by Marion Nestle

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May 11 2012

FDA panel recommends approval of another iffy weight-loss drug

I was riveted by an article in today’s New York Times about the latest decision of an FDA drug advisory panel.

The panel voted to approve a new weight-loss drug, lorcaserin.  The vote was mixed: 18 for approval, 4 against, and 1 abstention. The majority felt that the benefits outweighed the risks and that even if there were risks, “new tools are needed to treat a major health problem.”

The benefits are worth a look.

  • People taking the drug lost an average of  5.8% of their body weight in a year, compared to 2.5% for people taking a placebo.  This difference is below the FDA’s standard for approval which requires a 5% difference.
  • Among those taking the drug, 47% lost at least 5 percent of their weight after a year, whereas only 23% of those taking the placebo did so.  This meets a second FDA standard for approval.

What about the risks?  The drug:

  • Causes tumors in rats (although perhaps at higher doses than might be taken by people).
  • Damages heart valves (in the same way the withdrawn drug, Fen-Phen, did).

Also in the Times is a piece by Dr. Danielle Ofri on her experience with patients who want weight-loss drugs.

She quotes from an essay called “Lemons for Obesity” by Dr. Michael S. Lauer, who was a minority voter on the FDA panel that approved the weight-loss drug Qnexa earlier this year.

The weight-loss field is strewn with lemons, more so than other areas of medicine, Dr. Lauer argues. Because of the enormous potential market for these drugs — two-thirds of American adults are overweight or obese — pharmaceutical companies rush new drugs to market after conducting only small clinical trials. The F.D.A. and doctors are complicit in the process, Dr. Lauer says, leaving the population at large to act essentially as guinea pigs.

Shares of the maker of the drug nearly doubled after the decision.  The Times reported that “Arguments by investors have been passionate.”

People who cannot easily lose weight are desperate for help.

But is it ethical to put them at this kind of risk?

Mar 7 2012

U.N. Special Rapporteur: Five Ways to Fix Unhealthy Diets

Olivier de Schutter, the United Nations Special Rapporteur on the Right to Food, has issued five recommendations for fixing diets and food systems:

  • Tax unhealthy products.
  • Regulate foods high in saturated fats, salt and sugar.
  • Crack down on junk food advertising.
  • Overhaul misguided agricultural subsidies that make certain ingredients cheaper than others.
  • Support local food production so that consumers have access to healthy, fresh and nutritious foods.

De Schutter explains:

One in seven people globally are undernourished, and many more suffer from the ‘hidden hunger’ of micronutrient deficiency, while 1.3 billion are overweight or obese.

Faced with this public health crisis, we continue to prescribe medical remedies: nutrition pills and early-life nutrition strategies for those lacking in calories; slimming pills, lifestyle advice and calorie counting for the overweight.

But we must tackle the systemic problems that generate poor nutrition in all its forms.

Governments, he said:

have often been indifferent to what kind of calories are on offer, at what price, to whom they are accessible, and how they are marketed…We have deferred to food companies the responsibility for ensuring that a good nutritional balance emerges.

…Heavy processing thrives in our global food system, and is a win-win for multinational agri-food companies…But for the people, it is a lose-lose…In better-off countries, the poorest population groups are most affected because foods high in fats, sugar and salt are often cheaper than healthy diets as a result of misguided subsidies whose health impacts have been wholly ignored.

Much to ponder here.  Let’s hope government health agencies listen hard and get to work.

For further information, the press release adds these links:

Feb 6 2012

Happy 2nd Birthday Let’s Move!

On the occasion of the two-year anniversary of Michelle Obama’s Let’s Move! campaign, it’s time to reflect again on what the campaign means for the White House, for childhood obesity, and for the food movement.

A year later, I summarized some of the campaign’s accomplishments.  From the beginning, I’ve been impressed with its smart choice of targets: to reduce childhood obesity by improving school food and inner city access to healthy foods.

I’m reminded of the political savvy that went into the campaign by an editorial in The Nation (February 6), “America’s First Lady Blues.”  In it, Ilyse Hogue writes about Michelle Obama’s careful treading of the fine line between marital independence and submission, using Let’s Move! as an example.

Hogue praises Mrs. Obama’s choice of a target that looks “soft,” but is anything but:

In an effort to fit Michelle’s role into a traditional profile, the media constantly reminds us that her work is on presumably soft subjects, primarily her hallmark cause to end childhood obesity…Slurs aside, what critics miss is that this campaign is not aimed at soft targets.

The food and beverage industry is a powerful lobbying force, spending nearly $16.3 million in the 2008 cycle to defeat initiatives—like a “soda tax” and limits on aggressive advertising aimed at kids—that would encourage a healthier diet and thus cut into its massive profits.

To tackle childhood obesity, we’ll have to confront complicated issues of race, class, entrenched corporate power, and access to healthy food.

Indeed we will.  Childhood obesity is a focal point for issues of social justice.

Happy birthday Let’s Move!  And many more.

Jan 16 2012

The latest in meat safety: another form of zapping?

Bacterial contamination of meat is an ongoing problem and everyone wishes for an easy fix—one that does not require meat producers and packers to prevent contamination.

Irradiation works, but raises feasibility and other concerns.

How about electrocution?

Food Production Daily reports that hitting meat with electrical current reduces toxic E. coli O157:H7 on meat surfaces by 2 log units.

The research report says researchers inoculated meat with the bacteria and then applied electrical current.  But by inoculation they must mean just on the surface, because they only counted surface bacteria.

Surface bacteria, alas, are not the problem.  Searing meat effectively kills surface bacteria.   Bacteria in the interior (of hamburger, for example) survive unless the meat is well cooked.

And 2 log units is unlikely to be good enough for bacteria that cause harm at low doses, as this kind does.  The FDA requires a 5 log reduction for fresh juices, for example.

I wish researchers would apply their talents to figuring out how to keep toxic bacteria from getting into and onto animals in the first place.  Then we wouldn’t have to worry about designing techno-fixes to deal with contaminated meat.

 

Dec 23 2011

United Nations’ Special Rapporteur vs. the World Trade Organization

On December 19, Food Chemical News reported that Pascal Lamy, secretary-general of the World Trade Organization (WTO) “traded blows” with  United Nations’ Special Rapporteur on the Right to Food, Olivier De Schutter, over the role of trade in food security.

As far as I can tell, the “blows” were figurative, not literal, but the debate was real.   De Schutter had written a report questioning whether greater trade liberalization—the goal of WTO—could deliver on food security (for the basis of this debate, see below).

“Developing countries are rightly concerned that their hands will be tied by trade rules,” De Schutter said, and called for higher tariffs and targeted farm subsidies to stimulate local food production.   He labeled the “WTO’s vision as “outdated. … The right to food is not a commodity, and we must stop treating it that way.”

For some time now, I’ve been following the De Schutter’s work, not least because he is using the office of Special Rapporteur as a bully pulpit from which to promote healthier and more sustainable and equitable food systems throughout the world.

De Schutter, among other things, is my occasional colleague at NYU.

Olivier De Schutter (LL.M., Harvard University ; Ph.D., University of Louvain (UCL)), the UN Special Rapporteur on the right to food since May 2008, is a Professor at the Catholic University of Louvain and at the College of Europe (Natolin). He is also a Member of the Global Law School Faculty at New York University and is Visiting Professor at Columbia University.

As Special Rapporteur, he is supposed to

Report both to the UN General Assembly (Third Committee) and to the Human Rights Council on the fulfillment of the mandate…In addition to addressing structural issues threatening the full enjoyment of the right to food, the Special Rapporteur may send communications to governments, called letters of allegation, in urgent cases brought to his attention by reliable sources.

Professor De Schutter has used this office to produce a remarkable succession of reports and position papers on a broad range of topics related to food, agriculture, and human and environmental health:

Take a look at the documents listed under these categories.  They are a terrific resource for anyone interested in the human right to food.

As for De Schutter vs. WTO, see:

Dec 20 2011

FDA tests apple juice for arsenic, says most are OK

Perhaps in response to Consumer Reports’ charges that levels of arsenic in children’s juices are so high that more restrictive standards would be healthier (see previous post), the FDA has done its own tests, updated its arsenic home page, and strengthened its Q and A on arsenic.

The Q and A includes these questions:

Is the arsenic in apple juice predominantly organic or inorganic?  Due to limited data available to answer this question, in October 2011, FDA collected and analyzed 94 samples of apple juices available for sale in the United States. Results from this data indicate that there are relatively low levels of arsenic in apple juice, with 95 percent of the apple juice samples tested being below 10 ppb total arsenic, but that the arsenic in these samples was predominantly the inorganic form [the bad kind].

Did the FDA test any of the samples tested by the Dr. Oz Show? On September 10-11, 2011, the FDA completed laboratory analysis of the same lot of Gerber apple juice that was tested by the Dr. Oz Show [Dr. Oz complained about the dangers of arsenic in juice], as well as several other lots produced in the same facility. The FDA’s testing detected very low levels of total arsenic in all samples tested. These new results were consistent with the FDA’s results obtained in the FDA’s routine monitoring program and are well below the results reported by the Dr. Oz Show. The FDA has concluded that the very low levels detected during our analysis are not a public health risk and the juice products are safe for consumption.

Food Quality News reports that safe or not, the FDA is still “considering setting a guidance level for inorganic arsenic in apple juice and apple juice concentrate that will further minimise public exposure to this contaminant.”

As well it should.  And preferably at the lower levels recommended by Consumer Reports.

 

 

Nov 23 2011

Happy Occupied Thanksgiving!

From Brian McFadden’s “The Strip,” New York Times, November 20.

Enjoy the holiday, family, and friends!

Nov 21 2011

Budget talks fail: what’s happening with the farm bill?

As of this morning, it looks like the SuperCommittee process has failed.  This committee was supposed to recommend specific budget cuts by tonight.  If it fails, automatic budget cuts, half to the military, go into effect in January 2013—after the 2012 election.

What does this mean for the farm bill?

The chairs and vice-chairs of the House and Senate agriculture committee have been meeting in secret—from the rest of the agriculture committee members as well as from the public—to recommend how to cut $23 billion from agriculture appropriations.

On Friday, the Environmental Working Group obtained a leaked copy of the secret recommendations.

These recommendations, rumored to be not quite final, were to go to the SuperCommittee today.  Now what?

I’m guessing the farm bill is up for grabs and will now have to go through the usual legislative processes.  This could be good or bad, depending on the politics.

In the meantime, I counted 97 recommendations in the secret committee’s report.  A few of the most interesting:

Commodities

  • Eliminate direct payments, counter-cyclical payments, average crop revenue election, and supplemental revenue assistance payments to create $15 billion in savings.
  • Expand crop insurance for “underserved” crops, including fruits and vegetables.
  • Create a special program to protect cotton producers.
  • Protect commodity producers against both price and yield losses.
  • Restrict benefits to farmers who make less than $950,000 per year (adjusted gross), or twice that for couples.
  • Set payment limits of $105,000 per producer, or twice that for couples.
  • Do something complicated with dairy by replacing two programs with two others.

Conservation

  • Cut the budget by an unspecified amount (continuing a long tradition of cutting conservation).
  • Reduce reserve acres from 32 million to 25 million over 10 years.

Nutrition

  • Cut SNAP (food stamp) benefits by about $4 billion a year, by eliminating automatic enrollment for anyone who gets energy benefits.
  • Require retailers to stock more fruits and vegetables.
  • Give USDA the authority to require documented need for states to allow SNAP benefits to be used in restaurants by the disabled and homeless.
  • Give USDA $5 million per year to prevent trafficking of benefits.
  • Require USDA to set rules to prevent lottery winners from getting SNAP benefits (what is this about?).
  • Grant $10 million to encourage whole grains in school meals.
  • Grant $20 million a year for incentives for SNAP recipients to buy fruits and vegetables.

“Specialty” crops (translation: fruits and vegetables)

  • Fund promotion program for farmers’ markets at $20 million a year
  • Give USDA $5 million to collect data on organics
  • Provide $61 million a year for programs to prevent agricultural pests
  • Give $70 million a year for grants to states to promote specialty crops
  • Allot $15 million a year to run the National Organic Program
  • Provide $40 million a year for specialty crop research.
  • Provide up to 75% of the cost of organic certification (maximum $750).

As in the past, SNAP takes up about 80% of the total farm bill budget, with the remainder going mainly to commodity support and insurance programs.

As always, large agricultural producers get most of the support money—$ billions—but this plan throws a handful of small benefits ($ millions) to help fruit-and-vegetable growers.

How any of this might work in practice is unclear, as is what happens next.  A whole new opportunity for lobbying, perhaps.  Stay tuned.

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