Tuesday, September 4, 2012

Homeopathy Takes Some Hits

The Food and Drug Administration (FDA) recently uncovered significant violations at one of the world's largest manufacturers of homeopathic products. It is only the latest in a long line of blows to the homeopathy industry, both in Europe and the United States.

For example a major medical insurance company in the U.K. recently stopped paying for homeopathic treatment, citing no evidence that homeopathy is effective.

Homeopathy was invented around 1796 by a doctor named Samuel Hahnemann. He believed (contrary to the principles of physics) that homeopathic medicines become more effective the more they are diluted.

Homeopathic solutions are often so literally watered-down that they don't contain a single molecule of the original medicine or substance: the patient is drinking nothing but water. Homeopathic medicines have not been shown to work better than placebos, yet many people use and endorse homeopathy.

In 2009 the British Science and Technology Select Committee conducted a comprehensive study into whether homeopathy has any scientific validity. The report was devastating:"homeopathy is not efficacious, and explanations for why homeopathy would work are scientifically implausible."

Even professional homeopathic practitioners admitted that basic claims made about homeopathy have never been tested nor proven.

Homeopathic products from A Nelson & Co., a British company that manufactures many products including Nelson's line of pain relievers, digestion aids, emotional aids, energy, acne products and Bach Rescue Remedies sold in America were inspected by the Food and Drug Administration and the conclusions are alarming.

FDA Homeopathy Investigation

In a July 26, 2012, warning letter the FDA informed Nelson's that:

During the inspection, the [FDA] investigator observed glass fragments present during the manufacture... Your firm failed to implement adequate measures to prevent glass contamination and had no documentation to demonstrate that appropriate line clearance and cleaning is conducted following occurrences of glass breakage, which has been a recurring problem.
While the presence of glass in any drug or food is alarming, what should be of bigger concern is that because the manufacturer's dispensing machine was broken, one in six bottles in a sample batch of the homeopathic preparation was never even filled with the product they were selling -- yet not a single homeopathic practitioner or patient noticed!
The investigator also observed for Batch #36659 that one out of every six bottles did not receive the dose of active homeopathic drug solution due to the wobbling and vibration of the bottle assembly during filling of the active ingredient. The active ingredient was instead seen dripping down the outside of the vial assembly. Your firm lacked controls to ensure that the active ingredient is delivered to every bottle.
Imagine if an error was made in the manufacturing of an important life-saving drug, and one out of six pills had no active ingredient at all: Doctors and patients would quickly realize that there was something terribly wrong. But because most homeopathic medications literally have no active ingredient in the first place, any pain relief is attributable to the placebo effect. It makes perfect sense that no one would notice that there was no active ingredient in the preparation, since there's no active ingredient in the medicine even when the bottles are correctly and properly filled.

Skirting Drug Regulations

Most manufacturers of homeopathic preparations sold in the United States try to get around the law requiring that they prove their products are safe and effective. One method is to include a legal warning on the packaging that any statements about what the product does be followed in fine print with the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease."

By explicitly referring to alternative medicines and homeopathic preparations as dietary supplements instead of drugs, manufacturers avoid any legal obligation to prove that what they sell works. In addition to the other problems, the FDA found that Nelson's had made claims about their products that would classify them as drugs:

Your product labeling documents the intended uses of your products including, but not limited to the following: Arnica: "Homeopathy, such as the homeopathic remedy Rhus tox and Arnica, has been traditionally used to help relieve the symptoms of rheumatoid and osteoarthritis." Arnileve: "Apply Arnileve Arnica Cream liberally to the affected area in order to reduce inflammation and hasten recovery time." Based on the above labeling and claims, these products are drugs...because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and...because they are intended to affect the structure or any function of the body.
In one strange effort to avoid scrutiny from public health officials, a leading manufacturer of homeopathic remedies is considering marketing their (supposedly efficacious) homeopathic pills and preparations as candy. Any "medication" which can simply and accurately be re-labeled as "confectionary" is no medication at all.

This move seems like a glaring admission that homeopathic preparations do nothing for the body. Any drug or medication that can benefit a patient can also harm a patient; there are risks to any active ingredient, from ibuprofen to statins. Candies, on the other hand, are simply sugary confections that pose no risk to anyone whether you take them or not -- just like placebos.

Radford, Benjamin. 2012. "Homeopathy Takes Some Hits". Discovery News. Posted: August 21, 2012. Available online: http://news.discovery.com/human/homeopathy-takes-hits-in-europe-us-120821.html

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