For those doing or thinking of doing intravenous Vitamin C Tx:

coloCan
coloCan Member Posts: 1,944 Member
edited March 2011 in Colorectal Cancer #1
"Peer Reviewed publication supporting Intravenous Vitamin C For Cancer Patients" at

medicalnewstoday.com/articles.220327.php

Funny, I also read recently that FDA was trying to restrict or out right ban this treatment
«1

Comments

  • Buckwirth
    Buckwirth Member Posts: 1,258 Member
    Broken link
    Could you repost it? I'd love to read something on this.
  • pete43lost_at_sea
    pete43lost_at_sea Member Posts: 3,900 Member
    Buckwirth said:

    Broken link
    Could you repost it? I'd love to read something on this.

    this will keep you quiet for a while
    thanks steve,

    read for an hour a now have a headache.

    presume its the same paper.

    interesting .............

    http://www.translational-medicine.com/content/pdf/1479-5876-9-25.pdf

    enjoy,

    pete
  • Buckwirth
    Buckwirth Member Posts: 1,258 Member

    this will keep you quiet for a while
    thanks steve,

    read for an hour a now have a headache.

    presume its the same paper.

    interesting .............

    http://www.translational-medicine.com/content/pdf/1479-5876-9-25.pdf

    enjoy,

    pete

    Yours is on the treatment of Sepsis
    In other words, a rampant infection in patients with advanced disease.

    Interesting, but I don't think this is what Steve was posting.

    Btw, I am a fast reader, with great comprehension. Takes more than this to keep me quiet.

    (;-D)
  • Buckwirth said:

    Yours is on the treatment of Sepsis
    In other words, a rampant infection in patients with advanced disease.

    Interesting, but I don't think this is what Steve was posting.

    Btw, I am a fast reader, with great comprehension. Takes more than this to keep me quiet.

    (;-D)

    This comment has been removed by the Moderator
  • Buckwirth
    Buckwirth Member Posts: 1,258 Member
    unknown said:

    This comment has been removed by the Moderator

    Letter from FDA
    Letter: Response to concerns on injectable Vitamin C and other injectable nutrients
     
    Dear Concerned Consumer,
     
    Thank you for your e-mail expressing concerns about FDA’s December 28, 2010 warning letter to an individual manufacturer (McGuff Pharmaceuticals Inc.) of intravenous (IV) vitamin C along with other prescription drugs.
     
    Unlike oral vitamin C—which could be a dietary supplement— these particular IV solutions are, by law, unapproved drugs. Moreover, the manufacturers neglected to follow current good manufacturing practices, potentially exposing users to unnecessary risks.
     
    Such risks have occurred before. In the E-Ferol tragedy of 1983, premature babies received E-Ferol, an intravenous form of vitamin E. E-Ferol was associated with adverse reactions in 100 premature infants, forty of whom died. It is highly likely that this tragedy would have been prevented if the product had been reviewed and approved by the FDA before its introduction to the market. 
     
    Since FDA announced its Unapproved Drugs Initiative in  June 2006, marketers of unapproved drugs have been on notice that addressing risks from unapproved drugs is a high priority for FDA, and that the Agency plans to systematically and  responsibly ensure that all products on the U.S. prescription drug market become compliant with current FDA approval  requirements for safety and efficacy. 
     
    The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that safe and effective drugs are available to the American public. Drugs that have not been approved by FDA may not be safe and effective, may have been  manufactured under sub-standard conditions, may contain too much or too little (if any) active  ingredients, and may not have necessary labeling information and warnings.
     
    FDA's drug approval process ensures that drugs are safe, effective, of a suitable quality and purity, and are properly labeled. The Agency remains committed to assisting all firms with meeting these standards.
     
    Again, we thank you for your input and hope that we were able to address your concerns.
     
     
    Sincerely
    The U.S. Food and Drug Administration
     
        
    -
  • Buckwirth
    Buckwirth Member Posts: 1,258 Member
    Buckwirth said:

    Yours is on the treatment of Sepsis
    In other words, a rampant infection in patients with advanced disease.

    Interesting, but I don't think this is what Steve was posting.

    Btw, I am a fast reader, with great comprehension. Takes more than this to keep me quiet.

    (;-D)

    May be the same.
    http://www.medicalnewstoday.com/articles/220327.php

    Early paper, not published in the traditional peer reviewed journals, and, if it is the paper Pete posted, not quite what was reported.

    ?

    Right now I have more questions than answers.
  • coloCan
    coloCan Member Posts: 1,944 Member
    Buckwirth said:

    May be the same.
    http://www.medicalnewstoday.com/articles/220327.php

    Early paper, not published in the traditional peer reviewed journals, and, if it is the paper Pete posted, not quite what was reported.

    ?

    Right now I have more questions than answers.

    Mistype on my part.....it should be as Blake posted above:
    medicalnewstoday.com/articles/220327.php with title as I originally posted...I just tried it....Sorry.....back to bed.....
  • pete43lost_at_sea
    pete43lost_at_sea Member Posts: 3,900 Member
    Buckwirth said:

    May be the same.
    http://www.medicalnewstoday.com/articles/220327.php

    Early paper, not published in the traditional peer reviewed journals, and, if it is the paper Pete posted, not quite what was reported.

    ?

    Right now I have more questions than answers.

    a better death anyone ?
    everyone,

    i feel we all should read this important paper i posted above. its not snake oil, or biased from what i could see.

    i care about alternatives, so i was happy to investigate steve news item re cancer and aa.

    this paper offers some hope that those approaching death through cancer may have a better quality of life at the end. i would consider aa for myself after reading this paper if i needed its help at the end.

    we all make mistakes but please what i posted was a very detailed paper of aa and cancer
    not just sepsis. the paper is freely available on the net.

    it takes 4 seconds to goggle this subject and find the links and follow the links to source journal. it takes hours to read and review. which i did.

    http://www.bradenton.com/2011/03/25/3062022/peer-reviewed-publication-supporting.html

    my feathers are being ruffled here, as i have offered to our community the source info thats certainly critical to the quality of life and yes much detailed than the summary news item. weather the news is an accurate summary is another matter. i felt it was based on my study of the paper.

    any sensible discussion needs to based on the science in the paper presented, it should not be dismissed. the science appears valid, our need is real.

    that dismissal would rob many suffering of a potential way to avoid that suffering.

    this paper is an example of the weakness of science. is this science embracing an alternative. until science opens its mind, many of us will die. these papers indicate just how critical and complex our decisions as colorectal patients are. placing all faith in your onc is not for me, these papers backup my personal approach to questioning everything and having an open mind and heart.

    at the heart of science is an open mind and a questioning mind and open and frank discussion. here the medical scientific community may accept this. i fear the oncs will not. the reason is ego, turf wars and complexity. it will be interesting if anyone here reads this paper and offers a comment either way about the papers conclusions.

    did you read the paper from beginning to end in detail ?
    i would seriously appreciate your take on it.

    if the way you dismissed it off was after studying it, then i guess that dissmissal speaks for itself.

    these critical news items need to be actively discussed here. if not here where else?

    i feel we are all united like in the same country and are at war with a common enemy.

    is anyone interested in reading this wonderful hopeful paper.

    first to help terminal cancer patients and second as an example that alternatives can be embraced by science given time.

    my issue is that i don't have time to wait for science. i certainly appreciate that medical science has offered me so far.

    just my thoughts .....

    love to all,
    pete
  • coloCan
    coloCan Member Posts: 1,944 Member

    a better death anyone ?
    everyone,

    i feel we all should read this important paper i posted above. its not snake oil, or biased from what i could see.

    i care about alternatives, so i was happy to investigate steve news item re cancer and aa.

    this paper offers some hope that those approaching death through cancer may have a better quality of life at the end. i would consider aa for myself after reading this paper if i needed its help at the end.

    we all make mistakes but please what i posted was a very detailed paper of aa and cancer
    not just sepsis. the paper is freely available on the net.

    it takes 4 seconds to goggle this subject and find the links and follow the links to source journal. it takes hours to read and review. which i did.

    http://www.bradenton.com/2011/03/25/3062022/peer-reviewed-publication-supporting.html

    my feathers are being ruffled here, as i have offered to our community the source info thats certainly critical to the quality of life and yes much detailed than the summary news item. weather the news is an accurate summary is another matter. i felt it was based on my study of the paper.

    any sensible discussion needs to based on the science in the paper presented, it should not be dismissed. the science appears valid, our need is real.

    that dismissal would rob many suffering of a potential way to avoid that suffering.

    this paper is an example of the weakness of science. is this science embracing an alternative. until science opens its mind, many of us will die. these papers indicate just how critical and complex our decisions as colorectal patients are. placing all faith in your onc is not for me, these papers backup my personal approach to questioning everything and having an open mind and heart.

    at the heart of science is an open mind and a questioning mind and open and frank discussion. here the medical scientific community may accept this. i fear the oncs will not. the reason is ego, turf wars and complexity. it will be interesting if anyone here reads this paper and offers a comment either way about the papers conclusions.

    did you read the paper from beginning to end in detail ?
    i would seriously appreciate your take on it.

    if the way you dismissed it off was after studying it, then i guess that dissmissal speaks for itself.

    these critical news items need to be actively discussed here. if not here where else?

    i feel we are all united like in the same country and are at war with a common enemy.

    is anyone interested in reading this wonderful hopeful paper.

    first to help terminal cancer patients and second as an example that alternatives can be embraced by science given time.

    my issue is that i don't have time to wait for science. i certainly appreciate that medical science has offered me so far.

    just my thoughts .....

    love to all,
    pete

    Rather lengthy so I'll finish it later when I'm more awake-howev
    however, my feelings are if you feel its safe and beneficial or for what ever reason, worth trying -why not? I don't mean just AA I mean anything thats not blantantly harmful to yourself or conducive to more cancer. Whether it increases my odds or not I see no logic in returning to the way I was living before my Dx.....changes must be made
  • pete43lost_at_sea
    pete43lost_at_sea Member Posts: 3,900 Member
    Buckwirth said:

    Letter from FDA
    Letter: Response to concerns on injectable Vitamin C and other injectable nutrients
     
    Dear Concerned Consumer,
     
    Thank you for your e-mail expressing concerns about FDA’s December 28, 2010 warning letter to an individual manufacturer (McGuff Pharmaceuticals Inc.) of intravenous (IV) vitamin C along with other prescription drugs.
     
    Unlike oral vitamin C—which could be a dietary supplement— these particular IV solutions are, by law, unapproved drugs. Moreover, the manufacturers neglected to follow current good manufacturing practices, potentially exposing users to unnecessary risks.
     
    Such risks have occurred before. In the E-Ferol tragedy of 1983, premature babies received E-Ferol, an intravenous form of vitamin E. E-Ferol was associated with adverse reactions in 100 premature infants, forty of whom died. It is highly likely that this tragedy would have been prevented if the product had been reviewed and approved by the FDA before its introduction to the market. 
     
    Since FDA announced its Unapproved Drugs Initiative in  June 2006, marketers of unapproved drugs have been on notice that addressing risks from unapproved drugs is a high priority for FDA, and that the Agency plans to systematically and  responsibly ensure that all products on the U.S. prescription drug market become compliant with current FDA approval  requirements for safety and efficacy. 
     
    The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that safe and effective drugs are available to the American public. Drugs that have not been approved by FDA may not be safe and effective, may have been  manufactured under sub-standard conditions, may contain too much or too little (if any) active  ingredients, and may not have necessary labeling information and warnings.
     
    FDA's drug approval process ensures that drugs are safe, effective, of a suitable quality and purity, and are properly labeled. The Agency remains committed to assisting all firms with meeting these standards.
     
    Again, we thank you for your input and hope that we were able to address your concerns.
     
     
    Sincerely
    The U.S. Food and Drug Administration
     
        
    -

    by making alternatives drugs heaps will suffer and die
    blake,

    thanks for posting the letter. we are all caught between a rock and a hard place.
    the fda approval process must cost heaps of money and take alot of time. i can see the valid reasons of the fda, its logical but heartless and biased to big pharma. but i give more wait to the poor and the needy who could benefit from cheap and simple alternatives like aa in this post. I am so glad i don't live in the usa with these changes occuring.

    when the alternative becomes a drug, its cost has to go up, the needy suffer, all yanks will pay more. you already have a very costly health, it appears that even the most needy will suffer the most. i also doubt given your massive budget deficit if any compensation would be offered to the poor for increased drug costs resulting from the fda plans.

    cheap and simple herbal remedies now being called drugs and fra regulated. if our dieting stuff turns out to be true then most of the foods in your greengrocer will eventually be classed as drugs. then the pharmacies can merge with the green grocer.

    you might then need to go to your gp to get a script for tomorrow lunch salad if it contained a drug say blueberries or beetroot.

    interesting times we live in.

    pete
  • coloCan
    coloCan Member Posts: 1,944 Member
    coloCan said:

    Rather lengthy so I'll finish it later when I'm more awake-howev
    however, my feelings are if you feel its safe and beneficial or for what ever reason, worth trying -why not? I don't mean just AA I mean anything thats not blantantly harmful to yourself or conducive to more cancer. Whether it increases my odds or not I see no logic in returning to the way I was living before my Dx.....changes must be made

    Oh yeah, just got this in an email so i don't know exact link
    outside of the site and title.....

    Title of article dated 3/27
    "Fast Tracking Oncology Drugs Questioned"

    at www.medpagetoday.com I think in the public health and policy section (need to get some breakfast so I'll fully read it later. when I wake I usually scroll thru titles of the multitude of stuff Iget and read later in the day...Not sleeping too much again!!!!!)
  • tanstaafl
    tanstaafl Member Posts: 1,313 Member
    Buckwirth said:

    May be the same.
    http://www.medicalnewstoday.com/articles/220327.php

    Early paper, not published in the traditional peer reviewed journals, and, if it is the paper Pete posted, not quite what was reported.

    ?

    Right now I have more questions than answers.

    FDA's Uncle Sham, the predatorial Monopoly Man
    The FDA has been running around attacking cheap, well known foods and generic drugs that have been available for generations for several years now, allowing them back only under expensive, highly restricted competition (prescriptions, exclusive pre-approved brands), if at all. This includes some of the safest versions of oral vitamins, as well as parenteral nutrients (e.g. C, magnesium, B1, B complex), and dried organ stuffs (pancrelipase, thyroid) that are required foods for life itself for some.

    The US price of IV vitamin C from McGuff has doubled after shutdown of McGuff's manufacturing, and many items formerly available directly, are now through doctors only. Unfortunately this appears to be only round one with IV vitamin C, if prior experience with the earlier FDA food attacks repeats.
  • Buckwirth
    Buckwirth Member Posts: 1,258 Member

    a better death anyone ?
    everyone,

    i feel we all should read this important paper i posted above. its not snake oil, or biased from what i could see.

    i care about alternatives, so i was happy to investigate steve news item re cancer and aa.

    this paper offers some hope that those approaching death through cancer may have a better quality of life at the end. i would consider aa for myself after reading this paper if i needed its help at the end.

    we all make mistakes but please what i posted was a very detailed paper of aa and cancer
    not just sepsis. the paper is freely available on the net.

    it takes 4 seconds to goggle this subject and find the links and follow the links to source journal. it takes hours to read and review. which i did.

    http://www.bradenton.com/2011/03/25/3062022/peer-reviewed-publication-supporting.html

    my feathers are being ruffled here, as i have offered to our community the source info thats certainly critical to the quality of life and yes much detailed than the summary news item. weather the news is an accurate summary is another matter. i felt it was based on my study of the paper.

    any sensible discussion needs to based on the science in the paper presented, it should not be dismissed. the science appears valid, our need is real.

    that dismissal would rob many suffering of a potential way to avoid that suffering.

    this paper is an example of the weakness of science. is this science embracing an alternative. until science opens its mind, many of us will die. these papers indicate just how critical and complex our decisions as colorectal patients are. placing all faith in your onc is not for me, these papers backup my personal approach to questioning everything and having an open mind and heart.

    at the heart of science is an open mind and a questioning mind and open and frank discussion. here the medical scientific community may accept this. i fear the oncs will not. the reason is ego, turf wars and complexity. it will be interesting if anyone here reads this paper and offers a comment either way about the papers conclusions.

    did you read the paper from beginning to end in detail ?
    i would seriously appreciate your take on it.

    if the way you dismissed it off was after studying it, then i guess that dissmissal speaks for itself.

    these critical news items need to be actively discussed here. if not here where else?

    i feel we are all united like in the same country and are at war with a common enemy.

    is anyone interested in reading this wonderful hopeful paper.

    first to help terminal cancer patients and second as an example that alternatives can be embraced by science given time.

    my issue is that i don't have time to wait for science. i certainly appreciate that medical science has offered me so far.

    just my thoughts .....

    love to all,
    pete

    Pete
    I was not being dismissive, just posting a couple of quick questions.

    If, as mentioned in the article, this is the first published article for peer review then it is the first step of a long process. For those of us in the US I would guess one that takes about five to ten years from this point. It was interesting to hear that the sponsoring group applied for a patent.

    It will be interesting to watch this as it moves through the process. In a few years this may be a standard for end of life treatment.

    "my issue is that i don't have time to wait for science. i certainly appreciate that medical science has offered me so far."

    A little drama from Pete! You don't have metastasis yet, and personally I believe you are going to live a long healthy life!

    Put that positive thinking to work for you Pete!
  • pete43lost_at_sea
    pete43lost_at_sea Member Posts: 3,900 Member
    coloCan said:

    Oh yeah, just got this in an email so i don't know exact link
    outside of the site and title.....

    Title of article dated 3/27
    "Fast Tracking Oncology Drugs Questioned"

    at www.medpagetoday.com I think in the public health and policy section (need to get some breakfast so I'll fully read it later. when I wake I usually scroll thru titles of the multitude of stuff Iget and read later in the day...Not sleeping too much again!!!!!)

    sorry your not sleeping
    all the news items I find worthwhile same to glance over and some to study.
    are you on steroids, how come your not sleepig so well ?
    mind you I have had those nights often. Last night for me was a good one, I think iots all the exerise. I even had a midday nap and still got a good rest.

    Hope you sleep better, come for a walk, if you can.

    cheers,

    Pete
  • coloCan
    coloCan Member Posts: 1,944 Member

    sorry your not sleeping
    all the news items I find worthwhile same to glance over and some to study.
    are you on steroids, how come your not sleepig so well ?
    mind you I have had those nights often. Last night for me was a good one, I think iots all the exerise. I even had a midday nap and still got a good rest.

    Hope you sleep better, come for a walk, if you can.

    cheers,

    Pete

    Pete: I'm a thin believer in walking, making it a point to do
    several miles a day if I can and I'm getting back into my exercise, even if its takes all day, five,ten minutes here, ten minutes there, as I can no longer do much more than 15 minutes if I go with what is now for me "heavy".....At times it was taking me three days to do what I use to do in my 40 minute sessions.....I often wonder what the hell is this sixty year old doing lifting weights....But then I always regret not doing more than I did!!!!!
  • pete43lost_at_sea
    pete43lost_at_sea Member Posts: 3,900 Member
    Buckwirth said:

    Pete
    I was not being dismissive, just posting a couple of quick questions.

    If, as mentioned in the article, this is the first published article for peer review then it is the first step of a long process. For those of us in the US I would guess one that takes about five to ten years from this point. It was interesting to hear that the sponsoring group applied for a patent.

    It will be interesting to watch this as it moves through the process. In a few years this may be a standard for end of life treatment.

    "my issue is that i don't have time to wait for science. i certainly appreciate that medical science has offered me so far."

    A little drama from Pete! You don't have metastasis yet, and personally I believe you are going to live a long healthy life!

    Put that positive thinking to work for you Pete!

    this is too important to let slide
    Hi Blake,

    Sorry a little drama, yes. I hope your correct that I don't have metastatasis yet. I don't know have not had a scan for 6 months, onc would not give me until chemo finsihed. I will find out soon, its just common for stageIII to have a met popup and you get a ticket for another roller coaster ride.

    At this stage of my illness I feel I have the greatest opportunity to take effective action with alternative supports. My TCM onc said this as well. When its spread its a whole different ball game, as we all so sadly know.

    Your reply made me feel frustrated, the paper covered so many areas benefical to us all, not just sepsis. I hope to some analysis from others here that verified my hope for end of life care. we have some friends who could benefit right now I feel.

    I did expect you to be quiet for a while, this paper is one heavy duty sucker, I felt its such a complex paper that you need a degree in cell biology and medicine to fully comprehend it, to be honest I tried and failed. I thought it would be right down your scientific ally and some other board members.

    I am still looking for other opinion's.

    I don't agree with your comments and they may stop others from reading the paper.
    March 28, 2011 - 3:18pm
    "Yours is on the treatment of Sepsis" no its about IV ascorbic acid and how it may produce better health outcomes.
    "In other words, a rampant infection in patients with advanced disease." no, its also about quality of life at end of life, its about so much more.
    "Interesting, but I don't think this is what Steve was posting." wrong this is the source of the news.
    "Btw, I am a fast reader, with great comprehension." Almost always and I enjoy and learn alot from you but not on this occaision and this paper is important in itself and what it represents.
    "Takes more than this to keep me quiet. " I know I was wrong LOL, but I this paper would get anyone quiet except I could hear the gears in my brain grinding in protest.

    I call it informed positive thinking now. We share this journey together with so much sorrow and joy. That the life we have.

    Thanks for replying, the reading the paper and your comment "this may be a standard for end of life treatment".

    hugs,

    Pete
  • pete43lost_at_sea
    pete43lost_at_sea Member Posts: 3,900 Member
    tanstaafl said:

    FDA's Uncle Sham, the predatorial Monopoly Man
    The FDA has been running around attacking cheap, well known foods and generic drugs that have been available for generations for several years now, allowing them back only under expensive, highly restricted competition (prescriptions, exclusive pre-approved brands), if at all. This includes some of the safest versions of oral vitamins, as well as parenteral nutrients (e.g. C, magnesium, B1, B complex), and dried organ stuffs (pancrelipase, thyroid) that are required foods for life itself for some.

    The US price of IV vitamin C from McGuff has doubled after shutdown of McGuff's manufacturing, and many items formerly available directly, are now through doctors only. Unfortunately this appears to be only round one with IV vitamin C, if prior experience with the earlier FDA food attacks repeats.

    its just such a sad situation
    On one hand the fda will raise quality and control at a huge price.

    The one major benefit is that the studies generated for fda approval may get the alternative drugs into the medical system faster and more wider spread than the current do it yourself or naturopathic channels.

    I appreciated your examples above.

    cheers,

    Pete
  • coloCan
    coloCan Member Posts: 1,944 Member

    its just such a sad situation
    On one hand the fda will raise quality and control at a huge price.

    The one major benefit is that the studies generated for fda approval may get the alternative drugs into the medical system faster and more wider spread than the current do it yourself or naturopathic channels.

    I appreciated your examples above.

    cheers,

    Pete

    Hey Pete, thanks for a remedy for my sleeplessness....
    I started reading the article on AA and about after the sixth page........

    (warped sense of humor here)

    seriously, tho,I did attempt to read it but I'm not versed in technical stuff of this nature..

    (you ever check out the abstracts at plosone.org

    or try

    7thspace.com and try reading anything off their "medical news")

    i never studied bio and was terrible at that time in science,chemistry,etc.....My major was History; my minor, Sociology......
  • John23
    John23 Member Posts: 2,122 Member

    its just such a sad situation
    On one hand the fda will raise quality and control at a huge price.

    The one major benefit is that the studies generated for fda approval may get the alternative drugs into the medical system faster and more wider spread than the current do it yourself or naturopathic channels.

    I appreciated your examples above.

    cheers,

    Pete

    Pete -

    The FDA isn't all it's said to be:

    FDA Scientists Complain to Obama of "Corruption"
    Thursday 08 January 2009
    by: Ricardo Alonso-Zaldivar | The Associated Press


    Culture Of Corruption At The Fda
    October 2, 2008


    FDA - The Rest of the Story
    March 7, 2007. By Evelyn Pringle


    The FDA's Risk/Benefit Strategy: Your Risk, Drug Companies' Benefit
    2006


    Corruption Doesn’t End at Abramoff
    by Jason at 6:00 am on April 18th, 2006 in Politics, Science


    Whistleblower removed from job for talking to the press
    Jeanne Lenzer 2004


    The list is near endless, and the storys are the same in 2011
    as they were as far back as one can research.

    Where there's money, Pete, there's a greedy hand to grab it.

    Cheers!

    John
  • Buckwirth
    Buckwirth Member Posts: 1,258 Member
    Buckwirth said:

    Letter from FDA
    Letter: Response to concerns on injectable Vitamin C and other injectable nutrients
     
    Dear Concerned Consumer,
     
    Thank you for your e-mail expressing concerns about FDA’s December 28, 2010 warning letter to an individual manufacturer (McGuff Pharmaceuticals Inc.) of intravenous (IV) vitamin C along with other prescription drugs.
     
    Unlike oral vitamin C—which could be a dietary supplement— these particular IV solutions are, by law, unapproved drugs. Moreover, the manufacturers neglected to follow current good manufacturing practices, potentially exposing users to unnecessary risks.
     
    Such risks have occurred before. In the E-Ferol tragedy of 1983, premature babies received E-Ferol, an intravenous form of vitamin E. E-Ferol was associated with adverse reactions in 100 premature infants, forty of whom died. It is highly likely that this tragedy would have been prevented if the product had been reviewed and approved by the FDA before its introduction to the market. 
     
    Since FDA announced its Unapproved Drugs Initiative in  June 2006, marketers of unapproved drugs have been on notice that addressing risks from unapproved drugs is a high priority for FDA, and that the Agency plans to systematically and  responsibly ensure that all products on the U.S. prescription drug market become compliant with current FDA approval  requirements for safety and efficacy. 
     
    The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that safe and effective drugs are available to the American public. Drugs that have not been approved by FDA may not be safe and effective, may have been  manufactured under sub-standard conditions, may contain too much or too little (if any) active  ingredients, and may not have necessary labeling information and warnings.
     
    FDA's drug approval process ensures that drugs are safe, effective, of a suitable quality and purity, and are properly labeled. The Agency remains committed to assisting all firms with meeting these standards.
     
    Again, we thank you for your input and hope that we were able to address your concerns.
     
     
    Sincerely
    The U.S. Food and Drug Administration
     
        
    -

    What may have set FDA on this track
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2898816/

    Very little jargon and an interesting read. I only think that this alerted the FDA because it was published in Pubmed and the timeline would fit.