Tightening the nuts

The FDA is going to make life a little more difficult for homeopaths

Anna Kerman, XX2 century, according to The Washington Post: FDA takes more aggressive stance towards homeopathic drugs

On Monday, the US Food and Drug Administration (FDA) proposed to tighten the policy on homeopathic medicines. According to representatives of the Department, such "medicines" are unsafe – they may, for example, contain potentially harmful components or be positioned as a means to treat cancer, cardiovascular diseases, alcoholism or opioid addiction, while being pacifiers.

Homeopathy is based on a concept proposed in the XVIII century. According to the creators of this approach, substances that cause symptoms characteristic of certain diseases can – if injected into the body in very small quantities – cure the same symptoms. Modern evidence-based medicine, based on the results of numerous studies, has refuted the main provisions of homeopathy and demonstrated that homeopathic remedies are useless at best and dangerous at worst.

According to US law, homeopathic medicines must undergo the same registration procedure as conventional medicines. However, based on a document adopted in 1988, the FDA uses a "selective application of law" that allows the production and distribution of homeopathic "medicines" without FDA approval. The heads of the Department do not plan to force homeopathy manufacturers to get approval – according to the FDA management, such a decision would be "impractical". However, the policy regarding homeopathic medicines that pose a threat to health should soon change.

As an example of dangerous homeopathic remedies, we can name homeopathic preparations intended for injection, recommended for use in especially vulnerable groups of patients (in particular, the elderly and children). The concerns of the experts of the Department were also caused by homeopathic "medicines" labeled as means to combat serious diseases.

A little over a year ago, homeopathic pills to relieve teething symptoms caused 10 infant deaths, and 400 more children received poisoning of varying severity.

After this incident, the FDA laboratories confirmed that the product contained "belladonna in excessive and unstable concentrations."

"Once homeopathic remedies were niche products. Now homeopathy has turned into an industry with a three-billion turnover. Buyers are offered homeopathic medicines for all diseases, starting with oncological and ending with colds, – the representative of the FDA said in a statement Scott Gottlieb. "In many cases, people will spend money and pin their hopes on therapy that can bring little benefit, not bring it at all or, worse, cause significant and even irreversible harm to health." Among the possible reasons for the danger of homeopathic "medicines" Gottlieb called the poor quality of production and the use of unsafe ingredients.

Now, Gottlieb added, the Department wants to find a balance between safety considerations and the needs of people who want to continue using homeopathic medicines.

According to the plan, many funds will not be classified as "high-risk" and will remain on sale. Janet Woodcock, director of the Center for Drug Evaluation and Research (Center for Drug Evaluation and Research) of the FDA, told reporters about this during a teleconference.

The plans of the FDA have already attracted criticism from the National Center for Homeopathy (National Center for Homeopathy) of the USA.

At the same time, Steven Salzberg, a biomedical engineer from Johns Hopkins University, who previously reproached the FDA for inaction, noted that the marketing of homeopathic remedies suggests that the drugs contained in the boxes "treat everything: pain, colds, asthma, indigestion, arthritis – you can continue list by yourself. At the same time, there is no evidence of the effectiveness of homeopathy in nature. From a scientific point of view, homeopathy is just nonsense, it is closer to religious views than to scientific ones."

Over the past few years, the FDA has repeatedly issued warnings regarding homeopathic remedies, for example, zinc–containing intranasal homeopathic forms that can cause loss of sense of smell. The warnings also concerned anti-asthma drugs and other "medicines" containing strychnine, a poison used to control rodents.

Recall that

– in November 2016, the US Federal Trade Commission demanded that the labels of all homeopathic remedies sold without a prescription indicate that a) there is no scientific evidence of the effectiveness of the product and b) all statements about the benefits of homeopathy are based on theories created in the 1700s and not recognized by modern experts in the field of medicine;

– in February of this year, a memorandum on the pseudoscience of homeopathy was published by the RAS Commission on combating pseudoscience;

– In July, the National Health Service of England announced that it was ceasing to purchase homeopathic medicines at public expense;

– In September, the Scientific Advisory Council of the European Academies made a statement on the need to strengthen criticism of homeopathy.

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