Is the Nation's Vaccine Program in Trouble?

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June 15, 2000 (Washington) -- Even though more Americans than ever are getting vaccinations, the system supporting the effort is "unstable," according to a new report from a panel of experts commissioned by a congressional committee. At the same time, another congressional panel took a hard look Thursday at whether conflicts of interests influenced scientific advisers who recommended an ill-fated vaccine in the late '90s.

As things stand now, the nation's vaccine program is still solid, but cracks are beginning to show, particularly since many states have reduced their immunization efforts, including identifying and reaching out to medically underserved communities. That's a key conclusion of "Calling the Shots, Immunization Finance Policies and Practices," an analysis prepared by the Institute of Medicine (IOM) of the National Academies for the U.S. Senate Appropriations Committee.

The report recommends an overhaul of the way vaccinations are financed, including an injection of $1.5 billion over the next five years by federal and state governments. During the '90s, the experts say, instability in funding at the state level discouraged broader coverage and increased differences between low and high-income groups.

"The infrastructure itself has begun to come apart ... because there isn't as much funding. There aren't as many outreach efforts. There isn't as much work going on with the private sector," panel chair Bernard Guyer, MD, tells WebMD. Guyer is a professor at the Johns Hopkins School of Hygiene and Public Health in Baltimore.

In the meantime, the demand for vaccinations continues to grow. Each day, according to the report, 11,000 children are born in the U.S. who must either be immunized or face life-threatening infections. For example, a measles outbreak in the late '80s led to 43,000 cases and 100 deaths. Diseases that could be prevented by vaccination still kill 300 children and up to 70,000 adults annually, the report says.

Other disturbing trends: Vaccination rates are as much as 19% lower for inner-city children than for those living outside city limits. Some 63% of adults get flu shots, but the percentage for seniors getting pneumonia vaccinations is significantly lower.

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Of equal concern, says the report, 9% fewer poor children complete the full series of the most critical vaccines than their wealthier counterparts. One of the reasons for these gaps is that many low-income children have shifted their Medicaid coverage to a managed care organization. HMOs only report on children who've been enrolled continuously for one year.

"This approach tends to undercount or miss children on Medicaid who frequently change [health care] providers," the report's authors say. Meanwhile, the list of available vaccines is rapidly increasing with equal increases in cost. Some states, the IOM says, already are struggling to offer the chicken pox vaccine. Less than 50% of American children have received this vaccine, even though the CDC recommends it.

The proposed remedy by the IOM panel is the $1.5 billion investment over the first five years, with an annual increase of $175 million over current spending. The report also says Congress should spend $50 million more to buy vaccines for needy adults and states should kick in another $11 million.

On Capitol Hill, the FDA and CDC were under attack at a hearing of the House Committee on Government Reform. The concern, expressed by Chairman Dan Burton (R-Ind.), is that there are possible conflicts of interest issues that unduly influenced the approval of the rotavirus vaccine.

The vaccine, RotaShield, was approved by the FDA in 1998 to prevent infant diarrhea and recommended for universal use by the CDC in March of 1999. However, it was pulled off the market last October after some children developed serious bowel complications.

Burton says that three out of the FDA advisory committee members who voted for the vaccine had financial ties to drug companies that were developing different versions of the product. He also notes that four of the eight CDC part-time experts who gave their OK for using RotaShield also had interests in firms working on similar vaccines. Both the FDA and CDC rely heavily on a system of freelance experts to help them reach decisions about putting pharmaceuticals on the market.

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"How confident can we be in a system when the agency [FDA] seems to feel that the number of experts is so few that everyone has a conflict and thus waivers must be granted? It almost appears that there is a[n] 'old boys network,'" Burton said. The congressman is an outspoken critic of FDA vaccination policies. He says his grandson was stricken with autism just after receiving a series of vaccinations, although there is no scientific link between vaccines and the mental disorder.

"My fear is that the chairman has reached a predetermined conclusion that vaccines are dangerous. It is difficult for him to persuade others to agree with this conclusion, because it is so far out of the scientific and medical mainstream," Rep. Henry Waxman (D-Calif.) told the committee.

Both the FDA and CDC defended their policy of not precluding panelists with industry ties. "If this were the case, FDA would not get the top scientists in the field, and the recommendations of the advisory committees would not be of the highest scientific nature," says Linda Suydam, FDA's senior associate commissioner.

Experts on the government's policies on ethics and financial disclosure told the committee that agencies have a great deal of freedom in picking committee members, even if they have some financial ties to business or advocacy groups.

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