Ephedrine Dangers: BS?

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    Ephedrine Dangers: BS?


    From a Brinkzone Newsletter:

    Second, the rest of this email is dedicated to the new anti ephedrine
    onslaught that appears to be going on in the media. The anti ephedrine camp
    seems to be making another wave of worthless emotional based statements,
    which as usual, lack any real data. This tactic is of course an old one. As
    the man said:

    'All propaganda has to be popular and has to adapt its spiritual level to
    the perception of the least intelligent of those towards whom it intends to
    direct itself.' - Adolf Hitler, Mein Kamp

    Most of you may have heard of a new 'study' supposedly showing how
    dangerous ephedrine is and the death of baseball player Steve Belcher is
    being blamed on ephedrine. Both are complete shams!

    Ok, below is my lay commentary of this 'study' followed by BrinkZone members
    Doug Kalman MS, Jose Antonio, Ph.D., FACSM, and Richard B. Kreider, PhD,
    letter to the editor of the journal that published the study with a nice
    analysis of the data of the study.

    Finally, is a link to a press released from Miami Research Associates
    (also written by Doug Kalmen) that looks at the death of this base ball
    player the media is blaming in ephedrine.
    ______________________________ _____


    - 'Anti Ephedrine Campaign's latest bogus study':

    Well gang the anti supplement powers that be, are at it again with a new
    'study' that supposedly shows the dangers of ephedrine. Typical of the
    'don't confuse us with the facts' media, this study is being plastered
    all over the news and held up as a reason to pull ephedrine containing
    products off the market. At this point, it appears they are so desperate to
    find proof that ephedrine is a health hazard, they are willing stretch the
    truth to absurd levels.

    What am I referring to? A new study called 'The Relative Safety of Ephedra
    Compared with Other Herbal Products' published in Annals of Internal
    Medicine (2003;138:000-000). This study is not bad science, it's not science
    at all.

    What the authors did was examine reports put into the American Association
    of Poison Control Centers Toxic Event Surveillance System Database Annual
    Report for 2001, and make conclusions about the safety of ephedra based on
    those numbers.

    For example, the authors state:

    'Ephedra is widely used in dietary supplements that are marketed to promote
    weight loss or increase energy; however, the safety of this product has
    been questioned because of numerous case reports of adverse events.'

    Translated: they have already decided that ephedra is unsafe and are going
    to prove it no matter what they have to do. Hence, the authors were biased
    (more on that in a minute) from the start and made it their job to confirm
    their biased belief.

    Basically what these authors did was compare the adverse reaction reports
    from American Association of Poison Control Centers Toxic Event Surveillance
    System vs reports on other herbs and shock of all shocks, conclude that
    compared to other herbs such as ginko and kava, that ephedra has more side
    effects.

    Well Duh. They concluded that ephedra containing products accounted for
    64% of all reported adverse effects from herbs compared with kava and
    Ginkgo biloba (see letter data showing thats not even true).

    They state:

    'This risk was defined as the ratio of adverse reactions to ephedra versus
    other products, divided by the ratio of their relative use in the United
    States.'

    Translated: a fancy way of saying that they compared apples to oranges
    (ephedrine vs ginko or Kava) and concluded ephedrine accounted for a higher
    rate of reported side effects. This is equivalent to comparing coffee (a
    stimulant) to fruit juice and coming to the shocking conclusion that coffee
    has more side effects than fruit juice! Now, why didn't they compare it to
    say other diet products, in particular diet drugs with similar mechanisms?

    You would find that pharmaceutical diet drugs are involved in considerably
    more adverse events than ephedrine based products, and those events, on
    average, are of a more serious nature. Let's not forget the recent study
    published in the Journal of Strength and Conditioning Research, that found
    an ephedrine caffeine based supplement was superior for weight loss with
    less side effects than the popular diet drug Xenical (Orlistat), one of
    the most commonly prescribed diet drugs in the United States.

    Of course, in truth none of this info from this new report from the Poison
    Control Centers can be used to represent the true risk of any drug or
    nutrient as it is simply people calling into claim some product made them
    ill.

    It does tell public health officials if some product in particular
    should be looked for un expected side effects, etc, but it's of little use
    in making real decisions regarding the safety profile of any drug or
    nutrient. That's what true double blind placebo controlled human studies
    are for, of which there are MANY with ephedrine. What about those studies
    with ephedrine? Every single study to date-with more than a decade of
    research-has concluded the side effects are minor, transient, and short
    lived.

    The authors didn't bother to mention any of the real data that exists on
    ephedrine but focused on a single study that had a high drop out rate
    from the study. Of course ephedra is not without risk and there are
    many people who should not use it, such as those with high blood pressure
    and other contraindications, but as weight loss compounds go, it is
    exceedingly safe. Safer in fact than most over the counter medications
    found in stores, such as aspirin and acetaminophen.

    Bottom line is, considering the billions of doses sold of ephedra containing
    products and the millions of people using such products, the number of
    adverse events reported is amazingly small.

    The authors of this bogus study conclude:

    'Ephedra use is associated with a greatly increased risk for adverse
    reactions compared with other herbs, and its use should be restricted.'

    Translated: they had an agenda to show ephedra was unsafe, and found a
    unscientific way of showing it vs following the real data that exists or
    comparing ephedra to drugs for the same purpose that are more toxic than
    ephedrine. But wait, it gets better. If you recall I mentioned the authors
    were clearly biased. Why? All of the authors of this so called study have
    worked for various lawfirms who are involved in anti-ephedra lawsuits!

    That's right, the authors of this report are paid by law firms and called
    as expert witnesses in cases against companies (e.g., Cytodyne, MuscleTech,
    Next Nutrition, TwinLabs, GNC, Phoenix Labs, Chemins Labs, etc.) that
    produce and market supplements containing ephedra!

    Yes folks, that's how low the anti ephedra camp is willing to go; to any
    lengths to get ephedra banned, and the facts based on science be damned.
    People that would like to read the full study can view it on line at:
    http://www.acponline.org/journals/annals/ephedra.htm

    People that would like to view the annual poison control data to see what
    crazy things are reported can see it at the Poison Control Center web site
    at: http://www.aapcc.org/

    Finally, people that want to see my opinion on the best ways to use
    ephedrine based products, avoid side effects, etc, should read my book
    Diet Supplements Revealed found at: http://www.aboutsupplements.com
    ______________________________ ______


    - An Analysis of the Relative Safety of Ephedra
    By Doug Kalman MS, Jose Antonio, Ph.D., FACSM, and Richard B. Kreider, PhD,

    In an early Internet release, the Annals of Internal Medicine posted an
    upcoming brief communication concerning the dietary supplement ephedra (1).
    This study raised media frenzy concerning the regulatory status of ephedra.

    The authors utilized the Toxic Exposure Surveillance System (TESS) report
    of 2001 and compared it with ephedra sales data provided to them by SPINS,
    a market analysis firm. In addition, the authors also utilized a magazine
    report to approximate the total sales of ephedra within the United States
    for the year 2000 (2). There are several methodological and fundamental
    flaws with the design and conclusions made by Bent et al.

    The TESS raw data indicates that 55.5% of all Poison Control Center reports
    related to Ma Huang (ephedra) alone or in combination with another herb
    (multi-botanical) were in people under the age of 19. Additionally, 27.9%
    of all of the exposures were in children less than 6 years of age (3).

    This information is vital as in 7,927 exposures; the Poison Control Centers
    deemed 14% (1,178) to be an adverse reaction. In clinical research the
    guidelines set forth by the International Committee on Harmonization (ICH)
    defines an adverse reaction/event (AE) 'any untoward medical occurrence in
    a patient or clinical investigation subject administered a pharmaceutical
    product and which does not necessarily have to have a causal relationship
    with this treatment' (4). The TESS system defines an adverse reaction (AR)
    as 'an adverse event occurring with normal, prescribed, labeled or
    recommended use of the product, as opposed to overdose, misuse or abuse'.

    The TESS system also captures AR's that are 'unwanted effects due to an
    allergic, hypersensitive, or idiosyncratic response to the active or
    inactive ingredients, or excipients'. Thus, the definitions and
    establishment of clear causality or relationship is not clear within the
    TESS system and when contrasted with normal research guidelines for
    defining and AE/AR appear to be questionable. The Center for Drug
    Evaluation and Research (CDER) policy on AR/AE's is that accumulated case
    reports (AER's) cannot be used to calculate incidence or estimates of drug
    risk (5). This misguided calculation is exactly what the authors attempted
    to do.

    The 2001 TESS report details that the vast amount of exposures were
    unintentional (85.2%). In the ephedra analysis, 46.7% of the exposures were
    of the unintentional variety (using TESS definitions and data from table
    22B). It cannot be downplayed that the TESS report only captured data on 12
    known herbs, Drs. Bent et al mistakenly state that ephedra accounts for 64%
    of all herbal related adverse reactions, however, there are hundred of
    herbals sold on the U.S. market, not 12, thus their conclusion is
    overstated.

    The sales data that Drs. Bent et al utilized in an attempt to correlate the
    TESS data with sales is incomplete. The SPINS database does not capture
    data by zip code nor does it capture the true mass market (i.e., Walmart,
    Costco, GNC Corporate stores), thus any data generated by the SPINS agency
    is only a small snapshot of what is truly happening in the sales of ephedra
    or ephedra-related products. The Nutrition Business Journal estimates that
    in 2000, ephedra and ephedra related products generated $1,050,000,000 (6).

    Utilizing the NBJ market analysis, the best estimate is that 26,250,000
    servings (or individual capsules/tablets) of ephedra or ephedra related
    products were sold in 2000. The sales figures are based upon retail mass
    market, mail order, practitioners, Internet sales and natural food/health
    chain channels (6). In the Bent report, it is stated that an assumption was
    made that ephedra related sales were one-half of all non-retail herb sales
    and this accounted for 0.82% of herbal product sales.

    The confliction in detail does not make sense. It appears that the SPINS
    data is inaccurate when comparing it to the more comprehensive NBJ data.
    Thus, this section of the Bent paper appears to be out of context and unreliable.

    While we as scientists and health care providers need to know the evidence
    (direct, not computed) concerning the safety of ephedra or ephedra related
    products, we must not fail to use the published peer-reviewed clinical
    studies as the basis for an understanding. While the clinical trials are
    limited in subject size as compared to Phase III drug studies, they do give
    us a basis for understanding the potential for serious adverse events and
    what population is best suited for potential use of these products.

    It is clear that people under the age of 19 should not take this herb; there
    simply have been no studies in that age group (on the herbal ephedrine).

    The TESS data states 55.5% of all exposures were from people 19 or younger.
    The comparison of ephedra versus other herbs inherently inaccurate as the
    TESS data only captured 12 total named herbs. Given the TESS data for
    ephedra reporting an adverse reaction rate of 14% (TESS conclusion) and a
    mortality rate of 0.000757% (comparison of 6 deaths versus 7,927
    exposures), one would expect a better comparison to be made using this
    data.

    For example with relation to kava, there was one death in 336 exposures
    (0.002976%), thus we can also conclude that kava is 3.9 times as likely
    to cause death as ephedra. It should also be noted that the adverse
    reaction frequency was similar for Gingko biloba (13.7% vs 14%) as ephedra
    and the AR for kava was much higher (17.5%). Perhaps, a less negative
    conclusion would not serve the purpose of the study.

    The manipulative presentation of the data shared by Bent et al viewed
    alongside the fact that the authors have and still testify for plaintiff
    law firms on behalf of anti-ephedra litigation, leads to speculation that
    this study's intent was to establish their published paper as evidence that
    ephedra is dangerous. An informed professional audience must wonder where
    the truth actually lays. Whose future and benefit does this paper serve?

    Douglas S. Kalman MS, RD, FACN
    Miami Research Associates
    6280 Sunset Drive
    Suite 600
    Miami, FL. 33143

    Disclosure: Mr. Kalman has testified in cases related to ephedra on behalf
    of Cytodyne Technologies, Inc.

    Jose Antonio, Ph.D., FACSM
    Adjunct Professor
    Exercise Science & Health Promotion
    Florida Atlantic University
    777 Glades Road
    P. O. Box 3091
    Boca Raton, FL 33431-0991

    Richard B. Kreider, PhD, EPC, FACSM, FASEP
    Professor & Chair
    Exercise & Sport Nutrition Laboratory
    Center for Exercise, Nutrition, and Preventive Health
    Department of Health, Human Performance & Recreation
    Baylor University
    PO Box 97313
    Waco, TX 76798-7313

    Disclosure: Dr. Kreider has served as an expert in litigation for Metabolife.

    References:

    1) Bent S, Tiedt TN, Odden MC, Shiplak MG. The relative safety of ephedra
    compared with other herbal products. Ann Intern Med 2003;138:000-000.
    www.acponline.org/journals/annals/ephedra.htm Accessed online February 5,
    2003

    2) Richman A, Witkowski JP. 7th Annual Herb Sales Survey. Whole Foods
    Magazine. 2001:23-30.

    3) Litovitz TL, Klein-Schwartz W, Rodgers GC, Cobaugh DJ, Youniss J,
    Omslauer JC, May ME, Woolf AD, Benson BE. 2001 Annual report of the
    American Association of Poison Control Centers Toxic Exposure Surveillance
    System. Amer J Emerg Med 2002;20(5):391-452.

    4) Cohen A, Posner J. A Guide to Clinical Drug Research. 2nd edition Kluwer
    Academic Publishers 2002. Pp XI, 34,-35, 154.

    5) www.fda.gov/cder/aers/ and
    http://www.fda.gov/medwatch/articles...ostrep.htm#aer Accessed February 18,
    2003.

    6) NBJ's Supplement Business Report 2002. Penton Media, Inc. Pp 5-171-2,
    Figure 5-5, Figure 5-7. Available: www.nutritionbusiness.com
    ______________________________ _______________

  2. YellowJacket's Avatar
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    Another good post Sheesh...appreciated...
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    Very, very nice Sheesh...

    "You have the truth, and then you have the media" - LG


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    I'll I can say is that most pharmaceutical companies wish they could have patented ephedrine many many years ago. The rate of side effects per capita for ephedrine are what most of these companies dream of as far as drugs go.
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    Great post, Sheesh. There is some risk with ephedrine, but mostly from fools who overdue everything. Those idiots always make it hard on the sensible supp user. One reason I'm against teens using ph. As a group, they have a "more is better," "nothing can hurt me" attitude. I did at 17!

    Also, you can find arguments against everything from aspartame to table sugar. I take all those with a grain of salt.
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    good post...

    what ever happened to personal responsibility in this country? everyone is always trying to label something dangerous, or put the blame on someone else... when they fail to realize it was their own stupidiy that injured themselves, got themselves fat( that damn mc donalds case), or got them killed...ephedrine is a great suppliment... granted it is not to be used by people with certain conditions and can cause injury or death with improper use..... but i can feel confident saying that if you use it right, and you should be using it, that it is a safe, effective fat loss tool
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    Originally posted by Lifeguard
    "You have the truth, and then you have the media" - LG

  

  
 

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