tag:blogger.com,1999:blog-9002218232182793493.post699280568151118815..comments2024-03-19T02:26:00.624-07:00Comments on PharmaLittle: THE NEW PHARMALITTLEUnknownnoreply@blogger.comBlogger9125tag:blogger.com,1999:blog-9002218232182793493.post-40312063582547641872022-10-09T18:50:42.990-07:002022-10-09T18:50:42.990-07:00Greeat reading your blog postGreeat reading your blog postBaltimore Home Buildershttps://www.find-home-builder.com/us/custom-house-maryland/baltimore-home-builders.shtmlnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-26085618841851093382009-10-27T06:44:28.556-07:002009-10-27T06:44:28.556-07:00Yes Justice. This story is important, and sad, an...Yes Justice. This story is important, and sad, and heartbreaking. I’m sure the trial patients had a lot of hope for good outcomes and never guessed they were being lied to and mistreated.<br /><br />After Tuskegee, this type of thing was not supposed to happen again.Diannenoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-81967597735835704632009-10-26T21:20:15.800-07:002009-10-26T21:20:15.800-07:00Thanks for the interesting and important post, Dia...Thanks for the interesting and important post, Dianne.<br /><br />In one of the recent cases in which court documents were released--perhaps just as well that I don't recall which one--there was a memo which specifically noted that Hispanic patients were easy to "manipulate."<br /><br />Ugly, to say the obvious.Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-12673916296442881092009-10-26T15:33:43.943-07:002009-10-26T15:33:43.943-07:00It would be interesting to know if human trials ca...It would be interesting to know if human trials carried out in developing countries are more dangerous than some conducted at prestigious hospitals in the U.S..<br /><br />Columbia University Medical Center (now New York-Presbyterian Hospital) conducted a study from 1999-2001 involving 215 heart patients, some of whom were “Spanish-speaking patients who lived in low-income neighborhoods near the hospital and were admitted through the emergency room…”<br /><br />The study involved four FDA approved blood expanders, two of which contained hetastarch. Although studies as far back as 1981 had shown that high doses of hetastarch could prevent blood from clotting, “…the Columbia trial was to test whether a new formulation of hetastarch, manufactured by Abbott Laboratories, was less likely to trigger serious bleeding at high doses than the other fluids.”<br /><br />The study was “largely funded from a $150,000 unrestricted grant given by the drug company to the hospital and lead researcher.” <br /><br />“In the consent form used in the study, patients were told that they would receive one of four fluids approved by the FDA and routinely ‘used to replace blood and fluid lost during surgery.’" Patients were not advised that one of the fluids (hetastarch) might cause severe bleeding.<br /><br />Approximately half of the patients were given hetastarch. Some received up to three times the recommended amount. <br /><br />Two patients died soon after being given the fluid and more than two dozen others required transfusions.<br /><br />Over the past decade, Columbia has conducted several internal reviews regarding this study. Although reviewers posed serious questions, they always concluded that there was no evidence of wrong-doing. Federal regulators did not agree, however, and in 2003 insisted that Columbia contact trial patients (or their survivors) to inform them that patients had not been advised of the “‘true nature’ of the drug study, the risks they faced or the consequences of their participation.” <br /><br />That hasn’t happened yet. However, in a March 2009 letter to regulators, Columbia conceded some fault, but still concluded that, “…the conditions necessary for a finding of patient harm had not been met."<br /><br />Once again, federal regulators have asked the hospital to contact former patients, or their survivors. They also want a full accounting of what happened to the heart patients. If Columbia fails to comply, they could lose federal funding for research.<br /><br />If they wait a little longer there won’t be anyone to contact.<br /> <br />See: http://www.huffingtonpost.com/2009/10/07/government-orders-columbi_n_312536.htmlDiannenoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-23189532483783631732009-10-25T08:33:18.592-07:002009-10-25T08:33:18.592-07:00A related issue is how many of these trials are be...A related issue is how many of these trials are being done in developing countries which have little or no regulatory requirements, including informed consent. While a variety of other codes are supposed to guide practice, that is not always reality.Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-50970299946861765902009-10-25T08:29:26.570-07:002009-10-25T08:29:26.570-07:00Anon--Do tell!.....
James--Thanks for the interes...Anon--Do tell!.....<br /><br />James--Thanks for the interesting link. My impression is that doc's offices are being more aggressive in promoting clinical trial participation. In my experience, it's often what you hear about on the line while waiting to reach the appointments person. I have been approached several times in the context of being a pt. at an academic medical center.<br /><br />To me, it comes down to how clearly risks and benefits are relayed to the average person. As we know, the likelihood is most instances is that there are no benefits to the trial participant. There might be to others in the future. Or it may be about phase IV marketing of whatever drug. <br /><br />In any event, the average pt., I think, believes they are getting the "latest, greatest" and is inclined to participate. Pleasing their doctor can also be a motive. Almost no pts. are aware of the financial benefit to docs in recruiting them.<br /><br />In one recent instance, I agreed to be part of a study. It was financed entirely by public funds, and, indeed, had the potential to provide information of real and immediate use to me. There was full disclosure about the purpose, risks, benefits. It turned out I did, indeed, get useful, tx-related information.<br /><br />But I agree that this is a significant amount of corrupt practice in this area.Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-25309244504233868852009-10-24T19:03:08.866-07:002009-10-24T19:03:08.866-07:00Contrary to sooth sayer, I do not think it is good...Contrary to sooth sayer, I do not think it is good bye - just stayed tuned... SOme important stuff is about to appear....Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-78509752641834579492009-10-23T07:35:55.332-07:002009-10-23T07:35:55.332-07:00The attached link to an article on cancer research...The attached link to an article on cancer research funding may be of general interest and fit within the parameters set out by JiM.<br /><br />http://www.nytimes.com/2009/10/23/business/23carle.html?pagewanted=1&ref=businessUnknownhttps://www.blogger.com/profile/10063644654105039683noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-34802900393924634332009-10-22T14:50:07.094-07:002009-10-22T14:50:07.094-07:00Well, maybe it _is_ good-bye. Pharmalot is too mu...Well, maybe it _is_ good-bye. Pharmalot is too much fun....soothsayernoreply@blogger.com