Re: Re: OT: Senate hearing on dietary supplements

[Guest guest]

ditto to that one! Especially the PATIENT part. Actually, saintly would be a better description.

Re: [ ] Re: OT: Senate> > > > hearing on> > > > > dietary> > > > > > > supplements> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > > Hi Karolyn,> > > > > > > > As a question to you how do you feel about > adverse> > > > event> > > > > > reporting> > > > > > > to the> > > > > > > > FDA by supplement manufacturers? To date > there is> > > > > nothing in the> > > > > > > > legislation of DSHEA to compel supplement> > > > manufacturers> > > > > to comply> > > > > > > with this> > > > > > > > request. Without new regulations it (adverse > > event> > > > > reporting)> > > > > > will> > > > > > > remain> > > > > > > > voluntary. Given the number of adverse events> > > > reported> > > > > (and> > > > > > > recognition> > > > > > > > that they are underreported) if these > supplements> > > > were> > > > > to have> > > > > > been> > > > > > > drugs> > > > > > > > they would have been withdrawn and recalled > long> > > > ago.> > > > > Baycol was> > > > > > > recalled> > > > > > > > based on 35 adverse events....many supplements> > > > exceed> > > > > this number> > > > > > > and are> > > > > > > > still available...is that protecting the > public? > > > As> > > > > DSHEA is> > > > > > > written> > > > > > > > reoporting of adverse events alone is not > > > sufficient> > > > > evidence> > > > > > that> > > > > > > the> > > > > > > > supplement is unsafe. The law as currently > > written> > > > > requires the> > > > > > > FDA to> > > > > > > > perform independent testing to determine if a> > > > supplement> > > > > is> > > > > > > unsafe...it> > > > > > > > (theFDA) cannot act on reports of adverse > events> > > > > alone....unlike> > > > > > > drugs.> > > > > > > > Then we have the problem of what does the FDA > > test?> > > > Are> > > > > the> > > > > > > supplements> > > > > > > > standardized and identical across > > > brands...NO...then> > > > > what and how> > > > > > > would you> > > > > > > > reccomend the FDA overcome this > obstacle...there > > is> > > > > nothing in> > > > > > > DSHEA to> > > > > > > > address this issue whatsoever!! How would > you > > > like> > > > to> > > > > see the> > > > > > > withdrawl> > > > > > > > of dangerous supplements proceed? How about > the> > > > issue> > > > > of> > > > > > doctored> > > > > > > > supplements? Current law requires the > > manufacturer> > > > to> > > > > do nothing> > > > > > > as far as> > > > > > > > proving the supplement contains what the label > > says> > > > it> > > > > contains.> > > > > > > The> > > > > > > > current law requires that the FDA test each and> > > > every> > > > > supplement> > > > > > it> > > > > > > wishes> > > > > > > > to regulate...an enormous and expensive > > proposition> > > > > which could> > > > > > > easily be> > > > > > > > avoided by requiring the manufactuer to > provide > > > data> > > > on> > > > > purity> > > > > > and> > > > > > > label> > > > > > > > compliance....the current law has nothing > > requiring> > > > > this. Would> > > > > > not> > > > > > > > modification of the law putting the burden of > > proof> > > > on> > > > > the> > > > > > > manufacturer be> > > > > > > > a much better route...they are, after all, the > > ones> > > > to> > > > > benefit> > > > > > from> > > > > > > the> > > > > > > > sales of the product much like a drug company.> > > > > > > >> > > > > > > > Not requiring the supplement manufacturer to > > > provide> > > > > proof of> > > > > > > quality and> > > > > > > > purity opens the door for all of the fraudulent> > > > products> > > > > which> > > > > > are> > > > > > > ever so> > > > > > > > prevelant on the internet and elsewhere. The > law> > > > > (DSHEA) has> > > > > > > hamstrung the> > > > > > > > FDA and its ability to effectively regulate and> > > > protect> > > > > > consumers.> > > > > > > How> > > > > > > > would you feel if your prescription meds were> > > > > adulterated with> > > > > > > unknown (to> > > > > > > > you) substances and/or drugs? I wouldn't feel > > very> > > > good> > > > > about> > > > > > that> > > > > > > would> > > > > > > > you? We haven't even touched on claims of > > efficacy> > > > just> > > > > on> > > > > > quality> > > > > > > > control. I see manny complaints, and rightly > so, > > > of> > > > > > pharmaceutical> > > > > > > > companies making misleading claims about drug> > > > efficacy> > > > > and safety> > > > > > > yet the> > > > > > > > same folks complaining have no problem with> > > > fraudulent> > > > > claims and> > > > > > > bogus> > > > > > > > products being available to the public...of > course> > > > the> > > > > caveat is> > > > > > > always it> > > > > > > > is up to the consumer to educate themselves! > Why> > > > not> > > > > say the> > > > > > same> > > > > > > about> > > > > > > > presription drugs...anything goes and it is up > to> > > > the> > > > > consumer to> > > > > > > be savvy> > > > > > > > enough to decide what they need and why they > need> > > > > it...as well> > > > > > what> > > > > > > is safe> > > > > > > > and what is not. I am sorry but there are > > numerous> > > > and> > > > > abundant> > > > > > > problems> > > > > > > > with the wording of DSHEA and until it is > modified> > > > the> > > > > fraud will> > > > > > > continue> > > > > > > > unabated.> > > > > > > >> > > > > > > > I am interested in your thoughts on these > matters!> > > > > > > >> > > > > > > > regards,> > > > > > > > BobK> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > >

[Guest guest]

The biggest problem I have with Weil's book is that it is filled with conjecture without any documentation of the "real" outcomes and what triggered those. Makes a good story and I am sure he sells a lot of books because of it....

regards,

BobK

Re: [ ] Re: OT: Senate> > > > hearing on> > > > > dietary> > > > > > > supplements> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > > Hi Karolyn,> > > > > > > > As a question to you how do you feel about > adverse> > > > event> > > > > > reporting> > > > > > > to the> > > > > > > > FDA by supplement manufacturers? To date > there is> > > > > nothing in the> > > > > > > > legislation of DSHEA to compel supplement> > > > manufacturers> > > > > to comply> > > > > > > with this> > > > > > > > request. Without new regulations it (adverse > > event> > > > > reporting)> > > > > > will> > > > > > > remain> > > > > > > > voluntary. Given the number of adverse events> > > > reported> > > > > (and> > > > > > > recognition> > > > > > > > that they are underreported) if these > supplements> > > > were> > > > > to have> > > > > > been> > > > > > > drugs> > > > > > > > they would have been withdrawn and recalled > long> > > > ago.> > > > > Baycol was> > > > > > > recalled> > > > > > > > based on 35 adverse events....many supplements> > > > exceed> > > > > this number> > > > > > > and are> > > > > > > > still available...is that protecting the > public? > > > As> > > > > DSHEA is> > > > > > > written> > > > > > > > reoporting of adverse events alone is not > > > sufficient> > > > > evidence> > > > > > that> > > > > > > the> > > > > > > > supplement is unsafe. The law as currently > > written> > > > > requires the> > > > > > > FDA to> > > > > > > > perform independent testing to determine if a> > > > supplement> > > > > is> > > > > > > unsafe...it> > > > > > > > (theFDA) cannot act on reports of adverse > events> > > > > alone....unlike> > > > > > > drugs.> > > > > > > > Then we have the problem of what does the FDA > > test?> > > > Are> > > > > the> > > > > > > supplements> > > > > > > > standardized and identical across > > > brands...NO...then> > > > > what and how> > > > > > > would you> > > > > > > > reccomend the FDA overcome this > obstacle...there > > is> > > > > nothing in> > > > > > > DSHEA to> > > > > > > > address this issue whatsoever!! How would > you > > > like> > > > to> > > > > see the> > > > > > > withdrawl> > > > > > > > of dangerous supplements proceed? How about > the> > > > issue> > > > > of> > > > > > doctored> > > > > > > > supplements? Current law requires the > > manufacturer> > > > to> > > > > do nothing> > > > > > > as far as> > > > > > > > proving the supplement contains what the label > > says> > > > it> > > > > contains.> > > > > > > The> > > > > > > > current law requires that the FDA test each and> > > > every> > > > > supplement> > > > > > it> > > > > > > wishes> > > > > > > > to regulate...an enormous and expensive > > proposition> > > > > which could> > > > > > > easily be> > > > > > > > avoided by requiring the manufactuer to > provide > > > data> > > > on> > > > > purity> > > > > > and> > > > > > > label> > > > > > > > compliance....the current law has nothing > > requiring> > > > > this. Would> > > > > > not> > > > > > > > modification of the law putting the burden of > > proof> > > > on> > > > > the> > > > > > > manufacturer be> > > > > > > > a much better route...they are, after all, the > > ones> > > > to> > > > > benefit> > > > > > from> > > > > > > the> > > > > > > > sales of the product much like a drug company.> > > > > > > >> > > > > > > > Not requiring the supplement manufacturer to > > > provide> > > > > proof of> > > > > > > quality and> > > > > > > > purity opens the door for all of the fraudulent> > > > products> > > > > which> > > > > > are> > > > > > > ever so> > > > > > > > prevelant on the internet and elsewhere. The > law> > > > > (DSHEA) has> > > > > > > hamstrung the> > > > > > > > FDA and its ability to effectively regulate and> > > > protect> > > > > > consumers.> > > > > > > How> > > > > > > > would you feel if your prescription meds were> > > > > adulterated with> > > > > > > unknown (to> > > > > > > > you) substances and/or drugs? I wouldn't feel > > very> > > > good> > > > > about> > > > > > that> > > > > > > would> > > > > > > > you? We haven't even touched on claims of > > efficacy> > > > just> > > > > on> > > > > > quality> > > > > > > > control. I see manny complaints, and rightly > so, > > > of> > > > > > pharmaceutical> > > > > > > > companies making misleading claims about drug> > > > efficacy> > > > > and safety> > > > > > > yet the> > > > > > > > same folks complaining have no problem with> > > > fraudulent> > > > > claims and> > > > > > > bogus> > > > > > > > products being available to the public...of > course> > > > the> > > > > caveat is> > > > > > > always it> > > > > > > > is up to the consumer to educate themselves! > Why> > > > not> > > > > say the> > > > > > same> > > > > > > about> > > > > > > > presription drugs...anything goes and it is up > to> > > > the> > > > > consumer to> > > > > > > be savvy> > > > > > > > enough to decide what they need and why they > need> > > > > it...as well> > > > > > what> > > > > > > is safe> > > > > > > > and what is not. I am sorry but there are > > numerous> > > > and> > > > > abundant> > > > > > > problems> > > > > > > > with the wording of DSHEA and until it is > modified> > > > the> > > > > fraud will> > > > > > > continue> > > > > > > > unabated.> > > > > > > >> > > > > > > > I am interested in your thoughts on these > matters!> > > > > > > >> > > > > > > > regards,> > > > > > > > BobK> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > >