Time to Eliminate the National Vaccine Injury Act?
By Sherri Tenpenny, DO

November 18, 2004

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