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Sunday, September 30, 2007

Autism, Immunizations, and Anecdotes
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Autism and its discontents are back in the news (were they ever out?) in three new areas:

  1. A celebrity (Jenny McCarthy) has written a book about her experiences with her 5 year old autistic child.

  2. More data is coming out from the Center for Disease Control (CDC) showing NO association of vaccines and thimerosal with autism.

  3. A federal court in Washington, D.C. is going to rule if the autism diagnosed in a 12-year-old girl was caused by a measles, mumps and rubella (MMR) vaccine administered when she was an infant.

I've written extensively about this before, so you likely know where I stand: I do believe autism is on the rise and, since our genes haven't changed, there may well be environmental triggers. While we don't know what these are, we do know what they are NOT: immunizations and thimerosal.

* * * *

Here are my thoughts about this latest trifecta.

1. First, a disclaimer: I haven't read Ms. McCarthy's book, so I'm speaking in general about the positives and the limits of one person's story. I've read some wonderful books by parents of an autistic child. They have taught me a lot about the feelings they went through in the process, how the medical system let them down at critical times, and what they found to be supportive. These stories are often moving and especially validating and instructive for other parents who are just beginning to go through the process.

But I have a caution: One person's story is just that: one person's story. In autism (as in all of life) every child is is different, as is every family. Yes, some parents chose to devote a lot of time to their child's treatment, but others - for all the right reasons - do not. There is no one right way to respond or feel, and I worry that parents who are different than the authors often feel guilty if they don't share the writers' perspective and feelings.

Second, one person's story is "anecdotal," meaning that you can't draw scientifically valid conclusions from it. Sure one child may have seemed to respond to one treatment, but that doesn't mean that another will. It takes looking at many kids and seeing how they responded to know if a treatment is really helpful. People write about successes but not the multiple failures with the same treatment. Since we have no cure for autism, I can't tell you how many parents I know who have tried the latest "cure" - based on one person's story - and the have been even more disappointed (not to mention shorter on cash) than they were before.

* * * *

2. I well remember one comment to my previous blog on this: "You are never gonna make me believe that vaccinations aren't the main cause of autism! My son was fine until he received his MMR vaccination." Sure, if your child showed developmental deterioration shortly after getting the MMR vaccine, you too would believe one caused the other. But, again, it's anecdotal information.

The human brain is brilliantly programmed to connect events that occur together in time. If you heard a roar and then saw a saber--tooth tiger, it was reasonable to assume the tiger caused the roar and to take appropriate precautions thereafter. It works great most of the time. But it also leads to superstitions, which most of us have (In Little League, I hit my one and only home run after spitting on my dry hands for the first time. Every time thereafter, I disgustingly spat on my hands. Of course I never hit a home run again and thus had to become a pediatrician instead of a major league baseball player, but when playing baseball my hands were never short on spit).

It's reasonable to wonder if the MMR causes autism. It's actually a very plausible theory. The only problem with it is that it's wrong. We know that because when you look at hundreds of thousands of kids who have received the vaccine and you do not find an association, you realize that the anecdotal cases are coincidences, pure and simple. When the rate of autism did not diminish after thimerosal was taken out of almost all immunizations, what should you conclude?

Yet, like the responder to my blog, many people refuse to believe careful studies, relying instead on their own superstitions or on conspiracy theories or on the advice of others who can't be bothered with scientific data (who essentially and irresponsibly say, "Don't bother me with the facts, I know what I know.").

* * * *

3. If ever there was a sign that we Americans have been "lawyered" beyond all reason, having a court decide this issue could be exhibit #1. (Remember these are the selfsame geniuses who decided that silicone breast implants caused a world of trouble and awarded huge dollars to women as a result. When the scientific data later refuted these claims, I doubt the money was returned.) What next for our legal system? Perhaps. when there is professional disagreement, your local judge should decide which anticonvulsant medication would best help your child's seizures.

* * * *

Here's our dilemma in the field of autism. We don't really know what causes it, nor what is the best treatment for it, nor do we have a cure. I don't like it (and am quite hopeful that all the new research will elevate this current state-of-the-art) but them's the facts. Responsible professionals at least admit it and do not succumb to anecdotal claims nor ask the courts to decide scientific issues. You shouldn't either.

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Posted by: Dr. Parker at 9/30/2007 10:30:00 AM

Thursday, September 20, 2007

Antidepressant Medications for Kids and the Law of Unintended Consequences
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Act 1:
The black box warning
in 10/04

In October of 2004, the Federal Drug Administration (FDA) mandated that a "black box" warning be put on all antidepressant (SSRI) medications prescribed for youths, age 17 years and younger. A "black box warning" is a black-bordered warning accompanying prescription medications that serves to inform about possible serious adverse side effects.

Here's what it looks like. Please click on it and read it. What is your reaction to it? How would you feel if your depressed teen was prescribed one of these medications and this is what you read? What might you do (or not do) about it?


Black Box Warning




As this is the most serious warning that can be given to a medication (the next step is to pull the drug off the market), it's instructive to ask what prompted it.

Thirty one experts had reviewed all of the available scientific information and held a two day hearing about the possible increased risk of suicide in youths when taking antidepressant medications. They found double the rate (4%) of teens reporting suicidal thoughts but - and this is important - zero cases of actual suicide in teens who took these medications.

Based on this analysis - in a divided vote - the committee recommended the black box warning you see above.

* * * *

Act 2:
Headlines on 9/6/07: "Youth suicides increased as antidepressant use fell"


This was based on an epidemiological study* which showed the following:

Use of SSRIs




Suicide Rates for Victims Less Than 20 Years Old


Suicide Rate - U.S.
Suicide Rate - Holland

Forget the statistical analyses; it's pretty easy for you to see that the drop in SSRI use in kids (green and blue lines) is mirrored by the increase in suicide rate in the U.S. and in Holland. This, of course, raises the concern that there has been an under-treatment of depression with medications, resulting in more actual suicides. The authors wonder if the FDA warning "may have left some of the most vulnerable youths untreated."

* * * *

Are you convinced that the black box warning led to an increased suicide rate? You shouldn't be. Here's why:

  • An apparent association (correlation) does not prove causation. (In fact, this is the problem with all such "epidemiological" studies). The increase in suicides could be a coincidence, due to completely different factors (I, for one, am quite depressed about the Detroit Tigers this year, not my lack of Prozac).

  • The reported increase represented just 248 additional deaths of the 62 million youths in the U.S. And 1/2 of those were 18 -19 years old and therefore not included in the black box warning. The actual numbers are very small.

  • The data only represents one year (two in Holland) and that is insufficient time to determine if it is truly an enduring trend.

So, yes, the black box warning could be the bad guy, but until there are further studies, we can't and shouldn't say with any certainty.

* * * *

Thoroughly confused? Good, you should be. It's too soon to tell.

But it also was too soon to tell three years ago, when the experts decided to issue their black box warning. One of them said: "I anticipate there will be alarm from parents and the child. I think that's worth that complication, because it will raise the threshold" for prescribing the drugs to children.

I find this viewpoint - which somehow captured the day - curious at best. Estimates of the lifetime risk of suicide attempts in depressed persons range from 2-15% (depending on the population studied). In contrast, the FDA analyses suggested an absolute risk of suicide in patients taking antidepressants as 0.01%. To me this suggests we should have a black box warning stating: "Caution, under-treatment of your child's depression could be hazardous to his/her health."



In medicine, alas, our Hippocratic Oath to "Do no harm" has been trumped by the more urgent and self-serving "Don't get sued." (The irony now is that grieving parents can and will sue for malpractice if their suicidal child had received antidepressant medications or if s/he had not.)

Additionally, the FDA had been rightly criticized for ignoring serious side effects in some popular medications and they were not going to make the same mistake again - data or no data. Finally, underlying this misguided decision, I believe, was a bias against using any psychoactive medications in children. This was a heavy-handed attempt by some to counter the trend of their use in kids.

* * * *

Beware the law of unintended consequences.

Go back and read the black box warning again. Who could not be frightened by it? If your teen is extremely depressed, better the devil you know (depression) than the one you don't (SSRI medications).

Frankly, most parents probably don't even read this dense, poorly written, and confusing warning. But the media dutifully (and, as usual, inadequately) did their job, hyping the possible link of medications and suicide without a careful critical analysis. You didn't need to read the warning - you were scared from the get-go at the thought of your kid taking an SSRI.

Are we now reaping the consequences of that rush to judgment by experts and lackadaisical critical analysis by the media? It's premature to say whether the black box warning has actually harmed children. But, I'll tell you this, in my opinion it hasn't done a bit of good.

* * * *


*Article cited:
"Early Evidence of the Effects of Regulators' Suicidality Warnings on SSRI Prescriptions and Suicide in Children and Adolescents"
Gibbons R, et al.
American Journal of Psychiatry, September 2007
ajp.psychiatryonline.org

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Posted by: Dr. Parker at 9/20/2007 07:29:00 PM

Thursday, September 06, 2007

Advertising and Your Kids
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* * * *

In the wee hours of Saturday night, 10/11/75, a young medical student (that would be me) was watching the very first episode of Saturday Night Live on his 13 inch, rabbit-eared TV. Near the end of the show, the following commercial spoof aired (slightly edited):

Announcer:
"Since the caveman, man has ardently striven to design the perfect shaving instrument. From the straight razor, to the safety razor, to the injector system, and finally the highly acclaimed twinblade cartridge.

Introducing the Triple--Trac. Not just two blades in one system, but three stainless, platinum teflex-coated blades.

Here's how it works. The first blade grabs at the whisker, tugging it away from your face to protect it from the second blade. Blade number two catches and digs into the stubble before it has the chance to snap back and injure you, pulling it farther out so that it is now ready for shearing. Triple-Trac's third blade, a finely-honed bonded platinum instrument, cuts cleanly through the whisker at its base, leaving your face as smooth as a billiard ball.

The Triple-Trac. Because you'll believe anything."

* * * *
It was hilariously absurd. I knew that neither I nor anyone else would ever fall for such ridiculous hype, no matter how slickly pitched. Three blades! Ha ha ha! (Please have the human decency not to ask me how many blades are currently affixed to my razor.)

But even Saturday Night Live could not have envisioned a world in which we would pay $8/gallon for water, especially when perfectly tasty and healthy water comes out of our tap for less than a penny. (One of my adolescent patients, going off to college, asked me if she could use tap water to water her house plants or must she use "healthy" bottled water.)

My point is obvious: advertising is incredibly effective in creating new categories of previously unknown human needs. That's fair game. I'm certainly not averse to the constitutional right to advertise and its vital role - both positive and negative - in our capitalist system.

* * * *



But all that applies to influencing adults. The $2 billion of advertising directed at children each year is quite another matter. It's simply not a fair fight - the power differential is too unbalanced, inviting a kind of corporate child exploitation in the service of profits.

Do you disagree? Consider:
  • Trusting little souls, young kids (certainly those less than 8 years) believe what they see on TV and magazines and billboards to be the gospel truth (of course, so do many of us adults) and they do not recognize the intent-to-sell motivation underlying commercials.

  • The average American child may view up to 40,000 TV commercials per year (1 hour of children's TV contains about 50 ads).

  • U.S. children, ages 4-12 years, influence the spending of an estimated $50 billion/year. Teens influence or spend about $150 billion/year. A billion here, a billion there, and soon you are talking real money and real economic clout.

  • As early as 3 years, children recognize brand logos (that's why, in 1991, 5-year-olds could better identify Joe Camel than Mickey Mouse). A recent study (which inspired me to write this post) showed that kids described carrots in a logo marked plastic bag as tastier than the same carrots on a plate.
* * * *


What to do?
I'm not an anti-advertising zealot and, if you have read any of my other stuff, you know I don't think TV viewing is the root of all evil. But I do recognize it has a very powerful influence on kids (and all of us). We need to get smarter on how to advantage its positive attributes and how to minimize the bad stuff. It's not the medium, it's the message.

How, for example, can we offset the promotion of junk food and expensive brands and cigarettes and alcohol and all those things that we know are bad for kids? How can we harness that power to promote positive messages, such as what constitutes good nutrition, the importance of exercise, safety issues, healthy emotional development, etc? Am I naive to think the current advertisers, who bludgeon our kids on Saturday mornings with crap, could be convinced to do more "public service announcement" type posts?

I don't think so, if we can convince them that the good will it would engender would be in their economic self-interest. Look at how the fast food providers are falling over themselves to offer "healthy"" alternatives. Even Cookie Monster is eating his fruits and veggies these days.

* * * *

Teach your kids to become "media literate."
Closer to home, as much as you can (and still retain your sanity), watch TV with your kids to teach them "media literacy." Among other things that means helping them to understand the true intent-to-sell message of advertising. Check out PBS Kids GO: Don't Buy It!, a fun web site to explore these issues with your kids.

Here's an educational exercise for you. Sit down for an hour or two on Saturday morning and watch children's TV with your kids. (Of course the quality and messages of the programming are an issue, but I'm focusing on the advertising for now). How many commercials did you see in an hour? What were their messages? What did they teach your kids? I think you'll see why media literacy is a must. (For more great tips on teaching your kids media literacy, go to PBS Parents Guide to Children and the Media.)


* * * *

You wouldn't hire a babysitter without checking references and talking to her about how she will deal with your kids. Well, I've got news: your TV is that babysitter. Alas, she often has the attributes of a crazed salesman, spending much of her time showing your children violent images and then, as a break, beguiling your kids to buy the latest gooey confection or sparkly toy.

Do you really want this entity to care for your kids without your supervision? Don't you need to go out of your way to explain to your kids why and how the babysitter is out to lunch? Time for the empire (that would be you) to strike back and seize control. Make your kids media literate.


Original cartoon by Jack Maypole, MD

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Posted by: Dr. Parker at 9/06/2007 07:23:00 AM

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