{"id":116,"date":"2014-07-30T12:57:17","date_gmt":"2014-07-30T17:57:17","guid":{"rendered":"http:\/\/conservativelefty.wordpress.com\/?p=116"},"modified":"2014-07-30T12:57:17","modified_gmt":"2014-07-30T17:57:17","slug":"obamacares-ludicrous-sunshine-act-tcot","status":"publish","type":"post","link":"http:\/\/www.conservativelefty.com\/wp\/?p=116","title":{"rendered":"Obamacare\u2019s ludicrous Sunshine Act – #tcot"},"content":{"rendered":"

Dear God, I thought I was up on Obamacare, but this one had gotten by me.\"American<\/a><\/p>\n

Obamacare\u2019s ludicrous Sunshine Act<\/a>.<\/p>\n

If you have – or know someone who has – a disease which doctors are still trying to figure out how to treat, forget about any new drugs or diagnostic tools anytime soon. \u00a0This rule is the death of private research in medicine.<\/p>\n

I’ve spent more than 30 years involved in medical research in both the clinical and industry settings. \u00a0The way a new drug or device gets to market usually goes something like this. \u00a0The new product is researched inside the company through the first stages of trials. \u00a0A few industry leading docs are typically involved to provide guidance and even initial patient tests. \u00a0The doctors and often patients are typically compensated for their involvement. \u00a0There’s nothing wrong with this. \u00a0The time and risk connected with a trial have a real value.<\/p>\n

As confidence in gained in safety and efficacy, trials are broadened to larger groups of doctors and patients. \u00a0Again, participation is typically compensated both for doctor and subject. \u00a0For the patient, this compensation could include both monetary payment and extended care and testing of their condition. \u00a0Clinical trials are incredibly time intensive for everyone involved; sponsor, investigator and patients. \u00a0And since that is time that eaten up by the sponsor studying results, that the doctor could use seeing patients and time that the patient would otherwise by using for their job, it is also incredibly expensive.<\/p>\n

A nickel and dime act is going to pile an unsustainable burden on research without bringing any real results.<\/p>\n

There is already a very effective check of which\u00a0most people are not aware. \u00a0You see, most clinical research arrangements include rights to publish their research for the investigators. \u00a0Often, the real reward is the fame and glory for being among the first to publish. \u00a0Ethics requirements demand disclosing all relationships with the sponsors of the trials in those papers and abstracts. \u00a0Falsification of credentials, relationships or results will<\/strong><\/em> be caught and that scientific malfeasance\u00a0will end the researcher’s career<\/em>. \u00a0Again, industry sponsorship of these initial studies if not only acceptable but necessary due to the costs. \u00a0In fact, without this sponsorship, these first studies will not occur.<\/p>\n

However, a few industry-sponsored studies is not enough to gain acceptance for a new drug or device. \u00a0All these studies do is alert the healthcare community of a potential new tool. \u00a0Independent studies follow to corroborate or challenge the initial results. \u00a0These studies may be funded by some combination of academic institutions, industry, professional societies and\/or public or government organizations such as NIH. \u00a0Again, it’s expensive and slow. \u00a0It’s also necessary if you want to avoid patient harm and to gain clinical acceptance.<\/p>\n

Yes. \u00a0There are pens and knick-knacks and coffee cups and even bagels given away during these trials. \u00a0So what?<\/p>\n

Do you go to your bank because they give you a pen with their name one it? \u00a0Anyone who thinks a doctor is going to throw away his or her career for a bagel is a damn fool.<\/strong><\/p>\n

Outside of the research community it is much the same. \u00a0Of course the manufacturers spend money buying lunches or bagels for doctors, nurses and staff. \u00a0These people are giving up their time in order to listen to the vendor and the time available – considering typical patient schedules – is almost always lunch time. \u00a0These presentations are essential for getting information out about new drugs or devices. \u00a0Once again, only the king of all idiots would think that a healthcare professional is going to flush their career down the toilet for a piece of chicken and some pasta or for a light-up pen.<\/p>\n

Of course, there are exceptions to good ethical practice. \u00a0Those are already dealt with by treaty, institutional policies and law. \u00a0People who violate ethics for personal gain will have it catch up with them. \u00a0At worst, their practice and reputation is ruined. \u00a0More likely they end up the subject of lawsuits and\/or criminal investigations. \u00a0This law will do nothing to deter these violations. \u00a0All it will do is impede research and the transfer of knowledge to the detriment of the public interest.<\/p>\n

Then again, perhaps that is part of the goal. \u00a0Where I noted earlier that research will dry up… well that’s only partially true. \u00a0There will still be government funded research. \u00a0Only now it will be disconnected from industry advancement. \u00a0It will be driven by political interests and policies.<\/p>\n

That<\/strong> should scare you. \u00a0Scare. \u00a0You. \u00a0Badly. \u00a0Look at the VA. \u00a0If you want\u00a0that<\/em> as your standard of care, then welcome to Obamacare.<\/p>\n","protected":false},"excerpt":{"rendered":"

Dear God, I thought I was up on Obamacare, but this one had gotten by me. Obamacare\u2019s ludicrous Sunshine Act. If you have – or know someone who has – a disease which doctors are still trying to figure out … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2}},"categories":[3,6],"tags":[22,30,72,94,100,115],"class_list":["post-116","post","type-post","status-publish","format-standard","hentry","category-current-news","category-healthcare","tag-tcot","tag-aca","tag-healthcare","tag-obamacare","tag-politics-2","tag-tea-party"],"jetpack_publicize_connections":[],"aioseo_notices":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p5yCHs-1S","_links":{"self":[{"href":"http:\/\/www.conservativelefty.com\/wp\/index.php?rest_route=\/wp\/v2\/posts\/116","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.conservativelefty.com\/wp\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.conservativelefty.com\/wp\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.conservativelefty.com\/wp\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.conservativelefty.com\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=116"}],"version-history":[{"count":0,"href":"http:\/\/www.conservativelefty.com\/wp\/index.php?rest_route=\/wp\/v2\/posts\/116\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.conservativelefty.com\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=116"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.conservativelefty.com\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=116"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.conservativelefty.com\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=116"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}