Guest guest Posted July 29, 2009 Report Share Posted July 29, 2009 Hi Joe & Joanie, So sorry to hear the decision from Gilead. Did the doctor say if he could intercede with the drug company? Do you know why they excluded you? Have you met with your new doctors at Emory yet? Dorothy-Fayetteville, GA UIP - 7/05 To: "Breathe-Support@yahoogrou" <Breathe-Support >Sent: Wednesday, July 29, 2009 1:50:47 PMSubject: Artemus Test Dr. called me yesterday from Emory and said that Gilead Pharmaceutical Co. Has decided they do not want me for a candidate as of right now so I will be taken off trial list. He did say they felt there were results from my last test that changed there mind. H e did say he still felt I was a good candidate but itn is there rules. Just wanted to let all know. Joe   JOE & JOANIE LAMENSKIE IPF JAN. 2008 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 29, 2009 Report Share Posted July 29, 2009 Dorothy The drug companies have to establish certain hard rules for trials. Now, the path Gilead has taken with Ambrisentan is to find very early stage IPF patients. This is much the same as the rules Pirfenidone used. I know in both trials I wouldn't have been eligible on the day I was diagnosed. I know the argument for doing so is to catch the patient earlier. However, this also presents many problems. It means to be a good trial it typically needs to run longer with follow up even outside the basic trial. This was one of many issues with the Pirfenidone study in Japan, that it was ended too early. A second issue is that at such early stages the chance of misdiagnosis is significant. It's my understanding that Gilead is not requiring one to have had a biopsy. At those very early stages with less than 5% honeycombing and reasonably good lung capacity, the chance of misdiagnosis of one ILD vs. another by CT is extremely large (40% or greater). The third issue is that so many patients at those stages remain relatively stable for a period and often think because they're remaining stable it must be the drug. They then find out they were on the placebo. So, any information or assumptions prior to all the date being collected can be misleading. In contrast, the Sildenafil trial required a DLCO less than 35% and a six minute walk distance of less than 50 meters prior to the study. So, they were looking for a patient further along. Meanwhile, the VA is conducting a study allowing FVC's from 40-90% and DLCO's from 30-90%. I'm sure for evaluation they will have to break it down into sub-segments as they have such a broad range of conditions. I can't see how their overall numbers would be of great benefit as the drug might benefit one of the groups more than the others. > > Hi Joe & Joanie, > So sorry to hear the decision from Gilead. Did the doctor say if he could intercede with the drug company? > Do you know why they excluded you? > > Have you met with your new doctors at Emory yet? > > Dorothy-Fayetteville, GA > UIP - 7/05 > > > > > ________________________________ > From: JOE & JOANIE LAMENSKIE jjskie@... > To: " Breathe-Support@yahoogrou " Breathe-Support > Sent: Wednesday, July 29, 2009 1:50:47 PM > Subject: Artemus Test > >  > Dr. called me yesterday from Emory and said that Gilead Pharmaceutical Co. Has decided they do not want me for a candidate as of right now so I will be taken off trial list. He did say they felt there were results from my last test that changed there mind. H e did say he still felt I was a good candidate but itn is there rules. >     Just wanted to let all know. >                                        Joe >   > JOE & JOANIE LAMENSKIE > IPF JAN. 2008 > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 29, 2009 Report Share Posted July 29, 2009 Hi Dorothy, My Dr. Just said they did not like my test results to go forward with the trial. Dr. has no influence on the candidates. I have not met new Dr. Yet. Joe   JOE & JOANIE LAMENSKIE IPF JAN. 2008 -- Artemus Test Dr. called me yesterday from Emory and said that Gilead Pharmaceutical Co. Has decided they do not want me for a candidate as of right now so I will be taken off trial list. He did say they felt there were results from my last test that changed there mind. H e did say he still felt I was a good candidate but itn is there rules. Just wanted to let all know. Joe   JOE & JOANIE LAMENSKIE IPF JAN. 2008 Quote Link to comment Share on other sites More sharing options...
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