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SPECIAL EDITION XI —
Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Ethics And The FDA

Jim Prevor’s Perishable Pundit, July 17, 2008

Although the FDA has had any number of experts present at the various conference calls it has conducted, it has yet to include an ethicist. This is a significant problem.

Today every major medical center has a committee devoted to ethics. Every medical school has courses on ethics and there are many journals specializing in the field. A luminary named Arthur Caplan, who is now at the University of Pennsylvania, is the “Dean” of the field.

Commonly called bioethics, it is a big and interesting field at the intersection of philosophy and medicine. If you want to sum it up in a sentence, though, you could do worse than saying this:

The fact that a given course of action will produce the best outcome does not mean that this course of action is ethical or permissible.

So even if we posit that by blocking borders, bankrupting farmers, hurting distributors, putting laborers out of work and having consumers dispose of their food, FDA was doing enormous good in alleviating human suffering and reducing the spread of illness, it is not clear that FDA is acting ethically.

The people whose livelihoods and businesses are being destroyed are innocents; they are not guilty or culpable in any way. There is no ethical standard accepted in America by which the growers and their employees should be punished — even if it does some good.

In other words, we are told by CDC that there are about 5,000 people who die from foodborne illness each year, about 350,000 that are hospitalized and about 76 million that have lesser illnesses.

If we knew there was a God of Foodborne Illness, and all we had to do to placate him was to sacrifice the fortune of one farmer each year — burn his farm and money in a sacrificial bonfire and leave him penniless — we would all instantly recognize we couldn’t do it.

It offends our sense of ethics that an innocent person should be punished even if it would save many lives.

Yet this is precisely what FDA is doing with its actions, punishing individuals on the basis that it hopes to do the “greatest good for the greatest number” by reducing foodborne illness and if hundreds or thousands or tens of thousands of people get hurt in the process, well, the “greater good” of enhanced public health justifies it.

Actually this is wildly overstating the justification that FDA has for its actions — which is why there’s the need for an ethicist. Even if the FDA wants to justify its actions on this kind of crude utilitarianism, it still has to actually do the utilitarian calculations.

Yet FDA has done nothing of the sort. For example, we know driving cars has risks — 45,000 people die each year in America from auto accidents. So when the FDA advises consumers to throw out their tomatoes, a certain percentage of those consumers will make an extra trip in their cars to the stores to buy some new “not associated with the outbreak” tomatoes or another food entirely.

FDA has not released any calculations and almost certainly hasn’t done any, but it is entirely likely that more people died from driving additional miles to restock at a store or to eat an extra meal out of the house than would have died from eating their stock of tomatoes.

Much has been made of FDA’s apparent mistake in fingering tomatoes and, indeed, this kind of error points to a need for various institutional checks and balances to make such mistakes less likely.

Yet human error is always going to be with us so it is important that the actions of our government, with its enormous power, be circumscribed by some ethical limitations.

The problem, however, is that all the MDs and scientists running this outbreak investigation are constrained by nothing. They think the ends justify the means. Yet today in medicine no doctor can run a trial without getting approval of the medical school or hospital ethics committee. So the people at FDA should have to present their proposed course of action to an ethics committee that would be charged with giving voice to those who are not being considered in FDA’s action plans.

People have independent rights and the FDA simply has no right to treat them as collateral damage. We need an ethics-based reform to introduce these concepts into the decision-making process at FDA.

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