The battle rages on between the power of belief and the evidence of science as US government researchers are pushed by desperate parents to test an unproven treatment on autistic children. It's a move some scientists see as an unethical experiment in what they refer to as voodoo medicine.
The disputed treatment purports to remove heavy metals from the body, and is based on the fringe theory that mercury in vaccines triggers autism - a theory never proved, and rejected by mainstream science. Mercury hasn't been in childhood vaccines since 2001.
But many parents of autistic children are believers, and the head of the National Institute of Mental Health supports testing the treatment on children provided the tests are safe. "So many moms have said, `It's saved my kids'," institute director Dr Thomas Insel said.
For now, the proposed study, not widely known outside the community of autism research and advocacy groups, has been put on hold because of safety concerns, Insel told The Associated Press.
Many experts strongly reject treatment on children
The process, called chelation, is used to treat lead poisoning.
Studies of adults have shown it to be ineffective unless there are high levels of metals in the blood. Any study in children would have to exclude those with high levels of lead or mercury, which would require treatment and preclude using a placebo.
One of the drugs used for chelation, DMSA, can cause side effects including rashes and low white blood cell count. And there is evidence chelation may redistribute metals in the body, perhaps even into the central nervous system.
"I don't really know why we have to do this in helpless children," said Ellen Silbergeld of Johns Hopkins University's Bloomberg School of Public Health, who was invited to comment on the study to a review board of the national institute.
Despite lawsuits and at least one child's death, several thousand autistic children are already believed to be undergoing chelation, their parents not content to wait for a study.
Autism is a spectrum of disorders that hamper a person's ability to communicate and interact with others. Most doctors believe there is no cure. Conventional treatments are limited to behavioural therapy and a few medications, such as the schizophrenia drug Risperdal, approved to treat irritability.
3 000 kids on treatment at any given time
Frustrated parents use more than 300 alternative treatments, most with little or no scientific evidence backing them up, according to the Interactive Autism Network at the Kennedy Krieger Institute in Baltimore, Maryland.
"With a lot of mothers, if they hear about a treatment, they feel
like they need to try it," said project director Dr Paul Law. "Anything that has a chance of benefiting their child, they're willing to give it a shot."
More than two percent of the children tracked by the project use chelation. If that figure holds for the general population, it would mean more than 3 000 autistic children are on the treatment at any time in the US. Chelation drugs can be taken in pill form, by rectal suppository and intravenously.
Dr Susan Swedo, who heads the federal institute's in-house autism research and wants to study chelation, gained notoriety by theorising that strep throat had caused some cases of obsessive compulsive disorder. The theory was never proved.
She proposed recruiting 120 autistic children aged four to 10, and giving half DMSA and the other half a dummy pill. The 12-week test would measure before-and-after blood mercury levels and autism symptoms.
Questions not being answered in time
The study outline says that failing to find a difference between the two groups would counteract "anecdotal reports and widespread belief" that chelation works. But the study was put on hold for safety concerns after an animal study, published last year, linked DMSA to lasting brain problems in rats. It remains under review, Insel said.
Insel said he has come to believe after listening to parents that
traditional scientific research, building incrementally on animal
studies and published papers, wasn't answering questions fast enough.
"This is an urgent set of questions," Insel said. "Let's make
innovation the centrepiece of this effort as we study autism, its
causes and treatments, and think of what we may be missing."
Last year, the National Institutes of Health spent less than 5% of its $127-million autism research budget on alternative
therapies, Insel said. He said he hopes the chelation study will
be approved. Others say it would be unethical, even if it proves chelation doesn't work.
Reason vs. science
Federal research agencies must "bring reason to science" without "catering to a public misperception", said Dr Paul Offit, chief of infectious diseases at the Children's Hospital of Philadelphia and author of an upcoming book on autism research. "Science has been trumped by politics in some ways."
Offit is concerned vaccination rates may fall to dangerous levels because some parents believe they cause autism.
Dr Martin Myers, former director of the federal National Vaccine Program Office, said he believes giving chelation to autistic children is unethical - but says the government can justify the study because so many parents are using chelation without scientific evidence. "It's incumbent on the scientific community to evaluate it," he said.
Actress Jenny McCarthy, whose bestseller Louder than words
details her search for treatments for her autistic son, Evan, told thousands of parents at a recent autism conference that she plans to try chelation on him.
"A lot of people are scared to chelate ... but it has triggered many recoveries," she said.
Drugs mix-ups are fatal
Those claims of recovery are anecdotal, not scientifically documented; and there are serious risks. Of the several drugs used in chelation, the only one recommended for intravenous use in children, is edetate calcium disodium. Mix-ups with another drug with a similar name, edetate disodium, have led to three deaths, including one five-year-old autistic boy who went into cardiac arrest and died after he was given IV chelation therapy in 2005. A Pennsylvania doctor is being sued by the boy's parents for allegedly giving the wrong drug and using a risky technique.
No deaths have been associated with DMSA, which can cause rashes, low white blood cell count and vomiting. It is also sold as a dietary supplement, which is how some parents of autistic children get it. A Food and Drug Administration spokeswoman said the agency is "is looking into how these products are marketed". – (Sapa)
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