28 February 2017. A U.S. regulatory agency – the Food and Drug Administration (FDA) – took physicians and scientists by surprise late last year. The FDA warned that repeated or lengthy use of general anesthetic and sedation drugs during surgeries in children younger than 3 years or in pregnant women during their third trimester may negatively affect the development of children’s brains. Readers of this web site are familiar with the possible risks from anesthesia, which relies on substances that – at higher doses – can cause lasting toxic effects to brains. Small amounts that trigger (only) deep sedation are often considered safe, as no proof otherwise is available from medical research. Adverse effects are plausible from long-lasting or repeated anesthesia, as supported by studies carried out in monkeys. But clinical research is much less clear and difficult to document. And there are no alternatives, e.g., when you want to save the life of a child with congenital heart disease or other serious condition where surgery is life-saving.
The FDA’s decision was a surprise to the medical professions. Why would FDA focus on essential anesthetic agents with unclear (and perhaps very small) risks and not some of the more obvious chemical brain drainers? It sounds like an application of the precautionary principle, although substitution of the agents is not realistic at present. In addition, many brain-toxic chemicals are within the jurisdiction of the FDA, but the agency has far from a perfect record in protecting the public and the developing brains, and certainly not a precautionary record. Recent examples are arsenic-laden rice cakes, or pesticide residues in baby food. What has the FDA done to secure the brains of the next generation? Not much. Just think of mercury-polluted fish. After many years of debate, FDA last month decided for a new way of advising consumers about healthy fish and seafood diets. Green, yellow and red lights, a very reasonable approach for busy consumers, but FDA listed canned tuna as one of the best choices of fish (green color) – even though calculations show that small tuna (sometimes called jackfish) causes at least one quarter of American consumers’ mercury exposure (and the content of omega-3 fatty acids is not high enough to allow tuna special treatment).
So what about BPA, the substance that can leak from certain plastic containers or from the inside lining of food cans? The agency believes that “low” BPA exposures are safe, although research is ongoing to determine the chemical’s impact on human hormones. So we should apparently allow the exposures until we know for sure that they are unsafe. Phthalates then? They are almost ubiquitous plastics additives used in food wrapping materials. No luck, FDA is not acting, even after FDA was petitioned to act by 200,000 consumers.
While strong action against polluted rice cakes, phasing out certain plastics materials used in food packaging, or advice to avoid tuna would likely be met with widespread support, much more is at stake with the anesthetic agents. An estimated 1.5-2 million American children below 3 years of age annually undergo surgical procedures that require anesthesia. Many of the treatments cannot be postponed until the child is 3. Among the few alternatives are the opium-derived pain-killers, but they are insufficient for general anesthesia. Physicians writing in the New England Journal of Medicine this month approve of the protection of developing brains, but they are uncomfortable to be forced to discuss anesthesia with parents and medical colleagues when no attractive alternatives present themselves.
May we propose to the FDA that they keep a low profile on anesthesias for now and instead focus on some low-hanging fruit that could have immense benefits to millions of developing brains?