FYI- FDA doesn't require disclosure of placebo content!

Discussion in 'Lyme Disease Archives' 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.

    http://www.annals.org/content/153/8/532.abstract
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    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.

    Abstract

    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.