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As regular readers know, I’ve been posting studies funded by food companies with results favorable to the companies’ interests whenever I run across five of them.   Since mid-March, I’ve posted 7 such collections for a total of 37 studies (two of the posts listed 6 studies).  These are all papers published since March.

With each set, I asked readers to send examples of studies that do not favor the sponsor’s interest.

They are rare, but do exist.  I’ve been sent two so far.  I’m guessing it will be a long time before I collect five, so have a look:

Butter increased total and LDL cholesterol compared with olive oil however resulted in higher HDL cholesterol than habitual diet. Sara Engel and Tine Tholstrup.  American Journal of Clinical Nutrition, July 1, 2015, doi: 10.3945/​ajcn.115.112227.

• Conclusions: Moderate intake of butter resulted in increases in total cholesterol and LDL cholesterol compared with the effects of olive oil intake and a habitual diet (run-in period). Furthermore, moderate butter intake was also followed by an increase in HDL cholesterol compared with the habitual diet. We conclude that hypercholesterolemic people should keep their consumption of butter to a minimum, whereas moderate butter intake may be considered part of the diet in the normocholesterolemic population.
• Sponsor: Danish Dairy Research Foundation
• Comment: The data clearly show that butter raises blood cholesterol levels.  The authors spin it as positively as possible—higher HDL and it’s OK for people with normal cholesterol to eat moderate amounts of butter—but they make the downside quite clear.  In this study, “moderate” butter means 4.5% of calories or just 2/3 of a tablespoon for someone eating 2000 calories.  That’s not much, alas.

Influence of Pistachios on Performance and Exercise-Induced Inflammation, Oxidative Stress, Immune Dysfunction, and Metabolite Shifts in Cyclists: A Randomized, Crossover Trial.  David C. Nieman, Johannes Scherr, Beibei Luo, Mary Pat Meaney, Didier Dréau, Wei Sha, Dustin A. Dew, Dru A. Henson, Kirk L. Pappan.  PLoS One, November 19, 2014. DOI: 10.1371/journal.pone.0113725

• Conclusion: In summary, 2-weeks pistachio nut ingestion was associated with reduced 75-km cycling time trial performance and increased post-exercise plasma levels of raffinose, sucrose, and metabolites related to leukotoxic effects and oxidative stress.
• Funder: This work was supported by American Pistachio Growers. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
• Comment:  It’s obvious that the funders had no role.  I’ll bet they are quite unhappy with the results.

This second study came out last year but I’ll take any of these I can get.  Please do send.

But if I’m just counting since March, the ratio is 37 studies favoring the sponsor’s interest, to 1 that doesn’t.  Coincidence?  I’m not convinced.

Earlier this week, President Obama announced a plan to reduce toxic emissions from coal-burning power plants.  The purpose of the EPA’s Clean Power Plan  is to reduce greenhouse gases that contribute to climate change.

But from the standpoint of food politics, the new rules do something really important.  They will force coal-burning power plants to further reduce emissions of mercury.

In 2005, the EPA promulgated a rule to control mercury emissions from fossil fuel-fired power plants under section 111(d): the Clean Air Mercury Rule (CAMR). The EPA established a nationwide cap-and-trade program that took effect in two phases: In 2010, the cap was set at 38 tons per year, and in 2018, the cap was lowered to 15 tons per year. The EPA expected, on the basis of modeling, that sources would achieve the second phase, 15-ton per year cap cost-effectively by choosing among a set of measures that included shifting generation to lower-emitting units.

Mercury from coal-burning power plants is the largest human-induced source of methymercury in the fish food chain, accounting for 40% of the amount that gets into oceans (most of the rest comes from underseas volcanos).  Mercury is converted to toxic methylmercury in seawater, and the toxin moves up the fish food chain as bigger fish eat smaller fish.  Methylmercury does very bad things to the nervous system of the growing fetus (recall the mass poisonings in Minamata, Japan in the 1950s and the shocking photos of the victims). 

Fish advisories

Large, predatory fish have the most methymercury and should not be eaten in large amounts, or at all by pregnant women.

Fish advisories expect pregnant women to know the kinds of fish they can and cannot eat, and how much.  This is not easy.

Wouldn’t it be better to prevent mercury from getting into seawater in the first place?

I like to use eliminating methylmercury as an example of why public health (“upstream”) approaches work better than personal responsibility (“downstream”) approaches.

An exceptionally clear example is how to avoid toxic levels of methylmercury in fish.   We can teach pregnant women to recognize which fish are high in methylmercury and hope this works well enough so they will avoid buying such fish (personal responsibility) or we could–as a society–require coal-burning power plants to scrub their emissions so mercury doesn’t get into ocean or lake waters in the first place (public health).

That’s what this rule does.

For explanations of how the Clean Power Plan will work, see the Union of Concerned Scientists’ review.

Vox.com explains:

The basics of the Clean Power Plan are fairly simple. The EPA is giving each state an individualized goal for reducing emissions from their electric power plants. States can then decide for themselves how to get there…. Power plant emissions have already dropped 15 percent between 2005 and 2013, thanks to a brutal recession, cheap natural gas pushing out coal, the rise of wind power, and improved efficiency. So with this new plan, EPA is expecting a further 20 percent cut in power-plant emissions from 2013 levels by 2030.

For what Obama stands to gain from this rule, see the New York Times.

But hold the celebration.  Politico Pro Energy reports that Republicans in Congress view the rule as a key component of the administration’s “war on coal” and will try to block it or sue to stop it.   The Supreme Court says that the EPA has the authority to issue this rule, but “Challengers are expected to argue that the rule is invalid because it exceeds EPA’s authority, contradicts a Clean Air Act provision meant to avoid duplicative rules, and violates the 5th and 10th Amendments to the Constitution.”   And, of course, a post-Obama president could undo the whole thing, as it is an executive branch action, not a law passed by Congress.

Yesterday’s New York Times had a front-page story on how coal lobbyists and corporate lawyers started organizing more than a year ago to fight this plan.

An important ally in the effort was the American Legislative Exchange Council, or ALEC, a conservative advocacy group that pushes policy through state legislatures. Typically, the council’s committees of corporate members will craft a model bill designed to push through policies it supports, such as rolling back environmental regulations.

The Clean Power Plan deserves massive support.

This may be a climate-change plan, but it is also a critically important public health measure.

Anyone who likes eating fish should do everything possible to support this measure.

Despite my long interest in and dubious opinion about the benefits of Golden Rice (genetically modified to contain the beta-carotene precursor of vitamin A), I somehow completely missed the huge and highly embarrassing uproar over a study demonstrating the effectiveness of this rice in raising vitamin A levels in young children.

This particular uproar began with publication of the study in the American Journal of Clinical Nutrition in 2012.  Last week the journal announced that it has retracted the study—on ethical, not scientific, grounds.

To explain:  Dr. Guangwen Tang, a long-time researcher at Tufts University, and her colleagues at Tufts, in China, and at Baylor and the NIH, compared the effectiveness of vitamin A capsules, Golden Rice, and spinach in raising vitamin A levels in the blood of Chinese schoolchildren.  They reported that Golden Rice proved just as effective as capsules, and somewhat better than spinach, in inducing higher vitamin A levels, just as it is supposed to do.

Golden Rice, of course, is the poster child for the benefits of GMOs, extolled by many as the solution to the developing world’s high prevalence of vitamin A deficiency (I’m dubious because I view vitamin A deficiency as a social problem requiring policy and cultural shifts).

Soon after, Greenpeace, which is decidedly anti-GMO, challenged the ethics of the study, charging that the children were being used as “guinea pigs.”

As reported in Nature,

none of the children, their parents or school teachers was aware that Golden Rice was involved, according to a 45-minute investigative news programme broadcast on 8 December on CCTV, China’s state television channel.  The informed-consent form said that the rice contained β-carotene, but not that it was genetically modified or that it was Golden Rice. Nor did it highlight uncertainty around any potential risks of ingesting such rice…Moreover, Wang didn’t apply for ethical evaluation of the trial, instead fabricating the approval documents, according to CDC. And Tang brought Golden Rice from the United States to China illegally, without due declaration to the relevant Chinese authorities, it said.

According to a report on NPR, Tufts University did a year-long investigation and agreed that ethical standards had been violated:

the study was not “conducted in full compliance with … policy or federal regulations”… the researchers did not adequately explain the nature of golden rice and made some changes in the study without getting approval from the committee at Tufts that is supposed to review all research involving human subjects.  Guangwen Tang will be banned from conducting research on human subjects for two years. For two years after that, any research that she conducts will be under the direct supervision of another investigator.

A report on the case in ScienceInsider explains the ethical problem raised by the study’s informed consent form :

U.S. guidelines stipulate that such forms use plain language understandable to lay people, and the IRB [the Tufts Institutional Review Board] agreed to let Tang say that “Golden Rice is a new rice which makes beta-carotene,” without using the loaded words “genetically modified.” (The consent form for a very similar study by Tang among adults in Boston, published in 2009, didn’t use that term either.) Given the sensitivities over transgenic food, which existed in China as well, that was the wrong decision, according to the external panel.

In 2014,  Dr. Tang sued the ASN:

ASN twice asked Tang and her six co-authors to withdraw the paper voluntarily, which they declined to do. The society recently decided to retract the paper on its own…but it has agreed to a 90-day stay after Tang filed her lawsuit, to see if the matter can be settled out of court.

But the court ruled in favor of ASN.  Hence, the retraction.  ASN issued a press release:

In a ruling by the Massachusetts Superior Court, Judge Salinger…cleared the way for the American Society for Nutrition (ASN) to retract the article “β-Carotene in Golden Rice is as good as β-carotene in oil at providing vitamin A to children”…ASN is very pleased that the Massachusetts courts have upheld the organization’s First Amendment rights and have allowed ASN to move forward with the retraction of the article.

In its online retraction notice, ASN states the reasons:

1. The authors are unable to provide sufficient evidence that the study had been reviewed and approved by a local ethics committee in China in a manner fully consistent with NIH guidelines….
2. The authors are unable to substantiate through documentary evidence that all parents or children involved in the study were provided with the full consent form for the study.
3. Specific eligibility issues were identified in regard to 2 subjects in the study.

Last week, Retraction Watch published a lengthy summary of this case that includes a long statement from Tufts University:

No questions were raised about the integrity of the study data, accuracy of the research results or safety of the research subjects…Tufts University has always been and remains deeply committed to the highest ethical and scientific standards in research.  In September 2012, w …convened an external review committee to interview those involved and to review documentation of the study…There was no evidence found of falsification or fabrication of the data that underlie the study’s primary findings. Those reviews did, however, determine that the research had not been conducted in full compliance with Tufts research policies and federal research regulations.

The retraction is a huge embarrassment, not only for the researchers involved but also for Tufts University’s Friedman School of Nutrition Science and Policy, Tufts’ Institutional Review Board, the American Journal of Clinical Nutrition, and the American Society for Clinical Nutrition.

The study was funded by NIH, USDA, as well as a program in China.  NIH takes research ethics very seriously and expects the researchers it funds to adhere to the highest possible standards for research on human subjects.  Because the study did not follow standard ethical guidelines, especially with regard to research on children, Tufts had no choice but to investigate and impose sanctions, and the journal had no choice but to retract the paper.

This case reinforces my views about GMOs in general and Golden Rice in particular.

The controversies are not (or not usually) about the science.  They are very much about ethics and other questions of values.

Once again, I am posting five food industry-sponsored studies with results that come out just the way the sponsor wants them to.  Coincidence?  Or something more serious?  I am trying to remain open-minded.  If you know of food industry-sponsored research that does not favor the sponsor’s interests, please send.  As soon as I collect five, I will post.

The FDA announced this morning that it is proposing a Daily Value (the maximum) for Added Sugars on food labels—10% of calories.

Susan Mayne, FDA’s Director of the Center for Food Safety and Applied Nutrition, explains the rationale: this is the percentage recommended by the Dietary Guidelines and practically every other health authority that has examined the evidence on sugars and health.

Ten percent of calories means 200 calories on a 2000 calorie daily diet, or 50 grams, or 12 teaspoons—the amount in one 16-ounce soda.

If you drink a 16-ounce soda, you have done your added sugars for the day.

If this seems abstemious, consider that 10% of calories is more generous than the amount recommended by the UK’s Scientific Advisory Committee on Nutrition:

It is recommended that the average population intake of free sugars should not exceed 5% of total dietary energy for age groups from 2 years upwards.

The World Health Organization’s recent report on sugars and health also views 10% as the absolute maximum:

• In both adults and children, WHO recommends reducing the intake of free sugars to less than 10% of total energy intake (strong recommendation).
• WHO suggests a further reduction of the intake of free sugars to below 5% of total energy intake (conditional recommendation).

The WHO report explains:

The recommendation to further limit free sugars intake to less than 5% of total energy intake, which is also supported by other recent analyses, is based on the recognition that the negative health effects of dental caries are cumulative, tracking from childhood to adulthood…No evidence for harm associated with reducing the intake of free sugars to less than 5% of total energy intake was identified.

Americans, on average, consume way more than 10% of calories from added sugars, so this recommendation means a sharp restriction.

It means consuming less of sugary products: sodas, baked goods, and all those packaged foods with added sugars.

The proposal is up for comment.

You can bet that there will be plenty.

Congratulations to the FDA for this one.  Let’s hope it sticks.

How to Comment

To comment on the proposed changes to the Nutrition Facts Label:

1. Read the proposed changes.
2. Starting Monday, July 27, 2015, go to Regulations.gov to submit comments.

Let’s review where we are on the 2015 Dietary Guidelines for Americans.  The Dietary Guidelines Advisory Committee (DGAC) filed its scientific report in February.  More than 25,000 people filed comments.  Now, USDA and Health and Human Services staff must deal with the comments and write the actual dietary guidelines, the policy document scheduled for release later this year (see Timeline).

Recall that the DGAC report caused much controversy when it linked agricultural to health policy by recommending a diet that promotes health and protects the environment—one that is largely plant-based.

Lobbyists for food companies affected by such recommendations went straight to Congress.

The result?  Congress used the appropriations process to set limits on what the guidelines could say.

House Agricultural Appropriations Bill 

SEC. 734. None of the funds made available by this Act may be used to release or implement the final version of the eighth edition of the Dietary Guidelines for Americans…unless the Secretary of Agriculture and the Secretary of Health and Human Services comply with each of the following requirements:

(1) Each revision to any nutritional or dietary information or guideline contained in the 2010 edition of the Dietary Guidelines for Americans and any new nutritional or dietary information or guideline to be included in the eighth edition of the Dietary Guidelines for Americans— (A) shall be based on scientific evidence that has been rated ‘‘Grade I: Strong’’ by the grading rubric developed by the Nutrition Evidence Library of the Department of Agriculture; and (B) shall be limited in scope to only matters of diet and nutrient intake.

(2) The Secretaries shall release a preliminary draft of the eighth edition of the Dietary Guidelines for Americans, including a list of all the scientific studies and evidence supporting each revised or new nutritional or dietary information or guideline, for a period of public comment of at least days.

(3) Following the end of the public comment period, the Secretaries shall provide a period for agency review of public comments of at least 60 days.

Senate Agricultural Appropriations Bill 

SEC. 733. None of the funds appropriated in this Act may be used to issue, promulgate, or otherwise implement the 2015 Dietary Guidelines for Americans edition unless the information and guidelines in the report are solely nutritional and dietary in nature; and based only on a preponderance of nutritional and dietary scientific evidence and not extraneous information.

The White House Office of Management and Budget objected to the House provision:

The Administration strongly objects to using the appropriations process for objectionable language provisions that are wholly unnecessary to the operation of the nutrition programs…The Administration is also concerned with objectionable language that interferes with evidentiary standards, limiting the ability of USDA and the Department of Health and Human Services to develop dietary recommendations based on the preponderance of the strongest available scientific evidence, as is current practice. The language would also delay the availability of updated guidelines.

The appropriations bills have not yet been reconciled or sent to the President.  Let’s hope Congress decides to leave nutrition advice to people who know something about it and stay out of it.

Ordinarily I don’t pay close attention to early congressional legislative initiatives until they seem likely to be passed by both houses and signed by the President.

But the House seems likely to pass the Safe and Accurate Food Labeling Act of 2015 (HR 1599) tomorrow, and what’s happening with it is worth a look.  Opponents call the bill the “Denying Americans the Right to Know (DARK) Act.”  (Update July 23: the House passed the bill with a vote of 275 for and 150 against, with the help of African-American representatives).

The purpose of HR 1599 is to block states—like Vermont, for example—from requiring labels on GMO foods [see details below at *].

How it works is best seen in the amendments that will be considered tomorrow.  Of the 14 amendments proposed, the House Rules Committee will allow discussion of these four.

• Rep. Peter DeFazio, D-Ore:  if a U.S. company or subsidiary labels a product as containing GMOs in any foreign country, it must label the equivalent product the same way in the United States.  (Defeated 122 to 303)
• Rep. Jared Huffman, D-Calif: ensures tribal sovereignty to prohibit or restrict the cultivation of GMOs on tribal lands. (Defeated 196 to 227)
• Rep. Rosa DeLauro, D-Conn: prohibits use of the term “natural” on GMO foods. (Defeated 163 to 262)
• Rep. Chellie Pingree, D-Maine: strikes the entire bill and creates a USDA non-GMO certification program and label. (Defeated by voice vote)

In an op-ed in the Boston Globe, Reps. Chellie Pingree and Jim McGovern say “Let consumers decide for themselves.”

Americans want more information, not less. What we need is one law that makes GMO labeling mandatory across the country and establishes a single national standard that eliminates confusion and puts consumers in charge.

This debate isn’t about the safety of GMOs. It’s about consumers’ right to know what’s in the food they put on their tables. We ought to give them that right.

It’s interesting to see who is for this bill, and who against. One major proponent is the Grocery Manufacturers Association, which joined 475 other members of the industry “front group,” the Coalition for Safe and Affordable Food, in signing a letter in support.

Those opposed include the National Organic Coalition and the Just Label It campaign.   Also opposed are Food Democracy Now and the National Farmers Union, along with a long list of farm, consumer, and environmental groups.

Even if the House passes the bill, nobody in the Senate seems interested in it as yet.  So maybe this is all just theater.

But I read it as acknowledgment by the GMO industry and its food product supporters that the labeling issue is not going to go away.  Therefore, they had best try to preempt it by passing a law they can live with and making sure that states do not pass their own, stronger bills.

Stay tuned.

*Addition: I received a request to unpack the bill and state its terms.  HR 1599:

• Calls for premarket notification of new GMOs introduced into the food supply.
• Says the process of GMO is not sufficient to require labeling.
• Says non-GMO labeling cannot imply that non-GMO is safer.
• Blocks voluntary non-GMO labeling.
• Prevents states from requiring GMO labeling.
• Allows the term “natural” on labels of GMO foods.
• Establishes a non-GMO certification program requiring process controls and preemption of state laws.

Update, July 27: According to OpenSecrets.org, representatives who voted against GMO labeling received three times as much money from agribusiness as those who did not.  OpenSecrets calls this a “cash crop.”

Union of Concerned Scientists food systems analysts Karen Stillerman and Lindsay Haynes-Maslow have issued firm rebuttals to the School Nutrition Association’s excuses for opposing nutrition standards for school meals.

• Excuse #1: There’s a shortage of whole grain Rice Krispies Treats
• Excuse #2: Healthier standards have driven up school food costs
• Excuse #3: Lowering sodium levels at school may harm kids *
• Excuse #4:  Students won’t eat whole-grain rich foods*
• Excuse #5: Some schools are struggling to implement the new requirements

*These two are congressional targets (see below)

Dana Woldow explains what’s really happening with schools that drop out of the meal programs ostensibly on the grounds that the new standards cost too much.

Bettina Siegel explains how anti-standard campaigns play out in Texas:

Tucked within an Orwellian press release touting its efforts to “combat child obesity,” the Texas Department of Agriculture has made official its lifting of a decade-old ban on deep fat fryers in Texas schools, as well as rolling back other common sense school nutrition measures…despite the fact that our state ranks fifth in the nation for obesity among high school students, and despite public comments reportedly opposing the TDA’s plan by an astounding margin of 105 to 8.

USDA Secretary Tom Vilsack pleads with the School Nutrition Association to stop fighting the healthier school meal standards.

*But the House and Senate continue to roll back the standards for whole grains and salt in their respective versions of the Agriculture Appropriations Bills.*

• House Agricultural Appropriations Bill (see Sec. 732 and 733)
• Senate Agricultural Appropriations Bill (see Sec. 745)

If you are baffled as to why the School Nutrition Association would oppose healthier meals for the children they serve, consider the food company sponsors of that organization and how aggressively SNA courts food company sponsors.  (But there’s a ray of hope.  Maybe, Dana Woldow suggests, the new SNA President will put kids’ health first).

If you are baffled as to why healthier meals for school kids would induce Congress to try to undermine them, consider the companies that profit most from selling products that do not meet nutrition standards to America’s schools.

Maybe the President will veto?  The White House Office of Management and Budget filed an objection:

The Administration strongly objects to using the appropriations process for objectionable language provisions that are wholly unnecessary to the operation of the nutrition programs and would impede efficient administration of the programs. For example, on whole grains, USDA has provided States and school districts with the flexibility they need now and would consider continuing that flexibility, if needed. However, the Administration opposes inclusion of this provision in the bill, as it signals that the
waivers are not dependent on the availability of reasonably priced whole grain options.

Let’s hope Congress removes these micromanaging provisions before sending the bill to the President.

*Addition: Ten reasons why Congress should stay out of school lunch.