Cost of Treatment A Double Whammy

After years of frugal living and careful saving, Mark and Susan Johnston finally got the place of their dreams: a four-bedroom house in a new development where their kids, Conner and Madeleine, have room to roam.

But two years after moving in, the walls are still white. Only one window has curtains. Though the couple would like to paint, add new furniture and spruce up the backyard, those plans are on hold, along with regular family vacations. After paying $1,300 a month for one-on-one therapy for Conner, who has autism, there’s little money left for splurges.

The therapy, known as applied behavioral analysis, or ABA, uses repetition and reward to help people with autism develop skills they can build upon. Conner works six days a week for three hours a day practicing words and sounds with University of Delaware students. In a year and a half, the 5-year-old has gone from having no vocabulary to more than 100 words. Recently, he’s started pointing and telling his parents he wants juice when they offer him milk.

“This wouldn’t be a big deal for most families, but this is huge for us,” said Conner’s father, Mark Johnston.

Though ABA is considered a standard therapy for children with autism, it isn’t covered by most private insurance or Medicaid in Delaware. That means families often have to pay out of pocket for ABA and additional speech, occupational and physical therapies they believe help draw their children out socially and emotionally. In some cases, parents are able to have extra services covered, but only after spending hours on the phone with medical and insurance personnel and haggling over diagnostic codes that would qualify their children for treatment.

A bill introduced last month by state Sen. Liane Sorenson, R-Hockessin, aims to help families burdened by the cost of paying out of pocket for autism-related services. Senate Bill 204 would require private insurance companies to cover the cost of services related to the diagnosis and treatment of autism disorders up to age 21, including up to $50,000 a year for ABA alone. The legislation was drafted by Autism Delaware, a statewide advocacy organization, and the office of Delaware Insurance Commissioner Karen Weldin Stewart.

Mandating insurance coverage for these services can not only save families money, it also increases the odds that children with autism will grow up being able to communicate and participate in the world around them, said Susan Jennette, investigative supervisor for life and health insurance with Weldin Stewart’s office. Fifteen other states, including Pennsylvania and New Jersey, already have private insurance mandates for autism.

For many parents, it’s also a matter of fairness.

“If your child had any other sickness, they would get the help they need,” said Johnston, who believes the financial sacrifice his family makes is well worth it based on Conner’s success since starting one-on-one ABA. “You have this double whammy of getting the diagnosis and then finding out the only treatment that’s been proven successful, you have to pay out of pocket for it.”

A promising therapy

Autism is a complex neurological disorder that affects about one in 110 children born in the United States, according to the Centers for Disease Control and Prevention. Boys are four times as likely to be diagnosed as girls. Most experts believe a number of genetic, environmental and other factors play a role.

Social dysfunction is considered to be the hallmark of autism spectrum disorders.

That can take several forms, including a desire to escape from social environments or avoiding eye contact with other people. Many with autism have limited verbal communication, relying on only a few words and pointing to picture cards or using assistive technology to convey what they want. Repetitive gestures and a narrow, almost obsessive focus on items of personal interest are other symptoms.

Although there is no cure, the ABA method is considered one of the more effective means to coax social, verbal and behavioral improvements from people with autism. The method works by asking children to engage in a particular behavior, such as saying “mom,” then rewarding them if they comply. If they don’t, the behavior is requested again.

Children with autism also may need speech and occupational therapies to learn new sounds, how to dress themselves and to encourage more social behavior. They may require weekly physical therapy to improve low muscle tone — common in autistic children — and better control their body movements. Prescription medication can help anxiety, sleep and other issues.

The challenge for families is how to pay for it all. Because autism is not covered by most private insurances, parents either have to pay out of their own pocket or work with their physician to see if the therapies can fit under another, accepted diagnosis that qualifies for coverage. Even when private insurance covers physical or occupational therapies, it often caps the number of visits annually, Jennette said. Children with developmental disabilities often exceed those visits before the year is over.

The insurance labyrinth

Stacey O’Rourke, who has three daughters on the autism spectrum, said she has learned the importance of letters of medical necessity, prior authorization and knowing which diagnostic codes will help her eldest daughter, Katelyn, who has a severe form of autism, get the treatment she needs. Doctors are often sympathetic, choosing to write physical therapy prescriptions for hypotonia, known as low muscle tone, rather than autism.

“There is a high demand to do speech therapy, occupational therapy and physical therapy with kids who have autism, but if that diagnostic code or symptoms on the bill say ‘autism,’ most insurance companies will say it’s an exclusion,” said O’Rourke, of Wilmington, who spends what little free time she has calling physician offices and her insurance company about her daughters’ care.

“First there’s the heartbreak associated with autism. And then it’s like, ‘I have to play the insurance game?’ ” O’Rourke said.

Some families rely on Medicaid to help with coverage even when they have private insurance. The Children’s Community Alternative Disability program provides Medicaid coverage to severely disabled children, including those with developmental issues, said Dave Michalik, spokesman for the state Division of Medicaid & Medical Assistance. Children who qualify for this coverage can get developmental and nutritional assessments, speech and other therapies and nursing services, but ABA services are not covered.

Johnston said Conner went on Medicaid after being denied private insurance coverage. O’Rourke’s children are covered through private insurance and Medicaid. When children have other health insurance, Medicaid pays only after private insurance has issued payment, Michalik said.

A push for legal mandate

Two years ago, officials at Autism Delaware began working on insurance mandate legislation after hearing horror stories of families whose savings and retirement funds were decimated to pay for autism therapies, said Kim Siegel, director of development for the organization. Proponents teamed up with Weldin Stewart’s office.

With 15 states already mandating that private insurance cover autism services, more than two dozen others, including Delaware, are considering similar legislation, according to Autism Speaks, a national advocacy organization.

In general, insurers are opposed to mandates because they ultimately raise the cost of coverage and make it less likely employers can afford it, said Susan Pisano, vice president of communications for America’s Health Insurance Plans, which represents nearly 1,300 companies.

Therapies for autism are complicated by the fact that some are classified as medical services by pediatricians, while others are considered educational. With more states and school districts facing funding crises, some of those therapies are being eliminated, she said.

But O’Rourke said without needed interventions, children with autism will become adults who can’t function on their own or without expensive supports. Because of ABA-based drills, her 5-year-old daughter can pull her pants down on her own, though she still wears a diaper.

“If we would mandate insurance companies to pay, it would save money and get the services we need,” said O’Rourke, who has spoken at Lesiglative Hall on behalf of early intervention programs. “If we can make them more productive, in the long run, that’s less cost on the state.”

Value of one-on-one

More than 900 children in Delaware have autism, Sorenson said. Many attend school through the Delaware Autism Program, the only statewide educational program in the country for children with autism. Some students may meet the medical criteria for autism but not the educational standard, so they don’t receive school-based services.

While ABA instruction is a big part of the curriculum for students in DAP, it isn’t always on a one-to-one basis, said John Dewey, principal of the Brennen School, which provides educational services for New Castle County students in the program. A child’s instruction is based on what skills they already have, so if a child is learning something new, the student may get one-on-one time with an educator while doing a set of drills. Later, the student may work in small groups with an instructor and two or three other students to better generalize the skill, Dewey said.

Many parents, including the Johnstons, want their kids to spend more time in one-on-one instruction because that’s where they see the most improvement. During the school day, Conner attends a class at Wesleyan Church of Newark that’s run by DAP.

But for families whose children aren’t in DAP, who haven’t been given an educational diagnosis of autism or who are considered higher-functioning, it can be a challenge to make sure they are getting the services they need to build their vocabulary and interact with the world around them, said Theda Ellis, executive director of Autism Delaware. With a mandate in place, parents could supplement services for their children without worrying about whether their insurance will cover the cost.

While families such as the O’Rourkes and Johnstons are hopeful the legislation will pass and ultimately be signed by the governor, it won’t change their plans to provide additional therapies for their children, only how the bills are paid.

“We never knew when Conner was hungry, when he was thirsty or wet. Everything was a guessing game,” Johnston said. “His progress has been slow, but it’s real.”

Fire Safety Book Designed for Kids With Autism

A new, interactive fire safety book has been designed to help children with autism spectrum disorder respond appropriately to the sound of a smoke alarm.

“I Know My Fire Safety Plan,” produced by The National Fire Protection Association (NFPA), can also be helpful to children with other developmental disabilities, according to Lisa Braxton of the NFPA public education project.

“Autism is the fastest growing developmental disability. It is important that we reach children on the autism spectrum and encourage parents and caregivers to use this new NFPA educational tool to help children understand what they should do to escape safely when they hear the smoke alarm sound,” Braxton said.

The book uses easy-to-follow steps in a story format, acknowledging the apprehension children with autism may feel at the sound of a smoke alarm or presence of fire trucks and firefighters.

Parents are advised to practice their fire safety plan with their children, and then read the story with them.

Participants are encouraged to use the interactive story to its full capacity by typing in their name, age, physical features, and the location of their outdoor meeting place. Children can also take part in the story by clicking on the corner of each page to turn it and they may start and stop at will.

The interactive story has been reviewed, at all stages of development, by the NFPA public education division’s Parents and Teachers of Children with Disabilities Advisory Group, Braxton said.

It has also been reviewed by a psychologist from a school that serves children and adults with autism and by a respected author of manuals on crafting social stories.

New Genetic Autism Test Beats Older Tests

A new genetic test for autism, known as chromosomal microarray analysis (CMA), finds more genetic abnormalities than two older tests, a study shows.

”CMA is much better than karyotyping or fragile X testing at detection — it’s at least three times better,”  Bai-Lin Wu, PhD, medical director of the genetics diagnostic laboratory at Children’s Hospital, Boston, and a study co-researcher, tells WebMD.

While the other two tests are now standard practice, Wu and his colleagues say the new test should also be part of the initial diagnostic evaluation of patients when a clinical diagnosis of autism or autism spectrum disorder has been made or is suspected.

The study results are published online in Pediatrics.

Autism, a complex disorder, involves impairments in social interaction as well as deficits in language and communication along with rigid and repetitive behaviors. It affects about one person per 1,000, the researchers write; autism spectrum disorder (ASD) affects six per 1,000.

Comparing CMA With Other Tests

The researchers compared the results of the three tests in more than 800 patients. Among the findings:

• The standard genetic test known as G-banded karyotype testing found abnormal results in 19 of 852 patients, or about 2%.
• The fragile X testing found abnormalities in four of 861patients, or about 0.5%. (Fragile X syndrome is a condition associated with autism.)
• The CMA test found abnormalities in 154 of 848 patients, or about 18%; 59 of these, or about 7%, were associated with possible or known genetic disorders. 

”Karyotype testing is looking for changes visible by the microscope,” Wu, a clinical molecular geneticist, tells WebMD. “CMA is looking at the molecular level.”

Wu and co-researcher Yiping Shen, PhD, assistant director of the genetics diagnostic laboratory, compare karyotype testing to a map that can detect a highway that’s missing in a state, and CMA testing to a map that can detect individual highway exits that are missing.

In the study, Shen and his colleagues say that CMA ”should be considered as part of the initial diagnostic evaluation of patients with ASD.”

CMA an ‘Excellent’ Test

The new study confirms smaller studies finding that CMA is an excellent test, says Randi Hagerman, MD, medical director of the MIND Institute at University of California, Davis, and an autism expert.

”This [new study] demonstrated that the CMA picked up abnormalities at a much higher rate [than other tests],” says Hagerman, who reviewed the findings for WebMD.

The patients studied, she says, were a relatively high functioning group of people with ASD. That population, she says, ”reflects more closely what clinicians are seeing now in their office.” She says the rate of intellectual disabilities of those with autism and ASD has gone down in recent years.

The bottom line of the study? “You should do genetic testing on everyone with autism or ASD,” Hagerman says. “That’s been the recommendation for years.” With the new study findings, she says, the message is clear that “you should include CMA.”

Doing all three tests would be ideal, she says. But if you can only do two, she would pick fragile X and CMA. If someone has autism or ASD, she says, the CMA test “is the No. 1 test to yield an abnormal result.”

Genetic testing can help parents get early intervention, Wu says. And it can help them in family planning, predicting the risk of having another affected child.

But genetics still only explains a minority of autism and ASD cases, Wu says, perhaps up to 15%. CMA can help detect about half of that 15%.

One other obstacle, Hagerman and others say, is that insurance does not always cover the costs. Fees vary, but the CMA alone can cost about $1,200 in California, Hagerman says.

Andy Shih, PhD, a spokesman for Autism Speaks, cautioned in an email to WebMD that “this CMA methodology is not yet ready for commercial application and does not specifically test for autism and therefore is a tool of limited value for concerned parents and families.”

He calls for more research on the new test, “especially on how to interpret the findings from CMA relative to autism risk, before it can help families make more informed health care decisions.”

Autism Study Doctor Facing Grant Probe

A Danish scientist involved in two major studies that debunked any linkage of vaccines to autism is suspected of misappropriating $2 million in U.S. grants at his university in Denmark.

Poul Thorsen, a medical doctor and Ph.D., was an adjunct professor at the Drexel University School of Public Health for several months before resigning Tuesday.

On Jan. 22, Aarhus University said that it had uncovered a “considerable shortfall” in grant money from the U.S. Centers for Disease Control and Prevention for a research program that Thorsen had directed. The university referred the matter to police, who are conducting an investigation.

Anti-vaccine groups have seized on the allegations to contend that scientific studies disproving the vaccine link to autism are wrong. Those groups have long argued that thimerosal, a preservative in some vaccines, can cause autism, as can the MMR vaccine for measles, mumps, and rubella.

“I think it is quite significant,” said Dan Olmsted of the Age of Autism. “I think someone allegedly capable of ripping off his own university by forging documents from the CDC is capable of pulling off anything.”

The CDC and coauthors of the two studies published in major U.S. medical journals maintain the studies remain valid.

“CDC is aware of the allegations by Aarhus University against Poul Thorsen,” agency spokesman Tom Skinner said in a statement. Federal authorities are investigating.

Skinner noted that Thorsen was one of many coauthors on peer-reviewed studies looking at autism, cerebral palsy, Down syndrome, and alcohol use in pregnancy.

“We have no reason to suspect that there are any issues related to the integrity of the science,” Skinner said.

Efforts to reach Thorsen for comment by phone and e-mail this week were unsuccessful.

In a statement, Drexel University said that Thorsen was an adjunct at its School of Public Health from Dec. 11 until “he resigned his appointment with the school of public health on March 9, 2010.”

Drexel’s statement noted that his role was limited to serving as a member of the thesis committee of one doctoral student.

“To our knowledge, Dr. Thorsen has performed no other work directly connected to Drexel while holding a title at Drexel University,” the statement said.

In 2002, Thorsen was the sixth named author of a study published in the New England Journal of Medicine that analyzed whether where is a connection between the MMR vaccine and autism by examining 537,303 children born in Denmark from 1991 through 1998.

The researchers concluded that their data provided “strong evidence” that there is no link.

“Poul Thorsen had absolutely no influence on the conclusions regarding this paper,” wrote Mads Melbye, head of the division of epidemiology at the Statens Serum Institut in Copenhagen and senior author of the study, in response to e-mailed questions.

“Thorsen was not actively involved in the analysis and interpretation of the results of this paper,” Melbye said.

The second study, published in Pediatrics in 2003, examined 956 Danish children diagnosed with autism from 1971 to 2000. It concluded the incidence of autism increased in Denmark after thimerosal was removed from vaccines.

Kreesten Meldgaard Madsen, the lead author, said Thorsen played a minor role.

“Dr. Thorsen was not in a position to change or compromise the data,” Madsen wrote. “Dr. Thorsen was part of the review cycle, but never very active in giving input. Dr. Thorsen never had access to the raw data nor the analysis of the data.”

Others, such as Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a vocal opponent of the anti-vaccine groups, said even if the allegation against Thorsen is true, it does not mean his science is bad.

“Let’s assume it is true that he embezzled money,” Offit said. “The notion that it casts the science into question is false. For these big epidemiological studies, it is hard to believe that one person could effectively change the data.”

Offit pointed out that a dozen major studies show no link between MMR and autism and at least a half dozen say the same about thimerosal, which contains mercury.

But the Internet was afire over the allegations.

“Questions about Thorsen’s scientific integrity may finally force CDC to rethink the vaccine protocols since most of the other key pro-vaccine studies cited by CDC rely on the findings of Thorsen’s research group,” Robert F. Kennedy Jr. wrote on the Huffington Post. “The validity of all these studies is now in question.”

In its statement, Aarhus University said the Danish Agency for Science, Technology, and Innovation (DASTI) has gotten grants from the U.S. National Center for Birth Defects and Developmental Disabilities since 2001. Thorsen directed the administration of the grants, the university said.

After discovering that money was missing, DASTI and Aarhus “became aware of two alleged CDC funding documents as well as a letter regarding funding commitments allegedly written by Randolph B. Williams of the CDC’s procurement grants office. . . .”

“Upon investigation by CDC, a suspicion arose that those documents are forgeries.”

The university’s statement goes on to say that in March 2009, Thorsen resigned from its faculty.

Last month, the Copenhagen Post Online reported on the issue without naming Thorsen. The paper pegged the shortfall at 80 million kroner, about $2 million.

In Atlanta, where Thorsen is thought to live, Emory University said he began working there Sept. 1, 2003, as a part-time adjunct professor in its School of Public Health. Emory said that from April 2008 to June 2009, Thorsen “served as a full-time research professor. He is no longer employed at Emory.”

“It is a sad story,” wrote Melbye of the Statens Serum Institut in an e-mail. “We are all here with one big question: What has happened and why?”

Children with Autism Placed in “Pen” Sparks Outage

The New South Wales (NSW) education department confirmed that students with special needs at Seven Hills West Public School were put into a fenced off area while other students spent their breaks in a larger playground.

The pen was reported to have just one tree, one bench and no grass.

The NSW opposition Liberal Party said separating autistic children was inhumane and “outrageous”.

Andrew Constance, the opposition disability spokesman, said he had seen cattle yards in better condition.

“You cannot treat children with autism in this way,” he told the Australian Broadcasting Corporation.

“It is, I think, no doubt in breach of every discrimination act in the country.”

One parent of an autistic child who attended another school said Seven Hills West was treating the children “like rats”.

However, the school, which has 52 students with special needs, has defended its decision, claiming that the fenced-off area kept the children out of danger.

The school is located close to a busy road and teachers were concerned that children with “no sense of boundaries” could wander into traffic.

Michael Coutts-Trotter, the head of the education department, said the area was fenced off at the request of parents and was always supervised. He admitted the area needed to be grassed, but praised the school for the way it dealt with autistic students.

“There are some children who, when they are new arrivals to the school, come without knowing to behave safely in the playground,” he said

“It’s a school that has a busy road next to it and some of the children who come into the school have a history of running out of schools, which in this case could mean running on to a very busy road and dying.”

“Clean Room” Study Could Shed Light on Autism

PITTSBURGH — A controversial method is being used in Pittsburgh to study children who live with autism. The method involves having the children spend hours inside a so-called “clean room.”

Nationwide, there is one child in every 100 with autism. In Allegheny County, there seems to be a cluster of cases as the county has the highest rate of autism in the state.

Researchers hope to determine whether the local environment is playing a role in the problem. Starting in a few weeks, children and their parents will stay in the new room so researchers can see what happens to them.

Malissa Guerrero’s daughter, Mckenzie, is 7 and energetic and has autism. Guerrero said she tried many different things to help, but nothing has worked.

“I would try anything at least once to try to help her because something has to break her — something,” said Guerrero.

She hopes “something” is the new clean room. A swoosh of air blows away dust and prevents bad air from coming inside the room, which is free of toxins, pollution or allergens. “It’s the first of its kind ever for an autistic child,” said Skip Kingston, an analytical chemistry professor.

Researchers want to know if this pure environment will impact children with autism.

The special ceiling tiles are all sealed, as are the outlets and window.

All the air runs through a HEPA air filter, which cuts the particles in the air down from billions per cubic meter to less than 100.

The walls are plastic and painted with a special tinted glue. The bathroom keeps away all molds and bacteria and the water is filtered.

Some doctors disagree, but Dr. Scott Faber of the Children’s Institute is convinced autism is caused by a combination of genetics and the environment.

“Sometimes situations are so critical, things have gone so awry in the environment, there’s such a paradigm shift occurring, that we need to reach for new possibilities new opportunities,” said Faber.

For some reason, many children with autism have poor immune systems and can’t get rid of toxin build up in their bodies, Faber said. He wants to see if a pure environment will help reset the immune system and help them detoxify.

The study will begin next month. In the first phase, children with autism and their parents will be sleeping in the room for two weeks at a time to see if there are any changes in their blood work.

“Starting with the sleeping room, and hopefully that does make some difference, and then we can move on to a full, perhaps, month experience where their friends and family can come in and out and teachers, even therapists, can come in and out, but they would stay for about a month or so,” Faber said.

Kingston said the Pittsburgh region is the perfect place for this study because he says our environment is polluted.

“Our air is unique in Pittsburgh,” Kingston said. “We have the mercury coming from the stacks of those. We can’t eat any of the fish. EPA has monitored all our fish, and we’re not allowed to eat any fish we fish in western Pennsylvania, because they all have higher levels of mercury than are tolerable.”

Guerrero said she knows some people might think it’s extreme, but she’s willing to give it a chance.

“Anything to help her,” Malissa said. “I think they all deserve it. They all deserve a chance.”

The study will cost $330,000 and has big backers that include Alcoa and the federal government.

Researchers will be monitoring the levels of 70 different toxins in the participants bodies, and Kingston said he hopes the study will allow them to come up with a list for everyone on how to make their homes cleaner.

Doctors Sued Over Autism Chelation Therapy

In perhaps the first lawsuit of its kind, a parent of a boy with autism is suing his son’s doctors, claiming they provided treatments without proven scientific benefit. The suit says the treatments were expensive and carried risks of serious harm.

James Coman filed the suit in Cook County Circuit Court against Dr. Anjum Usman and Dr. Daniel Rossignol over the treatment of his 7-year-old son with autism. Usman treated the boy at her clinic in Naperville, Ill., while Rossignol prescribed treatments by phone without meeting the patient, the suit alleges.

“It’s fraud, pure and simple, and they made a lot of money off my family and they’re making a lot of money off a lot of families,” Coman told ABCNews.com.

Usman and Rossignol are part of a physician’s group called Defeat Autism Now, part of the Autism Research Institute. The group advocates a number of autism treatments for autistic children discredited by mainstream doctors. As of press time, the directors had not replied to an e-mail seeking comment.

Among the treatments prescribed, according to the suit, were 30 different vitamin supplements and the use of intravenous chelation therapy. Chelation, which in this case was done 37 times, is used medically to remove heavy metals from the body. The procedure is done based on the largely-discredited theory that autism is caused by heavy metal poisoning.

The National Institutes of Health cancelled a 2008 study of chelation as an autism treatment, saying “there was no clear evidence for direct benefit to the children who would participate in the chelation trial and that the study presents more than a minimal risk.”

That assessment has been confirmed by experts since.

Chelation Therapy: Doctors Say it Can be Dangerous

“There doesn’t seem to be any scientific justification for using chelation to treat autism,” said Dr. Paul Wax, executive director of the American College of Medical Toxicology and a toxicologist with the University of Texas, who is not involved in the case. “To date there’s not been any scientific study that’s revealed any definitive link between an environmental chemical and autism.”

Chelation can cause a number of adverse effects, including kidney failure and death.

Coman, who is divorced from the mother of his son, said that as he researched the treatments being performed on his son, he became convinced something was wrong.

“I wasn’t fully aware of the extent of the treatments, and when I researched the treatments online, I found that there was a very strong consensus that the treatments are not valid treatments for autism,” he said. “My son does not have heavy metal poisoning. I’m not a doctor, so I don’t know any of the details, but as far as I can tell and from what the doctors have told me, this is not a valid treatment for autism.”

“It is surprising that someone would turn against the physician who represents himself as the only one that cares,” said Dr. Paul Offit, chief of infectious diseases at the Children’s Hospital of Philadelphia and author of “Autism’s False Prophets,” a book about questionable autism treatments.

The most similar case to the current one involved Dr. Roy Kerry, who was charged with the death of a 5-year-old child with autism named Abubakar Tariq Nadama. He received chelation treatment in Kerry’s office. Kerry voluntarily surrendered his medical license in 2008. While the charges were eventually dropped, the state medical board suspended his license for six months, with two and a half years of probation in 2009.

But while this case might be different, Offit does not believe it will make a difference in how doctors providing questionable autism treatments are perceived.

“I don’t think it will have much of an impact at all, because it’s a big business,” he said. “False hope, to many people, is better than no hope.”

Dr. Stephen Barrett, who is acquainted with the case documents, said that while he hears from parents who believe they have been deceived by providers of alternative autism treatments. “This is the first time a parent has had the fortitude to do something about it.”

Barrett, a retired psychiatrist, is vice president of the National Council Against Health Fraud.

Barrett said he hopes the Coman case will discredit the urine toxic metal test — a test used by some doctors who use chelation therapy on patients with autism.

Lawsuit Challenges Chelation Therapy Against Autism

For this test, patients are given a chelating agent, a chemical that binds to metals in the body and then is excreted in urine. Barrett points out that this leads to unusually high levels of metal in the urine, since they have been drawn out by the chelating agent.

Barrett said the test often gives a false impression that there are toxic levels of metal in patients who do not have it.

“They should just chelate everybody who comes in the door, because that’s what they try anyway,” Barrett said.

Wax, the Texas toxicologist, said many labs use chelation improperly, “Chelation can be dangerous if it’s not used in the right circumstances,” he said. “Since there’s no scientific justification for it… my group really frowns upon the use of chelation in this setting.”

For his part, James Coman said he hopes his suit helps other parents of children with autism.

“I hope to make it very, very expensive to do this kind of quackery, because it is predatory and it’s fraudulent and it needs to stop,” he said.

“There is a reason why most doctors won’t do this, and I realize that people are desperate to do something, and that they definitely feel good about doing these things, and I also understand that children get better, but children do get better with age. That doesn’t mean they’re cured and there’s no way to know if the doctors doing these things are what’s causing this improvements.”

Coman added, “Parents should be very wary of anyone who says they can cure an incurable disease.”

Got a Question?

The McCarton Foundation will be creating it’s own YouTube channel this week and Dr. McCarton will be answering your questions on it weekly! If you have a question about schools, medication, treatments, or anything else related to autism, e-mail it to mccartonackerman@hotmail.com She will answer questions selected randomly each week.

British Doctor Resign As Head of Autism Center

Facing the possible loss of his medical license in England, Dr. Andrew Wakefield has stepped down as executive director of the Thoughtful House Center for Children, an autism education and treatment center for children that he helped found in Austin in 2005.

Last month, a panel of the General Medical Council, which regulates doctors in the U.K., found that Wakefield was dishonest and irresponsible in conducting research on children in England a dozen years ago. The panel also said Wakefield showed a “callous disregard” for children at his child’s birthday party in 1999 when he had blood taken from them and paid them about $10 each. He later joked at a conference about the children being “paid for their discomfort.”

Wakefield’s 1998 work, published in The Lancet, a prestigious British medical journal, fueled a worldwide scare over vaccines and autism. The Lancet retracted the study earlier this month.

Thoughtful House would not answer questions about Wakefield’s departure. By Thursday morning, he was removed from the center’s staff list, and the center issued a statement when asked whether Wakefield had resigned.

“The needs of the children we serve must always come first,” it said. “All of us at Thoughtful House are grateful to Dr. Wakefield for the valuable work he has done here. We fully support his decision to leave Thoughtful House in order to make sure that the controversy surrounding the recent findings of the General Medical Council does not interfere with the important work that our dedicated team of clinicians and researchers is doing on behalf of children with autism and their families. All of us at Thoughtful House continue to fight every day for the recovery of children with developmental disorders.”

Wakefield, who is in his early 50s, helped draw musicians and other celebrities to the Thoughtful House, where he was said to be in charge of research.

Parents who brought their children to the clinic said they saw him as a persecuted hero whose staff helped their children improve. The parents said they believe in the theory he advanced in the Lancet paper — that some children might develop a form of autism and gastrointestinal disease from exposure to the combined measles-mumps-rubella vaccine.

Other researchers have widely disputed the theory. Mainstream practitioners also oppose many of the alternative treatments at Thoughtful House, including chelation — the use of chemicals to remove metals from the body.

Starting April 7 in England, Wakefield will go to the next level of hearings before the General Medical Council, which will decide whether he is guilty of serious professional misconduct and whether he should be sanctioned, which could include losing his medical license.

Wakefield does not have a U.S. medical license.

Last month, he told reporters outside the medical council’s office in London, “The allegations against me and against my colleagues are both unfounded and unjust. I repeat, unfounded and unjust, and I invite anyone to examine the contents of these proceedings and come to their own conclusion.”

Lancet Retracts Controversial Autism Paper

It was the scientific paper that served as a central pillar for the idea that vaccination could increase children’s risk of developing autism.

Now, with a formal retraction from the Lancet, the medical journal which in 1998 published this piece of research by Dr. Andrew Wakefield, most researchers will view the study as if it had never been published in the first place.

In a statement explaining its retraction of Wakefield’s paper, the Lancet said: “Following the judgment of the U.K. General Medical Council’s Fitness to Practice Panel on Jan. 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect … in particular, the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.”

“The Lancet is an enormously prestigious journal with worldwide circulation, so its action of repudiation is very important,” said Dr. William Schaffner, chair of the Vanderbilt University School of Medicine’s Department of Preventive Medicine in Nashville, Tenn. “The retraction puts another nail in the coffin of this awful, painfully erroneous study.”

But the retraction is unlikely to close the Pandora’s Box that the Wakefield study opened, other vaccination experts said.

“Unfortunately, the idea that vaccines cause autism is already out there and the damage has already been done,” said Robert Field, professor of Health Management and Policy at the Drexel University School of Public Health in Philadelphia. “Years of research have clearly disproven a vaccine-autism link, yet many people continue to believe in it. If all of that research hasn’t changed their minds, the Lancet’s retraction is not likely to make much difference.”

Dr. Gregory Poland, editor-in-chief of the journal VACCINE and director of the Mayo Vaccine Research Group in Rochester, Minn., called the Lancet’s action merely “procedural.”

“What is more important is that an investigator, on the basis of false pretenses, published a paper and propelled a controversial hypothesis forward that led to decisions among individuals and groups to reject vaccination, with resultant outbreaks of these diseases,” he said. “The results are highly significant: millions spent needlessly, hundreds of thousands — maybe even millions — unimmunized, and a fog of suspicion cast upon vaccines.”

On Jan. 28, the United Kingdom’s General Medical Council (GMC) found Wakefield guilty of acting unethically during the time he conducted the famous case report of 12 children that questioned if a childhood vaccine caused a new form of autism.

Wakefield’s hypothesis was that by combining vaccines for measles, mumps and rubella into a single shot, known as MMR, the vaccine weakened the immune system and damaged the gut. He said that this, in turn, led to the development of autism.

The GMC concluded that Wakefield participated in “dishonesty and misleading conduct” while he conducted the research. Specifically, it found Wakefield responsible for an ethics breach because he wrote that the children involved in the case report were referred to his clinic for stomach problems, when he knew nearly half of the children were actually part of a lawsuit looking into the effects of an MMR vaccine. Some children didn’t have stomach issues at all.

Wakefield also failed to disclose he was paid in conjunction with the lawsuit, or that he had a patent related to a new MMR vaccine in development when he submitted the case report for publication.

Moreover, according to one of the findings against the doctor, Wakefield took blood samples from children at his own child’s birthday party and paid them each five British pounds for their trouble.

Following the GMC’s Jan. 28 ruling, Wakefield declined an interview with ABCNews.com, but issued a statement saying, “The allegations against me and against my colleagues are both unfounded and unjust and I invite anyone to examine the contents of these proceedings and come to their own conclusion.”

The GMC ruling is unlikely to erase the apparently false connection between vaccines and autism from the public mind. Nor will it detract from Wakefield’s positive reputation among some activists groups.

Following the GMC’s decision, the advocacy group the Autism Society issued a statement in which it said it “strongly supports funding research into gastrointestinal pathology, as well as any links between this pathology and the symptoms of autism. … In this field, Dr. Wakefield’s contributions to our families and members are greatly appreciated and there are many who support him in his research efforts.”

Similarly, the parent groups who stood behind Wakefield in rallies and in press statements say his theories have led to anecdotally successful treatment in their children and also doubt that a finding by the GMC will change any minds.

It is on this point that critics of Wakefield’s work agree.

“In some ways I think [the GMC ruling] is irrelevant,” said Dr. Paul Offit, chief of the Section of Infectious Diseases at Children’s Hospital of Philadelphia, who has been twice threatened with lawsuits for critical statements he has made of Wakefield’s work.

According to Offit — and international studies supported by the CDC as well as a 2004 review of large international studies by the Institute of Medicine — high-quality studies could not confirm Wakefield’s hypothesis about vaccines.

Still, when the public got word of Wakefield’s work, worried parents skipped vaccines, and the percentage of children who were not vaccinated in the United States rose from 0.77 percent in 1997 to 2.1 percent in 2000, according to an article by Dr. Michael Smith in the journal Pediatrics. A similar rise in children not being vaccinated occurred in Britain.

Although the U.S. Centers for Disease Control declared the United States cleared of measles in 2000, the lower vaccination rate brought back the disease in a 2008 outbreak. At least 131 cases were reported to the CDC, and 11 percent of the cases were hospitalized. A handful of children in Britain died of the measles around the time of the U.S. outbreak.

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Since the publication of the 1998 article, Wakefield has left England and has set up an alternative research and treatment organization called Thoughtful House in Austin, Texas. On April 7, the GMC is scheduled to decide whether his ethical breaches constitute “serious professional misconduct” and if so, how Wakefield will be reprimanded or whether he will lose his license.

Regardless of the outcome, many vaccine efforts hope that this latest chapter in the debate over a connection between vaccines and autism will be the last.

“I think it is vital that the public and more importantly the press move past this issue,” said Dr. Nancy Minshew, professor of psychiatry and neurology and director of the University of Pittsburgh’s Autism Center of Excellence.

“It is time for a new script,” she said. “In a time when scientists have discovered a prevention for ASD in infants and toddlers with the tuberous sclerosis gene, the public and press should be racing to understand how this came about and where the next discovery will come from.”