Earlier quoted context omitted.
because people have olive oil already...
Well, you are assuming they cannot be combined.
That would be a completely different study. You can't make any claims about the effect of a&b if you've only studied a|b.
Are Placebos Really Sugar Pills?
131–140 of 141 posts
Re: Are Placebos Really Sugar Pills?
#132Aren'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.
There are certainly ways to simulate fish oil with biologically inert ingredients.
There are? What do you have in mind? If you use mineral oil or Olean, you get diarrhea as a side effect in doses of more than a few grams per day.
Re: Are Placebos Really Sugar Pills?
#133His 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…
More importantly: if the tested drug can't beat olive oil on the very thing that the drug is meant to treat, then why should it be approved at all? (Drugs should be tested against the best existing alternative treatment, not merely a placebo. We are not interested in whether a new drug has a non-zero effect - but whether it is an improvement on the state of the art in some way.)
It might be an improvement on the state of the art in some other way. For example, a new antibiotic might be less effective than existing antibiotics, but have no cross-resistance with them and therefore be useful in treating antibiotic-resistant strains in the future (the magainin case), or a new antipsychotic might be less effective than existing antipsychotics for average patients, but more effective or less damaging for a few. Finally, you might be able to get synergistic effects by combining the drug with the best existing alternative treatment.
Re: Are Placebos Really Sugar Pills?
#134Earlier quoted context omitted.
It makes no sense that the FDA receives extra information that is not available to peer reviewers. Why would that be?
The purpose of the FDA is quite different from that of a journal; why would you expect the information needed for each to perform its function to be the same? Among other issues, how much time to you expect a journal reviewer to spend vetting a study, compared to the amount of effort that the FDA spends reviewing the same study?
Because how can you have peer review of a study if an essential and complicated part of the study is not published. If only the pharmaceutical company and the FDA review placebo technique, then the study has not really been peer reviewed and placebo techniques are a mysterious black box.
Re: Are Placebos Really Sugar Pills?
#135http://imgur.com/a/7Vfnc
Here are some Alzheimer placebo samples (pictures) from Pfizer, handed out to doctors in Switzerland. Sorry for the bad quality. Pictures taken with a phone.
Re: Are Placebos Really Sugar Pills?
#136Having 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…
Not necessarily true; The veil of ignorance can be induced for doctors, if some care is taken. Direct psychological effects of the pill's appearance on patients can't be measured, but the effect of the doctors spoiling the study based on that certainly can.
Doctor hands patient sealed opaque pill blister pack, tells them to take two, nurse watching on a CCTV or via webcam sends a text message that they've verified the patient taking the pill.
Re: Are Placebos Really Sugar Pills?
#137Earlier quoted context omitted.
The purpose of the FDA is quite different from that of a journal; why would you expect the information needed for each to perform its function to be the same? Among other issues, how much time to you expect a journal reviewer to spend vetting a study, compared to the amount of effort that the FDA spends reviewing the same study?
Because how can you have peer review of a study if an essential and complicated part of the study is not published. If only the pharmaceutical company and the FDA review placebo technique, then the study has not really been peer reviewed and placebo techniques are a mysterious black box.
Is placebo design actually complicated? Other posts have indicated that you just have the manufacturer of the drug leave the active ingredient out of the normal formulation (so that all fillers, etc. are identical). If this is an important but well-understood aspect of study design (and ultimately vetted by the FDA), then a reviewer's time is better spent looking at the novel or error-prone aspects of the study.
Is there any evidence that poor placebo design is a problem in practice, or is this a theoretical concern?
Re: Are Placebos Really Sugar Pills?
#138Having 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…
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/CFRS...
Re: Are Placebos Really Sugar Pills?
#139Earlier quoted context omitted.
Because how can you have peer review of a study if an essential and complicated part of the study is not published. If only the pharmaceutical company and the FDA review placebo technique, then the study has not really been peer reviewed and placebo techniques are a mysterious black box.
Is placebo design actually complicated? Other posts have indicated that you just have the manufacturer of the drug leave the active ingredient out of the normal formulation (so that all fillers, etc. are identical). If this is an important but well-understood aspect of study design (and ultimately vetted by the FDA), then a reviewer's time is better spent looking at the novel or error-prone aspects of the study. Is t…
There is probably not much evidence because that which would constitute evidence is held effectively in secret. There is no way for the scientific community to look for flaws in methodology. Flaws in research methodologies are often found, sometimes years later, so it's to be expected that at least some placebos are making studies inaccurate perhaps dangerously so, and it's also to be expected that we will never know which studies are compromised since the data is not published publicly.
Yes, placebo design is extremely complicated and often involves active ingredients intended to simulate side effects and treatment experience without treatment effects.
There is quite a bit written in the comments here.
For instance, it would be quite easy for a company to fake efficacy accidentally or intentionally by using a placebo that inhibited natural healing or even made the treated condition worse. The control group would fare worse than the treated group, and the drug could advance toward the market. There is a massive economic incentive for this sort of cheating, and I don't think we can presume pharmaceutical companies are above economic incentives.
Re: Are Placebos Really Sugar Pills?
#140This 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…
>>That's a bit of a stretch. Can you imagine an "active placebo" for LSD, THK, methamphetamine (for example) ? "Placebo" must be a potent psychedelic or stimulator itself.
I'd probably go for 2C-T-7 directly against LSD (but ending the trial after ~4h; after 12+ hours, it would be obvious who had taken what), but I could easily imagine psychedelics as a class having a common effect.