Unable to watch the seizures continue to wrack their daughter’s tiny body, Ann Marie Angelucci said she and her husband were willing to try anything — and pay anything — to help their child diagnosed with autism.
On the advice of other parents, they took Carolyn to a doctor for hyperbaric oxygen treatments, which cost $90 each and required their 5-year-old to lie repeatedly in a pressurized chamber flooded with oxygen.
They also paid $15,000 to install a chamber in their Yardley, Pa., home. Six months later, with no sense the treatment was helping, the Angeluccis sold the device on eBay for about half the price they paid.
"I cannot say one way or another if it helped her. There was no measurable effect," said Angelucci, a nurse and central New Jersey native. "But I wouldn’t tell a family not to do it, because you never know. You’ll grasp at anything that might help."
Come January, the state health department will decide for the first time whether a hospital — Meadowlands Hospital Medical Center in Secaucus — should be allowed to offer this experimental and controversial treatment for children with autism.
Judging from the sentiments on both sides of the issue, there is a lot at stake. Traditional medical experts say hyperbaric treatment offers families false hope while draining their bank accounts because insurance doesn’t cover it. Advocates say the approach deserves more respect and attention by researchers because some families swear it has helped their children communicate and learn.
If the state licenses the hospital’s hyperbaric chambers for experimental use, the work would be overseen by Philip DeFina, who has a doctorate in clinical psychology from an accredited online university. His work with neurologist Jonathan Fellus treating coma and brain-injured patients commands $100,000 a year in out-of-pocket costs from hopeful families across the country, according to the two doctors.
Should the state give its approval, the statewide advocacy group Autism New Jersey won’t recommend it.
"There might be some anecdotes, and they are a nice start to develop a hypothesis, but they in no way substantiate claims of efficacy," said Suzanne Buchanan, clinical director for Autism New Jersey. She suggests families explore the evidence-supported applied behavioral analysis, which requires a child to break down desired actions into smaller steps that are repeated.
Buchanan also recommends "hopeful skepticism" with anything deemed experimental.
"You have to explore things that could make a positive difference," she said, "but if you are not skeptical, you could be led down the wrong path."
A CHALLENGE TO TREAT
With no confirmed cause or cure, autism is the most confounding of developmental disabilities, impairing a person’s ability to communicate, form personal relationships and learn. When New Jersey’s autism rate was evaluated nine years ago by the Centers for Disease Control and Prevention, it ranked the highest in the country, with one in 94 children.
The Interactive Autism Network, the world’s largest autism registry, which is run by the Kennedy Krieger Institute in Baltimore, says fewer than 1 percent of families reported they had tried the hyperbaric treatment, but New Jersey is one of three states where it was the most often used, spokeswoman Elise Babbitt Welker said.
Edison physician James Neubrander said he has treated approximately 800 children with autism using hyperbaric oxygen therapy since 2005, and thousands more with dietary supplements and other biomedical treatments. He also uses neurofeedback, a treatment that calms and regulates brain waves, which he said DeFina taught him when they met in 2007 to discuss "a mutual patient," he wrote in an e-mail.
The Undersea and Hyperbaric Medical Society says hyperbaric therapy is recognized to treat 14 conditions, such as wounds and "the bends" — decompression sickness sometimes suffered by scuba divers — by raising the oxygen level in the blood and revitalizing dying tissue. Autism is an "off-label" use not yet supported by evidence, executive director Peter Bennett said.
"Critics will say the studies are not out there, and the studies that are out there are contradictory," Neubrander said. "By the time we get the funding for everything, it takes too long. If something is safe and seems to be effective, it should be tried if it is something parents want and enter with full informed consent."
Neubrander warns the therapy is time-consuming and expensive, at about $125 a session. In rare cases, seizures or pain from pressure on the eardrum or sinuses may occur.
"I make sure they know they are not going to get a magic one-time quick fix — the magic-bullet dream that doesn’t exist," Neubrander said. "If done correctly, I have seen it work to some degree for a majority of children."
Tom and Polly Ellison paid $21,000 to put a hyperbaric oxygen chamber in their Egg Harbor Township home after they saw their son Tommy, then 2½, improve under Neubrander’s care. Some 300 hours in the chamber later and with the aid of vitamin supplements, a special diet and behavioral therapy, "Tommy has more friends than I think I ever had at this age. ... He’s a straight-A student. He has no speech impediments or delays," said Tom Ellison.
"It’s alarming the funding has not been put toward this research," he added.
Many pediatricians and neurologists, however, balk at the suggestion hyperbaric treatments should be given the same weight as behavioral therapies.
"Virtually all of the literature supporting the use of hyperbaric oxygen therapy in autism comes from one investigator and is published in obscure journals,’’ said Steven Lomazow of Belleville, president of the Neurological Association of New Jersey.
"The research was funded by the manufacturers of the equipment. Even these papers cite a low number of patients and a need for further investigation," Lomazow said.
Pediatric neurologist Mark Mintz of Cherry Hill said there is no evidence the brains of children with autism have ever been deprived of oxygen.
"Nobody credible seems to see a need to do a study (on hyperbaric treatment)," he said.
Although he would be the hospital’s point person on hyperbarics for autism, DeFina, the scientific officer for Meadowlands’ Institute of Neuroscience, said, "I always had a healthy skepticism for HBOT (hyperbaric oxygen treatments). I am of the belief there is no magical bullet in one treatment. The brain is too complex.
"The hospital will probably roll out some of those clinical programs, but I am not an advocate for them to do that until the research is done," he said.
Senate Health Committee vice chairman Joseph Vitale (D-Middlesex) said he sensed the hospital’s enthusiasm to offer the treatment when the facility’s co-owner, Richard Lipsky, showed him the chambers during a tour in August.
"He told me he was proud to have it because he was going to use those chambers for children with autism,’’ Vitale said during a committee hearing in September. The hearing was held to discuss Meadowlands’ recent change from a nonprofit hospital to a for-profit company and how the hospital is making money. A group of investors converted the nearly bankrupt hospital to a for-profit company last December.
"There is no real body of evidence that says a hyperbaric chamber in any manner treats children with autism," Vitale said. "Do insurance companies pay for that treatment? The answer is no, they don’t. That means parents that are desperate for an answer for their children would pay out-of-pocket to have the procedure."
Meadowlands CEO Tom Gregorio testified that DeFina and Fellus, are "not the most orthodox of physicians. ... For years, this treatment they did for vegetative-state patients was not accepted by the medical community, and it has recently been approved by the FDA to move into the research phase.’’
Vitale said in an interview he remains skeptical about the hospital’s motives. "I don’t believe they are doing this for the right reasons. I think it’s the money and taking advantage of families desperate for an answer," he said.
When Fellus ran the Kessler Institute’s traumatic-brain-injury program and DeFina served as a consultant, they used medication, dietary supplements and electrical stimulation on patients in various states of unconsciousness. Fellus left Kessler earlier this year. Of the 41 patients undergoing the treatment, 28 "woke up" or saw brain function improve, according to an article they published in the Journal of Restorative Neurology and Neuroscience in Germany, specializing in experimental strategies, according to its website.
DeFina and Fellus also gained attention for treating Steven Domalewski of Wayne, a then-12-year-old pitcher who suffered brain damage when a line-drive to the chest stopped his heart in 2006. His mother, Nancy, said he went from being in a coma to "making gains all the time" and now goes to school and went to the prom this year.
"We are with doctors who are really smart and positive," she said.
Dawn King of Boulder Creek, Calif., said she and her family raised $10,000 to fly in DeFina’s colleagues to evaluate her son Timmy, who suffered a severe brain injury when he was struck in the head with a baseball. They’ve waited for a year to find out whether the team will take the case.
"I know they’ve done good,’’ King said. "We are willing to do whatever it takes," to raise the funds.
Fellus said he and DeFina are inundated with calls from families "who have been told there is no hope.’’
"Where other doctors leave off," he said, "that’s where we pick up."
Like the treatments he researches, DeFina’s background is unconventional.
He obtained a doctorate in clinical psychology in 1995 from Fielding Graduate University, a nonprofit online college that provides the only online doctorate program accredited by the American Psychological Association.
He never became a licensed psychologist. According to the state Division of Consumer Affairs, DeFina obtained a three-year permit to practice psychology in 2005 and let it lapse in 2008. He said he decided to pursue "an administrative and research career instead."
The hospital website has identified him as a "neuropsychologist" and clinician, but DeFina said neither title is accurate. He acknowledged he saw patients when he collaborated with Neubrander, but "in my role as a research neuroscience consultant."
A CLOSER LOOK
An inquiry about DeFina to Consumer Affairs prompted the office to examine his activities and use of the title, division spokesman Jeff Lamm said. According to state licensing rules, psychologists who see patients must be licensed, but people don’t need a license to work in psychology if employed by a school, a research facility, the government or a nonprofit community organization supported by public money. DeFina said he has not violated any rules.
"Dr. Fellus has always overseen Dr. DeFina’s role as nonclinical scientist, researcher and adviser to physicians,’’ and will continue to do so, Meadowlands spokesman Bill Maer said.
DeFina founded the International Brain Research Foundation in 2005 to "advance cutting-edge brain research through global collaboration,’’ according to its mission statement. In 2009, he drew a $483,460 salary despite the foundation running a $406,082 deficit, according to the nonprofit group’s report to the IRS. DeFina said the foundation’s coffers took a hit after a donor sustained a big loss in the Madoff Ponzi scheme.
"Now we’re doing extremely well,’’ DeFina said, thanks in part to a $6.4 million grant from the federal Department of Defense that will allow them to build on their original research.
Health and Senior Services Commissioner Mary O’Dowd will ultimately determine whether Meadowlands can provide hyperbaric treatments for autism and other brain disorders. O’Dowd’s spokeswoman, Donna Leusner, said an answer is due on or about Jan. 6 — 90 business days from the hospital’s request.
"At this point, the licensing program is unaware of any hospitals outside New Jersey where this is being done,’’ she said.