Talk:Ephedra (medicine)/Archive 1

Archive 1

Redirects

Material from Ephedraceae moved here when making it a redirect

• Ephedra alata
• Ephedra altissima
• Ephedra americana
  • syn. Ephedra andina
• Ephedra distachya
  • syns Ephedra gerardiana, Ephedra vulgaris, Ephedra helvetica
• Ephedra equisetina
• Ephedra fragilis
  • syn. Ephedra altissima
• Ephedra gracilis
• Ephedra major
  • syns Ephedra nebrodensis, Ephedra scoparia, Ephedra procera
• Ephedra nevadensis
• Ephedra pachyclada
• Ephedra sinica Stapf
  • syns Ephedra flava, Ephedra ma-huang
• Ephedra triandra
• Ephedra tweediana

General NPOV

This article reads like an ad for traditional medicine. I suggest an extensive rewrite.

Dangers of ephedra

Are all species of the genus ephedra dangerous or are there some that are safe? --Evan Robidoux 21:32, 8 May 2006 (UTC)

"Ephedra is dangerous" is at least partially POV. More accurately, the general consensus is that ephedra may be dangerous to certain people in certain situations. Not all ephedra species contain active alkaloids (ephedrine/pseudoephedrine), I'm not familiar with them all but I'd imagine many of them are completely inert. --Bk0 (Talk) 00:23, 9 May 2006 (UTC)

In my opinion, low dose ephedra or ephedra/caffeine has certainly not been considered to be dangerous and that's exactly what the current court case in the legal system is all about. Hopefully, this comment is not too "polemic" for some of you who have contributed to this section and have 180 degree different (polemic) opinions. Please see the legal section below.

Also, with all due respect, this area needs some PhD input from the Nutrition versus Medical fields. There is extreme diversity of opinion that is not only reflected in scientific literature but in Congress and the Media. Unfortunately, for those who are obese, only one side (so far) is being heard. Thanks!Bodybydesign 05:07, 4 January 2007 (UTC)

Ephedra legal again?

In recent weeks I've been getting a lot of spam claiming that "ephedra is legal again". Is there something to it? Something worth mentioning in the article? Itub 14:04, 10 May 2006 (UTC)

I added a lot of detail to the article describing the legal staus. -- Beland 19:05, 3 June 2006 (UTC)

It is legal again. There are many websites out there selling it.

I note that whilst the article discusses the legality of ephedra in the US, it does not mention its legality in other countries. For one it has always been legal in the UK, and has been attainable through websites such as www.thatswholesale.com

As I understand, the Ephedra ban by the FDA is being challenged in court by Nutraceutical Corp. and the current legal status (according to Emord & Associates press release http://www.emord.com/pressrelease/101906.htm.) is that it is not currently legal in the U.S. in capsule form but appears to be legal in tea bags or food (see Jonathan Emord website).

I am new to Wikipedia (don't know how to approach getting my viewpoint heard without being deleted or erased) but there appears to be (significant) major differences of opinion in the acedemic world. For example, the International Journal of Obesity publishes the works of Nutrition scholars who appear to have a completely different point of view from the FDA and Medical Doctors. I personally give a lot of credence to the Nutrition PhD's like the ones at the University of California and the recent study published in the International Journal of Obesity (http://www.nature.com/ijo/journal/v30/n10/abs/0803283a.html) which is a scholarly international publication. This scientific study shows a low dose ephedra/caffeine combination not only to be safeBodybydesign 16:53, 4 January 2007 (UTC) but effective.

In the United States the Medical profession and drug industry appear to be at great odds with the Nutrition Industry and scholars. The Nutrition Industry (like the University of California)believe that low dose ephedra/caffeine is safe--in low dose. While they may feel the herb combination should have a caution label they certainly do not feel that someone would die from using the product as directed (even with high blood pressure issues). At least from their literature, this appears to be the case. Also, I understand the the approach to health is completely different between these two industries or disciplines. Nutritionist try to improve health before problems like obesity arise. Obesity certainly is linked to a lot of deaths. Hopefully I can link to the Emord site and the University of California site because I have discussed this with Emord and a few of the professors without my links being deleted by Wikipedia.

In the Wikipeida literature on ephedra I believe a statement is made which links ephedra to 155 deaths. I can't figure out where that information comes from (allegations or proven fact)? I thought that accuracy was what Wikipeida was all about?

The FDA studies are not "independent" studies. I know of no industry (for example, accounting) where being "independent" is not considered to be a significant conflict. Therefore, I can't understand why the FDA does not rely on independent science.

The other thing that I can't understand about the FDA is that they did this without the input of businesses selling ephedra or people using ephedra. For example, I used a low dose ephedra/caffeine combination for many years with great results (weight and health). My Medical Doctor advised me to stay on the products but the company had to discontinue selling the product because of the FDA.

I listened to the Ephedra Hearings which I felt were completely biased and the Chairman of the Committee is now the President of PHRMA (Billy Tauzin). I can't understand why his lack of independence in this matter is not brought out or at least questioned.

In this "safety" discussion the conflict between the "experts" in the Nutrition Industry and the other industries (Medical and FDA)is ignored. There is a 180 degree difference of opinion but this is never brought out in the Media or Congress. This leads a lot of people to conclude that the issue is about money and power. There are several over-the-counter drugs which have similar issues. However, they are not challenged by the FDA. Why?

So, what part of my comments get considered and what gets to stay. This article doesn't even begin to discuss the issues about this subject in my opinion. How does one go about getting some bias out of this write-up?? Thanks!Bodybydesign 03:56, 4 January 2007 (UTC)

I definitely see your point. The trick is to write about controversy in a neutral fashion, especially when you have a strong point of view. I think a good approach might be a second-level heading "Controversy over safety" with two third-level headings, "Evidence for the safety of Ephedra" and "Evidence against the safety of Ephedra". Much of the existing information fits in the latter, and you clearly know of information for the former. By presenting the evidence for both points of view, the article achieves NPOV. I'd offer to help, but I know about the plant, not the drug (although some years ago I looked at a lot of adverse reaction reports as part of a research project, and it's clear to me that it's possible to really mess yourself up with ephedrine, depending on dose and pre-existing health issues).--Curtis Clark 05:53, 4 January 2007 (UTC)

Curtis: The issues surrounding ephedra go way beyond the safety of ephedra (see comments by Nutraceutical Corp.) Recently, I had a PhD tell me (Dean of Pharmacy of a major University) that he wouldn't even think twice about putting (low dose)ephedra in a product. Most everything (including water) is toxic if you get too much of it and through his research he felt low dose ephedra to be completely safe and effective. Also, as I said before, the use of these products over many years, prior to the FDA ban, bear this out. People can't seem to get this to sink in to the media and people who have not used ephedra--thousands of Americans have used these products (that's the biggest study you can imagine). Also, thousands of people know that they got great results on the products no matter about those people who have never tried the products and feel they have some knowledge about the products. How can you know about something you never used personally? In fact, you are actually listening to the minority concerning your "evidence against the safety of ephedra." Obviously, we have to be talking about a non-toxic dose. Over and over through the Congressional hearings we heard experts speak about safety and they have never even used the products--why weren't people with first hand experience brought to the hearing. Also, we saw a lot of people at the hearing supporting ephedra who have very questionable backgrounds. That certainly is not the case with the products (company) I used. I would compare their Sci/Med board to any group in the world. I could bring you hundreds of people who had serious weight loss results without looking like a prune afterwards. I personally lost (35) pounds in 2-1/2 months and then went to my Medical Doctor who was competely shocked about my health results. According to FDA and FTC rules I can't even make those "result" statements.

The same scientist was very negative about fighting the FDA on ephedra--why? Because he was afraid that Congress would use this to go after the current laws on the books and further damage the Nutrition Industry. This industry is fragmented and not well represented in Congress (K Street). He, and many others, feel that the FDA saw ephedra as a an opportunity to damage the industry.

Why would the FDA and FTC want to do that? Well, as I said perviously, this subject goes way beyond ephedra. It goes to the heart of government power and authority. I know that a lot of people would think that is hyperbole and not factual. The fact is, it goes to the very structure of the Health Industry in America. Ephedra is just the lightning rod. Until you begin to understand some of these dynamics you will continue to feel that you have the majority opinion. Obviously, you do have the majority opinion of those who have never used the products (the media made sure of that)! Thanks!68.97.242.205 15:54, 4 January 2007 (UTC)

Curtis: One additional comment, the ephedra/caffeine that I used were taken from the active part of the herb (not synthetic). That too is a big part of the contoversy. According to Jonathan Emord, Attorney, a big part of the intial court case defense by the FDA was supported by a paid experiment that Emord calls "Junk Science." He also stated that this about that evidence: "The precedent established is devastating." 68.97.242.205 17:18, 4 January 2007 (UTC)

Mormon Tea

Why this called Mormon tea? Was it drank by Mormon pioneers or is it because Latter-day Saints don't drink Camellia sinensis?—The preceding unsigned comment was added by 198.236.216.252 (talk • contribs) .

My understanding is that it was the pioneers, but check out http://www.gcrg.org/bqr/7-3/mormon-tea.htm .--Curtis Clark 20:05, 23 June 2006 (UTC)

safety section expansion

I would suggest that the safety be expanded to include other views on Ephedra's safety other then just the FDA and manufacturers and advocates for Ephedra products. Hasn't other impartial scientists supported either the view that it's dangerous at any Level (the FDA view) or that's it's safe in low doses (the manufacturer's position)? Also, what has been said about the differences between Ephedra and PseudoEphedra in terms of their safety? Has anyone notable addressed why the FDA thinks one should a legal over-the-counter drug While the other should be illegal? --Cab88 18:04, 17 July 2006 (UTC)

It's interesting to see how Wikipedia works. One of the top Nutrition Universities in the world did an independent study showing that Ephedra/caffeine is safe and effective in low dose (Department of Nutrition, University of California, Davis http://www.nature.com/ijo/journal/v30/n10/abs/0803283a.html) and is referenced in a scholarly and recognized International Journal (International Journal of Obesity). While it is completely scientific, and written by people with resumes that would make the authors of this Ephedra Section look uneducated (in my opinion). Studies like this are not even mentioned. In fact, you would think that this section was written by employees of the FDA (not too sure that's not the case the way it was written). What a shame that this is so biased and one sided.Bodybydesign 02:03, 7 March 2007 (UTC)

There are two issues here: is ephedra safe and effective under carefully monitored and regulated conditions? There is evidence suggesting it is, at least for short-term weight loss. Then, is ephedra safe for sale as an unregulated dietary supplement? The answer from the FDA has been no, based on a large number of severe adverse reactions and even deaths resulting from unregulated sale of ephedra supplements. I think it would be useful to add a section summarizing the studies that have been conducted on ephedra, separate from the regulatory issues. It would also be useful to have information on ephedra's regulatory status elsewhere (e.g. Europe). BTW, if you're referring to me, I am not affiliated with the FDA. Also, since the issue of big pharma influence and conflicts of interest has been raised, did you notice that the study you cited above was funded by an unrestricted grant from AdvoCare, a supplement manufacturer? MastCell 18:12, 7 March 2007 (UTC)

BTW,I am referring to the bias that makes it to the front page of this section and it is all one sided and the only thing that makes it. I strongly suspect that Advocare nutritional supplements with ephedra/caffeine were used in the study because they are a (14) year old company that use to sell this very product (before the FDA hatchet job). Also, I strongly suggest that you go to the University of California WEB site and review the credentials of some of these scientists before trying to slant their character. Adverse event reporting means very little depending on the circumstances of each case. The minute a person goes to the Doctor with a sinus headache and tells the physician, who spends at most (5) minutes with the patients, that he uses a product with ephedra the doctor will tell him to stop using the product because most Doctors know that ephedra can raise blood pressure. They really don't have the time to consider anything else that is perhaps the real issue. As to the high visibility ball player always mentioned, know one really knows the circumstances, his general health, how much ephedra he had consumed, etc. Herbalife, Advocare, etc. are good examples to use because there is a long "history of use" by the thousands of people who consumed their products. 50 - 100 people die each year consuming peanuts. Recently, a lady overdosed on water (absolutely anything is toxic if too much is consumed). If the ephedra products were back on the market tomorrow (aside from the over-the-counter synthetics sold and the ephedra in tea bags) many thousands of people would begin to purchase the product immediately--I am certainly one of those. The FDA (1994 DSHEA) was required to consider the "history of use by humans" before they pulled this product. There is a "very" long and successful history of use by humans who used the ephedra products of each of these supplement companies (something you don't mention either). I personally know people who lost over 50 - 100 pounds on the products and had zero success from their MD who looked at them with a blank stare saying, "If you don't lose weight you will die." Other than radical surgery the MD had know idea how these people would lose weight (you can see why I am so upset and passionate about this subject). What do you think that weight lose did for the general health of those people??? This gets down to constitutional rights of thousands of people. If I see a caution label on the products (particularly after all the adverse publicity) and want to use a low dose ephedra/caffeine (which I personally consider--like many others--to be perfectly safe) I shouldn't be hindered by the bias and nonsense of people like yourself who gets the products removed from the market with your caustic one sided write-ups. The ephedra hearings were the biggest joke on the planet and the chair (Billy Tauzin) heads up a large AMA, FDA, Money making lobby. After (10) years of taking my sister to a cancer clinic before she died ask me how I feel about big drug companies. You can take anything on the planet as long as some MD writes a prescription...and that's the whole point--it's called big bucks! It's not about our health and if you think so you are somewhat naive.Bodybydesign 01:26, 8 March 2007 (UTC)

For the record, I had absolutely nothing to do with ephedra being removed from the market. I'm not dismissing your concerns, but I think it's best (at least in this particular forum) to focus on how to improve the article. Ephedra was the subject of a major regulatory action by the FDA, which was a test case for the limits of its authority under DSHEA. That needs to be described in the article, which is what I tried to accomplish in my edits. Again, I think it would be useful to summarize peer-reviewed studies of ephedra, and to add a section on its regulation outside the U.S. I don't think anyone is arguing that ephedrine is dangerous when used carefully - hence ephedrine is still available, regulated as a drug - but the unregulated availability of ephedra supplements, many of which contained zero to >1,000% of the labeled dose of ephedra alkaloids, was a problem in the FDA's view. Again, I'm not arguing with your personal experience - it's just that this is supposed to be an encyclopedic rather than testimonial forum, and I'm wondering what concrete improvements to the article you have in mind. MastCell 04:10, 8 March 2007 (UTC)

Instead of something about Orin Hatch's son we might include something about the chair of the ephedra hearings (Billy Tauzin) and how he is currently President of PHRMA a powerful lobby group supporting the drug companies. You might mention that the FDA does not have independent peer reviewed studies And has never had a legitimate (independent) study of ephedra at every dose level (in other words, they are clueless). Several University Studies show low dose ephedra to be safe "AND EFFECTIVE" (even though you give them no weight at all) and that the herb has a "long historical use by humans" etc. It kind of comes down to how you want to slant it,write it, and paint the picture doesn't it. It appears that Canada has followed the U.S. lead on banning the product at "all dose" levels without any studies at all. I understand perfectly about "your" forum by reading what is said in the write-up. Bodybydesign 14:24, 8 March 2007 (UTC)

Let's back up. I agree there are a number of studies suggesting ephedra (+/- caffeine/aspirin) is effective for short-term weight loss. I do give those studies credence, contrary to your assertion, and I think we should include a section detailing such studies. However, its safety in a carefully monitored controlled trial is different from its safety as an unregulated herbal supplement. The meta-analysis of ephedra commissioned by the FDA was peer-reviewed (published in JAMA). As to the "high profile ball player", the medical examiner concluded that ephedra played a major role in his death - I'm not stating my opinion here; it's verifiable. If there's a reliable source saying that the ME was wrong, then we could consider including it. Not every dose level has been studied, yes - the FDA made a judgement that there was enough evidence of harm to justify banning all dose levels. Whether one think that judgement was right or wrong, it happened and needs to be described in the article. I agree that Billy Tauzin is hardly free of lobbying/corporate influence; if we find a reliable source suggesting that pharma influence played a role in his decision, then we could add that (note the information about Orrin Hatch is sourced, to the L.A. Times). MastCell 16:42, 8 March 2007 (UTC)

We are going round and round for no reason so this will be my last entry. FACT: In 2-1/2 months I lost (35) pounds on a low/dose ephedra/caffeine and kept it off "several years" before ephedra was destroyed by the FDA and media. My MD told me to stay on the supplements but that is not possible since the company had to discontinue the product. So, your comment about "short-term weight loss" is not only unfounded it is incorrect based on my personal experience (don't care if you believe that or not). FACT: a lot of detractors have never used or experienced the benefits of low dose ephedra because they have never "personally" used the products (I would strongly bet you fall into that category--perhaps I am wrong?). FACT: Because I have followed this subject for a long time I know people who safely lost over 100 pounds (looking healthy instead of like a prune who has been operated on--excess skin) on an ephedra/caffeine supplement. They were not able to lose their weight in any other way (diet, exercise, MD, etc.). FACT: As you get older or experience an unhealthy diet your metabolism slows down making it harder to lose the pounds accumulated over the years (side issues: high blood pressure, high triglycerides, etc.). This is a vicious circle where people don't feel like exercising (that's for your great looking high profile major media types who need to experience some more years of life). FACT: I suspect there have been adverse issues related to ephedra but low dose ephedra/caffeine could be allowed and used by people like me with label warnings and policing of the supplements industry for controlled and standardized products (already being done by the FDA). FACT: The scientist listed in this low dose ephedra/caffeine study know perfectly well (through their own experience) that many people have experienced safe and effective weight lose for "many years" and it's not short-term health benefits. They have personally seen hundreds and perhaps thousands of people "experience" healthy "significant" weight loss so they understand full well about the BS published. FACT: Thousands of the readers of this and other articles (including nutrition Ph.D's and scientists) know that it is pure BS through their own personal experience and research. I have personally talked to several scientist on this issue. FACT: The FDA, and similar government agencies, is an agency that has way too much control and can destroy industries and constitutional rights at will. Have a great time searching the tabloid media.Bodybydesign 22:59, 8 March 2007 (UTC)

You seem upset, which is unfortunate and not my intention. The problem is that Wikipedia is a forum for verifiable, reliably sourced information, not for personal testimony of yours or my experience with ephedra. I'm not sure which "tabloid media" you have in mind, but I do think a section on ephedra studies (positive and negative) would be a useful addition. As to the FDA, that's an area where we disagree; I do think low-dose ephedra is probably safe, but that would require dosage standardization, quality control, stricter labeling, etc - compromises which the supplement industry has been unwilling to make, and would rather fight in court than accede to. The FDA is a convenient boogeyman, but the reality is more complex. MastCell 23:23, 8 March 2007 (UTC)

Reference links - biased linkage?

It appears that these links are pointing to some commerical sites, or sites that link directly to a commercial site. Shouldn't these be removed?

• www.thatswholesale.com
• health.groups.yahoo.com/group/ephedraforum
• www.sudafed.com/products/24hour.html
• www.drugstore.com/products/prod.asp?pid=152878&catid=9327&trx=29384&tab=0#0
• www.ephedra.com/ephedra-opinion.htm

External link

I added www.thatswholesale.com/ in test link since I found it helpful and I have similar experiences.

Linkspam

I don't know whether the Wikipedia robots.txt puts the talk pages off-limits to indexing, but why take a chance? I deactivated all the spam links on this page. I didn't remove them outright, since this is a talk page, but there is no point to giving the linkspammers any advantage. Anyone interested in the links can still copy and paste them.--Curtis Clark 14:31, 5 November 2006 (UTC)

POV addition

I reverted a recent addition because it was polemic in tone, and I don't know enough about the subject to make it NPOV. Perhaps the editor who added it can try again. It would be nice if the article presented well-referenced material (no linkspam) on both sides of the safety and efficacy issues.--Curtis Clark 05:26, 28 December 2006 (UTC)

IS THE FDA ABOVE THE LAWS OF THE LAND?

TO Curtis Clark:

Curtis, I think you can help me on this one so that it can get into the "History" of ephedra (appreciate any help you can give me):

This is from the FDA website: http://www.fda.gov/ohrms/dockets/98fr/95n-0304-bkg0003-ref07-10-Chapter1.pdf

"A 2000 survey by manufacturers of ephedra-containing supplement products estimated that three billion servings of these products were consumed in the prior year; these findings were revealed during testimony at a Public Meeting on the Safety of Dietary Supplements Containing Ephedrine Alkaloids held August 8, 2000. According to Michael McGuffin, an industry spokesperson, this figure represented a 65 percent increase in sales volume over the previous five years and would correspond to approximately $6.8 billion in total sales. Use of ephedrine alkaloid-containing products to promote weight loss or enhance athletic performance has garnered a great deal of media attention over the last year. This attention is due in part to a number of well-publicized adverse events reportedly associated with the use of ephedra or ephedrine alkaloid-containing products.

Herbal ephedra has been used in China to treat respiratory conditions for over 5,000 years; however, the herb is not used for weight loss of physical performance enhancement in eastern medicine. Its active alkaloid, ephedrine, was first used in western medicine as an asthma treatment in the 1930s. Since then, ephedrine and other sympathomimetic alkaloids have been used in many over-the-counter (OTC) decongestants and cold medicines. It was not until the early 1990s that herbal ephedra and other products containing ephedrine began to be promoted as weight loss aids in the United States.

Federal regulation of dietary supplement products differs considerably from that of products that are deemed drugs. Dietary supplement products, including those that contain herbal ephedra (as distinct from the purified alkaloid ephedrine), are regulated by the Dietary Supplement Health and Education Act (DSHEA) OF 1994. Under DSHEA, new products that contain only supplement ingredients that were sold in the United States before October 15, 1994 do not require FDA review before they are marketed, because they are presumed to be safe based on their history of use by humans. Manufacturers of a dietary supplement that contain a new ingredient not sold as a dietary supplement before 1994 must notify FDA of their intent to market that product and must demonstrate reasonable evidence for the safety of the product to humans. In turn, FDA can bar the new ingredient from the marketplace for safety reasons. However, manufacturers are not required to perform clinical or other studies to establish the safety of their products before marketing. Once a dietary supplement is marketed, FDA can restrict its use or order its removal from the marketplace only if it can prove that the product is not safe. In contrast to the rules for dietary supplements, before a drug product can be marketed, the manufacturer must obtain FDA approval by providing convincing evidence that it is both safe and effective."

As you can see, from the FDA literature, the FDA realizes that ephedra is considered a dietary supplement (not a drug) and is regulated by the 1994 DSHEA. Also, because ephedra has been used for 5,000 years "they are presumed to be safe based on their history of use by humans." And, "Once a dietary supplement is marketed, FDA can restrict its use or order its removal from the marketplace only if it can prove that the product is not safe."

How can I show this information along with these few remarks:

1. $6.8 billion in sales prior to the year 2000 shows a "lot of people" using the product without adverse effect (otherwise they would be sick). And, a 65% increase shows that they beleived they were getting the results they desired from using these products. Note: have you ever heard of the FDA outlawing peanuts because a minority of people have serious adverse reactions when they eat peanuts? Should the majority not be allowed to eat peanuts? The herb Ephedra is categorized as food!Bodybydesign 13:15, 6 January 2007 (UTC)

2. FDA's own literature shows that they must prove that it is not safe before they can remove it from the market. When and how did they prove it was not safe?

3. Does the FDA have to comply with the "Laws of the Land?" For example, does the FDA have to comply with the 1994 DSHEA and how did they come to the conclusion that their actions complied with this law.

Thanks for your help!Bodybydesign 21:57, 4 January 2007 (UTC)

I see two issues:

1. This is an article about ephedra, not about the FDA. Even the emphasis on the FDA is somewhat POV, since it only regulates in the United States, and this is the English Wikipedia for the world. Further, iirc, there are clinical studies from Europe and elsewhere on both safety and efficacy of ephedrine. Whether the actions of the FDA are proper or improper is immaterial to this article. All that matters is the evidence bearing on the safety of the herb ephedra, and the drug ephedrine.
2. "$6.8 billion in sales", plus the many spam links that have been added, raise the general suspicion that pro-ephedra screeds in this article are financially motivated. That perception can only be countered by evidence, carefully presented, without polemic. Fortunately that's always a good thing for a Wikipedia article.

Again, in my opinion, a focus on the evidence for and against the safety of ephedra is the most productive approach.--Curtis Clark 15:50, 5 January 2007 (UTC)

Thanks for your advise. Perhaps at some point I can figure out how to do this in a professional manner. Yes, I suspect it is about money for a lot of people and others are just sad because they lost a great product without recourse. Anyway, I still don't know where this came from in the history: "and eventually linked 155 deaths to Ephedra, most of them caused by cardiac problems and strokes.[citation needed]" Knowing how the current system works I really question that insertion. Thanks! Bodybydesign 16:38, 5 January 2007 (UTC)

Emord & Associates Press Release January 3, 2007

Nutraceutical Corporation Files Petition For Writ of Certiorari Asking U.S. Supreme Court to Review 10TH Circuit Ephedra Decision

Denver, CO -- Today Nutraceutical Corporation filed a Petition for a Writ of Certiorari with the U.S. Supreme Court. The petition asks the Court to review a 10th Circuit Court of Appeals decision which reinstated the FDA ban on dietary supplements containing ephedra. The U.S. District Court for the District of Utah struck the ban as unlawful under the Food Drug and Cosmetic Act (FDCA). Counsel for Nutraceutical on the Petition for a Writ of Certiorari are University of Chicago professor of law Richard A. Epstein and Jonathan W. Emord of Emord & Associates.

In its petition, Nutraceutical states:

   ...[T]he FDA has nullified the bedrock of adulteration law, that dose determines toxicity.  It has negated the fundamental requirement that FDA prove a dietary ingredient itself, rather than a surrogate substance, i.e., a drug, a significant risk before banning the ingredient from the market.  Without statutory authorization and against the plain and intended meaning of Congress, FDA has superimposed on the Adulterated Food section a drug risk-benefit standard, eliminating the essential divide between foods and drugs created by the FDCA and rendering the critically important Adulterated Food section internally inconsistent and irrational.  That rewrite of the law is causing instability in food and supplement markets.

For a copy of Nutraceutical’s, Petition for Writ of Certiorari call Shannon Young at 202-466-6937. Bodybydesign 02:33, 7 January 2007 (UTC)

Expansion

I've expanded the safety section per the request, and tried to replace some self-published and less reliable sources with more reliable sources. I think it would be useful perhaps to have a viewpoint from an organization that thinks ephedra is safe, or about its use in traditional Chinese medicine, but it needs to be more verifiable and reliably sourced than Yahoo! Health Forum. Do you have an online link to the writ filed by Nutraceutical Corp? If so, we can update the 'Legal Challenges' section. Also, what are the NPOV issues here, so we can address them and remove the tag? MastCell 00:26, 8 February 2007 (UTC)

Legality of Dried Herb

Is the dried herb itself legal to buy anymore. It used to be available at Chinese Herbal Shops, I'm just wondering if it is only the supplements that are banned or if the herb itself is also. Thank you. -- —Preceding unsigned comment added by 24.6.22.248 (talk • contribs)

• According to the FDA Ephedra FAQ, it appears that

"The scope of the rule does not pertain to traditional Chinese herbal remedies. It generally doesn't apply to products like herbal teas that are regulated as conventional foods. Ephedra is not Generally Recognized as Safe (GRAS) for foods and not approved for use as a food additive."

-- MarcoTolo 14:43, 14 February 2007 (UTC)

Unsourced text

The following was removed as unsourced:

Statistics show that Ephedra is safe in low doses and short term uses typical of traditional herbal preparations, and that the adverse cardiovascular effects were associated with higher doses. Virtually all adverse effects reported concerned the use of weight loss supplements or stimulants marketed as an "herbal high".

It could potentially be readded if a reliable source verifying its claims could be found. Also, I'll keep looking for sources on the athletes mentioned to have tested positive, but if I can't find some soon I'm going to remove that as well in accordance with WP:BLP. MastCell 16:50, 14 February 2007 (UTC)

Illegal Everywhere?

There has been a recent lift of this ban, at least in NY, as Ephedra can be sold if it's in pill form 10 Mg or less. Does this apply everywhere? This article needs to be updated. WiiAlbanyGirl 06:20, 20 February 2007 (UTC)

Could you point me to a source indicating that the ban has been lifted? Both the FDA website and the New York State Dept of Health make no mention of the ban being lifted, and historically New York was one of the first states to take action to ban ephedra, long before the FDA mobilized to do so. MastCell 18:02, 20 February 2007 (UTC)

Here is a source that indicates the ban has been lifted: <snip> Brightlight1997 15:41, 1 May 2007 (UTC)

Read the Wikipedia article a little more closely... that website is referencing the 2005 decision to lift the ban, which has since been overturned by the 10th Circuit Court of Appeals. For the most up-to-date info on ephedra's legality, you may want to look at the FDA's website instead of that of a manufacturer. MastCell ^Talk 15:49, 1 May 2007 (UTC)

Rename to "Ephedra alkaloids"?

Article currently opens as follows:

Ephedra is an alkaloid chemical compound traditionally obtained from the plant Ephedra sinica.

As far as my understanding goes, this is completetly false information. "Ephedra" is not the name of any one compound, it is the name of a plant genus whose members contain multiple compounds (including ephedrine and pseudoephedrine, as the article states).

If the idea is to have one article containing information on Ephedra preparations and extracts as drugs (this one) and another on the plant genus itself (currently at Ephedra (genus)), I think it makes more sense to have the plant one at Ephedra and the drug one at Ephedra alkaloids. This article is clearly a subtopic of the "Ephedra" topic. The genus article can also contain an overview of use of the genus in medicine; I think moving the (very long) list of species to the bottom of that article will aid readability there.

While it's possible there's something else in the plant than the alkaloids that contributes to the effects, only the alkaloids are actually discussed here. A discussion on this took place on this talk page about a year ago under "Split"; there are other ideas for names there.--Eloil 08:13, 2 April 2007 (UTC)

Maybe ephedra (supplement) would make the most sense? There's already a disambiguation header in the article, though, to avoid such confusion. I think the current scheme is based on the idea that people are more likely to be looking for info on the supplement, rather than botanical info. But I guess we could change it. MastCell ^Talk 16:58, 2 April 2007 (UTC)

The same is most likely true of the Cannabis and Cannabis (drug) articles (most people want the drug info). I think the main problem is that the genus article could/should contain a decent-sized section on uses of the plants in medicine and doesn't. I've moved the "Uses" section there to above the list of species, but it's still only a few sentences. As far as names for this article, Ephedra (supplement) or Ephedra (drug) would be fine with me.--Eloil 02:46, 4 April 2007 (UTC)

I've filled out the uses section at the genus page a bit; there's a paragraph now instead of just a couple sentences. I also messaged everyone who was part of the earlier discussion.--Eloil 05:05, 4 April 2007 (UTC)

Split?

Maybe this article should be split into two - one article that discusses the plant genus, and one that discusses the drug/supplement. Toiyabe 14:44, 10 May 2006 (UTC)

I agree totally. What shall the drug article be called?--Curtis Clark 15:02, 10 May 2006 (UTC)

While I am interested more in the genus, probably more people come here for info on the drug. Therefore I think Ephedra should be focused on the drug, and Ephedra (genus) should be used for the plants. Toiyabe 16:00, 10 May 2006 (UTC)

Done. I haven't looked yet at pages that link to properly disambiguate them, nor at the non-English articles, and I'm sure there's other cleaning up to be done.--Curtis Clark 23:05, 10 May 2006 (UTC)

I'd disagree on the new titling. My suggestion would be to keep the botanical details at Ephedra, and place the drug at its medicinal name Ephedrine - MPF 13:18, 11 May 2006 (UTC)

I agree that is a more correct usage. However, there is good evidence that most people coming to this page are interested in the drug, not the plants based on what gets vandalised. Also, as it stood most of the text of the combined article was on the drug. The "principal of least surprise", suggests that Ephedra should be used for the drug. Also while ephedrine is the medicinal name, I think it was mostly sold as Ephedra at least in the US.

I don't care strongly about the names, that's just what I think is consistent with wiki policy. I also think the incidence of vandalisim of the botanical article will drop off by a lot if it is named Ephedra (genus). Toiyabe 14:16, 11 May 2006 (UTC)

I have to agree with MPF on this one. -- WormRunner 15:00, 11 May 2006 (UTC)

There is ephedra as herbal remedy, so "ephedrine" doesn't line up perfectly. I'd rather keep "Ephedra" as the genus, because at least in the Mojave, locals are likely to know the plant as "ephedra" rather than "Mormon tea" or whatever (also because there are several species not easy to differentiate :-) ). People interested in the herbal remedy are also thinking of the plant genus, even if they don't know it :-) - I see the split as more for the benefit of focus and categorization, rather than as a disambiguation, which makes the genus the "main article" and "ephedra as herbal remedy" a subarticle, a la subarticles of countries and the like. Stan 17:40, 11 May 2006 (UTC)

I can go either way on article names, and will gladly make the changes when there is a consensus. I do strongly favor the split, though, which is why I went ahead and did it.--Curtis Clark 18:51, 11 May 2006 (UTC)

Don't let me stand in the way of consensus. It looks like we have 3 votes for "Ephedra" as the botanical article and 2 "I don't really care" votes. What should the drug/supplement article be named? Toiyabe 20:36, 11 May 2006 (UTC)

Ephedra (drug)? -- WormRunner 02:41, 14 May 2006 (UTC)

Ephedra (herb) --Bk0 (Talk) 03:04, 14 May 2006 (UTC)

• Ephedra in medicine
• Ephedra (medicinal uses)

--Curtis Clark 03:53, 14 May 2006 (UTC)

Moved this discussion to the bottom of the page so people see it.--Eloil 08:16, 2 April 2007 (UTC)

IS TOO MUCH OF ANYTHING SAFE ??

Maybe the FDA should have investigated what are safer dosages of ephedra and what health problems it is most effective for, I've noticed whenever they outlaw a natural remedie, they never realy say specificaly why or how it can be harmful to people, why it harms some people and not others, etc. Why ? Is it because a healthier U.S.A. would be less profitable for pharmaceutical companies ? Is the FDA in fact protecting U.S. citizens from harmful natural cures ? OR are they protecting the profits of " Big Pharma " ? —The preceding unsigned comment was added by 63.148.191.50 (talk) 14:49, 5 April 2007 (UTC).

They are protecting the medical establishment in general. But since the majority of the population seems to like this idea, it remains. See, most people like to be dumb. MGlosenger 00:38, 6 June 2007 (UTC)

Interesting. Since talk pages are not a forum for general discussion, though, let's stick to using this page to discuss concrete improvements to this article. That said, if you're interested in why the FDA didn't study lower doses of ephedra, the rationale is described in this New York Times article (cited in this Wikipedia article). Of course, reality is always less interesting than a conspiracy theory. MastCell ^Talk 03:33, 6 June 2007 (UTC)

A conspiracy theory would involve people deliberately cooperating in order to do 'bad' things (whatever that means). Where did I make such a claim? But I suppose you hope to just throw out the magical words 'conspiracy theory' and make any such discussion immediately meaningless.. Predictable. MGlosenger 03:59, 6 June 2007 (UTC)

Whether meaningless or not, this discussion is definitely off-topic. So let's end it here. MastCell ^Talk 15:17, 6 June 2007 (UTC)