Connecting the PWS Dots | ResearchNotes

Research Notes: Public Health

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(08/31/07 - Washington Post) HHS Toned Down Breast-Feeding Ads
Formula Industry Urged Softer Campaign

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, 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.

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, 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.

(06/28/07 - New York Times) Wider Sale Seen for Toothpaste Tainted in China

After federal health officials discovered last month that tainted Chinese toothpaste had entered the United States, they warned that it would most likely be found in discount stores. In fact, the toothpaste has been distributed much more widely. Roughly 900,000 tubes containing a poison used in some antifreeze products have turned up in hospitals for the mentally ill, prisons, juvenile detention centers and even some hospitals serving the general population.

The toothpaste was handed out in dozens of state institutions, mostly in Georgia but also in North Carolina, according to state officials. Hospitals in South Carolina and Florida also reported receiving Chinese-made toothpaste, and a major national pharmaceutical distributor said it was recalling tainted Chinese toothpaste.

The Food and Drug Administration has advised consumers to discard all Chinese-made toothpaste, regardless of the brand.

State officials in Georgia and North Carolina said all the tainted tubes were being replaced with brands made outside China. The officials said there had been no reports of illnesses caused by the toothpaste.

Officials of the Food and Drug Administration said toothpaste with even small amounts of the bad ingredient, diethylene glycol, a syrupy poison, had a �low but meaningful risk of toxicity and injury� for children and people with kidney or liver disease. �This stuff does not belong in toothpaste, period,� a spokesman for the drug agency, Doug Arbesfeld, said. �No Chinese toothpaste has come into the country since the end of May.�

Since the Panamanian government found Chinese toothpaste with diethylene glycol in May, countries from Latin America to West Africa to Japan have seized the toothpaste. Panama last year inadvertently mixed the poison made in China into 260,000 bottles of cold medicine, killing at least 100 people, prosecutors there said.

Diethylene glycol is often used in Chinese toothpaste in place of its more expensive chemical cousin glycerin. Chinese regulators have said that toothpaste with small amounts of diethylene glycol is not harmful and that international concern is unjustified.

After the drug agency expressed concern about tainted toothpaste, the Georgia Department of Administrative Services checked to see whether Chinese toothpaste was being used by the state. The department found it in 83 prisons, 4 mental health centers and 4 juvenile detention centers, said Rick Beal, contracts manager for the department. Mr. Beal said officials confiscated 5,877 remaining cases, each with 144 tubes, of the Springfresh brand. Tests showed the toothpaste had a diethylene glycol concentration of about 5 percent, he said.

The state bought the toothpaste for about 9 cents a tube in 2002. Mr. Beal said he did not know how many tubes had been used. There are no reports of harm resulting from the toothpaste, bought from a distributor, American Amenities in Seattle. �We do not know who their manufacturer from China was,� Mr. Beal said.

A lawyer for American Amenities, Jesse Lyon, said it had recalled all suspect shipments of the product and had decided to stop importing Chinese toothpaste. Mr. Lyon said he believed that American Amenities had about 30 institutional customers, with Georgia being the largest.

A spokesman for the North Carolina Department of Corrections, George Dudley, said his agency estimated that it bought 22,000 tubes of Pacific brand Chinese toothpaste with a small amount of diethylene glycol from Pacific Care Products in San Francisco.

Pacific Care did not respond to a request for comment, but an executive wrote to North Carolina officials that the toothpaste came from Amercare Products, also in Seattle. A spokeswoman for Amercare declined to comment.

Chinese toothpaste containing "trace amounts" of diethylene glycol has also been recalled from healthcare institutions by McKesson, a major pharmaceutical distributor and health services company, said a spokesman, James Larkin. Mr. Larkin said although this particular brand, McKesson EverFRESH, was not on the drug agency�s list of contaminated toothpaste, McKesson asked a laboratory to test it. When small amounts of diethylene glycol turned up, the company recalled the product, he said. �We went back through our records, and every customer that ever bought the product was contacted,� Mr. Larkin said.

He added that on short notice he could not determine how many customers had bought the product.

One institution that did was Florida Hospital Waterman, a 200-bed institution in Tavares, Fla. �We pulled that product,� Bonnie Zimmerman of the hospital said.

Ms. Zimmerman said that the toothpaste that replaced it also came from China and it had �trace amounts� of diethylene glycol. It, too, was removed, she said.

In South Carolina, four hospitals in the Greenville Hospital System also removed Chinese toothpaste, even though its distributor said it did not have diethylene glycol, said John Mateka, executive director of materials management for the group.

(06/25/07 - Chicago Tribune) Staph infections rampant
Study: 1.2 million hospital patients at risk

As many as 1.2 million hospital patients are infected with dangerous, drug-resistant staph infections each year, almost 10 times more than previous estimates, based on findings from a major new study. And 48,000 to 119,000 hospital patients a year may be dying from methicillin-resistant staphylococcus aureus (MRSA) infections, far more than previously thought, the study suggests.

The Tribune obtained the results during the weekend from the Association for Professionals in Infection Control & Epidemiology (APIC), which is releasing the report publicly on Monday. The author is Dr. William Jarvis, former acting director of the hospital infections program at the Centers for Disease Control and Prevention.

The findings come amid mounting public concern about the spread of antibiotic-resistant bacteria in health-care facilities and community settings. Medical experts consider the rise of so-called superbugs such as MRSA, a leading cause of deadly blood infections and pneumonias, one of the most alarming public health threats in the nation.

"We're hoping this survey is a wake-up call to health-care workers across America," said Kathy Warye, the association's executive officer.

It is the largest, most comprehensive survey of MRSA in health-care facilities to date. It's based on surveys sent last year to 10,000 infection-control practitioners, including doctors and nurses in hospitals, nursing homes and rehabilitation facilities. Health-care professionals were asked to select one day between Oct. 1 and Nov. 10, 2005, and report all known MRSA cases in their institutions. More than 1,200 hospitals and 100 nursing homes and rehabilitation facilities responded, supplying data about patients with MRSA infections and patients colonized with the bacteria.

People colonized with MRSA typically carry it in their nose without being symptomatic. They're at risk of passing the superbug to others unknowingly by wiping their nose and then touching a table that a doctor or nurse later touches, for instance. MRSA can live on surfaces for days or even weeks.

The new survey confirms what's been observed anecdotally for years - MRSA is rampant in health-care facilities. It found that 34 of 1,000 patients in the survey had active MRSA infections and that 12 were colonized with the superbug, for a total MRSA prevalence rate of 46 per 1,000 patients. (In Illinois, the prevalence rate was 37 per 1,000 patients, based on responses from 74 hospitals and other acute-care facilities.)

The most widely cited previous study, published by CDC researchers in June 2005, had estimated that the MRSA infection rate at in-patient hospitals was 3.9 per 1,000 patients. Based on that rate, it estimated that 126,000 patients were infected with the superbug each year.

The new report didn't translate its findings into actual numbers, but Jarvis outlined a means of doing so to the Tribune. He said it was important for the public to see the ballpark figures.

The calculation involves 35.2 million people hospitalized in the U.S. in 2005, the latest year for which information is available. Applying the prevalence rates in the new study, the data suggest that 1.2 million hospital patients are afflicted with MRSA each year and that an additional 423,000 patients are colonized with the superbug.

This is only an estimate, subject to the accuracy of the numbers reporting by infection-control practitioners and the limitations of a "single point in time" snapshot of the data, Jarvis said. Many hospitals don't routinely test patients to see whether they're colonized with MRSA, he said. Also, the findings haven't been peer-reviewed, which is standard in scientific publications.

"Most hospital leaders are paying very close attention to infections within their institutions. ... But I think this tells us that MRSA is an even bigger problem than we thought it was," said Nancy Foster, vice president of quality and patient-safety policy at the American Hospital Association, after reviewing an advance copy of the APIC report.

Dr. John Jernigan, a medical epidemiologist at the CDC and the agency's lead expert on MRSA, said he "applauded the study" even though he hadn't examined its results or methodology. He has co-written articles on MRSA with Jarvis that appeared in leading infection-control publications. "Everything we're finding is telling us the same thing: MRSA is an enormous problem in health-care facilities, more needs to be done to prevent it, and hospitals need to make infection control more of a priority," Jernigan said.

The CDC has said at least 5,000 patients die after being infected by MRSA at surgical sites, in their blood or in their lungs. That's a mortality rate of 4 percent, assuming a base of 126,000 patients. Using new prevalence estimates of 1.2 million MRSA patients a year, it suggests 48,000 patients a year may die of MRSA.

There is considerable uncertainty about the mortality rate associated with MRSA, however, and it may be as high as 10 percent, said Dr. Lance Peterson, director of infectious disease research at Evanston Northwestern Healthcare. Using the new estimates, that suggests as many as 119,000 hospital patients a year may be felled by the superbug. To put that figure in context, the Institute of Medicine has estimated that nearly 100,000 patients die of 2 million infections acquired in hospitals every year. MRSA constituted only a portion of those infections and deaths. The new numbers suggest the actual number of hospital-related infections and deaths could be much larger.

An important finding in the new study suggests that hospitals may not be focusing infection-control strategies on the right locations in their institutions. Though earlier research has indicated intensive-care units, which often treat patients with compromised immune systems, are hot spots of infection, this report shows that 67 percent of patients with MRSA infections were on medical wards. "This suggests that MRSA has become a problem throughout the institution and that [hospital staff] may need to look for it beyond the ICU," Jarvis said.

The study shows that 77 percent of patients with MRSA were identified within two days of entering a hospital, making it likely they were colonized or infected before being admitted. The vast majority of these patients picked up MRSA during an earlier stay at a hospital or nursing home, Jarvis said.

On the positive side, there is strong consensus about the steps hospitals need to take to control MRSA, said Dr. Don Goldmann, a senior vice president at the Institute for Healthcare Improvement in Boston. All health-care workers should practice rigorous hand-washing, and all institutions should have robust programs for disinfecting medical equipment and patients' rooms, he said. When patients are known to have MRSA, hospital staff should wear gowns and gloves to prevent transmission. And patients deemed at risk of carrying MRSA should be screened to determine where bacterial hot spots are festering.

"Now that the true extent of this scandalously tragic epidemic is known, I hope that health-care leadership will finally confront it with the effective means that have always been available," said Michael Bennett, president of the Coalition for Patients' Rights in Maryland.