Excerpted from NHS Choices

Full Article Here

By Dr Alicia White

If you’ve just read a health-related headline that has caused you to spit out your morning coffee (“Coffee causes cancer” usually does the trick), it’s always best to follow the Blitz slogan: “Keep Calm and Carry On”. On reading further, you’ll often find the headline has left out something important, such as, “Injecting five rats with really highly concentrated coffee solution caused some changes in cells that might lead to tumours eventually. (Study funded by The Association of Tea Marketing)”.

The most important rule to remember is: don’t automatically believe the headline. It is there to draw you into buying the paper and reading the story. Would you read an article called, “Coffee pretty unlikely to cause cancer, but you never know”? Probably not.

To avoid spraying your newspaper with coffee in the future, you need to analyse the article to see what it says about the research it is reporting on. Bazian (the company I work for) has appraised hundreds of articles for Behind The Headlines on NHS Choices, and we’ve developed the following questions to help you figure out which articles you’re going to believe and which you’re not.

Does the article support its claims with scientific research?

Your first concern should be the research behind the news article. If an article touts a treatment or some aspect of your lifestyle that is supposed to prevent or cause a disease, but doesn’t give any information about the scientific research behind it, then treat it with a lot of caution. The same applies to research that has yet to be published…

Click here to continue the full article.

The makers of antipsychotic drugs Risperdal and Invega are facing a series of lawsuits after boys taking the drugs grew breasts as large as ‘D’ cups.

The patients who were prescribed the antipsychotics for conditions ranging from attention deficit disorder to Tourette syndrome and disruptive behavior, experienced quick weight gain and breast growth to the tune of a size 38D, in some cases, the lawsuits say.

Because of the weight gain, the boys’ lawyer says their doctors may have overlooked the seriousness of the breast growth. Now many of the boys will require surgical breast removal.

The lawsuits accuse the manufacturers of Risperdal and Invega of negligence and fraud and say that the companies did too little to make people aware of the drugs’ potential side effects.

Risperdal is approved by the Food and Drug Administration to treat autism in addition to schizophrenia and bipolar disorder. Invega, a similar drug, is approved for the treatment of schizophrenia…
To read more click here.

Risperdal is also indicated in rapid weight gain and the development of diabetes. For more detailed information, see A Word of Caution About the Use of Risperidone.

“In 1998, Andrew Wakefield, a gastroenterologist at London’s Royal Free Hospital, published a study in the prestigious medical journal Lancet that linked the triple Measles, Mumps and Rubella (MMR) vaccine with autism and bowel disorders in children. The study — and Wakefield’s subsequent public statements that parents should refuse the vaccines — sparked a public health panic that led vaccination rates in Britain to plunge.

Wakefield’s study has since been discredited, and the MMR vaccine deemed to be safe. But now medical authorities in the U.K. have also ruled that the manner in which Wakefield carried out his research was unethical. In a ruling on Jan. 28, The General Medical Council, which registers and regulates doctors in the U.K., ruled that Wakefield acted “dishonestly and irresponsibly” during his research and with “callous disregard” for the children involved in his study.”

…

“The panel also criticized Wakefield for failing to disclose that, while carrying out the research, he was being paid by lawyers acting for parents who believed their children had been harmed by the MMR jab.

The panel’s ruling follows a refutation of Wakefield’s research from the scientific community. Ten of 13 authors in the Lancet study have since renounced the study’s conclusions. The Lancet has said it should not have published the study in the first place, and various other studies have failed to corroborate Wakefield’s hypothesis.”

Autism Treatment: Science Hijacked to Support Alternative Therapies
Researchers’ Fears of Misuse of Their Work Comes True

Autism Treatment: Success Stories More Persuasive to Some Than Hard Data
One Dad, a Doctor, Says He Was “Fooled”

Autism Treatment: Questionable Treatments for Children with Autism

By RONI CARYN RABIN
Published: July 27, 2009

Many parents of autistic children have put their children on strict gluten-free or dairy-free diets, convinced that gastrointestinal problems are an underlying cause of the disorder. But a new study suggests the complicated food regimens may not be warranted.

Researchers at the Mayo Clinic reviewed the medical records of over 100 autistic children over an 18-year period and compared them to more than 200 children without the disorder. The scientists found no differences in the overall frequency of gastrointestinal problems reported by the two groups, though the autistic children suffered more frequently from bouts of constipation and were more likely to be picky eaters who had difficulty gaining weight.

The study, published on Monday in the journal Pediatrics, is the first to look at the incidence of gastrointestinal problems in an autistic population, according to the paper’s first author, Dr. Samar H. Ibrahim, a pediatric gastroenterologist at the Mayo Clinic. She suggested that autistic children should only be put on restrictive wheat-free or dairy-free diets after having appropriate diagnostic tests done.

Read the full article here

However, a potentially permanent condition called Tardive Dyskinesia (TD) is listed as one side-effect of Risperdal use, and the study, featured on the New England Journal of Medicine, conducted was of too short a duration to measure instances of TD in the children.   “The short period of this trial limits inferences about adverse effects such as tardive dyskinesia.” (2)

TD is a serious, sometimes permanent side effect reported with RISPERDAL and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body.  Additionally, The Miami Herald reported in July of 2005 that several boys in Florida developed lactating breasts after taking Risperdal. (3)

Additionally Janssen, the manufacturer of Risperdal recently admitted that it “misled” health care professionals by downplaying the potentially fatal side effects of the drug including strokes, diabetes, and other potentially fatal complications in 2004. (4)

The Cochrane Collaboration, international not-for-profit and independent organization, dedicated to making up-to-date, accurate information about the effects of healthcare readily available worldwide, concluded  that “Risperidone can be beneficial in some features of autism. However there are limited data available from studies with small sample sizes. In addition, there lacks a single standardised outcome measure allowing adequate comparison of studies, and long-term followup is also lacking. Further research is necessary to determine the efficacy of risperidone in clinical practice.” (5)

AutismUAE cautions parents against the advice of physicians who would prescribe Risperdal for their children, especially if the children are under the age of those covered in the study (5) or do not present any of the symptoms of violence, aggression, or self-injury that Risperdal claims to be beneficial for.  Parents are strongly cautioned against the use of anti-psychotics or anti-depressant medications for children with Autism, and recommend seeking second or third opinions before making a decision about treatment.

(1) Official Risperdal Autism site

(2) The New England Journal of Medicine

(3)(4)  The Washington Post

(5) The Cochrane Database of Systematic Reviews 2009 Issue 3, Copyright © 2009 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).

By Dr. Stephen Barret, M.D.

Mercury is found in the earth’s crust and is ubiquitous in the environment. Because of this, it is common to find small amounts in people’s urine. The body reaches a steady state in which tiny amounts are absorbed and excreted. Large-scale population studies have shown that the general population has urine-mercury levels below 10 micrograms/liter, with most people between zero and 5 [1]. Similarly, many people circulate trivial amounts of lead.

Urine lead and mercury levels can be artificially raised by administering a scavenger (chelating agent) such as DMPS or DMSA, which attaches to lead and mercury molecules in the blood and forces them to be excreted. In other words, some molecules that would normally recirculate within the body are bound and exit through the kidneys. As a result, their urine levels are artificially and temporarily raised. How much the levels are raised depends on how the test is administered. The standard way to measure urinary mercury and lead levels is by collecting a non-provoked urine sample over a 24-hour period. Because most of the extra excretion takes place within a few hours after the chelating agent is administered, using a shorter collection period will yield a higher concentration.

When testing is performed, the levels are expressed as micrograms of lead or mercury per grams of creatinine (µg/g) and compared to the laboratory’s “reference range.” Several years ago, a well-designed experiment tested workers who had industrial exposure to mercury. The researchers found that provocation with DMSA raised the 24-hour average urine mercury level from 4.3 µg/g before chelation to 7.8 µg/g after chelation [2]. Because most of the extra excretion occurs toward the beginning of the test, it is safe to assume that the provoked levels would have been 2-3 times as high if a 6-hour collection period had been used.

Practitioners who use the urine toxic metals test typically tell patients that provocation is needed to discover “hidden body stores” of mercury or lead. However, the above experiment proved that provocation raises urine levels as much in exposed workers as in unexposed control subjects and that rise is temporary, should be expected, and is not evidence of “hidden stores.”

Doctor’s Data uses a reference range of less than 3 ug/g for mercury and 5 ug/g for lead. Standard laboratories that process non-provoked samples use much higher reference ranges [3], which means that if all other things were equal, Doctor’s Data is far more likely than standard labs to find “elevated” levels. But that’s not all. A disclaimer at the bottom of the above lab report states—in boldfaced type!—that “reference ranges are representative of a healthy population under non-challenge or nonprovoked conditions.” In other words, they should not be applied to specimens that were obtained after provocation. Also note that the specimen was obtained over a 6-hour period, which raised the reported level even higher.  

The management at Doctor’s Data knows that provoked testing artificially raises the urine levels. Yet their report classifies values in the range of 5-10 µg/g as “elevated. The report also states that “no safe reference levels for toxic metals have been established.” Practitioners typically receive two copies of the report, one for the practitioner and one to give to the patient. Very few patients understand what the numbers mean. They simply see “elevated” lead or mercury, and interpret the “no safe levels” disclaimer to mean that any number above zero is a problem. The patient is then advised to undergo “detoxification” with chelation therapy, other intravenous treatments, dietary supplements, or whatever else the practitioner happens to sell.

This advice is very, very, very wrong. No diagnosis of lead or mercury toxicity should be made unless the patient has symptoms of heavy metal poisoning as well as a much higher nonprovoked blood level. And even if the level is in the 30s—as might occur in an unsafe workplace or by eating lead-containing paint—all that is usually needed is to remove further exposure. Chelation therapy is rarely necessary.

Chelation therapy is a series of intravenous infusions containing a chelating agent and various other substances. One form of chelation therapy is occasionally used to treat lead poisoning. However, lead poisoning is rare and has well-established diagnostic criteria. Slight elevations of lead levels are not poisoning and need no treatment because the body will lower them when exposure is stopped. Proper diagnosis of lead poisoning requires symptoms of lead poisoning, not just a slightly elevated level. Acute poisoning is always accompanied by a rise in zinc protoporphyrin (ZPP), without which it should not be diagnosed. Chronic poisoning would have severe symptoms that would be obvious to anyone in addition to severely elevated lead (and ZPP) levels.

Doctors who offer chelation therapy as part of their everyday practice typically claim that it is effective against autism, heart disease and many other conditions for which it has no proven effectiveness or plausible rationale [4]. One such case was described in a recent decision by the U.S. Court of Federal Claims which found no credible evidence that childhood vaccinations cause autism. In that case, Colton Snyder underwent chelation therapy after a Doctor’s Data urine test report classified his urine mercury level as “very elevated.” After noting that the urine sample had been provoked (with DMSA) and that provocation artificially increases excretion, the Special Master concluded that a non-provoked test would have placed the result in the normal range. He also noted:

The medical records, including reports from Mrs. Snyder, reflected that Colten did poorly after every round of chelation therapy. . . . The more disturbing question is why chelation was performed at all, in view of the normal levels of mercury found in the hair, blood, and urine, its apparent lack of efficacy in treating Colten’s symptoms, and the adverse side effects it apparently caused [5].

In March 2009, Arthur Allen tried to interview an official at Doctor’s Data but received no response to his request. However, he did manage to talk with someone at the company who said that the lab was doing about 100,000 of the tests per year. When he asked about the reference range problem, he was told there was no way to establish a reference range for provoked speciments, because provocation might be done with various chelating agents, at varying doses. “The tests are ordered by physicians, so they can interpret the results,” the employee said. “They do what they want with this information.” [6]

Despite provocation, the toxic urine test report sometimes shows no elevated levels. But that doesn’t deter the doctors who are intent on chelating children. They simply tell parents that the children have trouble excreting heavy metals and the test may not detect “hidden stores.” In other words, no matter what the test shows, they still recommend chelation.

Regulatory Actions

At least four state licensing boards have been concerned about the issue of provoked urine testing as a prelude to chelation.

• Connecticut has included a provoked testing ban in settlement agreements with two practitioners. In 2005, Robban Sica, M.D., signed a consent order under which she was prohibited from using a provoked test to diagnose heavy metal toxicity [7]. In 2006, George Zabrecky, D.C., was ordered to stop all testing that might be preliminary to chelation therapy [8].
• In 2006, Washington’s Bureau of Medical Quality Assurance charged Stephen L. Smith,M.D., with unprofessional conduct for relying on unreliable tests that included a urine toxic metals test. In 2007, he was ordered to pay a $5,000 fine and undergo a practice evaluation [9].
• In 2007, Tennessee suspended the license of Joseph E. Rich, M.D., after concluding that he had mismanaged the care of 15 patients, including three who were chelated after undergoing a provoked urine test. [10].
• In 2007, the North Carolina Medical Board charged Rashid A. Buttar, M.D., with exploiting four patients by charging exorbitant fees for worthless tests and treatments. At a 2008 hearing Buttar indicated that he recommends chelation for nearly all patients who consult him and routinely uses the urine toxic metals testing to evaluate them.

In 2004, CIGNA HealthCare Medicare Administration, which processes Medicare claims for Idaho, North Carolina, and Tennessee, issued a “Progressive Correction Action Review” which concluded that many claim submissions for chelation therapy had been inappropriate. This conclusion was documented by a study of 40 claims which found that in many cases, “heavy metal toxicity” was inappropriately diagnosed and no need for chelation with edetate calcium disodium was documented. The review criticized provoked testing and noted that it does not provide a basis for diagnosing past or current poisoning [11].

I believe that several agencies can and should do something to stop the fraud. If the FDA has jurisdiction over the software used to generate the test reports, it could ban its use. State licensing boards could prohibit the use of provoked testing and discipline practitioners who use it. State laboratory licensing agencies could prohibit testing of provoked specimens or order Doctor’s Data to raise its reference ranges and to stop comparing provoked test results to these non-provoked ranges. The Centers for Medicare & Medicaid Services’ Division of Laboratory Services can also ban the testing of provoked specimens. In addition, all of these agencies can and should issue public warnings.

The Bottom Line

The urine toxic metals test described above—whether provoked or not—is used to persuade patients they are toxic when they are not. I recommend avoiding any practitioner who uses it. If this test has been used to trick you, please send me an e-mail describing what happened and include your phone number.

References

1. Baratz RS. Dubious mercury testing. Quackwatch, Feb 19, 2005.
2. Frumkin H. Diagnostic chelation challenge with DMSA: A biomarker of long-term mercury exposure? Environmental Health Perspectives 109:167–171, 2001.
3. Brodkin E and others. Lead and mercury exposures: interpretation and action. Canadian Medical Association Journal 176:59-63, 2007.
4. Green S. Chelation therapy: Unproven claims and unsound theories. Quackwatch, July 24, 2007.
5. Vowell DK. Decision. Snyder v Secretary of the Department of Health and Human Services. In the U.S. Court of Federal Claims, Office of Special Masters. Case No. 01-162V, filed Feb 12, 2009.
6. Allen A. Treating autism as if vaccines caused it: The theory may be dead, but the treatments live on. Slate, April 1, 2009.
7. Consent order. In re: Robban Sica, M.D. , Connecticut Board of Health Petition No. 2002-0306-001-043, Feb 15, 2005.
8. Consent order. In re: George Zabrecky, D.C., Connecticut Board of Chiropractic Examiners Petition No. 2003-0109-007-001, Nov 16, 2006.
9. First amended statement of charges. In the matter of the license to practice as a physician and surgeon of Stephen L. Smith, M.D. Washington Department of Health, Bureau of Medical Quality Assurance, Docket No. 05-01-A-1038MD, Filed Jan 3, 2006.
10. Final order. In the matter of Joseph Edward Rich before the Tennessee Board of Medical Examiners, Docket No. 17.18-073557A, Dec 21, 2007.
11. CIGNA HealthCare Medicare Administration. Progressive correction action review,Nov 28, 2004

This article was revised on April 29, 2009.

Article Reprinted from the National Austistic Society, UK. Original source here.

This web page has been written to provide information on a particular intervention/approach and any research connected with it, not as a recommendation. The outcome of any approach will depend on the needs of the individual, which vary greatly, and the appropriate application of the intervention. An intervention that may help one individual may not be effective for another. It would therefore not be appropriate for the NAS to recommend any one particular practice or therapy.

This web page has been written to provide information on a particular intervention/approach and any research connected with it, not as a recommendation. The outcome of any approach will depend on the needs of the individual, which vary greatly, and the appropriate application of the intervention. An intervention that may help one individual may not be effective for another. It would therefore not be appropriate for the NAS to recommend any one particular practice or therapy.

What is Auditory Integration Training?

Dr Guy Bérard (now retired) was an ear, nose and throat specialist, in Annecy, France, who invented and developed an auditory training device. Dr Bérard began developing this in the early 1980s, when he learned that he himself was becoming deaf. He conceived of the idea of developing an electronic machine that would exercise the entire hearing apparatus – the ear drum, the small bones in the ear, the cochlear membrane, etc as a form of physical therapy, in a manner somewhat similar to that in which deteriorating joints and muscles can be rejuvenated by physical therapy and exercise. This technique was used with many of Dr Bérard’s patients, some of whom had autism, and many others with a variety of auditory difficulties. In relation to autism, Bérard thought that sound sensitivity and consequent behavioural disturbance could result from distortions in hearing. Dr Bérard states that “Auditory Integration Training cannot be called a cure for autism, but many (people) benefit greatly from the treatment.” (Bérard, 1997).

Bérard believed that AIT would bring about a re-education of the hearing process (Sinha et al, 2004). However Mudford and Cullen (2005) argue that Bérard’s justification for using AIT with autism was scientifically tenuous at best. They report that AIT sparked controversy within the communication sciences’ professional community. Critics argued that there was no scientific evidence for the type of hearing abnormalities in autism reported by Bérard. It is also considered that AIT is theoretically inconsistent with knowledge about structures and mechanisms of the ear (Mudford and Cullen, 2005).

The device consists of a machine containing a number of electronic elements, including a variety of auditory filters, which makes the sound emanating from the machine modifiable to be appropriate for the individual person, in accordance with their auditory sensitivities and deficiencies as determined by audiometric testing. The treatment comprises thirty-minute sessions twice a day for ten days. In use, the child/adult sits before the machine, wearing earphones, while specially selected music is played into the machine. The machine filters and amplifies the music as necessary and feeds the resulting modified music to each ear independently. The volume is set as loud as is possible without discomfort. However Audiokinetrons and other auditory integration devices are subject to U.S. import ban due to exceeding maximum allowable exposure to sound pressure levels specified by the US Occupational Safety and Health Administration. (Mudford and Cullen, 2005).

The late Dr Bernard Rimland (from the Autism Research Institute in America) was in touch with a number of parents of children with autism who had taken their children to be treated by Dr Bérard. The mother of one of these children has written a book about the experience. (Stehli, 1992).

Research into AIT

An initial pilot project conducted by Drs. Rimland and Edelson at Portland State University in 1990 offered some interesting results and so a second study was undertaken which examined several specific issues of the AIT procedure.

Another research project carried out at The Autism Research Institute in Sydney (Bettison 1996) indicated that although Auditory Training (AT) did lead to a significant improvement in sound sensitivity in general, a structured listening (SL) programme led to about the same amount of improvement. (The structured listening programme was a simplified version of the AT procedure, and omitted the input of the special equipment used in AT). Bettison stresses however, that her results do not prove that AT and SL were the actual cause of the childrens improvements, nor, if the interventions were beneficial, which aspects were having the beneficial effect. She concludes that both SL and AT appear to help in reducing sound sensitivity in many, but not all, children with autism who are sound sensitive.

Mudford and Cullen (2005), Romanczyk at al (2004), Sinha et al (2004), and Simpson et al (2005) provide overviews and critiques of research studies on AIT to date. Romanczyk et al (2004) report that studies have produced mixed results regarding the efficacy of AIT as an intervention for people with autism. In particular Simpson et al (2005) state “few studies have convincingly produced scientific evidence that AIT is indeed responsible for reported changes in behaviour and functioning.” (p. 186). Sinha et al (2004) conclude that there is no clear evidence yet for AITs effect.

Mudford and Cullen (2005), Romanczyk et al (2004), and Sinha et al (2004) raise concerns regarding limitations of research findings including flaws that they argue limit interpretation of the data, questions regarding clinical significance, lack of replicability, and small sample size. Romanczyk et al (2004) also cite reports of negative side effects which they argue raise ethical questions concerning the use of this procedure with people with autism. AIT is one of the more expensive treatment options for people with autism (Simpson et al, 2005). Furthermore as Simpson et al (2005) point out AIT uses equipment capable of producing sounds at decibels that may be harmful to a persons auditory system, and therefore it is important that the intervention only occur under the direction of a trained AIT specialist.

Romanczyk et al (2004) conclude that the nonstandardised and unregulated manner in which AIT is practised may place those seeking this treatment at risk. Romanczyk et al (2004) and Sinha et al (2004) call for methodological changes for future research to ensure validity and replicability. In particular it is argued that research concerning the efficacy of AIT should identify and evaluate target behaviours using direct observation and behaviour checklists (Simpson et al, 2005). Sinha et al (2004) conclude that more research is needed to inform decision making about this therapy for individuals with autism spectrum disorders. However Mudford and Cullen (2005) came to the conclusion that future research efforts might better be placed studying potential treatments other than AIT. They categorically state: “Finally, our unambiguous recommendation for families considering purchasing AIT: There is no good evidence that AIT will change behaviour beneficially. No independent studies have shown that AIT has positive effects on behaviour of children or adults with autism.” (Mudford and Cullen, 2005, p. 361). Romanczyk et al (2004) recommend that if efficacy is validated standardised delivery and practice for AIT should be executed.