Common Off-label Drug for Autism No Better than Placebo

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The Alzheimer’s drug memantine (also known as Ebixa or Namenda) is being regularly used off-label in the treatment of childhood autism, Asperger’s, and Pervasive Development Disorder, so the US FDA ordered two trials of it in children. The results of these new unpublished studies show the risky drug is ineffective and should be avoided, writes pharmacist Larry Sasich in Patient Drug News.

“The results for both of these trials were released on the US FDA’s Web site in July 2014,” writes Sasich. “In both trials there was no statistical difference between memantine and an inactive placebo.” According to Sasich, the US FDA Medical Officer responsible for the review recommended that the new product labeling should ‘inform clinicians and families of the lack of memantine’s effect on the treatment of core symptoms of autism.’”

Sasich adds that “it is unlikely that your pharmacist or physician knows about these trials.”

Avoid Using! Memantine (Ebixa, Namenda) for Autism (Patient Drug News, August 29, 2014)

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7 COMMENTS

  1. What do they honestly expect. How can a drug smartly correct or improve functionally a brain made up of billions of separate cells. All they are looking for is if personality changes can be spun and sold as beneficial and not normally if the condition itself is treated, even despite the long term damage. We know drugs will never lead to anything serious besides the occasional profit boost and they keep wasting time and money and people on this, what the ****.

  2. The main thing drugs do well is damage cells. This alters personality, kills bacteria, kills fungus, kills viruses, and kills healthy cells alike. The damage to a persons brain/body is very orofitable yet otherwise is of no benefit. Yes killing bacteria/virus/fungus/parasites good, but peoples brains?

    Time to abandon drugs as treatments for biological function and move to effective alternatives.

  3. That’s why something should be done about using drugs off label. Using drugs off label is using drugs with ZERO evidence that they have beneficial effects against a given problem (while posing all the threat due to known side effects). Yet doctors, not only psychiatrists do that regularly.

    Btw, what the hell is Pervasive Development Disorder anyway?

  4. Clinical trials are underway to prove that a low dose of clonazepam corrects brain chemistry for persons with autism. I am guessing a new patented version specifically for autism will appear on the market soon, as was done with Paxil for hot flashes. The goal is long-term treatment. Benzodiazepine experts Malcolm Lader and Heather Ashton have made clear that these drugs are only effective short-term, and damaging long-term. Spread the word so that people don’t fall victim to reckless overprescribing.

    • There is no freaking way to treat a person with autism (whatever autism is in that case – there is a million of things that get classified as “autism”) with drugs to “correct chemistry”. “Autistic” is who these people are for better or for worse. Sure, for some forms of autism there may be cures (like for the Rett syndrome girls – you can totally reverse it in mice but that’s a genetic disease that comes together with a lot of nasty symptoms and early death) but for many people that’s just their personality. It’s all about “calming down” kids who can be a pain in the a** for caregivers.

  5. Autism drug study involves South Florida children

    “If it’s shown to convincingly and safely improve trial participants’ impairments in interacting and communicating with others, researchers would seek the FDA’s nod as the first drug approved for offsetting autism’s core effects, said Dr. Peter Ventre, co-owner and principal investigator for Research Centers of America in Oakland Park, which is leading the study in South Florida.”

    http://articles.sun-sentinel.com/2012-10-19/health/fl-autism-medication-trial-20121019_1_atypical-autism-autism-community-largest-study

    Peter Ventre was part of that crew at Compass Health Systems, where they “treated” Gabriel Myers . http://www.linkedin.com/pub/peter-ventre/2b/361/697

    http://abcnews.go.com/Health/doctors-put-foster-children-risk-mind-altering-drugs/story?id=15064560

    Check this out, more on these dirtbags and their studies.

    ” For years, drug makers did not study most medications on children, largely due to ethical concerns over using kids as test subjects. More recently, however, Congress passed laws to encourage pharmaceutical companies to test their drugs for safety and efficacy with children by extending patents on drugs approved for adults.

    In a trial for one drug that was not identified, Punjwani gave one child dosages “in excess of… specified limits,” the letter says.

    The child was discontinued from the trial before it was completed, the letter says, “due to worsening auditory hallucinations that apparently caused the subject to lacerate her wrists.” The girl was “overdosed” on the drug for more than two weeks.

    The letter says Punjwani submitted a corrective action plan to the FDA and revised his procedures to better protect his research subjects from dosing missteps. “However,” the letter says, “we are concerned that the response is not adequate to prevent future recurrence of the violation.”

    The clinical trials for a different drug were to adhere to a series of protocols that specified what dosage of the drug was to be used, depending on the child’s weight, the letter states. But for six of seven children — chosen at random — who received one of the tested drugs in Punjwani’s study, the dosage exceeded what was spelled out in the protocol.

    One child who weighed 103 pounds, for example, “was overdosed on study medication for 20 consecutive days while participating in the study,” the letter states. The child is identified only as “Subject 1001.”

    A child identified as “Subject 1003,” who was 15 at the time of the trials, “was overdosed on study medication for 21 consecutive days while participating in the study,” the letter says. “Subject 1004,” a 16-year-old, “received doses in excess of the maximum target dose for 3 consecutive days while participating,” the letter says.

    A 10-year-old, identified as “Subject 1007,” was “overdosed” for nearly two weeks while on the study, the letter states.

    Read more here: http://psychrights.org/2010/100316FDAWarnsPunjwani.htm#storylink=cpy

    Got to love how the drug companies seek out these dirtbags to do there “studies”.

    • It’s a disgrace to science. You can’t do a trial like that, if you want to make any reasonable conclusions you should treat all patients equally in terms of doses (that is relative to body mass) unless you have specific information about subgroups of patients in terms of how they metabolise the drug etc. (like men vs women). But these trials are not made to discover real medicines, they’re made for pharma to sell more pills.