Hyperbaric Oxygen Watch
Toronto HBOT center targets autistic children
- Autism hopes - CBC-TV - May 19, 2010
As autism numbers skyrocket, parents of autistic children are looking for treatments beyond the conventional. CBC's Ioanna Roumeliotis investigates.
In my opinion the clinic uses a number of unproved treatments for autism. The reporter provided no facts and allowed the owners of the clinic to make false claims. The average treatment, just for the HBOT therapy, is about $8,000. It doesn't include the supplements, or the expensive and unsupported laboratory tests that are sent to a questionable lab in the U.S.
The HBOT devices are made by PERRY BAROMEDICAL CORPORATION, in Florida.
The company claims that there are just a few studies that are underway or have been completed that were approved by the FDA to study autism. In my opinion, studies certainly wouldn't convince me that HBOT would do anything for autistic children.
Health Canada Device Branch refuses to stop the importation into Canada of these units. They don't give a damn about how the units are used or who imports them. In the U.S. the FDA have taken actions over the years against the manufacturers who have made unproved claims.
At the end of the show there is an interview with three women who have severe stresses on their families because of the expense. The naturopath, Scott Clack, sticks by his therapy. There is no support for biomedical intervention that I have been able to discover.
Toronto Hyperbaric group fills the air with false hope
Hyperbaric Technologies slapped by FDA
Oxygen Chambers Used to Treat Autism - This case was initiated based on a referral from OCI’s Kansas City Field Office. Information was developed relating to the manufacture and sale of unapproved devices without a 510(k) application by Ken Nix, President, Inland Divers, Inc., Broken Arrow, Oklahoma. During the investigation of Nix, information was developed that Gary Zack, owner of Michigan Neurologic and Wound Services, Saint Clair Shores, Michigan, purchased three hyperbaric oxygen chambers for his company. Zack was using the chambers to treat autistic and other brain damaged children. The chambers are not approved for these conditions.
On March 13, 2001, Mr. Chappell of the FDA sent a letter to Hyperbaric Technologies of Olney, Texas. The gist of the warning letter was that there were severe deficiencies in the manufacturing process of the company's hyberbaric chambers. Secondly, it was suggested that the company advertised and promoted the devices for unapproved conditions:
"Your firm's websites and links from your websites promote hyperbaric oxygen therapy and your devices for numerous additional diseases and conditions, for which you have not received clearance from the agency. These include:
In addition, a confidential informant alleged that Zack was forging his brother’s name, Dr. Joseph Zajchowski, on prescriptions and administering treatment to the children without his brother’s presence at the facility.
On April 3, 2003, Dr. Joseph Zajchowski was interviewed and denied having any knowledge of his brother signing his name to prescriptions. Dr. Zajchowski claimed that Zack does not operate the chambers when he is not at the facility.
On April 4, 2003, Zack admitted that he forged his brother’s signature on prescriptions and correspondence.
Zack also admitted that he administered treatment for conditions not approved by FDA, and with chambers that do not have 510(k) pre-market approval. Zack presented invoices from Inland Divers, Inc. which confirmed that he purchased the chambers from Nix.
Read this letter on the FDA's website
Brown Recluse Spider Bites;
Closed Head Injuries;
Chronic Fatigue Syndrome;
Reflex Sympathetic Dystrophy (RSD) Syndrome;
Stroke; and Traumatic Brain Injuries.
In addition to the Federal Food, Drug, and Cosmetic
Act, you may also
subject to provisions of the Federal Trade Commission
deceptive acts or practices in or affecting commerce,
of any false advertisement to induce the purchase of a
food, drug, or
(See Sections 52 and 45 of Title 15 of the United
Web sites controlled by Hyperbaric Technologies
This company has installed many units in Canada, including Ottawa and Toronto area. We complained to Health Canada about the wild claims that were made in regards to the use of HBOT for cerebral palsy when we found that these units were being used by pediatricians and other doctors to recruit infants and children.
We don't know if Health Canada has taken any action against those who are presently marketing these, or any other hyperbaric chambers for unapproved uses.
- Dr. Neubauer clinic HBOT Chamber Blast Victim Dies - May 2009
A 62-year-old Italian visitor badly burned in an explosion at a Lauderdale-by-the-Sea clinic died Saturday morning. Her 4-year-old grandson, who was with her in the private clinic's oxygen chamber, remains in critical condition.
The cause of Friday's explosion at the Ocean Hyperbaric Oxygen Neurologic Center is under investigation, officials said. Three of the hyperbaric chambers were taken as evidence and will be looked over by experts, Broward Sheriff's Office spokesman Mike Jachles said.
The victims were identified by the Sheriff's Office Saturday as Vincenza Pesce and Franchesco Martinizi, both of Italy.
- Fire, Fatal Injury, and Claims of Certification in an Independent HBOT Clinic - LBRB comments and links
- CBS-TV coverage and comments - 4 year old Francesco has Cerebral Palsy. It has prevented him from being able to talk, and he has difficulty walking. His family spends hundreds of thousands of dollars and most of their time on his treatment.
- Cerebral Palsy is not an Undersea and Hyperbaric Medical Society (UHMS)-approved indication for the use of hyperbaric oxygen therapy, and this was recently commented on by Dr. Charles S. Graffeo in an article in the New York Times online by Jane E. Brody.
- Dr. Neurbauer's center lives on even though he died in 2007
- Their doctors are DAN! doctors - specialize in treatment of autism. The doctor in charge graduated medical school in 1957 and used to practice surgery and thoracic surgery.
- Family Files Wrongful Death Lawsuit After Hyperbaric Chamber Explosion - The family of a boy who was fatally burned in a hyperbaric chamber explosion has filed wrongful death lawsuits, claiming the Ocean Hyperbaric Oxygen Neurologic Center was negligent in their treatment. A Miami TV station reported that the facility had been cited several times for violations of local codes and fire safety standards. The Lauderdale-by-the-Sea fire marshal told the station that the center had several unresolved violations related to its hyperbaric chambers. The marshal said there was no high-pressure alarm on the oxygen tank there.
The Broward County Sheriff’s office told the station that the chamber involved in the explosion is old. It used an electric motor to seal the hyperbaric chamber shut.
HBOT fails miserably in Canadian CP study
- Cerebral Palsy Treatment Doubted - The Lancet - Feb. 23, 2001
My comments on the results would suggest that anyone who offers these treatments for infants or children with CP should be investigated for malpractice and consumer fraud.
Complaints can be made against Ontario licensed medical doctors who use this method of treating infants and children for CP.
E-mail the College of Physicians and Surgeons at: firstname.lastname@example.org
CQ - Canadian QuackeryWatch's focuses on the questionable use of hyperbaric oxygen for unproved conditions, such as cerebral palsy, multiple sclerosis, and Alzheimers.
Earlier we covered the bizarre death Dan Skala, an adult who suffocated himself inside a chamber that he was using to treat his headaches.
Questions needing answers - Who killed Dan Skala?
- Why did a 36 year old Canadian man die in his own hyperbaric oxygen tank?
- Who supplied the oxygen, who sold him the tank?
- Were there any health professionals involved in his treatment or support?
- If health professionals were involved, who were they, and what do they practice?
Hyperbaric oxygen is a growth industry - so why isn't it regulated?
- Who are the parents who are willing to place their children inside hyperbaric chambers to treat their cerebral palsy? What are they being told?
- Who are the healthcare professional involved in this promotion, and what is their training, and liability?
- When does experimental treatment become quackery, and why aren't any of the regulated health professional colleges about to step in to do something about it?
- What does it cost?
- Why does the government allow this unproven procedure to go unregulated?
Warning these links are pro-HBOT links intended to support the use of hyperbaric oxygen treatment for things like cerebral palsy. They are not generally accepted by pediatricians or medical doctors, although ongoing research may or may not show any positive effect.
- Quack cancer treatment supporter wants to invest in Ottawa unit
A controversial cancer patient advocate
plans to open a clinic next April in Ottawa
that will offer hyperbaric oxygen therapy to
people with cancer.
Bill O'Neill, who runs the Canadian Cancer
Research Group, says the clinic will also
treat cerebral palsy, burns, head injuries
and multiple sclerosis.
- Here he is again in July 4, 1998 article on cancer serum. What won't he think of next?
- Oxygen therapy 'makes brain work better' - Florida MD visited Ottawa to describe brain-damage treatment. The good news is that he believes the controversial therapy can probably help children with brain damage. The bad news is that it takes 200 to 300 treatments -- far more than most parents can afford. And it doesn't help everybody.
Interesting links and reviews
- Is there no end to unscientific treatments for autism? - Science Based Medicine
HBOT can also be used to treat a variety of other conditions that are responsive to increased oxygen tension, such as anaerobic bacterial infections. But hyperbaric chambers are not without risk. Small errors can cause big problems, including death.
Strangely enough, though, you can buy your very own hyperbaric chamber for use in your own home, and parents of autistic children are doing just that.
So why does anyone think that HBOT might be appropriate for the treatment of autism? Is it even plausible? Autism spectrum disorder (ASD) is a very broad diagnostic category. Autism is a neurobehavioral disorder of inconsistent severity and unknown cause.
- Doctors question benefit of hyperbaric oxygen therapy for autistic children
Andrew, who is 10 years old, is autistic. His parents are giving HBOT a try even though no studies have been done on the effectiveness of HBOT in treating autism; even though insurance doesn't cover the 90-minute, $200 HBOT "dives" for the treatment of autism; even though virtually every doctor who doesn't make money administering the treatment to autistic children is skeptical about using it for such patients.
- HBOT: Is it just a bunch of hot air?
Hyperbaric Oxygen Therapy (HBOT) is arguably the hottest new fad in the “alternative” autism therapy world. Parents all over the US are stuffing their autistic children into zip-up “soft chambers” to experience this latest “cure”.
But what are they actually doing for (to) their children?
- HYPERBARIC OXYGEN THERAPY - Review Article - full text of the NEJM article
Hyperbaric oxygen has been described as "a therapy in search of diseases."88 Many of its past uses
had little or no scientific support. The discovery of beneficial cellular and biochemical effects has
strengthened the rationale for administering hyperbaric oxygen as primary therapy in patients with
severe carbon monoxide poisoning, decompression sickness, and arterial gas embolism, and as
adjunctive therapy for the prevention and treatment of osteoradionecrosis, clostridial myonecrosis,
and compromised skin grafts and flaps.
- Gillette Children's Hospital opinion - Under pressure from patients and their families to fund HBO treatment for children with cerebral palsy, the Quebec Health Ministry opted to first
conduct an investigative trial. The results, reported at the 2000 annual meeting of the American Academy of Cerebral Palsy and Developmental
Medicine, offer the first definitive evidence that HBO treatment in children with cerebral palsy is largely ineffective.
- Critique of Tibbles and Edelsberg article from NEJMTibbles and Edelsberg (June 20 issue) (1) present a complete and cogent summary of the therapeutic usefulness of
hyperbaric-oxygen therapy. However, their review contains a recommendation that is not supported by evidence.
The Role Of Hyperbaric Oxygen Therapy In Emergency Medicine - Thomas M. Bozzuto, D.O. is Medical Director, Hyperbaric Medicine & Wound Care Service for Baptist/St. Vincent's Health System. Jacksonville, Florida
Research in the effects of HBOT at the cellular level have provided enough data
that the majority of rational physicians no longer consider HBOT as magic, voodoo, or merely a waste of time and money. In
emergency medicine, there are two main indications for HBOT: Carbon Monoxide, Cyanide or Hydrogen Sulfide Poisoning,
and a constellation of symptoms categorized as Decompression Illness.
- Physician and Sports Medicine article reviews alternative medicine treatments
NO esearch documents the effectiveness of hyperbaric oxygen for such musculoskeletal injuries;
in fact, a recent randomized double-blind study (13) of 32 subjects with acute ankle sprains
found that hyperbaric oxygen treatment had no effect on time to recovery.
Nonetheless, professional teams have been purchasing hyperbaric oxygen chambers with the aim
of speeding players' recovery and even enhancing performance with pre-game doses.
- - Fife HBOT web site - Dr. Fife's site is full of so much misinformation about CP in children, it's worth a visit to see how much people can be bamboozled by false claims. They have criticized the Montreal study here. But, follow their own links to the research studies an you can sort it out for yourself.
Undersea and Hyperbaric Medical Society