5 ms·

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 _ther

by jarito 14y ago

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 critical by any measure, can be understood. How can a separate group reproduce the results of a study if they don't have this type of information? What you seem to have said is - trust us. We won't tell you what's going on, you can't evaluate how well we are doing, but this is a totally hard problem so don't worry about it. This is disingenuous when the drug companies have vested interests in the outcome of these studies. If the drug companies are truly doing such a great job, then they should be recognized for the excellent work. The only way to do that is to release the ingredients used in the creation of placebos.

refurb 14y ago
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 composition of the placebo was reported. Journal article are notoriously lacking in details and they have to be since no one want to read an article with pages upon pages of details. If his comment was "Hey, you guys who write papers on clinical trials, it would be awesome if you'd list the placebo composition, since I'd be more likely to believe your findings" I would say "fair point". But the blog post says "Hey! Drug companies are trying to pull a fast on all of you! Beware of what's in your medicine cabinet" which is a completely ridiculous statement. This "missing information" is available to the people that matter (the FDA). This is truly an example of making a mountain out of a molehill.
- jeremyarussell 14y ago
  "This "missing information" is available to the people that matter (the FDA)." - That's right, I'm just too unimportant and stupid to be trusted to look at this stuff, also when the issue a lot of people are having is not being able to trust big pharma and the FDA, well hiding stuff isn't going to fix that. Yes, I was being a bit dramatic for impact.
- hellerbarde 14y ago
  This was discussed 2 years ago here: http://www.doctorslounge.com/index.php/news/pb/14946 http://www.doctorslounge.com/index.php/news/pb/14946 and here: http://pharmastrategyblog.com/2010/10/whats-in-placebos-who-knows-analysis-of-randomized-controlled-trials.html/ http://pharmastrategyblog.com/2010/10/whats-in-placebos-who-... But all three article (including the Topic) seem to focus on the Journal articles and neglect to write anything about the reports to the FDA. I'd be really interested in more info on that. EDIT: I have no opinion nor info about the quality of the links i posted, I just found them through cursory duckduckgoing. So beware, they might both be total cranks. :)
- ahoyhere 14y ago
  > 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
- philwelch 14y ago
  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.
- jarito 14y ago
  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.
larrys 14y ago
"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).
api 14y ago
http://programinplacebostudies.org/ http://programinplacebostudies.org/
chasingtheflow 14y ago
This is a bit dense with legalese, but if you search for placebo it would seem to indicate that it /is/ required that they disclose placebos ... "(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an "Investigational New Drug Application" (IND) including, in the following order: ... (c ) A brief general description of the composition, manufacture, and control of any placebo used in a controlled clinical trial." http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.23 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

by jarito 14y ago

refurb 14y ago

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 composition of the placebo was reported. Journal article are notoriously lacking in details and they have to be since no one want to read an article with pages upon pages of details. If his comment was "Hey, you guys who write papers on clinical trials, it would be awesome if you'd list the placebo composition, since I'd be more likely to believe your findings" I would say "fair point". But the blog post says "Hey! Drug companies are trying to pull a fast on all of you! Beware of what's in your medicine cabinet" which is a completely ridiculous statement. This "missing information" is available to the people that matter (the FDA). This is truly an example of making a mountain out of a molehill.

jeremyarussell 14y ago
"This "missing information" is available to the people that matter (the FDA)." - That's right, I'm just too unimportant and stupid to be trusted to look at this stuff, also when the issue a lot of people are having is not being able to trust big pharma and the FDA, well hiding stuff isn't going to fix that. Yes, I was being a bit dramatic for impact.
hellerbarde 14y ago
This was discussed 2 years ago here: http://www.doctorslounge.com/index.php/news/pb/14946 http://www.doctorslounge.com/index.php/news/pb/14946 and here: http://pharmastrategyblog.com/2010/10/whats-in-placebos-who-knows-analysis-of-randomized-controlled-trials.html/ http://pharmastrategyblog.com/2010/10/whats-in-placebos-who-... But all three article (including the Topic) seem to focus on the Journal articles and neglect to write anything about the reports to the FDA. I'd be really interested in more info on that. EDIT: I have no opinion nor info about the quality of the links i posted, I just found them through cursory duckduckgoing. So beware, they might both be total cranks. :)
ahoyhere 14y ago
> 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
philwelch 14y ago
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.
jarito 14y ago
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.

larrys 14y ago

"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).

api 14y ago

http://programinplacebostudies.org/ http://programinplacebostudies.org/

chasingtheflow 14y ago

This is a bit dense with legalese, but if you search for placebo it would seem to indicate that it /is/ required that they disclose placebos ... "(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an "Investigational New Drug Application" (IND) including, in the following order: ... (c ) A brief general description of the composition, manufacture, and control of any placebo used in a controlled clinical trial." http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.23 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...