- Congress Poised To Rush Through Sweeping Immunity For
Possibly Unsafe Vaccines And Other Drugs
- Americans Likely To Become Human Guinea Pigs
- 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 HARMING 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,
- * 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
- * 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
- * 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 MASSIVE LIABILITY PROTECTION CONTAINED IN THIS BILL
DOES NOTHING TO ADDRESS THE REASONS WHY THIS COUNTRY EXPERIENCES FLU VACCINE
- 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.
- * 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
- * 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
- * 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 muuch of the vaccine
is bought in huge orders by government agencies, the price is low."
- * 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."
- THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (JAMA)
DISCOUNTED THE IMPORTANCE OF LIABILITY CONCERNS FOR CREATING VACCINE PRODUCTION
- 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."
- * "[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."
- 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
- * 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
- 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 Â§ 300 aa-1, table can be found on-line
- 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?"
- Center for Justice and Democracy
- 80 Broad Street, Suite 1600
- New York, New York 10004