two workers, a Burundian and a Liberian, were using scoops to weigh out portions of sugar. “Most of our production staff are refugees who were recently resettled in Rhode Island,” Salem said. After the Plumpy’nut was mixed, it was run through overhead pipes into a contraption that squirted it into foil packets, which were sealed and ejected onto a conveyor belt, where workers packed them for shipping. In an adjacent warehouse, there were pallets of boxes labeled for delivery to Haiti, Yemen and Nicaragua.

Salem led me to a gleaming stainless-steel tank, which was about as tall as she was and hot to the touch. She opened a door on top, and a fragrant peanut smell wafted out as we craned to look in. “Here it is,” Salem said. “The magic stuff.”

That magic is the property of Nutriset. To trace how a family-run company based in a small town in the Normandy countryside ended up owning the patent to one of the world’s most promising humanitarian interventions, you have to go back to André Briend. He never knew anything about manufacturing food, so at the time he was trying to demonstrate the worth of Plumpy’nut, he signed a consulting agreement with Nutriset, which specialized in making therapeutic milk products. He and the company’s founder, a food scientist named Michel Lescanne, were listed as inventors on the 1997 French patent. The patent has since been registered in 38 countries, including much of Africa.

“Michel is a guy who probably holds hundreds of patents, he thinks up things all the time, but he didn’t have a viable business” before Plumpy’nut, said Mark Manary, who now runs a nonprofit group that manufactures the product under license in Malawi. “So André and I were all about this as a therapeutic opportunity, and Michel was like, ‘This is an entrepreneurial opportunity.’ ” Lescanne’s expertise was invaluable when it came to engineering the taste, texture and shelf life of Plumpy’nut.

For its contribution, Nutriset has been richly rewarded. Last year, the company produced around 14,000 metric tons of Plumpy’nut and related products, more than a tenfold increase over the amount it made in 2004, registering $66 million in sales. The family-owned company has paid out millions in dividends, according to an internal document, although the company claims the money has largely been reinvested in expanding the business. The state institute where Briend did his research receives 1 percent of sale proceeds, Nutriset says, while the inventor himself has renounced any ownership interest.

A few years ago, after some pressure from buyers, Nutriset announced that it would take a more liberal stance on licensing the product — but only in the developing world. Its affiliate network has since expanded to 11 countries, most of them in Africa. But when it comes to Europe and North America, the company has been aggressive about protecting its interests. When Salem first approached Nutriset about obtaining a license to make Plumpy’nut, she says she received a frosty reception, even though her original idea was to build a factory in Tanzania, her father’s birthplace. After meeting with Salem and her husband, the company relented, although the plan changed a bit in the process. The locus of their new joint venture, Edesia, was shifted to Rhode Island, so that it could satisfy domestic-sourcing requirements for U.S. government aid.

“Our idea with Edesia is for it to really be an incubator,” said Adeline Lescanne, Michel’s daughter and the deputy general manager of the company. She said the company was investing its profits in research into a new generation of ready-to-use therapeutic foods, or R.U.T.F., as they are called in the jargon of the foreign-aid community. The new lines would be designed to prevent malnutrition, not just cure it. “It’s a kind of pity that there is not a lot of research on new R.U.T.F.,” Lescanne said. “There are only people fighting to produce this product.”

Nutriset’s critics say that line of argument is disingenuous, because the Plumpy’nut patent is so broad as to encompass just about any kind of nut-based nutritional paste. “There are other people that would like to enter into the business,” Ben Tabatchnick, who runs a New Jersey-based kosher soup company, said. “But everybody is afraid of being sued.” Last year, Tabatchnick went to France to talk to Nutriset about his plans to develop ready-to-use therapeutic foods on a for-profit basis. “I had a meeting with them that lasted about 10 minutes, and they threw me out of the room,” he told me. Afterward, Nutriset sent him a pair of ominous letters, indicating that it had found “some similarities” between Plumpy’nut and his product, Nutty Butta.

Nutriset has sent similar saber-rattling correspondence to a number of other potential competitors. Lescanne told me that Nutriset’s vigilance over its intellectual property has a benevolent purpose. Between now and the time the patent is scheduled to expire, in 2017, the company wants to focus on building its network of affiliates in countries like Congo, Mozambique and Niger. (Salem’s plant in Tanzania is supposed to open later this year.) “We have to protect this network,” Lescanne said. “We are a bit afraid that big industrial companies will come.” In recent months, to take one example, PepsiCo Inc. has talked publicly about playing “a more decisive role” in bringing ready-to-use foods to needy populations. This has raised hackles: in a recent journal article titled “The Snack Attack,” three nutritionists warned that Pepsi-branded therapies would potentially be “potent ambassadors for equivalently branded baby foods, cola drinks and snack foods.”

“What we don’t want,” Salem told me, “is for General Mills to take over and put our Ethiopian producer out of business.” Opponents of the patent, however, say that Nutriset is just trying to avoid competition that would cut into its bottom line. Recently, a handful of companies have set up shop in countries where, because of the vagaries of various treaties, the Plumpy’nut patent is not in force. In the United States, two would-be competitors have taken a more confrontational route. They filed a lawsuit with the federal district court in Washington, D.C., seeking to have the patent invalidated.

The plaintiffs are a Texas-based manufacturer called Breedlove Foods and the Mama Cares Foundation, the charitable arm of a snack-food manufacturer based in Carlsbad, Calif. Both are small nonprofit organizations with strong ties to Christian aid organizations. But Nutriset’s defenders suspect that larger corporate interests are lurking in the background. In the French press, the patent dispute has been portrayed as a case of a plucky Gallic company besieged, as Le Monde put it, by “ ‘légions’ Américaines.”

In fact, there is a not-so-hidden instigator behind the case: the American peanut lobby. A few years ago, a Unicef official gave a presentation to an industry trade group, forecasting dramatically increasing demand for peanut pastes. That got the growers excited. They looked at Nutriset’s patent and came to the conclusion that, as a technical matter, Plumpy’nut was really nothing more than fortified peanut butter. “People have been making this stuff for centuries,” Jeff Johnson, a board member of the Peanut Institute, said. “It’s nothing new.” Johnson is the president of Birdsong Peanuts, one of the country’s largest shelling operations. Through a friend, he heard about Breedlove Foods, which was based in Lubbock, close to one of his processing plants. Johnson met with the company and proposed a challenge to Nutriset.

“It's a cotton-pickin’ shame that they decided to take the stance that they have with the intellectual-property issue,” said David Fish, Breedlove’s chief executive, whose lawsuit contends that the patent is hurting starving children. But even some Nutriset critics have questioned the motives behind the lawsuit, pointing out that America has a long and controversial history of dumping its agricultural surpluses on poor countries through food aid. “If you want to develop countries out of third-world status,” Fish replies, “they’ve got to come out and compete on the open market.”

Plumpy! Plumpy!”

With the shouted order from Rosemond Avril, an agent of a charity group, workers began unloading cardboard boxes full of foil packets from the back of a rusty blue truck. It was a sweltering Haitian morning, and next to a hive of canvas tents, the women of Bineau-Lestere were lined up beneath the branches of a gnarled quenepa tree. They were a handful of the millions displaced by last January’s earthquake, which had turned the nearby city of Léogâne into a jagged pile of concrete. Their camp, thrown up amid fields of sugar cane, was surviving on aid. On this morning, the U.N.’s World Food Program was distributing Supplementary’Plumpy, a slightly weaker formulation of the original product, to mothers with children between 6 months and 35 months.

Haiti wasn’t starving, but experts were still concerned about the perilous condition of its children. Even before the earthquake, an estimated quarter of them were chronically malnourished, and now many breadwinners were dead, livelihoods disrupted and much of the country’s commercial infrastructure destroyed. By administering Supplementary’Plumpy to children in the age group most vulnerable to severe malnutrition, the World Food Program was trying to keep a bad situation from turning into a crisis. Across Haiti, the agency was distributing such aid to 500,000 people, and the results of a survey suggested that malnutrition levels had remained stable. “This is all new,” said Myrta Kaulard, country director for the World Food Program in Haiti. “It’s preventative action.”

Darting around the scrum of women and toddlers, as a relief worker announced instructions in Creole through a bullhorn, Navyn Salem snapped pictures with her Nikon. She looked on with satisfaction as one jug-eared little boy ripped open a packet and squeezed the light brown paste into his mouth. She clicked the photo, and before long it was on its way to the Facebook page of Edesia Global Nutrition Solutions.

Salem had flown to Haiti a few days earlier aboard a private jet, lent by her husband, on a characteristically blurry mission: part sales call, part fact-finding tour. Edesia was sending its products to agencies in Haiti, the World Food Program among them, but what interested Salem most was the prospect of using ready-to-use foods to address conditions beyond severe malnutrition. She and Maria Kasparian, her second-in-command at Edesia, were shuttling from one charity to another in a loaned van, carrying boxes of free samples and brochures promoting three products designed to be taken as daily supplements. “Everyone knows Plumpy’nut,” Salem said before the trip, “but what we’re really trying to do is push these others, to address malnutrition sooner.”

Scientists have shown that there is, in the words of The Lancet, “a golden interval” for childhood nutrition that occurs before the age of 2. “This is the period when brain growth is very extensive and babies are developing their immune systems,” said Kathryn Dewey, a professor in the department of nutrition at the University of California, Davis. Stunting that persists after age 2 is generally irreversible, while improved nutrition in early childhood correlates to greater educational success. One study, in Guatemala, showed that boys given a nutritional supplement as babies made 46 percent higher wages as men. Dewey has been testing whether Nutributter, one of Nutriset’s new (and patent-protected) products, might achieve similar results. “There has to be a way to break the cycle of poverty and malnutrition that has plagued these populations for hundreds and hundreds of years,” she said. “That’s the more grandiose vision of where this is headed.”

In Haiti’s Artibonite Valley, Ian Rawson, the managing director of the Hôpital Albert Schweitzer, took Salem to see malnutrition inpatients — “our failures,” he called them — in a dimly lighted ward where they lay beneath a mural of parrots. Many of the children were unnaturally small and had patchy, orange-tinted hair, a classic sign of protein deficiency. “This,” Rawson said, waving a packet of Plumpy’nut, “is our immunization.” He was applying for a U.S. government grant to distribute Nutributter in the surrounding mountains, where poverty is dire, 9 out of 10 adults can’t read and acute malnutrition rates can top 35 percent. “It seems simple to me,” he said. “What’s the downside to me giving every child who’s over 4 months old a tube of Nutributter per day?”

Advocates of the preventive approach foresee a future in which children around the world consume a daily packet of nutrient-filled paste. “It’s not just for poverty-stricken people,” Salem said. “It’s just like I give my children a multi­vitamin.” Of course, this changes the nature of the intervention from an emergency treatment to a habitual routine and also dramatically escalates its prospective cost to donors. As a practical matter, Salem says, supplements will probably have to reach children through consumer markets, perhaps with subsidies. Edesia is conducting testing in Tanzania to see whether Nutributter could be sold in stores.

Some experts, however, warn that enthusiasm may be running ahead of the science. “In their rush to be innovators, I think a lot of agencies are using ready-to-use supplementary foods without evidence,” said Steve Collins, who was a pioneering advocate of home-based care for severe malnutrition. “I wouldn’t want to see a new world order where poor people are dependent on packaged supplementary foods that are manufactured in Europe or the United States.”

His wariness reflects a larger ideological divide over the proper distribution of profit. Nutriset says it is committed to opening more developing-world franchises, a strategy that brings down shipping costs and hence prices, but the majority of its network’s inventory still comes from France, and now, with the entry of Edesia, Nutriset is going to be expanding exports from the United States. Collins asks, “How are they addressing the need for poor people in Haiti not to be dependent on outside intervention in the first place?”

This question hung, unanswerable, over Salem’s journey through Haiti. Salem went there with a promise to donate a shipping container filled with $60,000 worth of Nutriset-patented products to Partners in Health, the charity run by her friend Paul Farmer. While grateful, the organization still preferred to manufacture its own product, Nourimanba, with the profits accruing to local farmers. But even this program was more a principled exercise than a development strategy. Haiti’s endemic problem of malnutrition wasn’t something you could solve with peanuts. Partners in Health also took Salem on a couple of home visits. At a one-room shack in Cange, a mother presented her 3-year-old daughter, saying she had gained 11 pounds on a regimen of Nourimanba. But the mother complained that there was no help for other serious problems she faced, like the fact that she had no job and the tin roof of her shack leaked.

Out in the hills, down a muddy path shaded by coconut palms, the health workers checked in on a small wooden farmhouse. Two children living there were on a regimen of ready-to-use food — and six were receiving nothing. The older ones watched as their little sister wolfed down an entire cup of peanut paste for the benefit of the visitors. The children’s grandmother, who was looking after them, was asked why malnutrition had been diagnosed in these two and the others not. She said she couldn’t really say, except that there simply wasn’t enough food to go around. There was no foil-wrapped answer to the maddening persistence of poverty. All that existed was a determination to meet the challenge with all the fallible tools of human ingenuity.

“We’re trying to put ourselves out of business,” said Salem, still brimming with optimism, after the trip. “That would be the best-case scenario.”

Andrew Rice is a contributing writer and author of “The Teeth May Smile but the Heart Does Not Forget,” about a Ugandan murder trial.

Monday, August 30, 2010

NYT :Years Later, No Magic Bullet Against Alzheimer’s Disease

Years Later, No Magic Bullet Against Alzheimer’s Disease
By GINA KOLATA
Published: August 28, 2010

BETHESDA, Md. — The scene was a kind of science court. On trial was the question “Can anything — running on a treadmill, eating more spinach, learning Arabic — prevent Alzheimer’s disease or delay its progression?”

Elise Schoux has been more careful to exercise regularly and eat right as preventive measures since her husband, Bill, learned last year that he has Alzheimer’s. She figures it can’t hurt. “I don’t know what the answers are,” Mrs. Schoux said.

The Vanishing Mind
Analyzing the Research

Articles in this series are examining the worldwide struggle to find answers about Alzheimer’s disease.

Previous Articles in the Series »
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Mixed Evidence
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Health Guide: Alzheimer's DiseaseTo try to answer that question, the National Institutes of Health sponsored the court, appointing a jury of 15 medical scientists with no vested interests in Alzheimer’s research. They would hear the evidence and reach a judgment on what the data showed.

For a day and a half last spring, researchers presented their cases, describing studies and explaining what they had hoped to show. The jury also heard from scientists from Duke University who had been commissioned to look at the body of evidence — hundreds of research papers — and weigh it. And the jury members had read the papers themselves, preparing for this day.

The studies included research on nearly everything proposed to prevent the disease: exercise, mental stimulation, healthy diet, social engagement, nutritional supplements, anti-inflammatory drugs or those that lower cholesterol or blood pressure, even the idea that people who marry or stay trim might be saved from dementia. And they included research on traits that might hasten Alzheimer’s onset, like not having much of an education or being a loner.

It is an issue that has taken on intense importance because scientists recently reported compelling evidence that two types of tests, PET scans of Alzheimer’s plaque in the brain and tests of spinal fluid, can find signs of the disease years before people have symptoms. That gives rise to the question: What, if anything, can people do to prevent it?

But the jury’s verdict was depressing and distressing. So far, nothing has been found to prevent or delay this devastating disease, which ceaselessly kills brain cells, eventually leaving people mute, incontinent, unable to feed themselves, unaware of who they are or who their family and friends are.

“Currently,” the panel wrote, “no evidence of even moderate scientific quality exists to support the association of any modifiable factor (such as nutritional supplements, herbal preparations, dietary factors, prescription or nonprescription drugs, social or economic factors, medical conditions, toxins or environmental exposures) with reduced risk of Alzheimer’s disease.”

“I was surprised and, at the same time, very sad” about the lack of evidence, said Dr. Martha L. Daviglus, the panel chairwoman and a professor of preventive medicine and medicine at the Feinberg School of Medicine at Northwestern University. “This is something that could happen to any of us, and yet we are at such a primitive state of research.”

She said, “In the end, we concluded that the evidence is the evidence and we have to say what it is.”

The state of the evidence reflects in part the long time it took before researchers even realized that Alzheimer’s was a disease, said Dr. Richard J. Hodes, director of the National Institute on Aging. Until the mid-1980s, many thought dementia was a normal part of aging, and so serious studies of its causes and prevention did not really begin until then. Scientists have spent the years since searching for factors that might affect risk, checking data from other studies to see if, for example, diet or blood pressure or years of education might be associated with the disease.

In the meantime, doctors are in a bind. Should they tell people to do things like walk briskly or eat vegetables — activities that might someday be shown to protect against Alzheimer’s and that certainly cannot hurt? Or should they wait for absolute proof, confirmation that a diet or a drug or an exercise regimen prevents Alzheimer’s?

The Alzheimer’s Association tells people to exercise, challenge themselves mentally, remain socially engaged and keep their hearts healthy. Such measures can only help, says Dr. Maria C. Carrillo, a senior director of the organization.

But, she said, “The Alzheimer’s Association certainly agrees that there is not enough evidence to say anything definitive about the prevention of Alzheimer’s disease and any kind of intervention.”

Of course, Dr. Hodes said, there are many reasons to follow practices to improve general health. But, he said, researchers have to be careful about implying that any measures will protect against this degenerative brain disease.

“We don’t know that yet,” Dr. Hodes said.

Rating the Quality

Dr. John W. Williams Jr., head of the Duke group that evaluated the studies, thought the task would not be too arduous. He expected relatively few studies and clear results.

To its great surprise, the Duke group discovered a vast amount of literature on Alzheimer’s prevention. Instead of coming up empty on many topics, Dr. Williams said, “We came up empty on very few.”

The problem, the group wrote, was that “the quality of the evidence was typically low.”

Most studies observed people who happened to use or not use a possible preventive measure and then determined whether they got Alzheimer’s or not.

Such studies, known as observational ones, are not the gold standard, like those in which people are randomly assigned to take a pill or do something like exercise, or not. Observational studies are useful in generating hypotheses but are not proof. Still, if several well-done studies of this type come to the same conclusion, they can be valuable evidence.

In the case of Alzheimer’s prevention, though, the studies tended to have problems, Dr. Williams said.

Often it was not clear precisely what subjects were doing. They might have been using a drug or a supplement at the start of the study but the dose was not specified, nor was it clear whether subjects were taking the same doses, or for how long.

Some studies of drugs to lower blood pressure used self-reports as opposed to, for example, pharmacy data. A 12-year study asked participants about their use of cholesterol-lowering statins at the start of the study but never did again. A nine-year statin study used pharmacy records but included as users those who took the drugs at any time during the study period.

Definitions of conditions, like high blood pressure, tended to vary from study to study.

Descriptions of factors like “strong social support” were vague or idiosyncratic. For example, some studies classified married people as having strong social support for that reason alone, with no evaluation of whether the marriage was good or bad.

Often, there were vague assessments of Alzheimer’s disease. And often studies did not take into account other differences among subjects, like age or family history of Alzheimer’s, that might have independently led some to get the disease and others not.

Looking over the piles of studies, the group rated evidence as high, moderate or low, depending on how confident they were in the findings.

Low confidence did not necessarily mean the measures did not work — it meant the evidence was so faulty that there was no way of deciding.

In the end, it said it was highly confident in the findings for just one thing, the herb ginkgo biloba. But in that case the evidence pointed in only one direction: it did not prevent Alzheimer’s.

Moderate evidence, not totally convincing but not worthless, applied to only four factors studied.

Two were factors that increased risk. They were a particular gene, ApoE4, which, moderate evidence showed, increased risk about threefold, and menopause therapy with a combination of estrogens and progestins, which doubled risk.

The other moderate evidence indicated that certain things that had been hoped to be protective were not. For instance, there was moderate evidence that vitamin E, found in nuts, vegetable oils, green leafy vegetables and fortified cereals, had no effect on risk. There was also moderate evidence that cholinesterase inhibitors, drugs often used to treat Alzheimer’s symptoms, had no effect.

Other than that, evidence was poor.

There is only poor evidence, for example, that keeping your brain active, having a high level of education or exercising has a protective effect. There is also only poor evidence that eating a Mediterranean diet — high in fruits and vegetables, fish and olive oil — will help stave off Alzheimer’s.

There is only poor evidence that having poor social support or smoking increases risk.

In a way, it is not surprising that many thought the evidence was stronger than it was, says Dr. James R. Burke, a member of the Duke group and director of the Memory Disorders Clinic at Duke.

“You remember the positive studies,” Dr. Burke said. “The ones that are more marginal, you tend to put them out of your mind.”

And many things thought to protect against Alzheimer’s — a healthy diet, vigorous exercise and an active brain — just seem to be common sense. The science jury said it was still possible that those measures might be found to help and urged that better quality studies be done.

But that may not be so easy if studies have to follow people until they get the disease. Alzheimer’s seems to progress silently in the brain for a decade before the earliest symptoms of memory problems surface. It can take another decade until the distinctive signs of Alzheimer’s appear: profound memory loss and an inability to handle the normal activities of daily life like bathing and dressing.

“Once there is even minimal cognitive impairment, the brain is damaged, inflamed, burning like a bonfire,” said Dr. Caleb Finch, director of the Gerontology Research Institute at the University of Southern California.

As a result, high-quality studies of possible factors like diet and exercise or mental stimulation before the disease’s onset might have to last for decades.

In the meantime, patients, like those at Dr. Burke’s Memory Disorders Clinic, and their frightened family members want advice about things they can do now.

He tells them to do all they can to stay healthy: keep their heart disease risk factors under control, eat a good diet, exercise. He tells them that even if good health cannot prevent Alzheimer’s, it might delay its onset.

“We don’t have compelling evidence or proof that this will prevent Alzheimer’s disease,” he says. But those measures, he adds, “would improve quality of life.”

But Dr. Williams, head of the Duke group, said it was also important to keep an open mind; the measures may or may not affect a person’s chances of getting Alzheimer’s.

“Unfortunately, in medicine,” he said, “things that are logical and make good sense don’t necessarily work out.”

The Problem, Personified

Elise Schoux of Washington is facing the prevention problem. She is 53, an age when prevention might make sense — when Alzheimer’s strikes, people usually are in their 70s and 80s — and she is watching her 70-year-old husband’s slow decline into the dread disease.

Bill Schoux’s memory had been deteriorating for years, but in July 2009, when he got the diagnosis, Mrs. Schoux was devastated.

“For two weeks, we were at a loss, we would burst into tears,” she said. “How could this be?”

Mr. Schoux had been an athlete all his life, he ate a healthy diet, he was friendly and outgoing. He had been an expert on foreign aid, traveling around the world, and had certainly had a mentally stimulating career. Mrs. Schoux is not sure how much more her husband could have done to ward off Alzheimer’s. But she wants to do everything she can to protect herself from getting it and to slow the disease in him.

So Mrs. Schoux now unfailingly goes to the gym with her husband several days a week, lifting weights and spending 30 minutes on a treadmill or an elliptical cross trainer.

Her husband always worked crossword puzzles. Now she does them, too. She and her husband have a subscription to a local theater. And they read the newspaper every day.

“It can’t hurt to keep the brain cells moving,” Mrs. Schoux said.

Mrs. Schoux also tries to eat blueberries, salmon, intensely colored fruits and dark leafy vegetables, in case that helps.

She knows that much of what she is trying is unproved but feels that it can, at worst, be harmless.

“I don’t know what the answers are,” Mrs. Schoux said. “I hope they find something. It is a seriously debilitating disease.”