Testing, quality control, and scientific marketing for non-synthetic pharmaceuticals - Medical Anthropology

Townsend Letter for Doctors and Patients,  Dec, 2003  by Tim Batchelder

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Introduction

In part due to consumer interest and in part due to the great costs associated with total synthesis and economic un-productivity of chemical methods of drug discovery, the pharmaceutical industry is gradually winding its way back toward what I will call for this discussion, non-synthetically derived products (which originally provided the origin of our modern drugs). These products occupy a space between food and drug and have variously been called dietary supplements (a rather milk toast term for what are often powerful pharmacological substances of natural origin) and 'natural products' (a term often used by New Age faddists to mean any nutritional product derived from natural sources including oatmeal). In contrast today, chemists use the term natural products to refer to secondary metabolites, which are often the inspiration for drugs. My use of the term natural product will occupy a space between the New Age version and the strictly chemical use to refer to pharmacologically active substances--often relatively rich in secondary metabolites--of natural origin. I will also use the term ethnobotanicals and ethnopharmaceuticals to emphasize the fact that these products are often derived from the un-domesticated, non-agricultural settings of traditional societies which is largely responsible for their pharmacological activity.

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At any rate, if natural products are to successfully survive in US markets, increasing biochemical assessment of their effectiveness, safety and efficacy, will need to be conducted. Just as pharmaceuticals must undergo frequent and rigorous assessment in this country so must ethno-botanicals, albeit at a somewhat reduced level given the limited patent potential they face. This can range from laboratory studies of blood levels of marker substances to quality control testing of batches of the products. The end result must be the communication of this testing and quality control to the consumer, in the form of newsletters, consumer guides, and brand standards in order to help them make an informed decision and use the products safely and within regulatory guidelines. Over the past 5 years I have increasingly been involved in this aspect of natural products in my roles in communications and product development. Below are a number of case studies from actual clients I have worked with.

Adverse Events

Often the impetus for laboratory testing of an ethnobotanical comes not from purely scientific interest but rather from impending threats of lawsuit or consumer demand via standard communications channels. Violation of FDA/FTC regulations on dietary supplements is often a trigger for testing and technical communications projects. A consent order demanding all substantiation for all ads a company has ever done for years back is not uncommon. Corrective advertising, civil penalties and refunds to customers are all serious possibilities. Sometimes consumers might write or call into the company complaining repeatedly of a lack of effect or a defective product.

At this point procedures must be put into place to assure that the product is safe and effective and this message reaches the public. In the event of a severe reaction that requires hospitalization or medical attention, companies may test customer's actual product (sent by overnight delivery). However, if it is not a severe reaction, they will not test the actual product but rely instead upon the retained sample (actual product should be sent back ground but it will not be tested). In this situation I work to rapidly build up an arsenal of technical documentation on the product, identifying active compounds worthy of frequent assessment, conducting necessary laboratory testing by hiring a suitable lab, and communicating with consumers about new standards. In some cases I purchase a scanner and convert a company's scattered and disorganized paperwork into an efficient documentation system.

Unfortunately this is a painful and expensive process and frequently companies are not willing to take an aggressive stance on this topic out of a fear that it can "backfire" and put them on the radar of regulatory bodies. This is particularly the case with small to medium size companies that have the size to gain the attention of regulatory bodies but are not large enough to survive an extensive investigation and lawsuit. Some fear that their consumers will be alienated or that their sales will drop if they produce accurate, scientifically sound communications. Exactly the same concern occurs among pharmaceutical companies.

Despite this concern about "entering the spotlight" through technical communications and product testing, in my experience exactly the opposite is the case. Even small companies that suddenly adopt an aggressive stance on product testing, developing a science advisory board, newsletter, technical website, and other communications tools, buffer themselves from the sorts of adverse event complaints and product misuse that actually raise the red flags of regulatory agencies. Especially in the world of dietary supplements but also in pharmaceuticals, consumers want more than ever to learn the facts about products they are considering using and will respect and remain loyal to any company which gives them these facts.