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Richard Deth – gambling man

27 Apr

Maybe you don’t know, or have forgotten who Richard Deth (pronounced to rhyme with ‘teeth’) is.

He is:

Richard Deth, Ph.D., is a neuropharmacologist, a professor of pharmacology at Northeastern University in Boston, Massachusetts, and is on the scientific advisory board of the National Autism Association. Deth has published scientific studies on the role of D4 dopamine receptors in psychiatric disorders, as well as the book, Molecular Origins of Human Attention: The Dopamine-Folate Connection. He has also become a prominent voice in the controversies in autism and vaccine controversy, due to his theory that certain children are more at risk than others because they lack the normal ability to excrete neurotoxic metals.

Deth became ‘hot property’ in the anti-vaccine autism groups after publishing a paper (with which there were numerous issues – see Bart Cubbins excellent video for details) that was funded by one of those anti-vaccine groups – Safe Minds. Interestingly, during an exchange with Kathleen documented at neurodiversity.com, it also came to light that Richard Deth was registered as a paid expert witness in the vaccine litigation omnibus proceedings. Professor Deth said:

“I thank you for alerting me to the fact that my name was included on that expert witness list. It was done so without my knowledge or permission. It might be related to a phone call from that law office that was logged to my office while I was away on vacation in February. I never returned the call.”

To which Kathleen replied replied:

“It was quite an oversight for the attorneys to fail to confirm your willingness to serve in that role prior to naming you as a plaintiffs’ expert in the Petitioners’ Initial Disclosure of Experts, and filing that document with the Court of Federal Claims. However, their certainty is understandable, given your indication during our brief telephone conversation that the lawyer with whom you discussed the matter was “Andy” Waters, lead attorney in the thimerosal cases.”

Deth didn’t comment any further. As many have discovered, if you want to go head to head with Kathleen you better make sure your i’s are dotted and your t’s are crossed.

One of the statements Deth made during their exchange stood out to me at the time.

…I would like to make a virtual wager that within the next 18-24 months scientific evidence will make the thimerosal-autism link a near certainty. If you are willing, I’ll let you name the stakes.

Deth sent his email on March 22 2006. Luckily for him, Kathleen took pity on him and declined his rather gauche offer.

So what does this mean? What does it prove?

Why, nothing. Nothing at all. I just wanted LB/RB readers to be perfectly clear that a strong _belief_ in a scenario doesn’t make one right. In fact, when we look at all the recent evidence for the various beliefs of the various anti-vaccine/autism groups – from the prediction that the Omnibus Autism cases would be a walkover for them, to David Kirby’s certainty that thiomersal causation would be vindicated by CDDS data in 2005, then 2007, to this example of ego from Richard Deth what we see is a clear picture of a set of people who are consistently and unerringly wrong. This is because they simply cannot see the science right in front of them. Even such an august figure as Richard Deth, Ph. D.

Jennifer Lopez adds vocal support

25 Apr

In an interview with ‘Good Morning America‘ Jennifer Lopez stood up for vaccinations by talking about a new campaign and website. The website is very accomplished and features Ms Lopez talking about how to protect your baby from Whooping Cough.

The interview itself contained the following on vaccines:

She’s also raising awareness about pertussis, the potentially fatal disease better known as whooping cough.

Visit www.soundsofpertussis.com to find out more about the vaccine.

Pertussis cases were virtually nonexistent in the United States after a vaccine was developed. Reported cases of whooping cough hit a low of about 1,000 in 1976. That number has been on the rise over the past 30 years, and in 2005, 25,000 cases were reported, according to the Centers for Disease Control and Prevention. According to a CDC study of the disease, Hispanic infants were particularly hard hit by the disease, though there is no clear reason why.

Immunization from the whooping cough vaccine wears off over time, usually between five and 10 years, so adults can spread the highly contagious disease to infants.

Lopez said babies most often contract the disease from their parents, and it can go undetected. “We’ll be OK, but it could be fatal to the babies,” she said.

The Sounds of Pertussis campaign educates adults about getting a Tdap booster shot, which protects against tetanus, diphtheria and pertussis.

Lopez joins other responsible parents and celebs Jennifer Garner andAmanda Peet in making sure everyone knows that these vaccines are safe and available.

Dr Jay Gordon, HIPAA violation? Really?

23 Apr

We’re back to the Huffington Post again and this time rather than Jenny McCarthy’s boyfriend, we’re talking about Jenny McCarthy’s son’s doctor Dr Jay Gordon.

He recently blogged about an LA Times piece by fellow medical man Dr Rahul Parikh. In his piece Parikh said:

One night, we admitted a 9-month-old girl who was having trouble breathing. She arrived with her parents — Mom in tears and Dad tense with worry. Her parents were movie stars from a Hollywood borough who…needed nothing. In a way, they had chosen “nothing” for their daughter from the time she was born — refusing all vaccines for her.

From this information alone Dr Gordon decided that Dr Parikh:

…commits ethics and HIPAA violations so egregious that the Medical Board must take him to task

Interesting, I thought as I read on…

Dr. Parikh is a well-published medical author and blogger and he speaks of a patient he saw as an intern in the year 2000 at Cedars-Sinai Medical Center. (His bio on many sites lets you know that year.) He identifies the parents, their unique profession and their child’s age and illness. This family can be identified by anyone who can use Google.

I was confused by now – Parikh hadn’t mentioned the year (in fact *Gordon himself* did!), he hadn’t identified the parents and as for their ‘unique profession’…how is being a movie star from Hollywood in any way unique? Surely Hollywood is full of movie stars? I mean, I’m a Brit so maybe I’m just buying into a cliché – are there really not many movie stars in Hollywood? And as for identifying the child’s age and illness – a 9 month old with a repository infection? Is that massively uncommon? I don’t think it is.

I stopped reading at that point as I have never been Dr Gordon’s biggest fan. He lacks the balls to tell Jenny McCarthy she’s wrong about there being anti-freeze in vaccines (silliness repeated by Jim Carrey yesterday) amongst other things. I was now more interested in this ‘ethics and HIPAA violation’.

False modesty aside I’m pretty good at digging at information on search engines and try as I could (and I really did try), based on the info in Parikh’s piece, I could not for the life of me identify who the movie stars were whos daughter was ill. I still can’t.

However, finding out what constitutes a HIPAA violation in terms of identifiable data was very much easier. I hit gold on my first search. According to the site ‘Lawyers and HIPAA‘ a violation occurs when health information is made public – here’s the paragraph on health information and its public release:

Individually identifiable health information is information that is a subset of health information, including demographic information collected from an individual, and:

(1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and

(2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and

(i) That identifies the individual; or

(ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual.

I simply cannot see how Jay Gordon realistically believes that the information in Rahul Parikh’s LA Times piece meets that criteria.

Update: I see Autism News Beat has covered this also. In the comments Dr Gordon appears and says:

Good points. I’ve removed the nastier comments in the HuffPo piece. The Internet lends itself to false bravado and unpleasant ad hominem attacks [please see above 🙂 ] and I have to work on not being part of that problem.

I stand by my original unhappiness at the inaccurate proclamation of whooping cough

Yet when I return to Dr Gordon’s Huffington Post entry, I still see the references to HIPAA violations. Does Dr Gordon really believe that Dr Parikh’s article is full of HIPAA violations? Yes, I’m a Brit and no, I’m not a lawyer but my common sense tells me that Dr Gordon is playing with fire here. Lets hope for Dr Gordon’s sake that Dr Parikh is not going to sue for defamation. According to Autism News Beat that would be distinctly on the cards.

An open letter to Jim Carrey

22 Apr

Today on The Huffngton Post, actor Jim Carrey posted his thoughts about autism and vaccines. With his very first paragraph it became apparent how little Carrey understood the issues involved:

Recently, I was amazed to hear a commentary by CNN’s Campbell Brown on the controversial vaccine issue. After a ruling by the ‘special vaccine court’ saying the Measles, Mumps, Rubella shot wasn’t found to be responsible for the plaintiffs’ autism, she and others in the media began making assertions that the judgment was in, and vaccines had been proven safe. No one would be more relieved than Jenny and I if that were true. But with all due respect to Ms. Brown, a ruling against causation in three cases out of more than 5000 hardly proves that other children won’t be adversely affected by the MMR…

Point one Mr Carrey. The vaccine issue is only controversial to adherents of your belief system. Within scientific, medical, legal, autistic and parental circles its not even slightly controversial.

Point two, the three cases chosen were chosen – by the plaintiffs legal team – to represent their absolute best chance of winning. If they had won, there was an excellent chance all the cases that were suggesting MMR as causation would have just ‘won’ automatically. Thats why its called an Omnibus.

Point three, regarding the MMR, it has been firmly established that:

a) The data supporting the MMR hypothesis was fixed.

b) The science supporting the MMR theory was badly wrong – both badly done and exposed to contaminants.

You might also note that the court was not attempting to see if the children were ‘adversely affected by the MMR’, it was looking to see – using the three cases the legal team representing the families thought were the absolute best – if MMR caused autism. It didn’t. Thats probably why your Campbell Brown found it easy to say the MMR hypothesis was dead and buried.

You go to say Mr Carrey that:

Not everyone gets cancer from smoking, but cigarettes do cause cancer. After 100 years and many rulings in favor of the tobacco companies, we finally figured that out.

Yes, we did – and do you know how? With _good science_ – just like the science that established in the three MMR test cases that the MMR didn’t cause autism. And its fascinating that you bring up this parallel to the smoking issue and then later in your blog post invoke the name of Bernadine Healy. Healy – who’s ‘more sensible voice’ you say you’d rather listen to. Did you know Healy used to be a member of TASSC:

TASSC was created in 1993 by the APCO Worldwide public relations firm, and was funded by tobacco company Philip Morris (now Altria)….

According to Sheldon Rampton and John Stauber in their article How Big Tobacco Helped Create “the Junkman”, one of the forerunners of TASSC at Philip Morris was a 1988 “Proposal for the Whitecoat Project,” named after the white laboratory coats that scientists sometimes wear. The project had four goals: “Resist and roll back smoking restrictions. Restore smoker confidence. Reverse scientific and popular misconception that ETS (passive smoking) is harmful. Restore social acceptability of smoking.”

[own inserts]

Is that what you consider a sensible voice Mr Carrey? Someone who supported the tobacco agenda?

Moving on, you say:

If we are to believe that the ruling of the ‘vaccine court’ in these cases mean that all vaccines are safe, then we must also consider the rulings of that same court in the Hannah Polling and Bailey Banks cases, which ruled vaccines were the cause of autism and therefore assume that all vaccines are unsafe. Clearly both are irresponsible assumptions, and neither option is prudent.

First and foremost, the vaccine court did not rule at all in the Hannah Poling case. HHS conceded. And what they conceded was that Hannah Poling was damaged by vaccines resulting in ‘autism like features’. In fact, when we look at the the one piece of medical science carried out on Hannah Poling (co-authored by her own father), we see that only three of the symptoms described as being the result of vaccine injury appear on the DSM (IV) diagnostic criteria for autism.

As for Bailey Banks, this is a perfect illustration of both how the vaccine court in the USA was designed to work and also how terrible the evidence was in the three MMR test cases.

The Banks ruling (subtitled ‘Non-autistic developmental delay’ by the way) drew a line of causation from vaccine to PDD-NOS. It is able to do this as the burden of proof for any science presented to the vaccine court is ‘50% plus a feather’. In other words, it just has to be plausible, no causation needs to be shown.

What doesn’t seem in doubt is that Bailey was injured by a vaccine which resulted in a condition called ADEM. The judge in the case then went on to accept the plaintiffs position that the ADEM in turn caused PDD-NOS. He did this seemingly because there was no evidence to the contrary – e.g. no evidence that ADEM *doesn’t* cause PDD-NOS.

In any scientific situation – including civil court in the US – this would never have been accepted. The plaintiff would have had to have demonstrated that ADEM *did* cause PDD-NOS. And a search of PubMed reveals nothing for ‘ADEM autism’ or ‘ADEM PDD’.

So, in the Banks case, because there was no evidence that ADEM does not cause PDD-NOS, they won. In every situation bar the vaccine court, the Banks’ would not have won their case. There is no science to support the idea ADEM causes autism.

Bearing this ‘50% plus a feather’ concept in mind it is clear just how utterly dreadful the evidence was to support the idea MMR caused autism. Not only could plaintiffs not provide any evidence that MMR causes autism, respondents produced reams of evidence to show it clearly doesn’t.

You carry on Mr Carrey to say:

I’ve also heard it said that no evidence of a link between vaccines and autism has ever been found. That statement is only true for the CDC, the AAP and the vaccine makers who’ve been ignoring mountains of scientific information and testimony. There’s no evidence of the Lincoln Memorial if you look the other way and refuse to turn around. But if you care to look, it’s really quite impressive. For a sample of vaccine injury evidence go to http://www.generationrescue.org/lincolnmemorial.html.

Your analogy is ridiculous. I could go to any library and find evidence for the Lincoln Memorial without ever seeing it. In fact, what your analogy does is demonstrate exactly how blinkered and able to only face one direction at one time you and your colleagues are.

The evidence you present as that being supportive of evidence between a link between vaccines and autism is equally ridiculous and blinkered. I simply don;t have the time to tackle the mountain of misinformation presented on the page you link to suffice to say there’s not a single section that doesn’t have a major error. Most of them have been tackled on this and other blogs over the years.

Next you say:

In all likelihood the truth about vaccines is that they are both good and bad. While ingredients like aluminum, mercury, ether, formaldehyde and anti-freeze may help preserve and enhance vaccines, they can be toxic as well. The assortment of viruses delivered by multiple immunizations may also be a hazard. I agree with the growing number of voices within the medical and scientific community who believe that vaccines, like every other drug, have risks as well as benefits and that for the sake of profit, American children are being given too many, too soon. One thing is certain. We don’t know enough to announce that all vaccines are safe!

Mr Carrey, *vaccines do not contain anti-freeze* – for goodness sake, even Jay Gordon, Evan’s Paediatrician knows that! Did you also know that (to quote myself):

There’s also Aluminium in breast milk so lets compare the two.

According to this paper (which is from 1990 – any more up to date papers welcomed) the amount of Aluminium in breast milk is 49 ?g/L. The average amount of breast milk expressed per day is 0.85 liters.

This means that 41.65?g Aluminium per day is in breast milk.

Now, according to this paper, there is between 125 – 850?g of Aluminium per dose in a vaccine.

So, for a 6 year old, total Aluminium is between 2,125 – 14,450?g.

In real terms this means that after between 51 and 346 days breast feeding, a 6 year old will have taken onboard the same amount of Aluminium as from the total US vaccine schedule.

Now I couldn’t find out what vaccines contained the lower amount or which contained the higher amount. Even so, this means that if every vaccine a 6 year old has that contains Aluminium contains the highest possible amount, within a year of breast feeding they will have matched that.

Or to put it another way, an anti-vax tree-hugger soccer mom who doesn’t vaccinate her baby will have given him the same amount of Aluminium he would’ve had in six years after one year of breast feeding.

And thats of course, not even touched on the fact that:

In the Earth’s crust, aluminium is the most abundant (8.13%) metallic element, and the third most abundant of all elements (after oxygen and silicon)

And is found naturally occurring in sea water, fresh water, the human body etc etc.

[Regarding Formaldehyde]…There’s also Formaldehyde in Apples, Apricots, Banana’s and….ah, I lost interest. Lots of stuff. Including the human body.

So – how much is in vaccines?

According to this and using it in combination with the US vaccine schedule referenced above, we can see that the total amount of Formaldehyde in vaccines from the vaccine schedule for a 6 year old child is 1.2016mg (again, do your own maths, correct me if I’m wrong).

For comparison to that 1.2mg in all vaccines for a 6 year old, 1 (one) banana contains 16.3mg Formaldehyde.

Mr Carrey, you’ve got to stop throwing these scaremongering nonfacts around. Its damned irresponsible for a start.

Lastly Mr Carrey, you say:

If the CDC, the AAP and Ms. Brown insist that our children take twice as many shots as the rest of the western world, we need more independent vaccine research not done by the drug companies selling the vaccines or by organizations under their influence. Studies that cannot be internally suppressed.

In terms of autism, if you want to make a big deal out of the fact that ‘our children take twice as many shots as the rest of the western world’ then please consider this – the UK has less shots than you. We also have a higher prevalence than you. 1 in 100 vs 1 in 150.

And please also don’t invoke silly conspiracy theories. Think about how science works. A study is done, funded by Eli Lily for example. It is peer reviewed and found to be good quality and it is published in, lets say NEJM. Now, *every single reader of that study* can see exactly what methods and means were used to reach the studies conclusions. I ask you Mr Carrey, how much more independent can you get? How much more transparent? Basically anyone, anywhere can try and replicate that same studies results. If they can and a few others can – the results are good. If nobody can (think Andrew Wakefield) then the results must be bad.

And for goodness sake man, grow up, who is ‘suppressing’ what study exactly? Have you _any_ evidence at all that any study ever has been internally suppressed? Or are you just throwing this stuff out to scare people?

Mr Carrey, I loved the Truman Show but this isn’t it. There’s no god like figure overseeing every aspect of your life and wanting to control it. I ask you – get in contact with an actual scientist and go through your concerns with them. At the very least they’ll be able to stop you saying silly things like there’s anti-freeze in vaccines.

Bernadine Healy and the Hepatitis B myth

18 Apr

Kev has already commented on Dr. Bernadine Healy’s return to the autism world. Besides giving herself a big pat on the back for being part of a “war”, she made a number of mistakes (as Kev has pointed out).

Kev missed one of Dr. Healy’s mistakes–the Hep-B myth.

One of the recurring myths of anti-vaccine groups is that Hepatitis B is only transmitted in one of three ways

1) from an infected mother to a newborn
2) via shared needles
3) via sex

Thus, the logic goes, the Hep-B shot is unnecessary. (followed usually by, and only in the schedule to line the pockets of the evil vaccine manufacturers…but I digress).

As mentioned above, Dr. Healy has picked this theme up in her recent return to the vaccines-cause-autism spotlight.

On her recent visit to the Larry King Live show, she stated,

There are some vaccines here that one — a parent can legitimately question: giving a one-day old baby, or a two-day old baby Hepatitis B vaccine, that has no risk for it. The mother has no risk for it. That’s a heavy duty vaccine given on day two, at two months, at four months.

In her recent US News blog post,

The extras here include protection against the sexually transmitted hepatitis B virus…

Just because it’s sexually transmitted doesn’t mean it’s only sexually transmitted.

From the recent paper (with Dr. Offit as lead author, The Problem With Dr Bob’s Alternative Vaccine Schedule:

Before the hepatitis B vaccine became part of the routine schedule for children, every year ~16 000 children <10 years of age were infected with hepatitis B virus after nonsexual, person-to-person contact.[reference 2] Given that reported cases might not include subclinical infections, this estimate is probably low.

Reference 2 is Childhood Hepatitis B Virus Infections in the United States Before Hepatitis B Immunization.

Let’s face simple facts–if Dr. Healy is really in this discussion, she has to have read the recent Offit paper. More importantly, I would hope that she read the paper Dr. Offit references. I mean, really, how could she not? And, yet, she acts as though no one has publicly refuted the Hep-B myth.

In one of the stranger bits of logic I’ve seen in a while, Dr. Healy suggests putting off the Hep-B vaccinations until “school age”. Hmmm. Don’t give it at birth because it isn’t needed because it is a sexually transmitted disease. But, give it to, what, 5 year olds when they enter school? Did I miss something and our kindergardeners are sexually active drug abusers? Or, maybe she’s thinking we should give it at age 13 to catch the kids before they become sexually or drug active? Would that mean that she’s pro-gardasil?

I will give Dr. Healy credit for one thing–she dropped the misrepresentations of the IOM that permeated her entrance into the world of autism “personalities”.

I guess I should count myself lucky for that small bit of progress.

Bernadine Healy gets it wrong

17 Apr

Following Bernadine Healy’s April 14th post in USNews, Orac dealt her a dollop of respectful insolence which is a very good read, as are the comments.

However, I wanted to do a kind of accounting on Healy’s post, to see just how firm a grasp on the whole situation she has. So, lets start.

McCarthy and Carrey and two colleagues from the autism advocacy group she founded, Generation Rescue…

Oops. Sentence two, first error. McCarthy did not found Generation Rescue, JB and Lisa Handley did.

…and parents are raising legitimate concerns, yet unanswered…

I have been on the front line of this debate for the last six years. Once upon a time the question ‘do vaccines cause autism’ _was_ a legitimate one to ask. But that question has been asked and answered. Since about 2003/4 there have been _no_ legitimate concerns raised by parents or anyone else. The MMR question has turned out to be both a con and the result of bad science. The thiomersal question is just a defunct hypothesis, given that thiomersal was largely removed from vaccines by 2002 and yet autism rates continue to climb. Despite desperate attempts to rebrand the autism/vaccine question (aka when you know you’re right and yet turn out to be wrong, know you’re right with something else) into questions about greening vaccines when simple searching reveals that newborns contain most vaccine ingredients either naturally or via breast feeding. Or the hellacious vaccine schedule despite the fact that the UK for example has a higher rate of autism (1 in 100 vs 1 in 150) but a lower amount of vaccinations.

This controversy might be resolved if we can focus on a few big questions, with an open mind…

Mistake number three. There is no controversy. In the field of _science_ asking the _scientific question_ ‘do vaccines cause autism’, there is no controversy at all. What there is is a very good and well executed media campaign to manufacture one. However, the facts remain the facts – no vaccine, no vaccine ingredient and no vaccine schedule either solely or together cause autism. There is simply no sound science to support that set of ideas. If there is a controversy it is how the media continue to let people stoke the fire of this idea.

Influenza vaccine, mandated here starting at age 6 months…

Mistake number four. As far as I can tell, the flu vaccine is not mandatory in the US. Certainly this article covering the 2008/09 flu season states:

It will not be mandatory for every child to have the flu shot…

Onward.

…a study from Canada last year found that delaying the diphtheria, tetanus, and pertussis vaccination just a few months decreased by 50 percent the risk that a child develops asthma…

Mistake number five. This has absolutely no bearing an autism. The article is entitled ‘The Vaccines-Autism War: Détente Needed’. Not ‘vaccines, asthma, maybe other stuff as and when I think of it-autism war’. As such this strawman argument has nothing to do with autism.

(Side note: Healy says we should read two doctors thoughts on the pros and cons of a flexible vaccine schedule. It maybe will come as no surprise that the doctor who thinks the US needs a flexible vaccine schedule is ‘Vice chair, Section on Complementary and Integrative Medicine’ of the AAP).

The goal is to get all kids appropriately vaccinated…

Mistake number six. The organisation Healy references at least twice, Generation Rescue, have this on the front page of their Facebook Group

“I found that the whole vaccine business was indeed a gigantic hoax…” –Dr Kalokerinos MD June 1995

“There are significant risks associated with every immunization and numerous contraindications that may make it dangerous for the shots to be given to your child…” — –Dr. Robert Mendelsohn MD, pediatrician

Onward again.

…Hannah Poling, for example, who has an underlying mitochondrial disorder and developed a sudden and dramatic case of regressive autism after receiving nine immunizations, later determined to be the precipitating factor…

Mistake number seven. Nowhere, repeat, nowhere has it been published that Hannah Poling’s vaccines were the ‘precipitating factor’ in her autism. If anyone thinks that it has been published I would like a link to that document. I’ve been asking for this for over a year now and no one has ever managed to show me where this is stated.

What _has_ been said is that following her vaccines hannah showed ‘features of autism’. As I have said numerous times, ‘features’ of autism is not interchangeable with autism. If it was, then the medical report co written by four doctors including Hannah Polings father Jon Poling would have simply said ‘autism’. In fact, this medical case study listed a number of symptoms (over 20) of which only three were found on the DSM (IV) (the official diagnosis for autism). She may well have been autistic and she was determined to have been vaccine damaged but that does not automatically mean one caused the other and in fact by the lack of any of the many other symptoms needed to reach a diagnosis of autism, we can see that they were not.

Amd again, onward:

Other children may have a genetic predisposition to autism, a pre-existing neurological condition worsened by vaccines, or an immune system that is sent into overdrive by too many vaccines, and thus they might deserve special care. This approach challenges the notion that every child must be vaccinated for every pathogen on the government’s schedule with almost no exception…

Not exactly any mistake here but this is very misleading. Its well know _already_ that some kids _do_ have conditions that are not amenable to vaccines. Less than 30 seconds of searching the CDC website led me to the appropriate information. I think it is incredibly disingenuous and very ignorant of Healy to comment in the manner she has.

Onward we trudge through the morass.

Paul Offit, an infectious-disease expert from the University of Pennsylvania who has been a frequent spokesman and adviser on vaccine policy (and by his admission has become wealthy by developing the now mandated rotavirus vaccine)

Mistake number eight. The Rotavirus vaccine has never been mandated anywhere that I can see.

So this is Dr Bernadine Healy, a scientist with 125 records in PubMed. Impressive until you realise that, just like this, they are 125 blog entries from US News. That means we can say that on average Healy has got 1,000 mistakes into PubMed.

Good going Bernadine.

It’s different for girls

13 Apr

One of the puzzling things about autism has always been the disparity between the sexes.  Boys have always been more susceptible than girls. This is not in itself unusual. There are gender differences affecting a whole range of conditions and, if this New York Times article is correct, men frequently come off worse.

But if boys are more susceptible you might have assumed that as the severity of the condition increase this disparity would become more marked. In fact you would have assumed wrong. According to this source:

The greater severity and lower frequency of autism in females has been cited as evidence for a multifactorial polygenic mode of inheritance with differential loading by sex, which predicts greater severity in the less frequently affected sex.

Greater severity is usually taken to include severe cognitive impairment as well and the greater the degree of cognitive impairment the closer the ratio between boys and girls.  But there are problems with this model. David Skuse has argued that the association between cognitive impairment and autism is not because they share a common cause but simply because if you have both conditions you are more likely to be seen by a clinician and get a diagnosis. More able people may be just as autistic but have coping strategies that enable them to avoid a diagnosis.  And if girls have better coping strategies than boys they will be disproportionately overrepresented amongst autistic people without cognitive impairment who are missed by the system.

Last week Woman’s Hour broadcast a segment on Asperger syndrome took up this argument and suggested that there may be as many girls as boys on the spectrum. Most of them are not getting a diagnosis because they present in ways that are unfamiliar to clinicians who are used to seeing the condition in boys. The programme is no longer available but Sunday’s Observer carried a two page spread on the same story.

Experts like Judy Gould and Tony Attwood cited by the Observer still believe there is a gender difference but they estimate that it is only 2.5:1. Asperger girls may be more passive than boys. They do not assert their difference or draw attention to themselves. Instead they observe and copy other people’s behaviour. Their special interests may be intense but are also likely to be more socially acceptable; reading fiction, following soaps, celebrity culture – the sort of thing that lots of other girls do – and so they do not stand out.

Conformity comes at a cost. The Observer quotes Tony Attwood’s estimate that 20% of anorexic girls are undiagnosed autistics. Then there is self harm and other evidence of psychological stress. There are important differences between men and women. They need to be understood and respected. But it does not help autistic women if autism is described as an extreme male brain syndrome. The Observer ends by quoting professor David Skuse who believes that:

if we can prove the ratio of boys to girls is as high as many of us suspect, it would be as significant a milestone in this field as the discovery that the condition is on a spectrum.”

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All change

9 Apr

A new design (more a realign than a redesign really) for LBRB and the alteration of some functionality.

The biggest change in functionality is that from now on you’ll be offered the chance to sign in to comment. In order to make this as easy as possible I’ve signed up with the RPX service which allows LB/RB to offer you several easy passwordless ways to comment. If you have a Facebook, GMail, Yahoo, Flickr etc etc account then you no longer need to do anything but click. This does not store your passwords anywhere, its simply an easy way for technology to talk to each other to make life easier for you the user. If you’re still not happy with that you can still elect to sign in anonymously. The biggest advantage for LB/RB for doing this is making the site harder to spam.

The biggest change in interface is I guess the ad placeholders. LB/RB has to bow to the inevitable and do all it can to get some money through the door. But please rest assured the ads will be vetted and will not feature anything contrary to the editorial direction of this site. Its the first time in its nigh on 6 years online adverts have been placed. A necessary evil I guess.

If you have a Gravatar your goods will be displayed 🙂 If you don’t – go get one!

Its been made easy for you to add LB/RB to various Social Networking apps and sites. If we’ve missed one out your want to see please contact us.

Efforts have been made to make the site work primarily on Firefox, IE6, 7 and 8, Opera, Chrome and Safari. There are still some very minor niggles in IE6 but mainly we’re good to go. I’m also aware that Archives aren’t available right now.

You might also note that there is no search box. There’s a reason for this 🙂 keep watching the top right column just above the block of four ads.

Go and play with it, you won’t break it and if you do or you find a bug please contact us.

Lies, Damned Lies and Science

7 Apr

Prior to starting a family I was already a skeptic and a subscriber to Skeptical Inquirer. This means I looked twice at the “helpful” information I got from all sides. From whether or not my baby would be a boy or a girl, what might have caused his seizures (like that fact that I drank milk, which was offered as an explanation after the “helpful” person was told he was infant only on breastmilk), the assurances I got that he would talk “when he was ready” or that someone’s cousin four times removed or Einstein did not talk until age three, five, or thirty-five (by the way, the Einstein is a total myth, don’t believe it — and don’t accept your child being compared to Einstein, he really had several flaws! See Private Lives of Albert Einstein, I should mention that sitting in therapy waiting rooms does provide lots of reading opportunities), and most recently I was told to try cranial sacral therapy (like a light head massage is going to “fix” the pathways in the brain that make him different!).

There is a tendency for people to give unsolicited advice to young parents, and that seems to double when it involves a child with a disability. Not only does the amount of advice double, but the relative distance from reality increases exponentially. While a parent of a typically developing child would be told to buy a certain organic baby food or to try some kind of “teach your baby calculus” computer program, the parent of child on a different developmental path would be encouraged to try a myriad of supplements, various odd treatments and to try the “miracle cure” they heard from some famous guy on the news.

How does a parent of a newly diagnosed child wade through the “help”, and determine what is real and what is hype? Well there is help, and it is not a cure all, but a book that shows how to look and science and separate fact from hype: Lies, Damned Lies and Science by Sherry Seethaler, a science writer and education at the University of California in San Diego..

It is not a long book, and is separated into short chunks to help explain the basics of science, why disputes in science is not really a bad thing, how to interpret numbers, and who the stakeholders on an issue are, and why they are important. She includes many real world examples and even comparisons to situations in the Harry Potter book where he excels at potion making by using the notes in the margins of an old book.

In Chapter 7, “Fun Figures”, there is a subsection titled “Ask whether a statistical change reflects reality or the way the data were collected.” Readers of this blog should be very familiar with the example she uses. They will also be familiar with the tactics described in Chapter 9, “All the Tricks in the Trade”, especially the section on pseudo experts.

This is a quick, actually quite a fun book to read. It can be a bit repetitive, but that is in part makes it easier to understand the concepts. I knew much of the information (like statistics), but I still learned a great deal. Check it out of your local library, and even purchase a copy for those friends and relatives who keep giving you all sorts of “advice.”

More Hot Air about HBOT

6 Apr

A few weeks ago, BMC Pediatrics published an article that purports to show that Hyperbaric Oxygen Therapy (HBOT) can produce “…significant improvements in overall functioning, receptive language, social interaction, eye contact, and sensory/cognitive awareness..” in autistic children. This study (Rossignol et al, 2009) is billed as a “…multicenter, randomized, double-blind, controlled trial.”

It’s all that and much, much less.

Let’s start by looking at the six “centers” where this research was carried out.

The Centers

The International Child Development Research Center (ICRDC):

This imposing name is attached to a rather less imposing edifice. The ICRDC, brainchild Dr. Jeffrey Bradstreet, is located in a strip mall in Melbourne, Florida, where it not only carries out “cutting-edge research” but also sells a complete line of “supplements” and treats autistic children with a dizzying array of “alternative”, “biomedical” and “integrative” therapies, including HBOT.

Daniel Rossignol MD (Family Practice), Lanier Rossignol (Nurse Practitioner) and Scott Smith (Physician’s Assistant) were the authors from the ICDRC.

The Center for Autism Research and Education (CARE):

This “center” is located in Phoenix, Arizona and has – according to its website – a single practitioner, Cynthia Schneider, MD (OB/Gyn), who is also an author on this paper. One of the “integrative” therapies this “center” offers is HBOT.

One of the other authors, Sally Logerquist, is a PhD psychologist who – according to the paper – is also associated with CARE, but also appears to run social skills therapy groups for autistic children using the “Logerquist Excellent Attitude Program” (LEAP).

True Health Medical Center:

It’s rather difficult to find anything about this “center”, apart from the fact that it is located in Naperville, Illinois – in what appears to be an office complex. Anju Usman, MD (Family Practice) is the author associated with this location.

Neubrander Center:

Although not officially called a “center”, the office of James Neubrander, MD (Pathology) is apparently one of the “centers” of this study. His office is located in the Menlo Park Mall (near Macy’s) and offers – you guessed it! – HBOT as a treatment for autism.

Princess Anne Medical Associates:

A Family Practice medical group in Virginia Beach, Virginia, this “center” is the home of Eric Madren, MD (Family Practice). It’s not clear if this four-physician practice offers HBOT.

The Rimland Center for Integrative Medicine:

A small, one-physician “center” in Lynchburg, Virginia, this is practice location of author Elizabeth Mumper, MD (Pediatrics). Not surprisingly, this “center” sells HBOT services for autistic children.

So, of the six “centers” involved in this study, five are single-physician operations. The remaining “center” has two physicians (three, if you count the naturopath).

I’m underwhelmed.

Well, what about the research itself? Maybe that’s better than the “facilities” might suggest. Let’s take a look.

The Subjects

This study initially enrolled 62 children (33 treatment; 29 control), but only 29 of the treatment group and 26 of the control group finished all 40 sessions. For reasons that pass my understanding, one treatment subject who only finished 9 sessions was included in the analysis. The authors stated that including this subject did not alter results, which begs the question: “Why did they include this subject if it made no difference?”

Outcome measures

The authors used the Aberrant Behavior Checklist (ABC), the Clinical Global Impression (CGI) scale and the Autism Treatment Evaluation Checklist (ATEC) as their outcome measures. All except the ATEC are widely accepted for use in autism treatment trials.

The ABC is a 58-question checklist of – surprise! – aberrant behaviors which are each given a score from “0” (“not at all a problem”) to “3” (“severe problem”). This test has been use – and validated – in a number of disorders, including autism. It gives a global score as well as five subscales: a total of six measures.

The CGI is a generic rating scale used in a variety of clinical trials. For each parameter (e.g. “overall functioning”, “sleep pattern”), the rater gives a score of between “1” (“very much improved”) and “7” (“very much worse”). The authors had both the treating physician and the parents rate the subjects on overall improvement and eighteen discrete parameters: a total of 38 measures in all (19 by the physician and 19 by the parents).

The ATEC was developed by Bernie Rimland and Stephen Edelson and has not been validated. In fact, it has only been used in two published studies – one by Rossignol et al. The ATEC has 25 questions on which the evaluator rates the subject on either a three-point (“not true”, “somewhat true”, “very true”) or four-point (“not a problem”, “minor problem”, “moderate problem”, “serious problem”) scale. It provides a total score and four subscales: a total of five measures.

In all, each subject had a total of 49 evaluation measures (CGI scores and the change in ABC and ATEC scores), of which 47 are independent. The importance of this will become apparent in the section on statistical analysis.

Analysis

As I mentioned above, the decision to include one treatment subject who only completed nine sessions was curious. Why they included this subject and not any of the other three treatment subjects and three control subjects who also failed to complete the entire course of the study is concerning. The smart thing – and the proper response – would have been to drop this subject from analysis.

The authors’ method of analyzing the CGI scales was also curious. Rather than simply using the scores as they were provided, they took the scores and subtracted them from four (the “no change” score). There are a few problems with this.

For starters, the scores are not linear – the difference between “much improved” and “very much improved” is not necessarily the same as between “no change” and “minimally improved”. Nor is the difference between “no change” and “much improved” twice the difference between “much improved” and “very much improved”. For that reason, these types of numerical scores are often referred to as “pseudo-numbers”.

This may seem like nit-picking, but it is a serious concern. Imagine, if you will, that the numbers were replaced by colors. Is the difference between green and orange twice the difference between orange and red? If half of a population of birds are blue and the other half are yellow, is the “average” bird green? The simple fact is that it is not appropriate to treat these “scores” as though they were real numbers, to be added, subtracted and averaged.

Secondly, it appears that the authors used parametric statistics for their analysis of the CGI scores. This is a problem since – as I indicated above – it is nonsensical to do math on pseudo-numbers. I don’t have the raw numbers, so it isn’t possible for me to calculate the absolute impact of this mistake for all of the CGI subclasses, but I can figure out the raw numbers for one group, so let’s look at that one.

It took a little work, but the authors gave enough clues to tease out the raw numbers in the physician “overall functioning” CGI score. The treatment group had an “average” of 2.87 and the control group’s “average” was 3.62; using the unaltered data, a t-test [Note: not an appropriate use of the t-test] gives p-value of 0.0006, not far from what the authors report. When a more appropriate statistical test [Mann-Whitney U-test] is used, the p-value is 0.002, very different from the reported 0.0008. While this is still less than the threshold p-value of 0.05, see below for a discussion of multiple comparisons.

All of these statistical analyses of the CGI scores ignore the fact that these are pseudo-numbers and need to be treated as discrete groups rather than as actual numbers. In truth, even the ABC and ATEC scores should have been treated this way, as well, although it is fairly common practice to treat such multi-factor scores as real numbers. A Chi-square test or Fisher Exact test would be the ideal test, but the problem with that is that the treatment group has one score of “1” (very much improved) and the control group doesn’t. Likewise, the control group has two subjects with a score of “5” (minimally worse) and the treatment group has none. This prevents a Chi-square or Fisher test from comparing each score independently.

One solution is presented by the authors themselves, although they apparently didn’t use it. In their discussion of the CGI, the authors said:

“Children who received a score of ‘very much improved’ or ‘much improved’ on the physician CGI overall functioning score were considered to be ‘good responders’ to treatment.”

If we “bin” the scores into “good responders” and “others”, we find that there were 9 (out of 30 – 30%) “good responders” in the treatment group compared to 2 (out of 26 – 8%) in the control group. Unfortunately, this is not a statistically significant difference (p = 0.08) in the (Yates) Chi-square test and barely reached significance (p = 0.05, but see below) in the Fisher Exact test.

An even bigger problem in the statistical analysis was the failure to correct for multiple comparisons. This problem was brought up by one of the reviewers, and the authors responded by eliminating a table. They did not make the appropriate corrections.

The reason that multiple comparisons are a problem is that the analysis for statistical significance is based on probability. If the probability (the p-value) that the differences between the two groups (treatment and control) is due to random chance is equal to or less than 5%, that difference is considered to be “statistically significant” and accepted as real. That means that there is still a 5% (or less – look to the p-value) chance that the difference is due to chance and not real.

If multiple comparisons are made on the same group of subjects, the probability that one (or more) of them will be “statistically significant” by chance starts to climb. If 14 comparisons are made, the chance of an erroneous “statistical significance” is over 50%. If 47 independent comparisons are made – as in this study – the chance of an erroneous “statistical significance” is over 90%.

For this reason, it is standard procedure to apply a correction for multiple comparisons. The most well-known (and simplest) of these is the Bonferroni Correction, which changes the threshold for statistical significance by dividing it by the number of comparisons. In the case of this study, the threshold (normally p less than or equal to 0.05 or 5%) is reduced to 0.001.

Applying the appropriate correction for multiple comparisons changes the results of this study significantly. Only the physician CGI scores for overall functioning and receptive language reach significance – and these numbers are already suspicious because they were improperly handled to begin with. In fact, as I have shown above, the CGI “overall functioning” p-value wouldn’t reach significance. It is possible that – if the proper statistical tests were used – that the CGI score for “receptive language” would also not reach significance.

Another curious thing. The authors asked the parents after the study whether they thought their child was in the treatment or the control group. Rather than say that the parent’s guesses were no better than random chance (i.e. 50%), the authors stated:

“…there was no significant difference between the two groups in the ability of the parents to correctly guess the group assignment of their child.”

As I said, this was a curious way to put it. As I read this, all it says is that each group of parent were equally able to guess which group their child was assigned to. That could be a 50% accuracy (which would be equal to chance), but a 90% or 99% accuracy – if both groups were that accurate – would also fit that description.

Now, this could simply be an clumsy phrasing by the authors, or it could be a way to make it sound like their blinding was successful when it actually was not.

Summary

This study may have collected some useful data, but its analysis of that data rendered it useless. The CGI scores – where the only statistically significant result was (possibly) seen – were improperly manipulated and the wrong statistical analysis was used.

The other issue is that there is no discussion of why HBOT is thought to be superior to providing the same partial pressure of oxygen at room pressure. This study used 24% oxygen at 1.3 atm, which gives the same partial pressure of oxygen as 31% at sea level. This concentration of oxygen can be easily attained with an oxygen mask or simple oxygen tent – both of which are vastly less expensive than HBOT.

If the authors are arguing that the mild pressure of their inflatable HBOT chambers contributes to the treatment effect, they need to look at the literature on cell membrane compressibility. For those who want to do the calculations at home, the bulk modulus of water (the major component of cells) is 21,700 atm. This means that a 0.3 atm increase in pressure will reduce the cell volume by 0.0014%. The bulk modulus of the lipid bilayer in cell membranes is around 30,000 atm. This means that an increase of 0.3 atm pressure causes a 0.0010% reduction in membrane volume. These are well below the threshold for any clinical effects.

Real pressure effects on the central nervous system are seen at pressures over 19 atm. These effects are:

dizziness
nausea
vomiting
postural and intention tremors
fatigue and somnolence
myoclonic jerking
stomach cramps
decrease intellectual and psychomotor performance
poor sleep with nightmares
increased slow wave and decreased fast wave activity in EEG

None of these effects could be construed as “improvements”, even in autism.

So, this study fails to answer the following questions about HBOT and autism:

[1] Does HBOT improve any feature of autism?
[2] If so, is HBOT any better than supplemental oxygen (which is much cheaper)?

The only real effect of this study was to give a cover of legitimacy to practitioners who are already using HBOT to “treat” autism.

Prometheus

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