In an astonishing display of what can only be described as chutzpah* Del Monte sued the FDA for insisting on a recall last March of its cantaloupes likely to be contaminated with a toxic form of Salmonella Panama. Now Del Monte is also suing the State of Oregon.

On what grounds?

Notably, “[t]he FDA investigation ultimately found no connection between Del Monte Fresh cantaloupes and any cases of Salmonella Panama, including in Oregon,” the company says. “FDA issued a notice ending the recall on July 29, 2011.”

The CDC thinks otherwise.  Its investigations pointed to imported Del Monte cantaloupes as the source of an outbreak that affected 20 people in several states:

Twelve of 16 ill people reported eating cantaloupe in the week before illness. Eleven of these 12 ill people ate cantaloupes purchased at eight different locations of a national warehouse club. Information gathered with patient permission from membership card records helped determine that ill persons purchased cantaloupes sourced from a single farm. Product traceback information indicated these cantaloupes were harvested from single farm in Guatemala.

FoodSafetyNews reviews the history of this particular recall.  It agrees with Del Monte that tests performed in April on cantaloupe samples from the Guatemala farm came out negative for Salmonella and that the FDA has now ended the recall.  But:

Del Monte had announced the recall in March, after the suspect melons had passed their shelf-life date. It is not clear whether any of the cantaloupes tested were actually the suspect melons. In foodborne illness investigations, samples of the food from the same batch eaten may no longer available by the time the connection to an outbreak is made. Epidemiology, rather than a contaminated sample, is the evidence that points to a likely source.

For these reasons, attorney Bill Marler terms the lawsuit “frivolous.”  He is suing Del Monte on behalf of a sick client.

Public health agencies doing their jobs to protect the public now have to defend against lawsuits like this?  Putative cause is no longer enough to order recalls?

U.S. courts are not famous for understanding epidemiology or other aspects of public health and I’m wondering what effect this suit will have on public protection against foodborne illness.  What standard of proof will the courts require?

Lawsuits are chilling.  Congress has just granted the FDA the authority to order recalls.  Food producers were not happy about that provision.  This is one way to get around Congress and the FDA.

It is worth asking who gains and who loses from lawsuits like this.

*Hence: chutzpah, which if you aren’t familiar with the term, is the Yiddish word for outrageous audacity.

In the aftermath of Hurricane Irene, the British Medical Journal offers some cheery news.

A systematic review and meta-analysis of studies on chocolate and health concludes that the flavonol antioxsidants in chocolate reduce the risk for cardiometabolic disorders such as heart disease and stroke—by a whopping one-third.

As the investigators explain, previous research suggests that:

chocolate consumption has a positive influence on human health, with antioxidant, antihypertensive, anti-inflammatory, anti-atherogenic, and anti-thrombotic effects as well as influence on insulin sensitivity, vascular endothelial function, and activation of nitric oxide.

This seems like a lot for one food–let alone candy—to accomplish but their review of seven studies concludes that people who eat the most chocolate compared to those who eat the least have much lower disease risks.

Wisely, the authors point out that much more research is needed to confirm these benefits, not least because the studies were observational, not clinical trials:

Experimental evidence will be needed before any level of causality can be inferred from the existing findings, and residual confounding could be considered as a potential explanation for the associations observed. Considering the limited data available, any conclusions should be cautious.

As indeed they should.  The investigators point out:

The high energy density of commercially available chocolate (about 2100 kJ (500 kcal)/100 g) means excessive consumption will probably induce weight gain, a risk factor for hypertension, dyslipidaemia, diabetes, and cardiometabolic disorders in general.  [Oops.  Chocolate is fattening]

Although our studies included populations with and without prior cardiovascular disease, the small numbers meant we could not evaluate whether the associations found would differ in terms of primary or secondary prevention.  [Oops, small numbers]

…We found no papers studying the relation between chocolate consumption and the risk of developing metabolic syndrome, and we identified only one study showing the relation between diabetes and chocolate intake (a positive association, especially in men).  [Oops, chocolate makes diabetes worse]

…Only two of the studies included evaluated the potential association of chocolate intake with the risk of heart failure. Both studies found no significant effect.  [Oops, chocolate is irrelevant to heart failure]

My conclusion: a little chocolate is delightful.  A lot is not.

As in all matters pertaining to diet, everything in moderation.

The British journal, The Lancet, has a special series of papers on obesity and obesity policy, just out.

Don’t miss the Body Weight Simulator! It’s great fun to play with while waiting out a hurricane.

You type in your age, weight, and height (you can change the metrics to pounds and inches), and indicate your activity level.  It tells you how many calories you can eat every day to maintain that weight (Yikes!  That’s all? No wonder I have so much trouble).

It also tells you how many calories you need to reduce in order to lose weight over whatever time period you specify.

And here are the papers, reviews, and commentaries (you will need to log in to read more than the summary):

The future challenge of obesity
David King
Full Text | PDF

Reversing the tide of obesity
William H Dietz
Full Text | PDF

Where next for obesity
Harry Rutter
Full Text | PDF

The global obesity pandemic: shaped by global drivers and local environments
Boyd A Swinburn, Gary Sacks, Kevin D Hall, Klim McPherson, Diane T Finegood, Marjory L Moodie, Steven L Gortmaker
Summary | Full Text | PDF

Health and economic burden of the projected obesity trends in the USA and the UK
Y Claire Wang, Klim McPherson, Tim Marsh, Steven L Gortmaker, Martin Brown
Summary | Full Text | PDF

Quantification of the effect of energy imbalance on bodyweight
Kevin D Hall, Gary Sacks, Dhruva Chandramohan, Carson C Chow, Y Claire Wang, Steven L Gortmaker, Boyd A Swinburn
Summary | Full Text | PDF

Changing the future of obesity: science, policy, and action
Steven L Gortmaker, Boyd A Swinburn, David Levy, Rob Carter, Patricia L Mabry, Diane T Finegood, Terry Huang, Tim Marsh, Marjory L Moodie
Summary | Full Text | PDF

At the end of 2005, the Institute of Medicine (IOM) produced an unusually hard-hitting  report on food marketing to children.  The report complained about lack of cooperation from food companies in providing data.  Even so, the report concluded that “marketing works.” It is highly effective at getting kids to demand and eat junk foods.

The report gave the food industry two years to cease and desist.  If it didn’t, federal regulation should be considered.

Well, five years have come and gone and some of the people involved in the IOM report have just published a progress assessment in the American Journal of Preventive Medicine:  Despite lack of evidence in their review of the literature for real progress, the investigators’ assessment is anything but hard-hitting:

Food and beverage companies made moderate progress; however, limited progress was made by other industry subsectors. Industry stakeholders used integrated marketing communications (IMC) to promote primarily unhealthy products, which threaten children’s and adolescents’ health and miss opportunities to promote a healthy eating environment.

Miss opportunties?  That’s one way to put it.  Here are the conclusions:

Diverse industry stakeholders have several untapped opportunities to advance progress by promoting IMC to support a healthful diet; substantially strengthening self-regulatory programs; supporting truthful and non-misleading product labeling and health claims; engaging in partnerships; and funding independent evaluations of collective efforts.

The paper acknowledges:

the tensions among private- and public-sector stakeholders to promote a healthful diet to children and adolescents…conveying consistent and appealing messages; ensuring transparency by sharing relevant marketing data; obtaining company-wide commitments…balancing freemarket system goals with protecting young people’s health; and committing to monitor and evaluate all efforts.

Oh those pesky freemarket system goals.  Food companies cannot stop marketing junk foods to kids because the foods are profitable and their job as publicly traded companies is to grow profits every quarter.

That’s why federal regulation is essential, a point not mentioned by these investigators or in the accompanying editorial.  Instead, the editorial calls for counter-advertising:

The experience with tobacco is instructive. The most rapid period of decline in the use of cigarettes occurred not after television advertising was banned but in the period before the ban when counter ads were mandated as a proportion to the product ads.

I remember that period well.  The counter-advertisements were so effective that kids insisted that their parents stop smoking.

But those ads were mandated.  That’s still government.  Food companies cannot and will not stop marketing to kids on their own.

Note to physicians: you can 1 CME credit by reading this paper.

Remember New York City’s idea to ban purchase of sodas with SNAP (food stamp) benefits?  I supported the proposal and explained why in posts on April 16, April 30, and May 1.

USDA has just sent a letter turning down the proposal.  Most of its grounds for denial are technical: too much, too soon, too big, too complex, too hard to evaluate.

Underlying these concerns is a philosophical issue:

USDA has a longstanding tradition of supporting and promoting incentive-based solutions to the obesity epidemic, especially among SNAP recipients. In fact, USDA is currently partnering with the State of Massachusetts in implementing the Healthy Incentives Pilot, which increases SNAP benefits when fruits and vegetables are purchased….We feel it would be imprudent to reverse policy at this time while the evaluation component of the Healthy Incentives Pilot is ongoing.

SNAP is USDA’s biggest program.  The latest figures on participation and cost indicate that SNAP serves nearly 46 million people at a cost of more than $68 billion annually.

Advocates for SNAP prefer positive incentives.  They strongly—and successfully—opposed the New York City proposal.

Indeed, the public health and anti-hunger advocacy communities are split on this issue.

I wish they would find common ground.  Rates of obesity are higher among the poor than they are in the general population.

That, after all, was the proposal’s purpose in the first place.  As Mayor Bloomberg put it:

We think our innovative pilot would have done more to protect people from the crippling effects of preventable illnesses like diabetes and obesity than anything being proposed anywhere else in this country – and at little or no cost to taxpayers. We’re disappointed that the Federal Government didn’t agree..New York City will continue to pursue new and unconventional ways to combat the health problems that affect New Yorkers and all Americans.

Back to the drawing board.

The latest issue of JAMA has a paper on a “portfolio” of dietary means to reduce blood cholesterol levels.

The paper is likely to get lots of press because it concludes that consuming the “portfolio”—a combination of plant sterols, soy protein, viscous fibers, and nuts—does a better job of lowering LDL-cholesterol (the “bad” kind) than does dietary advice to reduce saturated fat.

The paper is unusually difficult to read  (see the Abstract, for example).  But besides that, I interpret the study in part as a drug trial.

One look at the Abstract and I immediately suspected that this study must have been sponsored by a maker of plant sterol margarines.

Bingo!

Plant sterols are well established to reduce blood cholesterol levels.  Unilever, which makes Take Control margarines, is one of the sponsors.

As I interpret it, the study shows:

• Advising people who weigh an average of 76 kg (167 pounds) to consume a healthy diet doesn’t work.  Study subjects did not change their diets by much during the six months of the trial.  No news here.
• Advising people to add things to their diets has a better chance of succeeding than advising taking things away (like saturated fat).
• All of the portfolio items have been established to lower blood cholesterol in clinical trials, although the evidence for soy protein seems a bit iffy these days.
• The study does not distinguish between the relative effects of soy protein, fiber, or cholesterol lowering margarines. If soy is eliminated, that leaves fiber and margarines. I’m guessing the margarines were the critical factor. Hence: a partial drug trial.

And because my book on calories is coming out next March, I must point out that the study groups reported losing  losing small amounts of weight, which means they must also have reduced their calorie intake.  Weight loss alone should help with blood cholesterol.

The take-home message: if you really do substitute nuts, sources of fiber, and healthy foods for whatever less healthful foods you used to eat, you ought to get some health benefit, with or without plant sterol margarines.

QED: Healthy diets produce health benefits.

It’s always nice to see that confirmed.

The USDA has just analyzed the effect of WIC (the Special Supplemental Program for Women, Infants, and Children) purchases of infant formulas on the companies that produce them. 

WIC provides coupons or vouchers for infant formula for women who are not breastfeeding.  Many people believe that WIC support of infant formulas discourages breastfeeding, but that’s not what this post is about.

WIC buys about half (57 to 68%) of all of the infant formula sold in the United States.   WIC is not an entitlement program.  It only has so much money; once that money is spent, the program has to turn away eligible clients.

The USDA delegates WIC management to states.  As the USDA report explains, 

To reduce cost to the WIC program, each State awards a sole-source contract to a formula manufacturer to provide its product to WIC participants in the State. As part of the contract, the WIC State agency receives rebates from the manufacturers.

Translation: States grant WIC contracts to the manufacturer who sells infant formula to it at the lowest price.  The winning prices may be as low as 10% of retail cost.

Why would companies want to do this?

In this study, we use 2004-09 Nielsen scanner-based retail sales data from over 7,000 stores in 30 States to examine the effect of winning a WIC sole-source contract on infant formula manufacturers’ market share in supermarkets.

We find that the manufacturer holding the WIC contract brand accounted for the vast majority—84 percent—of all formula sold by the top three manufacturers.

The impact of a switch in the manufacturer that holds the WIC contract was considerable. The market share of the manufacturer of the new WIC contract brand increased by an average 74 percentage points after winning the contract.

Most of this increase was a direct effect of WIC recipients switching to the new WIC contract brand. However, manufacturers also realized a spillover effect from winning the WIC contract whereby sales of formula purchased outside of the program also increased.

Mind-boggling, no?

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This seems to be my week for discussing ethical issues in food politics.

The September issue of Preventing Chronic Disease (PCD), a professional journal published by the CDC, is devoted to papers on this topic.

I taught a graduate course a couple of years ago at NYU titled “Ethical issues in nutrition, food studies, and public health.”   These papers, and the ones I referred to earlier this week, could be the basis for a course on their own.

You are wondering why childhood obesity interventions raise ethical issues?

This diagram, from the paper by Shiriki Kumanyika, is a good starting place.  It asks: Should governments, health professionals, advocates, and others balance the protection of vulnerable populations against corporate imperatives and, if so, how?

Maybe next semester!

In the meantime, here are the papers along with thanks to CDC for taking this on.