European experts demand consistent proof of efficacy, safety and quality for TCM

As we discussed previously, the WHO has included TCM diagnoses in the International Classification of Diseases (ICD). The WHO claim this is not an endorsement, but experts point out that the move will promote TCM and mislead the public into thinking that TCM is safe and effective. Thus consumers might use it as an alternative for effective treatments of serious conditions, in which case they would endanger their lives.

Prof George Griffin, the president of FEAM, was quoted saying “We don’t give drugs and surgical treatments unless there is real evidence that they work and do no damage and basically the feeling is that most of the traditional Chinese medicine drugs are unregulated. They are not tested properly for toxicity. They probably vary greatly between batches produced, for example seaweed, which is the latest, and they may be harmful. The other side of the equation is that they may be deluding patients into thinking they are taking appropriate therapies for serious disease.”

“Multiple risks of harm from herbal ingredients have been documented,” the joint statement warns. Sometimes herbal remedies have been adulterated with chemicals. Interaction with conventional drugs can be a serious threat. And acupuncture, they will say, “is not necessarily harmless”. A review in 2017 as well as numerous papers discussed on this blog (for instance here and here) found injuries to vital organs, infections and other adverse reactions.

Although those who use SCAM are being misled to think of them as originating from small scale enterprises, globally it is big business. “The production and delivery of TCM has become a large industry with estimates of $60bn [£46.5bn] a year and an annual growth rate above 10%,” says the statement.

The statement authors “urge the European Commission and member states to do more to ensure that all medical products and procedures are subject to an appropriate level of evaluation for quality, safety and efficacy consistent with standardised testing procedures”.

Here are further important points from the statement:

• We agree with the underlying principle that the proponents of TCM and other CAM should be invited to seek the same rigorous assessment as is applied to innovative, evidence-based medicines (from state-of-the-art clinical trials) developed and regulated worldwide.
• We accept that WHO has tried to make clear that their chapter in ICD-11 on TCM does not refer to, nor endorse, any specific form of treatment (Anon 2019a). However, because of the perceived encouragement created by ICD-11 inclusion of  TCM as a core principle and system of medicine, the qualification may be misconstrued or ignored.
• We agree that there have been examples where traditional medicine, Chinese or otherwise, has been subjected to thorough preclinical investigation and proven in rigorous clinical trials to contribute significant health benefit. The example of artemisinin therapy for malaria is notable (WHO, 2015). The success of artemisinin as an anti-malaria agent is due to meticulous research in pharmacognosy and medicinal chemistry, combined with clinical trials. Many of the artemisia TCM preparations tested originally had little reproducibility of activity. The compound that has been approved by medicinal product agencies is a chemically modified version of the naturally occurring molecule in order to improve its pharmacokinetic properties. It is well known that many natural products have significant pharmacological activities and provided the basis for much of modern medicine. And, there may be many more such leads to therapeutic benefit. But, none of this means that other claims can be accepted uncritically, even if the objective to ensure access for all to the benefits of medicine is worthy.
• European patients may be encouraged to self-administer unregulated products or seek unregulated diagnostic procedures outside of the remit and responsibility of public health services. This raises issues for efficacy, particularly if patients delay seeking evidence-based healthcare. There are also serious safety concerns. Multiple risks of harm from herbal ingredients have been documented (e.g. see Byard et al. 2017; Zhou et al. 2019) and in the absence of an approved framework for quality and formulation, adulteration and dose variation may bring additional health risks (Ching et al. 2018). Interaction with other medications is,
  additionally, a serious threat. It is also noteworthy that, contrary to common assumptions, acupuncture is not necessarily harmless (Chan et al. 2017). It is not our present purpose to review the evidence on TCM or to make judgement on particular practices, rather to emphasise the need for consistency in applying common standards to all of medicine. Although there is a very large literature on TCM, we note that clinical studies often fail to meet expected methodological criteria and highquality evidence is often lacking (for example as concluded from a systematic review of the literature on use of Chinese herbal medicines for rheumatoid arthritis, Pan et al. 2017). Follow-up surveillance and procedures for assessing liability, where necessary, may also be weak.
• European patients may be encouraged to seek diagnosis according to the proffered TCM precepts through public health services, thereby causing additional pressures on limited resources. It is likely that there will be increasing demands for these services across the EU. The European Commission, the EMA and Member State health authorities must revisit their regulatory strategies to ensure that appropriate, evidence-based patient information is readily accessible.
•  There should be consistent proof underlying the regulatory requirements for scrutiny to demonstrate efficacy, safety and quality for all products and practices for human medicine. There must be verifiable and objective evidence, commensurate with the nature of the claims being made. In the absence of such evidence, a product should be neither approvable nor registrable by national regulatory agencies for the designation medicinal product. The current EU Directive on Traditional Herbal Medical Products (Directive 2004/24/EC amending Directive 2001/83/EC) was established to provide a simplified regulatory approval process for traditional herbal medicines, and national procedures are overseen by the national competent authorities. However, designated categories within this legislation allow treatment based on traditional or well-established use in the absence of robust evidence. Medicinal herbal products registered by the European Medicines Agency for traditional use have the requirement of “bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years in the Community”5. Thus, the regulation is essentially to ensure that the product is harmless and there is no real requirement for demonstration of effect. As recommended in our previous assessment of homeopathy (EASAC, 2017) it would now be timely to reassess the validity and value of continuing to allow these simpler regulatory approval categories to apply.
• Diagnostic procedures should also be evidence-based and include validated diagnostic instruments to provide objective, reliable, reproducible assessment and reduce inter-rater variability. Whatever the diagnostic approach utilised, practitioners should be appropriately trained and audited by professional bodies.
• Similarly, use of other TCM procedures such as acupuncture should be evidence-based to demonstrate efficacy and safety, and subject to professional standards.
• Evidence-based public health systems and medical insurance systems should not reimburse products and practices unless they are demonstrated to be efficacious and safe by rigorous pre-marketing testing: a robust evidence base is essential for all medicines.
• The composition of standardised TCM remedies should be labelled in a similar way to other health products. That is, there should be an accurate, clear, verifiable and simple description of the ingredients and their amounts present in the formulation. TCM diagnostic and therapeutic procedures should, likewise, be clearly explained in patient information literature.
• Advertising and marketing of TCM products and services must conform to established standards of accuracy and clarity6. Promotional claims for efficacy, safety and quality should not be made without demonstrable and reproducible evidence