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Is the Nation's Vaccine Program in Trouble?


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.

"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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