Time to Eliminate the National Vaccine Injury Act?

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

 

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

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