AEGiS-WSJ: Wyeth, Nestle Offer Free Tins to Stem Spread of AIDS; Children's Agency Balks Wall Street JournalImportant note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
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Wyeth, Nestle Offer Free Tins to Stem Spread of AIDS; Children's Agency Balks

Wall Street Journal, Tuesday, December 5, 2000
Alix M. Freedman and Steve Stecklow


KAMPALA, Uganda -- When Busingye Scovia, who is infected with the AIDS virus, delivered a healthy baby girl last year, she was warned by hospital staff that breast-feeding could infect her newborn.

But no one at the hospital told her about an alternative: infant formula. As is true all over the developing world, hospitals here rarely supply formula to mothers -- even those with AIDS. Instead, Ms. Scovia was sent home, where she continued to nurse her baby, Latshia. "I knew what I was doing was wrong," Ms. Scovia now says.

Unicef vs. the Baby-Formula Industry: The Fight Spills Over

Eleven months later, Latshia tested positive for AIDS. Could this death sentence have been prevented?

Behind the scenes, this question has emerged as one of the most contentious among those trying to combat AIDS in sub-Saharan Africa. It's not because there's any doubt that breast-feeding can transmit the virus: To date, an estimated 1.1 million to 1.7 million infants have become infected this way, mostly in Africa.

Rather, the issue of whether and how infant formula should be made available to poor African mothers has become mired in an incendiary debate that appears to be driven more by politics and ideology than by science. On one side is the United Nations -- and principally its member agency Unicef, which is charged with protecting the interests of children. On the other is the $3 billion infant-formula industry.

One major formula maker, Wyeth-Ayerst Laboratories Inc., says it stands ready to donate tons of free formula to HIV-infected women. No. 1-ranked Nestle SA, says it too would donate, if asked. But Unicef refuses to green light the gifts, because it doesn't want to endorse an industry it has long accused of abusive practices in the developing world.

Relations between Unicef and the industry have grown, if anything, more bitter. Secret meetings to broker a free shipment of formula to 100,000 African babies broke down amid fingerpointing and unreturned phone calls. The imbroglio has also pitted two New York City Democratic political bedfellows against each other: Former vice presidential candidate Geraldine Ferraro was retained by Nestle to lobby former New York City Council president Carol Bellamy, now executive director of Unicef. Meanwhile, the industry hasn't donated a single tin of formula to HIV-infected mothers.

The bad blood between Unicef and the industry dates back to the 1970s, when Nestle and other formula makers routinely blitzed developing world countries with ads featuring fat formula-fed babies and gave out free samples in maternity wards to attract women to their product. By the time the freebies ran out, women's own breast milk usually had dried up, too. Few could afford to purchase any formula, or they diluted it to make it last longer, sometimes starving their babies in the process. In protest, activists organized a world-wide boycott of Nestle products, and Unicef refused to accept any cash donations from the big formula makers -- as Unicef has done with other pariahs such as makers of land mines and cigarettes.

A Voluntary Agreement

Eventually, the industry promised to mend its ways. Specifically, in the 1980s the major formula makers agreed to comply with a voluntary marketing code devised by Unicef and its sister U.N. agency, the World Health Organization. The 14-page document restricted advertising, specified labeling and -- most crucially -- imposed a nearly blanket prohibition against distributing free and low-cost formula.

Since then, Unicef and the industry have battled over interpretations of the code, with the biggest formula companies arguing they comply as much as possible and Unicef vehemently disagreeing.

But this much is clear: The code was devised long before anyone ever contemplated the ravages of AIDS in Africa. Now, even some U.N. officials contend that Unicef's decades-old distrust of the formula industry should yield to a moral imperative to get formula to destitute, HIV-infected mothers. "They're having difficulty accepting that the world has changed," says Peter Piot, executive director of UNAIDS, an interagency U.N. program responsible for tackling the AIDS crisis. Mr. Piot, a researcher who was among the first to discover that AIDS can be transmitted among heterosexuals, says the U.N. must look beyond the "fierce battles" of the past in an effort to save lives.

Indeed, Nestle says it has received "desperate" requests for free formula from some African hospitals. But the company says it's caught in a bind: If it donates the tins, it believes Unicef would view its action as a violation of the code -- which could generate bad publicity and possibly fuel renewed boycott efforts. Theoretically, formula companies could just ignore the code and bypass Unicef, but that wouldn't work as a practical matter, the companies argue. The imprimatur of Unicef, which is best known in the U.S. for its annual trick-or-treating drive and peace-themed holiday cards, is vital in much of the developing world. There, the agency not only has a history of saving lives but also sometimes functions as a country's de facto children's health system.

In an interview, Ms. Bellamy, Unicef's chief, says she doesn't believe Nestle and the other major formula makers have "a particular role" to play in the AIDS crisis. "What they should do is comply with the code," she says.

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Formula for an Epidemic

Since the Beginning of the AIDS Crisis. . .

* 3.8 million children worldwide have died of AIDS.

* Of those, an estimated 3.4 million were infected by their mothers.

* Of those 3.4 million, 1.1 million to 1.7 million were infected through breastfeeding.

In Sub-Saharan Africa. . .

* An estimated 90 of every 1,000 pregnant women are infected with the HIV virus.

* Of those 90 pregnancies, 27 to 36 babies are expected to contract the HIV virus from their mothers, either in utero, during labor or through breastfeeding.

* Of those infected babies, 9 to 18 are expected to contract HIV through breastfeeding.

Source: UNAIDS

-----------------------------------------------

Studies suggest that only about 15% of pregnant women with HIV in Africa will transmit the virus to their children through breast-feeding. Also, Ms. Bellamy says, formula poses risks of its own if prepared without adequate sanitation: It can expose infants to diarrhea and other traditional killers of the developing world, while breast milk contains antibodies to help ward off such illnesses. So, even if formula protects a baby from AIDS, it could prove deadly later on. In addition, Unicef officials are worried about a phenomenon known as "spillover" -- that providing formula to HIV-infected women would undercut support for breast-feeding among healthy women.

In Ms. Bellamy's view, Unicef has to focus on the vast majority of babies for whom breast milk is unquestionably the safest food. "We continue very much to advocate that breast is best," Ms. Bellamy says.

In 1998, in the wake of intense debate over the AIDS crisis, Unicef and other U.N. agencies agreed to modify their pro-breast-feeding stance in the developing world -- but not to the point of endorsing donations of formula. The new policy, known as "informed choice," states that infected women throughout the world should "be empowered" to decide the best way to feed their babies, and be advised on the benefits and risks of breast-feeding and alternatives such as formula. Though Unicef continues to lead the crusade for breast-feeding in the developing world, Ms. Bellamy says the agency is "supportive" of formula as an option for HIV-infected mothers. "We certainly don't rule it out," she says.

However, the policy says nothing about how the desperately poor, HIV-infected women who do choose formula are supposed to get it. In Uganda, formula is sold at supermarkets and in crowded food stalls at prices that are far beyond the reach of much of the population. Joyce Ganyana, a HIV-positive mother who lives in a Kampala slum, says she can't afford to buy a liter of cows' milk for 43 cents, let alone a one-pound tin of formula, which generally costs $6. "If I stop breast-feeding, the baby will fall sick and die because she'll starve," says Ms. Ganyana, 40, who ekes out a living selling vegetables. "Formula is for the rich ones who can afford it."

Many health workers in Africa and even some U.N. officials deride the informed-choice policy as little more than a cop-out. Health workers are rarely able to spend more than a few minutes with mothers whose education and resources often are extremely limited, and some mothers don't get any counseling at all. For instance, Latshia's 25-year-old mother, Ms. Scovia, learned about formula only from neighbors after she had come home from the hospital. Before, she says, "I thought formula was a powder for old people."

A Political Logjam

Thousands of miles from Ms. Scovia's unfolding family tragedy, the political logjam shows no signs of loosening. Unicef and the industry are still fighting over various details of the 1981 marketing code, and attempts at reconciliation over the past five years have left the two sides barely on speaking terms.

For example, an argument has raged over whether the code applies just to developing countries or everywhere in the world. Unicef says the code applies globally, leading Nestle to complain that its promotional giveaways in places such as Canada unfairly land it on the violators' list. Unicef says it's crucial that the code be applied world-wide because women everywhere should be able to choose how to feed their babies without undue pressure from formula marketers.

In the developed world, big formula companies are notably aggressive, showering new mothers in maternity wards with product samples and other gifts. Nestle's U.S. Web site (www.verybestbaby.com) offers a free subscription to the company's magazine, which features coupons for formula. Such outreach can be extremely lucrative, because once a mother starts feeding her baby with formula, she generally sticks to the same brand -- and the company locks in a good customer for at least a year.

Unicef also says it has ample evidence of wrongful industry marketing efforts in developing world countries such as Bangladesh and the Philippines, including cases of companies plying health clinics with free samples of formula and bestowing calendars, pen holders and other promotional gifts on health-care workers. Nestle and the rest of the industry deny they are violating the code, and claim Unicef relies for its information on a network of activist groups driven by a pro-breast- feeding ideology.

In addition, some inside Unicef fear the industry will try to exploit the AIDS crisis as a way to build its African market. The formula makers dismiss this, describing both current and potential sales in sub-Saharan Africa as minuscule.

When Ms. Bellamy, now 58 years old, was appointed in 1995 by U.N. Secretary General Kofi Annan as Unicef's chief, both she and the industry hoped to mend the rift. Her predecessor, the late James Grant, had held meetings with the formula makers that had degenerated into mutual accusations, participants say. Ms. Bellamy told the industry's trade association she wanted to avoid this, and invited the companies to come to New York and detail how they marketed infant formula around the world.

Nestle alone accepted, and in October 1997 its chief executive, Peter Brabeck, flew to New York from Switzerland. For the company, the stakes were high. Nestle makes some of the world's best known consumer products -- from Perrier bottled water to Nestle and Kit-Kat chocolate bars. Though infant formula represents less than 5% of Nestle's total annual sales of $43 billion, the company believed Unicef's longstanding criticism of its alleged code violations was stoking the fervor of anti- Nestle activists, who continued to attack the company at its annual shareholder meetings and on the Internet. Nestle claims that the boycott, which activists still invoke in 19 countries, including the U.S., hasn't affected sales. But it has been a public-relations problem for the company, which markets formula under the brand names "Nestle Nan" in Africa and "Nestle Carnation Good Start" in the U.S.

Mr. Brabeck, a career Nestle employee who only months before had been promoted to CEO, was hoping for a friendly audience with Ms. Bellamy. But the session in a 13th-floor conference room at Unicef headquarters soon became anything but amiable. Mr. Brabeck says Ms. Bellamy disappeared after about an hour to take a telephone call and, inexplicably, never returned. Ms. Bellamy says she had a scheduling conflict and thought Nestle knew this.

Left to run the meeting was Ms. Bellamy's deputy, Stephen Lewis, a vocal industry critic. The discussion soon dissolved into the familiar debate over whether the code applied only to developing countries. Mr. Lewis recalls telling the Nestle CEO that "a lot of babies have died as a result of formula, and the violations have to stop." With that, Mr. Lewis says, Mr. Brabeck "jumped up and pounded the table, and yelled." Mr. Brabeck, now 56, denies what Mr. Lewis calls a "tantrum," but concedes he conveyed frustration. "Perhaps my body language is stronger than my words," he says.

'Go Home'

A testy exchange of letters followed. In November 1997, a month after the meeting, Ms. Bellamy wrote to Mr. Brabeck, citing a number of "not reconcilable" differences over the two sides' interpretation of the marketing code, concluding: "It does not seem to us to be useful to maintain such contact in the future." Mr. Brabeck says he recalls thinking: "The world's leading food and beverage company is just being thrown a door in its face and told, 'Go home.' "

In December, he wrote to Ms. Bellamy, whose term ends in 2005: "I am not prepared to let this unsatisfactory state of affairs persist." Five days later, he fired off a letter to Secretary Annan, complaining that "Ms. Bellamy simply closed the door for any further conversation."

Mr. Annan responded that he shared Unicef's view that the code "applies to all countries" but said he hoped "for a continued dialogue in a constructive spirit" between Nestle and the U.N. Mr. Annan declines to comment.

The standoff persisted for nearly two years. Then, in January, Nestle tried a new tack with Unicef: It retained Ms. Ferraro, who works as a business consultant. Mr. Brabeck says he wanted her to get to the bottom of the "strange and very difficult-to-comprehend attitude of Unicef" toward Nestle. He charges that Unicef was treating the company "like a criminal." Counters Ms. Bellamy: "The only thing we consider Nestle to be is a non-code-compliant infant-formula manufacturer."

Ms. Ferraro and Ms. Bellamy have been close friends since 1978, when Ms. Bellamy successfully ran for New York City Council president and Ms. Ferraro, then a local prosecutor, campaigned alongside her. Having heard "terrible things" about Nestle, Ms. Ferraro says she was initially skeptical when the head of the advertising agency that represents Nestle -- and also owns her consulting firm -- asked her to take the assignment. But she says she changed her mind after spending several months reviewing Nestle's code-compliance procedures. "I want to get past this feud," says Ms. Ferraro, who declines to disclose her fee.

Lunch at the U.N.

In March, the two women lunched in the U.N. delegates' dining room. Later, Ms. Ferraro lugged to Unicef's headquarters a shopping bag containing a lengthy Nestle analysis on how its overseas sales force has been trained in code compliance. On June 8, Ms. Bellamy responded to her friend by letter, claiming there were "fundamental divergences" between the code and Nestle's view of it. For example, Ms. Bellamy objected to Nestle's assertion that the code doesn't apply to products like follow- up formula for older babies. Some Unicef officials accuse the companies of marketing these products heavily as an indirect means of promoting infant formula. "There is still much work to be done," Ms. Bellamy concluded.

Ms. Ferraro replied that she was "disappointed" by Ms. Bellamy's reaction but vowed not to give up. "If in Geneva at the human rights commission I could get Syria to join in a resolution condemning anti- Semitism, and in Beijing I could get the Holy See to agree to language accepting of nontraditional families&hellipI'm optimistic we can resolve our differences," wrote Ms. Ferraro, who has continued to lobby Ms. Bellamy.

As the contretemps between Nestle and Unicef dragged on, another formula maker quietly began putting out feelers to the agency. In 1998, Wyeth, a unit of American Home Products Corp. that sells formula under the brand names "SMA" and "Nursoy," caught wind that Unicef was planning to launch a pilot program at some African hospitals to try to reduce mother-to- child AIDS transmission. To conform with the new "informed choice" policy, formula likely would be offered as an option to participants. Wyeth sensed an opportunity, but the objective of saving babies' lives soon got overtaken by a dispute over public relations.

In November 1998, Daniel Spiegel, a Washington attorney for Wyeth, began conducting some very quiet conversations with top officials at UNAIDS, the U.N. interagency group. Mr. Spiegel, a former U.S. Ambassador to the U.N. in Geneva, told UNAIDS that Wyeth wanted to donate formula to HIV- infected women in Africa.

The company believed it could make such a donation because of an exception in the marketing code that allows formula giveaways to babies "who have to be fed on breast-milk substitutes." The company assumed this could include AIDS babies, and that a program administered by Unicef itself would use the formula safely, thereby averting the potential for bad publicity. UNAIDS began acting as a broker between Wyeth and Unicef to put the precedent-setting deal in motion.

"This was very new ground for everyone," recalls Jim Sherry, a UNAIDS official involved in the talks. "Because of AIDS, the public-health community was in a turnaround situation: Formula had been like tobacco and suddenly it wasn't."

After lengthy negotiations, Wyeth and Unicef representatives finally met face-to-face on March 26, 1999, at the company's Philadelphia headquarters. Unicef, worried that Wyeth would try to exploit its donation for marketing purposes, insisted the free formula could carry no brand name. Wyeth agreed. The company also said it was prepared to provide free formula for six months to 100,000 infants, a figure based on Unicef's initial estimates of what its pilot program would require, and was willing to give more later.

The Deal Unravels

At Unicef's request, Wyeth sent a draft proposal of its offer to the agency about a week later. But unknown to the company, the deal was fast unraveling. On April 28, Mr. Lewis, Ms. Bellamy's aide, received an e- mail from Unicef lawyer Peter Mason stating that Wyeth had suggested getting Unicef to commit to a thank-you letter. According to the e-mail, Wyeth's Mr. Spiegel expressed "outrage and shock" when told that Unicef might not agree to a letter, but said that the company might settle for a meeting with Unicef officials.

Liza Barrie, a Unicef spokesperson, says Wyeth also had requested a jointly issued press release and a photo opportunity with Ms. Bellamy and Wyeth executives. "It seemed that everything they were proposing could lead to a misunderstanding of our relationship with the company and our view of its practices," Ms. Barrie says.

Mr. Spiegel and Kevin Reilly, president of Wyeth's nutrition and vaccine division, counter that Wyeth made suggestions about recognition only after Unicef itself brought up the subject, and that these weren't conditions of the donation. "All we wanted was an appropriate acknowledgment ... that would conform with obviously a multimillion- dollar donation," Mr. Spiegel says. He adds that Wyeth only made one demand: "That we not make this donation and then be attacked by Unicef" for alleged past transgressions.

In the end, Wyeth needn't have worried: Unicef rejected its donation. Without giving any explanation, Mr. Mason simply stopped talking to the company. "He never got back to me," says Mr. Spiegel. Mr. Mason, the Unicef lawyer, says through an agency spokesman that Unicef and Wyeth had "informal and very regular conversations" and that "ultimately, it was pretty clear that Unicef wouldn't be going forward unless there was some new development."

Around this time, UNAIDS was also contacted by Nestle, which had learned of Wyeth's overture and didn't want to be left out. At two meetings in Switzerland in March 1999, Nestle said it favored an "all-industry approach," implemented by the industry's trade association, according to Niels Christiansen, Nestle's vice president of public affairs, who attended both sessions. But after the Wyeth deal faded away, UNAIDS heard nothing further from Nestle.

Unicef Buys Formula

Having rejected Wyeth's offer, Unicef still needed to line up a supply of formula for its pilot program. The agency's options were limited, since it considered most of the major formula makers to be in violation of the marketing code. Unicef, whose $1.1 billion annual budget comes entirely from government and individual donations, concluded it could afford to pay for the relatively small amount of formula required by the program.

Before soliciting bids, Unicef checked with a group of pro-breast- feeding advocates that coordinates the continuing Nestle boycott, and reviewed a 1997 report called "Cracking the Code" that was published by a coalition of charities, churches and nonprofit organizations, including the Church of England and the European offices of Unicef and WHO. The report accuses Nestle, Wyeth and several other companies of "systematic" code violations in Poland, Bangladesh, Thailand and South Africa, citing formula giveaways and other promotional activities aimed at mothers. (The industry's trade association dismissed the report as "unscientific, subjective and prejudged.") Eventually, Unicef decided to buy its formula from a French dairy cooperative, Jammet Dietetique Nouvelle SA, whose brands include Jammet formula and whose parent company makes Yoplait yogurt.

Almost as soon as it was implemented in Uganda this February, the pilot program began to suffer what Dr. Iyorlumun Uhaa, a Unicef official in Kampala, calls "teething problems." Some of these snafus were of the sort that inevitably occur when a large bureaucracy such as Unicef tries to do business in the developing world. For instance, the warning labels on the formula boxes were only in English and French. The marketing code requires all labels to be "in an appropriate language," and almost all the Ugandan women who visit the clinics speak only local dialects, health workers say.

Other problems were more fundamental. Some health workers believe Unicef may have subverted its own program by insisting that the Jammet formula be packaged in generic boxes. In Africa, HIV-infected women face enormous stigma and often are abandoned by their partners when their condition becomes known. "Because this Unicef package isn't anywhere in the shops, the moment people see it, they start suspecting," says Kampala midwife Joyce Matovu. Some HIV-infected women who did accept the formula were so fearful it would reveal their condition that they purchased tins of Nestle formula and refilled them with the generic powder, health workers say.

While acknowledging their approach may have reinforced the stigma of formula, Unicef officials say they settled on a no-name product in a deliberately unattractive box to discourage healthy women from wanting to use it.

A Drop in the Bucket

For the moment, Unicef's program does seem to be benefiting many women -- though the 25,000 mothers in 11 countries who have participated represent just a drop in the bucket of the HIV-infected female population.

For example, after being counseled about the pros and cons of breast-feeding and formula at Nsambya Hospital in Kampala, 23-year-old Betty Nanfuka chose formula and was taught how to prepare it. Now she recites how she boils water twice a day on charcoal left over from meals and mixes two scoops of water for every two "level" scoops of formula she puts into a clean flask. The HIV-infected mother says that to preserve her secret, she always feeds her baby inside the house.

Says Ms. Nanfuka: "If women are given a chance and told what to do, they can carry it out." So far, her baby, Maureen, has tested negative for the AIDS virus.

But if the Unicef official in charge of the pilot program prevails, not many more African women will have the same opportunity as Ms. Nanfuka. Urban Jonnson, Unicef's regional director for eastern and southern Africa, says that even if the pilot program proves successful and is expanded, infant formula "absolutely" won't be used. His rationale: "Infant formula is not the best alternative, even if it's free of charge." He says "home food" alternatives, like pasteurized breast milk, are cheaper. Nursing by another, noninfected woman is also an alternative. And, he adds, infant formula often leads to follow-up formula. "We don't want to create the dependence when the child grows older," he says.

Instead, Mr. Jonnson and a number of his Unicef colleagues are pinning hope on a recent and controversial South African study that suggests breast-feeding may be just as effective as formula in preventing HIV transmission, as long as the baby receives no other nourishment for six months. Anna Coutsoudis, the study's lead researcher at the University of Natal in Durban, hypothesizes that the antibodies contained in breast milk may shield infants against the AIDS virus. Under this scenario, anything other than breast milk -- including formula -- alters the digestive tract of babies, potentially making them more susceptible to disease.

Dr. Coutsoudis's finding has gained an enthusiastic following among the Unicef officials because it would enable them to preserve their long campaign to promote breast-feeding, an effort credited with substantial declines in infant mortality. But even if Dr. Coutsoudis turns out to be right, exclusive breast-feeding can be problematic, too. For starters, a massive education effort would be required, since most African women who breast-feed also give their babies tea, water, and other food. Dr. Coutsoudis also concedes it will take at least two years to confirm her hunch, though she is urging African governments to call for exclusive breast-feeding now.

However, researchers who support the use of infant formula in AIDS cases remain skeptical of her research. They note a recent study also done in South Africa, which suggests that breast-feeding can undermine the effect of new, low-cost AIDS drugs that block mother-to-child transmission.

Deep Suspicions

For Unicef's Mr. Jonnson, who works in Nairobi, and other officials on the ground, suspicion of the formula industry runs deep. "I've seen all combinations of rotten behaviors from these companies," Mr. Jonnson says. "I don't think for a second that has changed dramatically."

Such suspicion was on vivid display this summer, when a potentially serious problem arose with Unicef's pilot program in Uganda. In early July, supplies of formula at Nsambya Hospital suddenly ran out. By that time, more than half of the 235 HIV-positive women enrolled in the program at the hospital had chosen to use formula, and some were simply told to fend for themselves. Unicef says the reason for the delay, which lasted several weeks, is that Ugandan staffers mistakenly wrote the wrong product code number on their order forms.

As the situation worsened, Jacqueline Thibault, a children's-aid worker from Switzerland, happened to visit the hospital. Told of the formula shortage, she decided to seek an alternative supply -- from Nestle. Ms. Thibault asked the company for enough infant formula to feed about 250 babies for six months. On July 24, Nestle responded that it would be "pleased" to ship 4.4 tons of formula for free.

There were two caveats. Nestle didn't want to pay import duty on the donation. And to insure the donation would pass muster under the marketing code, the company said it wanted an "official authorization" from the Ugandan Ministry of Health "to prevent adverse actions against Nestle."

Dr. Saul Onyango, who oversees the pilot project for the Ugandan Ministry of Health, turned to Unicef for advice. He says neither he nor his agency objected to the proposed donation, but that when he told Unicef's Dr. Uhaa about it, Dr. Uhaa replied, "What? That is not acceptable." Dr. Uhaa says that a separate shipment of formula from Unicef finally did arrive in late July, and he was "suspicious" of the large quantity offered by Nestle.

Two days after his discussion with Dr. Uhaa, Dr. Onyango informed a surprised group of Nsambya Hospital officials that the government wasn't going to authorize Nestle's donation. "You have stepped into international politics," he told them. "That milk can't come in."

Write to Alix M. Freedman at alix.freedman@wsj.com and Steve Stecklow at steve.stecklow@wsj.com
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