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Comment by pkaye | Hacker News Reader

> 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?

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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.

Sometimes participants in clinical trials are shot during the trial, that also gets reported.

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.

The placebo group experienced adverse effects that were classified as side effects.

It does not mean necessarily mean that the effects were caused by being given the placebo ("placebo effect").

Placebo is strong medicine.

(It’s also possible this person had an unrelated condition)

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.

A follow-up study is using the placebo at a higher dosage.

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