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"The businessman's tool is values; the bureaucrat's tool is fear"  - Ayn Rand, Capitalism:  The Unknown Ideal, 1962

 "La presence de ce rat mort lui avait paru seulement bizarre...bref, il s'agissait d'une farce"  - Albert Camus, La Peste, 1947

"Who is John Galt?"  - Ayn Rand, Atlas Shrugged, 1957

The emergence of a new strain of influenza A/H1N1 virus this year created pandemic hysteria diverting attention away from more recent and sexier flu strains like H5N1 taking us back to the day when virulent strains termed Asian Flu's sickened millions worldwide in 1957 and 1968.   International agencies such as the WHO and federal agencies have fanned the flames of awareness --- perhaps to a frenzy.  It is yet unclear whether US or global influenza morbidity and mortality in calendar 2009 will even exceed the average of recent prior years [36,000 deaths].  By the standards of the 1950/60's this year's morbidity appears a bust [87 US "excess" deaths as of late June from the new strain alone] but not without cost.  The media's amplification of risk quickly helped to shut down, for example, the tourism industry in Mexico, particularly in states heavily dependent on Americans such as Quintana Roo and Baja Sur where few, if any, cases have yet been reported.  These well-intentioned, yet unthinking, bureaucratic efforts imposed instant hardships on local workers and accounted for untold lost revenues in Mexico and globally.  Our federal government's attempted "regulation" of an episodic infectious disease seems almost perverse as it ramped up irrational fear and damaged enterprise,  yielding a fiscal epidemic as a result.  Granted the pandemics of 50 years ago first reared their heads in early summer only to reappear in the fall.  So prudence is warranted not panic.

Now well into the summer of 2009 the US FDA has created yet another wave of fear and concern about the common cold, or more precisely its treatment with Zicam Nasal Gel [www.zicam.com].  In a formal warning letter issued June 16th the FDA blindsided the maker of Zicam, Matrixx Initiatives, with the threat of seizure, or other actions aimed at removing these "unsafe" nasal zinc products from the consumer market.  The FDA claimed 130 consumers reported loss of smell after use and that Matrixx was rumored to have 800 more reports that they need to divulge.  This all seems odd.  Zicam has been sold in the consumer market in the product forms in question since 1999.  Zicam contains a simple zinc salt not a new chemical entity.  Zinc salts have been alleged for years to be anti-viral agents against certain colds viruses, a fact sometimes shown in the lab and clinic, but are subject to continuing controversy in the medical and regulatory communities.

As of today the SEC has now piled on Matrixx for issuing false information (?) as have the plaintiff's bar while Matrixx just initiated a product recall.  One must ask:  but where has FDA been these last 10 years?  It turns out that the majority of drugs sold directly to consumers are regulated by a monograph system.  These monographs describe FDA-mandated labeling, ingredients, and warnings thereby creating a parity marketplace by allowing anyone to sell these products without pre-approval if they comply to the FDA's "cookbook".   Innovation beyond these government restraints depends on finding technology or claims outside of these monographs.  Traditionally this takes two paths:  either manufacturers invest in a drawn-out, expensive, and risky pre-approval process at FDA; or they find ways to exploit regulatory niches.  Zicam, introduced in 1999, is sold as a "homeopathic" product one that is regulated under a 1938 homeopathic monograph enacted via Congress and separate from OTC drug monographs.  Compliance with that monograph (established in 1988) has traditionally allowed manufacturers to sell products that conform to it.  In either case products sold under the OTC or homeopathic monographs and which comply with them are exempt from any governmental pre-approval to gain access to the market.  Further, the FDA has been aware of Zicam labeling, compliance and the rate of related complaints since at least 2006/07, if not earlier.  In 2006 Matrixx settled suits from a number of consumers who alleged loss of smell after use.  Since 2007 post-marketing adverse event reports associated with OTC products should have begun arriving at FDA.

Donald K. Riker, Ph.D.
Dr. Riker is the President & Founder, On Point Advisors, LLC, a healthcare consultancy, and Editor-in-Chief, OTC Product News dedicated to the over-the-counter healthcare industry. He is the former Vice President R&D & Chief Scientific Officer, Chattem, Inc. and Associate Director & Fellow, Personal Healthcare, Procter & Gamble. Dr. Riker is an elected member of several medical and scientific organizations, The Licensing Executive Society, and the Association of Healthcare Journalists.

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