Thoughtful House article

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http://www.statesman.com/news/content/news/stories/local/05/04/0504thoughtful.htmlAUTISM TREATMENTAustin center charts different course on autismThoughtful House supporters say children make big improvements there;mainstream doctors call treatments unproven.By Ann Roser<http://www.statesman.com/news/content/news/stories/local/05/04/mailto:maroserstatesman> AMERICAN-STATESMAN STAFFSunday, May 04, 2008 travels from northern Louisiana with her four sons to atan building on a hillside in Rollingwood for the kind of medical attentionshe says they can't get anywhere else.Mainstream medicine calls autism lifelong, but says that because ofthe treatment her 9-year-old has received at the Thoughtful House Center forChildren, he is "not autistic anymore." She credits the center withimprovements in her other sons - two of whom struggle with attention deficitdisorders, she says, and another with asthma.Since it opened in 2005, Thoughtful House has seen about 2,500 patients,officials there said. The nonprofit has attracted celebrity supporters inAustin and parents from around the world who say mainstream doctors offeredthem little help - and no hope - for their children. They say their childrenare recovering from autism at Thoughtful House.But government scientists, other researchers and many mainstream doctorshave repeatedly challenged the theory on which Thoughtful House anchors muchof its work, and they say there is no credible science behind many of itsprescribed medical treatments. Those include procedures that even the doctorwho oversees them at Thoughtful House says haven't been proved effective onautistic children through large scientific studies, such as a drug therapyfor removing heavy metals from the body called chelation that some doctorsconsider dangerous.The father of the autism theory is Thoughtful House's executive director, Wakefield, a British-born gastroenterologist.. He has theorized thatthe steep rise in autism could be linked to the three-in-one MMR vaccinationfor measles, mumps and rubella that toddlers get.Autism is a spectrum of disorders ranging in severity and affecting aboutone in 150 people. People with autism generally have trouble communicatingand interacting with others and exhibit odd or repetitive behaviors. Thoughmost doctors say improvements can occur, especially when behavioral andother therapies start early, they believe there is no cure.Under Wakefield's theory, live measles virus, apparently from the MMRvaccine, causes gastrointestinal problems such as abdominal pain, diarrheaand constipation in certain children. Toxins then leak from the intestinesinto the bloodstream and enter the brain, causing once-normal children todevelop autism. Wakefield and his research collaborators named thiscombination of autism and bowel problems autistic enterocolitis.Mainstream medicine has not found evidence of such a condition."I don't think there is any specific gastrointestinal problem that isassociated with autism," said Dr. , chairwoman of an expertpanel on autism for the American Academy of Pediatrics and a retiredprofessor of pediatrics at the University of Texas Health Science Center atSan . "Autistic enterocolitis has not been proven to exist."Wakefield was the lead author of a 1998 paper in The Lancet, a prestigiousBritish medical journal, that first suggested a link between the MMR vaccineand autism. That report unleashed a worldwide vaccination scare; onlyrecently have immunization rates begun to rebound in Britain.But his theory has made him a hero to a vocal group of parents and leadersof autism organizations who consider Wakefield a latter day Galileopersecuted by a close-minded medical establishment."He's a hero because he's brave enough to tell the truth," saidfrom her home in Ruston, La. "He has given a voice to all of us."A 'fatal conflict of interest'Wakefield says he is not anti-vaccine, but he believes some children haveweakened immune systems that may be overwhelmed by the MMR or othermultiplevaccines, which he contends have not been adequately tested for safety. Hehas suggested separating the MMR into individual shots or spreading outvaccinations over a longer time - a strategy mainstream medicine does notendorse.Wakefield concedes that many questions remain unanswered. "I don't know whatcauses the majority of autism cases. No one does," he wrote in a recente-mail.In the wake of The Lancet paper, the U.S. Institute of Medicine and largestudies in Europe concluded that the MMR vaccine is safe and there is noevidence that it causes autism.Since then, the controversy has spilled into the courts and other governmentforums. Cedillo, a 13-year-old from Arizona and a Thoughtful House patient,is the lead plaintiff in a class-action suit against the U.S. government onbehalf of 4,900 others who claim their autism was caused by vaccines.After publishing the 1998 paper, The Lancet said it learned that Wakefieldhad been paid about $90,000 by Britain's Legal Aid Board to study the MMRvaccine for a lawsuit against its manufacturers. Wakefield told theAmerican-Statesman in 2004 that the money went to London's Royal FreeHospital School of Medicine, where he had worked. The board eventuallydropped its support for the suit, citing a lack of evidence linking thevaccine to autism, according to published reports.The Lancet's editor told British media in 2004 that he considered the$90,000 payment a "fatal conflict of interest" that almost certainly wouldhave caused the journal to reject the paper. That year, 10 of Wakefield's 12co-authors retracted the paper's interpretation, saying there wasinsufficient evidence to suggest a link for the MMR vaccine,gastrointestinal illness and autism.Wakefield has never wavered. Britain's General Medical Council, whichregulates doctors, is now seeking to cancel Wakefield's British medicallicense, charging among other things that he was dishonest in obtaining theLegal Aid money, failed to disclose to The Lancet his involvement in apatent application for an alternative measles vaccine and took blood fromchildren at his son's birthday party for research samples, paying them about$10 each. Two of his co-authors also face allegations in connection with TheLancet study. All three are accused of causing children to undergounwarranted invasive procedures, including colonoscopies and spinal taps,according to council documents.All three have denied wrongdoing, and Thoughtful House Director ofOperations Anissa Ryland said the allegations against Wakefield "were basedon misinformation and incomplete knowledge of the facts. Not one patient orfamily has ever made a complaint against Dr. Wakefield, and he has acted atall times in the best interest of the children."As the months-long hearing continued this month in London, Wakefieldtestified that while he was unfamiliar with ethical guidelines on researchinvolving children, he relied on colleagues with expertise in that area,according to press reports in England.Thoughtful House says Wakefield's findings on intestinal disease and autismhave been confirmed by numerous independent researchers, including instudies in the United States, Italy and Venezuela. Wakefield is theco-author of most of those published studies. Former Wakefield colleagueswrote some of the others and in some cases received research funding fromcharities Wakefield headed.Thoughtful House also says Wakefield's work has been confirmed by a studymade public in 2006 by , a Thoughtful House adviser and anassistant professor at Wake Forest University's Institute for RegenerativeMedicine, and others, including Dr. Arthur Krigsman, a New York pediatricianand gastroenterologist who is one of the two physicians treating children atThoughtful House.But said the study is "not close to being published." He alsocautioned that it won't confirm the MMR vaccine causes autism. saidalthough he knew of no problems with The Lancet paper, he knew of no othermajor study that replicated Wakefield's work.From Austin, Wakefield continues to conduct research on the theories he laidout in The Lancet paper, often using blood and tissue samples from patientsat Thoughtful House.High-profile loyalistsWakefield resigned from hisLondon medical school job in 2001 - hewas quotedin news reports as saying he was asked to go "because my results areunpopular" - and came to the United States that year to continue his work.He already had supporters, including Liz Birt, an Illinois attorney who hadbrought her autistic son to England in 1999 to see if Wakefield could helphim. Birt, who died in a car wreck in 2005, created a nonprofitorganization, Medical Interventions for Autism, with Wakefield as president,to finance his research, according to IRS documents and published interviewswith Birt.That nonprofit laid the groundwork for Thoughtful House, raising $1.2million in 2004 alone, according to IRS documents. Of that, $1 million camefrom and Jane of New York, part of the family thatfounded the & health care products and services company. Thes' son had intestinal problems and was seeing Krigsman, and Jane said she became interested in supporting Wakefield's research afterattending a 2001 conference by Defeat Autism Now, a program of the AutismResearch Institute. The institute promotes alternative treatments forautism, and many Thoughtful House parents say they met Wakefield or heard ofThoughtful House at Defeat Autism Now conferences. , now co-managingdirector of the Thoughtful House board, said her son was misdiagnosed ashaving autism elsewhere but is actually learning disabled.Wakefield's work also has attracted prominent Central Texans as supporters:Former Dell Inc. executive Charlie Ball and his wife, Troylyn, whose sonstruggled with physical and developmental problems, were founders ofThoughtful House. Wakefield said he chose Austin because of its "wonderfulcommunity spirit" and the region's lack of "effective medical services"aimed at autistic children.Others joined as board members, includingformer major-league baseball playerand Texas Longhorn Greg Swindell; former Dell executive Nater; Robison of the Dixie Chicks; film producer Avellan, the formerwife of director ; and Dr.Deborah Peel, an Austinpsychiatrist and the founder of a national consumer organization, PatientPrivacy Rights. Martie Maguire of the Dixie Chicks and her husband, Gareth,are Thoughtful House advisers.In January 2005, Thoughtful House began offering education services, andlater that year, on-site collaborators started providing behavioral andnutritional services, according to Ryland, the operations director.Thoughtful House says on its Web site that it is "fighting to recoverchildren with developmental disorders" such as autism, attention deficitdisorder and nonverbal learning disabilities.Mainstream medicine treats autism mainly with speech, occupational andbehavioral therapies. Thoughtful House collaborates with the Center forAutism and Related Disorders, which has an office on the Thoughtful Houseproperty and uses one of those mainstream therapies, Applied BehaviorAnalysis. Research shows that the intensive therapy - which uses a varietyof techniques to change behavior, including positive reinforcement - iseffective for autism.Thirty-five percent of patients at Thoughtful House take part in researchoverseen by Wakefield, Ryland wrote in an e-mail. (Thoughtful Houseofficials declined to be interviewed in person or give a tour of thefacility.) She said those patients are already getting blood work or acolonoscopy as part of their care and consent to donate extra blood ortissue to research.Thoughtful House has been offering medical services since January 2006,Ryland wrote.Wakefield has no medical license in the United States and doesnot treat patients, leaving that work to Thoughtful House's physiciancollaborators, Krigsman and Jepson, a former emergency medicinedoctor. Jepson has a son with autism and wrote a 2007 book, "Changing theCourse of Autism," with Jane .Children who go to Thoughtful House may undergo a series of tests to bediagnosed, according to the center's Web site. If they have gastrointestinalproblems, Krigsman might perform an endoscopy at an Austin surgery center -a procedure in which the doctor uses a thin tube to examine thegastrointestinal tract. Colonoscopies, a type of endoscopy, typicallyinvolve sedating the patient.Krigsman had been performing endoscopies on children at Lenox Hill Hospitalin New York until he left there in December 2004. He sued the hospital,claiming it was wrongly trying to restrict his hospital privileges byalleging that he was doing endoscopies that were not medically necessary, hetestified during the Cedillo court proceedings.. Krigsman's suit wasdismissed on procedural grounds.After diagnosing a patient, Thoughtful House offers a variety of treatmentsthat may include vitamin and mineral supplements, antifungal medications totreat an overgrowth of yeast in the intestines and a strict diet that limitscertain grains and dairy products, according to parents.Jepson also prescribes chelation for some Thoughtful House patients. Theprocedure involves delivering drugs intravenously, orally, by suppository ortopically to remove heavy metals from the body such as mercury, aningredient in childhood vaccines until it was discontinued in 2001 (it isstill used in flu shots). In his book, Jepson said metals from vaccines, theenvironment or other sources can damage children's brain cells, intestinaltracts and immune systems.Pediatricians and mainstream researchers say they are especially concernedabout the use of chelation in autistic children, noting it's approved by theFood and Drug Administration only to remove lead from the body. It's notuncommon for doctors to employ "off label" treatments, but critics cite the2005 death of a 5-year-old autistic boy who was given the wrong drug duringchelation therapy in Pennsylvania.Jepson says in his book that it's difficult to diagnose heavy metal toxicityand there are no standards for determining when an individual should getchelation or for how long. Still, he wrote that "thousands of autisticchildren have been chelated by various means, and anecdotal reports arefavorable," and he considers chelation to be "generally safe and welltolerated if done under appropriate medical supervision." Children withautism improve with it, he wrote, even though, "to date, no controlledtrials of chelation in autistic children have been published."Gap in state, local oversightThoughtful House also recommends that some patients undergo sessions in ahyperbaric oxygen chamber, a technique used in hospitals for gangrene andwounds and for treating divers with the bends. Keefe, a Dallas lawyer, said Thoughtful House recommendedchelation, a special diet, hyperbaric therapy and other treatments for herson, who is in kindergarten and whose autism she blames on vaccines. Shesaid her son improved greatly in his speech after 20 hyperbaric sessions andhas done more than 100 sessions at the half-price rate of $50 at ThoughtfulHouse.Thoughtful House is compiling data on a clinical trial it conducted onhyperbaric oxygen therapy. In his book, Jepson wrote that the theory behindthe therapy is that pure oxygen relieves an oxygen deficiency in thetissues, which can help decrease intestinal bacteria and strengthen immunefunction in autistic children.As with chelation, Jepson wrote that no large, controlled scientific studieshave shown that hyperbaric oxygen, antifungals or various diets areeffective for treating autism. Instead, he cites anecdotal evidence - theexperience of parents and doctors - to support a variety of treatments thatlack scientific evidence. Ryland wrote that Thoughtful House staff members"all do our best to work together with the families to help them makeinformed risk vs. benefit decisions."The clinic at Thoughtful House is not inspected by state or local healthofficials. In Texas, small clinics headed by doctors are not regulatedexcept to the extent that a physician must answer to the Texas MedicalBoard, which investigates complaints against doctors, according to theDepartment of State Health Services. Neither Krigsman nor Jepson has beendisciplined by the board, although both were fined in 2005 for a technicalviolation: an announcement on the Thoughtful House Web site that the doctorswere accepting patients before the board had issued their medical licenses.Outside, independent institutional review boards hired by Thoughtful Houseto oversee its research trials said they have not received any patientcomplaints, nor have they visited Thoughtful House.Thoughtful House charges $390 per hour for consultations and follow-upvisits and $600 to $1,000 for "initial labs," according to its Web site.Several parents of Thoughtful House patients said the cost isn't asimportant as having access to treatments they say can yield life-changingresults.Hope with a sizable price tag said she suspects her youngest son became autistic at age 3 from a"toxic soup" of vaccines. That was when he stopped interacting with othersand became paranoid and terrified to be out of her sight, said."He had extreme temper meltdowns," she said.His immune system was not functioning properly and he would get staphinfections on his head that wouldn't heal, she said. He lost his short-termmemory.They went to doctors, but "no one could give me answers," said , wholearned of Wakefield's research on the Internet. of New York said she and her husband, s, spent $200,000the year their son, Christian, was diagnosed with autism at age 2.Christian, now 6, had chronic diarrhea and screamed and drooled constantly.He stopped speaking and rubbed feces on the walls, said , who wrotethe foreword to Jepson's book.They sought help from doctors in Boston, Chicago and Cleveland, said,before going to Krigsman for an endoscopy that resulted in a diagnosis ofbowel disease."We spent our life's savings ... until we addressed his underlying gutdisease," she said.Now, under Jepson's care at Thoughtful House, her son is on a special dietand gets chelation in New York. said they rent a hyperbaric chamberfor him and he also gets intravenous immunoglobulin therapy, a human bloodproduct that is used to improve immune function, at a cost of $7,000 amonth, said. It's covered by insurance because of his diagnosedmedical problems, she said. said her son is doing better, and with help from Thoughtful House anda nutritionist who collaborates with the center, she is managing hisintestinal disease.Families with incomes below $80,000 a year are eligible for up to $2,000 peryear in grants from Thoughtful House. The aid has helped 68 families sinceJuly 2006, said Jane , who added that education and therapy for anautistic child ranges from $20,000 to $60,000 a year no matter where thechild goes.The center does not accept insurance, but some parents said their healthplans have reimbursed them for some procedures.The center's charges don't sound "out of the ballpark" of what's reasonable,Austin pediatrician Ari Brown said, but "I'm leery to send a patient overthere."Brown, a co-author of two books on caring for children, said she's open tonew therapies as long as they are based on scientific evidence. Relying onanecdotal evidence is OK, she said, "when it's benign and not costly. Butthey're really raising the ante with the stuff they're doing."Dr. Fitzpatrick, a British pediatrician and author, said he iswriting a book on unproven autism therapies, including many of the treamentsused at Thoughtful House and elsewhere. As the father of an autistic son, hesaid, it surprises him that parents can be so critical about vaccines yethave "no qualms" about trying experimental therapies on their children.Mainstream medicine has let down parents because it doesn't know what causesautism and doesn't have a cure, said Dr. Offit, chief of infectiousdiseases at Children's Hospital of Philadelphia and a professor ofpediatrics at the University of Pennsylvania. That has left some parentsvulnerable to places like Thoughtful House, which, he said, "offer falsetherapies based on a biological premise that has been disproved.""The treatment they're offering is expensive, and it's misleading," addedOffit, a Wakefield critic and co-inventor of a vaccine to prevent diarrhealillness. "If this country were better at supervising quackery, places likeThoughtful House wouldn't exist."To parents who insist that Thoughtful House and Wakefield have made a bigdifference in their families' lives, such criticisms only make them angry."It's going to take a lot to convince me," said Mara LaViola of Frisco, whohas a son with autism, "that he's not our hero."maroserstatesman; 445-3619