WHEN NAMES MAKE CLAIMS: ETHICAL ISSUES IN MEDICAL DEVICE MARKETING

Ethics & Medicine, Summer 2004 by Bramstedt, Katrina A

Introduction

"Image is Everything," or so says the camera division of Canon, Inc. Product branding is ultimately about creating a relationship with the customer, and in the case of the direct-to-consumer advertising strategies of pharmaceuticals, the customer is both the physician and the patient. Even if a product is stripped of its print, radio, or television advertising, the name of the product itself is an advertisement. Thus said, the name of a product and the image it conjures are relevant to its marketing to consumers.

In the United States, the generic and trade names (also known as brand names) of pharmaceuticals are formally evaluated prior to marketing; however, there is no formal process of name analysis for medical device brand names (personal communication, US Food and Drug administration, 28 March 2003). Generic drug names are created and assigned by the United States Adopted Names Council, which establishes logical nomenclature classifications based on pharmacological and/or chemical relationships (for example, angiotensin-converting-enzyme inhibitors end in "pril"). Generic names are then sent to the International Nonproprietary Name Committee of the World Health Organization for review and approval. Generic names must not be misleading or confusing (similar to other drug names), or imply efficacy or application to particular anatomical parts.1

Trade names are first sent to the United States Patent and Trademark Office (PTO) for evaluation. The PTO review focuses only on assigning legal rights to a brand name and is not permitted to include an evaluation of the name with regard to its potential to cause clinical confusion in prescribing or use. Once approved by the PTO, the drug's trade name is then reviewed by the Food and Drug Administration Office of Postmarketing Drug Risk Assessment. Part of this requirement stems from the fact that critical errors can occur when two or more drugs have similar sounding names, names that are difficult to pronounce, or names that can be easily misspelled and interpreted as other drugs. Between 1993 and 1998, 52 deaths were reported in the US as caused by drug name errors (mixups made by medical professionals or patients due to drug name confusion).2 The confusion that comes from phonologically similar names for different drugs (see Table 1) can lead to clinical complications, should patients mistakenly take the wrong medication. Also, since certain letters of the alphabet (W, M, N, C, L, O) are susceptible to blurring or confusion when handwritten, there is concern about using such letters in drug trade names.3 An additional consideration is the potential for a drug trade name to impart notions of composition, quality, safety, and performance. Approximately one-third of the names submitted yearly to the Food and Drug Administration are rejected (www.fda.gov).

The international marketing of drugs can also pose potential problems. If a drug is intended to be marketed in both the US and the European Union, its trade name is also reviewed by European patent and trademark offices. The European Union's Invented Name Review Group (London, UK) reviews all manufacturer-submitted potential trade names to ensure that the names do not convey "misleading therapeutic or pharmaceutical connotations," that they are not misleading with regard to the composition of the product, and that they are not prone to cause "confusion in print, handwriting, or speech" with regard to an existing product.4 As in the case of Prostin, multiple chemical compounds (with different functions and side effects) can have the same trade name across various countries, leading to prescribing problems for travelers or physicians who relocate their practice.5 Conversely, some drugs have different trade names throughout the world (Table 2) because some names may not be appealing in certain countries for linguistic (difficult pronunciations) or cultural (negative associations with the word in either formal, conversational, or street/slang usage) reasons.

The issues involved in drug trade name assignment raise questions about the trade name assignment for medical devices. Because medical devices are generally marketed to physicians, is there a different pattern of product naming by manufacturers? The trade names of devices such as implants might very well be significant for patients, especially in the case of products which are life sustaining (e.g., pacemaker) and where such patients carry identification cards that are a daily reminder of the device name. This paper explores the ethical issues in trade name assignment by analyzing product naming for three types of medical device implants: 1) pacemakers, 2) implantable cardioverter defibrillators (ICD), and 3) coronary stents.

FDA Review of Medical Device Trade Names

New medical devices are reviewed by the FDA through either the manufacturer's Pre-Market Approval filing (PMA) or 510(k) Notification filing. PMA filings are made for devices that are critical (life-supporting) or of a new concept that has not been marketed before in the US. 510(k) filings are made for devices that are non-critical and substantially equivalent to devices manufactured prior to 1976. Manufacturer filings contain information such as device design, manufacturing processes, packaging, safety, and effectiveness. The FDA can reject a device name due to concerns of misleading either the public or physicians regarding the product's PDA-approved use; however, there is no formal, systematic process of name analysis.