Saturday, May 26, 2012

DSHEA: The Regulation of Supplements


For some odd reason, many people still believe that the FDA regulates everything consumable in their daily lives.  In actuality, the FDA does not regulate much and they are not a very powerful entity either.  For almost all of the 20th century, there was almost no regulation on consumable products, including supplements and alternative medicine.  But it wasn't until the early 1990's when consumers pushed for regulation of alternative therapies, thus the creation of the Office of Alternative Medicine and subsequent passage of DSHEA were born.
Although the creation of DSHEA is relatively new, it still struggles to maintain order in such a fast-paced, over stimulated, market.  The result being that it sometimes fails to protect consumers from harmful products. Under DSHEA, the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that the supplement or ingredient is safe before it is marketed.  There remains to be one large loophole and it is that the FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.  This current supplement approval method explains why some supplements are allowed to contain ineffective ingredients, toxic ingredients, and powerful ingredients.  One such ingredient was ephedra, which was found to be unsafe in large dosages but remained on the market for years consequently being sold to millions.  It took twenty-three reports of serious health problems and one teenage death before the FDA could force the manufacturers to voluntarily recall it.  An amended DSHEA could place greater responsibility on the manufacturers to prove pre-market product safety and give the FDA more authority in the regulation of products being marketed.
 Sales of dietary supplements have approximately doubled since 1998. This means more consumers are using dietary supplements and/or those using supplements are consuming more. Many supplements are purchased over the internet from foreign countries, like China and South America, and are not made with the same quality checks required in the U.S.  Consumers need to be accurately informed of what products’ uses are and how safe they are. Only 19% of people are receiving their information from CAM providers, 28% from doctors, the remainder from friends/family, advertising, and heath food store sales people. Therefore, the majority of people using dietary supplements are receiving their information from unqualified sources. In 2009, US Government Accountability Office (GAO) reports determined that consumers have difficulty understanding labels on dietary supplements and are not well informed when it comes to safety and efficacy of products.
The supplemental hormone melatonin is now available in the US, but the FDA would have to prove melatonin unsafe before removing its over-the-counter status. We see a wider selection of supplements presently available through health food stores and mail order companies because the FDA bears the burden of proof for supplement safety, not the producers or retailers.  According to Jane E. Henney, M.D., Commissioner Food and Drug Administration, Department of Health and Human Services, “The dietary supplement industry has grown exponentially since the passage of DSHEA. Surveys show that more than half of the U.S. adult population uses dietary supplement products. Annually, consumers spend $12 billion on dietary supplements, according to Nutrition Business Journal in their 1998 Annual Industry Overview.”
As a preventive measure, DSHEA grants FDA explicit authority to establish good manufacturing practice regulations for dietary supplements. Such regulations are intended to assure purity and consistency in dietary supplement products. Regarding labeling, DSHEA seeks to provide consumers with information to help guide personal choice. This includes specially tailored requirements for ingredient and nutrition labeling.
DSHEA also provides for use of claims to affect the structure or function of the body, claims of general well-being from consumption of a nutrient or dietary ingredient, and claims of benefits related to classical nutrient deficiency diseases. These claims require notification to FDA within 30 days after marketing, must be substantiated, and must be accompanied by the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." Finally, DSHEA contains ground rules for publications used in connection with the sale of dietary supplements.
Currently dietary products have to be proven unsafe, contain a controlled substance or have incorrect ingredient labeling to be removed from shelves. If the DSHEA continues to exist, it should impose more regulations to ensure the consumers’ safety. Supporting and strengthening DSHEA means dietary supplements will continue to be widely available and competitively priced for all who make or use them.  The European Union’s Food Supplements Directive is more restrictive than DSHEA. The Food Supplements Directive establishes a “positive list” that enumerates which vitamins, minerals, and other ingredients are permitted in dietary supplements. Amending DSHEA and incorporating several provisions of the Food Supplements Directive would be beneficial and better protect American consumers from unsafe dietary supplements.

Sources:

Bimal, H, Ashar, M, et al. Physician’s Understanding of Regulation of Dietary Supplements. Arch Intern Med. 2007;167(9):966-969.

Denham BE. Dietary Supplements-Regulatory Issues and Implications for Public Health. JAMA July 5, 2011.

Dietary Supplements. U.S. Food and Drug Administration. (2011) accessed on October 22, 2011, from http://www.fda.gov/food/dietarysupplements/default.htm

Gurley BJ, Gardner SF, Hubbard MA: Content versus label claims in ephedra-containing dietary supplements. Am J Health Syst Pharm 2000, 57:963–969.

Nowak RE. DSHEA’s Failure: Why a Proactive Approach to Dietary Supplement Regulation is Needed to Effectively Protect Consumers. U Ill L Rev. 1045. 2010.

http://illinoislawreview.org/article/dsheaas-failure-why-a-proactive-approach-to-dietary-supplement-regulation-is-needed-to-effectively-protect-consumers/ Accessed October 22, 2011. Full PDF: http://illinoislawreview.org/wp-content/ilr-content/articles/2010/3/Nowak.pdf

Monday, May 14, 2012

The Use of Homeopathy: Is It Worth It?


Homeopathic practitioners tend to believe that a combination of treatments for symptom relief as well as for disease progression is the most beneficial for the patient.  Those who do not believe in the effectiveness of homeopathy consider successful treatments a result of the placebo effect or positive thinking.  In the age of scientific positivism, idealistic philosophies generally do not fare well.  This brings us to the question: does homeopathy actually work, or is it just a under-studied, over-hyped philosophy?
Similar to allopathic medicine, homeopathy studies the outcome of the treatment and remedy compared to the placebo, and also relies on prescriptions after the full homeopathic evaluation of the patient.   However, different from allopathic medicine, homeopathy considers the whole constitution of the person as opposed to the sole presentation of symptoms.  Some of the diagnosis rely on examination of mental or emotional symptoms, certain sensations, location of symptoms, direction of symptoms, concomitant symptoms, modalities of sensations, intensity and duration of symptoms, onset and sequence of events leading up to the problem are taken into consideration.  Homeopathic practitioners often spend considerable amount of time with patients, obtaining a detailed history, which helps the homeopathic doctor to match the person and the remedy. Although patients may have the same diagnosis, the homeopathic treatment and/or dose is individualized therefore making it difficult conduct large studies.  There have been clinical trials done in homeopathy; however, since homeopathic treatments are personalized to an individual it is difficult to conduct the strict double-blind scientific studies which are generally used to test the validity of allopathic treatments. Conventional scientific wisdom states that homeopathy should have no effect above and beyond placebo. There are however, some experiments on ultra-high dilutions of solutes together with some clinical data that suggests the possibility that there may be health benefits under some circumstances.   Most of the clinical evidence comes from treating relatively minor self-limiting diseases and little comes from treating life-threatening disorders such as cancer, for example    Patients receiving homeopathic care may feel worse before they become better because homeopathic medicines often stimulate, rather than suppress, symptoms. This seeming reversal of logic is a relevant part of homeopathy because symptoms are viewed as the body's effort to restore health.
The experimental aspects of homeopathy date back to the beginning of the practice with outcome measures based upon improvement of symptoms and/or recovery from illness. Homeopathy began with hypotheses based on finding effective ways to improve caring for patients through less barbaric ways than were in practice in the mid 1700’s, including use of bloodletting, purging, cathartics and cupping.  The Law of Similars, formulated by Samuel Hahnemann puts forth the concept that a remedy can cure a disease if it produces similar symptoms in a healthy person. .  Hahnemann used scientific principles and methods to develop chemical compounds.  Hahnemann believed that the detailed association between patient’s clinical symptoms and the experimental pathogenesis of remedies mirrored a universal law of healing with medicinal substances. He first used himself and his family to experiment with various chemical compounds in healthy people.  Hahnemann was very meticulous about recording his observations and his results which are still the basis of the development of homeopathy today.  More clearly stated, the Law of Similars implies that a substance that can produce symptoms in a healthy person can stimulate self healing in a person with similar psychosomatic responses to an illness.   By definition, the underlying principles of homeopathy include treating “like with like” by remedies which are potentized by serial dilution and succession.
 The aspect of the homeopathic treatment working is measured through improvement, which occurs because the body is able to activate its innate ability to heal, leading to important philosophical principles of the practice.  An important foundational and philosophic concept of homeopathy defines health “as a state of freedom existing on three interrelated levels: the physical, the emotional and mental”.   When symptoms are more serious they are affecting the person more deeply. Hering’s Law of Cures, helps to provide a holistic assessment of individual progress following use of specific provings. The three laws describe progression of healing which begins with the deepest part of the organism; the mental and emotional parts and the vital organs. The second law describes the symptoms appearing and disappearing in reverse chronological order of appearance. The third law is that healing will progress from the upper part of the body to the lower part of the body. When there are exceptions to this, the homeopathic principle of assessing if the patient is improving is the final measure of continuation or change in type of treatment used.  Just as in so many scientific disciplines homeopathy is based upon strong scientific mathematical calculations which are driven by hypothesis to prove or disprove a belief or a question. In the case of homeopathy it is “is the patient getting better”? This yields the philosophy of practice. 
            The National Center for Complementary and Alternative Medicine of the United States’ National Institutes of Health states: “Homeopathy is a controversial area of CAM because a number of its key concepts are not consistent with established laws of science (particularly chemistry and physics). Critics think it is implausible that a remedy containing a miniscule amount of an active ingredient (sometimes not a single molecule of the original compound) can have any biological effect—beneficial or otherwise. For these reasons, critics argue that continuing the scientific study of homeopathy is not worthwhile. Others point to observational and anecdotal evidence that homeopathy does work and argue that it should not be rejected just because science has not been able to explain it.”
            Due to the lack of evidence in research, homeopathy remains controversial. In an evidence report review by British House of Commons Science and Technology Committee it was recommended that because the evidence was lacking in homeopathic treatments, the government should stop funding for research. The committee felt that due to the lack of active ingredients, it was basically placebo treatment and deceptive to consumers and patients. The government’s response included comments that CAM, including homeopathy has a long standing history and because the complexities of the placebo effect are not fully understood that it was not the place of the Department of Health to comment on the ethics of treatment in a particular setting.  They did comment that they expected all practitioners to use treatments that are in the best interest of the patient.
        

References:
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11.  Homeopathy: An Introduction. Controversies Regarding Homeopathy. National Center for Complementary and Alternative Medicine. http://nccam.nih.gov/health/homeopathy/#contoversies Accessed October 15, 2011.
13.  Government Response to the Science and Technology Committee report 'Evidence Check 2: Homeopathy’. http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_117811.pdf   Accessed October 16, 2011.
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