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Flu Vaccines.. Holding the Bush Administration Accountable for its (In)Action

Back in May 2001, the General Accounting Office issued a report [FLU VACCINE: Supply Problems Heighten Need to Ensure Access for High-Risk People - Report No. GAO-01-624]. The report warned of a possible shortage in the Flu vaccine supply. It sure would have been nice if somebody at FDA had been vigilant and guard against insufficient vaccine supplies. The warnings were spelled out by an independent agency (GAO). Unfortunately, at the time the report was issued, there was no Commissioner in charge of the FDA.

Actually, there was no Commissioner of the FDA from the start of the Bush Administration (1/21/2001) through November 13, 2002. We're talking 663 days that no one was at the helm!

You would think that if there were an issue here, it would get the attention of one of the other federal health agencies. Take for instance, the CDC (Centers for Disease Control); there was no Director of the CDC from April through July 2002. And what about the NIH (National Institutes of Health). There was no NIH Director all the way out through May 2002! It seems that no one was at the wheel of the three top health agencies in this country for an incredibly long period of time. Shouldn't there be continuity at the top? Why were there across the board lack of leadership in the health sciences for the top three agencies?

Here's what at stake

Every year, some 20,000 people die from influenza (the flu) in the United States. Additionally, 110,000 people are hospitalized having the flu. The flu weakens the immune system and makes people highly susceptible to pneumonia. The combined deaths between flu and pneumonia totals 42,000 every year (on average, 800 deaths per week). The populations at high risk are senior citizens, pregnant women, and infants under the age of 1. The cost to the government to purchase a vaccine is roughly $2.50 per dose and is roughly the same cost as a cup of coffee and a muffin.

Each year, 96 million people receive a flu vaccines. This year, because of the shortage, only 48 million vaccinations is regularly available. What will be the impact in terms of lives and hospitalizations? We'll know the answer to that question this time a year from now. In effect, it is as if we are running a gigantic clinical trial. Last year we had 96 million people receiving vaccinations. This year we have only 48 million taking flu vaccines.

The bulk of the deaths arising from the flu occur during a few short months in winter as is evident by the spiking death rates in the graph below. We are rapidly approaching the spike this year without adequate vaccination supplies.

The spreadsheet file is [here] and the source data was obtained from: [http://www.cdc.gov/flu/weekly/fluactivity.htm].

Here's how it translates to lives saved or lost

The interests of the general public is not being served. Someone in the Bush Administration may want to argue that a third party supplier in England provided contaminated vaccines. Well whose job is it to police over safety and efficacy? It's called the Food and Drug Administration. The FDA is supposed to be very aggressive in testing and validation. A 50% supply of the nation's flu vaccine is a critical resource. Interestingly, it turns out that Chiron (the supplier of the vaccine) has had a checkered history. In July 2002, its Diptheria and Tetanus vaccine was recalled (http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/defmedsrepcen/chironlet.pdf). In April 2004 its Rabies vaccine was recalled (http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/defmedsrepcen/rabvac_qa_5404.pdf). Is it at all surprising that their license was suspended on October 5, 2004 because of contamination of the flu vaccine? Well, it was a surprise to the FDA. More importantly, there was no rapid contingency plan in place to deal with a 50% drop in the nation's supply (only two manufacturers provide the vaccine). It is reckless not have had a contingency plan in place.

Where does the buck stop?

The warning signs were there all along. There is a responsibility to deal with this. And were does this responsibility rest? During the second presidential debate, the President affirmed:

Mr. Bush: "And that's why the FDA and that's why the surgeon general are looking very carefully to make sure it can be done in a safe way. I've got an obligation to make sure our government does everything we can to protect you."

In a letter to health officials dated September 28, 2004, the British Chief Scientist & Director of Health Protection (the British Department of Health) issused an alert that there would be delays and problems with flu vaccines produced by Chiron. The Bush Administration and the FDA should have been on top of this right away. Another fourteen days would pass before the FDA and the Bush Administration publicly acknowledged this as an issue. Being that this occurred near the height of a highly charged election season; the fewer the number of days voters are contending with this the better (for the incumbent). But each day that the Administration swept this under the rug, the more fatalities there would be.

It would appear that the Bush Administration was looking out after its own welfare before the interests of the public. You need to decide this for yourself, but we believe this issue transcends election year politics, because the public safety may have been compromised by not disclosing bad news when it first became known.