Further Ethical Issues in R&D

                Petryna’s article discusses some further ethical issues which exist within the clinical trial phase of drugs’ development, focusing on CROs heavy recruitment of ‘offshore’ subjects for these trials. She shows that there exist many less visible motivations for companies to engage in this practice, besides the mere cost effectiveness commonly accepted as the reason. The vast difference between the world of those involved in these trials and first-world users of the drugs makes the use of these trials both unethical and potentially ineffective for both parties involved. First, the lack of protective legal and government institutions in the countries where offshore trials are performed also leaves subjects vulnerable to unacceptable risks. These offshore trials also may rely upon subjects’ being inappropriately informed or lacking proper healthcare to begin with and making anything offered by drug companies look good. Petryna suggests that the ethical issues for these subjects are ignored or justified based upon an attitude of ethical relativism that is prevalent within the drug industry. 

Further, completing drug trials offshore allows drug companies much greater ability to manipulate the trials in order to achieve certain desired outcomes. Selecting subject groups from specific areas and a focus on those who are ‘treatment naïve’ allows CROs to engineer their studies for optimal results, but Petryna proposes that the information acquired from these subjects may not be appropriately applicable to the ‘treatment-saturated’ first-world subjects who will subsequently use the drug. Her article suggests that higher standards of protection in both of these regards are needed, as well as a broader change in mindset that will revert the system back to patient-, not profit-, centered healthcare. 

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One Response to Further Ethical Issues in R&D

  1. shitangshuroy says:

    Petryna’s analysis/ critique of Pharma’s preference for treatment-naive patients, which many bloggers have commented on, almost consistently in agreement with her, is problematic.

    Three accounts one might give for Pharm’s preference to treatment-naive patients in clinical trials:
    1- Petryna’s Version: Pharma wants to get more statistically significant results
    2- A More Charitable Version: Pharma researchers want to control variables; an important variable is other medications a patient is taking; these variables cannot be controlled in patients which are taking many other medications, but can be controlled with treatment-naive patients
    3- My own version: Both 1 & 2 matter to Pharma, but 2 is the more important reason

    Explaining 2:
    Imagine you have 3 possible sets of populations:
    Set 1: 10,000 people are each taking at least 3 of the following drugs: A, B, C, D, E, F, G, H, I or J
    Set 2: 10,000 people are taking no drugs
    Set 3: 10,000 people taking exactly drugs A, B & C

    If you want to control your “other drugs taken variable” (ODTV), which population set is desirable?
    Set 1: This is representative of Western patients. It is not desirable, as there is a large range of drug regiments any given patient will be on, and it will not be possible to control the ODTV
    Set 2: This is representative of Treatment-Naive Patients. ODTV is reasonably controlled.
    Set 3: ODTV is controlled. However, there is hardly any such population in existence.

    Conclusion: The scientific value of “treatment-naive” patients comes from the fact that the ODTV can be controlled in those populations. It is harder to get similarly useful and consistent data from Western patients, as there are too many variables that one cannot control.

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