The Bite of the Bivalve – How Much Pressure Can FDA Take?

In the very entertaining, historical and informative book The Big Oyster: History of the Half Shell, Mark Kurlansky outlines the highly central role played by the oyster in the development of America, particularly in the early years of settlement in New York where you could walk down to the water around Manhattan and scoop up a tasty treat with your hand.  (Please don't try this today).  The book reveals not only what a central role the oyster played in the diet, but in the very economic development of our young country.  The numbers of oyster recipes, and the way people wrote about and regarded oysters reveals not only our reliance on them and our high regard for their utility, but a deeply emotional connection as well.

The FDA, perhaps, would have been well-advised to read this book before embarking on their recent oyster fiasco.  On October 17, FDA's Michael Taylor announced in a speech FDA plans for trying to cut the number of health related issues connected with the consumption of raw oysters, specifically those coming from the Gulf of Mexico.  (By way of disclosure, I consume on average about 2 dozen raw oysters a week, and anyone who wants to stop me will have to pry that oyster from my cold, dead hands…)

The object of the speech was to signal the FDA's intent to require Gulf oysters to be processed before consumption.  In fact, California requires that any Gulf oysters to the state be processed and Michael Taylor  notes that as a result, the decline in illness from eating raw oysters dropped considerably.  (Though not apparent is whether the drop was due to the fact that the processing worked or that people simply didn't want to buy processed oysters, wishing to stick to the comfort offered by the Kusshi of British Columbia– one of my faves). 

The reaction was as swift and mighty as the reaction had by an oyster when you try to shuck it.  A powerful clamp down by a big muscle.  People did not want their oysters to be fooled with and a number of headlines spelled the beginning of a slippery slope for us oyster consumers….

Then, the nearly impossible happened.  FDA issued a statement less than a month later, saying that the matter deserved more scrutiny after the agency "heard" from Gulf oyster harvesters and elected officials.  Headlines appeared saying that the FDA had "backed off".  

But the subject here isn't oysters, it is about pressure that comes to bear on the FDA that actually causes a policy change.  There have been attempts by others to exert pressure on the agency to reverse a decision that have not borne fruit.  Consider, for example, the case of Dendreon's Provenge.  After an advisory committee recommended approval for this prostate cancer treatment, the FDA declined to approve the treatment.  Prostate cancer patient advocates reacted with considerable anger and over a lengthy period of time.  It involved blogs, and on-line petitions.  It involved lawsuits and filing for injunctions.   It did not, however, involve a change FDA of policy.

Now, after new clinical trials, Provenge is making a second attempt at approval. 

Similarly, there was the case of Plan B, an emergency contraceptive that was not initially moved to OTC status despite the overwhelming vote by the Advisory Committee, public reaction and lots of commentary from bloggers like me.  It took months and months before FDA changed its obviously politically motivated earlier decision, further negatively impacting the credibility of the agency.

The story of the oyster raises the question then.  As in shucking an oyster, where does one find pressure point that causes a stubborn and mighty status quo to give way to an about-face policy change.  I'm not sure I know it, but I do know it is somewhere between the case of Gulf oysters and the case of Provenge. The one who finds the exact point, discovers a valuable pearl indeed.

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2 Responses to The Bite of the Bivalve – How Much Pressure Can FDA Take?

  1. zealseo says:

    your limk to the “plan B” article is broken. One too many http://

  2. Brooke says:

    I think it’s important to note that it was not policy that was changed in the case of the oysters, rather just the decision to move forward with implementing policy was changed.

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