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Comments on IOM Report and 4/25-26 Congressional HearingsDate: Mon, 30 Apr 2001 12:18:53 -0700
Dear Members and Friends -
Many people throughout the country have been vocally critical of
the recent Institute of Medicine (IOM) report negating a causal relationship
between the MMR vaccine and autism. Also, below are some comments
from the April 25-26 Congressional Hearings addressing this topic.
Note: The Spring 2001 edition of The VacLib Letter will be mailed
first class on Tuesday (tomorrow.) Please email me if you do not receive
( Special note: Dr. Michael Gershon, whose wife is the developer of Merck's Chicken Pox vaccine was a member of the IOM panel...not just a reviewer, but a panel member.)
MMR Shots Under Fire at Autism Hearing
Lawmakers Dispute Accuracy and Fairness of New Vaccine Report
By Jeff Levine in WebMD Medical News
Washington -- A report that virtually cleared the measles-mumps-rubella vaccine as a possible cause of autism came under withering attack on Capitol Hill Wednesday, with legislators questioning the document's accuracy and integrity. Chairman Dan Burton (R-Ind.) of the House Committee on Government Reform said the analysis was a "disservice to the American people." The study, which was published Monday, said that the universally used preventive shot apparently doesn't cause the incurable brain disorder. Still, the panel of experts assembled by the National Academy of Sciences' Institute of Medicine (IOM) couldn't completely rule out the link between the disease and the vaccine in a small number of children. The ambiguity of the findings infuriated Burton, who is holding two days of hearings this week on the skyrocketing rate of autism in the United States.
"You put out a report to the people of this country, saying the [MMR vaccine] doesn't cause autism ... and then you've got an out in the back of the thing, and you can't tell me, the committee chairman, under oath, that there's no causal link, because you just don't know, do you?" Burton asked Marie McCormick, MD, ScD, of the Harvard School of Public Health and IOM panel chairwoman.
"I don't know," responded McCormick after saying earlier that the door was still open and that the theory had not been disproved. Her brother, incidentally, has two autistic children.
It's estimated that the number of children affected by this condition has grown from 4 per 10,000 five years ago to one in 500 children today. The symptoms range from violent behavior to total withdrawal.
Burton's grandson Christian reportedly developed the disease after receiving vaccines that are routinely recommended by federal health officials. And the public figure has adopted the vaccine safety issue as a political and personal crusade.
The congressman was also angered that two of the report's reviewers are believed to have had financial ties to the pharmaceutical industry. The IOM's committee on immunization safety was created as an independent body without conflicts of interests.
Susanne Stoiber, the IOM's executive officer, said the reviewers only offered suggestions. They didn't change the report's basic conclusion. "To the best of our knowledge, aside from the fact that [the reviewers] may own mutual funds that hold pharmaceutical stocks, there is no reason to believe that there are any financial ties," she said. Nonetheless, Burton insisted on seeing the financial records of the vaccine committee members, as well as the reviewers. He vowed to use his subpoena power if necessary.
Andrew Wakefield, MD, also testified at the hearing. The English scientist has his own theory about the relationship between the shot and autism. His studies of a small number of children suggest that a double-dose of the vaccine could lead to a low-level measles infection. He believes the measles virus could cause a leak from the bowel into the general system and ultimately the brain, causing a toxic reaction, in susceptible children, that could lead to autism.
Wakefield says the IOM panel requested information on his observations in a closed session, but it didn't wind up in the final report. At the time, his latest studies were still being reviewed for scientific publication, so he couldn't present them in public. When asked at the hearing if the MMR vaccine is as safe as it can get, he responded, "No, absolutely, not." But Wakefield was contradicted by another English scientist, Elizabeth Miller, MD, head of that country's Public Health Laboratory Service. Her studies show there has not been an increase of such problems in the U.K. since the vaccine was introduced there.
"I don't think it would be profitable to hijack the research agenda to concentrate on answering [Wakefield's] question, which is derived basically from speculation ... and ... unpublished evidence," she says. Burton raised additional concerns that some of the information clearing the vaccine in the IOM report came from Merck, the product's manufacturer.
During the hearing, several physicians whose children have autism told the committee about their ordeal. One of them is Sharon Humiston, MD. A former immunization scientist for the U.S. government, she says she doesn't believe that the MMR vaccine was responsible for her son Quinn's disease. But she's desperately looking for answers, particularly to one heartbreaking question.
"What is going to happen to Quinn after [my husband and I] die? What are we going to do now to help?" she asked tearfully.
Recall of MMR Vaccine Urged Citing Autism Risk
Reuters Health - The chair of the House Government Reform Committee Thursday blasted federal science and health officials for not recalling the combination measles, mumps, and rubella (MMR) vaccine that he says may be causing autism.
An Institute of Medicine (IOM) panel earlier this week issued a report concluding that there is no causal connection between the vaccine and an increased risk of autism in children (see Reuters Health report, April 23).Still, Rep. Dan Burton (R-Ind.) confronted officials from the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health over the vaccine. The vaccine contains thimerosal, a preservative in which mercury is an active ingredient.
The FDA has said that future lots of MMR vaccine will contain no thimerosal, or only trace amounts, as a precaution geared toward reducing overall mercury exposure in children. The NIH has just begun a 2-year, 10-center trial looking at blood and urine mercury levels in children who receive the vaccine.
But Burton expressed outrage that the agency is allowing two lots of thimerosal-containing vaccine--thousands of doses--to go to market before mercury-free vaccine is produced. "If there's any doubt whatsoever...and you're taking mercury out as a precautionary measure, then why in the heck don't you get that stuff off the market?" he asked.
Dr. Karen Midthun, who directs the FDA's office of vaccine research and review, told the committee that the agency lacks the authority to force a recall of vaccines unless it can verify that the product represents a clear and imminent threat to public safety.
"The preponderance of the evidence finds no causal relationship between vaccines and autism," she said. The FDA contends that the premarket testing required of all vaccines before sale to the public showed no increased risk of autism in children who received the MMR vaccine.
Dr. Midthun and others told the committee that the benefits of the MMR vaccine and other childhood vaccines in preventing infectious diseases far outweighs the chance that the immunizations increase the risk of autism. They said that pulling available MMR doses from the market would cause shortages of available vaccine and would also increase public concern about the safety of immunizations.
Burton called attention to his grandson, who he says developed autism shortly after receiving recommended vaccination shots.
"If you [at the federal health agencies] think this issue is going to go away, you guys are blowing smoke. If the health agencies don't deal with this and deal with it quickly, you're going to have a big problem over there," he said.
Autism Alarm Sounded In D.C. [By Jerry Kammer in the Republic.] http://www.azcentral.com/health/0426autism26.htmlPhoenix physician Cindy Schneider told a congressional committee Wednesday about the help she and her husband received six years ago, when their two young children were diagnosed with autism.
"We were left with a diagnosis and no more: no treatment, no plan of action, no hope," said Schneider, who gave up her medical practice to work on autism, a developmental disorder that repeatedly was described as an epidemic during a hearing of the House Committee on Government Reform.
Committee Chairman Dan Burton, R-Ind., who has an autistic grandchild, sounded an alarm about the disorder, which can wreak havoc not only on the personality and behavior of a previously normal child but also disrupt the life of an entire family.
"Autism rates have skyrocketed,"said Burton, noting that even according to conservative estimates 1 in 500 U.S. children is autistic.
Rep. Christopher Smith, R-N.J., said the number of children diagnosed as autistic in New Jersey schools jumped to 2,354 in 1999, from 241 in 1991. He expressed dismay at the federal response to the problem, which some believe is the result of environmental and genetic factors.
"I was amazed, shocked, dismayed and saddened at how little the Centers for Disease Control and other organizations knew about autism," said Smith, co-founder of a 114-member congressional caucus formed to support work on the disorder.
Caroline Champlin, a spokeswoman for the Arizona Department of Economic Security, said the number of people classified as eligible for autism services has risen in four years to 977, from 614.
While many experts say the numbers of autism cases speak for themselves, others caution that they also may indicate that a growing awareness of the disorder has led to more frequent diagnoses.
Several witnesses - most of whom are conducting autism research - spoke disapprovingly of media accounts of this week's report by a committee of the U.S. Institute of Medicine on the possibility of a link between autism and a childhood vaccine for measles, mumps and rubella, or MMR. The Institute is considered to be the Supreme Court of medical disputes.
The committee found that "the evidence favors rejection of a causal relationship." It also recommended that there be no changes in current vaccination procedures intended to immunize children during early childhood.
Schneider said in an interview that she thinks parents should be allowed to choose whether to have their children vaccinated for measles, mumps and rubella.
Agreeing with several of Wednesday's witnesses, she said some children apparently have a genetic predisposition to immune system disorders that cause autism by attacking the brain and digestive system.
"Unless we put medical freedom into the constitution, the time will come when medicine will organize into an undercover dictatorship....The Consitution of this Republic shall make special provision for medical freedom as well as religious freedom." Benjamin Rush MD, signer of the Declaration of Independence
And, unfortunately, the "signers" didn't have the foresight that Dr. Rush did....