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> But the blog post says "Hey! Drug companies are trying to pull a fast on all of you!…" Actually what it says is that placebo ingredients should be documented

> But the blog post says "Hey! Drug companies are trying to pull a fast on all of you!…" Actually what it says is that placebo ingredients should be documented in studies, and regulated by the FDA. Why is that such heresy? If placebos are sugar pills, they don't need regulation. If they are designed to cause side effects, they are drugs. And that will skew the results of the drug tests, too, and as he describes in the olive oil example, not always in favor of the drug company.

tptacek 14y ago
That's not all the blog post says. Your implicit summary is inaccurate. The blog overtly implies that drug companies use active placebos to minimize advertised side effects, and later suggests that active placebos be outlawed. In fact, active placebos are a requirement for drug trials, because without them, the trial can't be effectively blinded.
- ahoyhere 14y ago
  He doesn't simply call for active placebos to be outlawed. He lists several problems with the current system and then says: FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use. That's like saying "The US Govt either needs to outlaw medicines OR rigorously define acceptable conditions for their use." Which is not a statement most reasonable people would disagree with… hence the FDA. Everybody would obviously choose the second measure. It's a classic persuasion technique: give an extreme choice so the other choice will seem more reasonable. It gets attention. Nobody is going to outlaw active placebos. As for overtly implying drug companies manipulate their results, he had a small handful of examples and one of them is a counter example where the drug company looks to be undermining its own results by using a too-good placebo (olive oil) that made its drug look useless. Finally he raises the question: If you kick people out of the study when they improve on placebo, are you still actually testing against placebo? How can you know, if the trials don't document what's in the placebo, and the FDA doesn't regulate it?
  - tptacek 14y ago
    I'm not sure we read the same article. The one I read said, and this is the whole graf: FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use. That seems like a profoundly ignorant argument. The article doesn't account for the need to blind studies. Why does it come across as credible to you?
    - koide 14y ago
      Why do blind studies need the regulation on active placebos to be non rigorous?
      - tptacek 14y ago
        Who are you arguing with? Surely not me. But the case you're making isn't the case the blog post made. The blog post suggests, with varying levels of overtness, that there is something shady about active placebos.
        koide 14y ago
        I'm talking about the quote you used on your comment. That quote by itself does not sound particularly outrageous or ignorant. You should have chosen a different line to illustrate how shady the author thinks active placebos are.
        tptacek 14y ago
        Outlawing active placebos might be a reasonable course of action?
        nitrogen 14y ago
        The blog post author may have used the idea of outlawing active placebos as a "door in the face" to make regulating them seem more palatable. At the least, it seems koide is interpreting the second suggestion as having more weight, while you are focusing on the first.
- larrys 14y ago
  "and later suggests that active placebos be outlawed." And to repeat my point just made in another comment all of it based on "Over the weekend I was reading some medical studies involving placebos.....then I started to wonder..."
- Natsu 14y ago
  Their takeaway is the same one I got, so perhaps you are reading it differently than we are? The piece I read was alarmed that a very important detail can only be found in 8% of the studies they examined and wondered what's up with that.
- esrauch 14y ago
  Everything else aside, it should be illegal to advertise that your drug "has similar side-effects to placebo" if the placebo has active ingredients deliberately intended to cause the side effects. The claim as made by the ads indicates to the average rational person that taking the drug has no higher chance of side effects than simple sugar pills. The reasonable conclusion for anyone who would be willing to take sugar pills is that this medication is safe, when in fact it easily might not be.
thejsjunky 14y ago
> And that will skew the results of the drug tests, too, No, that's the entire point of placebos. Placebos are not supposed to be absolutely nothing they are supposed to account for all manner peripheral effects and determine efficacy. The idea is to test your treatment against something that should have no or very low effectiveness. It's fine for them to be drugs and it's fine for them to have an effect - there's a name for that: placebo effects. People tend to get this confused with the well known "the placebo effect", but that is not the only effect placebos are intended to control for. The example you point to is dubious to me. The study seems to be working as intended: if you have a drug that doesn't work better than olive oil - you don't have a useful drug. We're talking about a cholesterol drug here, and it's not that the drug didn't do what it was supposed to do - control cholesterol - better than olive oil; it didn't improve mortality (for a specific subgroup)...something you'd expect with cholesterol control however that doesn't mean it's not effective in it's primary objective. In fact Clofibrate was taken off the market for precisely that reason; it's effective in lowering cholesterol but it has side effects which lead to increased mortality. I'm all for increased transparency in placebo use; but this article seems to have done little to clear the confusion about what placebos are and what they are intended for.
- dittendatt 14y ago
  >The example you point to is dubious to me. The study seems to be working as intended: if you have a drug that doesn't work better than olive oil - you don't have a useful drug. Why not?
  - Volpe 14y ago
    because people have olive oil already...
    - dittendatt 14y ago
      Well, you are assuming they cannot be combined.
      - 14y ago

tptacek 14y ago

That's not all the blog post says. Your implicit summary is inaccurate. The blog overtly implies that drug companies use active placebos to minimize advertised side effects, and later suggests that active placebos be outlawed. In fact, active placebos are a requirement for drug trials, because without them, the trial can't be effectively blinded.

ahoyhere 14y ago
He doesn't simply call for active placebos to be outlawed. He lists several problems with the current system and then says: FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use. That's like saying "The US Govt either needs to outlaw medicines OR rigorously define acceptable conditions for their use." Which is not a statement most reasonable people would disagree with… hence the FDA. Everybody would obviously choose the second measure. It's a classic persuasion technique: give an extreme choice so the other choice will seem more reasonable. It gets attention. Nobody is going to outlaw active placebos. As for overtly implying drug companies manipulate their results, he had a small handful of examples and one of them is a counter example where the drug company looks to be undermining its own results by using a too-good placebo (olive oil) that made its drug look useless. Finally he raises the question: If you kick people out of the study when they improve on placebo, are you still actually testing against placebo? How can you know, if the trials don't document what's in the placebo, and the FDA doesn't regulate it?
- tptacek 14y ago
  I'm not sure we read the same article. The one I read said, and this is the whole graf: FDA needs to review its policies on placebos and either outlaw "active placebos" or rigorously define acceptable conditions for their use. That seems like a profoundly ignorant argument. The article doesn't account for the need to blind studies. Why does it come across as credible to you?
  - koide 14y ago
    Why do blind studies need the regulation on active placebos to be non rigorous?
    - tptacek 14y ago
      Who are you arguing with? Surely not me. But the case you're making isn't the case the blog post made. The blog post suggests, with varying levels of overtness, that there is something shady about active placebos.
      - koide 14y ago
        I'm talking about the quote you used on your comment. That quote by itself does not sound particularly outrageous or ignorant. You should have chosen a different line to illustrate how shady the author thinks active placebos are.
        tptacek 14y ago
        Outlawing active placebos might be a reasonable course of action?
        nitrogen 14y ago
        The blog post author may have used the idea of outlawing active placebos as a "door in the face" to make regulating them seem more palatable. At the least, it seems koide is interpreting the second suggestion as having more weight, while you are focusing on the first.
larrys 14y ago
"and later suggests that active placebos be outlawed." And to repeat my point just made in another comment all of it based on "Over the weekend I was reading some medical studies involving placebos.....then I started to wonder..."
Natsu 14y ago
Their takeaway is the same one I got, so perhaps you are reading it differently than we are? The piece I read was alarmed that a very important detail can only be found in 8% of the studies they examined and wondered what's up with that.
esrauch 14y ago
Everything else aside, it should be illegal to advertise that your drug "has similar side-effects to placebo" if the placebo has active ingredients deliberately intended to cause the side effects. The claim as made by the ads indicates to the average rational person that taking the drug has no higher chance of side effects than simple sugar pills. The reasonable conclusion for anyone who would be willing to take sugar pills is that this medication is safe, when in fact it easily might not be.

thejsjunky 14y ago

> And that will skew the results of the drug tests, too, No, that's the entire point of placebos. Placebos are not supposed to be absolutely nothing they are supposed to account for all manner peripheral effects and determine efficacy. The idea is to test your treatment against something that should have no or very low effectiveness. It's fine for them to be drugs and it's fine for them to have an effect - there's a name for that: placebo effects. People tend to get this confused with the well known "the placebo effect", but that is not the only effect placebos are intended to control for. The example you point to is dubious to me. The study seems to be working as intended: if you have a drug that doesn't work better than olive oil - you don't have a useful drug. We're talking about a cholesterol drug here, and it's not that the drug didn't do what it was supposed to do - control cholesterol - better than olive oil; it didn't improve mortality (for a specific subgroup)...something you'd expect with cholesterol control however that doesn't mean it's not effective in it's primary objective. In fact Clofibrate was taken off the market for precisely that reason; it's effective in lowering cholesterol but it has side effects which lead to increased mortality. I'm all for increased transparency in placebo use; but this article seems to have done little to clear the confusion about what placebos are and what they are intended for.

dittendatt 14y ago
>The example you point to is dubious to me. The study seems to be working as intended: if you have a drug that doesn't work better than olive oil - you don't have a useful drug. Why not?
- Volpe 14y ago
  because people have olive oil already...
  - dittendatt 14y ago
    Well, you are assuming they cannot be combined.
    - 14y ago