America Has Gotten Lazy:



America Has Gotten Lazy:

Looking for that Quick Fix

Lisa Brodie

Composition II

Cecelia Munzenmaier

Hamilton College

February 27, 2006

America has Gotten Lazy:

Looking for that Quick Fix

The emphasis on weight loss in America has been great for many years now, and many people turn to dietary supplements and diet pills for help. One of the most popular supplements used contained the plant ephedra. These supplements containing ephedra claimed to “promote weight loss, to suppress appetite, and to boost energy levels” (“Ephedra, Ma Huang,” 2003). There were also risks involved in taking these dietary supplements, and they outweighed the benefits. On April 12, 2004 the ban on the sale of ephedra and ephedra products was enforced. Some believe that ephedra is perfectly safe to use for short-term weight loss and want the ban to be lifted to help with the overwhelming problem of obesity in the United States. Others wonder how ephedra was ever released upon the public. They believe the ban needs to remain in place due to the fact that ephedra has too many adverse health risks and is improperly used by athletes.

Ma Huang is another name for ephedra, which came from the Chinese. They have been using ephedra in their medicinal practices for more than 5000 years. According to Clinical Pharmacology, “Ephedra is the genus name for no less than 40 species of herbs also known as Ma haung” (“Ephedra, Ma Huang,” 2003). Ma huang is actually little evergreen shrubs, and the stems and twigs are the only part used because they contain the most alkaloids. Formerly the herbs were only used in treatment of asthma, bronchitis, enuresis and headache, not weight loss (“Ephedra”, 2003).

Bring Back Ephedra

There is an enormous problem with obesity in the United States, “From 1999 through 2002, the prevalence of obesity in the United States increased by 1 percent per year, reaching a level of 19.8 percent among the adult population” (“Ephedra and Ephedrine,” 2003). Obesity is not only costly to those who are obese, but costly to the health care system as well. “By 1995, one study estimated direct cost for obesity at $70 billion” (“Ephedra and Ephedrine,” 2003), more than smoking and excessive drinking. Taking dietary supplements is a fast and easy way to rid of obesity. A review by Shekelle et al. (2003), found “a modest but relatively consistent effect of short-term weight loss from ephedrine or ephedra-caffeine combination products” (“Evidence”, 2003). Americans are continuing to use dietary supplements that may not be any less risky than ephedra-containing supplements.

There Are Adverse Health Risks

There are too many dietary supplements on the market to mention, and they may not all be safe, but ephedra is one of the most dangerous. Ephedra “accounted for 64% of all adverse reactions to herbs in the United States, yet these products represented only 0.82% of herbal product sales” (Bent, Tiedt, Odden, & Shlipak, 2003). Although ephedra may help reduce the problem with obesity in America, it is way too dangerous to the health of Americans to be put back on the market. According to the National Center for Complementary and Alternative Medicine (2004):

After a careful review of the available evidence about the risks and benefits of ephedra in supplements, the FDA found that these supplements present an unreasonable risk of illness or injury to consumers. The data showed little evidence of ephedra’s effectiveness, except for short-term weight loss, while confirming that the substance raises blood pressure and stresses the heart. The increased risk of heart problems and stroke negates any benefits of weight loss. (“Ephedra”)

Many of the people using dietary supplements were not aware of whether or not the supplement contained ephedra; further proving that just placing warning labels on the bottles is not protection enough for users. There is a huge chance that most people don’t read the labels, and therefore they are not aware of the dangers of the supplement.

The dangers are more widespread than just high blood pressure and increased heart rate. Using ephedra or ephedrine, with or without caffeine, “is associated with two to three times the risk of nausea, vomiting, psychiatric symptoms such as anxiety and change in mood, autonomic hyperactivity, and palpitations” (“Ephedra and Ephedrine,” 2003). The warning labels on the bottle warned of heart attacks, strokes, seizures, and death being reported after taking the product (“Wellness Guide”, 2003). Everyone is at risk for any of the adverse reactions to ephedra. In fact, according to University of California at Berkeley Wellness Letter (2003), “Though especially risky for people who have high blood pressure and cardiovascular disease, this herbal stimulant can cause serious reactions in even apparently healthy young people” (“Wellness Guide”).

The risk for heart attack, hemorrhagic stroke, and sudden death in healthy individuals is present when using ephedra. “In the cardiovascular system, ephedrine increases heart rate and therefore cardiac output. Because of its peripheral vasoconstriction activity, ephedrine increases peripheral resistance and can lead to a sustained rise in blood pressure” (“Ephedra and Ephedrine,” 2003). Ephedra also acts on the central nervous system as a stimulant. It stimulates release of dopamine and norepinepherine, which increase the alertness level and better the mood of the individual. The person doesn’t feel fatigue or the need for sleep, their physical activity is greater and there is an “anorexic effect via central effects of norepinephrine on satiety centers in the hypothalamus” (“Ephedra and Ephedrine,” 2003).

The FDA banned the sale of ephedra and ephedra alkaloids in 2004, but that doesn’t mean that they aren’t still out there. According to a 2004 statement from the Food and Drug Administration “The rule, which was published on February 11, 2004 in the Federal Register, declares dietary supplements containing ephedrine alkaloids (ephedra) adulterated because such supplements present an unreasonable risk of illness or injury” (Press release). In January 2006, the FDA called for the seizure of a supplement found to contain ephedrine alkaloids. The United States Attorney’s office recovered five boxes of Lipodrene, a supplement containing ephedrine alkaloids, from Oakmont, Pennsylvania. “The seized products are valued at approximately $16,000" (FDA Requests, 2006).

Ephedra in Sports

There is a history of stimulants being used in sports as far back as the 1900s. The International Olympic Committee banned stimulants from competition in the 1960s after the death of several athletes, but this wasn’t enforced until screening tests were developed in 1972 (“Ephedra and Ephedrine,” 2003). The NCAA also banned the use of ephedra back in 1997. Athletes use dietary supplements a lot more than the general public, and men more than women. Sobal and Marquart reviewed 51 different studies and found that “56 percent of athletes used one or more supplements” (“Ephedra and Ephedrine,” 2003). The use of supplements is most popular in the sports of body building, weight lifting, and ultramarathon running; 94% of elite Australian swimmers use dietary supplements (“Ephedra and Ephedrine,” 2003). Steve Bechler was a pitcher for the Baltimore Orioles who used a weight loss supplement that contained ephedra, and during spring training 2003 the 23-year-old tragically died. Ephedra has an effect on the body’s metabolism and ability to cool itself, which puts athletes at greater risk for harm. The athletes who are at the greatest risk for harm are young people. American College of Sports Medicine President Edward T. Howley said, “Young people don’t sweat as much as adults, so they don’t have the same ability to naturally adjust their body temperature exercising” (“ACSM”, 2003).

How did Ephedra Make it onto the Market?

Dietary supplements are regulated differently than prescription drugs. Supplement products (like ephedra) are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994, and prescription drugs are regulated by the FDA. DSHEA requires that

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 contains 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. (“Ephedra and Ephedrine,” 2003,p. 4)

From there, the FDA can decide whether or not to release the supplement containing the new ingredient. Manufacturers are not required to perform any formal studies regarding the safety of the ingredients before they market it. The supplement will only be removed from the market if it is proved unsafe. The FDA was receiving more than 600 reports claiming adverse reactions to ephedra by 1996, compared to only 300 in 1995 (“Ephedra and Ephedrine,” 2003). The year of 1997 was the first time a rule was proposed to limit the dosage of ephedra in dietary supplements. The rule was, however, short-lived. By 1999 the General Accounting Office reported that “the FDA had insufficient evidence to support dosage and duration limits. As a result, in early 2000, the FDA withdrew a large part of the 1997 proposal” (“Ephedra and Ephedrine,” 2003). Although the active alkaloid in ephedra is ephedrine, which is regulated as a drug, ephedra is still considered a botanical. For that exact reason, ephedra is considered to be a dietary supplement under DSHEA. If it was regulated as a drug it would undergo extensive evaluation and testing before being marketed.

It was not until December of 2003 that FDA released their alert stating that “dietary supplements containing ephedra present a significant and unreasonable human health risk of illness or injury” (“Ephedra, Ma Huang,” 2003). The alert urged the public to stop purchasing and using anything containing ephedra or ephedrine alkaloids. The ruling that ephedra sales be prohibited took effect on April 12, 2004.

The public should be aware of the difference in regulations of over-the-counter dietary supplements and prescription drugs. There were large numbers of fatalities and adverse reactions related to ephedra before the sale was banned. There is an overwhelmingly big problem with obesity in Americans and everyone is looking for a quick solution, but there is often a big price to pay. Ephedra did offer consumers a fast way to drop those pounds, but many suffered immensely for it. The health risks and misuse of ephedra were more devastating with each passing year and it was finally stopped. The large number of side effects, the extra risk for athletes, and the lack of proof for long-term effects are just a few of the reasons why the ephedra ban should and probably will remain in effect. Americans will have to look to more traditional weight loss methods to prevent further fatalities.

References

ACSM urges young athletes to avoid ephedra: Education and caution vital for parents, coaches and athletes. (2003, March 13). [Press release]. Retrieved February 27, 2006, from the American College of Sports Medicine Web site:

Bent, S., Tiedt., T. N., Odden, M. C., & Shlipak, M. G. (2003, March 18). The relative safety of ephedra compared with other herbal products. Annals of Internal Medicine, 138(6),468-71. Abstract retrieved February 27, 2006, from PubMed database.

Ephedra. (2004, April). [Consumer Advisory]. Retrieved January 30, 2006, from the National Center for Complementary and Alternative Medicine Web site:

Ephedra and ephedrine for weight loss and athletic performance enhancement: Clinical efficacy and side effects. (2003). “Ephedra and ephedrine”. Retrieved from the Food and Drug Administration (FDA) Web site:

Ephedra, Ma Huang. (2003, December 31). Clinical Pharmacology. Retrieved February 13, 2006, from Health Source—Consumer Edition database.

Evidence on the safety and effectiveness of ephedra: Implications for regulation [FDA White Paper]. (2003, February 28). Retrieved January 30, 2006, from

FDA announces rule prohibiting sale of dietary supplements containing ephedrine alkaloids effective April 12. (2004, April 12). (Press Release). Retrieved January 30, 2006, from

FDA requests seizure of more dietary supplements containing ephedrine alkaloids. (2006, January 12). (Press Release). Retrieved January 30, 2006, from

Wellness guide to dietary supplements: Ephedra. (2003, May). Retrieved February 13, 2006, from UC Berkeley Wellness Letter Web site:

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