Time to Eliminate the National Vaccine Injury Act?

[Guest guest]

Time to Eliminate the National Vaccine Injury Act?

http://www.redflagsweekly.com/conferences/vaccines/2004_nov18.html

 

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 Vaccine

Development in Developing Countries, Vaccination and World Health, FT

Cutts and PG Smith, eds. John Wiley & Sons, Chichester, 1994, p. 62

13. Businessworld. “A Dream Turned Sour,” by Gina S. Krishnan. Oct. 4,

2004.

14. 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

15. Sana Siwolop, Big Steps for Vaccine Industry