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The draft I made of this page is a copy of a work by the United States Federal government.
{{
citation}}
: Unknown parameter |month=
ignored (
help)This document is noncopyright because of the special copyright status of work by the U.S. government, and this eligible for copying into this article. Blue Rasberry (talk) 14:37, 2 April 2013 (UTC)
I am taking out the first reference and content based on it. First ref is an article written by the former president of the trade industry for dietary supplements. This is not a neutral reliable source for content on the history of the DSHEA. Here is the bio of the author http://www.crnusa.org/safetypdfs/AnnetteDickinson.pdf
am looking for a reliable, NPOV source on the history of DSHEA and will create content based on it when i find it. Jytdog ( talk) 15:25, 2 April 2013 (UTC)
A search of the NEJM turns up the following book review, which is a good explanation of what some of the critics are saying: http://www.nejm.org/doi/full/10.1056/NEJMbkrev57733 Natural Causes: Death, Lies, and Politics in America's Vitamin and Herbal Supplement Industry N Engl J Med 2007; 356:2659June 21, 2007 DOI: 10.1056/NEJMbkrev57733
The NEJM may be paywalled, but there is an article in the New York Times by the author of the book that gives the same basic argument. http://www.nytimes.com/2007/01/16/health/16diet.html?pagewanted=all
It is an understatement to say that the DSHEA is controversial. This article contains mostly primary sources, which is discouraged by WP:RS and WP:MEDMOS, which require comments from reliable secondary sources, according to WP:NPOV. -- Nbauman ( talk) 18:07, 4 November 2013 (UTC)
Why has all reference to ephedra and the deaths attributed to it been deleted from this article? -- Nbauman ( talk) 17:38, 10 March 2015 (UTC)
User:Bluerasberry, I don't know what you mean when you say that the text does not connect this law with ephedra. Here's one that user:Jytdog deleted:
http://www.nytimes.com/1996/04/19/opinion/natural-doesn-t-mean-safe.html
Natural' Doesn't Mean Safe
By Richard A. Friedman
Published: April 19, 1996
In banning the sale of the herbal stimulant ephedra, which has been linked to 15 deaths nationwide, Nassau County this week not only took on the multimillion-dollar dietary supplement industry but also issued a challenge to Congress.
The question is not whether local governments should protect consumers but why Congress has taken away the Food and Drug Administration's power to regulate potentially toxic products.
Herbal Ecstasy, Cloud 9, Ultimate Xphoria and other products containing ephedra (also called ephedrine and ma huang) have been linked to heart attacks, seizures, severe psychiatric disturbances and strokes, even when used as directed. And ephedra is not the only questionable dietary supplement on the market....
I think that's a clear connection. The New York Times had about 100 stories specificially associating the DSHEA with ephedra deaths, which you can find with the Google search "site:nytimes.com ephedra dietary supplement health and education act" or by searching in the NYT's own search.
At the time of the DSHEA/ephedra controversy, I was writing for medical magazines read by doctors, and I wrote a few stories about complementary and alternative medicine, so I read the medical literature carefully at the time and I remember what I read. Ephedra is literally the classic, textbook case of the inadequacies of the DHEA leading to deaths. The only stronger evidence you could have is randomized, controlled trials with humans. The best way to find it is with a PubMed search:
http://www.nejm.org/doi/full/10.1056/NEJM200006083422309
Editorial
Cancer and Herbs
David A. Kessler, M.D.
N Engl J Med 2000; 342:1742-1743
June 8, 2000
DOI: 10.1056/NEJM200006083422309
Among the other well-documented examples of adverse reactions are the association of germander with acute hepatitis, of comfrey with hepatic veno-occlusive disease, of yohimbe with seizures and renal failure, and of ephedra with death from cardiovascular causes.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2803%2915315-9/fulltext
363(9403):135, 10 January 2004
News
FDA issues alert on ephedra supplements in the USA
Roxanne Nelson
DOI:
http://dx.doi.org/10.1016/S0140-6736(03)15315-9
“Our action is based on diligent and thorough work by the agency as required by the challenging legal standard in the dietary supplement law”, said FDA Commissioner Mark McClellan.
http://jama.jamanetwork.com/article.aspx?articleid=196217
The need for regulation of dietary supplements--lessons from ephedra.
Fontanarosa PB, Rennie D, DeAngelis CD.
JAMA. 2003 Mar 26;289(12):1568-70. Epub 2003 Mar 10.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 established that substances classified as dietary supplements are not "drugs" and substantially changed the role of the FDA in regulating these products.
In this issue of THE JOURNAL, Shekelle and colleagues5 provide an evidence-based summary of the efficacy and safety of ephedra and ephedrine, which are among the most controversial dietary supplements. Based on their review of 52 controlled trials, the authors concluded that supplements containing these agents promote modest short-term weight loss (approximately 0.9 kg/mo more than placebo). However, the evidence was insufficient to support ephedra use for long-term weight loss or for enhancing athletic performance. Analysis of safety data from 50 trials revealed that ephedra and ephedrine are associated with 2- to 3-fold increases in the odds of psychiatric symptoms, autonomic symptoms, upper gastrointestinal symptoms, and heart palpitations. An additional evaluation of adverse event reports revealed 5 deaths, 5 myocardial infarctions, 11 cerebrovascular accidents, 4 seizures, and 8 psychiatric cases as "sentinel events" associated with prior consumption of ephedra or ephedrine.
http://jama.jamanetwork.com/article.aspx?articleid=196247
Review
Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance: A Meta-analysis
Shekelle PG, Hardy ML, Morton SC. et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis.
JAMA. 2003;289(12):1537-1545.
doi:10.1001/jama.289.12.1470.
[Free]
If you can't use PubMed you can do a Google search, which gives for example the following WP:RS:
http://illinoislawreview.org/wp-content/ilr-content/articles/2010/3/Nowak.pdf
DHEA's Failure: Why a Proactive Approach to Dietary Supplement Regulation is Needed to Effectively Protect Consumers
Richard E. Nowak
University of Illinois Law Review 2010:1046
--
Nbauman (
talk)
18:08, 11 March 2015 (UTC)
Threw up an NPOV tag due to some pretty heavy-duty editorializing. Not nearly enough time has passed for me between "woke up" and "logged into my computer" to do much about that section beyond tagging it, though, at least for right now. - Technogeek ( talk) 15:49, 16 October 2015 (UTC)
Either as a separate section or under FDA and DSHEA there is need for an explanation for the FDA's enforcement of DSHEA. This should cover when Good Manufacturing Practices became incorporated into law for dietary supplements, the black-box FDA disclaimer statement, why Warning Letters are issued and how enforced, the line drawn between supplements and foods so that supplement ingredients are not added to foods, etc. For international perspective, could include a paragraph on FOSHU (Japan) and EFSA (European Common Market). There should be a way to craft this so it does not deteriorate into dueling examples of the trespassing by industry and over-reaction by government. David notMD ( talk) 08:42, 31 March 2017 (UTC)
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[1] The Truth vs. Alex Jones: How the DSHEA of 1994 gave conspiracy mongers the means to fund their empires
I don't know how and if this WP:SBM piece by David Gorski can be integrated into the article. -- Hob Gadling ( talk) 06:59, 2 April 2024 (UTC)
![]() | This article is rated Start-class on Wikipedia's
content assessment scale. It is of interest to the following WikiProjects: | ||||||||||||||||||||
|
The draft I made of this page is a copy of a work by the United States Federal government.
{{
citation}}
: Unknown parameter |month=
ignored (
help)This document is noncopyright because of the special copyright status of work by the U.S. government, and this eligible for copying into this article. Blue Rasberry (talk) 14:37, 2 April 2013 (UTC)
I am taking out the first reference and content based on it. First ref is an article written by the former president of the trade industry for dietary supplements. This is not a neutral reliable source for content on the history of the DSHEA. Here is the bio of the author http://www.crnusa.org/safetypdfs/AnnetteDickinson.pdf
am looking for a reliable, NPOV source on the history of DSHEA and will create content based on it when i find it. Jytdog ( talk) 15:25, 2 April 2013 (UTC)
A search of the NEJM turns up the following book review, which is a good explanation of what some of the critics are saying: http://www.nejm.org/doi/full/10.1056/NEJMbkrev57733 Natural Causes: Death, Lies, and Politics in America's Vitamin and Herbal Supplement Industry N Engl J Med 2007; 356:2659June 21, 2007 DOI: 10.1056/NEJMbkrev57733
The NEJM may be paywalled, but there is an article in the New York Times by the author of the book that gives the same basic argument. http://www.nytimes.com/2007/01/16/health/16diet.html?pagewanted=all
It is an understatement to say that the DSHEA is controversial. This article contains mostly primary sources, which is discouraged by WP:RS and WP:MEDMOS, which require comments from reliable secondary sources, according to WP:NPOV. -- Nbauman ( talk) 18:07, 4 November 2013 (UTC)
Why has all reference to ephedra and the deaths attributed to it been deleted from this article? -- Nbauman ( talk) 17:38, 10 March 2015 (UTC)
User:Bluerasberry, I don't know what you mean when you say that the text does not connect this law with ephedra. Here's one that user:Jytdog deleted:
http://www.nytimes.com/1996/04/19/opinion/natural-doesn-t-mean-safe.html
Natural' Doesn't Mean Safe
By Richard A. Friedman
Published: April 19, 1996
In banning the sale of the herbal stimulant ephedra, which has been linked to 15 deaths nationwide, Nassau County this week not only took on the multimillion-dollar dietary supplement industry but also issued a challenge to Congress.
The question is not whether local governments should protect consumers but why Congress has taken away the Food and Drug Administration's power to regulate potentially toxic products.
Herbal Ecstasy, Cloud 9, Ultimate Xphoria and other products containing ephedra (also called ephedrine and ma huang) have been linked to heart attacks, seizures, severe psychiatric disturbances and strokes, even when used as directed. And ephedra is not the only questionable dietary supplement on the market....
I think that's a clear connection. The New York Times had about 100 stories specificially associating the DSHEA with ephedra deaths, which you can find with the Google search "site:nytimes.com ephedra dietary supplement health and education act" or by searching in the NYT's own search.
At the time of the DSHEA/ephedra controversy, I was writing for medical magazines read by doctors, and I wrote a few stories about complementary and alternative medicine, so I read the medical literature carefully at the time and I remember what I read. Ephedra is literally the classic, textbook case of the inadequacies of the DHEA leading to deaths. The only stronger evidence you could have is randomized, controlled trials with humans. The best way to find it is with a PubMed search:
http://www.nejm.org/doi/full/10.1056/NEJM200006083422309
Editorial
Cancer and Herbs
David A. Kessler, M.D.
N Engl J Med 2000; 342:1742-1743
June 8, 2000
DOI: 10.1056/NEJM200006083422309
Among the other well-documented examples of adverse reactions are the association of germander with acute hepatitis, of comfrey with hepatic veno-occlusive disease, of yohimbe with seizures and renal failure, and of ephedra with death from cardiovascular causes.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2803%2915315-9/fulltext
363(9403):135, 10 January 2004
News
FDA issues alert on ephedra supplements in the USA
Roxanne Nelson
DOI:
http://dx.doi.org/10.1016/S0140-6736(03)15315-9
“Our action is based on diligent and thorough work by the agency as required by the challenging legal standard in the dietary supplement law”, said FDA Commissioner Mark McClellan.
http://jama.jamanetwork.com/article.aspx?articleid=196217
The need for regulation of dietary supplements--lessons from ephedra.
Fontanarosa PB, Rennie D, DeAngelis CD.
JAMA. 2003 Mar 26;289(12):1568-70. Epub 2003 Mar 10.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 established that substances classified as dietary supplements are not "drugs" and substantially changed the role of the FDA in regulating these products.
In this issue of THE JOURNAL, Shekelle and colleagues5 provide an evidence-based summary of the efficacy and safety of ephedra and ephedrine, which are among the most controversial dietary supplements. Based on their review of 52 controlled trials, the authors concluded that supplements containing these agents promote modest short-term weight loss (approximately 0.9 kg/mo more than placebo). However, the evidence was insufficient to support ephedra use for long-term weight loss or for enhancing athletic performance. Analysis of safety data from 50 trials revealed that ephedra and ephedrine are associated with 2- to 3-fold increases in the odds of psychiatric symptoms, autonomic symptoms, upper gastrointestinal symptoms, and heart palpitations. An additional evaluation of adverse event reports revealed 5 deaths, 5 myocardial infarctions, 11 cerebrovascular accidents, 4 seizures, and 8 psychiatric cases as "sentinel events" associated with prior consumption of ephedra or ephedrine.
http://jama.jamanetwork.com/article.aspx?articleid=196247
Review
Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance: A Meta-analysis
Shekelle PG, Hardy ML, Morton SC. et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis.
JAMA. 2003;289(12):1537-1545.
doi:10.1001/jama.289.12.1470.
[Free]
If you can't use PubMed you can do a Google search, which gives for example the following WP:RS:
http://illinoislawreview.org/wp-content/ilr-content/articles/2010/3/Nowak.pdf
DHEA's Failure: Why a Proactive Approach to Dietary Supplement Regulation is Needed to Effectively Protect Consumers
Richard E. Nowak
University of Illinois Law Review 2010:1046
--
Nbauman (
talk)
18:08, 11 March 2015 (UTC)
Threw up an NPOV tag due to some pretty heavy-duty editorializing. Not nearly enough time has passed for me between "woke up" and "logged into my computer" to do much about that section beyond tagging it, though, at least for right now. - Technogeek ( talk) 15:49, 16 October 2015 (UTC)
Either as a separate section or under FDA and DSHEA there is need for an explanation for the FDA's enforcement of DSHEA. This should cover when Good Manufacturing Practices became incorporated into law for dietary supplements, the black-box FDA disclaimer statement, why Warning Letters are issued and how enforced, the line drawn between supplements and foods so that supplement ingredients are not added to foods, etc. For international perspective, could include a paragraph on FOSHU (Japan) and EFSA (European Common Market). There should be a way to craft this so it does not deteriorate into dueling examples of the trespassing by industry and over-reaction by government. David notMD ( talk) 08:42, 31 March 2017 (UTC)
Hello fellow Wikipedians,
I have just modified one external link on Dietary Supplement Health and Education Act of 1994. Please take a moment to review my edit. If you have any questions, or need the bot to ignore the links, or the page altogether, please visit this simple FaQ for additional information. I made the following changes:
When you have finished reviewing my changes, you may follow the instructions on the template below to fix any issues with the URLs.
This message was posted before February 2018.
After February 2018, "External links modified" talk page sections are no longer generated or monitored by InternetArchiveBot. No special action is required regarding these talk page notices, other than
regular verification using the archive tool instructions below. Editors
have permission to delete these "External links modified" talk page sections if they want to de-clutter talk pages, but see the
RfC before doing mass systematic removals. This message is updated dynamically through the template {{
source check}}
(last update: 5 June 2024).
Cheers.— InternetArchiveBot ( Report bug) 13:14, 10 September 2017 (UTC)
[1] The Truth vs. Alex Jones: How the DSHEA of 1994 gave conspiracy mongers the means to fund their empires
I don't know how and if this WP:SBM piece by David Gorski can be integrated into the article. -- Hob Gadling ( talk) 06:59, 2 April 2024 (UTC)