{"id":46376,"date":"2014-05-20T13:29:04","date_gmt":"2014-05-20T17:29:04","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=46376"},"modified":"2014-05-20T13:29:04","modified_gmt":"2014-05-20T17:29:04","slug":"international-clinical-trials-day","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/05\/20\/international-clinical-trials-day\/","title":{"rendered":"International Clinical Trials Day…<\/font><\/strong><\/em>"},"content":{"rendered":"\n

Flash:<\/font><\/strong><\/em> see the press release from the Nordic Cochrane center et al: Backpedalling on EMA’s “proactive publication of clinical-data” draft policy<\/a>…<\/p>\n

\n

Well, today is International Clinical Trials Day<\/font><\/strong><\/em> once again – celebrated from all sides of the controversies.The AllTrials campaign has a new video about Data Transparency:<\/p>\n

<\/object><\/p>\n

… while Clinical Research Organizations have many things planned around the world. I’m spending the afternoon celebrating by going over Clinical Report Forms from an old trial that was misreported. My favorite part of the festivities is a simulated ClinicalTrials.gov<\/font><\/strong> write up for James Lind<\/a>‘s first ever clinical trial on Scurvy in 1747 – Study of the Effects of Multiple Medicines on Scorbutic Sailors Upon The High Seas<\/a>.<\/p>\n

When I think back to 1963 when I started medical school, I never thought about clinical trials. To be honest, I didn’t really know what they were. I learned pharmacology as a discipline much like chemistry where the mechanism of drug action was front and center. In an Internal Medicine Residency, that continued and the use of drugs was based on more apprentice learning and practical experience. Drugs that had a small or variable effects were not prominent on my [or anyone else’s] radar. The focus was on treating the [very] sick, learning how to use toxic chemicals safely. Like saving the life of a patient with septic shock with Kanomycin without ending up with a live, but totally deaf patient. In those days, the class of a drug mattered more that the particular member of the class. I always used Digoxin in heart failure because I knew how to dose it in the various situations where it was called for. A good friend always used Digitoxin because that’s what he learned with. The old doc in the clinic used Digitalis leaf, one step removed from the aboriginal who discovered that chewing certain leaves treated his dropsy<\/em>. We all did fine and never argued about the choice.<\/p>\n

A Psychiatry residency was my first encounter with the endless discussion of small differences among members of a class of drugs. On the in-patient unit, there were a lot of discussions about the differences among the [first generation] neuroleptic drugs and the [tricyclic] antidepressants. I’m a good boy so I learned what I was taught and used the drugs accordingly. But I’ll admit that privately, early on, I didn’t see that much difference. At first, I think I thought that since there were so few drugs available, Psychiatrists needed something to talk about. Later, I came around to seeing that there were side effect differences that were important – though I continued to think that there was a lot more talk than was warranted.<\/p>\n

I met Clinical Trials late in my career, actually when I began to wake up to their corruption – after I retired. I’m afraid my old Internist Chauvinism reared its ugly head when I realized that these differences among drugs was being measured with statistics, because the actual differences were so slight. Antipsychotics were like the drugs of my youth. They worked, but they could be plenty toxic and needed to be treated with much respect. Antidepressants were "light and variable" [and toxic], so I mostly stayed away from them when I practiced. When I started looking at the RCTs [Randomized Clinical Trials], I saw what small differences there really were, and how vulnerable these trials were to the analysts who converted the results into papers in a journal. But that’s old news.<\/p>\n

In my book, a lot of the medicine practiced today is trivial medicine, based on statistically significant but clinically irrelevant<\/em> differences that come from the modern clinical trials blown out of proportion [in a variety of dimensions] because they are anything but financially irrelevant<\/em>. So on International Clinical Trials Day<\/font><\/strong><\/em>, I’m praying for a return to a sane Medicine where a clinical trial is conducted in the full light of day, and is only one parameter in the quest to help the patient that arrives for treatment…<\/div>\n","protected":false},"excerpt":{"rendered":"

Flash: see the press release from the Nordic Cochrane center et al: Backpedalling on EMA’s “proactive publication of clinical-data” draft policy… Well, today is International Clinical Trials Day once again – celebrated from all sides of the controversies.The AllTrials campaign has a new video about Data Transparency: … while Clinical Research Organizations have many things […]<\/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":[2],"tags":[],"class_list":["post-46376","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/46376","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=46376"}],"version-history":[{"count":9,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/46376\/revisions"}],"predecessor-version":[{"id":46385,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/46376\/revisions\/46385"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=46376"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=46376"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=46376"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}