Part I
What with all the hearings and such, the news passed relatively unnoticed. On one day NewStar announced a recall of fresh cilantro from Mexico due to a risk for salmonella; then the next day NewStar announced that it was “unrecalling” as the whole thing was due to a lab error.
The whole incident was reminiscent of a situation Church Bros./True Leaf Farms experienced in July, 2007 which we chronicled here.
Church Bros/True Leaf also had a recall that turned out to be prompted by a lab error.
Yet there was one significant difference in the NewStar situation. In this case, it was not just any lab, but the lab the FDA used that committed the error, and the NewStar recall was prompted by the FDA saying NewStar should recall.
The event itself is insignificant. It was a small item, already in restricted use because of the Salmonella Saintpaul investigation and was rectified relatively quickly — although a one day recall of a large brand or item could cost many millions.
What is important about this small matter is that it reminds us that the FDA is just a group of people and they rely on other people and institutions. They have no special immunity against error.
This error was caught, but how many are never caught? How many are caught and some lab worker decides “let sleeping dogs lie” and tells no one?
Part II
Errors don’t only occur at labs, of course. There have been occasions we know of in which personnel from FDA field offices have marched into facilities and demanded recalls — only to be overruled by the FDA in Washington DC after private companies retained their own epidemiologist to study the data.
In other words, errors occur in epidemiology as well as in laboratories. Indeed epidemiology is, by its nature, a series of judgment calls and requires the most exacting effort. Doing epidemiology related to bulk fresh produce is especially difficult and, in all likelihood, such science, executed against tough time pressure in the case of suspected outbreaks, is going to be questionable fairly frequently.
This propensity for error points to a really useful function that the trade associations can serve in the event of an FDA attempt to have a produce company instigate a recall.
The purpose of trade associations is to enable the industry to do collectively what companies cannot do individually and in the event the FDA comes to visit a produce company that organization needs two things:
1. A world-class lawyer accustomed to dealing with the FDA.
2. A top epidemiologist expert in outbreaks on fresh produce, whose opinions would demand respect by experts in public health.
There are very few produce companies that have pre-existing relationships of these types.
In the publishing arena, one of the national trade associations contracts with an attorney who is expert in dealing with the US Postal Service. As a benefit of membership, all the members of that association receive free consultation with this expert postal counsel.
Yes, beyond initial consultations one might have to pay an additional fee, but that is not the point. The point is that if the postal service challenges some magazine’s filings, a tiny magazine has, by virtue of its membership in an association, instant access to world-class resources.
Produce associations should provide this same benefit to the companies of the produce industry. Basically the association would identify a top firm in FDA law and a top epidemiologist and enter into a retainer agreement with them.
The association would use the law firm and epidemiologist as it requires and the deal would be that association members, as a benefit of membership, get free consultations with the law firm if they have questions on FDA law. In the event of an outbreak or recall, the member could request the epidemiologist to be available for a free consultation. For an extra fee the lawyer and/or epidemiologist could be hired to represent the produce firm if it desires to hire one or the other.
This would mean that as soon as the FDA walks into produce companies, instead of not knowing how to proceed or what to do, the produce firms would have the tools at hand to immediately arrange for competent legal representation with the FDA and to have the epidemiology looked at by an expert.
Right now only a few firms have such capabilities. Fresh Express, for example, has long retained Dr. Michael T. Osterholm, whose distinguished career would give him credibility in any discussion with a public health authority.
We don’t think the few large firms with these capabilities would object to the relatively small expenditures such association retainer agreements would involve. It benefits no one in the industry to have recalls announced that are not justified by the epidemiology.
The associations want to make a difference, so here is an opportunity to really do so.
Part III
One can’t discuss the issue of mistakes by public health authorities without addressing the Saintpaul Salmonella outbreak and the implication of tomatoes.
To date CDC has not released sufficient epidemiological information for an outsider to judge definitively the reasonableness of its initial implication of tomatoes.
CDC has stuck to its story that the initial data implicated tomatoes — pointing to a distinction in survey results in which about 50% of the general population reported eating tomatoes whereas 80% of the sick people reported the same. That statistic though begs many questions.
The first is the make up of the questionnaires. No epidemiologist is better than the raw data he is given to work with. We have been told, but have been unable to confirm, that the questionnaires given to the initial group of 18 sick people asked an initial question regarding beef that inquired whether it had been eaten in a restaurant or at home. After that, we are told, the questionnaire neglected to ask, at all, about restaurant consumption. Is this true? If so, it would indicate flawed data and thus the resulting epidemiology would be flawed.
The second issue is that the story comparing tomato consumption among the healthy and the sick is sort of epidemiology on the crassest level. The question is what more sophisticated relationships did the epidemiologists at CDC explore before implicating tomatoes? For example, press reports indicate that upon taking a second look at the data, the CDC noticed that although there existed this 80%-50% discrepancy in reported tomato consumption, a closer look at where people ate revealed an oddity — it turned out that people who had eaten tomatoes in fast food restaurants or in Italian restaurants rarely fell ill, whereas those who ate in Mexican restaurants frequently fell ill.
If this is true, it would mean that the initial epidemiology was simply sloppy and incomplete.
Fast food being exonerated could imply that the aligned supply chains of the fast food companies worked and protected them from any problem. Italian restaurants, with a few exceptions, such as Darden’s Olive Garden chain, are often independents and would buy through the same supply chains as Mexican restaurants — so if Italian restaurants are exonerated it is highly unlikely to be tomatoes.
So we don’t know precisely what happened but it certainly seems likely that CDC jumped ahead of itself and acted either on shoddy data — such as the survey without a restaurant option — or as a result of a crass epidemiological theory that failed to consider subtleties such as the possibility of different cuisine types providing additional evidence.
In either case, it seems likely that had the data collection been done properly or the epidemiology done with sophistication, CDC would not have implicated tomatoes.
Ray Donovan was Ronald Reagan’s Secretary of Labor and was indicted on a criminal charge related to the Genovese crime family. After he was acquitted, he turned to the press and famously asked, “Which office do I go to to get my reputation back?”
To some extent, the tomato growers are asking the same question. With strong evidence that tomatoes were not the likely source of the outbreak, how do they get the CDC to acknowledge an error?
Perhaps the pleas of the tomato growers will not be sufficient to prompt action, but on this issue all those concerned with the respect that public health authorities are held in should speak loudly.
Respect for the authority of public health officials depends on a faith in their competency and honesty. This situation, with a confusing and complicated scenario of first implicating tomatoes with all kinds of caveats and then jalapenos and then Serrano peppers, have made consumers question the competency of our public health authorities.
Now once competency is in question, the next question is obvious:
“Is the CDC refusing to exonerate tomatoes — or even just state that had the epidemiology been correct it never would have implicated tomatoes — because it may make the CDC look bad?”
This question strikes straight at the issue of whether the CDC and broader public health authorities are being straightforward and transparent with the American people.
To reassure the American people about its competency and honesty — and to learn as much as possible from the situation — the CDC ought to ask the National Academy of Science to appoint an independent working group of outside epidemiologists to review the way this outbreak was conducted.
The group should look at questions such as the reliability of state data, review the questionnaires used, reanalyze the epidemiology and come out with a report addressing whether the surveys were proper, whether the epidemiology was sophisticated and, of course, whether tomatoes were properly implicated.
Mistakes can be and will be made at every level of the food safety system. If the authorities are willing to be subjected to independent scrutiny, they will grow in esteem. If they are perceived as looking to protect their own reputations and avoid independent inquiry, they will increasingly lack credibility.
Public heath authorities that lack credibility are a public health concern in their own right.
