FYI-Little disclosure of placebos in research!?!

Discussion in 'Fibromyalgia Main Forum' started by victoria, Nov 28, 2010.

  1. victoria

    victoria New Member

    I did not realize the FDA did not make researchers account for/disclose what is used in their placebos in drug trials, and it is rarely disclosed. I find this truly shocking.
    What's in Placebos: Who Knows? Analysis of Randomized, Controlled Trials

    1. Beatrice A. Golomb, MD, PhD; 2. Laura C. Erickson, BS; 3. Sabrina Koperski, BS; 4. Deanna Sack, BS; 5. Murray Enkin, MD; and 6. Jeremy Howick, PhD

    + Author Affiliations 1.
    From the University of California, San Diego, School of Medicine, San Diego, California; McMaster University, Hamilton, Ontario, Canada; and Centre for Evidence-Based Medicine, University of Oxford, Oxford, United Kingdom.


    Background: No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting.

    Purpose: To assess how often investigators specify the composition of placebos in randomized, placebo-controlled trials.

    Data Sources: 4 English-language general and internal medicine journals with high impact factors.

    Study Selection: 3 reviewers screened titles and abstracts of the journals to identify randomized, placebo-controlled trials published from January 2008 to December 2009.

    Data Extraction: Reviewers independently abstracted data from the introduction and methods sections of identified articles, recording treatment type (pill, injection, or other) and whether placebo composition was stated. Discrepancies were resolved by consensus.

    Data Synthesis: Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002).

    Limitation: Journals with high impact factors may not be representative.

    Conclusion: Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.

    The fact that the FDA does not require the disclosure makes things very uncertain. This seems like an incredibly big loophole that should be closed.... certainly makes me take a double look now. What remains unsaid is if the 'journals with high impact factors) require disclosure of the placebo used to them, at least... tho I'm betting they don't.
  2. gapsych

    gapsych New Member

    This article includes a lot of misinformation.

    1. "Natural News" anti science which makes it a poor source of information.

    2. Placebos are described in detail in the clinical trial application & the investigators brochure.

    3. It's the failure of the journals if they don't include this information, but not a failure to disclose this informations to the ethics committees or regulators, who are the most important people regarding the conduct and outcome of clinical trials & certainly.

    4.Placebos use inert ingredients. That means they have no pharmaceutical effect. If the ingredients aren't this would be noticed by the above and would have to be changed.

    5.If researchers are negligent enough to use a placebo that has a pharmaceutical effect you can bet that this is not the only flaw in the study. Over the last 15 years disclosure has become more transparent.

    6. There are sophisticated statistical ways that will tell you if there is a problem with the placebo.*

    It is rather ironic that a publication that is biased against regulation for supplements/vitamins but want regulation for something that is already included in the protocols in designing trials, and reviewed by the regulators and ethics committees.


    *With thanks from the members of the following forum for helping me to sort this out. Some of this information is new to me.
  3. gapsych

    gapsych New Member

    KJM, we did it again. Posted at the same time. :>)
  4. victoria

    victoria New Member

    Thanks Jean. I agree, KJM, it is unsettling.

    So you're saying Annals of Internal Medicine prints badly done research, Gap? I have read that at least one trial for Gardasil used a placebo containing some unexpected ingredients (to me) which the vaccine has in it, which would lessen side effect differences if true. I haven't had time to research this however and not going to get into details since I haven't.

    I do think this is an area that can too easily be tampered with in any case, and definitely it should be disclosed publically. What is there to lose.

    Interestingly, one of the contributors was Jeremy Howick, PhD. Guess where he works, I'd think you would respect it (I sure do):
    Centre for Evidence-Based Medicine, based at Oxford University.

    The info in the article about this research in the link Jean provided came from U of C, San Diego.

    I don't think any of these places are known for bad science in any case.

  5. gapsych

    gapsych New Member

    I've looked at this and still view this as something the alternative community is making a big deal out of when it is not warranted.

    If what you say is true about the above study, then the study is not valid. I would be interested in more info. about this study as it sounds interesting. Even when a study is not valid, you can learn from it.

    The definition of a placebo is inert ingredients. That means they have no pharmaceutical effects. This is something that is investigated before trials even begin and if they aren't that says a lot about problems with the study. The usual notion of a placebo being a sugar pill, is in fact not true as sugar does effect people.

    Evidence based medicine is not the same as Science based medicine. Evidence based science will do research but not adhere to the scientific method nor rely on the a priori principle, which is plausibility. A lot of alternative researchers use this type of methodology.

    An example would be if someone was doing studies about the tooth fairy. You could produce data about the tooth fairy such as what day of the week do kids get the most money, color of pillowcases, age, where the money is placed and come up with great looking charts and even conclusions. But there is no tooth fairy, the data is based on a hypothesis that is not credible.

    I don't care where someone works, I go by the science. Sometimes invalid science does slip through the cracks. This is why replication and peer review is so important. There are statistical methods of weeding out any "noise" interfering with the data.

    A recent example would be the studies with XMRV and the fact that part of science means getting together and sorting out why the studies are getting different results. It is a process and not an end by itself.

    This is bad science, not my opinion but if you go with the rigors upheld with the scientific method. This is the method I believe and at that point it becomes opinion.

    Other people may believe differently and that's okay.

    If someone can prove there is a tooth fairy, I will retract the above. :>)

    Thanks. This is an interesting subject.


    Something that just came to mind is that the study looked at the journal reviews which often do not contain this type of information even though it is there. My personal opinion it should not only be in the application for a study but also in the journal review whenever possible.

    Basically, they are studying a non issue. Why didn't they look at the original grant, notes from the ethics committee, etc. that I cited above.

    This does not mean the studies are necessarily flawed when they are printed in journals, but does mean that some journals just don't think the information is that important and perhaps that needs to change. It's a question of editing.

    I may be wrong but I think this is what the study is emphasizing.

    [This Message was Edited on 11/28/2010]
    [This Message was Edited on 11/28/2010]
  6. victoria

    victoria New Member

    these researchers are likely to be very grounded in science or evidence based research... unless you can discredit them individually one by one, it is your opinion from that site(s) that it is from alternative standpoints.

    Given the credentials these people have, it sounds like sour grapes from the pharma industry quite honestly. So be it. This kind of stuff goes on all the time, as we know. And hopefully in the end will become self-evident.

    Given the shenanigans by big pharma AND others, everything does need to be taken with a grain of salt. But bottom line is that - IMHO - there needs to be a standard placebo when it comes to pills or injections. It seems totally reasonable to me. And an analysis of the placebo done by an independent lab hopefully.

    This would work for "both sides" ultimately. I see this is a win-win and can't lose situation, actually, for everyone with any kind of patent or alternative medicine.

  7. victoria

    victoria New Member

    with "finessing" research studies, one has to always be careful. Seems to me a standard accepted placebo in most cases would work fine and end all questions or worries.

    this study or researchers in any case has nothing to do with that natural news site which is what I think you're referring to.
  8. gapsych

    gapsych New Member

    I think having a standard placebo sounds like a great idea and they are most likely already very similar if not identical. I wonder if their are circumstances where you would need a different type of placebo? Maybe shaped differently to mimic a pill? I'll have to look that one up.

    Who's "finessing" research studies?

    The placebo would be way down the list of things to worry about with s study's methodology. It's easy to find what the placebo is. You just have to know where to look.

    [This Message was Edited on 11/30/2010]
  9. victoria

    victoria New Member

    But... at first I didn't even know what you were referring to, as I hadn't even seen it (natural news website) and it really puzzled me. I had to re-google stuff to find it. That's not where I found it, so wasn't coming from that site's viewpoint (be it good or bad, I haven't read anything there at all). But, what you're talking about happens in all areas, pro and con everything.

    Yep, I love the placebo effect too, I have no argument against that effect! -sure wish I could control it to produce it when needed for myself and everyone else. Some studies showed a placebo worked better than the 'real' item being tested... and I remember hearing that no sleep meds rx'd or otc are marketed without blue being used.

  10. gapsych

    gapsych New Member

    LOL about the color blue for sleep medication. I had never heard that. Yes,there are marketing components to Big Pharma just like most products that are sold.

    If BP has been deceptive and it has happened, there needs to be accountability, just like any other business.

    But don't get me started about marketing. :>)


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