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Are Placebos Really Sugar Pills?

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Re: Are Placebos Really Sugar Pills?

#81

Post by xenophanes »

refurb wrote: post #40
xenophanes wrote: post #37

Earlier quoted context omitted.

They should list placebo ingredients after the trial is done so it's possible to duplicate the trial and get the same results, right? If you don't provide enough information in your paper to repeat the experiment (and get the same results!!), then it's not good science. Good scientific studies need to be repeatable and need to provide enough information to do it. And even if people don't want to repeat the full exper…

If your argument is that journal article should include more details so that they are reproducible, that's fine but there is no need to pick on the ones published on clinical trials. I would say it's a rare paper that is so exhaustive in detail that you can easily reproduce the results. Many times I've had to contact original authors to get more details. You'd be amazed at what gets left out.

Then it's a rare paper that is good science. This would not really shock me but it doesn't make it any better.

Re: Are Placebos Really Sugar Pills?

#82

Post by jarito »

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…

I'm a little late responding to this, but there are good points here. It seems like a good compromise might be to have the FDA release the details of the trials / placebo ingredients. That way they can be mapped to the studies that used them (assuming the studies don't just start documenting them). That might be happening already, I don't work in the field, so I don't know.

Anyway, I found this comment useful. Thanks for replying.

Re: Are Placebos Really Sugar Pills?

#83

Post by jeremyarussell »

tptacek wrote: post #70
jeremyarussell wrote: post #43

Earlier quoted context omitted.

"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…

Your argument here basically questions the whole idea of blinded studies ("Who cares if doctors will figure out which medication is the placebo?", it suggests; "After all, that only matters if doctors are crooked.") But you're replying to a comment that lays out a scenario in which 8-9 figure clinical trials were ruined by the incidental outcome of reasonable honest doctors accidentally unblinding studies.

I don't mean more disclosure to the doctors on the pills, if that's what you thought, which I'm only assuming because I wasn't attempting to question the validity of clinical trials at all. I was saying given the language the person I was replying to used, it seemed like the doctors were actively trying to figure out what which pills were which, evidenced by the fact that instead of going "dang, we accidentally figured it out and now are susceptible to bias. We should start the trials over right NOW instead of wasting money" They went, lets retest these patients since the outcome isn't coming out like we think it should, something they should know isn't going to fly.

Also not saying specifically that it was malice, but that it's either malice or stupidity, or both.

Also, I have ethical and intellectual standards of doctors doing things that will impact hundreds of thousands of people.

Not sure why you said "Who cares if doctors will figure out which medication is the placebo?" - Since I didn't even insinuate that.

Re: Are Placebos Really Sugar Pills?

#84

Post by refurb »

starpilot wrote: post #80
Locke1689 wrote: post #63

Earlier quoted context omitted.

That presents massive ethical issues. One would have to knowingly not give subjects a drug that we know helps them (i.e., the current standard of care).

There are no ethical issues. 1. Study participants are told that some of them will receive a "sham" (placebo) treatment. Participation is voluntary. 2. It is not known whether the drug they are testing is effective or comparable to the current standard of care. Determining that is the purpose of the study.

This is not correct and not currently accepted policy by the FDA.

Take oncology drugs for example. Let's say you come up with a great new drug to treat Non-Hodgkin's lymphoma (NHL). Currently approved drugs already are very effective, pushing overall survival to close to a decade.

If you're a drug company, there is zero chance you'd get approved (by the independent IRB board who monitor ethical considerations) to run an NHL trial using a placebo. Even if patients agreed to take part in the trial, it would be unethical to deny effective treatments for a potentially fatal disease.

Hence, the FDA has softer data and efficacy requirements for oncology therapies. There is no requirement for a placebo arm unless there is no currently effective treatment available.

Re: Are Placebos Really Sugar Pills?

#85

Post by quasque »

DanBC wrote: post #32

Ben Goldacre says that testing against placebo is sub-optimal. You're testing that a medication is better than nothing. What you want is a medication that tests better than whatever we're currently using. I don't know how that fits in with blinding everyone involved. As abtinf and refurb mention, designing placebo is a difficult process. And you don't need to include anything to create side-effects; people taking sug…

"What you want is a medication that tests better than whatever we're currently using."

This is also done, depends on the trial. For example, new vaccines are often tested against the existing one(s).

Re: Are Placebos Really Sugar Pills?

#86

Post by Locke1689 »

DigitalJack wrote: post #69
Locke1689 wrote: post #63

Earlier quoted context omitted.

That presents massive ethical issues. One would have to knowingly not give subjects a drug that we know helps them (i.e., the current standard of care).

These issues are already present. You already know that some population of the participants are getting a placebo. You don't know which ones, which possibly dulls the anguish you might feel over it. I think at best you could say it would amplify already present ethical issues.

The "placebo" mostly is the current standard of care in many cases.

Re: Are Placebos Really Sugar Pills?

#87

Post by larrys »

jarito wrote: post #33
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…

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…

"but the actual point of the article is that _there is no data_"

According to the OP whose is (just checked) a tech evangelist at Adobe. Additionally the sum of their research is "Over the weekend I was reading some medical studies involving placebos".

What I'm seeing is that someone wrote something (the OP) and made some statements and additionally pointed to one journal article (which I'm sure only a few HN'ers have even bothered to click through and glance at.)

This is interesting to discuss and that's it (at this point at least).

Re: Are Placebos Really Sugar Pills?

#88

Post by api »

jarito wrote: post #33
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…

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…

http://programinplacebostudies.org/

Re: Are Placebos Really Sugar Pills?

#89

Post by larrys »

tptacek wrote: post #55
ahoyhere wrote: post #51

Earlier quoted context omitted.

> 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.

"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..."

Re: Are Placebos Really Sugar Pills?

#90

Post by bestes »

pleiotrope wrote: post #26
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.

I think you're correct. The example given in the linked article mentions dry mouth, but it's arguably important in double-blind studies to have both the controls and test groups develop similar side effects, to prevent both the patient and the administering physician from determining which is the placebo group. I don't think it's entirely due to nefarious motives from the drug company.

True. Just a happy side effect for the advertising in that example.

Also, I'm not a huge fan of more regulation, but scientific integrity seems to demand the placebo ingredients be disclosed.

From the discussion, it seems clear the doctor-scientists have to think about and carefully consider what to use for the control. A single, simple answer cannot work.

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