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J&J's Tylenol-PM Clinical Doomed to Fail?

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Tylenol-PM

The design of clinical protocols has to be right to succeed.  The protocol to support Tylenol-PM, as described in FDA's letter to the CHPA [link], suggests that the clinical protocol was doomed from the start.

Any new attempt must invest in the right vehicle.

 

J&J's Other Tylenol Problem: Tylenol-PM

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Tylenol-PMWith all the notoriety of the J&J quality assurance meltdown Reuters' Susan Heavey reminds us that a flagship component of the Tylenol brand, Tylenol-PM, is under review at FDA. [link] The efficacy of Tylenol-PM (J&J) and Excedrin-PM (Novartis) is still not confirmed to the satisfaction of FDA.

Here's why...

 

FDA Indictment of J&J Product Quality Suggests Gross, Cavalier Incompetence

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Tylenol InfantsJ&J, pressured by a two-week FDA audit at its Fort Washington, PA plant announced a store-wide recall of its children's liquid products under its Tylenol, Motrin, Zyrtec and Benadryl brands [http://www.fda.gov/Safety/Recalls/ucm210443.htm ].  The FDA issued a damning 17-page, 20-point 483 on May 4, 2010.  The cited deficiencies are gross, systemic and widespread and suggest a "screw-the-consumer" insouciance.  This recall of 44 sku's and 1,500 production lots is the fourth recall in seven months involving their key OTC brands.  The fact that these are products targeting infants makes it even more reprehensible.  J&J admits the impact of the recall will dent 2Q10 earnings.  On May 2nd The NY Times recognized damage to J&J brand equities [http://www.nytimes.com/2010/05/03/business/03drug.html?fta=y] reported months earlier by OTC Product News in January, 2010 [Safety of Brand Name Products Badly Damaged b...].  OTC/PN was prescient in calling out J&J's disregard for its brands and consumers early on.

 

 

Our View on Pandemic Flu in Early 2009 Corroborated Again

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flu virusWe predicted in June 2009, early into the pandemic flu scare, that the news media was wrong in presuming that the 1957 and 1968 flu pandemics were the correct harbingers of events in 2009-10.   We postulated that the swine flu epidemic of 1976-77 would prove the best guide to future events and indeed that is the case.  Further corroboration of the closeness of these outbreaks was provided by Jonathan McCullers et al in their 1 June 2010 publication in Clinical Infectious Diseases 50:1487 (2010).

 

OTC Product News Celebrates First Birthday!

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Birthday CakeOn April 24th OTC Product News celebrates one year of operation.  During the year we published 45 editorials on issues ranging from OTC marketing to mergers to regulatory events.  Our readership is diverse spanning industry workers to those who cover or follow the industry as part of their jobs.  We have several hundred readers who choose to push new articles to them directly via our RSS feed.  Our website ranking on Alexa has consistently improved.  In 2009 we added a feature called "Picks & Pans" that comments on current OTC products from the point of view of how well these products provide value to the consumer and what strengths and weaknesses manufacturers reveal in their executions.  We believe this is a good source of competitive insight for other manufacturers and a source of product selection for consumers.

 

Congress Targets The Lowly Bar of Soap

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von hayek"An authority directing the whole economic system would be the most powerful monopolist conceivable... not our own view, but someone else's, of what we ought to like or dislike would determine what we should get."

   -FA von Hayek, The Road to Serfdom, 1944

 

 

The ambit of Congressional healthcare oversight extended to the lowly bar of soap this week.  In it effort to enforce federal control of soap-threatened public safety Ed Markey (D-MA), the powerful Chairman of the House Energy & Commerce Subcommittee, formally asked the FDA and EPA to clean up its act and that of the purveyors of triclosan (Ciba), a long time antimicrobial ingredient in soaps. The FDA stated it does not have sufficient reason to act at this time and that "triclosan is not known to be hazardous to humans" [http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm205999.htm].

 

Patents on OTC's: Does Anyone Care?

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"Naturetroilus & cressida...what things again most dear in the esteem, and poor in worth!"

         -Ulysses in Troilus and Cressida, Shakespeare, 1602

 

Often the value of patents on OTC healthcare products is held in high esteem but experience tells us that more commonly used, but proven, marketing tactics usually win the day.  The fact is that the consumer healthcare market, defined by several measures, is in essence a parity market.  Both share and volume are increased best by first-to-market entry, price/value, brand awareness, promotion and distribution, the blocking and tackling of any good marketer.  Intellectual property, specifically patents and excepting for trademark, know-how and trade dress, is of dubious use in this sector.  The value to both consumers and manufacturers is limited to a few situations.

 

OTC Statins to Lower Cholesterol: Dead On Arrival at FDA?

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On MarZocorch 19 FDA warned consumers and physicians that the risk of at least one statin (Zocor, Merck), when used at higher approved doses, may cause an unacceptably high incidence of a serious side effect (rhabdomyolysis).  Further, they warn of drug and disease interactions at all doses and hint at pharmacogenetic variables, such as race, that may change the risk profile.

 

 

Government Intervention: Walgreens Makes a Stand

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WalgreensWalgreen's announced on 15 March that it has given the State of Washington notice that after 15 April it will no longer honor prescriptions from new patients on Medicaid [http://news.walgreens.com/article_display.cfm?article_id=5288].  Washington has not adjusted up its reimbursements to Walgreens for Medicaid costs.  Branded script reimbursement does not cover Walgreens' costs.  Unlike the private insurers in this case government entities will increasingly seek to undercut the profit motive in healthcare's free enterprise.  The specter of Obamacare's iron-fisted central planning hangs over healthcare pricing and reimbursement.

 

 

"Label Fatigue"... Complexity Turns Off Consumers

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Holofernes in 2000 Branagh Film "He draweth out the thread of his verbosity finer than the staple of his argument"

     - Holofernes in Love's Labour's Lost, Shakespeare (1598)

 

Verbose, complex product labeling has increased driven by government regulation, multiculturalism, and tort liability (failure to warn).  Prescription labeling when directed at physicians nonetheless is still arcane.  OTC labeling aimed at the US consumer is more succinct yet now occupies nearly all the package's surface, and then some, akin to creating off-shore "artificial islands" of information.  A recent study of labeling comprehension reminds us what to avoid.

 

What's Under the Brand Umbrella? Not Maalox Apparently...

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The FDA pushed Novartis to reign in its self-imposed "dilution" of the Maalox trademark with an assortment of active ingredients under the Maalox brand [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm200795.htm].  The elasticity of OTC megabrands has been stretched to the point of confusing consumers and even OTC Product News.  Is a Kleenex a tissue?   Is Maalox an antacid?
 
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