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Ephedra Research IV: Other Dubious Research, Media Coverage, and Lawsuits

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Dubious Research: Elk Velvet Antler

The idea that investigators would conduct clinical research on humans to test the medicinal value of the furry bits of elk antlers might make you laugh, but it shouldn't. Elk velvet antler, or EVA, is claimed to be widely used in so-called Traditional Chinese Medicine for a variety of health complaints, but be that as it may, one thing is clear: in recent years elk herds in Canada and the northern US states have been infected with Chronic Wasting Disease, a type of transmissible spongiform encephalopathy (TSE) like Mad Cow Disease. While it's unclear how, or if, this might be transmitted to humans from elk, since such diseases are invariably fatal, it seems reckless to expose human subjects to this risk to test EVA in disorders for which there currently exist a number of safe and effective treatments.

University of Alberta [1998]

The University of Alberta study, entitled 'Strength Training Parameters in Edmonton Police Recruits Following Supplementation with Elk Velvet Antler', was presented at the 6th Annual International Congress on Anti-Aging and Bio-Medical Technologies in Las Vegas, Nevada. This preliminary research study was conducted by Dr. Brian Fisher, a professor at the University of Alberta faculty of Physical Education and Sports Studies, Mike Gilpin a strength training specialist, and Dr. Dave Wiles, an exercise scientist from the Edmonton police department.
There is a need for an effective nutritional supplement for athletes to use throughout their strength training program. The authors state that one such supplement may be elk velvet antler because of its excellent amino acid composition and mineral content (as found by Sunwoo 1998).
The double-blind study involved 18 Edmonton police department recruits who supplemented their diets daily either with 6 capsules of velvet antler, or with 6 capsules of a placebo, during a formal police training period of 9 weeks (3 capsules each morning, 3 each night). The training combined free weights and machines such as the Nautilus. The objective was to look at muscle strength, mass and blood plasma markers following this nine week period.

The results found no significant differences between the groups (velvet antler versus placebo) in blood levels of cortisol or IGF-I. There were however significant increases of blood plasma testosterone levels (five to six times, p<0.01) in the velvet antler group. (Levels of testosterone returned to normal very shortly after the recruits stopped taking the velvet). The velvet antler capsules were independently analyzed to confirm that they had no traces of anabolic steroids. No significant differences were found between the two groups in muscle strength or endurance.

Accessed on 2004-05-18 at: http://web.archive.org/web/20000607101921/www.elkantler.net/recent.htm

Strength Training Parameters in Edmonton Police Recruits Following Supplementation with Elk Velvet Antler.

Brian D. Fisher, PhD, Faculty of Physical Education and Sports Studies, University of Alberta; Mike Gilpin, MSc. Dave Wiles, PhD, Edmonton Police Department

Public Statement by the University of Alberta on Elk Antler Velvet (2000-02-11).

The University has research policies, certain of which have application to research contracts with private industry. Work on one such project has come to the attention of the University about which the University has a public responsibility to report.
Dr. Brian Fisher conducted a study of a specific elk velvet antler product in the summer of 1998. A research report presented by Dr. Fisher contains the statement that this product 'enhanced plasma testosterone five to six times above normal mean physiological values for this male age range.' The University has recently had an opportunity to review this conclusion from Dr. Fisher's report against the available laboratory records for this project. Our assessment of that information is that it does not support the above statement quoted from Dr. Fisher's research report.

Accessed on 2004-05-18 at: http://web.archive.org/web/20000817210750/http://www.ualberta.ca/ExpressNews/news/2000/ 060700c.htm

Edmonton (Cup) — The University of Alberta (U of A) is threatened with a $64-million lawsuit by an elk antler company.

InnerSense, is currently suing U of A Professor Brian Fisher for $4.5-million, and says it may now sue the university in a dispute over a controversial study by Fisher.
In his study's final report, Fisher claimed powdered elk antler raised testosterone levels in human subjects to five or six times the normal amount.
The professor is refusing to give InnerSense the raw data that backs up his reports findings.
Fisher has already been charged with unprofessional conduct by the university and has been barred from appearing at the International Symposium on Antler Science and Product Technology in Banff next month.
Steve Kurylo, president of InnerSense, said he blames the university for mishandling the study and damaging the credibility of the elk antler industry.
'We feel the university has a lot of explaining to do,' says Kurylo. U of A is refusing comment.

Accessed on 2004-05-18 at: http://varsity.utoronto.ca:16080/archives/120/mar16/news/news_shorts.html

FDA Guidance on Elk Products

FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed (15 May 2003)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled 'Use of Material From Deer and Elk in Animal Feed.' When finalized, this draft guidance will describe FDA's recommendations regarding the use in all animal feed of all material from deer and elk that are positive, or at high risk, for Chronic Wasting Disease (CWD).

The potential risks from CWD to humans or non-cervid animals such as poultry and swine are not well understood. However, because of recent recognition that CWD is spreading rapidly in white-tailed deer, and because CWD's route of transmission is poorly understood, FDA is recommending that any material from CWD-positive animals, or deer and elk considered to be at high risk for CWD, not be used in any animal feed or feed ingredients. High risk deer and elk are those from 1) areas declared by state officials to be endemic for CWD and/or to be CWD eradication zones and 2) those that at some time during the 60-month period before the time of slaughter were part of a captive herd with a CWD-positive animal.

CWD is a neurological (brain) disease of farmed and wild deer and the elk that belong in the cervidae animal family (cervids). Only deer and elk are known to be susceptible to CWD by natural transmission. The disease has been found in farmed and wild mule deer, white-tailed deer, North American elk, and farmed black-tailed deer. CWD belongs to a family of animal and human diseases called transmissible spongiform encephalopathies (TSEs). These include bovine spongiform encephalopathy (BSE or 'mad cow' disease) in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jakob diseases (CJD and vCJD) in humans. TSEs are very rare, but are always fatal.
Accessed on 2004-05-18 at: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01220.html

University of Calgary 2002

Health Canada internal correspondence, notes in passing elk velvet antler research put on hold by REB at the University of Calgary, 28 February 2002 (Health Canada, ATI A-2001-0845/ms): http://www.circare.org/FOIA/hcati2_220228.pdf

University of Calgary 2004

Does elk velvet antler relieve arthritic pain? Research study seeks participants.

A research study on the use of elk velvet antler in the treatment of rheumatoid arthritis is currently seeking participants in Calgary who suffer from this ailment. Elk velvet antler is an ancient Chinese remedy that is reputed to have a wide variety of positive physiological effects. Kathy Oberle, a U of C Faculty of Nursing professor, together with colleagues from the University of Alberta, conducted a successful pilot study two years ago and received national funding for the next phase of the research - a randomized controlled clinical trial. About 100 patients from Edmonton have already entered the trial, and the researchers are now seeking participants from the Calgary area.
Accessed on 2004-05-18 at: http://www.ucalgary.ca/gazette/april7-03/elkvelvet.html. The University of Calgary Gazette, 2003-04-07.

Surely the successful pilot study described is not the study they shut down voluntarily, and mentioned in passing in the Health Canada ATI correspondence obtained on EmpowerPlus research. It would be difficult to call a clinical trial conducted without requisite federal approvals a successful pilot trial, especially persuant to seeking grants from the Canadian Health Research Institute, given that a condition of release of funds is an institutional pledge of compliance with the Tri-Council Guidelines and Health Canada regulations.

University of Alberta 2004

Dr. Allen PhD, as principal investigator, has expertise in chronicity and the effect of chronic disease on the day to day lives of individuals. She has conducted numerous qualitative studies with individuals with chronic illness, examining the effects of chronic illness on quality of life. She has an avid interest in complementary therapies. Although she has not participated in clinical trials to this point, she has participated in quasi-experimental investigations and has well-developed research skills.
Accessed on 2004-05-18 at: http://www.nursing.ualberta.ca/ArthritisStudy/The_Research_Team/Dr__Marion_Allen/ dr__marion_allen.html

EVA: Easing the Symptoms of Rheumatoid Arthritis

So now these institutions have approved Clinical Trials Licenses from Health Canada, correct? Since the recruitment advertisements go out of their way to reassure prospective research subjects that this product is safe, how have they acccomplished this? The safety of these products depends upon the ability to detect TSE. If they have indeed discovered a way to detect TSE, and so can offer such reassurance to prospective research subjects, these researchers ought to announce this dramatic advance immediately so public health can benefit from their discovery.

A good overview of some of the troubling issues arising from this research:

Elk Velvet Antler
Terry Polevoy MD, Canadian QuackeryWatch, 2000-04
URL: http://www.dietfraud.com/Pumping-up/Elk- velvet/


Lawsuits and Related

Jefferson City, Mo. Attorney General Jay Nixon today filed a lawsuit in St. Louis against the maker of Hydroxycut.

The lawsuit claims that in order to obtain the research results it sought, MuscleTech would replace research subjects who had to drop out of the company's studies because they could no longer tolerate the Hydroxycut or because it became too dangerous for them to continue. In at least one study, Nixon said, those dropouts were concealed and not treated as an adverse effect of Hydroxycut. In another study cited in the lawsuit, one subject was rushed to the hospital due to a serious change in heartbeat. This incident was not treated as an adverse reaction in the final study.

Press Release, Office of the Missouri Attorney General, 2003-03-27
URL: http://www.ago.state.mo.us/newsreleases/2003/032703.htm

blue star State of Missouri v. MuscleTech Research and Development Inc. pdf icon

Related material

University of Guelph, Contract Funds - Individual Sponsors: 1 May 2000 - 30 April 2001 pdf icon
Muscletech Research and Development: $112,670

University of Guelph, Research Funds Received by Colleges (Biology): 1 May 2001 - 30 April 2002 pdf icon
Muscletech Research and Development: $30, 723

Media Coverage

Metabolife officials suspected of massive tax evasion
Stephen Barrett MD, Quackwatch.org, 2004-01-24
URL: http://www.quackwatch.org/14Legal/blevins. html

Studies of dietary supplements come under growing scrutiny
Ford Fessenden, the New York Times, 2003-06-23
URL: http://www.pages.drexel.edu/~pa34/dsstudies .htm

Convtroversy weighs heavy on ephedra
Penny Crabtree, San Diego Union Tribune, 2003-02-09
URL: http://www. signonsandiego.com/news/business/20030209-9999_1b9ephedra.html

Triple stack pills may be rushing migrants to death
Susan Carroll, The Arizona Republic, 2003-08-07
URL: http://www.tucsoncitizen.com/index.php?page=local&story_id= 080703a1_drugsmuggler&PHPSESSID=287cc75ca1bcfec83c5e19009

Metabolife execs, worker face subpoenas in ephedra probe
Toby Eckhert, Copley News Service, 2003-07-11
URL: http://www. signonsandiego.com/news/business/20030711-9999_1b11ephedra.html

Little pill, big trouble
Penni Crabtree, San Diego Union Tribune, 2003-07-20
URL: http://www. signonsandiego.com/news/business/20030720-9999_mz1b20metabo.html

Outsider Daniel Troy fought the FDA for decade: now he's helping to run it
Stacey Schultz, US News and World Report Online, 2003-03-24
URL: http://courses.che.umn.edu/02fscn1102-1s/general_food_safety/Ephedra/web% 20pages/USNew3-03DanielTroy.html

Speed Lobbying: Wentworth and Green Revolve the Door From Inside the Building
Michael King, The Austin Chronicle, 2002-10-25
URL: http://www. austinchronicle.com/issues/dispatch/2002-10-25/pols_capitol.html


Last Updated: 2009-03-21

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