Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 The only input I can provide here is I believe that this is why Dr. H and some other top doctors have suggested that we (the RSS Division at MAGIC) may want to consider " joining " with non-RSS kids that are undiagnosed IUGR/SGA - because getting FDA approval is critical. For those who might not understand the criticalness of FDA approval, getting it is kind of like a " mandate " that tells insurance companies that GHT is a mandatory treatment for RSS/SGA kids. Like that insurance companies have to cover insulin for diabetics, or GH for GHdeficient kids or 's Syndrome kids. Because there is so much misdiagnosis on RSS, and other IUGR/SGA kids that aren't technically RSS have the same problems - it doesn't surprise me to learn that the study is not an " RSS " study with GH, but an " IUGR/SGA " study for GH. S. RSS-Support wrote: > I just met with a new endocrinologist yesterday. Much more > informative and willing to talk with me than our last one. > However, he still seemed a bit too unconcerned with the actual > RSS diagnosis we just received a month ago from a geneticist. > Almost dismissive of the importance of an RSS diagnosis, his > perspective is that really with RSS the main issue is IUGR, and > what's important is how to address subsequent lack of growth in > all IUGR children. The other RSS characteristics that present in > varying degrees of severity are just issues that need to be > addressed as they come up. Like orthopedic shoe lifts, speech, > etc. His is a specialist point of view--the endrocrine system. > Although Dr. H is also an endo, it made me appreciate how she > seems to take a much broader view with our kids, and considers > all of the many other factors and characteristics connected to > RSS--like nutrition, behavior, develolpmental issues. She has > really embraced the RSS cause. Fortunate for all of us, but > especially for her direct patients. > > Anyway, to the point here... > Apparently there is a clinical trial that will begin sometime in the > fall involving growth therapy and IUGR kids. There was a > meeting of pediatric endocrinologists, Dr. Harbison was among > them, to give input on protocol for the study. The trial ties in with > FDA approval of GH therapy for non-growth hormone deficient > children. Does anyone know anything about this? Has Dr. > Harbison mentioned it to any of you who see her? The reason > I'm asking is because my daughter belle is a possible > candidate for this trial. Any thoughts from anyone? > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 The only input I can provide here is I believe that this is why Dr. H and some other top doctors have suggested that we (the RSS Division at MAGIC) may want to consider " joining " with non-RSS kids that are undiagnosed IUGR/SGA - because getting FDA approval is critical. For those who might not understand the criticalness of FDA approval, getting it is kind of like a " mandate " that tells insurance companies that GHT is a mandatory treatment for RSS/SGA kids. Like that insurance companies have to cover insulin for diabetics, or GH for GHdeficient kids or 's Syndrome kids. Because there is so much misdiagnosis on RSS, and other IUGR/SGA kids that aren't technically RSS have the same problems - it doesn't surprise me to learn that the study is not an " RSS " study with GH, but an " IUGR/SGA " study for GH. S. RSS-Support wrote: > I just met with a new endocrinologist yesterday. Much more > informative and willing to talk with me than our last one. > However, he still seemed a bit too unconcerned with the actual > RSS diagnosis we just received a month ago from a geneticist. > Almost dismissive of the importance of an RSS diagnosis, his > perspective is that really with RSS the main issue is IUGR, and > what's important is how to address subsequent lack of growth in > all IUGR children. The other RSS characteristics that present in > varying degrees of severity are just issues that need to be > addressed as they come up. Like orthopedic shoe lifts, speech, > etc. His is a specialist point of view--the endrocrine system. > Although Dr. H is also an endo, it made me appreciate how she > seems to take a much broader view with our kids, and considers > all of the many other factors and characteristics connected to > RSS--like nutrition, behavior, develolpmental issues. She has > really embraced the RSS cause. Fortunate for all of us, but > especially for her direct patients. > > Anyway, to the point here... > Apparently there is a clinical trial that will begin sometime in the > fall involving growth therapy and IUGR kids. There was a > meeting of pediatric endocrinologists, Dr. Harbison was among > them, to give input on protocol for the study. The trial ties in with > FDA approval of GH therapy for non-growth hormone deficient > children. Does anyone know anything about this? Has Dr. > Harbison mentioned it to any of you who see her? The reason > I'm asking is because my daughter belle is a possible > candidate for this trial. Any thoughts from anyone? > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 I would imagine that if Dr. H is involved, that she will notify people who are eligible to get into the study, wouldn't you think? At least the patients she sees or consults with. She told me the last time we were there-in April- that GH would be approved for SGA kids by the fall and therefore it would include the RSS kids too. We were concerned that even if it were approved for RSS that if we didn't have a definite diagnosis that we wouldn't be covered, but if it's for SGA, we would fit right in. Liz-Mom of Nate(?RSS)and Sam-32 month old twins and Arianna-13 months Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 I would imagine that if Dr. H is involved, that she will notify people who are eligible to get into the study, wouldn't you think? At least the patients she sees or consults with. She told me the last time we were there-in April- that GH would be approved for SGA kids by the fall and therefore it would include the RSS kids too. We were concerned that even if it were approved for RSS that if we didn't have a definite diagnosis that we wouldn't be covered, but if it's for SGA, we would fit right in. Liz-Mom of Nate(?RSS)and Sam-32 month old twins and Arianna-13 months Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 I would imagine that if Dr. H is involved, that she will notify people who are eligible to get into the study, wouldn't you think? At least the patients she sees or consults with. She told me the last time we were there-in April- that GH would be approved for SGA kids by the fall and therefore it would include the RSS kids too. We were concerned that even if it were approved for RSS that if we didn't have a definite diagnosis that we wouldn't be covered, but if it's for SGA, we would fit right in. Liz-Mom of Nate(?RSS)and Sam-32 month old twins and Arianna-13 months Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 Thank you for responding, . Yes, it does seem absolutely critical that GHT is approved by the FDA. The battle with insurance companies would be easier, or maybe even non-existent. As we consider GHT for belle, her inclusion in this study seems so fortuitous. She'll be at just the right age when the study starts. It means free growth hormone. And then when the trial's over, hopefully FDA approval will have occurred and there will be unquestionable evidence to support GHT treatmant for IUGR/SGA/RSS/etc. kids, and insurance companies will just have to go along. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 Thank you for responding, . Yes, it does seem absolutely critical that GHT is approved by the FDA. The battle with insurance companies would be easier, or maybe even non-existent. As we consider GHT for belle, her inclusion in this study seems so fortuitous. She'll be at just the right age when the study starts. It means free growth hormone. And then when the trial's over, hopefully FDA approval will have occurred and there will be unquestionable evidence to support GHT treatmant for IUGR/SGA/RSS/etc. kids, and insurance companies will just have to go along. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 Thank you for responding, . Yes, it does seem absolutely critical that GHT is approved by the FDA. The battle with insurance companies would be easier, or maybe even non-existent. As we consider GHT for belle, her inclusion in this study seems so fortuitous. She'll be at just the right age when the study starts. It means free growth hormone. And then when the trial's over, hopefully FDA approval will have occurred and there will be unquestionable evidence to support GHT treatmant for IUGR/SGA/RSS/etc. kids, and insurance companies will just have to go along. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 I was notified by the ped. endo. I have been talking with that this trial was going to start in the fall. We know that this is a very important study for our daughters because they were both IUGR/SGA and very possibly RSS. I am in the process of determining if either of my daughters fit the criteria specified in the clinical trial protocols. I was given a hint that the pharm company doing the study is Pharmica. They are looking to get approval from FDA for SGA babies who do not catch up with their peers. Donna --- davywest@... wrote: > I just met with a new endocrinologist yesterday. > Much more > informative and willing to talk with me than our > last one. > However, he still seemed a bit too unconcerned with > the actual > RSS diagnosis we just received a month ago from a > geneticist. > Almost dismissive of the importance of an RSS > diagnosis, his > perspective is that really with RSS the main issue > is IUGR, and > what's important is how to address subsequent lack > of growth in > all IUGR children. The other RSS characteristics > that present in > varying degrees of severity are just issues that > need to be > addressed as they come up. Like orthopedic shoe > lifts, speech, > etc. His is a specialist point of view--the > endrocrine system. > Although Dr. H is also an endo, it made me > appreciate how she > seems to take a much broader view with our kids, and > considers > all of the many other factors and characteristics > connected to > RSS--like nutrition, behavior, develolpmental > issues. She has > really embraced the RSS cause. Fortunate for all of > us, but > especially for her direct patients. > > Anyway, to the point here... > Apparently there is a clinical trial that will begin > sometime in the > fall involving growth therapy and IUGR kids. There > was a > meeting of pediatric endocrinologists, Dr. Harbison > was among > them, to give input on protocol for the study. The > trial ties in with > FDA approval of GH therapy for non-growth hormone > deficient > children. Does anyone know anything about this? Has > Dr. > Harbison mentioned it to any of you who see her? The > reason > I'm asking is because my daughter belle is a > possible > candidate for this trial. Any thoughts from anyone? > > __________________________________________________ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 Hi Everyone- I guess my comment about this would be I think this listserve and Magic should help ensure this study comes to fruition. This could help many of us in monumental ways. Does anyone know what age children the study will most likely include? F. From WV (mom to Dominic - 20 months, 16 lbs, RSS) --- Donna Klamer wrote: > I was notified by the ped. endo. I have been talking > with that this trial was going to start in the fall. > > We know that this is a very important study for our > daughters because they were both IUGR/SGA and very > possibly RSS. I am in the process of determining if > either of my daughters fit the criteria specified in > the clinical trial protocols. > > I was given a hint that the pharm company doing the > study is Pharmica. They are looking to get approval > from FDA for SGA babies who do not catch up with > their > peers. > > Donna > --- davywest@... wrote: > > I just met with a new endocrinologist yesterday. > > Much more > > informative and willing to talk with me than our > > last one. > > However, he still seemed a bit too unconcerned > with > > the actual > > RSS diagnosis we just received a month ago from a > > geneticist. > > Almost dismissive of the importance of an RSS > > diagnosis, his > > perspective is that really with RSS the main issue > > is IUGR, and > > what's important is how to address subsequent lack > > of growth in > > all IUGR children. The other RSS characteristics > > that present in > > varying degrees of severity are just issues that > > need to be > > addressed as they come up. Like orthopedic shoe > > lifts, speech, > > etc. His is a specialist point of view--the > > endrocrine system. > > Although Dr. H is also an endo, it made me > > appreciate how she > > seems to take a much broader view with our kids, > and > > considers > > all of the many other factors and characteristics > > connected to > > RSS--like nutrition, behavior, develolpmental > > issues. She has > > really embraced the RSS cause. Fortunate for all > of > > us, but > > especially for her direct patients. > > > > Anyway, to the point here... > > Apparently there is a clinical trial that will > begin > > sometime in the > > fall involving growth therapy and IUGR kids. There > > was a > > meeting of pediatric endocrinologists, Dr. > Harbison > > was among > > them, to give input on protocol for the study. The > > trial ties in with > > FDA approval of GH therapy for non-growth hormone > > deficient > > children. Does anyone know anything about this? > Has > > Dr. > > Harbison mentioned it to any of you who see her? > The > > reason > > I'm asking is because my daughter belle is a > > possible > > candidate for this trial. Any thoughts from > anyone? > > > > > > > __________________________________________________ > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 18, 2001 Report Share Posted May 18, 2001 Hi Everyone- I guess my comment about this would be I think this listserve and Magic should help ensure this study comes to fruition. This could help many of us in monumental ways. Does anyone know what age children the study will most likely include? F. From WV (mom to Dominic - 20 months, 16 lbs, RSS) --- Donna Klamer wrote: > I was notified by the ped. endo. I have been talking > with that this trial was going to start in the fall. > > We know that this is a very important study for our > daughters because they were both IUGR/SGA and very > possibly RSS. I am in the process of determining if > either of my daughters fit the criteria specified in > the clinical trial protocols. > > I was given a hint that the pharm company doing the > study is Pharmica. They are looking to get approval > from FDA for SGA babies who do not catch up with > their > peers. > > Donna > --- davywest@... wrote: > > I just met with a new endocrinologist yesterday. > > Much more > > informative and willing to talk with me than our > > last one. > > However, he still seemed a bit too unconcerned > with > > the actual > > RSS diagnosis we just received a month ago from a > > geneticist. > > Almost dismissive of the importance of an RSS > > diagnosis, his > > perspective is that really with RSS the main issue > > is IUGR, and > > what's important is how to address subsequent lack > > of growth in > > all IUGR children. The other RSS characteristics > > that present in > > varying degrees of severity are just issues that > > need to be > > addressed as they come up. Like orthopedic shoe > > lifts, speech, > > etc. His is a specialist point of view--the > > endrocrine system. > > Although Dr. H is also an endo, it made me > > appreciate how she > > seems to take a much broader view with our kids, > and > > considers > > all of the many other factors and characteristics > > connected to > > RSS--like nutrition, behavior, develolpmental > > issues. She has > > really embraced the RSS cause. Fortunate for all > of > > us, but > > especially for her direct patients. > > > > Anyway, to the point here... > > Apparently there is a clinical trial that will > begin > > sometime in the > > fall involving growth therapy and IUGR kids. There > > was a > > meeting of pediatric endocrinologists, Dr. > Harbison > > was among > > them, to give input on protocol for the study. The > > trial ties in with > > FDA approval of GH therapy for non-growth hormone > > deficient > > children. Does anyone know anything about this? > Has > > Dr. > > Harbison mentioned it to any of you who see her? > The > > reason > > I'm asking is because my daughter belle is a > > possible > > candidate for this trial. Any thoughts from > anyone? > > > > > > > __________________________________________________ > Quote Link to comment Share on other sites More sharing options...
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