Time to Eliminate the National Vaccine Injury Act?
By Sherri Tenpenny, DO
November 18, 2004
www.nmaseminars.com
The most recent drug debacle surrounding Vioxx lays bare the irresponsible
actions of Merck. The FDA estimates that more than
27,000 cases of acute myocardial infarction and sudden cardiac death occurred in
the USA between 1999 and 2003 due to Vioxx. [1] Could
this be a direct result of Merck changing its core values from "People above
Profits" [2] to "profits above all else"? Already feeling the economic hit as
stock values tumble, more bloodletting is bound to follow as the lawsuits filed
against Merck start pouring in. Merck's likely
litigation bill is targeted to be a staggering US$10-15billion.[3]
Highlights from a recent editorial in the Lancet [4] regarding Merck
and the FDA include the following statements:
"[the Vioxx issue] points to astonishing failures in Merck's internal systems
of post-marketing surveillance, as well as lethal weaknesses in the Food and
Drug Administration's regulatory oversight."
"But, too often, the FDA sees and continues to see the pharmaceutical industry
as its customer-a vital source of funding for its activities-and not as a sector
of society in need of strong regulation."
"For with Vioxx, Merck and the FDA acted out of ruthless, short-sighted
and irresponsible self-interest."
Merck certainly should be held accountable for its actions, which includes a
multi-year cover-up of known dangers regarding its high dollar-producing drug,
Vioxx. Hopefully, the ensuing punitive damages will send a chilling message to
all drug manufacturers, putting them on notice that cover-ups are eventually
uncovered, and profits gained deceptively are ultimately lost.
But what about being held responsible for cover ups and damages caused by other
products? Shouldn't Merck, along with other vaccine manufacturers, be held
accountable for damages caused by vaccines?
Admittedly, vaccines are known to have problems. The CDC's introductory
statement regarding the general use of vaccines states, "[Both] benefits and
risks are associated with using all immunobiologics. No vaccine is completely
safe nor 100% effective." [5] But is admitting that vaccines have problems justification for continuing
to use a vaccine shown to be associated with serious consequences?
Case in point: It has been estimated that the hepatitis B vaccine is associated
with a threefold increase in the incidence of MS within the three years
following vaccination. [6] Merck, the vaccine's manufacturer, must be acutely
aware of this study.
Or, is imperfection a justification for careless execution?
Case in point: This year's flu vaccine was found to be contaminated with the
bacteria, Serratia marcescens. And there is evidence to suggest that last year's
flu vaccine may also have been contaminated and passed on to the general public.
[7, 8]
Or, is the real reason that vaccine manufacturers appear unconcerned about
vaccine injuries due to the protection conferred by the National Vaccine Injury
Compensation Act (NVICA)?
The NVICA, a "no-fault" compensation system, was passed in 1986 to shield the
pharmaceutical industry from civil litigation due to problems associated with
vaccines. Under the law, families of vaccine-injured persons are required to
file a petition which may be heard by a Special Master in the vaccine court.
Successful claims are paid from a Trust Fund that is managed by the Department
of Health and Human Services, with Justice Department attorneys acting as the
legal representatives of the Fund. Sadly, it is estimated that less than 25% of
those who qualify for a hearing actually receive compensation.
Processing a claim through the vaccine court can take up to 10 years. In the
end, no blame or culpability is assigned and most families are denied of much
needed financial relief. In the mean time, medical bills pile up, the daily
potential for more children to be harmed goes on and the heartbreak continues,
all due to government legislated protection of products that are believed by
many to be the "sterling backbones" of our country's public health policy.
Who can parents and vaccine-injured adults hold accountable for injuries caused
by vaccines? The system is designed so that no one-neither a person nor an
entity-can be tagged with accountability: Not the vaccine manufacturer; not the
doctor who recommended the vaccines nor the person who administered them; not
the members of the Advisory Committee of Immunization Practices (ACIP) who added
the vaccine to the pediatric schedule; not the IOM members (Institute of
Medicine) who perpetuate the mantra "vaccines are safe and effective" and
stonewall opportunities for change and improvement. No one is to blame, that is,
except the "defective child" who could not tolerate the immunological onslaught
caused by the vaccines.
It may seem inconceivable that decision makers and people in a position of power
would take such a dubious position, but note the following, directly from the
CDC:
"There is no distinct syndrome from vaccine administration, and therefore, many
temporally [9] associated adverse events probably represent background illness
rather than illness caused by the vaccine..the DTP may stimulate or precipitate
inevitable symptoms of underlying central nervous system disorders, such as
seizures, infantile spasms, epilepsy or SIDS..A study of infantile spasms in
England showed that receipt of DTP or DT was not causally related to infantile
spasms, but the receipt [of the vaccine] may trigger onset in children in whom
the disorder is destined to develop. By chance alone, some cases of SIDS and
infantile spasms can be temporally related to the recent receipt of DTP or DT."
[10]
In other words, the CDC is suggesting that complications such as SIDS were going
to happen anyway. The problem was not induced by the vaccine; the problem lies
within the defective child.
A cursory review of package inserts will show that dispensed drugs contain a
long list of potential side effects and complications. Ordinarily, if one of
those complications becomes pervasive, the FDA initiates a product recall. The
company is then held responsible for the injuries caused by its product. Case in
point: Merck's imminent punishment regarding Vioxx.
Why, then, shouldn't vaccine manufacturers, including Merck, also be held
accountable for damages caused by their products? Why does a law exist that
excuses the pharmaceutical industry from accountability-and direct liability-for
one of its most widely used products? Why does it appear that vaccine "studies"
alone are allowed to distort data, perpetuate outright lies, and create
cover-ups such as those that have been uncovered regarding Vioxx and other
drugs? [11]
We must take bold steps to stop the damage that is being done to our children.
We must seriously reconsider any public health policy that includes blithely
injecting children with questionable solutions loaded with viruses, toxic
chemicals, and particles from bacteria. We must examine whether these
concoctions are truly "essential" and "good" for us. We must investigate whether
the beneficiary of vaccine brews are really the children, or more likely, the
vaccine manufacturers.
The pharmaceutical industry claims that vaccines are "not profitable." But the
truth is that annual vaccine sales have gone from approximately $2 billion in
1982 [12] to an estimated $8 billion in 2003 [13] . While still only a fraction
of the $337.3 billion in sales for the entire pharmaceutical industry, [14] the
vaccine market is projected to increase 12% per year. [15] Vaccine development
enjoys double-digit growth in part due to government protection from product
liability.
Merck is being taken to task for injuries caused by Vioxx. Likewise, the vaccine
manufacturers must be made to answer for injuries associated with vaccines.
Being held accountable for heart attacks is no different than being held
accountable for vaccine injuries. Substantial evidence demonstrates that, for
many children, more harm than good is being caused by vaccines. Now is the time
for the Trial Lawyer Association and elected officials to step up to the plate
and reexamine, revamp and perhaps even repeal, the National Vaccine Injury Act
of 1986.
1. The Lancet. "Vioxx, the implosion of Merck, and
aftershocks at the FDA." Published online 11-05-04.
2. From the book, Built to Last : Successful Habits of
Visionary Companies, by Jim Collins and Jerry I. Porras. 1994
3. Ibid. The Lancet. 11-05-04.
4. Ibid. The Lancet. 11-05-04.
5. MMWR. General Recommendations on Immunization. Feb.
8, 2002 / 51(RR02);1-36
6. Neurology. 2004;63:772-773, 838-842. "Hepatitis B
Vaccination Increases Multiple Sclerosis Risk."
7. UPI. Oct 22, 2004. "FDA 'would have' spotted flu
shot problems" by Mark Benjamin.
8. CDC. Update: Influenza-Associated Deaths Reported
Among Children Aged <18 Years --- United States, 2003--04 Influenza Season.
9. (Partial) definition of "temporal" from Webster's
New World Dictionary and Thesaurus: "chronologic, historical, in sequence,
according to chronology, in the order of time, sequential, successive."
10. CDC: Epidemiology and Prevention, The Pink Book,
6th Edition, Chapt 6: Pertussis, pg. 80-81
11. See Dr. Dave Weldon's letter to Dr. Julie
Gerberding
12. 3 JB Milstien, P Evans, and A Batson, Discussion
on paper
13. Vaccine Development in Developing Countries,
Vaccination and World Health, FT Cutts and PG Smith, eds. John Wiley & Sons,
Chichester, 1994, p. 62
14. Businessworld. "A Dream Turned Sour," by Gina S.
Krishnan. Oct. 4, 2004.
15. SN Glass, A Batson, and R Levine, Issues Paper:
Accelerating New Vaccines, paper written for the Global Alliance for Vaccines
and Immunization Financing Task Force, 2001 Sana Siwolop, Big Steps for Vaccine
Industry