October 20, 2004

U.S. flu vaccine shortage (continued).

A few days ago, we posted about some of the reasons for the flu vaccine shortage. The issue has continued to be a political football in the US presidential campaign, with John Kerry placing the blame for the shortage on inaction by Dubya's administration, and Dubya doing his best to weasel out of any responsibility at all.

Today, we have more detail about why the shortage exists, courtesy of a new report from Democratic US Rep. Henry Waxman of California. Here's part of the report:

Failure to Address Vaccine Supply Problems

From 2001 to the present, the Bush Administration has ignored a series of warnings about the fragility of the flu vaccine supply and recommendations for response.

National Vaccine Authority. In November 2001, the Council of the Institute of Medicine issued an extraordinary statement urging the creation of a National Vaccine Authority to coordinate a high- level response to a growing crisis in the supply of important vaccines, including the flu vaccine. The Council of the Institute of Medicine is the organizationís governing body. At the time, the Council included Dr. Anthony Fauci, head of the National Institute on Allergy and Infectious Diseases at NIH, Dr. Gail Wilensky, who had led the Health Care Financing Administration under President George H.W. Bush, and Dr. Kenneth Shine, the head of the Institute of Medicine.

The Administration did not create a National Vaccine Authority.

Fast Track Vaccine Approval. In September 2002, the Government Accountability Office (GAO) found that delays in FDA approval were creating a barrier to entry to the vaccine market. GAO recommended that FDA "consider revising FDA policies for fast track and priority review approval of vaccines currently under development to allow their use, even in periods of nonshortage,
in cases where FDA determines that applying them would help address the unmet need of a stable and sufficient vaccine supply."

The Administration did not implement this recommendation.

Manufacturer Incentives. In October 2002, the National Vaccine Advisory Committee to the Department of Health and Human Services released a major report on vaccine supply. The Committee recommended the creation of a ďmulti-disciplinary group to evaluate the nature of appropriate incentives for manufacturers to sustain the supply of existing vaccines and stimulate development of new vaccines."

The Administration never created this multi-disciplinary group.

Market Incentives. In August 2003, the Institute of Medicine identified inadequate reimbursement and gaps in insurance coverage of vaccination as key factors in reducing pharmaceutical company interest in vaccine production. The IOM found that "federal and state governments currently lack a coherent policy" to address this problem, creating "uncertainty among both producers and purchasers, which in turn reduces incentives for future vaccine

The Administration did not develop any major new initiatives to guarantee an acceptable market for the flu vaccine or other vaccines.

Adult Vaccine Availability. In February 2004, the CDCís director of immunization services made a presentation to the National Vaccine Advisory Committee on the influenza vaccine. Dr. Lance E. Rodewald stated that there was "no authority to finance vaccines" for adults. He also highlighted that there was "no clear lead" in the public health community to assure vaccination
of high-risk adults and "minimal" control of vaccines.

The Administration failed to address the concerns of Dr. Rodewald.

Public Health Preparedness. The Bush Administration has aggravated vaccine supply problems by seeking cuts in funding to support public health preparedness. The Presidentís fiscal year 2005 budget proposes reducing funding for state public health preparedness by $105 million. At a February 2004 hearing of the Government Reform Committee, Dr. Shelley Hearne of the nonpartisan Trust for Americaís Health testified that the Administrationís proposed $105
million dollar cut for state public health preparedness "places our public health defenses at serious risk." Dr. Robert B. Stroube, Virginiaís State Health Commissioner, testified that the "Administrationís proposed cuts could jeopardize our ability to respond to a terrorist event, outbreak of an infectious disease or other public health threats or emergencies."

The report goes on to detail the ways that Dubya's administration failed to make plans to deal with a vaccine shortage. You can read that section, and get the references for the whole report, if you go here here (PDF file).

Via Mark A.R. Kleiman, whose flu post also has links to reports from Rep. Waxman on how the US Food and Drug Administration bungled the vaccine issue and how manufacturer's liability in lawsuits isn't the reason for the vaccine shortage.

Posted by Magpie at October 20, 2004 01:35 PM | Health/Medicine/Health Care | Technorati links |