May you and your family have a happy holiday season.
(and may autism not wreak havoc on your plans)
Tuesday, December 21, 2010
Happy Holidays
Sunday, December 12, 2010
Bruesewitz v. Wyeth : Unavoidable Outcome
As I have talked above a few times before, there is a vaccine injury case - Bruesewitz v. Wyeth - currently being decided by the U.S. Supreme Court. If you are interested in reading the filings and arguments before the court or would like to read a summary written by someone who actually understands the legal issues, I would refer you to the excellent page on SCOTUSblog.
The arguments before the court were heard about a month and a half ago and, while I was planning to write about it at the time, I never had the chance to do so. But now, since a decision from the court might be handed down in the next few weeks, I thought it might might be a good time to talk about the case again.
First let me say that I am not a lawyer nor do I play one on the internet. I have read the filings and the transcripts from the the case several times and have attempted to understand the legal issues involved. I think I understand the basics but my knowledge in this area is extremely limited and I could very easily be misunderstanding what is involved.
However, having said all of that, it is my opinion that Bruesewitz is going to lose their appeal. I think that the Supreme Court is going to basically say that vaccine manufacturers cannot be sued in civil court for any injuries that could be reasonably be expected to occur after being given a vaccine. The Court is going to find that the only venue for these sorts of claims is the so-called vaccine court.
The reasons I say this have absolutely nothing whatsoever to do with any debate surrounding vaccines or vaccines and autism but rather are completely based on what the relevant laws are. In this case, the controlling law is the one that created the National Vaccine Injury Compensation Program in the first place. This law created the Office of Special Masters inside the US Court of Federal Claims - the so-called vaccine court, established how that program should work, and set the terms under which vaccine injury claims could be heard by civil courts.
So the central issue in Bruesewitz v. Wyeth is about how this law should be interpreted in general, and more specifically, what this section of the law means -
Product liability is the area of law that deals with how manufacturers (and others) should be held responsible for injuries that their products cause. There are a few different types of liability but the relevant one for this case is strict liability. Strict liability is the idea that a company is responsible for damage caused by their products regardless of any fault on their part.
Strict liability is different than other types of product liability, such as negligence, in that it doesn't matter how careful the company is or what steps it takes to prevent problems. If it can be proven that a company's product caused the damage then the company can be held liable. With this type of liability there are three basic types of claims that can be made.
The first type of claim is called a "manufacturing defect" and deals with injuries that are caused because of problems during the manufacturing process. For example, if a vaccine was contaminated by something while it was being made or if a worker didn't add some ingredient when they should have then that would be considered a manufacturing defect.
The second type of claim is called "failure to warn" and deals with injuries that occur because a company failed to warn about a non-obvious danger where the injury might have been able to have been avoided if the user knew about the risk. An example here would be the warning about kickback that comes on every chainsaw. Kickback is what happens if you get the tip of a chainsaw too close to an object, such as the ground - the blade has a chance of kicking back (rebounding) in the direction of your body and causing serious harm. A novice user might not realize the danger of that happening, hence the warning.
The final type of claim is called a "design defect" and deals with injuries caused by products that have a defective by design or products that cannot be made safe no matter what the design. A example here might be a chair that was designed to only have three legs instead of four or a car whose brakes would fail to work when the car is going faster than 15 mph.
Now, if you look back at the snippet of the law above, you can see that it mentions all three types of liability I just talked about. The question is how should the law be interpreted and what exactly was the intent of Congress in writing the law.
The laws says that if an side effect occurs even though a product was properly prepared (manufactured) and accompanied by proper directions and warnings then the company is not liable for that injury if it were unavoidable.
So, the case basically comes down to what an "unavoidable" side effect is. My opinion is that the Supreme Court is basically going to find that a side effect is "unavoidable" if it is known that it can happen as a result of the vaccination and that there was no way to change the vaccine to prevent the injury.
Or to put it another way, if the product was properly manufactured and the possible risks are disclosed to the end user (or their parents) that the company is not liable if one of those side effects happens.
Bringing it all the way back to the current case, the seizures that Bruesewitz had were certainly a known side effect of the DTP vaccine as it was listed in the vaccine injury table of the original 1986 National Vaccine Injury Act and was still there up until a month before the Bruesewitz's initial claim was filed with the vaccine court in 1995. There were no changes to the then-current vaccine that could have been made to prevent the injury. Hence the possibility of seizures was an "unavoidable" side effect of using the vaccine.
Now, there is the second part of the argument - that Wyeth had a different type of vaccine that it could have used and that type of vaccine might have been able to avoid the seizures. But that argument ignores the fact that the current vaccine was approved by the relevant agencies, was used properly, and (presumably) had the proper disclaimer pamphlet with it while the other vaccine was nothing more than vaporware. The mere possibility that another type of vaccine existed did not make the side effect of this one avoidable.
As a result, I think the Supreme Court will look at the evidence, decide that the seizures were "unavoidable", and uphold the decision of the 3rd circuit court. The only question for me is how far they will take it. Will the ruling be a narrow one limited to only this case or will the Court attempt to set a general precedent that vaccine manufacturers have broad based immunity and the only forum for hearing injury complaints is the vaccine court?
Time will tell.
The arguments before the court were heard about a month and a half ago and, while I was planning to write about it at the time, I never had the chance to do so. But now, since a decision from the court might be handed down in the next few weeks, I thought it might might be a good time to talk about the case again.
First let me say that I am not a lawyer nor do I play one on the internet. I have read the filings and the transcripts from the the case several times and have attempted to understand the legal issues involved. I think I understand the basics but my knowledge in this area is extremely limited and I could very easily be misunderstanding what is involved.
However, having said all of that, it is my opinion that Bruesewitz is going to lose their appeal. I think that the Supreme Court is going to basically say that vaccine manufacturers cannot be sued in civil court for any injuries that could be reasonably be expected to occur after being given a vaccine. The Court is going to find that the only venue for these sorts of claims is the so-called vaccine court.
The reasons I say this have absolutely nothing whatsoever to do with any debate surrounding vaccines or vaccines and autism but rather are completely based on what the relevant laws are. In this case, the controlling law is the one that created the National Vaccine Injury Compensation Program in the first place. This law created the Office of Special Masters inside the US Court of Federal Claims - the so-called vaccine court, established how that program should work, and set the terms under which vaccine injury claims could be heard by civil courts.
So the central issue in Bruesewitz v. Wyeth is about how this law should be interpreted in general, and more specifically, what this section of the law means -
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.While at first glance this passage seems to be as clear as mud, when you consider the backdrop of how product liability works it starts to make a certain kind of sense.
Product liability is the area of law that deals with how manufacturers (and others) should be held responsible for injuries that their products cause. There are a few different types of liability but the relevant one for this case is strict liability. Strict liability is the idea that a company is responsible for damage caused by their products regardless of any fault on their part.
Strict liability is different than other types of product liability, such as negligence, in that it doesn't matter how careful the company is or what steps it takes to prevent problems. If it can be proven that a company's product caused the damage then the company can be held liable. With this type of liability there are three basic types of claims that can be made.
The first type of claim is called a "manufacturing defect" and deals with injuries that are caused because of problems during the manufacturing process. For example, if a vaccine was contaminated by something while it was being made or if a worker didn't add some ingredient when they should have then that would be considered a manufacturing defect.
The second type of claim is called "failure to warn" and deals with injuries that occur because a company failed to warn about a non-obvious danger where the injury might have been able to have been avoided if the user knew about the risk. An example here would be the warning about kickback that comes on every chainsaw. Kickback is what happens if you get the tip of a chainsaw too close to an object, such as the ground - the blade has a chance of kicking back (rebounding) in the direction of your body and causing serious harm. A novice user might not realize the danger of that happening, hence the warning.
The final type of claim is called a "design defect" and deals with injuries caused by products that have a defective by design or products that cannot be made safe no matter what the design. A example here might be a chair that was designed to only have three legs instead of four or a car whose brakes would fail to work when the car is going faster than 15 mph.
Now, if you look back at the snippet of the law above, you can see that it mentions all three types of liability I just talked about. The question is how should the law be interpreted and what exactly was the intent of Congress in writing the law.
The laws says that if an side effect occurs even though a product was properly prepared (manufactured) and accompanied by proper directions and warnings then the company is not liable for that injury if it were unavoidable.
So, the case basically comes down to what an "unavoidable" side effect is. My opinion is that the Supreme Court is basically going to find that a side effect is "unavoidable" if it is known that it can happen as a result of the vaccination and that there was no way to change the vaccine to prevent the injury.
Or to put it another way, if the product was properly manufactured and the possible risks are disclosed to the end user (or their parents) that the company is not liable if one of those side effects happens.
Bringing it all the way back to the current case, the seizures that Bruesewitz had were certainly a known side effect of the DTP vaccine as it was listed in the vaccine injury table of the original 1986 National Vaccine Injury Act and was still there up until a month before the Bruesewitz's initial claim was filed with the vaccine court in 1995. There were no changes to the then-current vaccine that could have been made to prevent the injury. Hence the possibility of seizures was an "unavoidable" side effect of using the vaccine.
Now, there is the second part of the argument - that Wyeth had a different type of vaccine that it could have used and that type of vaccine might have been able to avoid the seizures. But that argument ignores the fact that the current vaccine was approved by the relevant agencies, was used properly, and (presumably) had the proper disclaimer pamphlet with it while the other vaccine was nothing more than vaporware. The mere possibility that another type of vaccine existed did not make the side effect of this one avoidable.
As a result, I think the Supreme Court will look at the evidence, decide that the seizures were "unavoidable", and uphold the decision of the 3rd circuit court. The only question for me is how far they will take it. Will the ruling be a narrow one limited to only this case or will the Court attempt to set a general precedent that vaccine manufacturers have broad based immunity and the only forum for hearing injury complaints is the vaccine court?
Time will tell.
Thursday, December 9, 2010
Autism Prevalence Mashup
Perhaps the most important unresolved question today about autism is whether it is becoming more common. Are we in the midst of an epidemic of autism or are social forces just making it appear that way. The answer to this question has the potential to reshape how we think about autism and how we should deal with it.
If the rate of autism is not increasing then our focus should be on providing services and finding new ways to help people with autism live more productive lives. But, if the rate of autism is increasing, then our immediate concern should be figuring out why and putting a stop to it.
While I don't think there is yet a clear answer to the overall question, I think it is safe to say that the number of children with a label of autism is increasing each year. The problem is trying to figure out if this increase is real or not.
Since I think the question is important, I decided to take some administrative prevalence data from studies that I was reading and put them together to see what they looked like. The papers are both about autism prevalence in Montreal, Canada and both use yearly administrative data from school boards to estimate the prevalence of autism.
There are several problems with what I am going to talk about below, so let me get those out of the way. First, the general disclaimers about administrative prevalence apply - so yes, I know that there are problems with using this type of data. Second, the papers used two different school boards so there is a problem with combining the data like I am doing. But, since both of the school boards are in the Montreal area and both used the same definition of autism, I think the comparison has some relevance.
So, without further ado, I give you the first chart. The years on the bottom are the birth year of the children. Keep in mind that the age of the children is going from the youngest on being on the right (2002) and the oldest being on the left (1987).
Although, the birth years aren't really exact birth years but rather an approximation based on what grade the child was in. So if a child was held back a grade or two as might be common for children with special needs (if that even happens in Montreal, I don't know), then the ages could be skewed.
The blue line represents the children from the first study and the green line represents the children from the second. I indicated the point at which the children on both lines would have been eight years old. That can be important because that is the age where we can assume that most children with autism have been recognized and given the appropriate label.
The red line is a three period moving average of both lines and represents the overall trend of the numbers.
I think there are a few notable things on this chart.
First, I think the overall trend is clear. Younger children are more likely to have a label of autism than older ones and the number of children with an autism label is growing by about ten percent per year.
Second, notice that the prevalence goes up as the children get younger up until age eight when it starts to fall? This is what I was talking about above where younger children might not yet have a diagnosis, so we can assume that the numbers before age eight are lower than they should be.
Third, if you look at where the blue and green lines overlap, you might notice that the rate of autism in the children from the second study is about half of that from the earlier study. For example, in 1993 the children in the earlier study were about ten years old and had a rate of about 71 per 10,000 but in the second study the children would have been 15 and had a rate of about 48 per 10,000.
As I have commented on before, it looks like there might be a substantial group of children who have a diagnosis of autism when they are younger but lose it as they get older. This is the third independent data set where I have seen this relationship and I am starting to wonder about it. If I am not mistaken, this rate is similar to the recovery rate that has been historically demonstrated for ABA.
Moving on, another nice thing about these two studies is that they gave a breakdown between the different types of autism. One of the theories about the increasing rate of autism is that, as time goes on, there are more milder cases being recognized and that is partially responsible for the increase. But, as you can see on the chart below, that didn't happen here.
Even though the average prevalence increased between the two studies, the breakdown of the types of autism is essentially unchanged. The majority of autism cases here are PDD-NOS, followed by classic autism, and finally Aspergers bring up the rear. And, as I talked about before, CDD is extremely rare with only 1 child having that label.
Take away from this what you will, I just found it to be interesting. Or maybe this is a sign that I need to get a better hobby...
References
1. Fombonne, Eric, Rita Zakarian, Andrew Bennett, Linyan Meng, and Diane McLean-Heywood. 2006. “Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations.” Pediatrics 118:e139-50. doi: 10.1542/peds.2005-2993
2. Lazoff, Tamara, Lihong Zhong, Tania Piperni, and Eric Fombonne. 2010. “Prevalence of pervasive developmental disorders among children at the english montreal school board.” Canadian journal of psychiatry. Revue canadienne de psychiatrie 55:715-20. Link
If the rate of autism is not increasing then our focus should be on providing services and finding new ways to help people with autism live more productive lives. But, if the rate of autism is increasing, then our immediate concern should be figuring out why and putting a stop to it.
While I don't think there is yet a clear answer to the overall question, I think it is safe to say that the number of children with a label of autism is increasing each year. The problem is trying to figure out if this increase is real or not.
Since I think the question is important, I decided to take some administrative prevalence data from studies that I was reading and put them together to see what they looked like. The papers are both about autism prevalence in Montreal, Canada and both use yearly administrative data from school boards to estimate the prevalence of autism.
There are several problems with what I am going to talk about below, so let me get those out of the way. First, the general disclaimers about administrative prevalence apply - so yes, I know that there are problems with using this type of data. Second, the papers used two different school boards so there is a problem with combining the data like I am doing. But, since both of the school boards are in the Montreal area and both used the same definition of autism, I think the comparison has some relevance.
So, without further ado, I give you the first chart. The years on the bottom are the birth year of the children. Keep in mind that the age of the children is going from the youngest on being on the right (2002) and the oldest being on the left (1987).
Although, the birth years aren't really exact birth years but rather an approximation based on what grade the child was in. So if a child was held back a grade or two as might be common for children with special needs (if that even happens in Montreal, I don't know), then the ages could be skewed.
The blue line represents the children from the first study and the green line represents the children from the second. I indicated the point at which the children on both lines would have been eight years old. That can be important because that is the age where we can assume that most children with autism have been recognized and given the appropriate label.
The red line is a three period moving average of both lines and represents the overall trend of the numbers.
 |
| (Click for a larger version) |
First, I think the overall trend is clear. Younger children are more likely to have a label of autism than older ones and the number of children with an autism label is growing by about ten percent per year.
Second, notice that the prevalence goes up as the children get younger up until age eight when it starts to fall? This is what I was talking about above where younger children might not yet have a diagnosis, so we can assume that the numbers before age eight are lower than they should be.
Third, if you look at where the blue and green lines overlap, you might notice that the rate of autism in the children from the second study is about half of that from the earlier study. For example, in 1993 the children in the earlier study were about ten years old and had a rate of about 71 per 10,000 but in the second study the children would have been 15 and had a rate of about 48 per 10,000.
As I have commented on before, it looks like there might be a substantial group of children who have a diagnosis of autism when they are younger but lose it as they get older. This is the third independent data set where I have seen this relationship and I am starting to wonder about it. If I am not mistaken, this rate is similar to the recovery rate that has been historically demonstrated for ABA.
Moving on, another nice thing about these two studies is that they gave a breakdown between the different types of autism. One of the theories about the increasing rate of autism is that, as time goes on, there are more milder cases being recognized and that is partially responsible for the increase. But, as you can see on the chart below, that didn't happen here.
 |
| (Click for a larger version) |
Take away from this what you will, I just found it to be interesting. Or maybe this is a sign that I need to get a better hobby...
References
1. Fombonne, Eric, Rita Zakarian, Andrew Bennett, Linyan Meng, and Diane McLean-Heywood. 2006. “Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations.” Pediatrics 118:e139-50. doi: 10.1542/peds.2005-2993
2. Lazoff, Tamara, Lihong Zhong, Tania Piperni, and Eric Fombonne. 2010. “Prevalence of pervasive developmental disorders among children at the english montreal school board.” Canadian journal of psychiatry. Revue canadienne de psychiatrie 55:715-20. Link
Tuesday, December 7, 2010
The Woo of Woo
Over on the blog formerly known as Countering Age of Autism there was a post a few weeks back that claimed to be a guide to help parents avoid "woo". The premise of the post was that there are a lot of sites on the internet that try and sell treatments for autism and it can be difficult to separate the good ones from the bad ones -
While I do agree with the overall theme of the post - that it is hard to determine whether a particular treatment is worth it - I have to disagree with the idea that all you need is a cheat sheet of things to avoid.
As anyone who has seriously looked into treating autism can tell you, it can be difficult to determine whether any treatment - mainstream or alternative - will be able to deliver on its promises. And, even when you can establish that a treatment can work, it is still very difficult to know whether a specific treatment will work for a specific person with autism. Take a well-supported, mainstream treatment like ABA - for some children it can do wonders and give them back their ability to function while others won't respond to it at all.
The problem is that, because so little is known about what autism is or what causes it, it is hard to know what exactly what will help in general let alone what will help a specific person.
In general, science understands very little about autism and, specifically, has no clue why some things will work for one person but not another. "Woo" or "pseudoscience" has nothing to do with it.
Although, I have to say, I strongly dislike the idea of "woo". Science is about the open exchange of ideas and is a methodology for trying to understand the world. There is absolutely nothing about science that proclaims that the current understanding is "The Truth" and everything else is wrong. If anything, the idea of "we know that isn't true" is almost the opposite of what science is about. Science is more "we think this might be the case" but is willing to quickly change its mind if some new bit of evidence comes along.
Sure you will find people who cling onto an idea long past the point that there is any evidence supporting it, but that problem applies equally to those who think that they know what "Science Says". As soon as you get too attached to the idea that you know something and consider the "other side" to be the great unwashed who worships woo, you have missed the entire point. You have become the problem rather than the solution.
Arrogance is the antithesis of science.
So, rather than labeling something as "woo" simply on the basis of required legal disclaimers and marketing terms, I would suggest putting down the woo detector and using your head instead. It is possible to develop a general understanding of a subject area without having to spend years and years becoming an expert.
It is important to develop this general understanding because, most of the time, the responsibility for treating a child's autism is left up to the parents. Sure, in a perfect world you would have an expert medical team on your side that can evaluate your child's specific situation and come up with an appropriate care plan. But the chances of that happening are remote.
The majority of time, parents are left on their own and have to sort through a large set of possible treatments and decide what is appropriate with very little guidance from medical "experts".
So, if you are a parent and want to treat your child's autism, you are going to have to develop at least a basic understanding of what it is that you are doing. You will have to have a way to determine what is an appropriate thing to try and what is not.
I personally find it helpful to find out the answers to the following questions whenever I run across some new treatment option -
1. What exactly is the treatment?
2. What is it supposed to do?
3. How is it supposed to work?
4. Do other independent and reputable sources agree?
And then look at the specific reasons for trying this treatment with this child -
5. What specific problem am I trying to address?
6. Why do I think that this treatment will help with this problem?
Before finally getting to the problem of reputation -
7. Do I trust this specific company or entity to provide this treatment?
If I don't know or am uncomfortable with any of the answers to the questions then I would not try the treatment.
This list of questions doesn't just apply to those "woo" treatment like vitamins and probiotics but rather to any treatment that you are thinking of trying. You need to take the time to understand what it is any why you would want to do it because it is unlikely that anyone is going to do it for you.
How do we evaluate the claims of these products and prevent ourselves from (1) wasting precious financial resources, and (2) putting our precious children in harm's way? There are some key things that one can look for that indicate woo and pseudoscience. We don't have to be experts in a field; we just have to know how to evaluate claims and evidence.The post continues with six tips on how to avoid bad treatments, aka "woo". The tips start out with phrases to look out for such as "Natural", "Organic", and "Doctor recommended", continue on with an admonition about discounting testimonials, anecdotes, guided questionnaires, and illegitimate published articles, before finally ending with the suggestion that only people with an appropriate pedigrees can make a good product.
While I do agree with the overall theme of the post - that it is hard to determine whether a particular treatment is worth it - I have to disagree with the idea that all you need is a cheat sheet of things to avoid.
As anyone who has seriously looked into treating autism can tell you, it can be difficult to determine whether any treatment - mainstream or alternative - will be able to deliver on its promises. And, even when you can establish that a treatment can work, it is still very difficult to know whether a specific treatment will work for a specific person with autism. Take a well-supported, mainstream treatment like ABA - for some children it can do wonders and give them back their ability to function while others won't respond to it at all.
The problem is that, because so little is known about what autism is or what causes it, it is hard to know what exactly what will help in general let alone what will help a specific person.
In general, science understands very little about autism and, specifically, has no clue why some things will work for one person but not another. "Woo" or "pseudoscience" has nothing to do with it.
Although, I have to say, I strongly dislike the idea of "woo". Science is about the open exchange of ideas and is a methodology for trying to understand the world. There is absolutely nothing about science that proclaims that the current understanding is "The Truth" and everything else is wrong. If anything, the idea of "we know that isn't true" is almost the opposite of what science is about. Science is more "we think this might be the case" but is willing to quickly change its mind if some new bit of evidence comes along.
Sure you will find people who cling onto an idea long past the point that there is any evidence supporting it, but that problem applies equally to those who think that they know what "Science Says". As soon as you get too attached to the idea that you know something and consider the "other side" to be the great unwashed who worships woo, you have missed the entire point. You have become the problem rather than the solution.
Arrogance is the antithesis of science.
So, rather than labeling something as "woo" simply on the basis of required legal disclaimers and marketing terms, I would suggest putting down the woo detector and using your head instead. It is possible to develop a general understanding of a subject area without having to spend years and years becoming an expert.
It is important to develop this general understanding because, most of the time, the responsibility for treating a child's autism is left up to the parents. Sure, in a perfect world you would have an expert medical team on your side that can evaluate your child's specific situation and come up with an appropriate care plan. But the chances of that happening are remote.
The majority of time, parents are left on their own and have to sort through a large set of possible treatments and decide what is appropriate with very little guidance from medical "experts".
So, if you are a parent and want to treat your child's autism, you are going to have to develop at least a basic understanding of what it is that you are doing. You will have to have a way to determine what is an appropriate thing to try and what is not.
I personally find it helpful to find out the answers to the following questions whenever I run across some new treatment option -
1. What exactly is the treatment?
2. What is it supposed to do?
3. How is it supposed to work?
4. Do other independent and reputable sources agree?
And then look at the specific reasons for trying this treatment with this child -
5. What specific problem am I trying to address?
6. Why do I think that this treatment will help with this problem?
Before finally getting to the problem of reputation -
7. Do I trust this specific company or entity to provide this treatment?
If I don't know or am uncomfortable with any of the answers to the questions then I would not try the treatment.
This list of questions doesn't just apply to those "woo" treatment like vitamins and probiotics but rather to any treatment that you are thinking of trying. You need to take the time to understand what it is any why you would want to do it because it is unlikely that anyone is going to do it for you.
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