FDA Has Withheld From Congress Documents on Flu Vaccine Shortage, Lawmaker Says
House Committee on Government Reform ranking member Henry Waxman (D-Calif.) in a letter to FDA Acting Commissioner Lester Crawford wrote that he has information that the agency is intentionally delaying until after the presidential election the release of documents requested by Congress that could determine whether FDA could have prevented a recent national flu vaccine shortage, USA Today reports (Manning, USA Today, 10/27). California-based Chiron on Oct. 6 announced that the British Medicines and Healthcare Products Regulatory Agency suspended the company's manufacturing license at its sole flu vaccine manufacturing plant in Liverpool, England, and as a result the company will not ship any doses this season. U.S. officials expected to have about 100 million flu vaccine doses for the upcoming flu season. Because of Chiron's problems, the United States will have about 56 million standard flu vaccine doses manufactured by France-based Aventis Pasteur, the other U.S. supplier. Maryland-based MedImmune will produce about three million doses of its nasal-spray flu vaccine FluMist for this influenza season, while federal health officials are looking into acquiring additional doses of injectable vaccine from Canada and Europe.
Waxman and Committee Chair Tom Davis (R-Va.) requested that FDA officials by Oct. 20 produce, among other materials, the results of a June 2003 FDA inspection that showed evidence of contamination at the Liverpool plant, along with communications between Chiron and FDA officials and British health authorities. FDA did not meet the deadline; Crawford said FDA officials needed additional time, citing the agency's obligations to distribute the nation's existing flu vaccine. Waxman last week requested that Davis issue a subpoena for the documents, but Davis declined to do so (California Healthline, 10/25).
In his letter to Crawford, Waxman states that he has received a "confidential communication" from within FDA that the agency is withholding documents concerning oversight (Nesmith/McKenna, Atlanta Journal-Constitution, 10/27). Waxman said an unidentified FDA employee recently told him that "an array of materials" were prepared last week for public release, according to the Los Angeles Times (Peterson, Los Angeles Times, 10/27).
Waxman quoted the source as saying that Crawford or his staff "made a decision not to release these documents to Congress until after the election" (Jacobs, San Jose Mercury News, 10/27). Waxman wrote, "These are serious allegations. Public health, not political expediency, should be guiding FDA's actions" (Los Angeles Times, 10/27). He added, "Millions of Americans who are at high risk of severe illness from influenza will not be vaccinated this year. They and their elected representatives in Congress have a right to know whether FDA acted responsibly and what can be done to prevent this health crisis from happening again."
Davis in a statement Tuesday said that he allowed the delay of the documents' release to "let the FDA focus for the time being on the problem of finding and distributing more doses of the vaccine -- because our priority is public health, not election-year politics" (San Jose Mercury News, 10/27). Davis spokesperson Robert White said that Davis "expects to receive all the relevant material from the FDA in the very near future" (Goldstein, Kansas City Star, 10/27).
Crawford said, "The production of the requested documents is a multi-step process across several FDA centers of operation" (Atlanta Journal-Constitution, 10/27). He said that responding to the vaccine shortage "remains our most immediate public health priority," adding that "FDA staff are working diligently to provide a complete response to all of the committee's questions" (Los Angeles Times, 10/27).
Representatives for Democratic presidential nominee Sen. John Kerry's (Mass.) campaign have called a "flu education tour" organized by HHS officials last week "troubling," the Journal-Constitution reports. The tour, which began last week in the Midwest, involves federal health officials including Surgeon General Richard Carmona, CDC director Julie Gerberding, CMS Administrator Mark McClellan and Director of NIH's National Institute of Allergy and Infectious Diseases Anthony Fauci.
Kerry campaign spokesperson David Wade said, "The Bush White House owes skeptical Americans an explanation why the bus tours for nonpartisan officials just happen to take them through so many political battleground states while the president is in a political free-fall because he bungled the flu vaccine shortage." CDC employees who said they were concerned that Gerberding had been sent on the tour during the shortage provided Journal-Constitution staff with documents describing the tour, which will go through "swing states" such as Florida, Minnesota, Ohio, Pennsylvania and Wisconsin, according to the Journal-Constitution.
HHS Assistant Secretary for Public Affairs Kevin Keane on Tuesday said criticisms of the tour are misleading. Keane said, "It is absolutely not politically motivated. Our public health officials are going throughout the country spreading important public health messages about the flu, and it is imperative they do so. It makes no sense to sit here in Washington and hope for the best." He added, "From our perspective, the only people who are politicizing this issue are certain Democrats who are trying to scare people" (Atlanta Journal-Constitution, 10/27).
More than 77% of U.S. residents "place a great deal of blame" on drug manufacturers and government health officials for the shortage, according to a USA Today/CNN/Gallup poll conducted last weekend, USA Today reports. Researchers surveyed 776 adults and found that 47% of respondents blamed companies a "great deal," and 31% of respondents blamed drug manufacturers a "moderate amount."
Meanwhile, 30% of respondents blamed federal health officials a "great deal," and 37% blamed federal health officials a "moderate amount." About 18% of respondents placed a "great deal" of blame on trial lawyers, and 17% placed a "great deal" of blame on President Bush (USA Today, 10/27).
CDC officials have established a Web site that aims to help state officials determine "where vaccine supplies are abundant and where they are scarce" in an effort to redirect vaccine doses to clinics and nursing homes. The site lists the names and addresses of hospitals, clinics and nursing homes to which Aventis has shipped vaccine and the quantities sent to each, according to state officials who have accessed the site. The counties in which private physicians who received vaccine are listed; however, in several instances the names of the doctors are not listed.
There are "still kinks in the system," as some states have been unable to log on to the site, according to the New York Times. The site is restricted to public health officers. According to the Times, the site "shows that some states are in much better shape than others" (Harris, New York Times, 10/27).
The Victoria Clipper ferry, "in an enterprising combination of tourism and health care," has begun transporting people 83 miles from Seattle to Victoria, British Columbia, to receive flu vaccinations, the AP/Houston Chronicle reports (Van Bronkhorst, AP/Houston Chronicle, 10/27). Vaccinations are administered inside the ferry terminal by Vancouver Island Vaccines as passengers disembark (Davidow, Seattle Post-Intelligencer, 10/26).
The ferries can hold 330 passengers and have been full all week (Rowland, Boston Globe, 10/27). The ferry rides are typically two-and-a-half hours and cost $105; a typical round-trip fare on the Clipper is $115 without a vaccination. The ferry operator can transport as many as 800 people a day on three Victoria Clippers (Houston Chronicle, 10/27). The Victoria Clipper will continue to offer flu shot "packages" through mid-December and longer, depending on demand, according to the Post-Intelligencer (Seattle Post-Intelligencer, 10/26).
HHS said that Federal Occupational Health, a part of Public Health Service that provides health care services to about 240,000 federal employees, on Wednesday will begin distributing free flu vaccinations at its clinics to thousands of federal employees who are in high-risk categories. FOH, which purchased flu vaccine early from Aventis, serves the largest bloc of federal employees, but many agencies contract with private-sector vendors for health services.
According to the Washington Post, it is "unclear ... whether the shots [will] be made available in those other agencies." HHS spokesperson Bill Hall said he had no reliable estimate as to how many federal employees would qualify to receive the vaccine (Barr/Levine, Washington Post, 10/27).
The Advisory Committee on Immunization Practices on Wednesday will gather in Atlanta for one of its three annual meetings and will discuss whether CDC should recommend that the entire U.S. population be vaccinated against the flu every year. According to the Atlanta Journal-Constitution, recommending vaccinations for every person older than six months -- about 288 million people -- could "reassure pharmaceutical companies and encourage them to expand vaccine production," as well as provide an infrastructure that could be used "to combat a potential influenza pandemic."
Committee members also said universal vaccination could emphasize the importance of the vaccine. While such a recommendation from CDC in light of the current shortage might "seem absurd," the committee has discussed recommending universal vaccinations for flu shots for more than a year, the Journal-Constitution reports.
Dr. John Treanor, a committee member and associate professor at the University of Rochester School of Medicine and Dentistry, said, "It would take a lot of vaccine, but it has a couple of potential benefits" (McKenna, Atlanta Journal-Constitution, 10/27).