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Are Placebos Really Sugar Pills?

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Re: Are Placebos Really Sugar Pills?

#51

Post by ahoyhere »

refurb wrote: post #39
jarito wrote: post #33

Earlier quoted context omitted.

I think you may have missed the point. You have stated that the article 'pointed out a few random oversights', but the actual point of the article is that _there is no data_. How can anyone, including you, know how effective the choice of placebo ingredients are if they aren't disclosed? It doesn't seem an undue burden to ask that the placebo ingredients be documented so that their effect on the study, which is criti…

I don't think he's saying "trust us", he's saying "this is an issue that everyone knows about, thus it's a non-issue". When you submit a drug for approval at the FDA, you need to list in exacting detail exactly how trials were run, including how they were blinded. The ingredients and form of the placebo are critical for this. The paper referenced in this blog post examined journal articles to determine if the composi…

> 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.

Re: Are Placebos Really Sugar Pills?

#52

Post by philwelch »

refurb wrote: post #39
jarito wrote: post #33

Earlier quoted context omitted.

I think you may have missed the point. You have stated that the article 'pointed out a few random oversights', but the actual point of the article is that _there is no data_. How can anyone, including you, know how effective the choice of placebo ingredients are if they aren't disclosed? It doesn't seem an undue burden to ask that the placebo ingredients be documented so that their effect on the study, which is criti…

I don't think he's saying "trust us", he's saying "this is an issue that everyone knows about, thus it's a non-issue". When you submit a drug for approval at the FDA, you need to list in exacting detail exactly how trials were run, including how they were blinded. The ingredients and form of the placebo are critical for this. The paper referenced in this blog post examined journal articles to determine if the composi…

Journal articles are short because journals have limited space. In the year 2013, this is no longer a relevant issue. Just add appendices, online only if necessary, covering placebo composition and other details so that people who want to dive deep can.

Re: Are Placebos Really Sugar Pills?

#53

Post by oneandoneis2 »

His cited example of a placebo that could skew data is olive oil, which by reducing heart disease would make the drug appear less effective than it might actually be.

Pointing out a study where the pharma company might have used a placebo that made their drug harder to approve is hardly in keeping with the insinuation that they're using placebos for "disturbing" ends.

Seems more like a case of "throw all the mud and hope some of it sticks" to me. Sorry.

Re: Are Placebos Really Sugar Pills?

#54

Post by hermannj314 »

From the article: It's inconceivable (to me, at least) that there are no laws requiring drug companies to list placebo ingredients.

From CFR 21 Part 312.23 (a)(7)(iv)(c): A brief general description of the composition, manufacture, and control of any placebo used in a controlled clinical trial. [is required to be supplied for an Investigational New Drug Application]

What is the difference? It seems the law clearly states that for new drugs, you must list the composition of your placebo to the FDA. It would seem the article is mistaken. I am not a lawyer nor do I work in the pharmaceutical industry. I just did a google search for "placebo composition site:fda.gov"

Re: Are Placebos Really Sugar Pills?

#55

Post by tptacek »

ahoyhere wrote: post #51
refurb wrote: post #39

Earlier quoted context omitted.

I don't think he's saying "trust us", he's saying "this is an issue that everyone knows about, thus it's a non-issue". When you submit a drug for approval at the FDA, you need to list in exacting detail exactly how trials were run, including how they were blinded. The ingredients and form of the placebo are critical for this. The paper referenced in this blog post examined journal articles to determine if the composi…

> 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 t…

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.

Re: Are Placebos Really Sugar Pills?

#56

Post by peeters »

ahoyhere wrote: post #44
refurb wrote: post #24

This seems like a ridiculous blog post. Only 6% of clinical studies list what their placebo was, so the conclusion from that is that there is a concerted effort by drug companies to unscrupulously modified the outcomes of their studies by choosing biologically active placebos. That's a bit of a stretch. Typically what is done for a study is that drug company will manufacture the drug for the study in tablet form, com…

so the conclusion from that is that there is a concerted effort by drug companies to unscrupulously modified the outcomes of their studies Did we read the same blog post? The author didn't claim any such thing. In fact, he referenced a study where (if you ascribe intent) it sounds like the drug company was undermining itself by using a placebo that worked better than the drug (the olive oil). His actual conclusion, f…

>> so the conclusion from that is that there is a concerted effort by drug companies to unscrupulously modified the outcomes of their studies

> The author didn't claim any such thing.

Actually, the author did claim any such thing:

> Active placebos are designed to mimic the side-effects of drugs under study. So for example, if a new drug is known (or thought by the drug company) to produce dry mouth, the drug company might use a placebo containing ingredients that produce dry-mouth. That way, of course, they can say things in their ads like "[drug name] has a low occurrence of side effects, such as dry mouth, which occurred about as often as they did with placebo."

The author here is accusing drug companies of using active placebos to make the side effects seem less critical, when there's no evidence of that presented.

Re: Are Placebos Really Sugar Pills?

#57

Post by secabeen »

jeremyarussell wrote: post #43
abtinf wrote: post #36

Earlier quoted context omitted.

The effects of unblinded doctors can be catastrophic and might not even be discovered. There was one study where a drug was designed to improve motor response in patients with retarded motor skills. The doctors had found a way to determine which patient was receiving which drug. So when it came time for the doctors to measure efficacy of the drug, they would do the motor skills test. If the patient was on the actual…

"The doctors had found a way to determine which patient was receiving which drug." - This implies that they consciously tried to bypass their blindness, physical design of the pill being different would do this sure, but that's not an issue with too much disclosure, that's an issue with people either A) Not doing their job well enough(the pill designers) OR B)Trying to find out which one so they could fudge the resul…

You're attributing to malice what is more likely stupidity. Doctors with patients on experimental trials want the drugs to succeed. They expect the drugs to succeed. That impacts their evaluations.

Re: Are Placebos Really Sugar Pills?

#58

Post by tedunangst »

jat850 wrote: post #31
cooldeal wrote: post #3

Aren't the side effects mimicked so that participants won't see the lack of them and then know that they're taking the placebo which will defeat the double blind study? For example, if you're testing fish oil, you wouldn't use a sugar pill since it's easy to know what you're taking by looking at it. You would use something like olive oil.

Is it not possible that, via whatever mechanism placebo drugs have positive intended effects, that they could also cause side effects?

Placebo effect is not a 100% effective substitute for the real deal. If the drug makes you pee more, you could convince yourself of that. If the drug makes your pee turn purple, that'd be harder to achieve just by willing it to happen.

Re: Are Placebos Really Sugar Pills?

#59

Post by crpatino »

abtinf wrote: post #21

Having worked in the pharma industry, this article is complete bullshit. For double and triple blind (the third blind comes from not even the pharma company knowing the blinding details until after the trial) placebo design is an extraordinarily complex undertaking. A placebo must match the drug in physical appearance, taste, texture, density, state (liquid/solid/gas), and anticipated side effects. Any material diffe…

While the article might have pulled a few cheap shots at pharma companies, the point stands. We need disclosure of this incredibly complex placebo matching methodology (for lack of a better term), at minimum because the experiments cannot be replicated by a third party without it.

Another reason for disclosure is the ethical risk assessment. What is to prevent a misguided executive from arranging a placebo with minimal doses of active components that produce adverse effects... just to push the results of a marginally effective drug. I am sure that 99.9% of people in the industry would not do that, but there is no reason to avoid putting checks and balances in place, for the day when some random sociopath decides to push it a little bit and get away with it.

Re: Are Placebos Really Sugar Pills?

#60

Post by Goronmon »

ahoyhere wrote: post #44
refurb wrote: post #24

This seems like a ridiculous blog post. Only 6% of clinical studies list what their placebo was, so the conclusion from that is that there is a concerted effort by drug companies to unscrupulously modified the outcomes of their studies by choosing biologically active placebos. That's a bit of a stretch. Typically what is done for a study is that drug company will manufacture the drug for the study in tablet form, com…

so the conclusion from that is that there is a concerted effort by drug companies to unscrupulously modified the outcomes of their studies Did we read the same blog post? The author didn't claim any such thing. In fact, he referenced a study where (if you ascribe intent) it sounds like the drug company was undermining itself by using a placebo that worked better than the drug (the olive oil). His actual conclusion, f…

I'd argue these are the main points of his blog posts. Or at least the ones he emphasized.

Active placebos are designed to mimic the side-effects of drugs under study. So for example, if a new drug is known (or thought by the drug company) to produce dry mouth, the drug company might use a placebo containing ingredients that produce dry-mouth. That way, of course, they can say things in their ads like "[drug name] has a low occurrence of side effects, such as dry mouth, which occurred about as often as they did with placebo."

and

The current anarchy that prevails with regard to placebos calls into question the reliability not just of drug-company research but of virtually every placebo-controlled study ever done. Which is a hell of a thing to have to say, or even think about. In fact it's nauseating.

Sounds to me like he's saying drug companies are manipulating the outcomes of studies and implying that any study containing a placebo shouldn't be trusted.

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