tag:blogger.com,1999:blog-7476621888383604834.post2183102052323947608..comments2024-02-15T03:26:38.897-05:00Comments on Health Care Organizational Ethics: ALS, the Rule of Rescue, and the FDAJim Sabinhttp://www.blogger.com/profile/03087828142188534542noreply@blogger.comBlogger8125tag:blogger.com,1999:blog-7476621888383604834.post-20838062582040924002010-02-26T08:06:39.525-05:002010-02-26T08:06:39.525-05:00Hi Ryan -
Sorry for my own delay in responding - ...Hi Ryan -<br /><br />Sorry for my own delay in responding - I've been distracted from the blog by the medical ethics class I teach that started recently.<br /><br />I wouldn't want to say that scientists are concerned with societal benefits and not with individuals. In seeking to develop new treatments one envisions individuals in the future who might be helped and protection of subjects who might be harmed by the intervention that is being studied.<br /><br />I personally would not support the idea that a caring society should guarantee experimental interventions to patients. As a society we're doing a very poor job ensuring access to simple, proven forms of treatment. Focusing on unproven interventions that may be (a) useless, (b) worse than the available alternatives or (c) actively harmful, would encourage our societal fantasy that we're doing fine with established forms of care and that new is better.<br /><br />You probably noticed that I've used the word "experimental interventions" not "experimental treatments." We don't know whether something under study will end up being a "treatment." Not being eligible to participate in an experiment isn't the same as being denied treatment!<br /><br />Thank you for your interest. And, again, my apologies for the slow response!<br /><br />Best<br /><br />JimJim Sabinhttps://www.blogger.com/profile/03087828142188534542noreply@blogger.comtag:blogger.com,1999:blog-7476621888383604834.post-48987197635374060552010-02-15T20:11:48.376-05:002010-02-15T20:11:48.376-05:00Hi Jim,
Thanks! I enjoyed reading your thoughts ...Hi Jim,<br /><br />Thanks! I enjoyed reading your thoughts as well. I agree in that we need to consider "the societal benefits" at stake when it comes to enrollment in clinical trials -- and, that seems to be the biggest concern among scientists and clinicians.<br /><br />I've been discussing this with a few folks, and we seem to come to the following conclusion: there needs to be a defined point where patients, who would be unable to enroll in experimental studies otherwise(b/c of certain characteristics like a two wk prognosis), would be able to get the same experimental therapy through another protocol.<br /><br />The key is defining this point where the patient would no longer be eligible. This appears to be the logical balance I keep striking when it comes to this access.<br /><br />What do you think?<br /><br />Best,<br />Ryan<br /><br />P.S. - sorry it took so long to respond. feel free to email me at witt.rj@gmail.com to ensure quicker responses. Thanks!Unknownhttps://www.blogger.com/profile/08025965663535024473noreply@blogger.comtag:blogger.com,1999:blog-7476621888383604834.post-20537361748389777462010-01-18T10:14:31.729-05:002010-01-18T10:14:31.729-05:00Hello Ryan -
Thanks for the link to your website....Hello Ryan -<br /><br />Thanks for the link to your website. I see that your passionate focus is on access to "last chance" interventions for people who are at death's door. <br /><br />As I indicated in this post, and <a href="http://healthcareorganizationalethics.blogspot.com/2008/01/access-to-experimental-drugs-supreme.html" rel="nofollow">here</a> in another post about access to experimental therapies, I believe that several values should be considered in making policy. You are focused on possible extension of life as the overriding value. In my view, other values need to be considered as well, including the "common good," as reflected in scientific progress and stewardship of shared resources.<br /><br />But even though I analyse the circumstances differently than you do, I think it's great that you have developed the website and ideas about legislation. And I especially liked the values you expressed, with such a strong emphasis on thoughtful, civil discussion and compassionate care.<br /><br />Best<br /><br />JimJim Sabinhttps://www.blogger.com/profile/03087828142188534542noreply@blogger.comtag:blogger.com,1999:blog-7476621888383604834.post-14718370509853926322010-01-10T21:15:09.479-05:002010-01-10T21:15:09.479-05:00What do you think? - www.innovationandchoice.com
...What do you think? - www.innovationandchoice.com<br /><br />I'd be intrigued to get both your opinions. To me there is no greater urgency than one's fight for life. And this urgency and rudimentary right to self-preservation is not to be defaced for the "common good." For is not making that common good a little less accurate balanced by allowing patients facing death to access these therapies as their last hope at survival?<br /><br />: ) Love to hear your thoughts, RyanAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-7476621888383604834.post-36543919590153589062009-06-17T21:54:00.457-04:002009-06-17T21:54:00.457-04:00Dear Anonymous -
Thank you for your insightful co...Dear Anonymous -<br /><br />Thank you for your insightful comment!<br /><br />Your comment proves an important point - one does not need formal training in ethics to be able to reflect insightfully about complex issues. All human beings are "ethicists" in that we consider questions of competing values and make decisions about how values conflicts can best be handled all the time.<br /><br />I agree that the tension between the rule of rescue and our responsibilities as stewards is ongoing. I think it's a healthy tension. Trying to rescue our comrades is a fundamental good. So is recognizing collective needs and the common good. There aren't any easy answers. It would be a cruel society that simply turned its back on folks in dire situations. But it would also be a foolish and callous society that neglected the common good, as we in the U.S. have done by allowing health care expenditures to rocket out of sight.<br /><br />I don't fault advocacy groups for fighting for their particular concern. I do fault them if they fail to recognize that others have legitimate claims, and that an honorable and just society will have to make choices. Cancer gets as much attention as it does because of its prevalence, but also because the image of cancer invading the body expresses our primitive fear of attack.<br /><br />I would disagree with you in one way - you may not have studied ethics but you are an ethicist!<br /><br />Best<br /><br />JimJim Sabinhttps://www.blogger.com/profile/03087828142188534542noreply@blogger.comtag:blogger.com,1999:blog-7476621888383604834.post-59946184173118586692009-06-17T19:48:39.100-04:002009-06-17T19:48:39.100-04:00This shows the ongoing tension between the rule of...This shows the ongoing tension between the rule of rescue and our responsibility to be stewards of the resources given to us (including the opportunity to conduct clinical trials to find out what works). A related issue that is increasingly bothering me is the power of disease advocacy groups to leverage special treatment for their constituency. <br />This is most notably true of the cancer lobby. It is refreshing to see patients with an equally fatal but less prevalent disease get thoughtful treatment. In fact, you would be better off to be diagnosed with many types of cancer than with ALS. But we all instinctively fear getting cancer. Few people have nightmares about getting ALS. I am not trained as an ethicist, but favoring cancer patients over others with equally serious diseases appears to me to violate the principle of justice.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-7476621888383604834.post-61773770459017071862009-05-19T21:38:44.572-04:002009-05-19T21:38:44.572-04:00Hello Anonymous -
My guess is that Kathy Thompson...Hello Anonymous -<br /><br />My guess is that Kathy Thompson's extraordinarily devoted pursuit of (a) information about experimental treatments for ALS and then (b) strong advocacy for access to Iplex on a compassionate basis, (c) forced the question onto the FDA's agenda. I don't know how she and the other advocates responded to the FDA plan for a randomized trial. My guess about that is advocates were disappointed, perhaps bitterly so, that access to the drug wasn't given in an open ended way. But I think the FDA decision was correct. In my view, it recognizes the urgent situation ALS patients are in, and also the public need for good information on the drug, so that it can be made available if it is effective, but not approved if it has no positive impact or is actually harmful.<br /><br />Best<br /><br />JimJim Sabinhttps://www.blogger.com/profile/03087828142188534542noreply@blogger.comtag:blogger.com,1999:blog-7476621888383604834.post-87116230103780475312009-05-19T13:42:00.000-04:002009-05-19T13:42:00.000-04:00How much did Kathy's incredible devotion and hard ...How much did Kathy's incredible devotion and hard work (and money in the family), influence the FDA, do you think?Anonymousnoreply@blogger.com