Archive | April, 2016

FDA proposes a ban on electric shock devices such as used at the Judge Rotenberg Center

28 Apr

I’ll keep this simple and direct: the FDA has proposed a new rule: Banned Devices; Proposal to Ban Electrical Stimulation Devices Used to Treat Self-Injurious or Aggressive Behavior.

Here’s the summary from that document:

SUMMARY: The Food and Drug Administration (FDA or we) is proposing to ban electrical stimulation devices used to treat aggressive or self-injurious behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. FDA is proposing to include in this ban both new devices and devices already in distribution and use.

Also:

We are aware of only one manufacturer, JRC, that has recently manufactured ESDs and that currently uses ESDs, including devices that we have not previously cleared.

JRC is the Judge Rotenberg Center, a residential school in Massachusetts for disabled students, many of whom are autistic. The JRC uses the ESD’s (electrical stimulation devices) as punishments to try to control behavior for some of their students. According to the document, the JRC used their devices (called GED at the school) on 82 individuals in 2014.

The document states that a parent group from the school and 2 former students provided comments in support of keeping the shock devices. One student and

In addition to NASDDDS and a JRC parents group, referenced earlier, 15 other organizations concerned with the treatment and the rights of individuals with disabilities spoke at the Panel Meeting, all of which supported a ban. Twenty-two disability rights organizations submitted written comments to the Panel Meeting docket, one of which was signed by 23 disability rights groups. Nine of these organizations were among the 15 represented at the Panel Meeting. All of these comments support the ban. FDA also received a comment from the U.S. Department of Justice Civil Rights Division supportive of a ban, and we considered information from the National Council on Disability, the National Institutes of Health, and the United Nations Special Rapporteur on Torture.

The FDA is not just relying upon community input. They also note the scientific literature which shows significant risks of PTSD and anxiety and other adverse events following the use of shock devices.

Here is a survivor’s letter, an account from a former JRC student who was subjected to the shocks.

The JRC was in the news after a student was tied to a board for 7 hours and shocked 31 times. The original news story links are no longer valid, but I will try to find them and link to them here.

The shock devices just do not have a sound backing–scientifically or ethically. If this FDA rule goes into place, the days when disabled students in America can be subjected to electric shocks like these will come to an end.

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By Matt Carey

Andrew Wakefield to Grace Hightower: “your family’s life [has] been blighted by autism”

22 Apr

One thing I have noticed over the years–those who are antagonistic towards vaccines are quite willing to use the disability community, but are rarely willing to offer us respect. Consider Andrew Wakefield, who introduced one book with a fictionalized account of a mother murdering her autistic child. He framed it as an act of love by the mother. Or his film, “who killed Alex Spourdalakis”. Alex was an autistic young man with extraordinary needs. Andrew Wakefield tried to make Alex’s life  into an episode for his (now failed) reality TV show. When Alex was brutally murdered by his mother and another caregiver, Wakefield took his footage and made a film.  It was an apology piece for the murders, using Alex as a hammer to attack mainstream medicine.

So now we have Wakefield apparently leaking his celebrity emails and showing again his misunderstanding for and contempt of autistic people. This is discussed at length by ScienceMom at JustTheVax: Paging De Niro and Hightower…Wakefield isn’t really in it to help autistics

I’ll just quote one email:

On Mar 29, 2016, at 9:18 AM, Andy Wakefield wrote:
Grace, whatever may have happened – and I guess I will never know – in truth my heart goes out to you and Bob. Not only has your family’s life been blighted by autism, but you have experienced some of the relentless and ruthless pressure that has been my life for as long as I can remember.
In truth and healing
Andy
—
Andy Wakefield
Director
Autism Media Channel

Just to be clear, Mr. Wakefield:

My child is not a blight. On me, my family or on anyone else.
My child is not blighted.
My life is better for my child. Challenges, struggles and all.

Just to be clear Ms. Hightower: if you didn’t respond to Mr. Wakefield in a way similar to the above, shame on you. But, while I am at it, shame on you for promoting this man and his damaging message. If you believe him, take a moment and ask yourself: if he’s lying (he is) how much harm has he caused to me, my family and mostly my son?

When you dehumanize people Mr. Wakefield, you make it easier for people to murder my child. You made it easier for people to abuse my child. You make it easier for people to disrespect my child. It is already a struggle to get adequate supports and assistance. How much will people be willing to help the “blighted”?

My child doesn’t need the charity of pity. My child needs the helping hand of respect.

And you, Mr. Wakefield, are in the way of that.

People ask me why do I spend my time countering your misinformation. This is why.

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By Matt Carey

Why do people have to see Vaxxed to criticize it? Wakefield’s own description of us tells us Vaxxed is bogus.

21 Apr

Andrew Wakefield got an interview on Fox to defend his film Vaxxed (the video and transcript are at Fox Provides Platform For Discredited Doctor To Claim CDC Is Hiding Evidence That Vaccines Cause Autism). And he’s shooting back at his critics: if you haven’t seen the film you can’t criticize it. It’s doubly ironic. First Wakefield’s team didn’t send out DVD’s to the press, and, second, many critics have seen the film. But the “you can’t comment on the film because you haven’t seen it” is the same argument he used with his horrible “Who Killed Alex Spourdalakis” film. (For those who are unfamiliar with it, it’s a film where Wakefield defends a mother and caregiver for the brutal murder of an autistic young man.) That film was worse than I expected it to be. And I was expecting bad.

Wakefield describes his film in the Fox interview. And just based on Wakefield’s own words, we can see that the film is inaccurate.

Wakefield:

Dr. William Thompson comes forward and says they have known for 14 years that MMR vaccine is causally associated with autism and they have covered it up.

This is wrong. First, the study Wakefield is talking about can not show causality. This sort of epidemiology can show researcher “here’s a place to look for causality”. Anyone who has been in this field for 20 years, like Andrew Wakefield, would know that. ]

But let’s get more to the point–Thompson didn’t say that they showed a causal connection.

From a statement by William Thompson:

The fact that we found a strong statistically significant finding among black males does not mean that there was a true association between the MMR vaccine and autism-like features in this subpopulation.

no “true association” means it doesn’t show causality.

Wakefield goes on:

And so the film, it’s his words, it’s his opinion, it’s his documents that really carry the message of this film that there has been a huge cover-up which has put millions of American children in harm’s way and it was totally unnecessary.

But as we’ve just seen, the key point of the film is precisely not Thompson’s words or opinion.

Wakefield appears to be using William Thompson as a sock puppet. We are told what Wakefield seems to either believe or wants us to hear. And with the claim that it’s not Wakefield doing the telling but Thompson.

But Wakefield’s own words about Vaxxed don’t match Thompson’s own words.

But per Wakefield people can’t criticize the film.

For whatever it’s worth, it’s not just William Thompson who stated that the study doesn’t show a causal connection. Even Brian Hooker, a colleague of Wakefield, didn’t claim a causal connection in his re-analysis of the CDC data. Here’s as close as Brian Hooker gets to claiming causality in his (now retracted) paper:

Additional research is required to better understand the relationship between MMR exposure and autism in African American males

Not “we found a causal connection”, but effectively “someone should test this for causality”. Frankly I don’t think this was a moment of intellectual honesty from Brian Hooker as much as pragmatics: referees know that this study can’t show causality so they would have rejected Hooker’s paper had he tried.

Thompson’s documents don’t show a causal connection either. I’ve made them public so people can check what is in them. Wakefield hasn’t. But Wakefield asks people to “make up their own mind”. The documents don’t show a “huge cover-up”. They don’t show “millions of children in harm’s way”.

Simple check of facts here: The “huge cover-up” putting millions of American children in harm’s way”, shouldn’t we address this? Wakefield is discussing one preliminary result in the CDC study: African American boys vaccinated before age 3. In all other groups, the study (confirmed by Brian Hooker) shows what all the other MMR studies show: no indication of an MMR/autism link. This point, by the way, isn’t stressed in Vaxxed. Even when they bring in autism families, they are mostly white.

But, back to this result. Leaving aside that Vaxxed isn’t accurate, shouldn’t we be concerned? Well let’s do some checking. Brian Hooker in his paper is saying that African American boys are 3.36 times more likely to be diagnosed autistic if they get the MMR vaccine before 36 months. If that is due to a real causal connection, we should easily see that in other data. MMR uptake is generally comparable by race. So even though African Americans are a minority in the U.S., 3.36 is high enough that some indication of a risk would have shown up in one of the other autism/MMR studies. But let’s not just handwave like that. Let’s check directly: is the autism prevalence higher in African Americans? Boys are roughly 4 times more likely to be diagnosed as girls, using Hooker’s 3.36 increased risk for African American boys (and if I’ve done my math correctly) African Americans should have an autism prevalence 2.9 times higher than Caucasians.

2.9 times higher autism prevalence. That’s big. We would see that on autism prevalence studies easily.

The CDC recently released an autism prevalence estimate. And they show that African Americans are less likely to be diagnosed.

Estimated ASD prevalence was significantly higher among non-Hispanic white children aged 8 years (15.5 per 1,000) compared with non-Hispanic black children (13.2 per 1,000), and Hispanic (10.1 per 1,000) children aged 8 years.

Yes, African Americans are less likely to be diagnosed (about a factor of 0.85). Again, using the data that Wakefield claims shows a “causal” connection between the MMR and autism, we expect 2.9 times higher prevalence. The facts just don’t match up with Wakefield’s claims.

The fact that autistic people from racial/ethnic minorities or low income families are less likely to be diagnosed is a problem true autism advocates are trying to fix. Many are not receiving the appropriate services and supports. But that’s what real autism advocates are working on, not Andrew Wakefield.

So, we have a film that by comparing Andrew Wakefield’s own description with the facts is inaccurate. But per Andrew Wakefield people can’t criticize Vaxxed if they haven’t seen it. That’s a bit of a logical fail on Mr. Wakefield’s part. Not like we have a shortage of those.

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By Matt Carey

Movie review: VAXXED

2 Apr

Andrew Wakefield’s film, VAXXED, opened today in a theater in New York. Mr. Wakefield somehow convinced Robert De Niro to break the rules of the Tribeca Film Festival and personally insert the film into the lineup of TFF. When this was discovered, Mr. De Niro first defended his decision and, after getting input from people whose expertise is science, pulled the film. Mr. Wakefield, with no apparent sense of irony about having avoided due process to get into the festival, cried out that he was denied due process in the removal process. But didn’t hesitate to add the tagline to his film poster, “the film they don’t want you to see”.

The opening of VAXXED had about 20 people in the audience by one account. I couldn’t attend, but someone I know did and gave me a lot of feedback. I was preparing to give summarize that feedback here when a review on indewire came out: ‘Vaxxed: From Cover-Up to Catastrophe’ is Designed to Trick You (Review) which concurs with the impressions I was about to relate here. Here’s a paragraph from that review:

In a statement leading up to the film’s release, Wakefield’s co-writer Del Bigtree claimed that “Vaxxed” is “not an anti-vaccine movie,” which is kind of like saying “Triumph of the Will” is anti-Hitler. Strung together in obvious ways to induce a constant sense of dread (look out for the slo-mo shot of a crying child!), “Vaxxed” shamelessly repeats the same non-arguments over and over again, drowning facts in murky proclamations.

VAXXED purports to be the story of a “CDC Whistleblower”, William Thompson, who contacted Brian Hooker, a vocal proponent of the idea that vaccines cause autism. The “about” page for the movie pretty much only talks about Thompson. One thing people going to see VAXXED will find is that the CDC study/William Thompson part is a very small part of the film. Most of it is filler, much of the conversation that goes on all the time online about vaccines.

But what is the Thompson story and why is it supposedly so explosive? Well, William Thompson was researcher who worked on vaccine epidemiology at the CDC. Most of that was many years ago. In fact the research discussed in VAXXED started in 2001. Thompson sought out Brian Hooker, a very vocal proponent of the idea that vaccines cause autism and led Hooker to a finding that was not reported when the paper was published in 2004.

Since this is really the heart of the film, allow me to go into some detail. The main claim was that the CDC team found in their first pass/rough analysis that autism was more common in African American boys who got the MMR vaccine than those who didn’t. Another finding was that for children without other conditions, there also appeared to be a higher autism risk. This group was called at the start of the study “isolated autism”, as in autism isolated from other conditions.

Let’s take that second one first, isolated autism. Here’s the thing–when the CDC team published their study in 2004, they did report on this. Instead of autism isolated from all other conditions, they showed autism without intellectual disability. The CDC reported that the calculated risk for this group was “statistically significant”.

In other words–what did they hide? Nothing. It’s the same result that Wakefield says was hidden. The only question I have– if this result is so important, why didn’t Wakefield or Hooker notice for the 10 years after it was published?

So, what about the other result? Thompson told Hooker that the CDC team another possible result. This result was limited to only African American boys, a fact that is largely glossed over in a film of largely white people. And this Autism/MMR/African American boys result didn’t remain statistically significant under the CDC planned, more complete, analysis. Which is to say, it’s not strong, it’s not really controversial.

But let’s ignore that for the moment. Let’s ask ourselves, if this is the smoking gun, the finding that was so explosive that a CDC researcher reached out to Brian Hooker to tell him about it, why don’t we don’t hear about that that finding until about 1/2 way through the film? And why is so little time spent on it? I’d think this would be a huge part of the film.

Let’s take another step back, a step away from the film. Here’s the thing about this from my perspective as an autism parent–if you believe this represents a real effect (that the MMR causes autism in African American males), you act very differently than Andrew Wakefield. You try to answer the question. Wakefield was at one point running a charity whose stated purpose was autism research (in the end, about half the money went to Wakefield’s salary). He is reported to have raised $400k for this film. Four hundred thousand dollars. I have seen no effort whatsoever by Mr. Wakefield to investigate this claim of a link between MMR and autism in African American boys. Instead we keep hearing about efforts on getting a congressional hearing on the subject. For those outside the autism community: there have been two autism related congressional hearings in recent years. While they have provided much YouTube footage for people pushing the idea that vaccines cause autism, they haven’t done anything to make life better for the autism communities. Nothing.

But one might argue, William Thompson tells us that this shows vaccines cause autism, right? No, he doesn’t. Here’s a public statement (one of only 2 I am aware of) that Mr. Thompson wrote:

The fact that we found a strong statistically significant finding among black males does not mean that there was a true association between the MMR vaccine and autism-like features in this subpopulation

But you won’t find that point emphasized in VAXXED. Instead you will find Wakefield and cowriter Del Bigtree claiming that Thompson says that the CDC “…knew that vaccines were actually causing autism”

There’s a huge difference between “does not mean a true association” and “knew that vaccines were actually causing autism”. I don’t know how big the difference is in film producer land, but in science, it’s night and day.

While we are exploring whether this claim of an MMR/autism link in African American boys, it’s worth noting that just yesterday the CDC came out with their latest autism report (they do this every year at the beginning of April). The CDC autism prevalence numbers show a very different story about the possibility of the MMR causing autism in African American boys. The autism prevalence in African American children is lower than that in whites. If the MMR/Autism link were real and as large as the rough analysis claimed, it would be higher.

And what about the dramatic claim of research fraud by the CDC team? This claim not only doesn’t hold up, but it’s morphed a bit over time. Originally Wakefield and Hooker claimed that the CDC changed their analysis plan after finding the “race effect”. That is–they saw a result they didn’t like and then changed the analysis plan. Let me show you. Here’s a quote from an earlier Wakefield video on the subject

“Over the ensuing months, after the data after the data had been collected and analyzed, and strictly forbidden in the proper conduct of science, the group abandoned the approved analysis plan, introducing a revised analysis plan to help them deal with their problem.”

We also see this claim in the press release that accompanied Brian Hooker’s “reanalysis” of the CDC data:

According to Dr. Thompson’s statement, “Decisions were made regarding which findings to report after the data was collected.” Thompson’s conversations with Hooker confirmed that it was only after the CDC study co-authors observed results indicating a statistical association between MMR timing and autism among African-American boys, that they introduced the Georgia birth certificate criterion as a requirement for participation in the study. This had the effect of reducing the sample size by 41% and eliminating the statistical significance of the finding, which Hooker calls “a direct deviation from the agreed upon final study protocol — a serious violation.”

Emphasis added.

The problem with that statement was that the final “revised analysis plan” was dated Sept 5, 2001 and the “race effect” wasn’t seen until late October/early November 2001. Two months later. In other words, for this version of the fraud claim to work, the CDC team would have to travel back in time. We know this timeline because the William Thompson documents are now public and we can compare the analysis plans and analysis.

If this seems confusing, it gets worse in VAXXED where we are taken into a discussion of the CDC team switching from using race data from school records to birth certificates and how this reduces the statistical power and hides an effect and all.

Rather than go into details about that, I’ll state this: this argument is a red herring. And wrong, but a red herring. Yes the CDC had data from both school and birth records. But they always planned on using the birth certificate data for their final analysis. From the analysis plan we read:

For the subset of children with Georgia birth records, sub-analyses will be performed in which potential confounding variables from the birth certificate will be used to adjust the estimated association between the MMR vaccine and autism. The variables that will be assessed as potential confounders will be birth weight, APGAR scores, gestational age, birth type, parity, maternal age, maternal race/ethnicity, and maternal education

Or to put it simply, the school records didn’t include things like APGAR scores and so much more that the CDC team planned to use from the start.

So much for “research fraud”.

We can go through the details, but let me just say that a great deal of VAXXED is not really directly the story–the story that is promised in the VAXXED web page. A lot of discussion about and by Andrew Wakefield, for example. We also get parents speaking about their beliefs that vaccines caused their child to be autistic. While very emotional and not something to be dismissed, this doesn’t address the question of whether vaccines cause autism or if there was malfeasance at the CDC.

We a significant amount of filler in the “Big Pharma is bad” sort. The industry insider they get to speak is person who worked in sales for Vioxx. No expertise on vaccines, no experience on the inside for vaccines. And more that I just won’t go into detail about.

Does that mean it won’t be convincing? Well, a large part of the audience for this is already convinced. But will they convince more people with this film? Sadly, the answer is yes. People are not afforded the chance to see the counter arguments. And the appeal to emotion that is much of the film will play. Much better than dry analysis like the above that I have provided. But do I find this movie in the least accurate? No.

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By Matt Carey