Actos – The New Fad

14 Sep

In the world of autism quackery, I’m of the growing opinion that the ‘doctors’ who play about with the drugs they experiment with on autistic kids sometimes sit around in a big club somewhere one-upping each other:

Chelation? Pfft – thats nothing. I give all my kids IV Chelation…..Oh yeah, well, I give all _my_ kids IV Chelation of garlic and vinegar….[an impressed rumble goes around the table]….thats nothing – I give my kids HBOT…..Really? HBOT? Well, I give my macaques, I mean, kids _Lupron_….

And there it rested for awhile. That is until a new kid on the block came long. Actos. What the hell is Actos? Its a drug used to treat Type 2 Diabetes. Why’s it being used to experiment on autistic kids? Well, the DAN! party line is that autism is or causes or whatever neuroinflammation. Actos reduces inflammation.

In a Newsday story DAN! doctor, Marvin Boris tells how he uses Actos all the time and in fact has co-authored a paper on its use:

Discussion and evaluation: In a small cohort of autistic children, daily treatment with 30 or 60 mg p.o. pioglitazone for 3–4 months induced apparent clinical improvement without adverse events. There were no adverse effects noted and behavioral measurements revealed a significant decrease in 4 out of 5 subcategories (irritability, lethargy, stereotypy, and hyperactivity). Improved behaviors were inversely correlated with patient age, indicating stronger effects on the younger patients.

Conclusion: Pioglitazone should be considered for further testing of therapeutic potential in autistic patients.

Happy days right?

Well of _course_ not. Would I be blogging about it if it was?

First problem I thought of was the discrepancy between sample size (25) and conclusion. At _best_ I would think of this as a pilot study.

The second issue was the utter lack of clarification regarding Actos and what exact risks were spelled out to the patients or their guardians. Actos is pretty heavy stuff.

Last week Actos received a “black box warning” from the U.S. Food and Drug Administration, the agency’s strongest level of caution. Actos, and a similar diabetes drug, Avandia, can increase the risk of heart failure, the FDA warned.

A black box warning means that the drug in question has a large black box drawn the text of the warning just to make it perfectly clear what the issues are. The warning confirms the Newsday story:

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

And whilst the study _claims_ Actos has a good safety record, what it neglects to mention is that:

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

So here we have a situation wherein a heavy duty drug is being used in a very off-label way, on a population it has no safety record for and which carries a black box FDA warning regarding its side effects.

Now, maybe its just me but two things strike me almost immediately about all this.

Firstly, call me silly and old fashioned, but I would much rather have an autistic kid then take a chance on having a dead kid. But maybe thats just me.

Secondly, all these parents who scream blue murder about the evil Big Pharma and complain bitterly about the safety records of thiomersal are apparently more than happy to fall into the loving embrace of this medication, made by Big Pharma and with no safety record at all.

My guess? Dr Boris wins at the DAN! bragging contest this year.

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7 Responses to “Actos – The New Fad”

  1. bones September 14, 2007 at 12:34 #

    “Secondly, all these parents who scream blue murder about the evil Big Pharma and complain bitterly about the safety records of thiomersal are apparently more than happy to fall into the loving embrace of this medication, made by Big Pharma and with no safety record at all.”

    That was my immediate reaction, too. Rather ironic, ain’t it?

  2. Bonnie Ventura September 14, 2007 at 15:16 #

    The parents may not even be aware of the warnings. They probably think it’s similar to taking fish oil or other natural anti-inflammatory supplements. The DAN! crowd doesn’t have a history of being scrupulous about getting informed consent, after all.

  3. Matt September 14, 2007 at 15:16 #

    “Happy days right?

    Well of course not. Would I be blogging about it if it was?”

    Actually, yeah, you would be. If it really was a proven good thing for people with autism (however that could be proven), I expect you would be talking about it.

    There is a followup story by the same writer:

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

    Matt

  4. Gretl September 14, 2007 at 15:39 #

    I’m sorry — I thought you were talking about Mentos.

    *grin*

  5. bullet September 14, 2007 at 22:37 #

    That is extremely worrying.

  6. Ms. Clark September 15, 2007 at 01:15 #

    Besides possibly causing heart failure, apparently it can cause glaucoma that can cause blindness. A glaucoma test consists of getting a puff of air blown into an open eye while the head is held still, chin resting on an apparatus…

    Why do I think kids are not going to want to cooperate with this? Actos apparently can also cause osteoporosis (brittle bones).

    Heart disease, broken bones, possibly permanently weak bones (it’s not easy to get calcium back into bones once they get that weak), and possible damage to the optic nerve, messing with blood sugar levels, for what? I sincerely doubt that Dr. Boris and the parents are seeing anything more than a placebo response.

    Scary patient reported side effects:

    http://www.askapatient.com/viewrating.asp?drug=21073&name=ACTOS

    More about side effects:

    http://www.medicinenet.com/pioglitazone-oral/article.htm

    So is a non-verbal kid supposed to be able to report all these pains?

  7. Jon September 16, 2007 at 00:46 #

    A glaucoma test consists of getting a puff of air blown into an open eye while the head is held still, chin resting on an apparatus…Why do I think kids are not going to want to cooperate with this?

    And while trying to keep eye open, despite reflex to blink when faced with something like a puff of air. Having had this done a couple of times, I don’t think I wanted to cooperate with it ;)

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