tag:blogger.com,1999:blog-4241416962008169508.post8061802274178231326..comments2024-03-27T21:03:58.972-04:00Comments on Just A Life Sciences Blog...: CRO Touts "Innovative Patient Recruitment Strategies" -- As It Hires Merck-ified Patient RecruiterUnknownnoreply@blogger.comBlogger3125tag:blogger.com,1999:blog-4241416962008169508.post-18240135897264617122010-08-24T07:40:36.256-04:002010-08-24T07:40:36.256-04:00Working in the industry I can only say that the us...Working in the industry I can only say that the usual intentions are to create good drugs that sell good.<br /><br />Companies working on projects of this magnitude have to operate in the financial system of today where 'shareholder value' is #1.<br /> <br />However, should healthcare depend on academia alone the trickle of new drugs would dwindle down ultra fast. Pharma as we know it is about to melt down IMHO. In the cycle of life the industry will have to redesign itself rapidly. <br /><br />Adverse events and their incidence rates can not be evaluated in the proper perspective of all circumstances which might skew the risk-benefit evaluation, narratives help by painting the fuller picture-not necessarily a brighter picture.<br /><br />Narratives do not ever replace the cold safety data that is evaluated by regulators, but they can put the right perspective on matters by describing the relevant circumstances under which the events occurred.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-61050122489224083652010-08-23T23:38:03.725-04:002010-08-23T23:38:03.725-04:00Right.
I am aware of that. I highlighted the ment...Right.<br /><br />I am aware of that. I highlighted the mention fo the patient narratives, because -- as Salmon will no doubt shortly swim by, and inform us -- there is an "<i>art</i>" to the <i>science</i> of writing the adverse event narrative, in a way that is truthful, yet does not unduly harm the chances of the drug candidate putatively under study.<br /><br />That sometimes dark art is exactly the sort of thing that more than occassionally leads to the FDA's approval of some dubious drugs.<br /><br />Do stop back -- I do appreciate varying perspectives, here. I think you presume drug companies motivations are generally benign; I presume that the companies are generally motivated by the promise of a blockbuster -- even if they have to create it through a manufactured "<i>sizzle</i>", rather than just letting the steak's <i>taste</i> sell it, by word of mouth.<br /><br /><br />NamasteCondorhttp://shearlingsplowed.blogspot.comnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-57674139933678165932010-08-23T14:39:53.591-04:002010-08-23T14:39:53.591-04:00think you need to dig some further; patient narrat...think you need to dig some further; patient narratives are written to describe a.o. adverse events that did occur in more detail. Narratives aid the evaluation of trial data by describing events more completely and by putting events into perspective in most if not all trials.Anonymousnoreply@blogger.com