By Thomas Lang
The politics of flu became an issue earlier this month when British regulators shut down a Chiron Corporation vaccine plant that was set to provide almost 50 percent of the United State’s influenza vaccine. Seizing on the news, John Kerry blamed the shortage on the ineptness of the Bush administration. The Bush campaign, in turn, said the whole problem was indirectly the fault of Kerry and other congressmen like him because of their refusal to put limits on malpractice suits.
A flurry of political stories ensued, cataloging the various charges and counter-charges, but failing, as usual, to tell the reader which aspect, if any, of either candidate’s arguments holds water. Meanwhile, a number of major papers have assigned their Health or Science sections to provide detailed explanations of the crisis. Few though, have managed to effectively mix politics and health together. So here’s our shot at doing just that.
The Kerry campaign has charged, first, that the Bush administration was warned three years ago that the health system wasn’t prepared for a disruption in the supply of flu vaccine, and second, that the administration was warned as recently as August of the impending crisis and failed to act.
The first part of the charge is true. In a report issued May 15, 2001, the General Accounting Office warned, “Currently, there is no system to ensure that high-risk people have priority when the supply of vaccine is short. In a typical year, enough vaccine is available in the fall to meet total demand, both from high-risk individuals and from others who simply want to avoid the flu…When [earlier] shortages developed, manufacturers and distributors had limited ability to identify and give priority to those providers serving more high-risk individuals.” The GAO sent a list of recommendations to the Department of Human and Health Services, where it, based on this year’s trouble, had little or no impact.
The second accusation is more problematic.
In August, Chiron did warn that it had detected contamination problems in eight of its vaccine batches, but it assured US health officials that it would still be able to deliver 46 million to 48 million doses of the vaccine. Is Kerry suggesting that the Bush administration should have found another flu vaccine supply? The fact is that even if the administration had found that Chiron’s entire supply was contaminated, it could not have found an adequate replacement. (That same GAO report from May 15, 2001 notes, “Producing the vaccine is a complex process that involves growing viruses in millions of fertilized chicken eggs. This process, which requires several steps, generally takes at least 6 to 8 months between January and August each year.”) Is the Kerry campaign suggesting that the Bush administration did not adequately respond to the August warning by informing the public and developing a plan to ensure those in the high-risk group receive the vaccine? A spokesman with HHS told me that, after being warned of a potential supply problem, HHS developed revised recommendations to be implemented if the problems in Chiron turned out to be worse than anticipated. At the time the Center for Disease Control and Prevention, after discussions with Chiron, did not “anticipate an overall shortage,” and chose, not to revise its recommendations on just who should be immunized.
Yesterday, HHS Secretary Thompson cited the August release of the Draft National Pandemic Preparedness and Response plan. Today the Atlanta Journal Constitution reports that that plan has been in the works since 1993, and has itself been criticized by both the Government Accounting Office and Trust for America’s Health for leaving “significant gaps in preparation for flu.”
The Bush administration has responded with the counter-argument that it’s really congressional liberals who are to blame for the vaccine crisis. The shortage, it contends, is a result of manufacturers exiting the market because of potential liability lawsuits. (Translation: Trial lawyers like John Edwards did it!) Thus, it says, what’s really needed to ensure a full supply of the flu vaccine is tort reform.
Quick history lesson: As both the New York Times and USA Today reported today, Congress first passed a law, the National Childhood Vaccine Injury Act, limiting manufacturers’ liability 18 years ago. The law created the National Vaccine Injury Compensation Program that requires those injured by vaccines to seek compensation from a special government fund that is supported by an excise tax. Only after being denied by that fund can victims file a lawsuit against a manufacturer. Earlier this year, according to a Human and Health Services Department spokesman, Congress passed a bill that would add the influenza virus to the National Vaccine Injury Compensation Program. President Bush has not yet signed it.
In addition, the administration asserts that the flu vaccine business is not profitable because manufactures have to throw out unsold doses. Thus, incentive to make the stuff goes right out the window.
This is true. Arnold Monto, an epidemiologist and flu specialist at University of Michigan’s School of Public Health, told USA Today that flu vaccines cost $3 to $10 a dose and aren’t as profitable as producing drugs. The New York Times reported on Sunday that this years list price for a dose is $8.50.
Profits are further eaten away because manufacturers have to toss any excess vaccine at the end of any given flu season. According to the GAO, “Each year’s vaccine is made up of three different strains of influenza viruses, and typically each year, one or two of the strains is changed to better protect against the strains that are likely to be circulating during the next flu season. The FDA decides which strains to include…” Thus, extra flu vaccine from one year cannot be used the following year.
Strict manufacturing regulations enforced by the FDA have also chased some companies from the business. As the New York Times reported on Sunday, a new inspections system put in place in 1999 resulted in more violations and, faced with expensive upgrades to meet standards, many companies chose to exit the business. J. Leighton Read, the founder of Aviron, a manufacturer of the nasal spray flu vaccine, told the Times, “Over time the barriers to make vaccines and stay in this business have gone up, but the prices for old vaccines haven’t gone up that much.”
The result has been a steady trickle of manufacturers exiting the influenza vaccine business. A report by the Institute of Medicine, a unit of the National Academy of Sciences, found that 30 years ago 25 companies supplied the U.S. influenza vaccine supply. This year only two companies were responsible for the majority of the supply.
In its own defense, the Bush campaign has said that funding for influenza preparedness has increased to $283 million from $39.3 million in Bill Clinton’s final year in office.
Based on statistics from the Department of Health and Human Services, this is true. This number includes influenza-related funding for the National Health Institute, the Food and Drug Administration, the Center for Disease Control, the Vaccine for Children program, and other programs.
Thus, as usual with politics, neither side is telling the complete truth. The flu vaccine shortage would appear to be less a result of bad policy than of absent policy. As the GAO has warned for years, over time fluctuating demand for the vaccine in a free market is not sufficient to ensure an adequate supply. The Sunday New York Times story laid out some solutions. One is to vaccinate every child, thus increasing the demand. Another is to charge more for the vaccines. Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, suggested that the government guarantee manufacturers that it will buy a certain amount of vaccine each year and also urged increased research into alternatives to the way the vaccine is currently produced.
All this is a complicated story — a story that centers on the convergence of public policy, economics, election-year politics and science and medicine. Just the sort of story that voters are never going to sort out by listening to the simplified, semi-hysterical rhetoric of presidential candidates.
No, for that, they need a press outlet that tracks down all the strings and then threads them together. As it stands right now, most readers and viewers looking for that from a newspaper or a magazine, much less a TV network, are flat out of luck. As a consequence, they’re just as much in the dark on the politics of the flu as the candidates themselves pretend to be.