Safety issues in herbal medicine
The World Health Organisation (WHO) recognises two criteria for assessing the safety of herbal medicines. First is the long period of traditional use of herbal medicine without documented or reported adverse effect or harm and second is scientific-based evidence.
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This criteria is a fall-out from the workshop aimed at regulating herbal medicine in international commerce held in Tokyo in 1986 and subsequently Paris, in 1989. Traditional use here refers to documentary evidence that a herbal medicine has been used over three or more generations or several decades for specific health-related or medicinal purpose. It may also infer community knowledge of the existence and application of a substance without necessarily carrying with it any scientific scrutiny.
In fact, a guiding principle in assessing safety of herbal medicine by regulators is that, if the product has been traditionally used without demonstrated harm, then no specific restrictive regulatory action should be undertaken unless new evidence demands a revised risk-benefit assessment.
However, in the absence of documentation of a long historical use or where there is uncertainty about the safety of herbal medicine, additional toxicity studies should be performed. A researcher puts it this way, “the issue is not how safe and effective your herbal product is but how consistently safe and effective your product is.”
With this understanding, let us now delve into some safety issues and the necessary actions that need to be taken by stakeholders to address. There are several facets of safety that players in the industry, especially manufacturers, need to tackle by way of continuous training and education.
The writer would, however, touch on one major and most common aspect and what manufacturers need to do.
The problem of adulteration
Although adulteration may be due to the environmental contamination of the herb with a chemical and also unintentional substitution of one or more herbal ingredients with a toxic species, researchers consider adulteration as the deliberate addition of ingredients often undisclosed, and which may or may not cause adverse reactions when consumed. The adverse effect may include liver and kidney failure, stroke, etc.
On Wednesday, July 22, 2015, the Food and Drugs Authority (FDA) banned the advertisement of six ‘Manpower’ drugs. The supposedly herbal aphrodisiacs were adulterated with Verdanafil, an orthodox drug for treating erectile dysfunction. Again on August 12, 2015, in the Daily Graphic, the FDA said it had discovered a plot, trend in which some service providers presented genuine products for registration but later criminally adulterated those products for selfish intent.
Overcoming adulteration
The problem can be overcome at the following three stages; pre-production, production and post-production stages. Manufacturers must consult the services of experts in taxonomy and botany, during the plant sourcing process to appropriately identify plants that are actually intended for a particular preparation, as well as phytochemistry to also perform phytochemical screening on herbs to identify active ingredients in them before production. Second, quality checks must be carried out at every stage during the production to prevent any unintentional infiltration, as well as application of Good Manufacturing Practices (GMPs). Post-production quality control checks must be conducted as the last test for any adulteration by the manufacturer himself before post-market surveillance by the FDA and pharmacovigilance.
What critics ought to know
It is important to state that all consumers of substances deemed medicinal, including herbal remedies and supplements, should be cautious with regard to dosage, safety, efficacy, regulation and certification among others.
However, critics of Complementary or Alternative Medicine (CAM) have mounted platforms to denigrate the practice, practitioners, and scientists as well as allied professionals who are continuously advancing the field of herbal medicine through cutting-edge scientific technology for the betterment of mankind. While some of these critics do not have adequate information in the field, others are sycophantic. Some even erroneously assert that it was risky for any person to seek herbal solutions for certain health needs.
The Point of Difference (POD) from the research and marketing perspective is that the safety and efficacy, as well as the performance of a well-researched herbal medicine can be empirically and scientifically attested to, as opposed to that which has not been properly researched, tried and tested.
The impression created by some commentators that all herbal medicines and supplements are dangerous is, therefore, a major flaw. Is the danger due to the fact that it is herbal-based?
What about the myriad of orthodox supplements ranging from dietary, body building, sports and vitamins, to mineral supplements?
The writer wishes to state for purposes of education that there are a myriad of research publications in the field of herbal medicine and it is incumbent on consumers to read some of these publications and also check for the appropriate licensing and regulatory approvals for all medications, including herbal ones before usage.
The writer the Commercial Manager, Centre for Plant Medicine Research, Mampong Akwapim
E-mail: [email protected]