Formula Industry Urged Softer Campaign

by Marc Kaufman / Christopher Lee

In an attempt to raise the nation's historically low rate of breast-feeding, federal health officials commissioned an attention-grabbing advertising campaign a few years ago to convince mothers that their babies faced real health risks if they did not breast-feed. It featured striking photos of insulin syringes and asthma inhalers topped with rubber nipples.

Plans to run these blunt ads infuriated the politically powerful infant formula industry, which hired a former chairman of the Republican National Committee and a former top regulatory official to lobby the Health and Human Services Department. Not long afterward, department political appointees toned down the campaign.

The ads ran instead with more friendly images of dandelions and cherry-topped ice cream scoops, to dramatize how breast-feeding could help avert respiratory problems and obesity. In a February 2004 letter (pdf), the lobbyists told then-HHS Secretary Tommy G. Thompson they were "grateful" for his staff's intervention to stop health officials from "scaring expectant mothers into breast-feeding," and asked for help in scaling back more of the ads.

The formula industry's intervention -- which did not block the ads but helped change their content -- is being scrutinized by Congress in the wake of last month's testimony by former surgeon general Richard H. Carmona that the Bush administration repeatedly allowed political considerations to interfere with his efforts to promote public health.

Rep. Henry A. Waxman's Committee on Oversight and Government Reform is investigating allegations from former officials that Carmona was blocked from participating in the breast-feeding advocacy effort and that those designing the ad campaign were overruled by superiors at the formula industry's insistence.

"This is a credible allegation of political interference that might have had serious public health consequences," said Waxman, a California Democrat.

The milder campaign HHS eventually used had no discernible impact on the nation's breast-feeding rate, which lags behind the rate in many European countries.

Some senior HHS officials involved in the deliberations over the ad campaign defended the outcome, saying the final ads raised the profile of breast-feeding while following the scientific evidence available then -- which they say did not fully support the claims of the original ad campaign.

But other current and former HHS officials say the muting of the ads was not the only episode in which HHS missed a chance to try to raise the breast-feeding rate. In April, according to officials and documents, the department chose not to promote a comprehensive analysis by its own Agency for Healthcare Research and Quality (AHRQ) of multiple studies on breast-feeding, which generally found it was associated with fewer ear and gastrointestinal infections, as well as lower rates of diabetes, leukemia, obesity, asthma and sudden infant death syndrome.

The report did not assert a direct cause and effect, because doing so would require studies in which some women are told not to breast-feed their infants -- a request considered unethical, given the obvious health benefits of the practice.

A top HHS official said that at the time, Suzanne Haynes, an epidemiologist and senior science adviser for the department's Office on Women's Health, argued strongly in favor of promoting the new conclusions in the media and among medical professionals. But her office, which commissioned the report, was specifically instructed by political appointees not to disseminate a news release.

Wanda K. Jones, director of the women's health office, said agency media officials have "all been hammering me" about getting Haynes to stop trying to draw attention to the AHRQ report. HHS press officer Rebecca Ayer emphatically told Haynes and others in mid-July that there should be "no media outreach to anyone" on that topic, current and former officials said.

Both HHS and AHRQ ultimately sent out a few e-mail notices, but the report was generally ignored. Requests to speak with Haynes were turned down by other HHS officials.

Regarding the changes made to the earlier HHS ad campaign, Kevin Keane, then HHS assistant secretary for public affairs and now a spokesman for the American Beverage Association, said formula companies lobbied hard, as did breast-feeding advocates.

"We took heat from the formula industry, who didn't want to see a campaign like this. And we took some heat from the advocates who didn't think it was strong enough," Keane said. "At the end of the day, we had a ground-breaking campaign that goes further than any other administration ever went."

But the campaign HHS used did not simply drop the disputed statistics in the draft ads. The initial idea was to startle women with images starkly warning that babies could become ill. Instead, the final ads cited how breast-feeding benefits babies -- an approach that the ad company hired by HHS had advised would be ineffective. The department also pulled back on several related promotional efforts.

After the 2003-05 period in which the HHS ads were aired, the proportion of mothers who breast-fed in the hospital after their babies were born dropped, from 70 percent in 2002 to 63.6 percent in 2006, according to statistics collected in Abbott Nutrition's Ross Mothers Survey, an industry-backed effort that has been measuring breast-feeding rates for more than 30 years. In 2002, 33.2 percent of women were doing any breast-feeding at six months; by 2006, that rate had declined to 30 percent.

The World Health Organization recommends that, if at all possible, women breast-feed their infants exclusively for at least six months.

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The breast-feeding ad campaign originated in a formal "Blueprint for Action on Breastfeeding" released in 2000 by David Satcher, who had been appointed surgeon general by President Bill Clinton. The Office on Women's Health convinced the nonprofit Ad Council to donate $30 million in media time, and it hired an ad agency to work alongside scientists from the National Institutes of Health, the Centers for Disease Control and Prevention, and elsewhere.

Officials met with dozens of focus groups before concluding that the best way to influence mothers was to delineate in graphic terms the risks of not breast-feeding, an approach in keeping with edgy Ad Council campaigns on smoking, seat belts and drunken driving. For example, an ad portraying a nipple-tipped insulin bottle said, "Babies who aren't breastfed are 40% more likely to suffer Type 1 diabetes."

Gina Ciagne, the office's public affairs specialist for the campaign, said, "We were ready to go with our risk-based campaign -- making breast-feeding a real public health issue -- when the formula companies learned about it and came in to complain. Before long, we were told we had to water things down, get rid of the hard-hitting ads and generally make sure we didn't somehow offend."

Ciagne and others involved in the campaign said the pushback coincided with a high-level lobbying campaign by formula makers, which are mostly divisions of large pharmaceutical companies that are among the most generous campaign donors in the nation.

The campaign the industry mounted was a Washington classic -- a full-court press to reach top political appointees at HHS, using influential former government officials, now working for the industry, to act as go-betweens.

Two of the those involved were Clayton Yeutter, an agriculture secretary under President George H.W. Bush and a former chairman of the Republican National Committee, and Joseph A. Levitt, who four months earlier directed the Food and Drug Administration's Center for Food Safety and Applied Nutrition food safety center, which regulates infant formula. A spokesman for the International Formula Council said both were paid by a formula manufacturer to arrange meetings at HHS.

In a Feb. 17, 2004, letter to Thompson (pdf), Yeutter began "Dear Tommy" and explained that the council wished to meet with him because the draft ad campaign was inappropriately "implying that mothers who use infant formula are placing their babies at risk," and could give rise to class-action lawsuits.

Yeutter acknowledged that the ad agency "may well be correct" in asserting that a softer approach would garner less attention, but he said many women cannot breast-feed or choose not to for legitimate reasons, which may give them "guilty feelings." He asked, "Does the U.S. government really want to engage in an ad campaign that will magnify that guilt?"

He also praised Keane, the HHS public affairs official, for making "helpful changes" and removing "egregious statements," but asked that more be done. Two months later, Yeutter wrote Thompson to thank him for meeting with a group that included Levitt and an official of the council. The group members supported breast-feeding, he said, but they wanted HHS to use "positive visual images."

The formula companies also approached Carden Johnston, then president of the American Academy of Pediatrics. Afterward, Johnston wrote a letter to Thompson advising him that "we have some concerns about this negative approach and how it will be received by the general public."

The letter made a strong impression at HHS, former and current officials said. But it angered many of the medical group's members and the head of its section on breast-feeding, Lawrence M. Gartner, a Chicago physician. Gartner told Thompson in a letter that the 800 members of the breast-feeding section did not share Johnston's concerns and had not known of his letter.

"This campaign needed to be much stronger than it was," Gartner said, adding that in his view, the original ads were backed by solid scientific evidence.

According to former and current HHS officials, Cristina V. Beato, then an acting assistant secretary at HHS, played a key role -- in addition to that of Keane -- in toning down the ads. They said she stressed to associates that it was essential to "be fair" to the formula companies.

Beato was then serving in an acting capacity because lawmakers refused to vote on her confirmation because of complaints that she had padded her official resume. In a 2004 interview with the ABC newsmagazine "20/20," which described some of the industry's efforts to change the breast-feeding ad campaign, Beato confirmed that she "met with the industry, because they kept calling my office, every two weeks." She said in a telephone interview that their complaints played no role in her decisions.

"I brought together our top public health people to examine the health claims, and they examined the science and concluded what should be in and what should be out," Beato said.

Duane Alexander, head of the government's National Institute of Child Health and Human Development, was among the officials contacted by the industry who later supported eliminating some of the ads.

"Our concern was that the campaign was going to discredit itself if it included these things -- these wild claims really -- that had no sufficient basis in science," Alexander said.

Another top agency official who weighed in on the campaign was Ann-Marie Lynch, then in charge of the agency's Office of Planning and Evaluation. Lynch, a former lobbyist for the drug industry trade association PhRMA, reversed an HHS decision to finance a $630,000 community outreach effort to promote breast-feeding, according to an e-mail obtained by The Washington Post. Asked to comment, Lynch said she never discussed "baby formula issues with baby formula manufacturers" at HHS.

Speaking to the International Lactation Consultant Association in 2005, Haynes, of the HHS women's health office, said she was "overruled." Veteran pediatrician and breast-feeding researcher Ruth A. Lawrence of the University of Rochester, who was on the initial advisory committee brought together by Haynes, said the science undergirding the ads was "entirely convincing. Everyone on the committee had to agree on a finding before it was approved. We were very distressed by what happened."

After the changes, the advertising company, McKinney + Silver of Durham, N.C., withdrew from the campaign in protest, according to sources inside and outside HHS. A company spokeswoman declined to comment. Carmona, meanwhile, was told that Beato and HHS press officer Christina Pearson did not want him to become involved in the campaign's launch or in any public promotion of the underlying themes, according to current and former HHS officials. Beato and Pearson said they do not recall giving that advice.

The industry substantially increased its own advertising as soon as the HHS campaign was launched. According to a 2006 report by the Government Accountability Office, formula companies spent about $30 million in 2000 to advertise their products. In 2003 and 2004, when the campaign was underway, infant formula advertising increased to nearly $50 million.

Staff researcher Madonna Lebling contributed to this report.
© 2007 The Washington Post Company