3 ms·

What would that consent form look like? "You hereby acknowledge that neither the safety nor efficacy of this....procedure/substance has not been established.

What would that consent form look like? "You hereby acknowledge that neither the safety nor efficacy of this....procedure/substance has not been established. As a result of taking it, literally anything could happen to you and/or your future unborn children." It is already really hard to assess costs and benefits of medical treatments; expecting an ordinary person--dealing with a scary diagnosis--to do so with even less information seems ethically...fraught.

hilbert42 6y ago
Given your quoted text was written by hprotagonist, perhaps you should be addressing him in the first instance rather than me. But then you've also addressed me by asking 'What would that consent form look like?' and that impinges on or is inferred from what I said in reply to hprotagonist. That said, as I've addressed the matter of the wonderful Frances Kelsey and her rigorous approach to the approval of thalidomide, I will address issue of experimental treatments more in general as well as emphasizing same issues with respect to COVID-19 and the ongoing shemozzle that surrounds them. As with the Frances Kelsey/thalidomide matter where the outcome could have been truly disastrous for thousands of unborn kids if Kelsey had not dealt with it as a matter of urgency and that she had done so with rigor and tenacity, a similar situation exists with the various therapies for COVID-19, especially those that are truly experimental and or have not yet demonstrated their medical effectiveness. As you rightly acknowledge when you quote hprotagonist where he says "that neither the safety nor efficacy of this....procedure/substance has not been established. As a result of taking it, literally anything could happen to you and/or your future unborn children." As with just about any vexing matter, I'd assert that the key issues always involve both its magnitude and our perceived urgency to rectify it, thus it's the product of both that will determine how soon and how proactively we will act. As COVID-19 is an out-of-control pandemic that continues to kill people on mass, we are forced to act urgently in order to stem its spread. This call to urgent action alters everything, as it has now forces us to undertake risks that are not normally associated with responsible prudent behaviour. As I mentioned in an earlier post on a different issue, 'desperate times call for desperate measures'—and with desperate measures come very considerable risks. Moreover, with COVID-19, when it comes to weighing up options, the luxury of time is not on our side. And as we've seen everywhere, that has had a considerable and often very detrimental bearing on the ways we've responded to the pandemic not to mention the many decisions we've already made in our attempts to combat it. Such experiences are not new to human beings, as we've faced many similar situations in the past. The problem here however is that we've not learned much from the fact. For instance, we could have drawn valuable knowledge from well-established protocols that have evolved from battlefield triage experience. Here, ambulance personnel, stretcher-bearers and medicos charged with aiding the wounded and dying face terrible extremes that they would never experience in normal life. As an experience, it's as bad as it ever gets, and that's why it's such a worthwhile and relevant example in our ongoing battle with COVID-19. Moreover, tragically, such experience is all too commonplace (thus it's a realistic one): as the history of warfare shows, battlefield triage situations have occurred many hundreds and hundreds—if not thousands—of times in the past, and no doubt, they will continue to occur repeatedly into the future. Not learning from the experience of history is a form collective madness. There is any number of instances where with enormous courage and often without previous experience, rescuers have had to make decisive life-changing decisions in an instant—an instant that encompasses anything and everything that's truly relevant at this point, from triage decisions and concomitant actions thereof, to considerations of one's own safety and the safety of others around one, to one's own ethical behaviour and related humanitarian considerations. Moreover, rescuers not only have to remain self-composed to adequately manage the enormous stress they are under but also they must remain capable of performing their appalling and arduous task without fail, and for that, they call heavily on their training. As a medico in a war triage situation, you will be surrounded with dozens of wounded and dying soldiers and you'll only have split seconds to decide between those who may likely live and thus be rescued and those who you will have to leave out on the battlefield to die—and you'll have to do all that almost automatically as you'll have precious little time to think through your actions. Right, you will find yourself in an ethically fraught situation—one that's as ghastly and truly horrible as it's ever possible to be in. This is where training is crucial—vitally important. You will have been trained to be decisive, objective and as unemotional as it's possible to be in these circumstances in order that you will not only save as many lives as is humanly possible but also later to stop you going mad from PTSD—or at least ameliorating its effect (as you can comfort yourself from knowing that you've performed your duty to the extent of doing everything humanly possible in extremely difficult circumstances). The logistics of introducing new and untested procures into the treatment of COVID-19 are similar to the triage scenario mentioned above. As a professional involved in the decision-making process, one would have to quickly weigh up the potential benefits that any new procedure would likely bring for the patient against possible unforeseen and potentially life threatening risks—and then be honest and as forthright as is possible with the patient by explaining everything. One's decisions will involve risks and sometimes they will be wrong and will result in disastrous consequences, at other times one's decisions will be correct but force majeure—an act of God will intervene and things will go horribly wrong. One may even make correct decisions based on the best advice available but ultimately in the light of further experience, this advice may also prove to be wrong. What one cannot do is to procrastinate or vacillate around making hard decisions, or failing to make them at all, or by watering them down because of nonsensical political reasons. For as we have all too often seen in the recent past, these dubious and hesitant actions have cost many, many lives. As all us know by now, this deadly virus waits for no one. With COVID-19, we are in new territory. Only later after the results of our present decisions and actions have been properly assessed, and after the statisticians have analyzed the data contained within their integrands, that a new best practice will be established for this current COVID-19 scenario. In the interim, we have to act as professionally as is possible by not only taking the best advice available but also by making informed decisions based actual evidence gathered from procedures and things that have already been demonstrated to work. By acting in as truly professional manner as is humanly possible, it is unlikely that your worst dreamt scenario that 'literally anything could happen' will, in fact, actually happen.

hilbert42 6y ago

Given your quoted text was written by hprotagonist, perhaps you should be addressing him in the first instance rather than me. But then you've also addressed me by asking 'What would that consent form look like?' and that impinges on or is inferred from what I said in reply to hprotagonist. That said, as I've addressed the matter of the wonderful Frances Kelsey and her rigorous approach to the approval of thalidomide, I will address issue of experimental treatments more in general as well as emphasizing same issues with respect to COVID-19 and the ongoing shemozzle that surrounds them. As with the Frances Kelsey/thalidomide matter where the outcome could have been truly disastrous for thousands of unborn kids if Kelsey had not dealt with it as a matter of urgency and that she had done so with rigor and tenacity, a similar situation exists with the various therapies for COVID-19, especially those that are truly experimental and or have not yet demonstrated their medical effectiveness. As you rightly acknowledge when you quote hprotagonist where he says "that neither the safety nor efficacy of this....procedure/substance has not been established. As a result of taking it, literally anything could happen to you and/or your future unborn children." As with just about any vexing matter, I'd assert that the key issues always involve both its magnitude and our perceived urgency to rectify it, thus it's the product of both that will determine how soon and how proactively we will act. As COVID-19 is an out-of-control pandemic that continues to kill people on mass, we are forced to act urgently in order to stem its spread. This call to urgent action alters everything, as it has now forces us to undertake risks that are not normally associated with responsible prudent behaviour. As I mentioned in an earlier post on a different issue, 'desperate times call for desperate measures'—and with desperate measures come very considerable risks. Moreover, with COVID-19, when it comes to weighing up options, the luxury of time is not on our side. And as we've seen everywhere, that has had a considerable and often very detrimental bearing on the ways we've responded to the pandemic not to mention the many decisions we've already made in our attempts to combat it. Such experiences are not new to human beings, as we've faced many similar situations in the past. The problem here however is that we've not learned much from the fact. For instance, we could have drawn valuable knowledge from well-established protocols that have evolved from battlefield triage experience. Here, ambulance personnel, stretcher-bearers and medicos charged with aiding the wounded and dying face terrible extremes that they would never experience in normal life. As an experience, it's as bad as it ever gets, and that's why it's such a worthwhile and relevant example in our ongoing battle with COVID-19. Moreover, tragically, such experience is all too commonplace (thus it's a realistic one): as the history of warfare shows, battlefield triage situations have occurred many hundreds and hundreds—if not thousands—of times in the past, and no doubt, they will continue to occur repeatedly into the future. Not learning from the experience of history is a form collective madness. There is any number of instances where with enormous courage and often without previous experience, rescuers have had to make decisive life-changing decisions in an instant—an instant that encompasses anything and everything that's truly relevant at this point, from triage decisions and concomitant actions thereof, to considerations of one's own safety and the safety of others around one, to one's own ethical behaviour and related humanitarian considerations. Moreover, rescuers not only have to remain self-composed to adequately manage the enormous stress they are under but also they must remain capable of performing their appalling and arduous task without fail, and for that, they call heavily on their training. As a medico in a war triage situation, you will be surrounded with dozens of wounded and dying soldiers and you'll only have split seconds to decide between those who may likely live and thus be rescued and those who you will have to leave out on the battlefield to die—and you'll have to do all that almost automatically as you'll have precious little time to think through your actions. Right, you will find yourself in an ethically fraught situation—one that's as ghastly and truly horrible as it's ever possible to be in. This is where training is crucial—vitally important. You will have been trained to be decisive, objective and as unemotional as it's possible to be in these circumstances in order that you will not only save as many lives as is humanly possible but also later to stop you going mad from PTSD—or at least ameliorating its effect (as you can comfort yourself from knowing that you've performed your duty to the extent of doing everything humanly possible in extremely difficult circumstances). The logistics of introducing new and untested procures into the treatment of COVID-19 are similar to the triage scenario mentioned above. As a professional involved in the decision-making process, one would have to quickly weigh up the potential benefits that any new procedure would likely bring for the patient against possible unforeseen and potentially life threatening risks—and then be honest and as forthright as is possible with the patient by explaining everything. One's decisions will involve risks and sometimes they will be wrong and will result in disastrous consequences, at other times one's decisions will be correct but force majeure—an act of God will intervene and things will go horribly wrong. One may even make correct decisions based on the best advice available but ultimately in the light of further experience, this advice may also prove to be wrong. What one cannot do is to procrastinate or vacillate around making hard decisions, or failing to make them at all, or by watering them down because of nonsensical political reasons. For as we have all too often seen in the recent past, these dubious and hesitant actions have cost many, many lives. As all us know by now, this deadly virus waits for no one. With COVID-19, we are in new territory. Only later after the results of our present decisions and actions have been properly assessed, and after the statisticians have analyzed the data contained within their integrands, that a new best practice will be established for this current COVID-19 scenario. In the interim, we have to act as professionally as is possible by not only taking the best advice available but also by making informed decisions based actual evidence gathered from procedures and things that have already been demonstrated to work. By acting in as truly professional manner as is humanly possible, it is unlikely that your worst dreamt scenario that 'literally anything could happen' will, in fact, actually happen.