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Trusting PhRMA?

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3 Responses

  1. Frank says:

    Given the industry practices below (as summarized and quoted from Efthimi Parasidis’s Patients over Politics, p. 976), the Breyer of Sorrell may have been a bit closer to the mark:

    1. Excluding patients with profiles that are judged to be more likely to suffer adverse health events;

    2. clinical trials with short durations so latent effects are less likely to be uncovered;

    3. Limiting the number of participants in clinical trials so as to reduce the likelihood of uncovering all adverse health effects;
    4. Recording only selective side effects;

    5. Excluding patients who removed themselves from clinical trials because they could not tolerate the side effects;

    6. Selectively publishing study results to disproportionally favor positive research findings;

    7. Removing patients who have strong placebo responses;

    8. Testing some patients before the trial officially begins and selecting only those patients who have an initially positive response to the product under evaluation;

    9. Secretly un-blinding interim results midway through a clinical trial and altering the trial design prior to reblinding the study;

    10. Conducting trials in countries where quality and ethical oversight is lacking;

    11. Utilization of ingredients from sources where FDA oversight is minimal or precluded;

    12. Ghost writing scientific articles;

    13. Ghost managing academic research; and

    14. Off-label promotion absent evidence of safety and efficacy

    Based on: Donald W. Light, Bearing the Risks of Prescription Drugs, in THE RISKS OF PRESCRIPTION DRUGS 15-17 (Donald W. Light ed., 2010). See also Ernest R. House, Blowback: Consequences of Evaluation for Evaluation, AMERICAN JOURNAL OF EVALUATION 2008. (“In a study of 370 ‘randomized’ drug trials, studies recommended the experimental drug as the “treatment of choice” in 51% of trials sponsored by for-profit organizations compared to 16% sponsored by nonprofits.”).

  2. Frank says:

    By the way, industry fans (and devotees of empirical legal studies) may want to take a look at these documents, and the podcast:
    “Yong on Science, Replication, and Journalism”
    http://www.econtalk.org/archives/2012/06/yong_on_science.html

  3. Ken Rhodes says:

    I am puzzled by this case in its entirety. It appears to me that SmithKline has allowed Christopher et al to frame the issue based on one part of the FLSA (outside sales persons) and ignored another (exempt professionals).

    Look at this sentence from page 7:

    The overtime compensation requirement, however, does not apply withrespect to all employees. See §213. As relevant here, the statute exempts workers “employed . . . in the capacity ofoutside salesman.” §213(a)(1).1

    Footnote 1 at the bottom of that page says: 1This provision also exempts workers “employed in a bona fide executive, administrative, or professional capacity.” 29 U. S. C. §213(a)(1).

    Why all the discussion of whether the “detailer” are, in fact, sales people. Why not simply stipulate that they are not sales people, as they claim? Then, given that they are highly compensated, and given the function they perform, which is educating and assisting doctors, they are clearly “professional” within the FLSA and DOL meanings of that word. So they are exempt, and thus not entitled to overtime pay.

    What am I missing here?

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