CONGRESS POISED TO RUSH THROUGH SWEEPING IMMUNITY FOR POSSIBLY UNSAFE VACCINES AND OTHER DRUGS -

AMERICANS LIKELY TO BECOME HUMAN GUINEA PIGS

Center for Justice and Democracy
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New York, New York 10004
Telephone: 212-267-2801
E-Mail: centerjd@centerjd.org
Web Site: www.centerjd.org



Posted: 19 October 2005


On October 17, 2005, a new Biodefense bill will be introduced in the U.S. Senate and is expected to be pushed through the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, without hearings.

THE BILL WOULD WIPE OUT BOTH REGULATORY AND LEGAL SAFEGUARDS AGAINST CERTAIN UNSAFE VACCINES, DRUGS AND DEVICES, LEAVING THE INDUSTRY COMPLETELY OFF THE HOOK FOR HURTING AMERICAN CITIZENS

THE MASSIVE LIABILITY PROTECTION CONTAINED IN THIS BILL DOES NOTHING TO ADDRESS THE REASONS WHY THIS COUNTRY EXPERIENCES FLU VACCINE SHORTAGES

The drug industry is engaged in colossal and unjustified fear-mongering, blaming "lawsuits" and "liability" for the flu vaccine shortages in 2004. Nothing could be further from the truth. According to a 2004 Washington Post investigation,1 flu vaccine shortages are due to arcane production and supply and demand problems, not liability problems.

  1. The flu virus mutates easily, requiring new annual production. According to the Washington Post, "Generally, at least one strain each year undergoes so much mutation that it needs to be replaced by an 'updated' version in the next year's vaccine. Consequently, a new flu vaccine formula has to be drawn up each year."2
  2. The industry uses old-fashioned, risky technology. The flu vaccine is made "by injecting virus into fertilized chicken eggs. ... Each egg must be hand-inspected and hand-injected. One egg grows enough virus for 4 or 5 doses of vaccine. Millions are needed ... They have some of the risk, time pressure and uncertainty of political races and military attacks."3
  3. The market for flu vaccines faces uncertain supply and demand and a small profit margin. According to the Washington Post, "In 2001-02, 10 million doses were pitched. The next year (Wyeth's last) the number was 13 million. Last winter, despite a run on vaccine in an earlier-than-usual flu season, 4 million doses, out of 87 million made, were discarded.... The waste is particularly hard for vaccine makers to stomach because their profit margin is small.... Because much of the vaccine is bought in huge orders by government agencies, the price is low."4
  4. The industry is about to radically change its production. As the Washington Post stated, "[N]obody wants to invest hundreds of millions of dollars and five-to-seven years in building an egg-based vaccine plant when the whole industry is on the verge of switching to a radically new way of making the product.... Sometime in the next decade, flu vaccine will start to be grown in cell cultures, not eggs. It is a technology far more clean, predictable and expandable than the egg-based way of old."5

THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (JAMA) DISCOUNTED THE IMPORTANCE OF LIABILITY CONCERNS FOR CREATING VACCINE PRODUCTION PROBLEMS

Consistent with the above Washington Post investigation, a recent article in JAMA found:

THE DRUG INDUSTRY ALREADY BENEFITS FROM LIABILITY PROTECTION FOR PRODUCTION OF SEASONAL FLU VACCINES AND OTHER CHILDHOOD VACCINES

The Vaccine Injury Compensation Program (enacted under the Childhood Vaccine Injury Act of 1986) provides drug manufacturers protection from lawsuits arising out of injuries caused by vaccination, forcing injured victims into an administrative compensation program8 The Program covers the major childhood vaccines as well as the seasonal flu vaccine (this was added in 2004).9


To view the entire 88 page bill in PDF format CLICK HERE (It will open in a new window)


NOTES

  1. David Brown, "How U.S. Got Down to Two Makers Of Flu Vaccine," Washington Post, October 17, 2004),
  2. Ibid.
  3. Ibid.
  4. Ibid.
  5. Ibid.
  6. Mello MM, Brennan TA. Legal Concerns and the Influenza Vaccine Shortage. JAMA. October 12, 2005, 294: 1820.
  7. Ibid.
  8. 42 USC 300 aa-1, table can be found on-line at http://bhpr.hrsa.gov/vicp/table.htm
  9. Fact Sheet, Flu Vaccine Crisis: The Role of Liability Concerns, Office of Rep. Henry A. Waxman, Committee on Government Reform, U.S. House of Representatives, October 18, 2004.
  10. John Hanchette, Legislation to Improve Vaccine Injury Compensation Introduced, Gannett News Service, (Mar. 29, 2001)
  11. Elizabeth c. Scott, "The National Childhood Vaccine Injury Act Turns Fifteen," 56 Food Drug L.J. 351 (2001)
  12. 24 J. Health Pol. Pol'y & L. 82.
  13. Statement of the National Vaccine Information Center Co-Founder & President, Barbara Loe Fisher, September 28, 1999, House Oversight Hearing, "Compensating Vaccine Injury: Are Reforms Needed?"