Terra Sigillata

“It’s shameless,” says David Colquhoun, professor of pharmacology at University College London. “Medicines work or don’t work, and they should be labelled accordingly,” he says.

Professor Colquhoun is quoted in today’s New Scientist in response to the first registration of an herbal product (arnica gel) in the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

Mind you, this effort aims only to provide a registry of a product’s name and purity, not efficacy:

For a herbal medicine to be allowed on the register, its maker must show that it is safe and manufactured to a sufficiently high standard. The maker must also provide proof, not of efficacy, but that the substance has been used in traditional medicine for many years.

While I am scientifically respectful of folk healing traditions, there are many modern concoctions of herbal products (i.e., organic extracts concentrated manifold relative to the folk herb itself) who action and safety have no bearing on how these medicines were used in folk traditions. The goal of registration, however, seems to be the establishment of a central database to track manufacturers and their remedies in the event that adverse events are encountered, such that recalls could be issued and executed efficiently should problems arise.

But, much like our discussions earlier this week on whether teaching alternative medicine in US medical schools somehow legitimizes questionable practices, the concern raised by British critics is similar: Could the official registration of herbal medicines be seen as medical approval?

Federal registration is one step toward mandating improvements of herbal product quality. But when it comes down to associating the word, “medicine,” with a product, there is an implication of effectiveness. Unfortunately, the UK system stops short of that requirement.

So, how can a compromise be reached between herbal medicines (many of which can be grown in one’s garden) and the immensely cost-prohibitive standard of gaining drug approval in Western countries?

Well, let us turn to our neighbors to the north: Canada. Quietly and with their characteristic common sense, Health Canada has established the Natural Health Products Directorate to provide a middle ground between the “Wild West” conditions of the US dietary supplement market and the high bar required for formal drug approval.

Canada recognizes that 71% of their population uses some sort of herbal/dietary supplement each year and feels that there is a middle ground that can be achieved to protect consumers. This effort will be phased in over several years and I’m still sifting through the voluminous guidelines for such products. I still fail to see how Canada will assure the effectiveness of homeopathic products (those herbal based products diluted beyond their potential to contain anything but water), but I commend the authorities there on their efforts to put some meat behind a simple registration procedure: to require some evidence of historical or prospective efficacy.

And, yes, even historic evidence of efficacy is a reasonable expectation that is superior to the current situation. In 1962 when the US passed retroactive efficacy rules for marketed drugs, some prescription and over-the-counter remedies in use between 1938 and 1962 (such as acetaminophen) fell in a state of limbo. As a result, the US FDA asked the US National Academies of Science to convene an expert panel to review the literature on older remedies that could not be grandfathered in under the new guidelines passed in 1962. In 1968, the FDA formed the Drug Efficacy Study Implementation (DESI) that incorporated the recommendations of the NAS investigation of effectiveness of drugs marketed between 1938 and 1962. This permitted older drugs to be approved under an expedited process called an Abbreviated New Drug Application (ANDA). Then-over-the-counter drugs were evaluated by a similar retrospective mechanism beginning in 1971.

Frankly, I don’t see why such a commission could not be assembled today in the US for herbal medicines, although there would be a very low percentage of remedies marketed now that might pass such scrutiny.