Letter to Senator Shelby on Vaccines

Senator Richard Shelby December 13, 2005
110 Hart Senate Office Building
United States Senate
Washington, D.C. 20510

Dear Senator Shelby:

I understand that very shortly Sen. Frist intends to slip into the Defense Appropriations bill a sweeping proposal that would immunize the drug industry from liability in the event of a pandemic outbreak. This provision was not passed by either the House or the Senate, nor ever debated on either Chamber’s floor.

No industry in this country has ever received the kind of sweeping immunity contemplated in this proposal. It would let the industry completely off the hook for conduct that is grossly negligent, reckless or even intentionally harmful in developing unsafe emergency vaccines, drugs and other countermeasures. Moreover, unlike any other kind of vaccine legislation enacted previously, this proposal fails to provide any means to compensate first responders and others who may be injured by taking unsafe emergency vaccines and drugs.

The emergency vaccines, drugs and other countermeasures that are covered by this immunity law will likely receive expedited approval, meaning that they will not have gone through standard safety testing before being administered. Yet it is the lesson of history that vaccines are often unsafe, sometimes causing far more casualties than the diseases themselves caused in the first place (See attached statement from the National Association of County and City Health Officials, representing health care workers, which strongly opposes this legislation.)

To leave innocent injured victims without any recourse or protection whatsoever, especially first responders who may be required to take these vaccines before assisting others, would be gross recklessness on the part of Congress and unprecedented in our history.

Moreover, as Rep. David Weldon (R-FL), who is a medical doctor, has warned, people may decide not to get vaccinated if they know there is no recourse should they be injured by the vaccine’s side effects or hurt by a defective batch of vaccine.

The immunity advocates allege that the liability laws are obstacles to the production of vaccines. But this is untrue. There exists a wealth of evidence showing that liability concerns are not causing vaccine shortages; rather a poorly structured vaccine market is the root cause. Financing Vaccines in the 21st Century: Assuring Access and Availability, Institute of Medicine, August 2003.; Mello MM, Brennan TA, “Legal Concerns and the Influenza Vaccine Shortage,” JAMA, October 12, 2005, 294:1820; David Brown, “How U.S. Got Down to Two Makers of Flu Vaccine,” Washington Post, October 17, 2004.

This is an extremely unfair and shortsighted proposal, and is opposed by major consumer and health care organizations, including:

Alliance for Justice
American Nurses Association
American Public Health Association
Association of State & Territorial Health Officials
Center for Justice and Democracy
Council of State and Territorial Epidemiologists
Nat’l Assoc. of County and City Health Officials
Public Citizen
Trust for America’s Health
USAction
USPIRG

I urge you to oppose this dangerous proposal. Do not let the Senate give the pharmaceutical industry carte blanche to cut corners and endanger the health of millions of our nation’s citizens.

Sincerely,

Ralph Nader

PO Box 19312
Washington, DC 20036