tag:blogger.com,1999:blog-1812431336777691886.post7345604454533517040..comments2024-02-29T03:57:00.088-05:00Comments on The Mermaid's Tale: Clinical trials on trialAnne Buchananhttp://www.blogger.com/profile/09212151396672651221noreply@blogger.comBlogger8125tag:blogger.com,1999:blog-1812431336777691886.post-58071981913468479152010-09-20T19:26:15.163-04:002010-09-20T19:26:15.163-04:00Hear, hear.Hear, hear.Anne Buchananhttps://www.blogger.com/profile/09212151396672651221noreply@blogger.comtag:blogger.com,1999:blog-1812431336777691886.post-81277723725576417672010-09-20T19:12:31.490-04:002010-09-20T19:12:31.490-04:00To me it is issues like these that show the dilemm...To me it is issues like these that show the dilemmas facing science. When you mix in the vested interests, difficulty of obtaining cogent data, the complex nature of causation, and the poignant nature of people suffering life-threatening diseases and yearning for relief, you have a science and society dilemma.Ken Weisshttps://www.blogger.com/profile/02049713123559138421noreply@blogger.comtag:blogger.com,1999:blog-1812431336777691886.post-14067601421765460452010-09-20T17:02:17.060-04:002010-09-20T17:02:17.060-04:00I suppose medical science needs statistical result...I suppose medical science needs statistical results from double-blind trials to verify that size matters.James Goetzhttps://www.blogger.com/profile/02412501436355228925noreply@blogger.comtag:blogger.com,1999:blog-1812431336777691886.post-20759454894660359482010-09-20T16:22:15.945-04:002010-09-20T16:22:15.945-04:00If the main tumor is smaller then it might take lo...If the main tumor is smaller then it might take longer to grow to dangerous size, or else perhaps continuing on the drug would keep shrinking it.<br /><br />But the drug may not reach all metastatic sites, so that the main tumor being smaller may not relate to life extension. However, you'd generally expect it to, on the simple principle that size matters!Ken Weisshttps://www.blogger.com/profile/02049713123559138421noreply@blogger.comtag:blogger.com,1999:blog-1812431336777691886.post-7496277544291591102010-09-20T16:00:16.481-04:002010-09-20T16:00:16.481-04:00Thanks, Bethany. Very interesting to see the pape...Thanks, Bethany. Very interesting to see the papers you cite. <br /><br />I wondered the same thing about shrinking tumors and life extension. It's possible that no one is yet willing to go on record saying that shrinking tumors extends life, because no trials have yet formally established that for this drug?Anne Buchananhttps://www.blogger.com/profile/09212151396672651221noreply@blogger.comtag:blogger.com,1999:blog-1812431336777691886.post-60751571228131010332010-09-20T15:54:05.571-04:002010-09-20T15:54:05.571-04:00It's interesting - I've been thinking a lo...It's interesting - I've been thinking a lot about this article, too. And deciding what route I would take to get the PLX4032 if it was me or someone I loved who had that form of melanoma. <br /><br />What wasn't clear to me in the article was how shrinking the tumors didn't automatically lead to a longer life, even if the tumors eventually return. If the early results show that the tumors shrink, and quality of life is enhanced, then how could this not lead to a longer life expectancy, if the tumors are what kill people? This does seem like the kind of study that should be halted because early results show such significant promise.<br /><br />The only question I had was to what degree the reporter had the results correct. I worry about the outcry about a news article if the other studies haven't been published yet. But a search on PubMed showed a recent article from the New England Journal of Medicine about the Phase 1 study that showed, "The estimated median progression-free survival among all patients was more than 7 months" (Flaherty et al 2010). In fact, the mutation targeted is in frequent in other cancers, and thus the drug may be useful for other patients, also (Bollag et al 2010). Once it's released, I wouldn't be surprised to see off-label trials for other cancers with the same mutation.Bethany Ushernoreply@blogger.comtag:blogger.com,1999:blog-1812431336777691886.post-51776290724906136352010-09-20T11:32:03.069-04:002010-09-20T11:32:03.069-04:00I agree that it's a tricky call. Formal proto...I agree that it's a tricky call. Formal protocols and statistics are the only way we know of to reliably evaluate new drugs and therapies. Given the economic pressures and potential rewards to pharmaceutical and instrument companies for new regimes, it's clearly important that these be followed, and with strict oversight.<br /><br />However, it seems a little less tricky in this case, if the NYT story is correct. If it's true that average longevity is well-known following the current treatment for advanced-stage melanoma, then it's not at all clear to me why this had to be confirmed again. Given that the only way to confirm it is for patients to die, and in extreme pain.Anne Buchananhttps://www.blogger.com/profile/09212151396672651221noreply@blogger.comtag:blogger.com,1999:blog-1812431336777691886.post-30147758639297071412010-09-20T10:58:34.145-04:002010-09-20T10:58:34.145-04:00I have mixed feelings about this. I would never pa...I have mixed feelings about this. I would never participate in double-blind trials. And I would never encourage a seriously ill person to participate in double-blind trials. However, I know that most any medicine ever prescribed to me was subject to double blind trials while I typically read the synopsis of those trial results to learn about the medicine that I'm ingesting.<br /><br />I suppose that I would favor using what we already know about the average course of an illness with a placebo or no intervention and compare that with a "sighted" trial. But I understand that those results would lack the credibility of using "human guinea pigs" in double-blind trials. (I'll clarify that I've an overall respect for medical trials despite my mixed feelings.)James Goetzhttps://www.blogger.com/profile/02412501436355228925noreply@blogger.com