Does it matter what's in a placebo?

[HuckleB]

http://scienceblogs.com/gregladen/2010/10/does_it_matter_whats_in_a_plac.php

"Yes, it does matter what is in a placebo (as well as how it is administered, and so on) because the placebo is an important part of the experimental protocol used in pharmaceutical research. Before we get to why this question has even been raised, and an interesting point or two about it, lets quickly cover what a placebo really is.

A placebo is a tool used for making a control in an experiment. So what is a control? A control is a subset of individual variates (which may be people, or samples of some kind, or whatever) that is given a "treatment" that is just like the treatment you are testing out but missing the critical part(s) of the experiment. The control has two closely related purposes (the importance of each will vary): 1) To provide a baseline with which to compare the results of the experiment and 2) to subject the experimental variate (the person, the sample, the whatever) to things that are not part of what you are testing but that happen anyway because you are doing the experiment.

For instance, if your experiment is on humans and it requires that the humans show up at your lab for 10 minutes to have the experiment run on them, you need to rule out that some aspect of coming to your lab for 10 minutes is not the cause of whatever effect you measure. Perhaps you will be bombarding the test subject with rays from a machine you've invented. Well, what if your graduate students are playing around with test versions of this machine all the time so your lab tends to be bathed in the rays. Just showing up will cause anyone to be bombarded with rays, so the specific doses and methods you are using on your test subject may not be sufficiently distinct. So if you have your "controls" (a subset of your test subjects) show up and hang around for 10 minutes and leave with no treatment, you would be catching this problem.

A placebo is a special subset of control conditions where things that you think might result in a faux version of the desired effect are invoked. In the above case you may think that there is a psychological effect, where a subject who thinks they were bombarded with rays (but was not) will give a more positive assessment of their state of being afterwords than otherwise. they will say the pain from their condition is reduced, thinking that the rays must have worked. So, bombarding the patient with fake rays would be a placebo.

..."


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This is a mildly interesting follow-up to this study: http://www.annals.org/content/153/8/532.abstract , as well as to a ridiculous quack extrapolation made by one of the Internet's biggest quacks. (Links to that can be found at the full article. I won't post them.)


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It's likely that there will be more discussion on this topic in the coming days and weeks. I look forward to it.

:hi:

[pnwmom]

1. Absolutely. For example, a placebo may contain the same adjuvant

as the one contained in a vaccine. (I believe this was the case with Gardisil.) This adjuvant has a useful purpose in the vaccine, but it happens to make the vaccine more painful. If the adjuvant isn't put added to the placebo, the subject and the investigator will both know whether the subject is receiving the placebo or the vaccine. This is the argument for putting the adjuvant in the placebo, and why, in FDA approved trials, the investigators will request to do this.

On the other hand, when the adjuvant itself has other side effects (besides pain), then those side effects will be masked when the side effects of the vaccine are reported; the number of reactions (both to the vaccine and to the placebo) caused specifically by the adjuvant will be about the same. Instead of comparing the side effects of a new vaccine with a neutral, non-reactive placebo; the comparison has been made with a placebo with its own reactive component. This will reduce the reported difference in the number of reactions caused by the vaccine vs. the placebo, making the vaccine appear to have fewer adverse effects than it actually does. This might not matter if all proposed adjuvants were equally well studied.

[Name removed]

2. Deleted sub-thread

Sub-thread removed by moderator. Click here to review the message board rules.

[HuckleB]

3. Your post has nothing to do with the OP, as it amounts to nothing but supposition sans context.

And that supposition (sans any evidence other than your own imagination) is clearly spun to serve a preconceived agenda, rather than to actually discuss the matter. Further, your supposition has very little to do with the action of a vaccine under investigation, since vaccines are not offering up subjective pain control, etc... The benefits of vaccines can be measured without patient input. This, of course, is quite different from the things SCAM practitioners push, but that is why they are SCAM practitioners.

Thanks, anyway.

[pnwmom]

4. I directly answered your OP question, which was "Does it matter

what's in a placebo?" I said yes and gave an example why.

You can't have a double-blind study if the investigator knows whether the active drug/vaccine or the placebo is being used. The drug companies themselves have argued for the use of adjuvants in placebos so that the investigators won't be able to tell if the subjects are getting the placebo or the active injection. So the drug companies themselves are arguing that it "matters what's in a placebo."

If you have an issue with that, maybe you should take it up with the FDA.

[HuckleB]

5. You gave an off the cuff example without context...

... and you simply "answered" the headline (as your response is meaningless in the context of the content of the article), which means you didn't read the article. Further, it's very clear what your agenda is, and it's not exactly surprising. Nor does it have a leg to stand on.

Nice.

:eyes:

[pnwmom]

6. Silly me, I thought your question was an actual question.

Now you claim to be missing a context for my "imaginary" example. I assumed you'd be capable of finding your own links with regard to an adjuvant being an important part of a placebo, but here's one.

Again, to answer your question, it clearly DOES matter what's in the placebo, or else these investigators could have just used saline solution. Instead, they used saline plus an adjuvant.

As to the rest of your post, it was a discussion of the meaning "placebo" and "control." So what?

http://webcache.googleusercontent.com/search?q=cache:oNvd0dAqfUIJ:www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM184997.ppt+adjuvant+trial+FDA+placebo+Gardasil&cd=1&hl=en&ct=clnk&gl=us&lr=lang_en

Study V501-020 Design

4065 males, 16-26 years of age, randomized 1:1 to:
Gardasil 0.5mL IM, at 0, 2 and 6 months
Control (AAHS adjuvant in saline) 0.5mL IM, at 0, 2 and 6 months

[HuckleB]

7. Thank you for yet another answer to the headline, but not to the content of the article.

Sheesh.

Please read the article before responding. You are wasting the time of others by responding to a conversation that's already way beyond your responses, because you haven't bothered to read the article.

:eyes:

[pnwmom]

8. I read your entire post and didn't see anything worth talking about.

It discusses the meaning of placebo and control. So what? If the article contained something more interesting than that, then you should have posted the more interesting parts.

[laconicsax]

9. You're blaming your intellectual laziness on the OP?

:shrug:

[pnwmom]

10. That's rich. A person who hasn't spoken a single word till now

talks about my intellectual laziness.


So why haven't you responded to the contents of the OP? Is that because of your own intellectual laziness, or simply because you also understood the definition of "placebo" and "control"? And found nothing in the OP of special interest?

[laconicsax]

11. I read this article before the OP posted it here, so I was already familiar with its contents.

When I read the discussion thread to see what was being said about the article. I found that you were addressing the headline rather than the article and blaming the OP for the fact that you didn't read past the headline.

Responding to a headline isn't a sign of intellectual curiosity. Refusing to read the subsequent article is, however, a sign of laziness.

What's really rich is that you, having been called on not reading the article, keep trying to change the subject to hide that fact. First by attacking HuckleB for only excerpting the 'boring' parts, then by attacking me for calling you on it and for not having posted anything prior in the thread.

Look out! Your credibility is nearing zero!

[pnwmom]

12. I had already read the entire OP but, as I said, there wasn't anything

of interest in it; which probably explains why no one else has bothered to post in this thread, either.

It's curious that you claim to already have read the entire article and yet even you -- someone who likes to throw around terms like "intellectually lazy" -- can't find something worth quoting in it.

If one of you wants to get a discussion going (instead of a forum for flaming people), then you could start by posting a part of the article that contains something more interesting than an extended definition of "placebo" and "control."

[HuckleB]

14. If you had read that article, you would not have responded as you did.

Anyone who bothers to read the article will know that. (BTW, I don't post "interesting parts." I generally post the start of a piece, and let others choose to read it, or not read it.) For the Health Forum, this piece has gotten plenty of attention, even if it's not in the mode of responses. But that is missed on you.

Game over.

[petronius]

16. I'm confused - you posted an OP with a snip from a blog, you chose a part that

was apparently not the part you found interesting, included no actual commentary of your own in the OP, and now you're snarking at a poster because she decided to talk about something that isn't exactly what you wanted to talk about? :wtf:

[pnwmom]

17. Thanks , petronius. An excellent summary

of the situation.

:rofl:

[HuckleB]

20. I see you found someone to push your BS spin.

That's quite pitiful.

[Name removed]

19. Deleted message

Sub-thread removed by moderator. Click here to review the message board rules.

[laconicsax]

15. I'm sorry I don't post for your benefit.

Why would I quote something from an article if I don't have anything specific to say about it?

I suppose it hasn't occurred to you that not everyone has a compulsive need to post an uninformed ad hoc reckon about everything they see.

[pnwmom]

18. And I didn't post for yours.

This isn't all about you, laconicsax.

[laconicsax]

21. Who's been trying to make it about me?

That would be you, pwnmom.

-You wrote that you read the OP and didn't see anything worth talking about, yet you felt the need to post a response to an imaginary argument, and that it was HuckleB's fault that you weren't interested in clicking the link.
-I asked if you were seriously blaming your shortcomings on the OP.
-You dodged the question and attacked me.
-I summarize the exchange so far, including your attempt to change the subject to me.
-You again write that you didn't think the OP was worth responding to, and continued the attempt to change the subject to me.
-I responded that it isn't about me.
-You allege that I'm trying to make it about me.

You still haven't addressed the original issue, nor the other questions posed to you:

Why, if you didn't think the OP was worth responding to, did you feel the need to invent an imaginary argument and respond to it?
Why is your lack of curiosity the OP's responsibility?
Why, after being told that your imaginary argument had nothing to do with the linked article, did you elect to repeat your imaginary argument rather than read the linked article?

[Celebration]

22. actually her post was related to the op

Not directly, but it answered a question in the OP with an example. Therefore it was on topic and fine. Often original posters don't get exactly the response to their posts that they want, and it obviously happened in this case. So what? When most people start threads, and someone answers with a comment on a part of the post that they don't care to discuss, the response is to ignore them.

Why wasn't the post ignored? The response wasn't mean, and it wasn't off topic. But because it wasn't the exact response the OP wanted, it was from that point forward, attack, attack, attack-- and for absolutely no reason whatsoever.

The attack makes no sense. The OP didn't even discuss the content of the post.............why bother saying anything? Does someone have too much time on their hands? Or just love being contentious for no reason at all? Sheesh.

[HuckleB]

23. The headline does not equate to the "OP."

Nor does the limited amount of an article that someone can post in an OP. The link, as anyone who actually cares about health care and science knows, is the most important piece. The full story is needed before discussion can begin.

She got caught trying to post without having read the article. (Heck, it's clear she didn't even read the first sentence of text posted in the OP.) And now she's gone on and on and on, instead of acting like an adult and taking responsibility for her actions.

[Celebration]

27. Get a life n/t

[HuckleB]

28. Awwwwwwwwwwwwww.

:rofl:

[pnwmom]

24. All these words. Too bad they're a bunch of hooey. n/t

[laconicsax]

26. Yes, your response is "a bunch of hooey." n/t

[HuckleB]

13. BS.

:rofl:

[uppityperson]

25. I read your post, read the whole article and just needed to say I see nothing to comment about so I

am not going to waste time commenting because you could have at least given my brain something to stimulate it rather than the same old same old....











:sarcasm:
off to read and think before posting