Time to Eliminate the National Vaccine Injury Act?

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.


The Lancet. "Vioxx, the implosion of Merck, and aftershocks at the
FDA." Published online 11-05-04.
From the book, Built to Last : Successful Habits of Visionary
Companies, by Jim Collins and Jerry I. Porras. 1994
Ibid. The Lancet. 11-05-04.
Ibid. The Lancet. 11-05-04.
MMWR. General Recommendations on Immunization. Feb. 8, 2002 / 51
(RR02);1-36
Neurology. 2004;63:772-773, 838-842. "Hepatitis B Vaccination
Increases Multiple Sclerosis Risk."
UPI. Oct 22, 2004. "FDA 'would have' spotted flu shot problems" by
Mark Benjamin.
CDC. Update: Influenza-Associated Deaths Reported Among Children Aged
18 Years --- United States, 2003--04 Influenza Season.
(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."
CDC: Epidemiology and Prevention, The Pink Book, 6th Edition, Chapt
6: Pertussis, pg. 80-81
See Dr. Dave Weldon's letter to Dr. Julie Gerberding
3 JB Milstien, P Evans, and A Batson, Discussion on paper Vaccine
Development in Developing Countries, Vaccination and World Health, FT
Cutts and PG Smith, eds. John Wiley & Sons, Chichester, 1994, p. 62
Businessworld. "A Dream Turned Sour," by Gina S. Krishnan. Oct. 4,
2004.
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