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The Committee on Energy and Commerce

2125 Rayburn House Office Buliding

United States House

Washington, DC 20515 

RE:  Opposition to HR-5282 and S-2053 

Honorable Chairman Bilirakis and Members of the Committee,  

James Greenwood (R-PA) recently introduced HR 5282 into the House of Representatives as a  companion bill to S2053¾a bill orginally introduced in the senate by Bill Frist (R-TN) as the  “Improved Vaccine Affordability and Availability Act.“  Vaccine legislation typically enjoys wide bi-partisan support...one would be hard-pressed to question an effort that provides affordable and available vaccines.  Unfortunately, that is not the case with these current pieces of legislation.  They are using the concerns brought on by the recent shortages of vaccines as a guise to increase the already unprecidented protection afforded to the pharmaecutical industry by the Vaccine Injury and Compensation Act of 1988.       

In recent statements made by Senator Frist on the senate floor, the purpose of his legislation is twofold; to increase vaccine availabilty and prevent a re-occurance of the recent vaccine shortages, and to improve and clarify the vaccine injury compensation program.  But why in an era where vaccines have enjoyed an unprecedentded expansion would we have need for such a bill to prevent shortages?  A glance back just a few years gives us insight into the cause of these “vaccine shortages“ and the real motivation behind the Frist and Greenwood initiative. 

In 1988, the Vaccine Injury Compensation Program was established and funded by an excise tax placed on every dose of vaccine purchased.  This program was intended to provide appropriate and swift compensation to children injured by vaccines while affording vaccine manufacturers some relief from the uncertainities of civil litigation. Although supporters of the Frist and Greenwood Bills claim that intervention is needed to address concerns over the vaccine supply, the problems that occurred are a result of long overdue FDA enforcement actions concerning violations of good manufacturing practices.  They are not the result of deficiencies in the compensation program, but complacency on the part of the manufacturers for the production and distribution of their products. 

This is evidenced by recent FDA sanctions against numerous vaccine manufacturers. Production of four injectable products, including Diptheria/Tetanus and Flu vaccines manufactured by Wyeth, were haulted in December of 1999 while the facility underwent manufacturing process improvements.  According to June 19^th, 2000 issue of the Pink Sheet, the FDA seized vaccines manufactured by Wyeth citing “good manufacturing practice violations that rendered the product “adulturated“ and called into question the assurance of sterility. In October of 2000, they were fined 30 million dollars for manufacturing problems.  Ultimately Wyeth decided to leave the market rather than comply with the recommendation that it upgrade its facility and manufacturing processes.  

In 2001, Merck was cited for numerous quality control problems at a facility which manufactures several important infant vaccines, including Measles, Mumps, Rubella, as well as the Chicken Pox vaccines.  These included improperly performed procedures for sterility, testing and documentation, among other citations. The facility was closed for six weeks.   

Another vaccine that was recently introduced into the market topped sales charts for all new pharmaceuticals in 2000. At $232 per series, Prevnar pulled in $461 billion in sales for its first year. This vaccine has also been in short supply from what the manufacturer has described as “demand being greater than anticipated.“ When the vaccine was recommended by the CDC for every child born in the US, it is difficult to understand how the manufacturer could be unprepared for such demand.  This is akin to McDonalds running out of hamburgers!    

These failures by individual vaccine manufactures pale in comparison to the FDA‘s 1999 announcement that infants who received multiple vaccines containing Thimerosal, a mercury-based preservative, exceeded federal safety guidelines for allowable mercury exposure.  Mercury is a well known neurotoxic metal that is especially damaging to the developing fetus, infants and children. Although the FDA had recognized that Thimerosal was toxic (as documented in the Federal Register, Vol 47 No. 2, January 5, 1982) and called for its elimination in over-the-counter products, somehow it was allowed to remain in infant vaccines. 

It was not until 1999, under the requirements of the FDA’s Modernization Act, that the government agency publicly acknowledged that Thimerosal should be eliminated from infant vaccines.  Thimerosal was utilized in multi-dose vials of vaccines to prevent bacterial contamination from repeated punctures into the vial.  An alternative would have been to package vaccines in single-dose vials (which would eliminate the need for a preservative) or to use other approved mercury-free preservatives. 

With the expansion of the early childhood vaccine schedule during the late 1980‘s and early 1990‘s to include the Hepatitis B and Hemophilus Influenza B vaccines, infant exposure to mercury essentially tripled.  Since that time, a national epidemic has unfolded¾thousands of children now suffer from ADD/ADHD, speech and language delays, and other neurodevelopmental delays.  In fact, an investigation conducted by the CDC in over 100,000 children utilizing the Vaccine Safety Database, found “statistically significant“ associations between the development of these disorders and Thimerosal exposure during the first six months of life. In July 2001, the Institute of Medicine determined that it was “biologically plausible“ that infant exposure to Thimerosal could result in adverse neurodevelopmental outcomes. They then  called for extensive research and investigations.  

With awareness that infants were exposed to mercury in their vaccines, clinicians have recently identified children whose development regressed after exposure to these vaccines. They reported finding elevated levels of mercury in these children and symptoms consistent with that of mercury toxicity (IOM, Immunization Safety Review Committee, Public Meeting July 16, 2001, Thimerosal Containing Vaccines and Neurodevelopmental Outcomes).  Because mercury toxicty is insidious in onset and there was no awareness that infants had been exposed to mercury from infant vaccines prior to 1999, the etilogy of their disability went unexplained for years.  In fact, many were misdiagnosed with PDD-NOS (Pervasive Developmental Disorder-Not Otherwise Specified)...a form of autism.  Since the statute of limitations to file for compensation under the Vaccine Compensation Program is three years after the administration of the vaccine the ability to file a claim has already elapsed in many cases which has resulted in these cases being filed in civil court. 

This brings us to the second goal of the Frist Bill: to improve and clarify the Vaccine Injury Compensation Program. The original intent of this program, as outlined by Congress, was a no-fault expidited alternative to lawsuits that would provide “simple justice for children.“  It was never meant to prevent a parent from filing a civil suit for damages, but to offer an easier alternative. The Frist Bill is in direct conflict with the initial intent of the program and gives immunity, unprecedented under American law, to the vaccine manufacturers who utilized Thimerosal as a means to decrease production costs and increase profits.  Under the current compensation program a parent may turn down an award or exhaust their appeals and still be able to file civil case.  Under the Frist bill this door is permanently closed for being able to file a civil case, which was never the orginal intent of the program. These bills also extinguish parental claims and preclude any equitable relief such as scientific studies and medical monitoring for children exposed and injured by vaccines and Thimerosal.    

The American public and its representative Senators and Congressman need to be aware of the facts and motivation behind the Frist and Greenwood bills.  

The vaccine industry has a long history of increasing regulatory compliance issues and has known for years that their products contained a dangerous amount of mercury. Still they failed to act. These bills sacrifice our children’s welfare and the future of this country...all for the sake of protecting the vaccine manufacturers. Why? The tobacco industry, after years of denial, is now paying restitution to those who were affected.  Why do we not have the same requirements for the vaccine industry when they knowingly exposed children to the second most poisonous substance on earth?    

 Lyn Redwood RN, MSN

(Parent of a mercury poisoned child)

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