{"id":93,"date":"2007-07-18T09:59:13","date_gmt":"2007-07-18T17:59:13","guid":{"rendered":"http:\/\/hodakvalue.com\/blog\/?p=93"},"modified":"2007-07-18T09:59:13","modified_gmt":"2007-07-18T17:59:13","slug":"the-fdas-incentive-to-let-you-die","status":"publish","type":"post","link":"http:\/\/hodakvalue.com\/blog\/the-fdas-incentive-to-let-you-die\/","title":{"rendered":"The FDA’s incentive to let you die"},"content":{"rendered":"


\nHealth policy advocates<\/a> have long contended<\/a> that the FDA’s power to review medical treatments has lead to far more patient deaths<\/a> than lives saved. The theory, supported by a growing body of evidence, is underpinned by a simple set of incentives<\/a>. If an approved drug leads to someone’s illness or death, it may get all over the news<\/a>, and we know how the FDA’s antsy, congressional patrons would react<\/a> to that. If an unapproved drug might have prevented hundreds or thousands of deaths, there would be no media or congressional reaction, because no one would likely know about it. So, the FDA has an institutional bias against drug approval below the very highest margins of safety, a decidedly non-economic standard, one that costs countless lives.<\/p>\n

The exception that proves the rule: AIDS drugs. Here, the FDA’s cumbersome, time-consuming, costly review process was highlighted by a politicized, media-savvy group that acutely felt the lack of progress in the development of treatments.<\/p>\n

Last year, the FDA’s authority was successfully challenged<\/a> in court by the Abigail Alliance<\/a>. This group was founded on behalf of 20-year old Abigail Burroughs (pictured above) who was denied access to a drug in 2001 that had passed Phase I trials. The drug that was later approved by the FDA, after she died. Imagine an FDA bureaucrat patiently trying to explain to you why a particular drug might have only an 9.3 percent chance of working on your dying child, and thus preventing your doctors or the drug manufacturer from selling it or giving it to you until more tests are done on its efficacy.<\/p>\n

So, for the non-politicized masses with rarer diseases or no press agents, how far will the FDA go to protect its authority to tell dying patients what potentially life-saving drugs they may or may not take? After the court’s Abigail Alliance decision last year, the FDA filed a brief challenging the standing of Abigail Alliance members who have all died<\/em> since their original briefs were filed in 2003. That’s right. The FDA, which arguably hastened their deaths, is arguing that their death undermines their standing to challenge the FDA.<\/p>\n

That might be a statement about the size of their agency’s balls, or about the agency’s desperate grasp at a remedy for a judgment that threatens their regulatory body.<\/p>\n","protected":false},"excerpt":{"rendered":"

Health policy advocates have long contended that the FDA’s power to review medical treatments has lead to far more patient deaths than lives saved. The theory, supported by a growing body of evidence, is underpinned by a simple set of incentives. If an approved drug leads to someone’s illness or death, it may get all […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[],"class_list":["post-93","post","type-post","status-publish","format-standard","hentry","category-invisible-trade-offs"],"_links":{"self":[{"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/posts\/93","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/comments?post=93"}],"version-history":[{"count":0,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/posts\/93\/revisions"}],"wp:attachment":[{"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/media?parent=93"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/categories?post=93"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/tags?post=93"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}