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Project on Government Oversight

POGO letter to DHHS Secretary Sebelius: Greater transparency in the flu vaccine program is urgently needed

Related Content: Pandemic Flu Vaccine
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August 26, 2009 | By: Ned Feder, M.D.

To Kathleen.Sebelius@hhs.gov 
and by fax to 202-690-7203

The Honorable Kathleen Sebelius
Secretary, U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, D.C. 20201

Subject: Greater transparency in the flu vaccine program is urgently needed

Dear Secretary Sebelius:

We are writing again to request that you deal quickly with a pressing issue: ensuring full transparency in the government's program for producing H1N1 swine flu vaccine. While recognizing the demands of your time‑consuming focus on health care legislation, we nonetheless believe that the need for greater transparency in the vaccine program is urgent enough to require your prompt attention.

Vaccine will almost certainly be in short supply during the next few months of the flu pandemic. You and other government leaders must soon deal with those who demand vaccine but are not eligible to get it. If, for reasons outlined below, the planned supply of vaccine is interrupted, the problem of unmet demand for vaccine will worsen, and it could become a crisis. For this reason, the possibility of a severe vaccine shortage should be faced now. You and other senior members of DHHS should, at the very least, discuss this possibility frankly and openly.

In our July 20 letter to you, with its accompanying Commentary,[1] we urged you to deal promptly with the current lack of full transparency in the flu vaccine program. Specifically, we asked that you direct DHHS employees to post a broad range of information about flu vaccine production, information that is otherwise difficult or impossible to obtain from online government sites. This includes information about: 

  • Contracts as well as performance evaluations of contractors 
  • Pursuit of alternative vaccines
  • Foreign sources of vaccines for domestic use in the U.S. 

Over a year ago the Project On Government Oversight, concerned about the lack of transparency in the flu vaccine program, raised precisely these points (and others) in its report of March 2008, Pandemic Flu: Lack of Leadership and Disclosure Plague Vaccine Program. [2] A series of POGO documents – its report of March 2008, two follow-up documents [3] in 2008, another [4] in April 2009, and our Commentary and letter to you last month – cover many topics for which full disclosure is overdue. The then‑Secretary of DHHS, Mike Leavitt, ignored our request to seek the very same goals – full transparency, full disclosure – that we are now urging on you. Whatever the reasons for his failure to act, a likely result is an impaired ability by DHHS to ensure that enough swine flu vaccine is available to the public during the current pandemic. The vaccine shortages that are likely in the next few months can be traced in part to the failures, past and present, to disclose details of the government's planning for vaccine production. We urge you and your associates, with this in mind, to read our report of March 2008 and our Commentary of July 20, 2009.

The Associated Press, in a recent article entitled "Fight for swine flu vaccine could get ugly," cited flu experts who expressed concern about international competition for limited supplies of vaccine and added: 

Public health officials are aware that so-called "vaccine wars" might break out if the swine-flu outbreak worsens, but are loath to even discuss the topic. [5]

Loath to discuss the topic! These public health officials – the AP is presumably referring here to your own officials in DHHS – won't talk with journalists, evidently because the facts will alarm the public, as indeed they may. We think that you should be concerned about these efforts within your agency to shield the public from an unpleasant truth. Disclosing the truth right now is better than doing so later, during a crisis, when a vaccine shortage and its causes will become impossible to conceal.

The U.S. public may be the loser in a "vaccine war" if the government's current optimistic plans for importing most of its vaccine fall apart. Michael Osterholm is one of the U.S.'s best-known non‑governmental public health experts on pandemic influenza. According to the AP article, Osterholm said that about 80 percent of the United States' pandemic vaccine supply will be coming from abroad. He added:

If there is severe disease, countries will want to hang onto the vaccine for their own citizens. . . . It's easy to move vaccine around if the disease is relatively mild. But if it is more severe, countries may not be willing to let it go.

It's a gamble. If swine flu remains a disease no more severe than the usual seasonal flu (about 30 or 40 thousand deaths per year in the U.S.), the federal government may be able to obtain the vaccine it needs – most of it from foreign suppliers. In that case, the DHHS may get away with its current policy of selective disclosure. But what if death rates go up, and the shipment of promised vaccine from abroad is blocked by foreign governments? Our government's failure to level with the public by disclosing and explaining this possibility in advance will not quickly be forgiven or forgotten by a public already mistrustful of government pronouncements. Government leadership will be weakened in a time of crisis, when it's most needed.

Even if this country weathers the storm during the swine flu pandemic, other epidemics undoubtedly lie ahead. In the SARS outbreak of 2002-2003, about 10% of those infected died; in human cases of H5N1 avian flu, about half of those infected during the past few years have died. This country, as well as the rest of the world, needs to be ready for outbreaks of viral infections that are both highly contagious and deadly. This will require the capacity for quick, large‑scale manufacture of vaccines against newly emerging viruses.

The government's planning for flu vaccine production in a pandemic was flawed, and the public will soon suffer the consequences, which could be either minor or severe, depending on unpredictable events beyond anyone's control. The shortcomings of plans made by the government in the past should be displayed, not hidden, so that they the same mistakes won't be repeated. In addition, it is not too late to correct or ameliorate some of the current problems in vaccine production.

We hope that you agree with us on the urgent need for full transparency in the swine flu vaccine program.

We propose a meeting with you and your associates to discuss this important issue.

Sincerely,

Danielle Brian
Executive Director
Project On Government Oversight

Ned Feder, M.D.
Staff Scientist
Project On Government Oversight
1100 G Street, NW
Washington, DC 20005
Phone: 202-347-1122
Fax: 202-347-1116
nfeder@pogo.org

Attachments:
Letter of July 20, 2009 from Danielle Brian to Secretary Sebelius
Commentary of July 20 by Ned Feder



1.   A copy of the letter and the Commentary ("Flu Vaccine Shortage? The Whole Truth, Please") are attached to this letter.

2.  Released on March 6, 2008, at http://www.pogo.org/pogo-files/reports/public-health/pandemic-flu-vaccine-program/pandemic-flu-vaccine-program.html

3.  April 6, 2008. We sent a message on the need for full transparency to Secretary Leavitt through his online blog. There was no response.

See http://archive.hhs.gov/secretarysblog/my_weblog/2008/03/pandemic-exerci.html  http://www.pogoarchives.org/m/ph/secretarysblog-20080320.pdf   

June 2, 2008,  an article in Federal Times. We again called on Secretary Leavitt to take action, again without apparent effect. See http://www.federaltimes.com/index.php?S=3555398  http://pogoarchives.org/m/science/flu-vaccine/panflu-federaltimes-20080601.pdf

4.  April 28, 2009, "Pandemic Flu Threat Raises Question: Is U.S. Ready to Protect the Public?" posted on POGO's website at http://www.pogo.org/pogo-files/alerts/public-health/ph-pfv-20090428.html  

5.  The AP story by Maria Cheng was posted on July 16, 2009, at http://www.mercurynews.com/nationworld/ci_12850495 as well as on many other sites. Most of these printed “loathe” instead of “loath” as above.

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