Opening Statement
Dan Burton (R-IN)
Chairman
Government Reform Committee
“Mercury in Medicine – Are We Taking Unnecessary Risks?”
July 18, 2000
2154 Rayburn House Office Building
Washington, D.C.

       For the last year, the Government Reform Committee has been looking at issues regarding vaccine safety, research, and policy.  A few people have tried to portray this investigation as “anti-vaccine.”  Nothing could be further from the truth.  Safe, effective vaccines save lives.  On the other hand, vaccines that have not been thoroughly tested and reviewed can be dangerous.  The rotavirus vaccine was a good example.  The Government and manufacturers ignored the warning signs.  A lot of babies were injured and required surgery.  One baby died before the vaccine was pulled from the market.

Is it irresponsible to ask questions about why that happened?  Of course not.

We have a lot of doctors who serve on Federal advisory committees who have serious conflicts-of-interest problems.   They’re allowed to vote on vaccines made by companies that they get money from. 

Is it irresponsible to ask questions about conflicts of interest?  Of course not.

Today we’re holding a hearing about why mercury is put into vaccines that are given to children.

Is that irresponsible?   Of course not.

If someone holds hearings about mismanagement of the Department of Education, that doesn’t mean they’re anti-education.  That means they want our education system to be as well run as possible.  That is the way that I feel about our vaccine policies.  No area is so sacrosanct that the world will come to an end if we ask some sensible questions and expect to get some sensible answers.

I think this kind of oversight will make our vaccine program stronger, not weaker.

This spring, we held a hearing about possible connections between autism and the MMR vaccine.  We heard lots of testimony on both sides of the issue.  After the hearing, I sent a letter to Secretary Shalala.  So did Congressman Waxman.  We both asked her to put together a panel of the best experts in the field to look at this issue.  That was May 16 –two months ago.  No response.

That’s intolerable.   If your position is that we should base our policies on good science and good research, then fine.  I agree with you 100 percent.  But if you are not willing to do the research, if you’re not even willing to ask the questions, then we have a real problem on our hands. 

I believe that our primary focus in vaccine policy should always be what is best for the children.  We need to insure that only vaccines that are truly needed to protect the public are added to the Childhood Immunization Schedule.  At no time should the interests of vaccine developers be a higher priority than our children’s health and well being. 

Vaccines are the only drugs that Americans are required by a Government agency to take.   It is thus imperative that the Federal Government ensures the safety of these mandated vaccines.  Each state sets a schedule for the vaccines a child must receive in order to attend school or day care.  The states rely on the Federal Government for guidance on which vaccines should be mandated.  The Federal Government is also the largest purchaser of vaccines.

That brings us to today’s hearing topic – mercury in medicine.  This would seem to many to be a “no-brainer.”  We all know that mercury is a toxic substance.  Long term exposure to low levels of mercury has been linked to mental retardation, cerebral palsy, and central nervous system disorders.  We assume that the

FDA would protect our children from exposure to any level of mercury through drugs.  But that hasn’t been the case. Thimerosal was first marketed in 1930 and has become the most widely used preservative in vaccines.  It is present in over 50 licensed vaccines.  

The FDA recently acknowledged that in the first six months of life children get more mercury than is considered safe by the EPA.  The truth is that sometimes kids go to their doctor’s office and get four or five vaccines at the same time.  My grandson received vaccines for nine different diseases in one day.  He may have been exposed to 62.5 micrograms of mercury in one day through his vaccines.  According to his weight, the maximum safe level of mercury he should be exposed to in one day is 1.51 micrograms.  This is forty-one times the amount at which harm can be caused. 

How much mercury are kids being exposed to at once? 

One would think that the FDA would have moved aggressively to remove vaccines that contained mercury from the market immediately.  They did not.  

On July 9, 1999, the American Academy of Pediatrics and the United States Public Health Service issued a joint statement recommending the removal of thimerosal from vaccines.[1]   On May 31, 2000, the Food and Drug Administration notified vaccine manufacturers that their review of mercury compounds in drugs and foods concluded that reducing or eliminating thimerosal from vaccines is merited.[2]  However, there has been no mandatory action.  These vaccines are still in use. 

The FDA continues to allow the mercury-containing vaccines to remain on the market.   Today, over eight thousand children in America may be given a toxic dose of mercury in their vaccines.[3]   

Many parents who have contacted the committee are concerned about other ingredients as well, including formaldehyde, MSG, and aluminum.  We have also been contacted by many individuals who have concerns about mercury in dental amalgams.  While this is not the focus of today’s hearing, it certainly warrants discussion as well. 

Congress directed the Environmental Protection Agency to contract with the National Research Council to prepare recommendations on the appropriate dose for mercury exposure.  That report was released on July 11[4].  While the FDA relies on the Agency for Toxic Substances and Disease Registry’s dosing level for mercury of 0.5 micrograms per kilogram of body weight per day is significantly higher than the EPA’s dose of 0.1 microgram per kilogram of body weight.  In that report, it was confirmed that the EPA’s reference dose is correct.  We will hear from Dr. Vascken Aposhian, University of Arizona at Tuscon, one of the scientists who worked on this report. Ramona Trovato will testify on behalf of the Environmental Protection Agency.

Section 413 of the Food and Drug Administration Modernization Act of 1997[5] required the FDA to compile a list of drugs and foods that contain intentionally introduced mercury compounds, and provide a quantitative and qualitative analysis of the mercury compounds in this list.  The Act also requires the agency to compile the list and provide the analysis within two years after the date of its enactment on November 21, 1997.  Dr. William Egan will be testifying on behalf of the Food and Drug Administration.

While thimerosal has previously been ruled by the FDA to fit the  “generally recognized as safe” standard, when the FDA conducted their Over the Counter (OTC) drug review they changed their minds.  The FDA determined that mercury compounds used as active ingredients in Over the Counter drug products were not found to be “generally recognized as safe.”  Additionally the FDA has not approved any mercury containing compounds as food additives and does not consider any mercury containing compounds to be “generally recognized as safe.” [6]  On their own website, the FDA states, “lead, cadmium, and mercury are examples of elements that are toxic when present at relatively low levels.”[7] 

How is it that mercury is not safe for food additives and Over the Counter drug products, but it is safe in our vaccines and dental amalgams?

Dr. Roger H. Bernier, Associate Director for Science at the National Immunization Program, Centers for Disease Control and Prevention will testify regarding the recent discussion of the Advisory Committee on Immunization Practices regarding thimerosal. 

Autism is a syndrome characterized by impairments in social relatedness and communication, repetitive behaviors, abnormal movements, and sensory dysfunction.  Autism may now affect 1 in 150 U. S. children.   We will hear from Dr. Marie Bristol-Powers of the National Institutes of Health regarding the existing research in autism.  The characteristics of autism and of mercury poisoning are strikingly similar.[8]

          Dr. Stephanie Cave, a physician from Baton Rouge, Louisiana will be testifying about the mercury toxicity she is seeing in the 200 autistic children she has as patients.

          Autism strikes families from a diverse background.  We will hear from five parents today:  Elizabeth Birt of Chicago, an attorney and the mother of an autistic child will be testifying about the need to remove mercury from all vaccines and a citizens petition that is being presented to the FDA making this request.

Several parents with scientific and medical backgrounds have written a report entitled, “Autism: A Unique Type of Mercury Poisoning.” Three of these parents will be testifying today.  The lead author of the report is Sallie Bernard of Cranford, New Jersey.  Lyn Redwood of Tyrone, Georgia is a nurse practitioner.   Dr. Sharon Humiston, a doctor with an autistic child will also be testifying.

          Our children are the future of this country.  As a Government we have a responsibility to do everything within our power to protect them from harm, including insuring that vaccines are safe and effective. Every day that these mercury-containing vaccines remain on the market is another day we are putting eight thousand children at risk.

The Record will remain open until August 1, 2000.