![\"anime](\"http:\/\/1boringoldman.com\/images\/eyes.gif\" "\\"anime")
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I was kind of surprised how much letting the EMA decisions sit for a day softened my reaction, because my first take was to catalog what was missing from my wish list and privately groan [worry…<\/a>, beyond the blind…<\/a>]. I’m hungry too. And so there was more reflection to be done, and what I came up with may well be idiosyncratic – but that’s not for me to decide. So I’ll just say what I think.<\/p>\n I think what happened with PHARMA and Medicine was at least as much our own fault as PHARMA’s, and I’m including myself in the indictment. I’m not talking about the KOLs or in the case of psychiatry, the ones who jumped into the quick visit\/psychopharmacology-for-symptoms mode because it was lucrative or because "it just was what happened." They deserve whatever blame comes their way. I’m talking about all of us who passed responsibility to others to maintain a standard of scientific integrity and medical ethics. We just didn’t pay attention.<\/p>\n When the great reform of requiring clinical trials came along in 1962, it was seen as a plan that would keep PHARMA honest. It worked for a while and we stopped looking. In psychiatry, when the DSM-III came along, it made an equal place for the biological side of the equation, but opened the door to making that the only side. It was obvious the day it was published, but we didn’t keep on top of it. When the CROs and PHARMA took control of Clinical Trials, we just didn’t pay attention. Many of us didn’t even notice. When the reform of ClinicalTrials.gov was added, PHARMA basically ignored many parts of it, mostly the reporting requirements, and that continued even when they were strengthened. We acted like reforms solved the problem, and ignored the fact that such things need constant monitoring – because the response to reforms from the other side is to evolve creative solutions that undermine their essence. And like what happened to the great reform of state mental hospitals, things festered when they were out of sight and out of mind. <\/p>\n At least in medicine, there have been some watchdogs along the way: David Healy, Bernard Carroll, Bob Rubin, Danny Carlat come quickly to mind in psychiatry, but they are exceptions in a sea of sheep who didn’t pay enough attention to the wolves in drag wandering among the flock. So in my view, we can’t expect the EMA, or NICE, or the FDA to maintain the scientific and ethical standards of medicine or psychiatry. The forces of Hospital Corporations, Managed Care, Governmental Agencies, and the Pharmaceutical and Device Industries are powerful, but they all feed off of medicine. Only medicine can provide the required ongoing oversight, and we just haven’t done it. The "good guys" have been so quiet that many have forgotten that there are still any left. <\/p>\n I was kind of surprised how much letting the EMA decisions sit for a day softened my reaction, because my first take was to catalog what was missing from my wish list and privately groan [worry…, beyond the blind…]. I’m hungry too. And so there was more reflection to be done, and what I came […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-50424","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50424","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=50424"}],"version-history":[{"count":20,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50424\/revisions"}],"predecessor-version":[{"id":50444,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50424\/revisions\/50444"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=50424"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=50424"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=50424"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}So the real solution to these problems is the development of a "watchdog class" inside of medicine. We <\/strike> I <\/strike> Medicine itself dropped the ball, and it has been a disaster. Data Transparency is worth nothing without a lot of eyes looking at the data. To force an analogy from close to home [the South], we had the bloodiest war imaginable over human rights, but it didn’t solve the problem and segregation replaced slavery pretty quickly. The second time around a century later, we’d learned that we needed an ongoing "watchdog class" to keep things on track. I think it’s a fair analogy. The government can only do so much. And that’s true of the regulatory agencies. We have to make it part of medicine’s own task. So I’m more ready to settle than many, because this ball is really in our court. If we have the same information as the regulatory agencies promptly, we should be able to spot what we need to raise issues with. We can no more delegate medical ethics to the EMA than to PHARMA. If we don’t wake up and focus a lot of our own eyes on the integrity of our formulary in an ongoing way, we just aren’t what we claim to be – and that would be a sad state of affairs indeed…<\/div>\n","protected":false},"excerpt":{"rendered":"