DC Medical Malpractice & Patient Safety Blog

In support of holding the line on “too much information,” a study recently published by the American Journal of Clinical Nutrition showed how data devoid of context is often useless and sometimes misleading.

The study concerned the abundant amount of research associating certain foods with disease risk, and how bold claims so often make their way into the public consciousness. (See our blog, “TV Doctors: Good Entertainment, Bad Medicine.”)

The journal authors concluded that you’re better off ignoring most of these food findings than you are changing your life to accommodate them. As noted in the Washington Post, if you conduct a Google search with the terms “foods associated with cancer,” you get 196 million results, “including new studies … on salt, aspartame and high-carb diets.” In this case, as in so many, more is less.

Most of the food studies showed weak, even insignificant, links to cancer. In their survey, researchers Jonathan D. Schoenfeld and John P.A. Ioannidis analyzed 50 common ingredients from random recipes in a cookbook; 40 had been the subjects of studies associating the ingredient with the risk of cancer. Staples such as salt, pepper, eggs and coffee were nabbed in the net of often sketchy research, as well as more exotic fare such as lobster, rum and mace (a spice).

Nearly 4 in 10 ingredients were deemed to increase the risk, 3 in 10 registered a decreased risk and nearly 1 in 4 showed no clear evidence either way. But the vast majority of the studies—8 in 10—showed really weak associations between the specific ingredient and cancer risk.

And, tellingly, the more statistically significant results showed up only in the abstracts of research studies, rather than in the meta data, where statistically insignificant results were more likely to appear. Abstracts summarize the results of a single study. Meta analysis is more meaningful because it’s more thorough; it crunches the numbers of different studies to contrast and compare them with the goal of identifying patterns among a body of study results. It’s like having a tiny bite of a complicated stew versus eating a whole bowl—you don’t get a sense of the whole meal by sampling just one ingredient.

As Schoenfeld and Ioannidis wrote, “Associations with cancer risk or benefits have been claimed for most food ingredients. Many single studies highlight implausibly large effects, even though evidence is weak. Effect sizes shrink in meta-analyses.”

If you want to reduce your risk of cancer, cardiovascular disease, diabetes and other disorders, you probably know how to begin: limit fat, sugar and alcohol, eat whole grains, fruits and vegetables and drink water. People with certain individual risks might want to limit their intake of salt, avoid gluten (a protein found in wheat and some other grains) and make other dietary adjustments as indicated by blood tests and other objective factors. But to revise your eating habits because a cute doctor on a talk show is excited about one recent study is to fall victim to fashion, not science.

There’s been a lot of news lately about energy drinks, and none of it’s good. We recently wrote about how little is known about their contents, and their link to heart disease and high blood pressure.

Now, as reported in the New York Times, five people died in the last three years after drinking Monster Energy. And the parent of a 14-year-old Maryland girl has sued Monster Beverage, its manufacturer, for failing to warn consumers about its risks after her daughter died of heart arrhythmia.

The FDA released an incident report (which doesn’t prove Monster Energy caused the deaths or any other health issues) about the high-caffeine beverage, which was obtained by Wendy Crossland, the teenager’s mother. The girl had drunk large cans of Monster Energy on two consecutive days. In addition to the five deaths, the FDA has received a report of a nonfatal heart attack possibly associated with the drink.

Other incident reports, according to The Times, included other adverse events including abdominal pain, vomiting, tremors and abnormal heart rate. The reports covered the period from 2004 to June 2012; all the deaths occurred in 2009 or later. According to Bloomberg News, there were 37 adverse reaction reports since 2004 that mentioned Monster drinks.

The reports are not exhaustive—they aren’t clear for example, if the incidents involved other factors, such as alcohol or drugs. The reports are voluntary, so generally the number the FDA receives about any product it regulates represents only a fraction of all incidents.

Monster Energy is only one representative of the energy-blast product niche. Others include Red Bull, Rock Star and 5-hour Energy. Monster Energy has several derivative drinks—Monster Rehab, Monster Assault and Monster Heavy Metal. As their names indicate, the target market is teenagers and young adults. An FDA statement said manufacturers were responsible for investigating reports of death or injuries associated with their products, and that the agency had not established a causal link between the deaths and the beverage.

Still, the report raises concern about how well manufacturers monitor their products for safety and whether the feds exercise oversight of them. Product labels indicate that they’re “not recommended” for children under 12 and people “sensitive” to caffeine. The stimulant can pose risks for people with heart disorders, so there’s a lot of real estate between not being recommended and being deadly.

Manufacturers are not obliged to disclose caffeine content, and it is they who decide whether to call them drinks or dietary supplements. The latter are not subject to FDA oversight for ingredients and labeling.

Anais Fournier, the Marylander teen who died, drank 24-ounce cans of Monster Energy that each contained 240 milligrams of caffeine. An 8-ounce cup of brewed, generic coffee has about 133 mg of caffeine, according to the Center for Science in the Public Interest.

The lawsuit filed on her behalf, The Times reported, quoted autopsy and medical examiner reports that she had died of “cardiac arrhythmia due to caffeine toxicity” that had exacerbated an existing heart problem. Fournier apparently had Ehlers-Danlos syndrome, which can affect blood vessels. She and her family were aware of her underlying heart condition but apparently her doctors had not told her to restrict her physical activities or her caffeine use.

In April, Sen. Richard J. Durbin invoked Fournier’s death in a letter urging the FDA to enforce caffeine levels in energy drinks. In August, agency officials said that there was insufficient evidence to take action on caffeine levels in energy drinks, noting, however, that it had not received medical reports related to Fournier’s death. According to Bloomberg News, emergency room visits involving energy drinks increased tenfold from 2005 through 2009. About half of them, according to Bloomberg, were patients 18 to 25 years old and some involved drugs or alcohol,

If you want Congress to impose stricter ingredient and labeling practices on the energy drink industry, contact your representative. You can find out who and where they are by linking here. To report a problem with a food, drug or dietary supplement, contact the FDA's MedWatch program.

Good news from the nanny state: Compelling restaurants to cut the trans fat content of their food has a positive effect on public health.

Trans fat that does not occur naturally in meat or dairy products is artificially produced by rendering liquid oils solid. That’s useful in baked goods, and lengthens a product’s shelf life. But it also presents a greater risk to heart health than other forms of fat, such as unsaturated and monosaturated fat.

In the hope of informing consumers and encouraging better food choices, the federal government required that packaged food labels disclose the amount of trans fat contained per serving as of 2006. Restaurant food proved to be a stickier wicket.

According to the Associated Press, Americans, on average, get one-third of their calories from food prepared outside of their homes. When New York City mandated restrictions on artificial trans fat in restaurant meals, kitchens had to alter recipes to ensure that food contained no more than 0.5 grams per serving.

In a study published in the Annals of Internal Medicine, researchers surveyed fast-food chain customers for the New York City Department of Health and Mental Hygiene between 2007 and 2009, a period covering pre- and post-trans fat limitations. Nearly 15,000 meals were studied, and the results were significant: The amount of trans fat in each lunch sold decreased by an average 2.4 grams after the ban. The largest drop was recorded at hamburger chains, followed by Mexican food outlets and fried chicken stores.

According to the Journal of the American Medical Association (JAMA), Americans' trans fat consumption has dropped by more than half over the last decade, thanks to the combination of nationwide food-labeling and community restaurant restrictions such as the measures taken in New York. Because it’s not cost effective for chain restaurants to have different recipes for different stores, nutritional changes can affect many fast-food consumers throughout the country.

Despite resistance from the restaurant industry, the New York businesses were able to adapt to more healthful recipes without sacrificing taste, variety or profit. As AP noted, the study also suggests that restaurants didn't just replace one unhealthful ingredient for another; there was only a small increase in saturated fat.

Many processed foods still contain huge amounts of trans fat, such as microwave popcorn, frozen pizza and chips, and no single effort can address all of America’s unhealthful indulgences. But in addition to its implications for heart health, the study results give impetus to the FDA’s desire to address America’s obesity epidemic. The agency hopes to finalize requirements for many restaurants to post calorie counts next to menu items. You can still eat poorly, but at least ignorance won’t be your excuse.

Like hemlines, nutrients are subject to the whims of fashion. Lately, Vitamin D has taken center stage.

In excerpting a piece originally posted on The Scientist, Health News Review recently noted that U.S. consumer sales of vitamin D increased fivefold from 2005 to 2010. Caregivers are embracing doses higher than the 400 to 600 International Units (IU) the government recommends for maintaining healthy bones.

Readers of MedPage Today are largely medical professionals and people interested in their affairs—health media, the pharmaceutical and medical device industries, health-care administrators and insurers, as well as interested medical consumers. A recent poll of those readers confirmed the vitamin’s popularity. Most respondents were certain that supplementing one’s diet with vitamin D and calcium was a good idea.

Given the sketchy evidence, you have to wonder why.

As The Scientist article noted, hype is a constant companion to nutrient/supplement claims. Vitamin E’s anti-cancer properties were undermined by a 35,000-person clinical trial that was terminated prematurely after people taking the supplements showed a slightly higher risk of developing prostate cancer than the control group. Large clinical trials studying beta-carotene and its conversion into vitamin A found an increased risk of lung cancer and heart disease.

Said one Harvard Medical School epidemiologist, “You have to look at these previous randomized trials as cautionary tales because they show that time and time again, everyone jumped on the bandwagon and then the randomized trials did not have favorable results, and in fact, the risks outweighed the benefits.”

We broached this topic a while ago.

Under some circumstances, according to a new study, high doses of vitamin D do seem to prevent bone fractures among the elderly. (That study, however, was unable to determine the role of calcium, which its participants also took, and which could be a critical component of the benefit.) And last month, the U.S. Preventive Services Task Force said that, contrary to popular belief, low doses of vitamin D and calcium do not reduce the risk of bone fractures for older women. It also found insufficient evidence that higher doses protect the bones of postmenopausal or premenopausal women, or reduce the risk of cancer, which are among the reasons people give for taking them.

More than half of the 1,686 MedPage Today survey respondents said they would advise patients to take both supplements, although nearly 1 in 3 said no vitamin or mineral supplementation was necessary if patients ate a balanced diet.

Comments among respondents included advice to eat calcium-rich foods, and take small doses of calcium supplements as well as vitamin D; that eating sufficient amounts of vitamin- and mineral-rich food is difficult because their nutritional value has declined substantially before food is served; that only a particular form of vitamin D is beneficial.

It all speaks to the notion that people are routinely vitamin D deficient, because of poor diet, insufficient sunlight, winter, sunscreen … take your choice.

People with certain disorders do need nutritional supplementation, and some people are vitamin deficient. But it’s not a blank-check situation. The nutrient to be supplemented and the amount necessary depend on the disorder, the patient’s diet and other medications taken.

But as noted in a story on NPR, vitamin D deficiency is hardly a scientifically proven problem in the U.S., and the task force’s recommendations reflect reality more than fear.

The task force didn’t rule out that higher doses might confer some benefits, but there’s no question that they present certain risks. Kidney stones is one. The risk is small, but is that excruciating pain worth it for an otherwise healthy person who downs a couple supplements as poor-diet insurance?

At high doses, vitamin D can be toxic, and prompt nausea, vomiting, muscle weakness, dehydration and constipation.

Many of the MedPage survey respondents dismiss most vitamin D studies because, they claim, the doses were too low. They say the higher levels that would confer benefits are similar to what the human body would make from sun exposure.

Maybe. But we’re circling back to the original concern: Are doctors and patients misled into thinking there’s an epidemic of vitamin D deficiency whose putative solution potentially disposes healthy people to risk?

No one can draw solid conclusions about whether to take vitamin D, and how much, as noted on Health News Review, until studies address the factors related to prevention trials of nutrient supplements:

• Doses are too small.


• Doses are too risky.


• Outcomes are too uncertain (an increased risk of disease, rather than the disease itself).


• The study period is too short.


• There are too few participants.


• The treatment regimen is incorrect.


• Participants are not random, but cherry-picked. participants.


• There’s poor participant compliance.

Red Bull. Rockstar. Monster.

They could be the names of ultimate fighters or black diamond ski runs, but as any American not living off the grid knows, they are the names of energy drinks, a food category that exploded into consumer consciousness in the late 1990s.

Basically, whether marketed as food or dietary supplements, they all sell caffeine. And while caffeine in moderation isn’t harmful for most people, there’s little guidance about the quantity of caffeine—which some sources define as a drug, others as a food additive and others as a stimulant chemical found in plants—in these drinks. There’s also a paucity of information about other ingredients in these drinks.

As noted in a recent story on NPR, there’s no consensus on exactly what an “energy drink” is. Today, you find canned coffee, tea and even fruit juice spiked with extra caffeine. There’s little research about their effects.

One researcher for the Center on Young Adult Health and Development at the University of Maryland School of Public Health called for better labeling of these products in an article published in the Journal of the American Medical Association (JAMA) titled “The ‘High’ Risk of Energy Drinks.”

The American Beverage Association drafted guidelines for energy drinks, but it’s up to manufacturers to include them on product labels. The guidelines call for caffeine quantity, warnings about mixing drinks with alcohol and noting that they are not intended to be consumed by children, pregnant or nursing women or people who are sensitive to caffeine. A few years ago, we wrote about energy drinks being linked to heart problems.

Still, what is an energy drink? According to Susan Carlson of the FDA’s Office of Food Additive Safety, “They range all over the place, from products that have probably no caffeine to products that do have caffeine and products that have ingredients that may contain caffeine. But there is no regulatory definition for energy drinks, per se.”

Regardless of whether an energy drink calls itself a food or a dietary supplement, the FDA has no regulatory limits for caffeine content. Those apply only to cola drinks. Red Bull has about twice as much caffeine per can than Coke.

By law, the FDA has the right to question a manufacturer's use of an ingredient and its safe use of an ingredient. The agency is concerned about conventional foods being marketed as dietary supplements, and, Carlson told NPR, it has taken public comment to draft industry guidelines.

If you’re sensitive to caffeine, or simply like to be informed about the contents of manufactured food products before you consume them, make your feelings about energy drinks known to the FDA.

In addition, visit product websites, where more information might be forthcoming. If not, let manufacturers know that you’re not likely to purchase their product unless you know what’s in it.

Now that even Minute Maid has introduced juice “enhanced” with caffeine, the energy drink craze really deserves scrutiny.

We’ve come to expect inflated or simplistic “news” offered by careless, undertrained and/or headline-hungry media covering medical and health topics. Now, even the people in charge of publicizing a recent scientific study published in BMJ (formerly called the British Medical Journal) are guilty of pandering at best and dumbing down at worst.

“It’s official – chocolate linked to heart health” read the headline on the journal’s news release announcing publication of the study. As noted by Kevin Lomangino, editor of Clinical Nutrition Insight and a reviewer for HealthNewsReview.org , “Intrigued by the headline …, I searched the release for an indication that some prestigious independent body -- the Institute of Medicine? a World Health Organization expert committee? -- had come together to evaluate the evidence on chocolate's cardiovascular effects. As unlikely as I found that prospect, I recognized that it could justify an ‘official’ declaration of an association between chocolate and heart disease outcomes.

“But no: the ‘official’ designation was apparently bestowed by a headline writer in the BMJ press office.”

It was just another attempt to suck you into a sexy story, not unlike the exuberant teaser by NBC news anchor Brian Williams: “The science that just might justify an American addiction.”

But the network reporting wasn’t done by a science or medicine reporter, and it made the same mistake so many such stories do: It claimed things not proved by the study, whose results invited further research, not categorical conclusions.

Although the BMJ news release did include the caveats to the study, much, if not most, of the popular reporting found them uninteresting. Irrelevant.

Yes, the study did find a correlation between high levels of chocolate intake and lower risk of cardiovascular disease and stroke. But if you value useful information over partial information, you need to know, as the researchers noted:

• the study had many important limitations;


• the available literature on this topic is “limited and novel";


• more studies are required "to confirm or refute the results";


• the results might be explained "by some other unmeasured (confounding) factor" besides chocolate.

As Lomangino reminds us, most of the chocolate we love has a lower concentration of cocoa flavonoids -- the plant molecules responsible for the salutary effects researchers confirmed -- and lots of sugar, fat and calories. The more you eat of the latter, the higher your risk of developing a cardiovascular problem. So we need to study the particular constituents of chocolate that confer health benefits, and how to consume more of them and fewer of their unhealthful partners.

That’s not a wild claim, that’s science.

In 2007, the FDA proposed guidelines for gluten-free labeling. The gluten component of foods is important to people with celiac disease, a disorder in which essential nutrients can’t be metabolized when gluten is consumed. Gluten is a constituent of many grains, such as wheat, barley and rye.

Now, the FDA-approved definition of "gluten-free" is up for review, and the agency is reopening the comment period. Rules for what can be deemed gluten-free were never adopted.

As reported in Food Safety News, last week Michael Taylor of the FDA said, "We want to get the most up-to-date information and data from affected consumers, from the food industry, researchers and others to ensure that we're making the right public health call in defining gluten-free."

Approximately 3 million Americans suffer from celiac disease. "We want to make sure that those suffering from celiac disease avoid adverse health consequences from being exposed to food that may trigger the symptoms and cause long-term health effects," said Taylor.

The proposed language requires any food with the gluten-free label to contain fewer than 20 parts per million of gluten -- the equivalent of, roughly, about 2 grains of salt in a piece of bread. That recommendation includes a peer-reviewed assessment of the existing literature on gluten safety.

Some people believe that any amount of gluten is unacceptable in a product labeled “gluten-free.”

The rules are expected to be finalized next year.

To view the FDA documents related to the discussion, link here and here. The proposed regulations for gluten-free labeling are in the Federal Register, docket no. FDA-2005-N-0404 at www.regulations.gov.