One of the persistent themes we confront at SBM is the evolving double-standard in clinical medicine. On the one hand, in mainstream medicine there is a push for higher standards of science and evidence and more effective regulation. At the same time proponents of “alternative medicine” are constantly seeking ways to water down scientific standards and loosen regulations. This is sold to the public as “health care freedom“, with alternative products and services shrouded in the appeal to nature fallacy.
It is therefore useful to do what we can to inform and remind the public that alternative treatments do not exist in a separate magical world where the laws of nature are suspended, rules of scholarship and quality science do not matter, and being “natural” is enough to guarantee safety and effectiveness. Snake oil peddlers do not have your best interest in mind, only your wallet. And these fanciful treatments are not always harmless (as David pointed out earlier this week).
I myself have pointed out numerous times that herbs are drugs. They are not supplements and are not taken for their (negligible) nutritional value. They are drugs, taken for their pharmaceutical effects. They are poorly regulated, often contaminated, adulterated, and substituted drugs, with variable dosing, and poorly understood interactions and toxicity. And yet, in the US (under DSHEA) they are essentially regulated like food, or cleared under the principle of GRAS (generally regarded as safe). The public is led to believe they are safe because they are “natural”, even though the deadliest substances known to science occur in nature.
A recent study highlights once again the fallacy of assuming that alternative or “natural” remedies are automatically safe, and that effective regulation is essential. The study comes from India, but it should be noted that 25% of herbal products produced in India are exported to the US, amounting to $688 million per year. Many products are also imported from China. The supplement industry is global, and we cannot assume good manufacturing practice. In fact, the evidence shows an industry rife with problems.
The study focused on liver toxicity (hepatotoxicity), and specifically on acute chronic liver failure (ACLF). They looked at 386 alternative products in 91 consecutive patients presenting with side effects and receiving alternative treatments. They found:
“ACLF occurred in 39.6% of all patients (36/91) and 41.9% of those with hepatic adverse events (36/86), with associated mortality of 38.9% (14/36) compared to 10.9% (6/55) in non-ACLF presentations (OR 5.20, P = 0.004). Heavy metals exceeded WHO limits in many products: mercury (34%), cadmium (25%), arsenic (21%), and lead (14%). Cadmium exposure exceeding WHO limits showed a strong association with ACLF (75.9% vs 22.6%, P<0.001, FDR q<0.001). The association with mortality did not reach statistical significance after correction for multiple comparisons (34.5% vs 16.1%, uncorrected P = 0.061, FDR q=0.24). Undeclared pharmaceutical adulteration (at least one adulterant found in 27.7% of products; exposure to at least one adulterated product in 46.2% of patients) and animal-derived content (31.3%) were prevalent. Notably, unlabeled product consumption significantly predicted mortality (P = 0.025).”
Liver toxicity is a common problem with any potential pharmaceutical, as the liver is one of the main organs that metabolizes drugs. During drug development, 20% of promising new candidates fail due to liver toxicity. But imagine if such testing were not even required.
What the study found is not surprising, given prior research. It confirmed a high level of contamination (unintentional inclusion of a substance), mostly with heavy metals. It also found adulteration, which is the deliberate inclusion of an unlabeled pharmaceutical or animal product. It also found substitution, replacing the labeled ingredient with something else. If the product causing ACLF included an unlabeled ingredient, that significantly correlated with death from liver injury.
This is not surprising, because herbs are drugs, and many drugs cause liver toxicity. This is about what we would expect from exposing the public to untested and/or unlabeled drugs, often contaminated with heavy metals. Just being unlabeled is a significant risk, because consumers don’t know what they are taking, and may have reasons to avoid any product that is stressful to the liver. This is combined with the false “natural” health halo, giving consumers an unwarranted sense of safety.
The remedy for this situation is obvious, but we simply lack the political will to take the necessary steps. Senator Dick Durbin has just reintroduced the Dietary Supplement Listing Act, legislation to require dietary supplement manufacturers to register their products with the Food and Drug Administration (FDA). This has already failed in the Senate twice – this is the most basic regulation, requiring a minimum of transparency, and cannot get passed into law.
Such a listing act would only be the beginning of truly effective regulation. Right now manufacturers are trusted to regulate themselves, and are not required to prove their products are safe. The FDA has the burden of showing there is a problem with any product, and when they do it typically results in a warning letter, most of which result in no change.
The manufacture and marketing of health products, especially those intended to be taken orally as a pharmaceutical, should be carefully regulated. Industry should have to prove good manufacturing practice, and that their products do not contain any significant contamination, adulteration, or substitution. Product labels should also be completely transparent, with appropriate warnings of interactions and side effects – just like other drugs. Imported herbal drugs should meet the same standards.
This is especially true because the majority of the public already thinks that these products are regulated, even though they aren’t (another source of false security). Surveys show that most people using herbal products have chronic illness, making them more susceptible to toxicity, side effects, and drug-drug interactions. Many use them as a first line, before or instead of regulated drugs, on the marketed promise that they are safer.
This anti-consumer and pro-industry situation is partly due to the intense lobbying by the supplement industry to keep effective regulations at bay. They complain about “big pharma”, an industry not without its issues, but which is highly regulated. Meanwhile, “big supplement” is largely unregulated, uses demonstrably poor manufacturing practices, deceptive marketing, while providing very little in the way of demonstrable health benefit. Looking at the totality of evidence, it is reasonable to conclude that the supplement industry is a net negative on consumer health, while annually taking in $210-$250 billion globally (about $63 billion in the US).
It’s time for some common sense regulation.
