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U. Rochester researchers discuss diet-autism trial

20 May

We’ve already blogged this story a couple of times on LeftBrainRightBrain. The GFCF diet is not effective as an autism treatment. When I found these videos on the University of Rochester website, I thought they would be interesting to many readers.

Obviously, the Rochester team knew this study would be getting publicity

They discuss the methodology and show pictures of some of the snacks. They discuss how the GFCF diet is non trivial to implement. They recommend (strongly) working with a good nutritionist.

Clinical Trial of the GFCF diet in children with GI disorders

19 May

The gluten free, casein free diet is not beneficial to all autistics. Not even most. But the question remains, how about a small subset? What about autistics with gastrointestinal (GI) conditions?

A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders

I find the phrasing “Autism Associated Gastrointestinal Disorders” a bit odd. Are they trying to say that the GI disorders are linked to the autism? Since there is no group as yet shown to have GI disorders linked to autism, this would seem a tricky criteria to implement. How will they, for example, chose those who have GI disorders “associated” with autism vs. those who have autism and GI disorders which are not associated?

Ah well, best not to get tied up in those details.

Here are the inclusion criteria:

Inclusion Criteria:

* Informed consent / Assent, as applicable must be signed prior to executing any study related procedure
* Children, male or female, 2 to 17 years old (inclusive)

Confirmed diagnosis of ASD according to the diagnostic measures:
o DSM-IV Symptom Checklist
o Autism Diagnostic Observation Schedule(ADOS)&/or Autism Diagnostic Interview Revised(ADI-R)within 18 months prior to entry into the study
* Able to consume at least 2 cartons of the study drink daily

Subjects must present with a current history of at least two of the following persistent GI symptoms as confirmed by the study physician:
o Diarrhea, as characterised by three or more loose stools a day for at least 8 out of 14 days
o Constipation as characterised by less than 3 bowel movements per week, for at least a 2-week period
o Esophageal reflux, as characterised by 3 or more episodes of regurgitation per day on 10 out of 14 days
o Abdominal pain manifested as pain after eating or self injurious behavior on at least 8 out of 14 days
o Suspected food allergy which is confirmed by a physician, as characterized as a recurrent reaction or association with specific foods

I think that last one is key–suspected food allergy with recurrent reactions to specific foods. Of course such conditions should be treated, and would likely respond to changes in diet.

I also question “Abdominal pain manifested as pain after eating or self injurious behavior on at least 8 out of 14 days”. How is self-injurious behavior a manifistation of abdominal pain? Yes, I can see how a child with abdominal pain could be self injurious, but I can also see that many children with self injurious behaviors could have them as a result of other conditions.

Here are the exclusion criteria:

Exclusion Criteria:

* Children with a history of anaphylaxis to dietary milk and wheat proteins
* Children with severe concurrent illness
* Children who are prescribed systemic steroids
* Children currently receiving chelation therapy, hyperbaric or antifungal treatment within 1 month of entry into the study and during the study period.
* Children with a confirmed diagnosis of celiac disease
* Subjects who have previously tried dietary elimination of casein and gluten for at least 1 month period and failed to demonstrate a response by parent perception
* Children who are unable to consume at least 2 cartons of the study drink daily

It strikes me a bit odd that children who have been on “The Diet” in the past but didn’t respond would be excluded while those whose parents who tried “The Diet” and perceive benefit would be included. But, I guess this is a treatment study, not a “demonstrate that GI complaints exist in autistic children” so that selection bias may be OK. It will be interesting to see to what level parents’ perceptions are accurate in these cases.

The real question I have is, why? Why do this study? Why focus on autistics? If a person, child or adult, autistic or not, has a food allergy and reacts to those foods, of course take them out of the diet.

But, not all of the children in this study will have suspected food allergies. Any two of the criteria above are required for inclusion in the study. But, I’m still stuck with “why autistics”. Why not study children, any children, who have GI complaints and see if they respond to the GFCF diet? Or, why not study both autistics and non-autistics and shed some light on the assertion that GI disorders are associated with autism?

The study is being conducted at Massachusetts General Hospital with Dr. Tim Buie as the investigator. Anyone interested in participating can find the contact information on the Clinical Trials announcement.

Blogging IMFAR: Opening Press Conference and GFCF Diet Trial Results

19 May

After air traffic/weather delays, I arrived in Philadelphia late last night. By the time I made my way downtown to the hotel, and had a chance to catch up on some required work e-mail, I was was pretty well ready for bed. Having had a very busy past couple of weeks at work did not leave me much time to preview the IMFAR program materials, so before turning in, I’d figured I’d better look through it thoroughly.

And that’s when the pure size of IMFAR finally sunk into my brain. To cover this, from one blogger’s perspective, is going to be a huge challenge. There is absolutely no way for one human to assign attention to all that is here in the field of autism research – a great deal of the presentations occur simultaneously in separate meeting rooms.

For me, IMFAR started with this afternoon’s press conference. Organized by INSAR, and following a brief introduction by Dr. David Amaral (INSAR’s president), Dr. David Mandell (the IMFAR Scientific Program Committee Chair) spoke briefly about just how large IMFAR has become – from couple of hundred abstracts and a few hundred attendees nine years ago, to closer to a thousand accepted abstracts and a couple thousand attendees this year.

Dr. Mandell shared what he thought were two imporant themes from this year’s scientific program, the first being the volume of good research that seems to be emerging. Although Dr. Mandell pointed to progress in animal models and gene research (and its subsequent relevance in gene-brain imaging/brain functioning research), he seemed to ascribe importance to pointing out a second theme, in that reasearch is also beginning to focus on more pragmatic things – or to paraphrase his words, research is beginning to look at things that can effect “real and positive change”.

For many in the autism community, this is bound to raise ethics questions about “treatment” for autism in general, but put aside debate over social vs. medical model of autism, if only for the moment. There’s another important aspect, and Dr. Mandell did not miss this. Studying treatments has the potential to effect real and positive change, because many treatments and “alternative medicine” in use by families on children are simply untested, and some even have the potential to be dangerous.

As an example of a treatment study that has the potential to encourage parents to take a closer look at the science, Dr. Susan Hyman from the University of Rochester presented her team’s findings from their GFCF study (this is the randomized, double-blind, placebo-controlled that began in 2003). I’ll spare the gory details, as they are well-documented in the previous post GFCF of no benefit. Suffice it to say that what started with anecdotal reports of specific benefits for autistic children from a GFCF diet, is not supported by scientific data when studied with good research methodology. While it’s important to note that this small study has more rigorous methodology than any previous study on the use of the GFCF diet with autistic children, it’s also important to note that these are pre-publication results shared with the press and at IMFAR. Additionally, when asked about any real scientific basis for the GFCF diet for autism, and after acknowledging the historical [but not necessarily scientifically founded] aspect of a “leaky gut and opioid excess hypothesis”, Dr. Hyman was careful to point out that there may be other complex areas in nutrition that are relevant for learning and behavior in autistic children.

Even with what are essentially negative results for this study, it appears that “nutrition and autism” research will continue at the University of Rochester. I suspect that this University of Rochester GFCF RCT will dominate autism news for the next couple of days, as it seems to have that appeal of a topic of popularity. It also wouldn’t surprise me if this story is a headline for some of the mainstream media tomorrow.

Next up: More on Autism and Divorce Debunked! Plus a little more about some of the other abstracts from the press conference. I’ll also share a little about the pieces of the program I plan to attend, so anyone wishing to, can follow along in the published program, as I attend and report back here.

(Disclosure: my attendance at IMFAR was funded in part, by a travel grant from the Autism Science Foundation.)

GFCF of no benefit

19 May

This post is from Eureka Alert

A popular belief that specific dietary changes can improve the symptoms of children with autism was not supported by a tightly controlled University of Rochester study, which found that eliminating gluten and casein from the diets of children with autism had no impact on their behavior, sleep or bowel patterns.

The study is the most controlled diet research in autism to date. The researchers took on the difficult yet crucial task of ensuring participants received needed nutrients, as children on gluten-free, casein-free diets may eat inadequate amounts of vitamin D, calcium, iron and high quality protein. Unlike previous studies, they also controlled for other interventions, such as what type of behavioral treatments children received, to ensure all observed changes were due to dietary alterations. Past studies did not control for such factors. And although no improvements were demonstrated, the researchers acknowledged that some subgroups of children, particularly those with significant gastrointestinal (GI) symptoms, might receive some benefit from dietary changes.

“It would have been wonderful for children with autism and their families if we found that the GFCF diet could really help, but this small study didn’t show significant benefits,” said Susan Hyman, M.D., associate professor of Pediatrics at Golisano Children’s Hospital at the University of Rochester Medical Center (URMC) and principal investigator of the study which will be presented Saturday (May 22) at the International Meeting for Autism Research in Philadelphia. “However, the study didn’t include children with significant gastrointestinal disease. It’s possible those children and other specific groups might see a benefit.”

In response to widespread parent-reported benefits, URMC initiated the trial in 2003 to scientifically evaluate the effects of the gluten-free and casein-free diet, which eliminates wheat, rye, barley and milk proteins. Parent observation has played an important role in earlier treatment discoveries in children with autism, such as melatonin’s benefits for sleep.

Hyman’s study enrolled 22 children between 2 ½- and 5 ½-years-old. Fourteen children completed the intervention, which was planned for 18 weeks for each family. The families had to strictly adhere to a gluten-free and casein-free diet and participate in early intensive behavioral intervention throughout the study. Children were screened for iron and vitamin D deficiency, milk and wheat allergies and celiac disease. One child was excluded because of a positive test for celiac disease and one was excluded for iron deficiency. Other volunteers who were excluded were unable to adhere to the study requirements. The children’s diets were carefully monitored throughout the study to make sure they were getting enough vitamin D, iron, calcium, protein and other nutrients.

After at least four weeks on the strict diet, the children were challenged with either gluten, casein, both or placebo in randomized order. They were given a snack once weekly with either 20 grams of wheat flour, 23 grams of non fat dried milk, both, or neither until every child received each snack three times. The type of snack was given in randomized order and presented so that no one observing – including the family, child, research staff and therapy team – knew what it contained. The snacks were carefully engineered to look, taste and feel the same, which was an exercise in innovative cooking. In addition, the nutrition staff worked closely with the families to make a snack that met their child’s preferences. Casein was disguised in pudding, yogurt or smoothies and gluten in banana bread, brownies, or cookies depending on the child’s food preferences.

Parents, teachers and a research assistant filled out standardized surveys about the child’s behavior the day before they received the snack, at two and 24 hours after the snack. (If the child’s behavior wasn’t usual at the scheduled snack time, the snack would be postponed until the child was back to baseline.) In addition, the parents kept a standard diary of food intake, sleep and bowel habits. Social interaction and language were evaluated through videotaped scoring of a standardized play session with a research assistant.

Following the gluten and casein snacks, study participants had no change in attention, activity, sleep or frequency or quality of bowel habits. Children demonstrated a small increase in social language and interest in interaction after the challenges with gluten or casein on the Ritvo Freeman Real Life Rating Scale; however, it did not reach statistical significance. That means because of the small difference and the small number of participants in the study, the finding may be due to chance alone.

The investigators note that this study was not designed to look at more restrictive diets or the effect of nutritional supplements on behavior. This study was designed to look at the effects of the removal of gluten and casein from the diet of children with autism (without celiac disease) and subsequent effect of challenges with these substances in a group of children getting early intensive behavioral intervention.

Hyman said, “This is really just the tip of the iceberg. There are many possible effects of diet including over- and under-nutrition, on behavior in children with ASD that need to be scientifically investigated so families can make informed decisions about the therapies they choose for their children.”

Transcripts of the Rashid Buttar hearings–a peek at how alternative medicine treats autistic children

4 May

Dr. Rashid Buttar was recently reprimanded by the North Carolina Medical Board. The reprimand was basically a slap on the wrist. A weak one at that.

The inquiry into Dr. Buttar discussed a number of his patients. One, patient E, was autistic. Dr. Buttar has allowed us to read about his practice by posting the testimony from the hearings.

This, from the opening statements for Dr. Buttar’s hearing:

Patient E is a pattern-in-practice patient. Patient E is an eight-year-old school girl who is severely autistic. Her mother contacted the Board after receiving a solicitation from Dr. Buttar to support him in this matter.
Like the ?- like the cancer patients, Patient E’s mother came across information that Dr. Buttar could help her child’s autism. And without ever seeing the doctor, without ever traveling to North Carolina, Patient E was sent a kit to ?- to basically self-administer a chelation therapy on her own daughter.
And when things started going ?- deteriorating for Patient E, Patient E’s only interaction with Dr. Buttar was through his nurse practitioner or other staff members in his office.
And the nurse practitioner who essentially, from the medical records, as you will see, made all decisions about the treatment and diagnosis of this child’s autism across state lines without personally seeing the patient, has no formal training in autism or oncology, much like Dr. Buttar who does not have any formal training in oncology or autism.
Yet, nonetheless, they convinced Patient E’s mother to take the child off of her medication so that he can apply a transdermal chelation cream on the child. A cream, not so coincidentally, that is developed and invented and sold directly by Dr. Buttar to his patients.
The mother did as instructed and took her daughter off her medication and applied Dr. Buttar’s transdermal chelation cream. Her daughter began to deteriorate. The child began to have violent tantrums. She couldn’t leave the house or attend school. During the weeks and months as the child deteriorated, Dr. Buttar never followed the child.
And when the mother did not get a satisfactory responses to her concerns, she called the office, made an appointment to see Dr. Buttar and drove her family to North Carolina. However, when she got to North Carolina, she did not see Dr. Buttar, only the nurse practitioner.
And the result of that meeting was that the nurse practitioner attempted to convince the patient ?- the patient’s mother that the child needed to be converted to a more aggressive intravenous form of chelation therapy.
The evidence will show that Patient E’s situation mirrors that of the other patients. Little or no physician involvement with the patient. Patients are seen primarily, if not exclusively, by the nurse practitioner. The patients have serious illnesses and Dr. Buttar and his nurse practitioner have no formal training in those illnesses.
The patients are prescribed expensive treatments that come straight out of their pocket because insurance does not pay for the treatments. The treatments are arbitrary, one size fits all. They have no basis or evidence of science. The therapies are ineffective and not been subjected to clinical trials and are potentially unsafe.

Dr. Buttar did not see the patient. She was in a different state, after all. But, her mother drove her to North Carolina to see Dr. Buttar and he still didn’t see her?

Without seeing her, he took her off her other medications and gave her his own–and she became worse.

Here are sections from the actual testimony.

Q And your daughter never made a personal visit to Dr. Buttar’s office prior to these treatments?
A That’s right.
Q When you had these telephone consultations with Dr. Buttar’s office, did ?- was it with Dr. Buttar?
A No.
Q Who was it with?
A With Jane Garcia.
Q And who is Ms. Garcia?
A I understand her to be his nurse.

Dr. Buttar was not in contact with the family. His nurse practitioner was handling the case. Remotely. Without seeing the patient.

Q Okay. Did Ms. Garcia ever make any recommendations about what to do with your child’s medication she was presently on?
A Yes. She insisted that we remove my daughter from the medication or they would not pursue the treatment.
Q What medication was your daughter on?
A Lexapro for anxiety ?-
Q And ?- and how long did ?- how long had your daughter been on Lexapro?
A About a period of a year.
Q And who prescribed that Lexapro?
A Her local pediatrician.
Q Did Dr. Buttar’s office consult with your local pediatrician when they recommended that she be taken off Lexapro?
A No, they did not.
Q And at some point what happened to your daughter after she started ?- after you started self-administering this chelation cream?
A Initially, it was uneventful, but she began to deteriorate, regress is how it’s referred to, and the regression was extremely significant. We were unable to even get her to come out of the home when she had previously been very social and happy. She wouldn’t wear clothes. She was no longer sleeping through the night. She wasn’t eating properly and she was extremely restless.
Q Okay. And did you consult Dr. Buttar’s office about these issues?
A Absolutely.
Q And what was the response?
A That we just needed to continue because this was to be expected, that she was moving metal and that we just needed to keep doing what we were doing.
Q Okay. And ?- and did you continue to do that?
A Yes.
Q And at some ?- and how did your daughter respond even after you continued the ?- the treatments?
A She just continued to get worse.
Q And at some point did ?- what did you do after that?
A Well, we had made an appointment to come to the office in person and we had hoped at that point, with an in-person physical examination by the doctor, we would get some remedy and advice for the significant amount of deterioration we were experiencing.

Dr. Buttar’s office pulled the young girl off of her anxiety medication. They had the family apply a trans-dermal chelation cream. The girl started to “deteriorate”

Q And I’ll read to you a note and ask you to comment. It says: Discussed plan with Jane, concur on issue regarding Lexapro, reassess patient that worsening is to be expected due to Herxheimer’s response and due to mobilization. Due to age consider IV challenge for best metal yield.
Is that when you talked ?- is that when you and Dr. Buttar’s office began talking about ?-
A I’m sorry, can you repeat that? My phone calling interrupted.
Q I’m sorry. It says: Discussed plan with Jane, concur on issue regarding Lexapro. Is that when you had a conversation about taking your child off Lexapro?
A Yes, but I hope that’s not referring to me concurring.
Q Okay. And above that there’s a typed note that says: Plan to wean off Lexapro, discussed with Dr. Buttar.
But is ?- were you having conversations with Ms. Garcia to take your child off Lexapro and then start this chelation therapy for your child’s autism?

Dr. Buttar suggested a “challenge” chelation test. Here is what the Americal College of Medical Toxicologists has to say about “challenge” testing:

It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

I guess I am curious as to why Dr. Buttar thought an IV chelation was needed for the challenge. If his trans-dermal cream chelates, shouldn’t that be sufficient?

Q I’m sorry. It says: Discussed plan with Jane, concur on issue regarding Lexapro. Is that when you had a conversation about taking your child off Lexapro?
A Yes, but I hope that’s not referring to me concurring.
Q Okay. And above that there’s a typed note that says: Plan to wean off Lexapro, discussed with Dr. Buttar.
But is ?- were you having conversations with Ms. Garcia to take your child off Lexapro and then start this chelation therapy for your child’s autism?
A Yes, we had discussed it twice.
Q Okay. And ?- and then you began the autism treatments in January, correct?
A Correct.
Q And how did the materials get to you?
A By the mail.
Q And ?- and was there any lab testing involved?
A Yes, routine lab testing was urine, stool, hair.
Q And who did this lab testing?
A Either we did or if it required a blood draw, a local phlebotomy clinic.
Q And all this was occurring in Michigan?
A That’s correct.
Q And when your daughter got the chelation cream, who administers that?
A We did, the parents.
Q And how did you do it? Did you do it pursuant to instructions from Dr. Buttar’s office?
A Yes.
Q And ?- and all this is occurring without you ever coming to North Carolina to see Dr. Buttar or his nurse practitioner?
A That’s correct.
Q Did you have to send money to Dr. Buttar’s office before these materials were sent to you?
A Yes.
Q How much money did you send?
A The initial was right at $3,000.
Q Okay. You talked about your daughter deteriorating and then you said you made an appointment to see Dr. Buttar. Approximately when was that?
A Approximately April.
Q And what happened after you made that appointment?
A We were ?- we did another round of testing that was expected to arrive in the office prior to our visit for a review on that and other than that, we simply prepared for the trip.
Q Okay. When you got to North Carolina what ?- did you go to Dr. Buttar’s office?
A Yes.
Q Was he there?
A No, he was not.
Q Who did you see?
A Ms. Garcia.

Yes, Dr. Buttar charged $3,000 for them to work with his nurse practioner. They made an appointment to travel from Michigan to North Carolina (a distance of over 800 miles) and Dr. Buttar did not see them. His nurse practitioner saw them and did not examine the patient:

Q (By Mr. Jimison) Okay. Did you have a meeting with Ms. Garcia?
A We did.
Q Did Ms. Garcia examine your child during that meeting?
A She was in a room, but she didn’t have an examination, no.
Q Okay. And what was the result of that meeting with Ms. Garcia?
A The large part of the meeting was the — for lack of a better word — sell — to first do IV chelation.
Q And ?- and did you do that?
A No, we did not.
Q And why not?
A My daughter was already significantly deteriorating and appeared to be very sick and there was no way we were going to go get a more aggressive form ?-
Q Okay.
A?- when we haven’t even seen the doctor.
Q And how is your daughter doing now?
A She’s fine, she’s much better.

The young girl is doing much better since leaving Dr. Buttar’s care.

I’ve kept the commentary to a minimum. Take a read. Tell me what you think. Take a look at the actual transcripts and let me know if I’ve been cherry picking.

Frontline’s Vaccine War episode ignites…well, a war of words

3 May

I first heard about the Frontline episode on “The Vaccine War“, it was from supporters of Jenny McCarthy. They were online telling us all about this upcoming episode and even providing links to where we could order the DVD.

Times have changed.

The show aired and it was not about how Jenny McCarthy and the rest are right and that vaccines cause autism. Jim Carrey had made a statement a while back, “We aren’t the problem. The problem is the problem.” Aside from the fact that it is a very strange way to phrase what he wanted to say, Frontline showed that, yes, indeed, you are the problem.

The night that The Vaccine War aired, Dr. Jay Gordon (Jenny McCarthy’s pediatrician) blogged about how his interview was left out. Jenny McCarthy followed shortly afterwards. Both were on the Huffington Post. Dr. Rashid Buttar was also interviewed and not shown. He took to a free press release to express his opinion.

Since then, many people have been claiming that Frontline should have given more time and weight to the vaccine-causation side. I guess representatives from a “Parent Founded, Parent Led” organization are not enough weight. They need the opinions of some doctors. As Kim at the Countering Age of Autism blog points out, the Age of Autism blog put their piece complaining about Frontline twice. AoA just changed the title and a bit of the introduction.

The editors of the Frontline episode have responded to the criticisms that some interviews were not aired:

Many thanks for your feedback on the program. FRONTLINE went to considerable lengths to include a wide range of viewpoints, even in the face of very strong scientific evidence against the hypothesized autism link to MMR and thimerosal. Despite the consistent negative epidemiology and the definitive verdict of the federal vaccine court, we included views from people who wanted more and different studies. The program also gave a great deal of time to the arguments of vaccine hesitant parents who think the CDC schedule is bloated. The companion FRONTLINE website contains full interviews with different stakeholders, including Dr Robert Sears, who promotes an alternative spread out vaccine schedule. The website also hosts a robust public conversation where a full range of viewpoints are being aired and engaged.

When making long form documentaries like FRONTLINE, it often happens that some interviews don’t make it into the finished program. Several interviews failed to make the final cut of “The Vaccine War”–not just yours but also interviews with contributors who support the CDC vaccine schedule.

One interview which did not air was that of Arthur Allen. He has commented on a few blogs. Not complaining about his interview being cut, but about people like Dr. Jay who don’t understand that in journalism these things happen. Interviews get cut.

That all said, let’s consider the argument that Frontline should have aired more of the vaccine-skeptic viewpoint. That people like Rashid Buttar should have been given more air time. Dr. Buttar, who was recently reprimanded by his state’s regulatory agency. Dr. Buttar who has used urine injections on autistic children.

For those who would like to have seen more of the opinions of such doctors, consider if Frontline does another episode entirely. This time, instead of “the Vaccine War”, they consider a show on “Curing Autism”, showing alternative medical practitioners.

I bet at this point many in the biomed community are saying, “yes!”

I put it to them that they didn’t learn their lesson. There is no good evidence behind the alternative medicine used in autism. Just like they thought that “The Vaccine War” was going to finally tell their story, another Frontline episode would not go their way. Yeah, it would tell their story, just as The Vaccine War did.

Let me put it another way. Think of two short words….Trine Tsuderos. I could have just as easily said Pat Callahan, as she worked with Ms. Tsuderos on the articles at the Chicago Tribune, but somehow it is Trine who gets the attention. It is her name that calls up the memories.

For those asking “Trine who?”, Ms. Tsuderos and Ms. Callahan wrote a series of articles for the Chicago Tribune. One article should give you an idea of how that series went: Autism treatments: Risky alternative therapies have little basis in science.

You see, the team of Callahan and Tsuderos took a look at alternative therapies and gave some balance–they asked the experts in areas such as neuroinflammation in autistics whether the alt-med practitioners were correctly applying the science. They weren’t.

So imagine if you will, Fronline putting Dr. Jay, Dr. Bob, Dr. Buttar’s interviews on the air. Together with Dr. Geier and his “lupron protocol”. Together with Prof. Boyd Haley and his industrial chelator turned nutritional supplement. Together with people “treating” neuroinflammation before they know whether it is harmful or beneficial.

Consider that team. Then consider the responses from experts in medical toxicology. Experts in neuroinflammation. Experts in hormones and autism.

Consider how that would play out before the American public.

It would not go well for the alternative medical community. Not because of any bias, but because their “science” is woefully poor.

60 Minutes exposes stem cell con men

21 Apr

Autism News Beat has a post, Avoiding false balance, 60 Minutes nails con men. It isn’t autism specific, but it does have to do with a type of “therapy” that comes up a lot in autism: stem cells.

60 Minutes, a U.S. television news magazine did a “sting” operation. They had patients go into the stem cell clinics and expose the charlatans. The patients were real, they have ALS (Amyotrophic lateral sclerosis)

The clinic run by a man named Larry Stowe claims to be able to cure cancer, ALS, MS, Parkinson’s disease and more…

He is a chemical engineering Ph.D. who claims he has cures for chronic diseases with herbs and vitamins, custom vaccines, and stem cell injections.

(below are the videos. Thanks to codeman38 for providing this link to the text)

http://cnettv.cnet.com/av/video/cbsnews/atlantis2/player-dest.swf
Watch CBS News Videos Online

Here is part 2

http://cnettv.cnet.com/av/video/cbsnews/atlantis2/player-dest.swf
Watch CBS News Videos Online

Major fail by medical regulators: Dr. Rashid Buttar given slap on the wrist

21 Apr

Beware, North Carolina. Beware. Dr. Rashid Buttar is free to practice medicine.

So goes the title of a blog post by Orac at Respectful Insolence.

Background, Dr. Rashid Buttar is an alternative medical practitioner who has, amongst other things, “therapies” to treat autism. He has been a major proponent of chelation. He is also notorious for his urine injections. Yes, urine.

Dr. Buttar was investigated by his state’s medical examiners. Again, from Orac: Rashid Buttar’s going down: The North Carolina Board of Medical Examiners finally acts

From a news report at that time:

The panel also found that Buttar exploited patients by charging exorbitant fees for unproven therapies that didn’t work. The panel recommended that his license be suspended indefinitely, but that the suspension be immediately stayed. Until the board decides, Buttar may practice without restrictions.

from a recent news story:

In that Michigan case, Buttar treated the child without having first performed an exam, a violation of the state’s medical practice act.

Did he “go down”? No. Dr. Buttar was able to benefit from laws he, himself, pushed through his State’s legislature:

Dr. Rashid Buttar, whose alternative medical practice in Huntersville has been under scrutiny by the N.C. Medical Board for a decade, has accepted a reprimand from the licensing agency.

But Buttar, who was facing potential restrictions to his license, instead can continue offering unconventional treatments as long as he asks patients to sign a form acknowledging his practice is outside the mainstream.

“This was a witch hunt from the beginning,” said Buttar, 44, whose practice attracts patients from 42 states and 37 countries. “They were trying to discredit me … but I didn’t do anything wrong.”

The consent order, signed Friday, marks the end of a battle that Buttar had vowed to take to the U.S. Supreme Court. He said he has spent “hundreds of thousands of dollars” defending himself against the board’s allegations that he exploited patients by charging exorbitant fees for unproven therapies that didn’t work and by arbitrarily ordering expensive tests to make more money.

In recent years, Buttar led a successful effort by the N.C. Integrative Medical Society to get legislators to change state law to make it friendlier to practitioners of alternative medicine.

Again, quoting Orac:

But back to why Dr. Buttar might have agreed to this consent decree. The answer becomes obvious if you peruse the actual consent order. All it does is to reprimand Buttar and order him (1) to provide informed consent to his patients dictated by the board; (2) to obey all laws, as well as rules and regulations governing the practice of medicine; (3) notify the board if he changes his address; and (4) meet with the board periodically. In other words, Buttar got a slap on the wrist.

“A slap on the wrist”.

Wow.

The top treatment listed on Dr. Buttar’s website is IV treatements which, as we know, include chelation. These have been “pioneered by Dr. Buttar” and the fact that the vast majority of the medical establishment rejects his ideas is a selling point:

However, the use of these highly effective treatments, suspiciously unpopular among traditional medicine regulators, is only determined by the medical providers in the clinic (ie, the Doctors, Nurse Practioners or PA’s).

Yes, your young child could sit with 7 other people in a room and stare at pictures of Pooh Bear (I wonder about the copyright issue on that?) while having an IV needle inserted to deliver “suspiciously unpopular” treatments. Here is the picture of his IV suite:

The main change between before the consent agreement and now is that all you have to do is sign a paper noting that you accept the fact that you accept the fact that these treatments have not been proven effective…

Do you think this “consent order” is anything more than a slap on the wrist? Here is a quote from it:

I understand and have been advised that the treatments and therapies that are to be provided by Dr. Buttar have not been proven effective by traditional research studies or conventional clinical trials and may not have been approved by the FDA for my diagnosis. Dr. Buttar makes no specific claims or representations that the treatments and therapies that he will be providing will be effective or cure the condition or diagnosis that I have.

Take a look at Dr. Buttar’s website (or the quote above) again.

However, the use of these highly effective treatments…

Yes, he’s still claiming that his treatments are “highly effective”, even though they “have not been proven effective by traditional research studies…”

Dr. Buttar was a part of the team involved with Desiree Jennings, the Redskins spokesperson who claimed the flu shot caused dystonia.

Dr. Buttar still has his supporters. From a recent story on this case:

Many of Buttar’s patients came to his defense in 2008. Among them was Elrene Thomas of Lexington. When contacted Tuesday, she was pleased to hear that Buttar can continue to practice. A retired nurse, she went to him for treatment seven years ago when she learned her breast cancer had spread to her spine. Instead of going through chemotherapy and radiation again, she tried IV infusions five days a week for months and had hyperbaric oxygen therapy twice a day for several weeks. She paid Buttar’s center $100,000 and said it was worth it.

“I really feel like he saved my life,” said Thomas, 77. “I’m not healthy in that I have stage 4 (cancer), but I’m surviving and I’m doing all these things that he taught me to do. I believe in his treatment.”

Yes, this is one of his success stories.

What do you call therapies a doctor makes up on his own, untested by “traditional” means? I would call that experimental. I think that is being generous.

Medical regulation exists for a reason. Slapping doctors on the wrist is not the reason.

Listen to parents…except when they say things you don’t want to hear

25 Mar

How many times do we hear, “Listen to the parents” on medical issues involving their autistic kids? Usually this comes from alternative medical groups who don’t have the science to back up the safety and efficacy of their therapies. What happens when a parent disagrees with these groups?

In Lawsuit against alternative medical practitioners Usman and Rossignal we discussed a father who has brought suit against prominent Defeat Autism Now (DAN) doctors Usman and Rossignol, and the laboratory Doctor’s Data.

Orac, at Respectful Insolence, has discussed this case as Suing DAN! practitioners for malpractice: It’s about time, where he uploaded the actual complaint.

In that complaint the father is alleging many things. High amongst them is the question of whether the “challenge” chelation tests are valid, These were used on his child and supposedly showed heavy metal poisoning. In a challenge chelation test, a chelator drug is given to a child before a urine test is taken. Chelators are designed to draw metals out of the body and allow them to be excreted through the urine (and other ways). There are no standardized references for metal contents in challenge testing. The American College of Medical Toxicology has made a very clear statement about challenge chelation testing. Here is their conclusion:

It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

Recall, challenge testing is noted in the lawsuit. From the section of claims against the Doctor’s Data (who are also defendents in the lawsuit):

The non-standardized method of testing that Defendant utilized on or about April 22, 2004, January 27, 2006, January 13, 2007, February 26, 2007, May 26, 2007, August 6, 2007, October 30, 2007, November 13, 2007, January 12, 2008, January 26, 2008, April 26, 2008, October 29, 2008, and March 27, 2009, wherein specimens were collected after the administration of a provoking agent and compared to unprovoked or unchallenged specimens was an improper method of determining whether A.J. had a potentially toxic level of heavy metals in his system

So, challenge chelation testing isn’t scientifically validated, has no benefit, but was used to justify certain therapies on this child. How did the Autism Research Institute respond to this? They blame the parent’s marital situation.

No, really, I’m not making this up. Rather than accept the complaints on their face and give this autism parent respect, they dismiss his multiple complaints as being…well, you read it:

Recent articles by ABC News and the Chicago Tribune on M.D.s who subscribe to the Defeat Autism Now! approach to treatment indicate the spread of misinformation and misunderstanding in recent months. The complaints about Drs. Usman and Rossignol resulted from a custody case– a painful situation for any family, one that can lead to accusations that must be sorted out in a court of law—not the media

Yes, it isn’t because the father is really annoyed that he was told challenge chelation testing is valid, or that his family spent lots of money on testing and on chelation. It couldn’t be that the father has not seen benefit from these therapies. It isn’t any of that. It is a custody battle issue. For the record, the defendants in the case do not include his wife.

ARI defends their approach in rather vague terms:

The Defeat Autism Now! approach to autism invites the medical community to be more responsive, inquisitive, and knowledgeable about treating these disorders.

The approach is not in itself a source of controversy, since many treatment interventions are commonly prescribed by traditional health professionals.

My view differs from the ARI statement. It would seem to this observer that the approach is the source of controversy. From their own website:

The best diagnostic test for toxic metal overload is the chelation challenge test. The chelation drug is administered, followed by a timed urine test to help assess the body’s burden of toxic elements.

This is in direct contradiction to the statement from the American College of Toxicologists. The ARI approach (including challenge testing) is a key point of the lawsuit. I am not able to reconcile this with the idea that the “approach itself a source of controversy”.

The great problem is rather that chronic, unaddressed illness plagues many, if not most, of the children and adults on the autism spectrum. These conditions, thoroughly documented in the scientific literature, often involve the gastrointestinal system and/or the immune system, but the medical establishment has been professionally insensible to what is a desperate situation in the expanding autism population.

Odd. If anyone outside of the alternative medical community ever makes a statement that the is driven by “desperation”, they are sure to get jumped on.

The focus of the Defeat Autism Now! approach is twofold: to provide patients with allergen-free nutritional support, to uphold and to repair the immune system as needed, and, if appropriate, to reduce the body burden of environmental toxins; to provide clinicians in-depth medical and scientific information, with Continuing Medical Education credits.

There is the mention of what is a main crux of the lawsuit, “body burden of environmental toxins”. That’s it. No mention of challenge testing. They mention that the approach includes reducing “the body burden of environmental toxins”, but doesn’t address the key question: when is this approach “appropriate”. How is that decided? The challenge testing approach has not, to my knowledge, ever been defended in court. This case is

The ARI press release doesn’t discuss the real questions here. Brushing this off as a custody issue is not doing anyone any good and is rather insulting to the parent bringing this suit forward and his child.

Trine Tsouderos and Patricia Callahan honored by the Association of Health Care Journalists for autism series

23 Mar

The Chicago Tribune has run a series of articles lately on alternative medicine and autism. The stories include OSR#1: Industrial chemical or autism treatment? (about a chelation chemical invented for mining operations, now labeled as a supplement and sold for “oxidative stress relief”), the self explanatory titled Autism treatment: Science hijacked to support alternative therapies, Autism’s risky experiments Some doctors claim they can successfully treat children, but the alternative therapies lack scientific proof and Autism treatment: Success stories more persuasive to some than hard data One dad, a doctor, says he was “fooled”

This is part of a series that won the Chicago Tribune one of two awards. Writers Patricia Callahan and Trine Tsuderos were honored.

“This powerful series combines first rate medical writing and rigorous investigative reporting to expose doctors who perform what the authors rightly call “uncontrolled experiments on vulnerable children” with autism,” commented the judges. “Writing with the authority that comes from total command of the material, Tsouderos and Callahan bring new clarity to a notoriously murky subject-autism treatments. They document a horrifying brand of bad science perpetrated by bad doctors on desperate families, but they do it without a hint of hyperbole or sensationalism. Their straightforward, professional tone lets the facts tell the story. The result is an important-and devastating-piece.”

With a tip of the hat to Autism News Beat for his story, Tribune investigation takes first place

addendum:

here is the text of the announcement about the Tribune team:

Chicago Tribune reporters examine Lupron – a testosterone inhibitor used to treat precocious puberty and to chemically castrate sex offenders – and its reputed ability to be a “miracle medicine” for a disease with few mainstream medical answers: autism. In looking into Lupron, the Tribune found a world of alternative treatments for autism with fervent supporters who made big claims they said were backed by science. But when reporters evaluated the treatments, painstakingly analyzing each claim, each paper, each therapy through a lengthy dialogue with scores of medical experts, parents and doctors, they found the therapies were risky and unproven and the science backing them was junk. The Tribune provided readers and parents with hard evidence and some difficult truths, concluding that thousands of children with autism are being subjected to mass uncontrolled experimentation every day.

Judges comments: This powerful series combines first rate medical writing and rigorous investigative reporting to expose doctors who perform what the authors rightly call “uncontrolled experiments on vulnerable children” with autism. Writing with the authority that comes from total command of the material, Tsouderos and Callahan bring new clarity to a notoriously murky subject-autism treatments. They document a horrifying brand of bad science perpetrated by bad doctors on desperate families, but they do it without a hint of hyperbole or sensationalism. Their straightforward, professional tone lets the facts tell the story. The result is an important-and devastating-piece.

For their piece Dubious Medicine

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