tag:blogger.com,1999:blog-1474751880645498536.post1973265317414236190..comments2023-10-10T10:14:36.340-04:00Comments on Medical Evidence Blog: Cost: The neglected adverse event / side effect in trials of for-profit pharmaceuticals and devicesScott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-1474751880645498536.post-5650229269807408832009-02-09T11:37:00.000-05:002009-02-09T11:37:00.000-05:00Thanks, Marilyn and Dr. Jaymez for your comments!D...Thanks, Marilyn and Dr. Jaymez for your comments!<BR/><BR/>Dr. J, I agree with you about the NAC. I also acknowledge that this company is done like dinner if the FDA doesn't approve the drug this time around, but I wonder if patients with IPF should subsidize future research on this agent with their payments for subscriptions? What will happen to the agent if the company goes bust? Will the company be capable of objectively testing the agent in phase 4 or post-approval studies if it is conditionally approved contingent upon these? If such studies failed to show efficacy, would approval actually ever be withdrawn? If not, of what practical use would such studies be?<BR/><BR/>I have further pondered the issue of cost as a side effect. There are concerns about the rash with this agent and its cost. Suppose it is priced at $6,000 a year or about $20/day. I'm thinking of economic analyses such as "willingness to pay" and I wager that many people would pay $20 per day to accept a rash. Likewise, many people with rash would NOT pay $20 per day to have it treated. So it seems to me that the rash is trivial compared to the cost. Of course, this perspective is diluted markedly if a third-party payer is picking up the cost of the medicine...Scott K. Aberegg, M.D., M.P.H.https://www.blogger.com/profile/17564774546019869201noreply@blogger.comtag:blogger.com,1999:blog-1474751880645498536.post-7006733059021369262009-02-08T09:52:00.000-05:002009-02-08T09:52:00.000-05:00Excellent points. If it were my dad, I would send ...Excellent points. If it were my dad, I would send him to GNC for <A HREF="http://content.nejm.org/cgi/content/short/353/21/2229" REL="nofollow">acetylcysteine </A>.<BR/><BR/>To play devil's advocate and argue on behalf of big pharma (Hey, somebody has to watch out for the big guy.):<BR/>They have a marginally effective drug that may be a basis for development of a future drug that may actually be helpful to patients. If they don't recover some cost from R&D for this one, the future useful drug may never happen.James R Knight, MDhttps://www.blogger.com/profile/00245811936304443870noreply@blogger.comtag:blogger.com,1999:blog-1474751880645498536.post-58077604100047174142009-02-04T18:27:00.000-05:002009-02-04T18:27:00.000-05:00I'm glad you are blogging again.I'm glad you are blogging again.Anonymousnoreply@blogger.com