Congressional Testimony: Compensating Vaccine Injuries: Are Reforms Needed

Statement of the National Vaccine Information Center
Barbara Loe Fisher, Co-founder & President
Hearing of the House Subcommittee on Criminal Justice,
Drug Policy and Human Resources
"Compensating Vaccine Injuries: Are Reforms Needed?"
September 28, 1999 

Chairman Mica and Members of the Subcommittee: 

Thank you for conducting this oversight hearing on the Vaccine Injury Compensation Program, which was created under the National Childhood Vaccine Injury Act of 1986 (PL99-660). The strength of your ongoing commitment to issues of vaccine safety and to protecting the integrity of our nation’s public health policies, is both honorable and commendable. In holding this hearing you offer hope to those families, who have directly experienced the life-shattering consequences of serious vaccine injury and death, that they will not have to continue to suffer alone because the qualities of justice, equity, charity and mercy do, in the end, prevail in our society.

The National Vaccine Information Center (NVIC) is a national, nonprofit educational organization founded in 1982 and dedicated to the prevention of vaccine injuries and deaths through public education. Our organization provides assistance to parents whose children have suffered vaccine reactions; conducts and promotes research to evaluate vaccine safety and effectiveness, including research to identify factors which place individuals at increased risk for suffering vaccine reactions; and monitors federal and state vaccine research, development, regulation, policymaking and legislation. NVIC supports the right of citizens to exercise informed consent when making educated vaccination decisions for themselves and their children.

In 1982, NVIC, then known as Dissatisfied Parents Together, was approached by Congress and the American Academy of Pediatrics (AAP) to participate in the development of legislation which would provide just and comprehensive financial assistance to vaccine injured children and their families.

The guiding tenant for parents, who agreed to help develop the law, was to institute safety reforms in the mass vaccination system that would make it safer so fewer children would be injured or killed by vaccines and thereby in need of compensation. Toward this end, safety provisions were written into the law which included mandating the development of benefit-risk information materials for parents; a centralized reporting system to collect reports of adverse events following vaccination; the duty for vaccine providers to record adverse events as well as the manufacturer and lot number in permanent medical records; and the duty of government to insure the safest possible vaccines were being produced for use by the American public.

The parent-founders of NVIC believed that they were participating in the development of a law which, in the words of Dr. Martin Smith of the AAP, would give "simple justice to children." Congress made it clear to all parties involved in the law’s development, that it intended the system to be "expeditious and fair" to vaccine victims and their families and be unlike a trial in order to provide parents with a "non-adversarial" alternative to a lawsuit against vaccine manufacturers and physicians.

This guiding principal was reiterated in the legislative history by the 1989 Amendments in which the House bill directed the U.S. Court of Claims to make revisions in order "to provide for a non-adversarial, expeditious and informal process for the resolution of petitions filed under the Program." The 1989 House and Senate Conferee Report made it clear to both DHHS and the Court that Congress was not happy with the fact that proceedings had become complicated, time-consuming and emotionally draining for petitioners and stated "The re-invention of the adversarial process will serve neither to compensate injured children nor maintain the stability of the immunization program in the U.S."

Despite attempts by Congress to direct DHHS to fulfill congressional intent, we find in retrospect more than ten years after the passage of the National Childhood Vaccine Injury Act, after years of watching three out of four vaccine injured children be turned away from the federal vaccine injury compensation program, that our faith in the justice, equity, efficacy and basic integrity of this legislative remedy was seriously misplaced.

We maintain that the spirit and intent of the law, as Congress and the public envisioned it, has not been fulfilled. In our view, the principal reason for this failure of implementation is because the Department of Health and Human Service, which was on record as opposing the passage of this legislation (as was the Department of Justice), was given too much discretionary authority in the law to change the rules for compensation after the law was passed. Through the wielding of this discretionary authority, both federal agencies have worked together to weaken the ability of vaccine injured claimants to obtain compensation. The net result has been the creation of an uneven playing field that has often turned what was supposed to be a fairer, expedited, less traumatic, less expensive, no-fault alternative to a lawsuit against vaccine manufacturers and administering physicians into a highly adversarial, lengthy, traumatic and unfair imitation of a lawsuit conducted in front of a Special Master instead of a judge and jury.

Parents of vaccine injured children, who were asked to give their support to the development and passage of the law, were assured repeatedly during the several year process that the guiding spirit behind the law was to provide an alternative mechanism to a lawsuit that would even the playing field for vaccine victims in that there would be a presumption that the vaccine caused the child’s injury or death if no other cause could be found. The emphasis was on presumption and there was recognition that this presumption, in the absence of scientific data and certainty, would be in the plaintiff’s favor even if the end result would be that a few children would be compensated who were not, in fact, vaccine injured.

This emphasis on presumption was integral to the integrity of a no-fault, expedited vaccine injury compensation system. Because of the lack of scientific data and understanding of the biological mechanism for most vaccine-associated injuries and deaths and the lack of pathological profiles to conclusively prove which health problems following vaccination are, in fact, vaccine-induced and which are not, the vacuum of scientific knowledge then and now demands that a no-fault vaccine injury compensation system must err on the side of presumption in the absence of a biologically demonstrated alternative cause.

Even so, the architects of the law knew that this presumption could by no means be arbitrary but had to be predicated on evidence in the medical literature that, when certain signs and symptoms were present following receipt of a vaccine and those signs and symptoms led to permanent injury or death, that the vaccine could be presumed to have played a role in the child’s injury or death in the absence of a biologically demonstrated alternative cause.

The mechanism to provide presumption that was agreed upon by all parties participating in the development of law was a Table of Compensable Events, known as the Vaccine Injury Table. This Vaccine Injury Table, devised after exhaustive review of vaccine medical literature and several years of discussion between American Academy of Pediatrics physicians, independent neurologists and immunologists, vaccine manufacturers and parents, was designed to remove much of the burden of proof of cause and effect that exists in a vaccine injury lawsuit. For example, the Table was intended to spell out the signs and symptoms associated with DPT vaccine reactions, which had been acknowledged in more than 60 years of medical literature, and would provide a framework to allow for a presumption of cause and effect to exist for the claimant. Therefore, the contents of the Table were made law by Congressional sponsors to ensure that the compensation process remained non-adversarial and expeditious.

The principal reason why the Vaccine Injury Compensation Program has become highly adversarial and is turning away three out of four claimants is that the Department of Health and Human Services (DHHS), with the assistance of the Department of Justice, has wielded it discretionary authority to all but eliminate a just list of compensable events in the Vaccine Injury Table, thereby destroying the guiding tenet of presumption. This action by DHHS constitutes the most egregious violation of the spirit and intent of the law and, in effect, is a fatal compromise of its integrity.

Ironically, it was the understanding of parents who participated in the development of the law that Congress granted the Secretary of DHHS broad discretionary authority to alter the Vaccine Injury Table primarily so the Secretary could expand the list of compensable events and make the system more inclusive not less inclusive. It was our understanding that the intent was to provide the Secretary with flexibility to accommodate the addition of new presumptions for injuries associated with the administration of existing and future vaccines.

However, over time, the Secretary has primarily used her discretionary authority through the regulatory process to remove compensable events from the Table sanctioned by Congress, and to redefine permanent injuries in the Aids to Interpretation long recognized by the medical community as being associated with vaccine reactions. In the words of one attorney for vaccine injured children, the Secretary’s arbitrary redefinition of the medically recognized definition of "encephalopathy" "is so restrictive that it is believed by petitioners’ counsels across this country that they will never again see an injury to a child that falls within the definition’s narrow confines."

In fact, as scientific evidence became available, which supported the existence of cause and effect with regard to DPT vaccine induced brain inflammation and encephalopathy leading to chronic brain dysfunction, as was documented in the 1994 follow-up and reanalysis of the National Childhood Encephalopathy Study published by the Institute of Medicine in 1994, the Secretary deliberately took action to remove from the Table of Compensable Events those signs and symptoms of brain inflammation and encephalopathy which would presume causation. The arbitrary and capricious redefining of encephalopathy to make it impossible for most DPT vaccine injured children to obtain awards under the Table of Compensable Events is clear evidence that DHHS has little intention of fulfilling the spirit and intent of the law.

The Secretary’s action to remove signs and conditions long recognized by the medical community as being vaccine-related has fatally compromised the system’s concept of presumption of causation and has unfairly increased the burden of proof for claimants. Again, we maintain that these actions run counter to the intent of sponsoring lawmakers, who sought to create a humane alternative to personal injury litigation through a no-fault system which presumed to err on the side of compensating, especially when there is no convincing alternative explanation for the child’s injuries.

We have reviewed the draft legislation "Vaccine Injury Compensation Program Amendments of 1999" proposed by DHHS and find it lacking in the kinds of substantive improvements required to restore the guiding spirit and intent of the law: to provide a "fair, quick and generous" federal compensation system alternative to a lawsuit for children who suffer catastrophic vaccine injury or death.

As we will explain in further detail, the changes proposed by DHHS simply tinker at the edges of what are fundamental problems inherent in the structure and administration of the Vaccine Injury Compensation Program. Resolving these problems will require strong and decisive measures from Congress.

PROPOSED REVISIONS TO THE VACCINE INJURY COMPENSATION PROGRAM

NVIC respectfully requests the Subcommittee to consider the following legislative changes to Vaccine Injury Compensation Program:

• 1. Amend the Vaccine Injury Table to return "residual seizure disorder" following administration of "DTP; P; DT; TD; or Tetanus Toxoid; or in any combination with Polio; or any Other Vaccine Containing Whole Cell Pertussis Bacteria, Extracted or Partial Cell Pertussis Bacteria, or Specific Pertussis Antigen (s)" to the Table of compensable injuries.
• 2. Amend the "Qualifications and Aids to Interpretation" of the Table to remove the current definition of "encephalopathy" and replace it with the medically sound, medically recognized definition further recognized in law through the creation of the Vaccine Injury Compensation Act (P.L. 99-660) where "encephalopathy" "means any acute or chronic significant acquired abnormality of, or injury to, or impairment of function of, the brain."

Explanation:

The vast majority (68%) of cases filed with the Vaccine Injury Compensation Program since 1988 have claimed injury following the administration of DPT vaccine. However, amendments to the Table and Aids to Interpretation, which took effect in 1995 through DHHS regulatory action, have made it all but impossible to establish a case for vaccine injury following the administration of DPT.

DPT is the most reactogenic of the childhood vaccinations due to its reliance upon the whole cell pertussis vaccine. Various controlled epidemiological studies, including the National Childhood Encephalopathy Study (NCES), have produced evidence that there is a causal relationship between the administration of DPT and subsequent brain inflammation and encephalopathy leading to chronic neurological dysfunction in previously healthy children. This fact has been confirmed by independent physician experts at the Institute of Medicine, National Academy of Sciences in published reports in 1991 and 1994.

A purified, less reactive accellular pertussis vaccine, DTaP, was licensed by the Food and Drug Administration (FDA) and recommended by the CDC and AAP for use in older children in 1991 and for infants in 1996. Although DtaP vaccine can still cause pertussis vaccine induced injury and death, studies have shown it does so at a much lower rate than DPT.

Our review of public documents including the current Center for Disease Control (CDC) "Vaccine Price List" and the National Institutes of Health (NIH ) Jordan Report for 1998, indicates that (1) despite the substantially increased risks associated with the use of DPT; (2) the ready availability of a less reactive DtaP alternative; and (3) the severely limited opportunities for federal compensation following DPT vaccine injury, the federal government is continuing to mass-purchase whole cell pertussis product in combination with Hib from Wyeth/Lederle and Connaught and is monitoring and possibly funding clinical trials involving whole cell pertussis product in combination with IPV and HBV.

The evidence of federal purchasing and pre-licensure activity would appear to disprove sworn testimony offered before the full House Committee on Government Reform on August 3, 1999 by Samuel L. Katz, M.D. representing the AAP and the Infectious Disease Society of America (IDSA) suggesting that vaccine containing whole cell pertussis is no longer administered in the United States.

As an adjunct to legislative changes to the Vaccine Injury Compensation Act, NVIC recommends to Congress the removal of the license for all whole cell pertussis vaccine products; the establishment of a moratorium on the federal purchase, distribution and use, by federal immunization grantees, of all whole cell pertussis vaccine products; and the termination of federal investment in all vaccine prelicensure activity, including clinical trials, involving whole cell pertussis product.

• 3. Add "death" to the Vaccine Injury Table as a presumptive injury of vaccination.

Explanation:

The Vaccine Injury Table, as currently amended by DHHS, places additional, unreasonable burdens upon petitioners to prove that vaccination caused the death of a child. The law should include a presumption that death within 72 hours of receipt of vaccine(s) may be causally related to vaccination unless an obvious, alternate cause of death exists (for example, death following an automobile accident).

• 4. Add to the language of the statute a requirement that deadlines be set for DHHS, Justice, the Court and plaintiff’s lawyers to expedite the compensation process with penalties attached for failing to adhere to the deadlines.

Explanation:

In the original law, Congress used the standard of "355 days" and the 1989 amendments extended that time to 18 months. The reality, however, has been that many vaccine victims have waited from three to seven years to receive compensation for their catastrophic injuries. A mechanism should be instituted to require all parties to adhere to reasonable deadlines to fulfill the law’s original intent to be an expedited alternative to a lengthy court trial.

• 5. Add to the language of the statute a requirement that plaintiff’s lawyers receive interim payments for fees and costs during the entire compensation process.

Explanation:

Salaried government physicians, administrators, lawyers and Court officials using public funds to fight vaccine injury claims are pitted against vaccine injured children and their lawyers, who do not have such funds to bring the claim. Petitioners and their lawyers do not get any financial reimbursement until the three to seven year ordeal has ended, while government and Court officials get paid a salary and have their administrative staffs and office costs paid from the trust fund all during the compensation process – no matter how long it takes. This uneven playing field needs to be leveled by removing caps on plaintiff’s expert witness fees and making interim payments for reimbursement of costs and fees to petitioner’s attorneys.

• 6. Toll the statute of limitations on all claims resulting from the administration of childhood vaccines to the age of majority.

Explanation:

The statute of limitations for filing vaccine injury claims are unreasonably brief, ranging from 2 to 3 years, even though significant vaccine injury may not be fully manifested until a child is much older. Most state law tolls statutes of limitation until a child reaches the age of majority.

Because vaccine reactions and subsequent vaccine-related chronic immune and neurological disorders are not always recognized or acknowledged by physicians, long delays can result from the time of the injury until a proper diagnosis or identification of the vaccine-related health problem occurs. Tolling to the age of majority creates a comprehensive approach to extending the statute of limitations provisions. It provides a generous and fair alternative to the hairsplitting involved in extending deadlines for varying amounts of time, as proposed by DHHS, depending upon the legal route by which a vaccine injury arrived on the Table (by statute or by regulation) and whether the injury resulted in death.

• 7. Amend regulatory language to require a return to lump-sum payments, or the removal of final "stipulation labels" from the life care plans used to determine settlement amounts and payment schedules. Require that any release of the final stipulation be accompanied by a formal statement from the Vaccine Injury Compensation Program clarifying the right of legal guardians to utilize settlement funds in the most appropriate manner on behalf of the injured individual in their care.

Explanation:

Because no one can precisely predict what the future needs of a vaccine injured child will be or what future technologies or therapies may contribute to their care, the final stipulation labels applied to settlement awards by the Compensation Program, specifying how funds must be spent on behalf of the injured child, represent the Program’s best guess of what the child will require for life. The Program tells parents that the labels will not be strictly enforced.

However, the state guardianship courts, which frequently serve as executors for the distribution of the government annuities which constitute the bulk of the award, are less flexible with respect to spending funds for purposes other than those which are explicitly prescribed by the labels. At times, families have been threatened with the possibility that settlement award checks might not be cashed if previously dispensed funds were not spent as explicitly prescribed. (For example, a parent may be prohibited under final stipulation labels to spend more on diapers every week than was originally determined by federal officials involved in negotiating terms of the child’s life care plan).

If the Program will not dispense the award as a lump-sum payment to parents as it did in the past, preferring that parents purchase federal annuities for the care of their vaccine injured children, then the final stipulation labels must be removed when it leaves

the U.S. Court of Claims or a letter must accompany the final stipulation clarifying the right of legal guardians to utilize settlement funds in the most appropriate manner on behalf of the vaccine injured child in their care.

• 8. Reiterate in the language of any planned amendments to the Act, or in official reports supporting these amendments, that the Secretary is obligated by law to confer with the Advisory Committee on Childhood Vaccines (ACCV) prior to amending the Vaccine Injury Table.
• 9. Establish in statute a mechanism to allow claimants turned down for compensation, due to previous Table changes enacted by DHHS, to re-apply to the system without prejudice.

Explanation:

The National Childhood Vaccine Injury Act provides that the ACCV shall advise the Secretary on revisions of the Vaccine Injury Table:

"(d) Role of Commission. Except with respect to a regulation recommended by the Advisory Commission on Childhood Vaccine, the Secretary may not propose a regulation under subsection (c) [changes to the Vaccine Injury Table] or any revision thereof, unless the Secretary has first provided to the Commission a copy of the proposed regulation or revision, requested recommendations and comments by the Commission, and afforded the Commission at least 90 days to make such recommendations."

42 USC Sec. 300aa-14 (d), see also 42 USC Sec. 300aa-19.

1992 ACCV meeting minutes reveal that the proposed rule, which removed shock-collapse or hypotonic-hyporesponsive collapse and residual seizure disorder following DTP vaccination from the Vaccine Injury Table, and which redefined "encephalopathy" in the Aids to Interpretation, were not provided to the Advisory Committee as required by the terms of the Act. At its March 1, 1995 meeting, the ACCV recommended that the Secretary "indefinitely postpone the effective date" of those portions of the Final Rule removing residual seizure disorder after DPT vaccination and amending the definition of encephalopathy. Despite this recommendation, the Secretary proceeded to publish the amended Final Rule.

In legislation now proposed by DHHS, the agency seeks to reduce the period of time available to ACCV for the review of proposed Table changes from 90 to 60 days. Consideration of this amendment is inappropriate until such time as the conditions described above are returned by statute to the Table and Aids to Interpretation, and the Secretary is reminded of her legal obligation to formally confer with ACCV.

• 10. Prohibit the addition of future vaccines to the Table until further scientific research is conducted into vaccine-related adverse events, including biological mechanism studies to develop pathological profiles of vaccine injury and death.

Explanation:

The addition of new vaccines to a Vaccine Injury Table, which has been seriously compromised with regard to existing vaccines such as DPT, is an added threat to the integrity of a vaccine injury compensation system already failing to win the trust of parents. If there is no longer a presumption that seizures occurring within 72 hours of a DPT shot are related to the pertussis vaccine, even though the bulk of more than six decades of medical literature describing DPT vaccine-induced brain injury involves seizures occurring within 72 hours of receipt of the vaccine, then almost no health problem following receipt of a newly licensed vaccine will be presumed to be caused by the new vaccine.

For example, hepatitis B vaccine was added to the compensation program on August 6, 1997 with only one compensable event on the Table: anaphylaxis. This, despite the fact that the medical literature is full of clinical reports of autoimmune and neurological dysfunction following hepatitis B vaccination in both children and adults. The Vaccine Adverse Events Reporting System (VAERS) also contains thousands of reports of the same kinds of chronic health problems following hepatitis B vaccination as have been reported in the medical literature. Therefore, every one of the hundreds of hepatitis B vaccine injury claims, which have been filed under the compensation program, will be required to prove causation as is required during a court trial involving a lawsuit against vaccine makers and providers.

Documents available through the NIH and the FDA show that there are more than 200 new vaccines being developed at this time, including an AIDS vaccine. Many of these vaccines in development are scheduled to be recommended for mandatory use by all children. How many children injured by these new vaccines or combinations of multiple vaccines will ever get fair treatment in the compensation program as currently structured?

Opening up the system and adding every newly licensed childhood vaccine to the compensation system will further shield vaccine manufacturers from liability for the safety of their products being sold in a stable, captive market. This two-way protection – everybody must use the product but no liability is attached to it – will further stifle any economic incentive for drug companies to improve the safety of the growing numbers of vaccines they sell to providers in the public and private sectors and will give less incentive to the CDC to review and modify "one-size-fits-all" vaccine policies to make them safer.

Recently, the FDA directed vaccine makers to remove mercury from childhood vaccines and the CDC was subsequently prompted to recommend use of hepatitis B vaccine in babies born to hepatitis B-negative mothers be suspended due to concerns about the cumulative effects of mercury exposure from vaccines in infants under six months old. The FDA also recently recommended use of the newly licensed rotavirus vaccine be suspended due to unexpected reports of bowel blockage in infants receiving the vaccine. These protective actions taken by the FDA reinforce the duty of government to ensure that the safest vaccines and public health policies are being provided to the public.

This duty, however, is again seriously hampered by the lack of well designed scientific studies to determine, precisely, the biological mechanism at the cellular and molecular level of immune and neurological system responses to vaccines. As mentioned previously this reality has been well documented (see Institute of Medicine. 1991. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: National Academy Press; and Institute of Medicine. 1994. Adverse Effects Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: National Academy Press).

In the absence of adequate scientific knowledge and until genetic and other high risk markers are established to identify and screen out high risk children from the mass vaccination system, adding new vaccines to the compensation program gives the illusion to the public that knowledge exists to conclusively determine which health problems are associated with new vaccines and which are not.

Without some provision in the compensation system for presumption of causation in the absence of scientific knowledge, there is no utility to adding new vaccines to a system that is already resisting compensating children being injured by existing vaccines (such as DPT) - unless the compensation program only exists to protect vaccine manufacturers from liability for products whose risks have not been thoroughly quantified prior to licensure.

• 11. NVIC strongly supports additional congressional appropriations for independent research into vaccine adverse events. However, funds for research must not be taken from the Vaccine Injury Compensation Fund which was created for the sole purpose of reducing the suffering of vaccine damaged children and their families.

Explanation:

The more than one billion dollars lying idle in the vaccine injury trust fund must not be used for any other purpose than that for which it was intended: to provide compensation for children suffering chronic immune and brain dysfunction following vaccination. Any other use of that money would be the ultimate betrayal of public trust of a federal vaccine injury compensation system into which parents pay a surcharge on each vaccine their children receive in order to insure that their child will receive financial assistance should a vaccine injury occur.

DHHS cannot be rewarded for fighting every vaccine injury claim by giving them the money they have withheld from vaccine injured children so they can design studies to try to disprove an association between vaccination and subsequent immune and brain dysfunction in order to defend the status quo. It is illogical to expect the same federal agency responsible for developing, licensing, regulating, making policy for and promoting the mandatory use of vaccines, which is also a hostile defendant in the vaccine injury compensation process, to be an impartial investigator of vaccine risks. Funding for independent research into vaccine-related adverse events is urgently needed but those funds should be carved out of the billions of dollars of existing congressional appropriations to the CDC and NIH currently used by DHHS for vaccine development and promotion. Congress should also give consideration to allocating a portion of DHHS annual appropriations to the FDA to strengthen this regulatory agency’s ability to maintain the highest standards for licensing of new vaccines.

The one billion dollar surplus in the trust fund should be immediately used to compensate at least a portion of the three out of four children who have been turned away from the compensation system because of changes DHHS made to the Table of Compensable Events and the remainder should be saved for future awards. If independent research eventually reveals that there is a causal connection between use of multiple vaccines in early childhood and subsequent development of such chronic disorders as learning disabilities, attention deficit disorder, asthma, autism, diabetes, chronic fatigue syndrome and other serious health problems, the one billion dollar surplus in the system will not begin to be enough to care for these children. The addition of an AIDS vaccine alone in the future could break the system.

Consequently, NVIC opposes legislative proposals to reduce the excise tax on vaccines which subsidizes the vaccine injury compensation trust fund.

• 12. Add to the list of Omnibus Budget Reform Act (OBRA ’93) requirements for providers participating in the Vaccines for Children a reporting requirement where, for any vaccine reaction experienced by the patient of a VFC provider participant, a report must be made to the Vaccine Adverse Event Reporting System (VAERS).

Explanation:

Adverse reactions to vaccines are systematically and seriously underreported by clinicians to federal authorities. If the rate of reporting of vaccine-related health problems mirrors that of reporting of adverse events following administration of prescription drugs, less than one percent of all adverse events following vaccination may be reported by physicians to VAERS (as estimated by former FDA Commissioner David Kessler, 1993, Journal of the American Medical Association).

Currently VAERS receives 11,000-12,000 reports annually. Of these, VAERS officials state that only 15% are considered "serious," such as a trip to the emergency room, a life threatening episode, hospitalization or permanent disability. (However, independent analysis of VAERS reports reveals that 1 in 3 adverse events following hepatitis B vaccination is "serious." For children under age 14, one in two hepatitis B vaccine-related adverse events fall into this serious category).

If only one percent of all physicians actually report vaccine-related adverse events, then there could be more than 1.2 million vaccine-related adverse events occurring every year in America instead of the 12,000 reported.

Through October of 1997, the National Immunization Program (NIP) had received applications for enrollment from almost 46,000 sites, many of them physician group practices, who intended to participate in the receipt and administration of publicly purchased vaccine through the Vaccines for Children (VFC) program.

OBRA ‘93 imposes requirements on VFC providers including: screening patients for VFC eligibility, maintaining records on VFC eligibility, making these records available to state and federal government upon request, complying with the recommended immunization schedule of the ACIP, complying with the DHHS cap for the state in imposing fees for the administration of vaccine, not charging for vaccine supplied through VFC, and not denying service based upon an inability to pay the vaccine administration fee. In compliance with the safety provisions of the National Childhood Vaccine Injury Act, providers must also provide patients with vaccine information statements developed by the CDC.

While PL99-660 created the current mechanism for reporting adverse vaccine reactions, VFC providers are not currently required to report to VAERS as a condition of enrollment. With this simple amendment to the statute, vaccine adverse event reporting by clinicians may be significantly improved. It was VAERS reporting data and the effective monitoring of that data by FDA officials that resulted in the protective suspension of rotavirus vaccine use after an unexpectedly high number of reports of bowel obstruction following receipt of that new vaccine.

COMMENTS ON THE DRAFT DHHS PROPOSAL, "VACCINE INJURY COMPENSATION PROGRAM AMENDMENTS OF 1999"

As previously indicated, amendments to the Act proposed by DHHS simply tinker superficially with the mechanics of what are serious, fundamental problems inherent in the structure and administration of the vaccine injury compensation program. Resolving these problems will require the enactment of a comprehensive remedy by Congress. Our comments on selected DHHS amendments follow:

• Administrative Revision of Vaccine Injury Table.

NVIC opposes the proposed shortening of the public comment period, maintaining that it is the federal government’s responsibility to ensure the broadest opportunities for public participation in all matters involving the mandatory use of government-endorsed biological products which carry a risk of injury or death. NVIC opposes the proposed shortening in the period for ACCV review for reasons previously outlined.

• Clarification of When Injury is Caused by Factor Unrelated to Administration of Vaccine.

NVIC strongly opposes the proposed clarification by DHHS intended to exclude vaccine damaged children from eligibility for compensation where genetic factors played a role in vaccine reactions. Adoption of this kind of language will fatally compromise an already broken system by excluding from compensation those children for whom genetic differences are potentially the only reason why they respond adversely to vaccines. In the absence of appropriate research to identify and exclude children genetically or otherwise at high risk for suffering vaccine injury from the mass vaccination system, all children suffering chronic immune or brain dysfunction following vaccination should be entitled to compensation regardless of whether intrinsic genetic differences played a role in their vaccine-related health problem.

SUMMARY

The National Childhood Vaccine Injury Act of 1986 could be viewed as a three-legged stool, intended by Congress to protect the vaccine supply through the protection of vaccine manufacturers from first-line liability; to stabilize the operation of the mass vaccination system; and to provide fair, expedited compensation for children who suffer vaccine injury while instituting safety reforms in the mass vaccination system to help prevent vaccine injuries and deaths.

The Act has been highly successful in furthering the first two objectives: protecting the vaccine supply and supporting the operation of the mass vaccination system. However, the third leg of the stool, the compensation and safety provisions of the law, is badly damaged and threatens to topple the entire mass vaccination system if Congress fails to repair the damage. This testimony concentrates on key issues regarding the compensation portion of the law and is a starting place for discussion of potential legislative remedies. There are also serious flaws in the implementation of the safety provisions in the law which hopefully will be examined at a future congressional hearing.

There is bitter disappointment and pervasive unhappiness among parents and the plaintiff’s bar with the current structure and administration of the vaccine injury compensation program of the law. Public opposition to forced vaccination with multiple vaccines in the absence of adequate scientific evidence documenting vaccine safety and effectiveness is growing. The failure to adequately communicate what medical science does and does not know about vaccine risks is perceived by parents as a fundamental betrayal of trust when a beloved child is injured or dies after suffering vaccine reactions. Then, when parents of vaccine injured children are unable to obtain financial assistance to care for a severely vaccine injured child, public faith in the mass vaccination system is further eroded.

US public health officials have endorsed a public policy of not only recommending but requiring by law that its youngest citizens use biological products which carry an inherent risk of injury or death. No matter how great or small that risk may be, there exists a moral imperative to care for those who may well have paid with their lives for that policy. To do any less is to fail as a society to be either just or humane.

Thank you, Mr. Chairman and Members of the Subcommittee, for your attention to this important public health issue.