> Though only 4.3 percent of children receiving the active drug experienced side effects categorized as severe, compared to less than 1 percent of the children on placebo...
So are they saying <1% (ie atleast one) of children on placebo experienced severe side effects?
Well, less than one percent can also be zero, but yes, maybe some of the children on placebo experienced severe side effects. It doesn't mean they were related to the placebo.
It’s because they don’t have a good causality link for adverse effect. If something bad happens, you’re not sure it’s because of the treatment.
So in the accounting, you take everything adverse against the treatment, wether it’s the placebo or the medicine under test, and you compare the difference between the two as rate of adverse effect for the medicine under test. And then there is a giant poker game to balance the benefits and the risks.
I met someone who worked on the admin side of NHS trials. They said exactly what you posted, anything noteworthy that happens should be reported. If you take the placebo and get hit by a bus outside the hospital, it should be reported. That way if 10% of patients in the study get hit by a bus they have more data.
Obviously a silly example but if things aren't reported because they don't appear to be connected to the study, we don't have the data to analyse at a higher level.
The funny thing is that such "irrelevant" data may hint at something real if it happens frequently enough. Like the whole Parkinson's medication with increases urge to gamble as a side effect. That sounds like somebody in a clinical trial making excuses at first glance.
Exactly. If people taking a drug tend to get hit by a bus more frequently, it could actually indicate that the drug increases risky behavior, decreases peripheral vision, causes lapses in attention span, etc.
It doesn't mean that getting hit by a bus is a side effect of the medicine, but rather getting hit by a bus is a potential outcome of one of the side effects of the medicine.
This sounds very similar to a treatment that my daughter is due to start next year at a Cambridge allergy clinic in the UK. She'll have to take the peanut based medication every day. She will have the initial dose in a hospital in case she has a reaction and then take the remainder of the doses home. Every two weeks we'll go back to the hospital to increase the dose.
I'm very excited about the potential for this to keep her safer, but also terrified at the prospect of deliberately feeding her peanut.
Please don't call it medication. It's peanut protein plain and simple. People have done this gradually increasing exposure method on their own for years - though it can be dangerous to do so and is not recommended (I might try it myself, but would not have my child do it). It's not a big medical breakthrough, it's a highly controlled increasing dose of peanut protein.
Sure, and some people who have gone through this eat a couple of reese's pieces each day for maintenance. I'm not kidding with that either. They don't call it medicine. That word in common usage carries a number of connotations that I don't think really apply in this case.
We've been doing this with my son here in Canada for the past 3 months. It's pretty scary, but after having multiple people with peanut allergies tell me they wish they could have had this we've hammered down on it. There have been side effects (diarrhea, mild eczema), but they've mellowed out after the first month. I hope things work out for your daughter with the treatment.
I suspect that is probably a good idea. When my daughters were babies the advice in the UK was to avoid nut products, which we did, it seems to have changed more recently.
I also wonder if the fact that my wife has a mild nut allergy and therefore avoids nuts would have been a factor, the girls would not have been exposed to nuts in the womb.
Just guessing though, ask a doctor.
A friend of mine is an allergist at a large Boston hospital, and she suggests changing standards of care to expose kids to their first peanut butter when they're young in the pediatrician's office where reactions could be handled.
Careful with that line of thinking. My son was 6 months old when I gave him a small bit of the peanut butter cookie I was eating. He could have died. I would not wish that experience on anyone.
Early exposure does indeed reduce risk. If your kid already has a severe allergy when they are exposed, obviously it won’t help. Otherwise, it can reduce the likelihood of developing the allergy.
Very similar experience with my son. We gave him a bamba (an Israeli peanut snack) at 6 months and he had an anaphylactic reaction. Very scary! However, we did get to see an allergist and have been doing OIT (like in the article) with him for the past 3 months now. Soon he'll be taking his doses as portions of bamba, which is very surreal.
> One of the most significant advances in food allergy occurred with the release of the results from The Learning Early about Peanut Allergy (LEAP) study in early 2015. Led by Dr. Gideon Lack of Kings College in London, LEAP showed a reduction in the development of peanut allergies of up to 86 percent by children who were exposed to peanut protein early
I say this not to diminish the scare you had. My son is allergic to peanuts so I know the fear. But if a population can see 86% reduction in new allergies, I'm all for it.
I was told that if one of the parents had asthma, or allergies, or eczema, the risk is higher that the child has one or several of those too. If that's the case, I really think you should reconsider or at least do it at a hospital.
In our case, both of us has/had all of the above, and our daughter did end up with it too. We don't have peanut allergies though, which she has. Curiously enough, she also reacts strongly to fish egg. Not fish itself, just the eggs (ie caviar, rom, etc). Shrimp and shrimp eggs are fine though.
I strongly remember the times she accidentally ate caviar. Took maybe a couple of seconds before she started screaming, saying her lips and mouth hurt, then vomiting like Linda Blair in the Exorcist. Quite scary. One of the times I hadn't cleaned the table good enough the night before when I was snacking on sandwiches with caviar. None visible, just must've missed some protein or so.
I’m really curious to see how much Aimmune charges for their drug, which the article states is just defatted peanut flour.
Of course, a lot of money went into the regulatory process of running the trials and getting it approved, but I still suspect people will be critical if they charge $15,000 per year for it.
In a similar Guardian article, the treatment course is stated to cost £17,000 GBP. Hopefully available free via NHS soon as I have a daughter with nut allergies.
>> The goal of the treatment is not to cure the allergy or enable children to eat peanut butter sandwiches, but to reduce the risk that an accidental exposure to trace amounts will trigger a life-threatening reaction in someone with a severe allergy, and relieve the fear and anxiety that go along with severe peanut allergies.
If ever a hedge a hedge there was, this is it: This works really well and they can eat a couple peanuts, but we don't actually know why or how or to what extent it's dependable...
It would have been unethical to make a less 'hedgey' claim. The authors did not test repeated doses, nor did they test the magnitude, severity, duration, etc of allergic responses.
While true, as a parent of someone with a life-threatening milk allergy, I can tell you that even this seemingly minimal outcome were able to be reproduced with consistency, it would be life-changing for my family. The amount of time, anxiety, emotions, and medical payments involved with a life-threatening allergy is staggering.
It does not seem that they are claiming this is dependable as a "cure", but they are claiming that it is dependable for incidental exposure, which seems to be a corollary from the ongoing treatment including eating a peanut a day.
Also, peanut allergies hardly affect anyone. As a society, why waste resources on such endeavors when we have diseases like cancer that affect millions every year?
"—Among children with some reaction to peanuts on the skin test: Only 11 percent of peanut eaters developed an allergy versus 35 percent of abstainers."
Yeah - who'd have thought that exposure to an allergen in small amounts could help build up resistance to that allergen?
The levels of peanut allergies correlates quite heavily with early-years education and parents freaking out about keeping schools and homes a nut-free zone.
We discovered my child's peanut allergy at around 8-9 months old, when she had barely-noticeable redness around her mouth the first time we gave peanut butter to her, followed by full-on hives the second time. She's been tested by an allergist a couple times since then, and still has a strong reaction.
Our home was not nut-free prior to that point, and obviously she did not attend school. Had we exposed her directly to peanuts earlier, would it have made a difference? Right now, no one knows because the underlying cause of these allergies is unknown. I have no allergies at all, and my wife has only seasonal allergies (ragweed for sure, maybe pollen).
So who'd have thought exposure to an allergen would help? Well when she was born the prevailing advice was explicit to avoid exposure in the first few months. That advice has reversed recently (and after my child was born), based on a study in 2015 [1]. There are still babies that get peanut allergies even when they're exposed at only a few months old, so it's not like this is fool-proof.
Maybe in a few years/decades the underlying cause of food allergies will be well understood, and we'll look back on this time in the same way we currently look back on the attitudes of smoking in the early 20th century.
We've done this with one of our children who has severe peanut-triggered anaphylaxis. Over the course of about 18 months, the dosage increased from milligram quantities of peanut flour dissolved in water to 3 grams of roasted peanuts. The dose typically doubled each time.
With the initial administration of each up-dose, we would typically see a barely detectable and mild reaction such as hives or coughing. After a few daily treatments at each dosage, there would be no discernible reaction. We have always been aware we were close to the edge of our child's sensitivity because certain things that seem to increase her immune system loading such as having a fever or being exposed to large amounts of seasonal pollen require reducing the dose slightly to avoid reactions.
We have reached a dosage where it is unlikely that our child would ever face a serious reaction from accidental exposure, which is the goal of the treatment.
I hope that the availability of an FDA approved peanut preparation (and patent protection for some elements of this) does not increase the cost of performing this treatment.
47 comments
[ 3.7 ms ] story [ 107 ms ] threadSo are they saying <1% (ie atleast one) of children on placebo experienced severe side effects?
(It’s also possible this person had an unrelated condition)
So in the accounting, you take everything adverse against the treatment, wether it’s the placebo or the medicine under test, and you compare the difference between the two as rate of adverse effect for the medicine under test. And then there is a giant poker game to balance the benefits and the risks.
Obviously a silly example but if things aren't reported because they don't appear to be connected to the study, we don't have the data to analyse at a higher level.
It doesn't mean that getting hit by a bus is a side effect of the medicine, but rather getting hit by a bus is a potential outcome of one of the side effects of the medicine.
It does not mean necessarily mean that the effects were caused by being given the placebo ("placebo effect").
As a partner of somebody with severe nut anaphylaxis I'm heartened by the news but still watching from the sidelines
Can you link me to anything? I was pretty discouraged by the result as the article explicitly says that the trial didn't work on adults:
"The treatment was not effective in the small number of adults enrolled in the study."
https://ir.anaptysbio.com/news-releases/news-release-details...
http://www.peanut.cuh.org.uk/
I think taking a prescribed amount of peanut protein to treat this allergy fits that definition.
I also wonder if the fact that my wife has a mild nut allergy and therefore avoids nuts would have been a factor, the girls would not have been exposed to nuts in the womb. Just guessing though, ask a doctor.
> One of the most significant advances in food allergy occurred with the release of the results from The Learning Early about Peanut Allergy (LEAP) study in early 2015. Led by Dr. Gideon Lack of Kings College in London, LEAP showed a reduction in the development of peanut allergies of up to 86 percent by children who were exposed to peanut protein early
I say this not to diminish the scare you had. My son is allergic to peanuts so I know the fear. But if a population can see 86% reduction in new allergies, I'm all for it.
In our case, both of us has/had all of the above, and our daughter did end up with it too. We don't have peanut allergies though, which she has. Curiously enough, she also reacts strongly to fish egg. Not fish itself, just the eggs (ie caviar, rom, etc). Shrimp and shrimp eggs are fine though.
I strongly remember the times she accidentally ate caviar. Took maybe a couple of seconds before she started screaming, saying her lips and mouth hurt, then vomiting like Linda Blair in the Exorcist. Quite scary. One of the times I hadn't cleaned the table good enough the night before when I was snacking on sandwiches with caviar. None visible, just must've missed some protein or so.
Of course, a lot of money went into the regulatory process of running the trials and getting it approved, but I still suspect people will be critical if they charge $15,000 per year for it.
[1] https://www.theguardian.com/society/2018/nov/18/peanut-aller...
If ever a hedge a hedge there was, this is it: This works really well and they can eat a couple peanuts, but we don't actually know why or how or to what extent it's dependable...
It does not seem that they are claiming this is dependable as a "cure", but they are claiming that it is dependable for incidental exposure, which seems to be a corollary from the ongoing treatment including eating a peanut a day.
I'm with you on that. I follow the links to every story like this and they're almost all the same - hope but no cure.
https://www.timesofisrael.com/israeli-kids-help-prove-early-...
Also, peanut allergies hardly affect anyone. As a society, why waste resources on such endeavors when we have diseases like cancer that affect millions every year?
"—Among children with some reaction to peanuts on the skin test: Only 11 percent of peanut eaters developed an allergy versus 35 percent of abstainers."
2) If we could cure cancer with peanut flour, I'm sure we would. Unfortunately that one's a bit harder.
The levels of peanut allergies correlates quite heavily with early-years education and parents freaking out about keeping schools and homes a nut-free zone.
Our home was not nut-free prior to that point, and obviously she did not attend school. Had we exposed her directly to peanuts earlier, would it have made a difference? Right now, no one knows because the underlying cause of these allergies is unknown. I have no allergies at all, and my wife has only seasonal allergies (ragweed for sure, maybe pollen).
So who'd have thought exposure to an allergen would help? Well when she was born the prevailing advice was explicit to avoid exposure in the first few months. That advice has reversed recently (and after my child was born), based on a study in 2015 [1]. There are still babies that get peanut allergies even when they're exposed at only a few months old, so it's not like this is fool-proof.
Maybe in a few years/decades the underlying cause of food allergies will be well understood, and we'll look back on this time in the same way we currently look back on the attitudes of smoking in the early 20th century.
[1] https://www.health.harvard.edu/blog/new-guidelines-preventin...
With the initial administration of each up-dose, we would typically see a barely detectable and mild reaction such as hives or coughing. After a few daily treatments at each dosage, there would be no discernible reaction. We have always been aware we were close to the edge of our child's sensitivity because certain things that seem to increase her immune system loading such as having a fever or being exposed to large amounts of seasonal pollen require reducing the dose slightly to avoid reactions.
We have reached a dosage where it is unlikely that our child would ever face a serious reaction from accidental exposure, which is the goal of the treatment.
I hope that the availability of an FDA approved peanut preparation (and patent protection for some elements of this) does not increase the cost of performing this treatment.