Currently browsing posts about: Conflicts-of-interest

Here are the burning questions about sodium (which is 40% of salt) intake:

(a) Does too much dietary sodium cause high blood pressure?   Answer: an unambiguous yes (although not necessarily in everyone).

(b) Are public health recommendations to reduce salt intake warranted?  I think so, but others disagree.

(c) If so, to what level?  Although virtually all committees reviewing the evidence on salt and hypertension view public health recommendations as warranted, and advise an upper limit of about 2 grams of sodium (5 grams of salt, a bit more than a teaspoon (see table from the Wall Street Journal), these too are under debate.

These recommendations are strongly opposed by The Salt Institute, the trade association for the salt industry, its industry supporters, and some groups of investigators.

Now the New England Journal of Medicine weighs in with three new studies, an editorial, and a cartoon video.  The papers:

• Association of Urinary Sodium and Potassium Excretion with Blood Pressure: A. Mente and Others | N Engl J Med 2014;371:601-611
• Urinary Sodium and Potassium Excretion, Mortality, and Cardiovascular Events: M. O’Donnell and Others | N Engl J Med 2014;371:612-623
• Global Sodium Consumption and Death from Cardiovascular Causes: D. Mozaffarian and Others | N Engl J Med 2014;371:624-634

Start with the video,  narrated by the editor, Dr. Jeffrey Drazen (click on video link on the right side).  It gives an excellent summary of the three papers.  Despite their methodological differences, all confirm (a).  They disagree on (c) and, therefore, (b).

Are public health recommendations warranted?

But note Dr. Drazen’s suggestion: “throw away the salt shaker.”

He is in favor of reducing salt intake.  But the salt shaker is not where most dietary salt comes from.  At least 75% of salt in American diets comes from restaurant and processed foods.   As Dr. Yoni Freedhoff explains:

If you’d like to reduce the sodium in your diet, rather than keep a running tally of how much you’re actually consuming, why not try instead to determine what percentage of your diet comes from restaurants and boxes? Sure, there’s data to suggest you might simply find other ways to add salt to your diet. But visit restaurants and consume processed foods less frequently, and I’d be willing to wager that you’ll be far more likely to see health benefits than were you to simply fill your grocery cart with low-sodium versions of highly processed foods.

Individuals cannot cut down on salt on their own.  That’s one reason why public health policies are needed—to get restaurants and processed food manufacturers to reduce salt content.

Two of the papers say that the only people who need to cut down on salt are those with hypertension and older people (one of the studies says that means people over age 55).

• How many Americans have hypertension?  67 million (1 out of every 3 adults) according to the CDC.
• How many Americans are over age 55?  More than 80 million, and rising.

You can’t expect 70 or 80 million people to reduce salt intake on their own.  Hence: public health recommendations.

Conflict of interest alert

Some of the investigators report receiving grants or fees from companies that make anti-hypertensive drugs but the editorial accompanying the papers is of special concern.   Written by Dr. Suzanne Oparil, it says about one of the studies:

These provocative findings beg for a randomized, controlled outcome trial to compare reduced sodium intake with usual diet. In the absence of such a trial, the results argue against reduction of dietary sodium as an isolated public health recommendation.

These conclusions sent me right to her conflict-of-interest disclosure statement.  Although Dr. Oparil reports receiving grants or fees from companies making anti-hypertensive drugs—-and, even more remarkable, from The Salt Institute—she states that she has no conflicts of interest.

I think she does.

Implications

Her editorial is especially unfortunate because it influences the way reporters write about the studies.

The Associated Press account, for example, begins:

A large international study questions the conventional wisdom that most people should cut back on salt, suggesting that the amount most folks consume is OK for heart health — and too little may be as bad as too much. The findings came under immediate attack by other scientists.

As well they should.  Blood pressure rises with age and huge swaths of the population would be healthier eating less salt.   The AP reporter quoted me saying so:

“People don’t eat salt, they eat food,” she said. “Lots of people have high blood pressure and lots of people are getting older,” making salt a growing concern, she said. “That’s the context in which this is taking place.”

The three studies are complicated to interpret because of differences in methods and discrepancies in outcomes.  They agree that if you already have hypertension or are “elderly,” or eat a lot of salt, you should cut down.

This seems like a good idea for just about anyone.   People don’t eat salt; they eat foods containing salt, and foods high in salt tend to be high in other things best consumed in small amounts.

The studies also talk about the protective effects of potassium, best obtained from vegetables.

Eat a lot of vegetables and not too much junk food, and you don’t have to worry about any of this.

Former USDA Secretary Dan Glickman has just been named chairman of the board of the Foundation for Food and Agriculture Research (FFAR).

Research on agriculture has long been the underfunded stepchild of the federal research enterprise.  The 2014 budget gave USDA under $3 billion in total to fund all of its in-house research units and their granting operations: Agricultural Research Service, National Institute of Food and Agriculture, Economic Research Service, and Agricultural Statistics Service.

This may seem like a lot, but NIH gets $30 billion a year.

The 2014 farm bill contained a provision aimed at raising money for agricultural research.  It provided $200 million (peanuts in federal dollars) to establish FFAR, which will operate as a non-profit corporation to obtain matching funds from private industry.

The members of the board were announced a couple of weeks ago.

It should be no surprise that many of the board members represent industry.  Industry nominated 7 of the members.  The other 8 were selected from a list provided by the National Academy of Sciences.

Now the board has to raise at least $200 million from industry, presumably with no strings attached.

Here’s the foundation’s dilemma: if industry funding has no strings—earmarks for certain research projects, for example—why would industry want to contribute?  But if the contributions do come with strings, they create conflicts of interest.

This will be fun to watch.  Stay tuned.

The big surprise in Michael Moss’s tough look at health claims on coconut water in today’s New York Times—worth looking at online for the terrific video—is this:

One Last Comparison

These days, coconut water’s big rival may be plain old water. How do they compare? Scientists are still wrestling with the question, and while their findings vary, water is starting to look just fine for most people. A 2012 study (funded by Vita Coco) in the Journal of the International Society of Sports Nutrition found that neither coconut water nor sports drinks were better than water in hydrating young men after hourlong workouts.

Really?  An industry-funded study that comes to a conclusion against the interest of the funder?

This requires a look at the original paper.

So a round of applause please for the authors who did this funded study, “Comparison of coconut water and a carbohydrate-electrolyte sport drink on measures of hydration and physical performance in exercise-trained men,” and nevertheless came to this conclusion:

Our data indicate that both coconut water (natural, concentrated and not from concentrate) and bottled water provide similar rehydrating effects as compared to a carbohydrate-electrolyte sports drink.  Moreover, none of the beverages impacted treadmill exercise performance differently during the rehydration period.

Lest there be any ambiguity about what this means, their data clearly show that VitaCoco, a sports drink (not named but I’d bet on Gatorade), and coconut water from concentrate all rehydrated men who spent 60 minutes on a treadmill to the same extent.

In other words: for rehydration, water works just as well as coconut water or sports drinks.   No surprise, really.

VitaCoco must be disappointed, but it still has one thing going for it: coconut water tastes really good.

August 1 is the deadline for filing comments on FDA’s food label proposals.

Two were released yesterday, one for and one against.

The Union of Concerned Scientists (UCS) organized a statement in support of listing added sugars signed by 280 scientists, physicians, and public health officials (including me).

The press release says:

In a letter submitted as a public comment for the agency’s first label update since 1994, the signatories point out that sugar overconsumption contributes to diabetes, cardiovascular disease and other ailments….Many food and beverage manufacturers add excessive amounts of sugar to their products, including those that they market as healthy options. In our current food environment, many people are unknowingly and unavoidably consuming excess sugar. Given our soaring rates of chronic diseases and the link between sugar and these diseases, citizens have a right to know how much sugar has been added to their foods.

People who signed the letter include many from Healthy Food Action, a national network of health professionals founded by Dr. David Wallinga.  I am a co-author of the statement with UCS staff and Dr. Robert Lustig.

In contrast, the American Society for Nutrition (ASN), an organization of nutrition scientists to which I belong, produced a strong statement against labeling added sugars.

ASN also has concerns that the inclusion of added sugars on the label may divert attention away from total calories and other important contributors to weight gain. The inclusion of added sugars on the label may confuse consumers and create the perception that naturally occurring sugars are somehow more beneficial because they are “natural” and do not have health effects similar to added sugars…There is no supporting evidence that indicates that the inclusion of added sugars on the food label will translate into the American public reducing caloric intake from added or total sugars or total energy intake…it is important to consider potential unintended consequences of  reformulation as well. When sugar is removed from a solid food product…The replacement is often fat and/or starch which could lead to a product with higher calories per serving. ASN encourages FDA to carefully consider potential adverse consequences of this proposed determination, including gaining input from food scientists…An investment in consumer education… is likely to be most productive for consumer understanding relative to added sugars, and would assure that consumers do not experience increased confusion, which they may encounter if added sugars are declared on the Nutrition Facts label.

These comments, which read as though written by sugar trade association groups, were signed by the president of ASN.  Although the statement letter gives no indication of the process by which these comments were developed, I’m told it was prepared by ASN’s public policy committee.

If so, it would help to know whether members of the committee have financial ties to the sugar industry or to food companies that use sugar in their products.

I wonder how much of the ASN membership agrees with this position on Added Sugars.   I certainly don’t.

 

Over the July 4^th weekend, a reader sent a link to a paper about to be published in the American Journal of Clinical Nutrition titled Increased fruit and vegetable intake has no discernible effect on weight loss: a systematic review and meta-analysis.

I took a look at the abstract:

Studies to date do not support the proposition that recommendations to increase F/V intake or the home delivery or provision of F/Vs will cause weight loss. On the basis of the current evidence, recommending increased F/V consumption to treat or prevent obesity without explicitly combining this approach with efforts to reduce intake of other energy sources is unwarranted.

This would seem to make some sense, no?  But the dismissal of recommendations to increase fruit-and-vegetable consumption sent up red flags.

My immediate question: who paid for this study?

Here’s the conflict of interest statement.

Note the presence of companies making processed foods whose sales would decline if people ate more F&V.

A coincidence?  I don’t think so, alas.

More evidence: just today, Bettina Siegel sent me her post on a paper sponsored by the Corn Refiners Association, once again with a predictable outcome.

When it comes to nutrition research, “guess the sponsor” is a game that is all too easy to win.

Today, Michael Goran and his colleagues published an NIH-funded study demonstrating that the proportion of fructose in products made with high fructose corn syrup is often higher than 55%—as much as 60% to 67%.

This matters because of concerns that high intake of fructose might induce insulin resistance and other metabolic problems.

Today also, a different group of investigators published a study saying just the opposite.  Fructose in products, it says, is in close agreement with the amount expected.

Who funded this one?  The International Society of Beverage Technologists, whose executive board represents soda companies.

Really, these kinds of results are so predictable that all I have to do is see the results to guess who must have funded the study.

Coincidence?  I don’t think so.

 

Yesterday, Food Navigator reported that Cornell economists calculated that GMO labels would cost the average family of four a whopping $800 per year.

This seemed so improbable that I immediately wondered:  Who paid for it?

I clicked on the link to the study: Bingo!

The work on this report was supported financially by the Council for Biotechnology Information.

You won’t find the list of companies and groups that support the Council on its website, but Source Watch fills the gap.

I am increasingly alarmed by the increasing extent of industry research sponsorship—it’s become a huge issue in  studies of nutrition, diet, and health.

The influence of funding source on research outcomes is so predictable—many studies have now shown that industry-funded studies almost invariably produce results that favor the sponsor—that I’m batting nearly 100% on conflict-of-interest  checks, of which this GMO study is a particularly blatant example.

It’s not that industry pays investigators to find the desired answers to questions.  It’s more complicated than that.  It has to do with the way investigators ask and try to answer the research questions.  The industry favored biases get built into the study’s assumptions and controls, often (I think) unconsciously.

This study, for example, is based on an elaborate set of assumptions leading to the $800 per family estimate.  Other assumptions might give different results.   The authors do not discuss the limitations of their estimates, nor are they required to in this type of report.

But I’m willing to hazard a guess that independently funded studies would come to considerably lower estimates.

Moral: if a study produces surprising results that favor an industry position, look hard to see who sponsored it.

Addition, May 24:

A reader sent in further information about the Council for Biotechnology Information:

Council for Biotechnology Information

1201 Maryland Avenue, SW., Suite 900, Washington, DC 20024 USA

Phone: 202-962-9200 web site: http://gmoanswers.com

(CBI: http://www.sourcewatch.org/index.php?title=Council_for_Biotechnology_Information.

http://www.powerbase.info/index.php/Council_for_Biotechnology_Information.

Experts: http://gmoanswers.com/experts. Founding members and supporting partners:

http://gmoanswers.com/about. There are also offices in Saskatoon (SK, Canada)

(http://whybiotech.ca)  and Mexico City (AgroBio Mexico: http://agrobiomexico.org.mx.)

Skeptic of the value of dietary supplements that I am, I cannot help feeling sorry for Herbalife.

The company sells protein shakes and snacks, vitamins and dietary supplements, and energy and fitness drinks which, it says, “combined with healthy eating and exercise, can help you lead a healthy, active life.”

Yes indeed, healthy eating and exercise will do that for you every time.

But Herbalife has become the victim of a bizarre hedge fund bet and its consequences.

In what is one of the most blatant conflicts of interest besetting a food product, a hedge fund manager, William Ackman, made a billion dollar “short” bet that Herbalife’s stock would fall.

When the stock did not do so immediately, Mr. Ackman set out to destroy the company’s reputation to force its stock down.

He even got members of Congress, including Senator Edward Markey (Dem-Massachusetts) to call for an investigation of the company’s marketing practices, an action that caused a 14-point drop in the stock.

This decidedly unsavory story was the subject of a New York Times investigative report yesterday: “Staking $1 Billion That Herbalife Will Fail, Then Lobbying to Bring It Down.”

The company has grown into a global powerhouse, with a worldwide team of more than three million so-called members and distributors who operate as independent contractors through a system that rewards many of them not only based on actual sales, but also on their ability to recruit more distributors.

The sales tactic, popular with many nutritional supplement companies, has frequently been the target of criticism. In 1986, California authorities issued an order prohibiting Herbalife from making false claims about the weight-loss powers of its nutritional drinks.

Herbalife reported sales of $4 billion in 2012 and is sold in more than 90 countries by distributors who earn profits on product sales and additional commissions from a “multi-level marketing” compensation structure.

Ackman argues that this is a pyramid scheme that particularly disadvantages Hispanic distributors and customers.  Other hedge funds disagree and have placed “long” bets on Herbalife.

This is food politics at a breathtaking level of income.  The Times story is well worth a look.