Monday, June 8, 2015

I Am Not A Placebo Effect

Am I willing to try something that the FDA hasn't approved
 and big Pharma doesn't control (yet)? 
You bet I am. 
You can also bet I'm not going to report it's working if it's not. 
You're not going to get away with insulting my ability to ascertain a reduction in seizures. 
" Mom reports" is not a phrase worthy of eye- rolling. 
I know when I'm not seeing seizures. 
You KNOW that!

I'm not done chastising Dr. Amy Brooks-Kayal and her ridiculous statements made throughout the Dateline special Raising Hope that we all watched last night. I've been mulling over them all day, to tell you the truth, especially while pushing my daughter in her wheelchair through the leafy streets of my neighborhood. We cut a tiny amount of Sophie's Onfi about three weeks ago, and just as it's happened every time we've weaned, she's experiencing some dreadful side effects. These include agitation, discomfort and excessive drooling. She has a tremor and some weakness, as well as what I call withdrawal seizures. 

I almost don't want to repeat a couple of Brooks-Kayal's statements because they were so -- let's call a spade a spade -- stupid. Beyond the usual call for more research (which we all want and which wouldn't be going on at all if a shitload of parents hadn't initiated this whole thing), she made some patently false claims about the Powers That Be concerns. She wondered what if it helps the seizures but makes your life worse? Even allowing for bad television editing, that was a loaded sentence that makes a mockery of the suffering our children have endured. She dismissed anecdote quite smugly and spoke of the placebo effect. My regular readers might remember that this line of smuggery was directed at me when I participated on a cannabis panel at the Epilepsy Foundation's Brain Summit a couple of months ago. I imagine that some of you might have thought that my emotions ran high, that a lot of our objections are knee-jerk ones. Surely these people aren't that arrogant? you might have thought. I'm secretly glad that Brooks-Kayal said what she said last night because it affirms what many of the people involved in this fight have experienced. These people really do think these things or they are, at the very least, spouting a party line.

Read the post that I quoted from above, written by my friend Mary Lou Connelly. She has a 30 year old son who has had refractory epilepsy for most of his life and who currently benefits from cannabis.

Another friend emailed me the following comment in response to my earlier post and after she herself viewed the Dateline special. She was puzzled by the doctor's comment about the placebo effect:

The way it was employed is sort of a misnomer. Placebo effect would mean
the seizures stop because of belief in a substance. Which would be pretty
impressive and hopeful and something to explore. (Is most certainly something very
under-explored in general.) But what is really being said is that parents' observations are inaccurate. Researchers' observations can be biased as well, obviously --- hence double blind
studies. But the adversarial rhetoric of this sort is absurd, because any drug that is used off-label,
and there are lots of them, is used on the basis of reported experiences, AKA anecdotal.
Neither placebo nor anecdotal should be used as pejoratives. It's all information.

I couldn't have said that better myself. 

Out of the 20 drugs that Sophie has been on in her twenty years, more than three-quarters of them were used off-label. During the hundreds of visits I've made to our neurologists' offices over the years, I've "reported" how things were going. The doctors have always studiously taken notes. I tell you what. It's becoming more and more difficult to take any of these people seriously. Dr. Brooks-Kayal is the head of the American Epilepsy Society, an extremely influential organization. Because I'm a woman with a tiny little mother mind,™ I'm going to throw out the words Big Pharma, Medical/Industrial complex, money, money and more money and just -- well -- wonder.*

*And those of you who like myself don't watch much commercial television were probably bowled over by the amount of commercials that ran during the program and their length. Nearly every single commercial was for a pharmaceutical, including a drug for your dog. It's enough to make you want to go off-grid.


  1. I also love when they so perfectly prove our points for us. Uh, there is no way 25 to zero seizures a day is placebo. Where is the common sense? THEY are crazy town.

    1. "THEY are crazy town" is my second favorite descriptive phrase after "clusterfuck."

  2. I noted that same thing about the commercials. There were SO many of them and so many of them were about drugs. "Ask your doctor...if Killerhea is right for you..."
    When Dr. Kayal made that statement about "What if it helps your seizures but makes your life worse?" Glen and I both snorted martinis out our nose. It made no sense. It was absolutely absurd.

    1. Ms. Moon -- If I hadn't seen that letter she wrote to the Governor of Pennsylvania, I would have felt sorry for her on the Dateline special because who knows how much she said and what was edited out, but now I just don't give a flying foo-foo about her feelings. She's AWFUL. And I do wish I'd been sipping martinis with ya'll while watching.

    2. oh, Ms. Moon! You have me snorting my COFFEE out my nose!

  3. I didn't understand how much worse life could be if it helped kids from having hundreds of seizures! That was something.

    1. Yes, "what a bird," is what my 79 year old father said.

  4. I've met a lot of doctors in my time, and every single one that was any good listened to the patient and the mother. All the worst ones didn't. This is just a bigger version of that.

  5. Most people with common sense will hear the stupid things said and see them for what they are. In the end I swear (but maybe it is just b/c I see it this way) that those stupid statements actually help people to see the obviousness of the situation.

  6. I didn't watch it. Question: how can it be a placebo effect if the "patient" doesn't know if it's a placebo or not? Why, oh why, would you go to so much trouble and expense if the darned stuff didn't work? Pul-eeze.

  7. Elizabeth, I watched Growing Hope online and got the same commercial over and over, for a skin condition prescription.

    I was blown away by the courage of the parents fighting for their children, and ridiculously frustrated with a government and system that restricts research, access and hope for sick children. Dr. Brooks-Kayal especially frustrated me with her tone and her narrow mindedness. I would expect the Board member of the Epilepsy Society and the Translational Epilepsy Research Program to be incredibly interested in collecting data from as many field cases as possible to analyze and aid in her research.

    Intellectual arrogance is the first step toward ignorance, isn't it?

    I glanced at her publications and areas of expertise and can only assume that she is trapped in a paradigm that causes her to dismiss information that does not pertain to neurotransmission and GABA receptors as irrelevent. Hooray for the intelligent, articulate and determined parents who will keep fighting to make her see that there are specific measurable positive results happening all over the country, and shame on her for trying to minimize their reports as wishful thinking or risky parenting. She came across as clueless and out to touch to me.

    Her question asking if making seizures better made lives worse was ridiculous, because she provided no data to support that any child's quality of life diminished with treatment, and I could find none to support that notion. It was a random and weak defense for her position.

    From the UCDenver website, her research lab's current studies focus on the role of signal transduction pathways, including CREB, JAK/STAT, BDNF and Egr on GABA(A)receptor expression and trafficking. The lab also studies the effects of early-life seizure activity and seizure treatment on brain development.

    Her lab needs to expand its mission to studying treatments as well as causation, and take advantage of the rare opportunity to analyze the data coming out of Colorado and California. Any researcher worth their salt would want to talk to the chemists in the CW labs and collect data on compounds, concentrations, doses and interview parents about their children's responses to the drugs over time. You know, research!

    I can only hope that as information continues to flow and public opinion begins to sway that our laws will change and allow legal access to the plant for study and that her mind will be opened to the possibility that she is wrong about CBD and seizure reduction.

    And then, I would like to hear an apology from the Doctor for being dismissive, for failing to work harder to change the system and the scope of her research to help ease the suffering of her patients.

    You know how long that wait will be, I'm sure.

    I thought of you and Sophie and your family with love and wonder the whole time I watched it.

    My hope for change is growing.


    1. Wow, Mel! Thank you for this wealth of information and for all of your support. I have more to say in response to your research into Dr. Brooks' work --

  8. The placebo effect does not work with our children. Neither Katie, nor Sophie I'm guessing, have any idea of what the drug they're taking is supposed to do or not do. Katie has PMS and she has never heard of it. It's real. The weed works, not because Sophie thinks it does, she is unaware, but rather because it works. The placebo effect can only come into play when someone has the mental ability to understand that "something" may make a difference. Our girls are unencumbered by this notion.

  9. Reading and following your piercing commentary and the comments here. So important, this conversation. I haven't seen the dateline special yet, but thank God you have this forum to peel back the layers of stupidity. What exactly do such doctors have to gain by insisting your experience is delusional? What am I missing, because it seems to me they would want to be first in line to investigate such a dramatic reduction in seizures. I don't get it.



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