Congressional Report Documents Federal Regulatory Failure on Mercury in Vaccines, Confirms Parents' Fears over Thimerosal Role in Autism

5/6/2003

From: Lyn Redwood of Safe Minds, 404-932-1786

CRANFORD, NJ, May 6 -- Parent advocates welcomed the report just issued by the US House of Representatives Committee on Government Reform, Mercury in Medicines: Taking Unnecessary Risks. The report documents in chilling detail how the Centers for Disease Control (CDC) and the Food & Drug Administration (FDA), the two agencies most responsible for insuring the safety of childhood vaccines, failed parents and the public over use of mercury in vaccines. Citing widespread regulatory "failures" and "philosophical conflicts" over thimerosal at these agencies that spanned decades, the Congressional report confirmed the assertions by Safe Minds and other parent groups that thimerosal in vaccines has likely caused neurological damage to thousands of children.

Mercury, a known neurotoxin, was the active ingredient in thimerosal, a preservative routinely added to many infant vaccines since the 1930s. After Congressional prodding, industry slowly removed thimerosal from 1999 to 2002 from the scheduled infant vaccines, yet a few vaccines given to infants and pregnant women, such as influenza and diphtheria-tetanus vaccines, still contain thimerosal. Citing lack of evidence of harm, the FDA has never banned thimerosal and CDC has never given preference to thimerosal-free vaccines.

"The Congressional report on mercury in medicines paints a completely different picture of thimerosal's safety than what FDA, CDC, and industry have told the American public," said Lyn Redwood, RN, president of Safe Minds and parent of an autistic child. "The investigation reveals massive evidence from the 1930s and reaching into the 1990s that both industry and government were well aware of the dangerous effects of vaccine mercury. For example, the report cites an industry research document from 1935 that found thimerosal "unsatisfactory" for use in dogs -- yet the FDA is insisting that thimerosal is okay for our children."

The Government Reform Committee report specifically condemned the FDA's failure to undertake safety studies even as scientific data on thimerosal's toxicity mounted. Equally disturbing, the report asks, given the current knowledge on mercury's dangers, how the FDA could have approved two new infant vaccines with thimerosal in the early 1990s, the Hepatitis B and the Haemophilus influenzae B vaccines. These two additions effectively tripled the mercury dose of infants in this country resulting in exposure levels that were 125 times EPA's Federal safety guidelines.

"By law, 42 USC 262(a)(2)(B)(i)(I), FDA must affirmatively find that a proposed vaccine is both safe and effective before licensing its use," points out Sallie Bernard, Safe Minds Executive Director. "The Congressional investigation was very thorough yet they were unable to find even a single study, submitted by industry or independently required or performed by FDA, that proved vaccine mercury was safe at the levels mandated by CDC. We feel that statutory laws may have been violated and we hope that the Government Reform Committee takes the next logical step of demanding a judicial investigation of FDA."

The report suggested that vaccine and thimerosal manufacturers may have withheld important studies from the FDA. Added Redwood, "It is clear that any judicial review of FDA needs to also consider the extent to which some companies may have documented thimerosal's toxicity but did not inform the regulatory agencies, which if true is also against the law."

Findings in the Congressional report indicate that swift and decisive action is needed by Congress in many areas of deep concern to parents of vaccine-injured children.

-- The restrictions in the Vaccine Injury Compensation Program that say claims for compensation must be filed within three years from first symptom must be entirely eliminated. Typically autism is not even diagnosed until after age 3, even though symptoms might appear in the first year of life. These babies would miss the statute.

-- The federal government has shown that it cannot always be trusted on vaccines. Traditional state products liability remedies must be preserved to ensure the integrity and efficacy of the federal vaccine compensation system.

-- Oversight of vaccine safety and the system for compensating vaccine-related injuries are so badly broken that their repair must take place following full public hearings and debate. Hurried "quick fixes" and ongoing efforts to expand liability immunity for vaccine companies under the cloak of darkness are inappropriate.

-- Significant federal research money must be allocated to further elaborate on the causes of the autism epidemic and on appropriate and necessary treatments.

-- A White House conference on autism to assemble the best scientific minds from across the country and mobilize a national effort to uncover the causes of the autism epidemic is urgently needed.

------ Safe Minds (Sensible Action for Elimination of Mercury Induced Neurological Disorders) is a non-profit parents organization founded to investigate the continuing risks to infants and children of exposure to mercury from medical products, including thimerosal in vaccines. Its Web site is www.safeminds.org.