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

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 Biodefense bill, likely written at the behest of drug and health industry lobbyists, basically eradicates regulatory safeguards against the production of unsafe vaccines, drugs and devices that the government determines to be for pandemic, epidemic or bioterrorism/security countermeasure use, and then wipes out liability for any drug company or health care provider that makes or dispenses them. It does so by:
  
  • Allowing accelerated approval of a drug, biological product, device or research tool that the government determines to be a national security or pandemic priority, severely weakening the normal safeguards that prevent unsafe vaccines, drugs and medical devices from reaching consumers, and,
    
  • Creating an exclusive federal cause of action against the manufacturer or health care provider of such vaccines, preempting all state products liability law, then taking away the right to bring these federal claims.
    
• As a result, families of patients who are killed or injured due to a defective or dangerous vaccine, drugs or devices that fit within this category will have no recourse, no ability to file a claim or lawsuit, no way to collect any compensation even if the drug company or health care provider was negligent, reckless or in some cases intentionally harmful.
  
• This legislation would remove all financial accountability for the drug industry that produces these vaccines, drugs and devices, removing the financial incentive they have to produce only safe products.
  
• This bill would be a massive intrusion into state law, pandering to the drug industry with provisions that also include eliminating anti-trust laws, and imposed without a single public hearing.

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

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

• "There are ample reasons to suspect that flu vaccine is not an attractive product to drug manufacturers quite apart from liability concerns."⁶
  
• [T]he historical record provides cause for skepticism that liability relief alone will prevent another flu vaccine shortage... These shortages likely resulted primarily from factors other than litigation costs, as did the flu vaccine crisis."⁷

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

• Since its conception almost 20 years ago, an average of 75 percent of claims are denied.¹⁰
  
• Many of these claims are denied after long and contentious legal battles taking an average of 7 years to be resolved.¹¹
  
• Attorneys are less likely to take on vaccine injury cases due to these bureaucratic and political hurdles.¹²
  
• The Fund is designed so that the Department of Health and Human Services may unilaterally tighten the restrictions on claimants. In 1995, DHHS changed the burdens of proof so drastically that claims went from being paid in one out of three cases to one out of seven.¹³

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?"