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Special Edition X — Salmonella Saintpaul Outbreak… FDA’s Contempt For Industry Causes Pain And Suffering

FDA Communications
Lack Vital Risk Assessments

Jim Prevor’s Perishable Pundit, July 10, 2008

Dr. David Acheson, FDA’s Associate Commissioner for Foods, made a statement during the conference on July 9, 2008, that indicates he doesn’t really understand what the complaint is with the way the FDA releases information:

If we feel we have got strong enough evidence to warn consumers about a product that may be contaminated with salmonella. It is our job to do that. Not to go out too soon, we have to be sure. And not to “point the finger,” so to speak, at different products without good evidence. But I can assure you there was good evidence. And that is why we went down that road.

Now I recognize that there are consequences to this. But as you have heard, tomatoes are still part of the investigation. And there are plausible explanations why this could have been two products shifting from one to another.

The FDA works for the people, and we know of nobody, literally nobody, who thinks the FDA should not tell people what it knows. If Dr. Acheson thinks the issue is that the industry wants FDA secrecy, he is mistaken.

Everything, though, is a matter of perspective.

For every numerator, there is a denominator and to say something is “dangerous” is not giving consumers actionable information. We are sure there are wonderful statisticians who work for the government and can help the FDA. When a statement is issued, it should contain ALL THE RELEVENT INFORMATION the government has.

So, a typical announcement should be phrased something like this:

“The epidemiology team at CDC is 80% confident that fresh widgets now in the distribution chain may be contaminated with Salmonella Saintpaul.

Over the last five years, there have been seven outbreaks associated with Salmonella and fresh widgets. On average those outbreaks resulted in XX illnesses, X hospitalizations and no deaths. Research done by CDC indicates that for every known sick person, there are over 30 people who get sick but are never counted in the government statistics, principally because they were less serious illnesses and the people did not pursue medical care.

If this outbreak were to be an average one, and we have no reason to suspect otherwise, we would estimate the likelihood of an average American needing to be hospitalized as a result of consumption of fresh widgets to be .XXXXXX%.”

In other words, we all take on risks. There are 45,000 people who die in car accidents every year and yet people drive cars. By telling us fully what the FDA knows, it can help people decide what risks they wish to run.

The problem with the FDA is that it never wants to quantify risk. This may be because few people would pay attention to an effort to get them to avoid an infinitesimal risk.

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