More on the question of Actos

[Matt]

Sorry to reopen a contentious debate. I hope we can have the debate without the contentious part.

Here is a news article people interested in this subject may want to read:

http://www.newsday.com/news/health/ny-hsside125370708sep12,0,4473614.story

It does appear to be valid to ask whether this is a good approach, as noted by researchers working on the drugs in question.

The start of the article:

A Long Island physician says he has successfully treated thousands of children with autism using Actos and Avandia, two diabetes drugs, but some experts yesterday called into question the wisdom of such therapy and suggested milder treatments.

Dr. Marvin Boris, a Woodbury specialist in the treatment of children of autism, said he has prescribed Actos to thousands of children, and among those who didn't respond well to it he prescribed Avandia.



Some of the concerns that are raised are similar to those in the previous thread:


GlaxoSmithKline's Avandia, which also carries the FDA's strictest warning, was found to increase the risk of heart attacks, strokes and heart failure.

Congestive heart failure is typified by a loss of the heart's pumping power.

Dr. Sonal Singh, who led one of the studies reported today, said both drugs can cause bone fractures and fluid retention in the eyes, which potentially can lead to blindness.


Dr. Boris' response is similar to that in the previous thread (i.e. the risk of congestive heart failure is not applicable to it's use on children since it is really a heightened risk for those already prone to heart failure)


Those studies "involve people who are prone to heart failure, and the extra water load they may retain from the Actos and Avandia may lead to heart failure and death," Boris said yesterday.



But, still the doctors who studied Actos don't seem to support the prospect of using this off-label to treat autism.


Dr. Michael Lincoff of the Cleveland Clinic, who authored a study on the drug, said he would not consider Actos an appropriate autism medication.

"I would find it shocking," he said. "If someone tests it in a clinical trial and it is being used as a result of evidence-based medicine, based on a body of research, but certainly not just not on gut instinct or a hypothesis."

Edward Carr, a psychology professor at Stony Brook University Medical Center and a specialist in autism, said the benefit does not outweigh the risks. Actos is not a cure. "What are the long-term side effects of administering this drug to small children? Does anyone have the answer to that question?"

There is a lot more there, please look at the entire article. I have tried to give some of both sides, but obviously that involves leaving some big pieces out.

Matt

[Andie]

Here is a news article people interested in this subject may want to read:

http://www.newsday.com/news/health/ny-hsside125370708sep12,0,4473614.story

It does appear to be valid to ask whether this is a good approach, as noted by researchers working on the drugs in question..



I've not read Dr. Boris' study so I don't know why he feels using Actos or Avandia is a worthwhile thing to do. Although the article mentions reducing inflammation. But, I'd like to make two comments.

First, Dr. Boris or any doctor who is treating children with autism using medications off label usually have good reasons to use a particular protocol with a particular child. The child must first meet some criteria to utilize a particular medication. This has been my experience. You don't walk through the door "Oh, your kids autistic...we need to give him Actos." I have a few friends who have children and we all see the same doctor. All 3 children are not being treated exactly the same. A responsible doctor has to explain why he wants a particular child on a medication. He has to understand and explain the risks and the benefits.

Also, Matt I'm sure your aware that some drugs start out for one particular disease state and end up treating something entirely different. I'm certain Dr. Boris has some very good reasons for using it. Unfortunately, the article doesn't elaborate beyond reducing inflammation. Maybe that researcher is not aware of Dr. Boris' research? It's very possible that Dr. Boris is using a very small dose- something the researcher doesn't know either. Who knows this is all specualtion and fear mongering IMO.

Now, my son's doctor wanted to put my son on Celebrex for chronic leg and foot pain- I said no because I'm afriad of what has happened with the other COX2 drugs. He said OK. Any of those parents could say "NO" if they are afraid of using a medication that has a black box warning. Every single day patients and doctors make decisions on medications together. That is why we consult doctors for their medical expertise.

Which brings me to my second point. All Doctors not just Dan! doctors or "Autism" doctors wirte prescriptions every single day to use medications off label. So, please do not imply that this is something unique to autism.

I have stated previously Dr. Boris has treated my son for allergies and he is a wonderful doctor and I'm really tired of him being drug through the mud for doing something that doctors do everyday in every doctor's office around the country. It's not some autism treatment conspiracy. By the way, why didn't he suggest Actos for my son when we were there seeing him for allergies?Autism=Actos, right?

[autismdiva]

Sorry to reopen a contentious debate. I hope we can have the debate without the contentious part.

Here is a news article people interested in this subject may want to read:

http://www.newsday.com/news/health/ny-hsside125370708sep12,0,4473614.story

It does appear to be valid to ask whether this is a good approach, as noted by researchers working on the drugs in question.

The start of the article:


Some of the concerns that are raised are similar to those in the previous thread:



Dr. Boris' response is similar to that in the previous thread (i.e. the risk of congestive heart failure is not applicable to it's use on children since it is really a heightened risk for those already prone to heart failure)



But, still the doctors who studied Actos don't seem to support the prospect of using this off-label to treat autism.



There is a lot more there, please look at the entire article. I have tried to give some of both sides, but obviously that involves leaving some big pieces out.

Matt

"Dr. Sonal Singh, who led one of the studies reported today, said both drugs can cause bone fractures and fluid retention in the eyes, which potentially can lead to blindness."

How many kids out of the thousand or whatever Boris is dosing with this will get glaucoma or break a bone, or even get heart disease?

If one or two kids die or go blind or get a broken bone out of this, is that acceptable risk because a bunch of parents became convinced that this drug changed their child's behavior somewhat? This is not curing autism, and since the placebo effect is so strong in autism, it's likely that the parents aren't seeing much of a real effect if any at all. Parents swear that drops of water make huge improvements in their autistic kids, so why wouldn't they say the same thing about Actos and then Avandia when it turns out that the Actos doesn't "work".

If half the kids lose serious amounts of bone density but don't break bones, is that an acceptable risk? It's hard to get calcium back into bones in adulthood, girls are supposed to be building bones seriously because it's downhill after adulthood.

How well is an autistic kid going to report that his vision is going bad because of glaucoma?

This is just very scary to me. I don't think it matters that those involved have good motives or not, the results will be the same and the side effect results may be horrible. And they don't know if they can get the same good results with a less dangerous drug, or with a placebo. From what I remember Dr. Boris isn't publishing in a peer reviewed journal so that other experts can see what he's doing.

[Matt]

I've not read Dr. Boris' study so I don't know why he feels using Actos or Avandia is a worthwhile thing to do. Although the article mentions reducing inflammation. But, I'd like to make two comments.

First, Dr. Boris or any doctor who is treating children with autism using medications off label usually have good reasons to use a particular protocol with a particular child. The child must first meet some criteria to utilize a particular medication. This has been my experience. You don't walk through the door "Oh, your kids autistic...we need to give him Actos." I have a few friends who have children and we all see the same doctor. All 3 children are not being treated exactly the same. A responsible doctor has to explain why he wants a particular child on a medication. He has to understand and explain the risks and the benefits.


How many autistic clients does he have? He is quoted in the article as having treated "thousands" with this drug.

If the statement is accurate and he isn't giving it to most of his patients, he has the largest practice I have ever heard of.


Also, Matt I'm sure your aware that some drugs start out for one particular disease state and end up treating something entirely different. I'm certain Dr. Boris has some very good reasons for using it. Unfortunately, the article doesn't elaborate beyond reducing inflammation. Maybe that researcher is not aware of Dr. Boris' research? It's very possible that Dr. Boris is using a very small dose- something the researcher doesn't know either. Who knows this is all specualtion and fear mongering IMO.


What part of my post was speculation? With all due respect, comments like "it's very possible that" are speculative.

If the story is accurate, there is no speculation that experts on Actos question its use on autistic children. That is not fear mongering. That is informing the public.

If in a few years there is a reason found to avoid giving this drug to children these researchers would be roasted on a spit if they had not come forward with their concerns.


Now, my son's doctor wanted to put my son on Celebrex for chronic leg and foot pain- I said no because I'm afriad of what has happened with the other COX2 drugs. He said OK. Any of those parents could say "NO" if they are afraid of using a medication that has a black box warning. Every single day patients and doctors make decisions on medications together. That is why we consult doctors for their medical expertise.


So, is there a problem with parents going into a doctors office with the information that researchers who have studied Actos question this use? That sounds to me like being an informed patient.


Which brings me to my second point. All Doctors not just Dan! doctors or "Autism" doctors wirte prescriptions every single day to use medications off label. So, please do not imply that this is something unique to autism.


Is there any mention of "off label" in what I wrote above?


I have stated previously Dr. Boris has treated my son for allergies and he is a wonderful doctor and I'm really tired of him being drug through the mud for doing something that doctors do everyday in every doctor's office around the country. It's not some autism treatment conspiracy. By the way, why didn't he suggest Actos for my son when we were there seeing him for allergies?Autism=Actos, right?


I am glad this worked out for you.

Did I say that he is giving Actos to all patients? No.

Matt

[Andie]

How many autistic clients does he have? He is quoted in the article as having treated "thousands" with this drug.

If the statement is accurate and he isn't giving it to most of his patients, he has the largest practice I have ever heard of.

I doubt the quote is accurate. His office is in with another Dr. and they probably have over a thousand patients (allergy, asthma, adhd etc..). Allergists and immunologists I believe. My son saw him 3 years ago and he is still classified as one of his patients. One he never offered Actos or Avandia too.





What part of my post was speculation? With all due respect, comments like "it's very possible that" are speculative.

If the story is accurate, there is no speculation that experts on Actos question its use on autistic children. That is not fear mongering. That is informing the public..

We are specualting as to why he uses it. I didn't mean you personally wrote anything speculative. Again is the article accurate? How long ago was the interview conducted? Do we know that?




So, is there a problem with parents going into a doctors office with the information that researchers who have studied Actos question this use? That sounds to me like being an informed patient...

I didn't say that at all. I'm encouraging parents to be informed. That's why I gave the Celebrex example regarding my son. I probably would say no to Actos for the same reason I said no to Celebrex.



Is there any mention of "off label" in what I wrote above?...

It would have to be off-label unless it was for diabetes. Unless those 2 drugs are approved for treatment for something else me and you don't know about, which is a possiblity since we aren't doctors and I don't own a PDR, do you?



Did I say that he is giving Actos to all patients? No.?...
No you didn't and I don't think I said you did. I was just emphasizing my son saw him, and he is autistic and he was not offered ACTOS. Most doctors I am familiar with that treat children with autism do not have one size fits all drug regimes. Yes, some things may be the same but I think they tailor to a child's needs. That has been my experience.

[George]

You don't have to have a PDR or be a doctor to see the prescribing information that is in the PDR. Just google "actos prescribing information" or whatever drug you're looking for and this is the package insert information which is the same as in the PDR. This is the Actos link http://www.actos.com/actospro/prescribinginfo.aspx Look under indications and usage for to see what the drug is approved for, Actos is for use in Type II diabetes. This is the Avandia link http://us.gsk.com/products/assets/us_avandia.pdf It is approved for Type II diabetes.

[Biomedmommy]

Hello Matt,

I found some interesting studies that might have spurred the use of Actos. (FYI - my child has never used it and this is not meant for debate - just interesting reading - I never even knew that theese studies existed until today).;)

http://care.diabetesjournals.org/cgi/content/full/28/4/925?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&searchid=1&FIRSTINDEX=0&sortspec=relevance&volume=28&firstpage=925&resourcetype=HWCIT

[Matt]

Hello Matt,

I found some interesting studies that might have spurred the use of Actos. (FYI - my child has never used it and this is not meant for debate - just interesting reading - I never even knew that theese studies existed until today).;)

http://care.diabetesjournals.org/cgi/content/full/28/4/925?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&searchid=1&FIRSTINDEX=0&sortspec=relevance&volume=28&firstpage=925&resourcetype=HWCIT

Thanks for the link. It is short, but an interesting start. Besides, I have a bias towards the hospital (Sick Children aka Sick Kids).

Matt

[Callista]

Wait, okay, some of us are new to this issue.

Could somebody explain why diabetes drugs are being tried for autism, what they are supposed to help with, and what the controversy is (other than trying to medicate neurology, anyway)?

[ihatethefda]

Thanks for reopening the debate!

Just for the record, let's see where we left off last time...
Ah...here it is!
http://www.autismspeaks.org/community/forums/showthread.php?t=1470

I see new posts on this thread making the same mistake that was made before - not acknowledging that diabetics who take this drug along with insulin are prone to heart failure. Thus the warning, which would not be relevant to people with autism.

Dr. Boris' response is similar to that in the previous thread (i.e. the risk of congestive heart failure is not applicable to it's use on children since it is really a heightened risk for those already prone to heart failure)
But, still the doctors who studied Actos don't seem to support the prospect of using this off-label to treat autism.

"Doctors?" Just one doctor who studied Actos is not supporting off-label treatment of the drug for autism. What's more, is this researcher an autism expert (as you're always asking our side)? Does he know anything about immune and possible inflammatory responses of people with autism? There seems to be no evidence of that. So why should we give his opinion more weight than we give to Dr. Boris who not only is extremely familiar with autism, but is also aware of the side effects of Actos in diabetes patients?

There is a lot more there, please look at the entire article.


Oh I did, and I found something so interesting. When a psychologist from Stonybrook University was interviewed, "He said there are simpler treatments, such as special diets that produce no side effects."

Wow!! So you're asking us to read an article which you obviously consider a solid source which advocates the use of special diets to treat autism. Hmmm. Now would that include the GF/CF diet? That would be the first diet for autism that comes to my mind!!

So I assume we can consider this article an endorsement of the GF/CF diet by you and your gang who responded so positively to it!!!!!

I'm so glad we finally have common ground. :)

[Matt]

Wait, okay, some of us are new to this issue.

Could somebody explain why diabetes drugs are being tried for autism, what they are supposed to help with, and what the controversy is (other than trying to medicate neurology, anyway)?

My first response seems to have gone into the ether...

1) why are diabetes drugs being tried for autism.

The best explanation comes from the researchers themselves and can be found here

www.4cures.org/SiteContent/Partnership%20for%20Cures%20Information%20Packet%2 0including%20Annual%20Report.doc (http://www.4cures.org/SiteContent/Partnership%20for%20Cures%20Information%20Packet%2 0including%20Annual%20Report.doc)

On about page 24 you will see:

Scientific Summary: Scientists have discovered that many patients diagnosed with ASD have an imbalance in the Th1 and Th2 lymphocytes in their immune system. The imbalance in this usually self-regulating system causes excess release of pro-inflammatory cytokines and leads to higher than normal allergies, autoimmune disorders and inflammation, including in brain cells of patients diagnosed with ASD. Drugs which bind to a particular receptor, termed the peroxisome proliferator activated receptor (PPAR), have been shown to restore Th1/Th2 balance in certain conditions, thereby reducing inflammation and some associated symptoms. One of these drugs, ACTOS (pioglitazone HCl), is already in use for treatment of type II adult diabetes, and has shown to have a good safety profile. ASD clinicians tested ACTOS off label in selected patients diagnosed with ASD. The pilot data collected from about 300 children diagnosed with ASD and treated with ACTOS showed good clinical and laboratory improvement in about 75% of the patients with few side effects. Whether treatment with ACTOS restored the Th1/Th2 balance has yet to be determined. This anecdotal information requires objective scientific testing in a Phase I clinical trial, to be carried out by independent physician-researchers, with the goal to replicate and validate these initial results, or refute these findings, under controlled (double-blind, placebo controlled) conditions.

2) what value is it supposed to help with?
Again, look to the people testing it. They have made the paper available on the web:

http://www.jneuroinflammation.com/content/4/1/3

They discuss parent-reported improvements in hyperactivity, irritability and one other area (I should look it up...)

3) What is the controversy?

The drug (Actos) has been linked to congestive heart failure. It has an FDA warning on it (the highest level warning the FDA gives). It was argued in the thread that this problem is not relevant because kids are not generally under risk from congestive heart failure.

It appears that the drug can also cause bone weakening and fracture and fluid retention in the eyes with the potential for blindness.

The article cites both an expert in the drugs in question and another expert in autism both stating that there are serious questions about these drugs.

Matt

[autismdiva]

My first response seems to have gone into the ether...

1) why are diabetes drugs being tried for autism.

The best explanation comes from the researchers themselves and can be found here

www.4cures.org/SiteContent/Partnership%20for%20Cures%20Information%20Packet%2 0including%20Annual%20Report.doc (http://www.4cures.org/SiteContent/Partnership%20for%20Cures%20Information%20Packet%2 0including%20Annual%20Report.doc)

On about page 24 you will see:



2) what value is it supposed to help with?
Again, look to the people testing it. They have made the paper available on the web:

http://www.jneuroinflammation.com/content/4/1/3

They discuss parent-reported improvements in hyperactivity, irritability and one other area (I should look it up...)

3) What is the controversy?

The drug (Actos) has been linked to congestive heart failure. It has an FDA warning on it (the highest level warning the FDA gives). It was argued in the thread that this problem is not relevant because kids are not generally under risk from congestive heart failure.

It appears that the drug can also cause bone weakening and fracture and fluid retention in the eyes with the potential for blindness.

The article cites both an expert in the drugs in question and another expert in autism both stating that there are serious questions about these drugs.


Matt

There is only a little evidence to show "inflammation" in the brain of autistics, in the case of "inflammation" of the brain it is associated with some good things, not just bad things as one would think, so they don't know if it's a bad thing in autism... and again they have a little evidence from the brains of a few deceased autistics, as I understand it. There's no evidence to show that lowering this "inflammation" would change autism in the kid anyway. Just stories that say it might. So people are giving kids risky (even very risky) drugs on a hunch that it might help.

[Biomedmommy]

I find the issue of PPAR very interesting. For those that are now scared to try actos, I did find an alternative. See link below.

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15698426&ordinalpos=6&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_RVDocSum

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[Matt]

There is only a little evidence to show "inflammation" in the brain of autistics, in the case of "inflammation" of the brain it is associated with some good things, not just bad things as one would think, so they don't know if it's a bad thing in autism... and again they have a little evidence from the brains of a few deceased autistics, as I understand it. There's no evidence to show that lowering this "inflammation" would change autism in the kid anyway. Just stories that say it might. So people are giving kids risky (even very risky) drugs on a hunch that it might help.

The paper you are thinking of is now being discussed in a new thread. The authors make the point of stating that they don't know if the inflamation they claim is helping or hurting. If helping, one would probably not want to apply a drug like Actos.

On a second point--the kids in the Boris study are entirely not a good random sample. They authors note this, but it seems to get lost in the discussions. First, they were non-responders to previous treatments. (we could sidetrack into a discussion of what it means to be non-responders to treatments like secretin which are believed by the "mainstream" to have no responders. We could, but I hope we don't). Second, the patients have a number of immune problems noted. If I recall, something like 30% had PANDAS. I think that is large. Most had allergies of some kind.

So, even if Actos works, does it work in a general population of autistics?

Matt

[ihatethefda]

My first response seems to have gone into the ether...


Mine too! No response. I'm still wondering what you think of the special diet suggested by the doc in the article you posted.

[autismdiva]

The paper you are thinking of is now being discussed in a new thread. The authors make the point of stating that they don't know if the inflamation they claim is helping or hurting. If helping, one would probably not want to apply a drug like Actos.

On a second point--the kids in the Boris study are entirely not a good random sample. They authors note this, but it seems to get lost in the discussions. First, they were non-responders to previous treatments. (we could sidetrack into a discussion of what it means to be non-responders to treatments like secretin which are believed by the "mainstream" to have no responders. We could, but I hope we don't). Second, the patients have a number of immune problems noted. If I recall, something like 30% had PANDAS. I think that is large. Most had allergies of some kind.

So, even if Actos works, does it work in a general population of autistics?

Matt

OK, so isn't PANDAS a disputed entity in itself. It's my understanding that PANDAS (if it is a real disorder) causes OCD and Tourette's. I heard the discoverer/inventor of PANDAS describe it in detail at the MIND and she never mentioned PANDAS causing anything like autism... so these kids had ASD then acquired PANDAS from a strep infection???

[KevLeitch]

I see new posts on this thread making the same mistake that was made before - not acknowledging that diabetics who take this drug along with insulin are prone to heart failure. Thus the warning, which would not be relevant to people with autism.

Hi,

I've read both this and the other page you've linked to and I can't see any source for the claim that Actos only causes heart failure when used in conjunction with Insulin? Could you provide me with a source for that please?

The Actos official website (http://www.actos.com/actos/home.aspx) states:

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause or worsen congestive heart failure.

Also worrying to me is the claim on the Actos Wikipedia page (http://en.wikipedia.org/wiki/Actos) that:

Its safety in....people under 18 is not established.

[autismdiva]

Hi,

I've read both this and the other page you've linked to and I can't see any source for the claim that Actos only causes heart failure when used in conjunction with Insulin? Could you provide me with a source for that please?

The Actos official website (http://www.actos.com/actos/home.aspx) states:



Also worrying to me is the claim on the Actos Wikipedia page (http://en.wikipedia.org/wiki/Actos) that:

Apparently there are a lot of side effects that involve pain in various parts of the body, so how good are autistic children at reporting pain? Not so great, I think.


A short article
http://www.kansascity.com/news/nation/story/274419.html
My favorite line:
Michael Lincoff of the Cleveland Clinic, who write[sic] a study on Actos, said he would not consider it an appropriate autism medication

I'm guessing that was supposed to be "wrote a study on Actos."


Maybe Autism Speaks with all it's doctors on boards could make a statement about the wisdom of putting small autistic children on a diabetes drug with potential side effects of heart damage, blindness and broken bones... and goodness knows what all else, the stuff looks scary to me. :confused:


Adult patients reported big weight gains on the stuff and all kinds of edema, swelling and pain, blurry vision, dry cough, anxiety, panic attacks, increased liver enzymes, anemia, flu symptoms, ...
http://www.askapatient.com/viewrating.asp?drug=21073&name=ACTOS

oh joy. Everything an autistic child needs.

[ihatethefda]

Hi,

I've read both this and the other page you've linked to and I can't see any source for the claim that Actos only causes heart failure when used in conjunction with Insulin? Could you provide me with a source for that please?


I don't believe I said "only" anywhere on my posts, and if I left that impression, then I would like to correct that here. My original source was Actos' original product labeling itself which I cited on my original thread, post #1. I cited it as evidence that Dr. Boris was almost certainly aware of risks, (one member suggested that he had no idea what the risks were when he prescribed it to people with autism.)

I will repost that original warning:

Second, a very clear warning was already part of Actos’ labeling which stated: “In insulin combination studies, a small number of patients with a history of previously existing cardiac disease developed congestive heart failure when treated with ACTOS in combination with insulin.”

My main point is that people with diabetes have a heart risk by nature of their disorder. People with autism do not. Again, I am not pushing Actos; I am only trying to clear up some misinformation in which a doctor was unfairly maligned on the original Actos thread on the science forum. Scare tactics and other propoganda techniques were used on that original thread, and my intent was to provide some balance.

Also worrying to me is the claim on the Actos Wikipedia page (http://en.wikipedia.org/wiki/Actos) that:

Regarding the "under 18" statement, that statement is true for well over a dozen drugs that are regularly prescribed for children on the autistic spectrum. I don't think a doctor prescribing Actos to a 10-yr.-old should receive greater criticism for prescribing it to someone under 18 than should a "mainstream" doc who prescribes Zyprexa to a 10-yr.-old.

The fact that you and others raise the "under 18" question regarding Actos, and don't voice that concern regarding so many other drugs that are much more frequently prescribed for autistic children (by "mainstream" doctors) would leave one with the impression that some members of this forum have a pro-mainstream med bias.

[KevLeitch]

Thanks for clearing that up, I guessed you'd not meant to mislead people but its nice of you to confirm it. Thanks :)