Exposed: Clinical Trials for Dual Use Research (DUR)

  • Exposed: Clinical Trials for Dual Use Research (DUR)

  • IveyTech

    Member
    May 23, 2021 at 10:21 am

    While clinical trials are usually with human subjects,

    https://www.fda.gov/drugs/development-approval-process-drugs/conducting-clinical-trials

    there are the precursor clinical trials with animal subjects, an ethical concern,

    Animal Data Is Not Reliable for Human Health Research …

    https://www.livescience.com/46147-animal-data-unreliable-for-humans.html

    A 2004 study from the U.S. Food and Drug Administration found that 92 percent of drugs entering clinical trials following animal testing fail to be approved. Of those approved, half are withdrawn …

    There is also an ethical issue
    because the Dual-Use/Gain of Function novel concept will tempt the intent of a researcher. There is money, power, the excitement of having the secrecy and not getting punished, or, conversely, the possibility of being the silent gatekeeper to evil, keeping secrets, preventing criminals from access to knowledge.

    The modern Tree of Knowledge of Good and Evil is located somewhere in the Garden of genetics research.

    Then there’s the government of any given nation, that calls it their duty to be in control of these kinds of things…

    Isn’t it better that we never knew about the potentially evil outcome of a discovery in genetics, never found a gain of function not an awful disfiguration or disease in an animal subject in one or more of our experiments?

    Guilt for torturing animals, whether deliberately as in a pre-teen youth attaching a grasshopper to a 4th of July pop bottle rocket, or inadvertently as a medical student that is part of a research team applies toxins to group A animals and nothing to Control group B, is suppression of compassion for a thrill or a ” higher cause”.

    Clinical trials can be disgustingly perverse when you are not gazing at the goal line.

    Ethics is at a critical crossroads at these early, pre-human subject trials.

    The WHO was concerned about dual-use research in 2009.

    https://www.who.int/bulletin/volumes/87/9/08-051383.pdf?ua=1

    https://www.who.int/bulletin/volumes/87/9/08-051383/en/

    The dual-use dilemma

    Scenarios where the results of well-intentioned scientific research can be used for both good and harmful purposes give rise to what is now widely known as the “dual-use dilemma” and there has been growing debate about the dual-use nature of life science research in particular. Four recent cases involving the publication of dual-use discoveries have been particularly controversial.

    In Australia, researchers inserted the mouse IL-4 gene into the mousepox virus hoping that the altered virus would sterilize mice and thus provide a means for pest control. To their surprise they discovered that they had produced a superstrain of mousepox that killed mice that were naturally resistant to, and mice that had been vaccinated against, ordinary mousepox.<sup>5</sup> This discovery implies that the same technique might enable production of vaccine-resistant smallpox. Because there is no known treatment for smallpox, vaccination is our only defence. This study was published in the Journal of Virology in 2001.

    In a second study, researchers at the State University of New York at Stony Brook artificially synthesized a “live” polio virus from scratch.<sup>6</sup> Following the map of the polio virus RNA genome, which is published on the Internet, they stitched together corresponding strands of DNA, which they purchased via mail-order. The addition of protein resulted in the creation of a virus that paralysed and killed mice. Upon publication of results in Science in 2002, the researchers said they “made the virus to send a warning that terrorists might be able to make biological weapons without obtaining a natural virus”.<sup>7</sup> Similar techniques might enable production of smallpox or Ebola.

    In a third study, published in the Proceedings of the National Academy of Sciences in 2002, researchers used published DNA sequences to engineer a protein – known as SPICE – produced by the smallpox virus.<sup>8</sup> The study revealed the ways in which, and the extent to which, this protein defeats the human immune system. Though the findings may facilitate development of protective medicines, they may also reveal ways to increase the virulence of the closely-related vaccinia virus (which is used in the smallpox vaccine).

    A more recent study, published in Science in 2005, employed techniques of synthetic genomics (similar to those used in the polio study) to “reconstruct” the Spanish Flu virus, which killed between 20 and 100 million people in 1918-19.<sup>9</sup> Though further research on the reconstructed virus may facilitate development of drugs and vaccines that provide protection against a major influenza pandemic, such a virus could also be used for nefarious purposes by malevolent actors.

    Each of these studies aroused substantial controversy. Given their implications for making biological weapons, critics complained that these studies should not have been conducted and/or that they should not have been published. Publication of studies like these, they argued, alerts bioterrorists to new ways of producing biological weapons and provides them with explicit instructions for doing so. At the very least, they argued, the materials and methods sections of the published articles should have been omitted or amended.

    Though they understood the dangers, the scientists and editors involved defended their actions. Among other things, they argued that these publications would play an important role in alerting the scientific community to the importance of developing protection against newly revealed dangers. In the case of the influenza study, it was argued that medical benefits of publication outweighed the risks associated with terrorism, especially given current concerns about pandemic influenza. In response to suggestions that materials and methods descriptions should have been omitted or altered, they argued that inclusion of such information is crucial to scientific method, i.e. for replication and verification.

    There’s also the dual-use research that gets away…DUAL USE RESEARCH OF CONCERN (DURC).

    Governance of dual-use research: an ethical dilemma Michael J Selgelid

    Scenarios where the results of well-intentioned scientific research can be used for both good and harmful purposes give rise to what is now widely known as the “dual-use dilemma”. There has been growing debate about the dual-use nature of life science research with implications for making biological weapons. This paper reviews several controversial publications that have been the focus of debates about dual-use life science research and critically examines relevant policy developments, particularly in the United States of America. Though the dual-use dilemma is inherently ethical in nature, the majority of debates about dual-use research have primarily involved science and security experts rather than ethicists. It is important that there is more ethical input into debates about the governance of dual-use research.

    https://www.nih.gov/sites/default/files/institutes/olpa/20120426-senate-testimony-fauci.pdf

    Dual Use Research of Concern (“DURC”) is a subset of Dual Use Research defined as life sciences research
    that, based on current understanding, can be reasonably anticipated to
    provide knowledge, information, products, or technologies that could be
    directly misapplied to pose a significant threat with broad potential
    consequences to public health and safety, agricultural crops and other
    plants, animals, the environment, materiel, or national security.

    Dual Use Research of Concern

    […]When a PI determines that his or her research does directly involve nonattenuated forms of one or more of these

    listed agents, he or she must also assess whether the research produces, aims to produce, or is reasonably antici-

    pated to produce one or more of the experimental effects listed below, and this assessment should be provided

    to the IRE for its consideration during the review of the research.

    The categories of experimental effects are as follows:

    Enhances the harmful consequences of the agent or toxin;

    Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/

    or agricultural justification;

    Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic

    interventions against that agent or toxin or facilitates their ability to evade detection methodologies;

    Increases the stability, transmissibility, or the ability to disseminate the agent or toxin;

    Alters the host range or tropism of the agent or toxin;

    Enhances the susceptibility of a host population to the agent or toxin; and

    Generates or reconstitutes an eradicated or extinct listed agent or toxin.

    The IRE will consider the PI’s assessment of the applicability of the categories of experimental effects as part of

    its review of the research. Therefore, the PI’s assessment should be documented in a format that can be easily

    supplied to the IRE when needed. An optional reporting template (Appendix 2) is provided to assist PIs in

    notifying the IRE of research that requires institutional review. Section C of this Companion Guide includes more

    detail on the IRE and its institutional review process. The Companion Guide’s Appendix 1, “Definitions to Assist

    in the Consideration of the Categories of Experimental Effects,” may also be useful.

    B. Research Involving a Listed Agent That Also Produces, Aims to Produce, or Can Be

    Reasonably Anticipated to Produce One or More of the Listed Experimental Effects

    There may be instances in which a project is referred to the IRE for review (e.g., the research involves one of the

    agents listed above), but the research is determined by the IRE not to involve any of the seven experimental

    effects. In these instances the research does not require further review. However, if there is a change in this

    research such that it produces, aims to produce, or can be reasonably anticipated to produce one or more of

    the seven listed experimental effects, the PI should then notify the IRE and supply a revised assessment of the

    applicability of the listed categories of experimental effects.

    C. Research That the PI Thinks May Meet the Definition of DURC

    There may also be instances in which an IRE determines that the research (a) directly involves nonattenuated

    forms of one or more of the listed agents, and (b) produces, aims to produce, or is reasonably anticipated to pro-

    duce one or more of the listed experimental effects but the IRE’s final determination is that the research in ques-

    tion does not meet the definition of DURC (and is therefore not subject to additional oversight). Because there

    are no further oversight requirements for such research, the PI should notify the IRE in the future if, for whatever […]

    https://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf

    https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-00726.pdf#page=1

    May we do into others as we would have them do unto ourselves.

  • IveyTech

    Member
    May 23, 2021 at 10:22 am

    Damn autocorrect. Do “unto” not into

  • IveyTech

    Member
    May 23, 2021 at 10:26 am

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