The National Center for Homeopathy (NCH) has once again been leading the fight to protect homeopathy from attacks.

The FDA this week sent a Warning Letter to the makers of the over-the-counter drug Zicam over concerns the drug may effect the sense of smell in those who use it.  Zicam contains a 1X  solution of zinc gluconate along with many other ingredients.

An AP news story covering the FDA warning contained a number of points about homeopathy that were flat wrong.  NCH - working closely with the American Association of Homeopathic Pharmacists (AAHP) swung into immediate action to correct those misstatements and protect homeopathy by issuing press releases, speaking with reporters, coordinating the responses of practitioners and by posting special alerts on the NCH websites.

The facts are very simple.  Homeopathy has an exemplary safety record and has maintained that record for over 200 years.  Every government agency that tracks drug safety has verified that fact.  Consumers and healthcare professionals alike should be assured that the FDA’s action in regards to certain Zicam products, does not apply to this class of drugs as a whole.  Rather, the FDA’s advisory relates only to the nasal application of a specific zinc product.

Media Contact:
Mark Land
AAHP President
610-325-8330
mark.land@boiron.com

Homeopathic Pharmacists Association Highlights the Extraordinary Safety Record of Homeopathic Medicines

Santa Rosa, Calif., June 19, 2009—The American Association of Homeopathic Pharmacists (AAHP) acknowledges the U.S. Food and Drug Administration’s (FDA) action to protect the public by sending a Warning Letter to Matrixx Innovations, Inc. in connection with that company’s sale of Zicam intranasal zinc medications. According to FDA, these intranasal zinc products have been associated with a number of cases of loss of smell. Matrixx now has an opportunity to respond to FDA’s concerns about the safety of their products.

However, the AAHP feels it is necessary to clarify misleading issues raised in a nationally syndicated Associated Press article “Zicam not alone in side effect reports” questioning the safety of homeopathic medicines in general. Consumers and healthcare professionals alike should be assured that the FDA’s action in regards to certain Zicam products, does not apply to this class of drugs as a whole. Rather, the FDA’s advisory relates only to the nasal application of a specific zinc product.

Homeopathic medications are regulated by the FDA and have been used safely in the United States since before the passage of the Federal Food, Drug, and Cosmetic Act in 1938. Homeopathic medicines have an extraordinary record of safety. FDA’s Compliance Policy Guide (CPG 7132.15) “Conditions Under Which Homeopathic Drugs May Be Marketed” has been an effective and workable way to regulate homeopathic drugs since 1988 and, as shown by FDA’s action on June 16th, it allows FDA to take action when action is required to protect the public.

To learn more about the regulatory process and the association’s work to better the understanding and appreciation of homeopathic medicines by both professionals and consumers, visit www.homeopathicpharmacy.org.

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About the AAHP

Founded in 1923, the AAHP is a not-for-profit corporation of the State Commonwealth of Virginia, representing the interests of homeopathic manufacturers, distributors, and individual pharmacists in cooperative efforts with regulatory agencies and other organizations nationally.

The AAHP functions as a trade association within the homeopathic pharmaceutical industry to represent the opinions and interests of homeopathic product manufacturers and distributors, to the FDA, other regulatory agencies and other trade associations. In addition, the association promotes high standards in manufacturing and distributing, communicates regulatory changes to member companies through a regular newsletter and promotes professional communication, education, and research within the homeopathic community.

An American Hospital Association survey shows that hospitals in the U.S. are providing more complementary and alternative therapies in addition to conventional services. More than 37% of hospitals responding to the survey offer one or more alternative therapies, compared with 26.5% in 2005. Complementary and alternative therapies offered include homeopathy, massage therapy, acupuncture, chiropractic, diet and lifestyle changes, and herbal medicine. 84% of the hospitals providing such care cited patient demand as a factor in their decision to offer it, and 64% gave clinical effectiveness as their main reason.

For example, in the Washington, DC area, homeopathy is among alternative therapies offered at George Washington University Medical Center and the University of Maryland’s Center for Integrative Medicine.

In addition to their effectiveness, another benefit cited for complementary and alternative therapies is their “green” nature. Reports Time Magazine’s Health and Science section: “Pamela Gray, a trustee of the Transition Network, a U.K.-based organization that supports community-level initiatives to improve sustainability and combat climate change …proposes also that by increasing insurance coverage of so-called alternative medicine—low-energy practices, like acupuncture, homeopathy, nutritionists, herbalists—more patients might seek greener care.”

—compiled from Congressional Quarterly HealthBeat,
September 13, 2008; The Washington Post,
September 16, 2008; Time Health and Science at www.time.com, November 10, 2008

Background: A “meta-analysis” of selected studies of homeopathy’s effectiveness published in the British medical journal The Lancet in August 2005 concluded that any effect from homeopathy was comparable to the placebo effect. The article dealt an enormous blow to homeopathy in Britain and around the world, as it has been cited as justification for discrediting homeopathy entirely.

Now, two new scientific studies of the same evidence conclude that The Lancet review was seriously flawed.

George Lewith, Professor of Health Research at Southampton University, comments: “The review gave no indication of which trials were analyzed nor of the various vital assumptions made about the data. This is not usual scientific practice. If we presume that homeopathy works for some conditions but not others, or change the definition of a ‘larger trial,’ the conclusions change. This indicates a fundamental weakness in the conclusions: they are NOT reliable.”

The Lancet study has been charged with bias previously, but the new studies are based on a full reconstruction of its methods and data. The authors note that the limited number of homeopathic studies makes selective interpretation less valid and cite the desperate need for further clinical studies of homeopathy.

The new studies appeared in October 2008 in The Journal of Clinical Epidemiology 2008; 61(10) and Homeopathy 2008; 97(4).

—reported in Eurekalert, November 3, 2008

An observational study of five homeopathic hospitals in England found that “up to three quarters of patients treated with homoeopathic remedies report an improvement in quality of life.” Published in the journal Homeopathy 2008;97:114, the report describes information gathered from 51 doctors about 1,797 patients. After six visits to a homeopath, 59% to 73% of patients reported improvement in their quality of life, depending on the condition being treated.

- reported in The Pharmaceutical Journal (UK), August 2, 2008

The Birmingham (England) Alliance of Homeopaths (BAH) will begin a six-month pilot project in January 2009, offering homeopathic care to “people in the support services suffering from emotional trauma.” Doctors, nurses, police, firefighters, and military personnel are among those BAH intends to serve. A founding member of BAH, Anne Gorham, learned that Britain’s Ministry of Defense is studying soldiers returning from Iraq and Afghanistan and fears up to 20,000 British troops may be affected by brain injuries and post-traumatic stress symptoms. Basing her comments on BAH’s two years’ experience providing care for people at risk of homelessness, Gorham said, “Counselling can be very useful but perhaps homoeopathy can be more effective in releasing the trauma. Sometimes people can’t find the reasons why they are feeling something, but the remedy gets to where the trauma is lodged in the body whether they know the reason or not.” Britain’s Army Families Federation is supporting and advertising the pilot project.

—reported in Birmingham Post (UK), August 8, 2008

A comprehensive study of the market for natural products including homeopathic medicines foresees enormous growth in this sector over the next four years. Market research firm Packaged Facts predicts that consumer spending on vitamins, minerals, herbals and homeopathic medicines will grow by 39% and reach $8.5 billion by 2012. The study cites this market sector’s 5% growth in 2006 and 8% growth in 2007 as evidence of consumers’ increasing interest in preventive self-care. Its publisher, Tatjana Meerman, says that consumers are taking “more aggressive steps to avert health problems before they occur.”

—reported in Progressive Grocer, August 21, 2008