Regulation of alternative medicine

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Because of the uncertain nature of various alternative therapies and the wide variety of claims different practitioners make, alternative medicine has been a source of vigorous debate, even over the definition of "alternative medicine". [1] [2] Dietary supplements, their ingredients, safety, and claims, are a continual source of controversy. [3] In some cases, political issues, mainstream medicine and alternative medicine all collide, such as in cases where synthetic drugs are legal but the herbal sources of the same active chemical are banned. [4]

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In other cases, controversy over mainstream medicine causes questions about the nature of a treatment, such as water fluoridation. [5] Alternative medicine and mainstream medicine debates can also spill over into freedom of religion discussions, such as the right to decline lifesaving treatment for one's children because of religious beliefs. [6] Government regulators continue to attempt to find a regulatory balance. [7]

Jurisdiction differs concerning which branches of alternative medicine are legal, which are regulated, and which (if any) are provided by a government-controlled health service or reimbursed by a private health medical insurance company. The United Nations Committee on Economic, Social and Cultural Rights – article 34 (Specific legal obligations) of the General Comment No. 14 (2000) on The right to the highest attainable standard of health – states that

Furthermore, obligations to respect include a State's obligation to refrain from prohibiting or impeding traditional preventive care, healing practices and medicines, from marketing unsafe drugs and from applying coercive medical treatments, unless on an exceptional basis for the treatment of mental illness or the prevention and control of communicable diseases.

—  [8]

Specific implementations of this article are left to member states. Two governments, acting under the laws of their respective countries, maintain websites for public information making a distinction between "alternative medicine" and "complementary medicine". In North America, the National Institutes of Health (NIH) (a part of the U.S. Department of Health and Human Services) states:

"...people often use the words “alternative” and “complementary” interchangeably, but the two terms refer to different concepts: 'Complementary' generally refers to using a non-mainstream approach together with conventional medicine. 'Alternative' refers to using a non-mainstream approach in place of conventional medicine. True alternative medicine is not common. Most people use non-mainstream approaches along with conventional treatments. And the boundaries between complementary and conventional medicine overlap and change with time. For example, guided imagery and massage, both once considered complementary or alternative, are used regularly in some hospitals to help with pain management."

In the British Isles, the National Health Service (England)'s NHS Choices (owned by the Department of Health) states:

"Although 'complementary and alternative' is often used as a single category, it can be useful to make a distinction between complementary and alternative medicine. This distinction is about two different ways of using these treatments". "Treatments are sometimes used to provide an experience that is pleasant in itself. This can include use alongside conventional treatments, to help a patient cope with a health condition. When used this way the treatment is not intended as an alternative to conventional treatment. The US National Center for Complementary and Integrative Health (NCCIH) says that use of treatments in this way can be called 'complementary medicine'. Treatments are sometimes used instead of conventional medicine, with the intention of treating or curing a health condition. The NCCIH says that use of treatments in this way can be called 'alternative medicine'. There can be overlap between these two categories. For example, aromatherapy may sometimes be used as a complementary treatment, and in other circumstances is used as an alternative treatment. A number of complementary and alternative treatments are typically used with the intention of treating or curing a health condition. Examples include: homeopathy, acupuncture, osteopathy, chiropractic, herbalism."

United States

In the United States the Food and Drug Administration's online warnings for consumers about medication health fraud [9] includes a section on Alternative Medicine Fraud, [10] such as a warning that Ayurvedic products generally have not been approved by FDA before marketing. [11]

Texas

In the state of Texas, physicians may be partially protected from charges of unprofessional conduct or failure to practice medicine in an acceptable manner, and thus from disciplinary action, when they prescribe alternative medicine in a complementary manner, if board specific practice requirements are satisfied and the therapies utilized do not present "a safety risk for the patient that is unreasonably greater than the conventional treatment for the patient's medical condition." [12]

New Zealand

In New Zealand, alternative medicine products are classified as food products, so there are no regulations or safety standards in place. [13]

Australia

In Australia, the topic is termed as complementary medicine and the Therapeutic Goods Administration has issued various guidances and standards. [14] Australian regulatory guidelines for complementary medicines (ARGCM) demands that the pesticides, fumigants, toxic metals, microbial toxins, radionuclides, and microbial contaminations present in herbal substances should be monitored, although the guidance does not request for the evidences of these traits. [15] However, for the herbal substances in pharmacopoeial monographes, the detailed information should be supplied to relevant authorities [16]

The production of modern pharmaceuticals is strictly regulated to ensure that medicines contain a standardized quantity of active ingredients and are free from contamination. Alternative medicine products are not subject to the same governmental quality control standards, and consistency between doses can vary. This leads to uncertainty in the chemical content and biological activity of individual doses. This lack of oversight means that alternative health products are vulnerable to adulteration and contamination. [17] This problem is magnified by international commerce, since different countries have different types and degrees of regulation. This can make it difficult for consumers to properly evaluate the risks and qualities of given products.

Denmark

In Denmark, herbal and dietary supplements is the designation of a range of products, which have in common their status as medicine belonging under the Danish Medicines Act. [18] In the Danish Medicines Act there exist four types of herbal and dietary supplements: Herbal medicinal products, [19] Strong vitamin and mineral preparations, [20] Traditional botanical medicinal products [21] and Homeopathic medicinal products. [22] Some dietary supplements [23] fall within a special category of products, which differ from the above in that they are not authorized medicinal products. Dietary supplements are regulated under the Food Act and are registered by the Danish Veterinary and Food Administration.

Alternative therapists

Denmark has a registration system for alternative therapy practitioners, RAB. [24]

Switzerland

The Swiss Federal Constitution prescribes that the Confederation and the Cantons shall, within the scope of their powers, ensure that consideration is given to complementary medicine. [25]

United Kingdom

Herbs & Acupuncture Herbs & Acupuncture.jpg
Herbs & Acupuncture

Safety, quality and efficacy are the only criteria on which United Kingdom legislation is founded to control human medicines. [26] Regulation of medicines and medical devices, to ensure they work and are acceptably safe, is the responsibility of the Medicines and Healthcare products Regulatory Agency. The legal status of medicines is determined under the Medicines Act 1968 and European Council Directive 2001/83/EC which control the sale and supply of medicines. The legal status of medicinal products is part of the marketing authorisation which allows products to be available on a prescription (referred to as Prescription Only Medicines), or in a pharmacy without prescription under the supervision of a pharmacist, or on general sale and saleable in general retail outlets without the supervision of a pharmacist. [27]

There are 12 organisations in the United Kingdom known as health and social care regulators. Each organisation oversees one or more of the health and social care professions by regulating individual professionals across the UK. [28] The General Medical Council is one of these, for medical practitioners who as physicians are registered and licensed to practise under the Medical Act 1983. Councils for other practitioners include the General Chiropractic Council under the Chiropractors Act 1994 and the General Osteopathic Council under the Osteopaths Act 1993.

See also

Related Research Articles

Alternative medicine describes any practice that aims to achieve the healing effects of medicine, but which lacks biological plausibility and is untested, untestable or proven ineffective. Complementary medicine (CM), complementary and alternative medicine (CAM), integrated medicine or integrative medicine (IM), and holistic medicine are among many rebrandings of the same phenomenon. Alternative therapies share in common that they reside outside medical science, and rely on pseudoscience. Traditional practices become "alternative" when used outside their original settings without proper scientific explanation and evidence. Frequently used derogatory terms for the alternative are new-age or pseudo, with little distinction from quackery.

Food and Drug Administration agency of the United States Department of Health and Human Services

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

Homeopathy Pseudoscientific system of alternative medicine based on the doctrine of "like cures like"

Homeopathy or homœopathy is a pseudoscientific system of alternative medicine. It was created in 1796 by Samuel Hahnemann. Its practitioners, called homeopaths, believe that a substance that causes symptoms of a disease in healthy people would cure similar symptoms in sick people; this doctrine is called similia similibus curentur, or "like cures like". Homeopathic preparations are termed remedies and are made using a process called homeopathic dilution. This process involves repeatedly diluting a chosen substance, typically until nothing—that is, not even a single molecule—of the original substance is likely to remain in the product. Between the dilution iterations homeopaths practice hitting and/or violently shaking the diluent, and claim that it makes the diluent remember the original substance after its removal. The diluent is typically either distilled water, ethanol or sugar. Practitioners claim that such preparations, upon oral intake, can treat or cure disease.

Dietary supplement Product that provides additional source of nutrients

A dietary supplement is a manufactured product intended to supplement the diet when taken by mouth as a pill, capsule, tablet, or liquid. A supplement can provide nutrients either extracted from food sources or synthetic, individually or in combination, in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, as for example collagen from chickens or fish. These are also sold individually and in combination, and may be combined with nutrient ingredients. In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The European Commission has also established harmonized rules to help insure that food supplements are safe and properly labeled.

The National Council Against Health Fraud (NCAHF) was a not-for-profit, US-based organization, run by Dr. Stephen Barrett, a retired American psychiatrist and author, that described itself as a "private nonprofit, voluntary health agency that focuses upon health misinformation, fraud, and quackery as public health problems." The NCAHF has been criticized by the supporters of the treatments it opposes, including practitioners of alternative medicine.

Prescription drug licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained

A prescription drug is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

Herbal medicine Study and use of supposed medicinal properties of plants

Herbal medicine is the study of botany and the use of medicinal plants. Plants have been the basis for medical treatments through much of human history, and such traditional medicine is still widely practiced today. Modern medicine makes use of many plant-derived compounds as the basis for evidence-based pharmaceutical drugs. Although herbalism may apply modern standards of effectiveness testing to herbs and medicines derived from natural sources, few high-quality clinical trials and standards for purity or dosage exist. The scope of herbal medicine is sometimes extended to include fungal and bee products, as well as minerals, shells and certain animal parts.

Nutraceutical class of nutritional product

A nutraceutical or 'bioceutical' is a pharmaceutical alternative which claims physiological benefits. In the US, "nutraceuticals" are largely unregulated, as they exist in the same category as dietary supplements and food additives by the FDA, under the authority of the Federal Food, Drug, and Cosmetic Act.

Federal Food, Drug, and Cosmetic Act Acts of the United States Congress that authorized the Food and Drug Administration to oversee the safety of food, drugs, medical devices, and cosmetics

The United States Federal Food, Drug, and Cosmetic Act, is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.

The health freedom movement is a libertarian coalition that opposes regulation of health practices and advocates for increased access to "non-traditional" health care.

The pharmaceutical industry in Bangladesh is one of the most developed technology sectors within Bangladesh. Manufacturers produce insulin, hormones, and cancer drugs. This sector provides 97% of the total medicinal requirement of the local market. The industry also exports medicines to global markets, including Europe. Pharmaceutical companies are expanding their business with the aim to expand the export market.

The Alliance for Natural Health (ANH) is an advocacy group founded in 2002 by Robert Verkerk and based in the United Kingdom. ANH was founded to raise funds to finance a legal challenge of the EU Food Supplement Directive. ANH lobbies against regulation of dietary supplements, in favour of pseudo-scientific alternative medicine, and advocates dietary and other lifestyle approaches to health. It also criticizes established science showing that Megavitamin therapy lack any health benefit.

Regulation of acupuncture is done by governmental bodies to ensure safe practice.

Regulation and prevalence of homeopathy

Homeopathy is fairly common in some countries while being uncommon in others. In some countries, there are no specific legal regulations concerning the use of homeopathy, while in others, licenses or degrees in conventional medicine from accredited universities are required.

The Foundation for Integrated Health (FIH) was a controversial charity run by Charles, Prince of Wales, founded in 1993. The Foundation promoted complementary and alternative medicine, preferring to use the term "integrated health", and lobbied for its inclusion in the National Health Service. The charity closed in 2010 after allegations of fraud and money laundering led to the arrest of a former official.

Nutrition Labeling and Education Act of 1990 US law

The Nutrition Labeling and Education Act (NLEA) is a 1990 United States Federal law. It was signed into law on November 8, 1990 by President George H. W. Bush.

Traditional African medicine

Traditional African medicine is a traditional medicine discipline involving indigenous herbalism and African spirituality, typically involving diviners, midwives, and herbalists. Practitioners of traditional African medicine claim to be able to cure various and diverse conditions such as cancers, psychiatric disorders, high blood pressure, cholera, most venereal diseases, epilepsy, asthma, eczema, fever, anxiety, depression, benign prostatic hyperplasia, urinary tract infections, gout, and healing of wounds and burns and even Ebola.

Dietary Supplement Health and Education Act of 1994

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.

Alternative medicine describes any practice which aims to achieve the healing effects of medicine, but which lacks biological plausibility and is untested or untestable. Complementary medicine (CM), complementary and alternative medicine (CAM), integrated medicine or integrative medicine (IM), and holistic medicine are among many rebrandings of the same phenomenon.

References

  1. ↑ Can Mainstream Medicine and Alternative Therapies Coexist?
  2. ↑ Mary Ann Liebert, Inc. – The Journal of Alternative and Complementary Medicine – 12(7):601
  3. ↑ "Nutritionist calls for tighter regulation of supplements". CNN. Retrieved 2010-04-23.
  4. ↑ Former Surgeon General: Mainstream Medicine Has Endorsed Medical Marijuana | DrugReporter | AlterNet
  5. ↑ Informed Public Debate Needed On Water Fluoridation
  6. ↑ Book Review by Janice Dickin – Rennie B. Schoepflin; Christian Science on Trial: Religious Healing in America.
  7. ↑ Dietary Supplement Regulation: U.S. Food and Drug Administration Public Hearing
  8. ↑ Committee on Economic, Social and Cultural Rights. General Comment No. 14 (2000) The right to the highest attainable standard of health : . 11/08/2000. E/C.12/2000/4. "Archived copy". Archived from the original on May 9, 2009. Retrieved 2013-01-14.CS1 maint: archived copy as title (link)
  9. ↑ FDA Medication Health Fraud
  10. ↑ FDA, Alternative Medicine Fraud
  11. ↑ FDA, Use Caution With Ayurvedic Products
  12. ↑ Tex. Admin. Code § 200.3. Complementary and Integrative Medicine: An Update for Texas Physicians
  13. ↑ "David Schnauer: Therapeutics bill must pass". The New Zealand Herald . 6 July 2007. Retrieved 16 September 2011.
  14. ↑ Therapeutic Goods Administration. "Regulation of complementary medicines". Archived from the original on 13 May 2009. Retrieved 17 May 2009.
  15. ↑ Therapeutic Goods Administration (2005). "Australian Regulatory Guidelines for Complementary medicines (ARGCM), Part III Evaluation of Complementary Medicine Substances" (PDF). Archived (PDF) from the original on 14 May 2009. Retrieved 17 May 2009.
  16. ↑ Therapeutic Goods Administration (2006). "EU Guideline – as Adopted in Australia by the TGA – with Amendment" (PDF). Archived (PDF) from the original on 19 May 2009. Retrieved 17 May 2009.
  17. ↑ Agin, Dan (2006-10-03). Junk Science: how politicians, corporations, and other hucksters betray us . Thomas Dunne Books. pp. Ch. 8. ISBN   978-0-312-35241-7.
  18. ↑ Herbal and dietary supplements in Denmark www.vifab.dk/uk
  19. ↑ Herbal Medicine Products in Denmark www.vifab.dk/uk
  20. ↑ Strong vitamin and mineral preparations in Denmark www.vifab.dk/uk
  21. ↑ Traditional botanical medicinal products in Denmark
  22. ↑ Homeopatic medicinal products in Denmark www.vifab.dk/uk
  23. ↑ Dietary supplements in Denmark www.vifab.dk/uk
  24. ↑ Registration of Alternative Practitioners – RAB, Knowledge and Research Center for Alternative Medicines homepage
  25. ↑ Art.118a Complementary medicine: The Confederation and the Cantons shall within the scope of their powers ensure that consideration is given to complementary medicine. In official language, German , French , Italian
  26. ↑ MHRA: How we regulate medicines
  27. ↑ MHRA: Licensing of medicines ,Legal status and reclassification,
  28. ↑ GMC: UK Health and Social Care Regulators
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