No Fizz in Soda Scare

By Steven Milloy
July 16, 2005, FoxNews.com

The food police filed a petition this week with the federal government to require that regular (non-diet) soft drinks carry health warning labels. But scientific data, including a new study published this week, expose such soda scaremongering for what it is — junk science-fueled nanny-ism.

Anti-fun food activists at the self-proclaimed “Center for Science in the Public Interest” called on the Food and Drug Administration to require a series of rotating health notices on containers of most non-diet soft drinks.

Warnings suggested by CSPI include: “The U.S. Government recommends that you drink less (non-diet) soda to help prevent weight gain, tooth decay and other health problems”; “To help protect your waistline and your teeth, consider drinking diet sodas or water”; “Drinking soft drinks instead of milk or calcium-fortified beverages may increase your risk of brittle bones (osteoporosis)”; and “This drink contains caffeine, which is a mildly addictive stimulant drug. Not appropriate for children.”

Ironically, the day after the CSPI news conference calling for the warning labels, a study published in the prestigious medical journal The Lancet undercut CSPI’s claims concerning weight gain.

Researchers studied the role of physical activity in relation to changes in bodyweight in about 2,300 adolescent girls for 10 years from ages 9-19 and reported that exercise, rather than eating, was key.

“These results suggest that habitual activity plays an important role in weight gain, with no parallel evidence that energy intake had a similar role,” concluded the researchers.

This new study is consistent with what scientists know about sugar intake and weight. “There is no clear and consistent association between increased intake of added sugars and [weight],” stated a 2002 report from the National Academy of Sciences’ Institute of Medicine titled, “Dietary Reference Intakes on Macronutrients.”

And let’s not forget about the more recent 15,000-child study spotlighted last fall in this column in which Harvard University researchers concluded that, “although snack foods may have low nutritional value, they were not an important independent determinant of weight gain among children and adolescents.”

While consumption of dietary sugars has been linked with dental caries (search), it’s not a simple relationship that merits a special warning label on soft drinks.

“Many factors in addition to sugars affect the caries process, including the form of food or fluid, the duration of the exposure, nutrient composition, sequence of eating, salivary flow, presence of buffers, and oral hygiene,” wrote researchers in a 2003 article entitled “Sugars and Dental Caries” published in the American Journal of Clinical Nutrition. Emphasizing the complexity of the issue, the researchers noted, “Since the introduction of fluoride, the incidence of caries worldwide has decreased, despite increases in sugar consumption.”

The researchers also noted a study linking white bread with caries. Will CSPI also demand that consumers be warned about the risk of tooth decay that might be posed by sandwich bread, French bread and pizza?

CSPI’s suggested warning about soft drinks increasing the risk of osteoporosis is also without merit. As discussed in an earlier column, there simply is no evidence that soft drinks are replacing milk in the diet of children and adolescents. That same column spotlighted a CSPI-inspired researcher who previously attempted to link cola consumption with bone fractures in high school girls; but her statistics were weak and she had no credible explanation for how cola consumption could lead to bone fractures.

By the way, while CSPI ostensibly worries about soft drinks replacing milk, it actively campaigns against the consumption of whole milk and 2 percent milk, advocating consumption of only 1 percent milk and skim milk. CSPI accuses the dairy industry of “putting profits ahead of the hearts of American’s school-aged children,” even though the activist group can’t point to a single child whose heart health has been compromised in the slightest by milk.

As to caffeine and children, a 2002 review of the science in Food and Chemical Toxicology concluded, “Overall, the effects of caffeine in children seem to be modest and typically innocuous.”

Of course children should avoid overconsumption of caffeine — that’s just common sense — but they can safely consume the typical amounts found in soft drinks.

CSPI attempted to legitimize its petition by having it endorsed by folks like New York University’s Marion Nestle, Harvard School of Public Health’s Walter Willett, and Harvard Medical School’s JoAnn Manson — all individuals well-known to readers of this column as having anti-food industry and anti-soft drink biases. Their goals seem to be the demonization of the food industry and of its products, and to dictate what we eat and drink. Placing scary warning labels on soft drinks would certainly further that twisted agenda.

The bottom line on soft drinks is that, like virtually everything else in life, moderation is the key. Soft drinks can be part of a healthy lifestyle — along with a balanced diet, plenty of exercise, sufficient sleep, good oral hygiene and other common sense lifestyle habits. If consumers need to be waned about anything, it should be CSPI’s alarmist antics.

Steven Milloy publishes JunkScience.com and CSRwatch.com, is adjunct scholar at the Competitive Enterprise Institute, and is the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001).

Scientists Stonewall on Spurious Soda Scare

By Steven Milloy
January 27, 2005, FoxNews.com

Harvard University researchers denied this week the charge that they omitted material information from a study they used to scare the public about soft drinks causing diabetes.
Study author Walter Willett told the Washington Post last August, “The message is: Anyone who cares about their health or the health of their family would not consume these beverages. Parents who care about their children’s health should not keep them at home.”

Among the criticisms of the study contained in my FOXNews.com column from last August, I noted that the researchers failed to mention in their write-up the directly relevant, but contradictory, results of an earlier study done by one of the members of the Harvard research team.

Intrigued by the researchers’ omission, Ian Murray and Sam Kazman of the Competitive Enterprise Institute wrote a letter to Journal of the American Medical Association, which was published this Jan. 26 in the journal.

Murray and Kazman wrote, “We were surprised that the [August study] did not discuss or cite the results of an apparently contradictory study [published in Diabetes Care in April 2003] that found that intake of total sugars and different types of sugars [sucrose, fructose, etc.] does not seem to raise the risk of type 2 diabetes (search). This was particularly striking since both articles share a co-author.”

As is its policy, JAMA provided the Harvard researchers the opportunity to respond to CEI’s letter. “[Because the Diabetes Care study] was not directly relevant to our study on soft drinks, we did not consider it an important reference,” responded the Harvard researchers. “The earlier study did not specifically address soda consumption,” they added.
They also wrote that “other studies have suggested” that the human body metabolizes sugar-sweetened beverages differently than sugar-sweetened foods.

With respect to the researchers’ latter point, it may or may not be true that sugar-sweetened beverages are metabolized significantly differently than sugar-sweetened solid foods — that remains to be studied — but that notion is irrelevant in this case because neither the JAMA nor Diabetes Care studies specifically examined the difference, if any, between soft drinks or solid food consumed on an empty stomach.

What is relevant is that the researchers failed to disclose key contradictory data amid their effort to sow panic about soda consumption. The Diabetes Care study did include significant data on soda consumption. The researchers knew it, have now (finally) acknowledged knowing it, and are now trying to downplay its significance by putting out a smokescreen that is not supported by data in either study in question.

The Harvard researchers tried to further distract JAMA (search ) readers by pointing to two other studies they seem to hope bolsters their soda scare: One study supposedly showed that a school-based educational program discouraging the consumption of sweetened soft drinks reduced obesity in children; another study supposedly showed that “consumption of sugars, mainly in the form of sugar-sweetened soft drinks, resulted in an increase in energy intake and weight in overweight men and women.”

First, neither study has anything to do with the focus of the JAMA and Diabetes Care studies — that is, whether sugar or soda consumption increases diabetes risk. So these references are just misdirection, pure and simple.

In the school study, while there appears to have been some reduction in obesity and being overweight among the kids who went through the intervention program, the data do not indicate that consuming fewer sugar-sweetened beverages was the reason. The kids in the intervention group consumed fewer carbonated soft drinks in total, but not fewer sugar sweetened drinks.

In the other study, it’s no wonder the already overweight men and women who drank lots of sugar-sweetened soft drinks gained even more weight than the control subjects in the study — the controls consumed fewer calories because they drank diet sodas instead of sugar-sweetened sodas!

The Harvard researchers have yet to make a credible case that soda consumption increases the risk of type 2 diabetes — but I am becoming quite convinced that they don’t really care about credibility in the first place.

Steven Milloy publishes JunkScience.com and CSRwatch.com, is adjunct scholar at the Cato Institute, and is the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001).

No Beef Behind Red-Meat Cancer Scare

By Steve Milloy
January 14, 2005, FoxNews.com

Eating a hamburger a day can increase your risk of colon cancer, according to a new study. Is it time to switch to chicken, fish or tofu ? Or is time to ask your congressman to check into whether the National Cancer Institute is spending its budget wisely? Continue reading No Beef Behind Red-Meat Cancer Scare

Soda, Diabetes Linked by Scientific Misconduct?

By Steven Milloy
August 27, 2004, FoxNews.com

If you doubt that our society’s lifestyle nannies are of dubious integrity, a new highly publicized study supposedly linking regular (non-diet) sodas with weight gain and diabetes should clear up any remaining skepticism.

“The message is: Anyone who cares about their health or the health of their family would not consume these beverages. Parents who care about their children’s health should not keep them at home,” study author Walter Willett of Harvard University told The Washington Post.

In a nutshell, Willett and his co-authors would have us regard Coca-Cola in the same way as they would have us regard Marlboro cigarettes — that is, no level of soda consumption is safe.

The study data collected from 51,603 women reportedly show that the 1,007 women who increased their consumption of regular soft drinks over a period of four years from less than one per week to one or more per day gained an average of 10.3 pounds. Among the approximately 16,600 women who consumed more than one soft drink per day, the researchers reported 83 percent more cases of type 2 diabetes.

The researchers would have us believe their results indicate that soda by itself causes weight gain and diabetes. But this conflicts with existing data and common sense. The National Academy of Sciences’ Institute of Medicine issued a report in 2002 titled “Dietary Reference Intakes on Macronutrients” that stated, “there is no clear and consistent association between increased intake of added sugars and [weight].” A single new study doesn’t change that fact.

Next, since the consumption of one 12-ounce soda per day (150 calories) for four years amounts to 219,000 calories — or a minimum of 62.5 pounds of added bodyweight at 3,500 calories per pound of body fat — it’s obvious that the women’s reported weight gain of 10.3 pounds is somewhat more complex than the simple-minded notion that the soda went straight to their hips and thighs. The real explanation for the reported weight gain more likely lies in the women’s genetics and their overall lifestyles.

Moreover, the study reports that women who consistently drank one or more regular soft drinks per day during those four years actually gained slightly less weight than women who consistently drank less than one soda per week during that same period.

The researchers’ contention that soda intake is linked with type 2 diabetes is also not borne out by their data or anyone else’s. The media-spotlighted claim of an 83 percent increase in diabetes among consumers of more than one soda per day — itself an inherently weak association from a statistical perspective — is misleading.

When the researchers statistically adjusted their results for bodyweight (a risk factor for diabetes) and for caloric intake (a proxy measure for consumption of sweetened foods other than soda), the 83 percent increase dropped to an even more statistically dubious (and soft-pedaled) 32 percent increase. That result is of the same magnitude as the study’s reported 21 percent increase in diabetes among consumers of more than one diet soft drink per day. Diet drinks, of course, do not contain any sugar at all.

I also discovered what I consider to be a flagrant and inexcusable omission on the part of the researchers. A recent study of 39,876 women entitled “A Prospective Study of Sugar Intake and Risk of Type 2 Diabetes in Women” (Diabetes Care, April 2003) concluded that sugar intake was not associated with the risk of type 2 diabetes and that “these data support the recent American Diabetes Association’s guideline that a moderate amount of sugar can be incorporated into a healthy diet.”

Certainly Willett and his co-authors could claim it was mere oversight on their part to not even mention this major conflicting study in the write-up of their study, but that assertion would be on thin ice given that Harvard Medical School’s JoAnn Manson was a co-author of both studies!

When I asked Manson how she reconciled the conflicting results, she reached for her media-training skills and tried deflecting me with congratulations for discovering the April 2003 study and for being the first media person to ask her that “great” question. She then told me that what really made the new study compelling was that it measured the health impact of a change in soft drink consumption. That still did not answer my question.

Her new study only presented data concerning a potential association between increasing soft drink consumption and weight gain. It presented no data on increasing soft drink consumption and diabetes. The omission of even a mention of her own extremely relevant and contradictory April 2003 study in the new study’s write-up — let alone an effort to reconcile the differences between the studies — is in my opinion an egregious one on the part of Manson and her co-authors.

Given that both studies were funded with taxpayer dollars (grants from the National Institutes of Health), I’d like to see an investigation by the federal Office of Research Integrity.

Researchers should be accountable for misusing taxpayer dollars to irresponsibly portray half-truths as scientific gospel, especially when such misconduct scares the public and harms legitimate businesses.

Steven Milloy publishes JunKScience.com.

Have a Coke and a Waistline

By Steve Milloy
June 25, 2004, FoxNews.com

Let’s “grab a Coke and a smile” this week as Arkansas Gov. Mike Huckabee (search) demanded proof that vending machines lead to childhood obesity before permitting the state to restrict the machines in schools.

Amid the hysteria about overweight adolescents, the Arkansas Board of Education is looking for ways to reduce children’s calorie intake, including targeting school vending machines.
“There are no studies that I know that clearly say if a kid has access to a soda machine that he’s going to be fatter than one who doesn’t have access,” Huckabee said, according to an Associate Press report.

State officials who support restricting vending machines allege that Huckabee is being ingenuous.

“I think it’s really pretty much a basic that candy bars and sugar colas are not conducive to good health,” said state representative Jay Bradford, D-White Hall, to the AP. “And I don’t think it takes a lot of research to realize that adds great amount of weight to certain individuals,” added Bradford.

So which makes more sense — Gov. Huckabee’s call for proof of harm, or Rep. Bradford’s reliance on “conventional wisdom?”

Consider the results of a survey conducted by the National Family Opinion WorldGroup Share of Intake Panel (search) (NFO SIP), as reported by Dr. Michael Ginevan in the April 2004 issue of The Journal of Pediatrics.

The NFO SIP surveys 12,000 persons per year. Participants keep two-week diaries of all beverages consumed, excluding tap water, and the location of where these were consumed.

In a survey conducted during the 2001-2002 school year, a demographically balanced sample of 2,716 students ages 12 to 18 years maintained beverage consumption diaries from September through May. The study reported that the average per capita consumption of non-diet carbonated soft drinks from school vending machines was 2.5 ounces per week — about 31 calories per week. Assuming for the sake of argument that those 31 calories were never burned as energy and were automatically turned into fat, it would take more than two years of such consumption at that rate to produce one pound of fat.

Given that children generally have rapid metabolisms (search) and are constantly growing and developing, the notion that we should worry about children consuming 31 calories per week from school vending machines seems to be absurd. The NFO SIP survey reported that only 20 percent of students actually drank beverages from vending machines. Only 9 percent drank non-diet beverages. Among the 20 percent who drank vending machine beverages, the average consumption was 12.5 ounces per week — about one can or 150 calories per week for consumers of non-diet beverages. One can of soda per week isn’t going to cause weight or health problems even among the most minimally active healthy children.

The NFO SIP survey was conducted with an unrestricted grant from the National Soft Drink Association (search), so some will undoubtedly view these results with some degree of skepticism.
That doesn’t really matter, though.

The ultimate validity of the NFO SIP survey isn’t the issue — more research versus factually unsupported demonization of school vending machines is. Vending machines in schools provide benefits to businesses and schools (jobs and revenue) and to students (on-campus convenience and a variety of beverages, including juices and juice drinks, milk-based drinks, water, diet and regular soft drinks, and sports drinks). The NFO SIP survey seems to indicate that school vending machines do not pose a threat to children’s health.

If there is evidence to the contrary, let’s see it and debate it before jumping to rash and truly harmful conclusions.

Steven Milloy is the publisher of JunkScience.com, an adjunct scholar at the Cato Institute and the author of Junk Science Judo: Self-Defense Against Health Scares and Scams (Cato Institute, 2001).

The Feds: Terrorizing With Fat

By Steven Milloy
December 14, 2001, FoxNews.com

The federal health nannies worry we’re too fat. So the surgeon general this week issued a “call to action” against overweight and obesity. “Thin is in” no longer is the slogan of a hip lifestyle — it’s government policy. Continue reading The Feds: Terrorizing With Fat

Harry Potter and the Sorcerer's … Soda?

By Steve Milloy
November 16, 2001, FoxNews.com

The much-anticipated movie Harry Potter and the Sorcerer’s Stone opens nationwide this weekend. So does another extreme and, frankly, silly crusade against soft drinks by the “food police” at the Center for Science in the Public Interest.

Exploiting the release of the new Harry Potter movie, CSPI is escalating its anti-soft drink offensive by attacking Coca-Cola’s sponsorship of the movie and promotion of the “Reading Is Fundamental” program for children.

At a time when parents and children could use a good distraction, CSPI’s unfortunate message seems to be “have a Coke and a frown.”

CSPI protested at the Washington, D.C., premier of the new movie, and launched a Web site goading visitors to send complaint letters to Harry Potter author J.K. Rowling.

CSPI wants Rowling to cease the Coca-Cola sponsorship deal or donate the royalties from the deal to fund “nutrition campaigns” — code words for nutty causes like CSPI’s.

The anti-Coca-Cola CSPI apparently would be more than happy to accept Coke’s money. No hypocrisy there.

The basis for the campaign is CSPI’s characterization of soft drinks as “liquid candy” that contain “a mildly addictive stimulant drug” — i.e., caffeine. CSPI alleges that “sugar promotes obesity, a worldwide problem” and that soft drinks displace “more healthful” drinks in the diet.

“The bottom line,” says CSPI, is that “liquid candy is bad for health.” The more accurate bottom line, though, is that CSPI is cavalierly ignoring scientific data and common sense in favor of its self-beneficial activism.

Until earlier this year, only two studies with conflicting results explored the potential relationship between soft drink consumption and childhood obesity. That’s now changed.

In April 2001, researchers from the Georgetown University-affiliated Georgetown Center for Food and Nutrition Policy presented four new studies at the Experimental Biology 2001 annual meeting.

The studies were based on analyses of data from two national surveys: The U.S. Department of Health and Human Services’ National Health and Nutrition Examination Survey and the U.S. Department of Agriculture’s Continuing Survey of Food Intake.

The researchers reported:

  • No relationship between consumption of carbonated soft drinks and obesity among 12- to 16-year-olds;
  • Soft drinks did not reduce calcium consumption among 2- to 20-year-olds;
  • Teens who consumed more soft drinks were as physically active as those who consumed fewer soft drinks; and
  • Soft drink consumption did not harm diet quality among children and teens as measured by the USDA’s Healthy Eating Index.

The researchers added, “We need to stress the vital role of physical activity for all students, not just the best athletes chosen for varsity sports teams.”
Other recent research also takes the fizz out of CSPI’s attack.

Michigan State University researchers reported in May 2000 at the U.S. Department of Agriculture National Nutrition Summit that soft drinks have not replaced milk in the diets of children aged 1-19. Over the last 10 years, according to the report:

  • Among children ages 1-5, milk consumption significantly increased and soft drink consumption significantly decreased;
  • Among children ages 6-9, milk and soft drink consumption remained steady; and
  • Among children ages 10-19, milk consumption remained steady while soft drink consumption increased.

While these data are undoubtedly not the last word on the subject of kids and soft drinks, they certainly seem to fly in the face of CSPI’s claims. Worse, CSPI brazenly ignores these data in hopes that the public will rely on a naïve and misplaced intuition that soft drinks are bad simply because they contain sugar and caffeine.

No one advocates that kids drink only, or too many, soft drinks. They have no nutritional value. But based on recent scientific data and generations of soft drink consumption, there is no question that soft drinks can be a safe treat in an otherwise balanced diet.

Through an $18 million grant associated with its sponsorship of Harry Potter and the Sorcerer’s Stone, Coca-Cola will place 10,000 sets of 120 to 150 new, high-quality hardcover children’s books in kindergarten through third grade classrooms and community centers throughout the country.

Maybe CSPI senses such generosity is a threat to its viability. The better kids learn to read, the less likely they will be to fall for junk science foolishness.

The public is already starting to wise up to CSPI’s gimmick-laden attacks. Reportedly, only about 10 people showed for the protest of the Harry Potter premiere in Washington, D.C.
Flat soda might have more zip than CSPI’s tired activism.

Steven Milloy is the publisher of JunkScience.com , an adjunct scholar at the Cato Institute and the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001).

Soft Drinks, Hard Bias

By Steven Milloy
April 20, 2001, FoxNews.com

Sen. Patrick Leahy, D-Vt., just introduced a bill to restrict sales of soft drinks in schools. “The Better Nutrition for School Children Act of 2001” comes on the heels of a series of anti-soft drink articles in The Washington Post.

But Sen. Leahy should know better than to believe everything he reads.

The notion that children who consume soft drinks tend to be obese is intuitively appealing. That is undoubtedly why the Post felt comfortable running three articles on Feb. 27 — “Soft Drinks, Hard Facts,” “Schools Hooked on Junk Food” and “Easy Cash Eroding Their Principles” — alarming readers about kids’ soft drink consumption.

The bias in the Post’s reporting is breathtaking.

“Soft Drinks, Hard Facts” reported: “One very recent, independent, peer-reviewed study demonstrates a strong link between soda consumption and childhood obesity. One previous industry-supported, unpublished study showed no link.”

As opposed to the latter study, the former study apparently was “independent” because it was funded by federal agencies, including the Centers for Disease Control and Prevention, and the National Institute of Diabetes and Digestive and Kidney Diseases.

But both government agencies already urge that children avoid soft drinks despite the scarcity of scientific data, ostensibly only one study, to support such advocacy. The agencies are hardly disinterested in the outcome of the research.

A background check into the authors of the “independent” study reveals the study outcome is not unexpected. The authors have long been in the childhood obesity research business, blaming childhood obesity on diet and television-viewing habits.

It shouldn’t be surprising longtime childhood obesity researchers might be somewhat biased toward producing results that promote their area of research interest.

The Post expanded on the “independent” study, claiming each daily serving of a sugar-sweetened soft drink increased the rate of childhood obesity 1.6 times. This rate was estimated based on a statistical analysis of a small population of children.

It is elementary in such an analysis that reported increases in health effects rates on the order of 2.0 and less are considered weak and unreliable.

More accurately reported, the “independent” study reported no significant increase in obesity for soft-drink consumption among children.

The Post went to great pains to explain this basic rule when similarly weak statistics were used to link abortion with increased risk of breast cancer. With respect to women who had abortions having 1.5 times more breast cancer, the Post reported: “Though this may appear to be a large increase in risk … it falls in the barely detectable range.”

Why the double standard? A cynic might suggest that abortion is more politically correct than soft drinks.

The Post’s conduct gets worse.

Researchers from the Georgetown University-affiliated Georgetown Center for Food and Nutrition Policy presented four new studies at the Experimental Biology 2001 annual meeting on April 3.
The studies were based on analyses of data from two national surveys: The U.S. Department of Health and Human Services’ National Health and Nutrition Examination Survey and the U.S.

Department of Agriculture’s Continuing Survey of Food Intake. The researchers reported:

  • No relationship between consumption of carbonated soft drinks and obesity among 12- to 16-year-olds.
  • Soft drinks did not reduce calcium consumption among 2- to 20-year-olds.
  • Teens who consumed more soft drinks were as physically active as those who consumed fewer soft drinks.
  • Soft drink consumption did not harm diet quality among children and teens as measured by the USDA’s Healthy Eating Index.

The researchers added, “We need to stress the vital role of physical activity for all students, not just the best athletes chosen for varsity sports teams.” Though the media was informed of the Georgetown studies’ release before the meeting, the Post didn’t see fit to report the news.

The omission is no surprise. The Georgetown studies were funded by the National Soft Drink Association. Though the group had no power to influence or alter the research findings, this funding arrangement apparently didn’t meet the Post’s dubious standard for “independence.”

But should the studies’ funding source really make them less newsworthy? Shouldn’t scientific studies be judged on their technical merits, not their financing? On their scientific, not political correctness?

The new studies certainly are not the final word on soft-drink consumption and children’s health, nor should they be. They are simply another analysis that should be considered among the limited database of relevant studies.

The problem, though, is that it seems as if the Post is more interested in frightening parents and children, and senators, rather than informing them.

Steven Milloy is a biostatistician, lawyer and adjunct scholar at the Cato Institute and publisher of JunkScience.com

The tail-end of the fiber myth

By Steve Milloy
February 2, 2001, FoxNews.com

If you’ve been shoveling down high-fiber cereals every morning in hopes of preventing colon cancer, you can stop.

The 30-year-old notion that cereal fiber reduces colon cancer risk is turning out to be yet another government-sanctioned myth. It may be time for the Food and Drug Administration to butt out of our colons.

A study published in this week’s The Lancet reports that a “… high-fiber diet and supplementation with wheat bran fiber may not be effective strategies for the prevention of [colon cancer].”

By itself, the study would not be overly persuasive. But it is the fourth study in a major medical journal in the last two years to reach the same conclusion, including a January 1999 study in the New England Journal of Medicine that followed about 89,000 women over a period of 16 years.

How did the myth get started?

British medical missionary Dr. Denis Burkitt gave birth to the idea that dietary fiber reduced colon cancer risk in 1971. Burkitt observed — almost casually, not in any scientific manner — that poor rural Africans had much less colon cancer than Westerners. He theorized this was due to the Africans’ fiber-rich diet.

The idea was that larger, faster moving stools reduced the colon’s exposure to carcinogenic bile acids. The theory’s intuitive appeal propelled it to become conventional wisdom. But it lacked persuasive scientific support.

Some studies seemed to support the theory; others did not. None of the studies were particularly well-designed — they tended to be retrospective in nature, relying on unverified self-reports of subjects’ dietary and lifestyle habits.

The National Research Council, the research arm of the National Academy of Sciences, thought the theory was so speculative that it declined in 1982 to make a specific recommendation about dietary fiber and colon cancer.

Eventually, though, commercial interests perceived value in the theory and the scientific controversy became a memory.

In 1984, cereal manufacturer Kellogg placed a message on its All Bran cereal claiming scientific evidence linking a high fiber diet with a reduction in colon cancer risk. The FDA took no action against Kellogg, though the claim seemed to defy a longstanding FDA rule prohibiting health-related messages on food products.

The National Research Council reversed itself and came out in favor of a link between dietary fiber and reduced colon cancer risk in 1989 — though the state of the science had not changed.

A 1990 federal law clarified the FDA’s authority over food label content and the agency subsequently issued rules permitting health-claims labeling, provided there was some scientific support.

In a 1997 effort to boost stagnant cereal product sales, Kellogg petitioned the FDA for permission to make the claim that some of its products contain ingredients that may help prevent certain cancers, especially colon cancer.

In July 1999, the FDA permitted whole-grain foods to claim on their labels that “diets rich in whole-grain foods and other plant foods and low in total fat, saturated fat and cholesterol may reduce the risk of heart disease and certain cancers.”

The FDA did not give the scientific research on whole-grain foods the scrutiny that goes into the approval of a new drug. Instead, the agency relied on recommendations made by the NRC 10 years earlier. The FDA ignored the NEJM study that was published six months before the approval of the Kellogg petition — even though it was the largest study ever on dietary fiber and colon cancer.

The result of the FDA’s scientific sloth is that millions of consumers will continue to be misled for the foreseeable future about an important health issue — all the while choking down bran cereals and imagining they’re preventing colon cancer. Certainly whole grains are part of a balanced diet. But by overestimating the benefits, many will have a false sense of security.

And while the FDA is allowing companies to market junk science-fueled myths, the agency uses junk science to remove a product with known benefits. Maybe you’ve noticed that your favorite laxative doesn’t work as well as it used to.

Researchers from the U.S. government’s National Toxicology Program reported to the FDA in April 1997 that mice fed high doses of the compound phenolphthalein had higher rates of cancer. At the time, phenolphthalein was the most effective active ingredient in laxative products.

The FDA bullied laxative manufacturers to reformulate their products without phenolphthalein despite that: (1) the mice were genetically engineered to be more susceptible to cancer — they were, in a sense, “cancer time bombs”; (2) the doses of phenolphthalein were 30 times higher than consumer use; and (3) phenolphthalein was used as a laxative ingredient for more than 100 years with absolutely no indication of increased cancer risk among users.

The several scientific studies published after the FDA decision also failed to link laxative-use with increased cancer risk.

Hey, who needs laxatives when you’ve got bran?

President Clinton this week announced a new effort to fight colon cancer, including, among other recommendations, that adults over the age of 50 have annual colon cancer screenings. Every year, there are an estimated 130,000 new cases of colon cancer and more than 50,000 deaths from the disease.

Colon cancer may be cured if detected early enough. It’s too bad there doesn’t seem to be any cure for junk science at the FDA.

Steven Milloy is a biostatistician, lawyer, adjunct scholar at the Cato Institute and publisher of Junkscience.com.

Fear of margarine: The trans fat myth

By Steve Milloy
November 29, 1999, JunkScience.com
(Note: The many links in this article are no longer active but have been left in for historical purposes.)

The Food and Drug Administration recently proposed (FDA proposal home page | Federal Register notice) to amend its regulations on nutrition labeling to require the amount of trans fatty acids in foods be included in Nutrition Facts panels. But the science behind this move is suspect.

A recent editorial in the New England Journal of Medicine reviewed the epidemiolgic evidence linking trans fatty acids to heart disease. The editorial concludes “Metabolic and epidemiologic studies indicate and adverse effect of trans fatty acids on the risk of coronary heart disease.” Below (in italics) is what the editorial says about the epidemiology studies — the studies that should validate the theories developed from the metabolic studies. My comments are in bold. Decide for yourself whether trans fats are guilty as charged.

  • In a case-control study of subjects in the Boston area, we found a strong and significant positive association between the intake of trans fatty acids, assessed with the use of dietary questionnaires, and the risk of acute myocardial infarction. The relative risk of acute myocardial infarction for the quintile with the highest intake of trans fatty acids as compared with the quintile with the lowest intake was 2.4 (P for trend less than 0.001); this association was entirely explained by the intake of these fats from hydrogenated vegetable oil.

    This small study (only 239 patients from the Boston area) did not consider non-dietary risk factors for heart disease other than age and sex. Astonishingly, smoking, exercise level, health history, family health history and alcohol consumption were not considered as confounding risk factors.

  • Bolton-Smith et al. performed a cross-sectional analysis of the association between the intake of trans fatty acids and the presence of previously undiagnosed coronary heart disease among participants in the Scottish Heart Study. The intake of trans fatty acids was positively correlated with the ratio of LDL plus very-low-density lipoprotein cholesterol to HDL cholesterol. The odds ratios for coronary heart disease in the quintile with the highest intake as compared with the quintile with the lowest intake were elevated but not significantly so (1.26 in women and 1.08 in men).

    The results from this study were weak statistical associations that were not statistically significant — meaning the probability was unacceptably high the barely detectable associations could have occurred by chance. Even the study authors conclude,”The results, therefore, do not support a major effect of dietary trans fatty acid…”

  • Studies in which the composition of fatty acids in tissue or plasma was used as a marker of trans-fatty-acid intake have yielded conflicting results. With one exception, however, these studies have been too small to detect an association reliably. The results of the only large study, which included 671 men with acute myocardial infarction from eight European countries, were inconclusive. The overall analyses revealed no association between the intake of trans fatty acids and the risk of myocardial infarction.

    No comment necessary.

  • The relative risk of coronary heart disease associated with an absolute increase of 2 percent in the intake of trans fatty acids was 1.36 (95 percent confidence interval, 1.03 to 1.81) in the Health Professionals Follow-up Study

    The result spotlighted is so misleading as to constitute scientific misconduct. The relative risk of 1.36 is a raw result, without any adjustment for other heart disease risk factors. When other risk factors are adjusted for — including age, body mass index, smoking habits, alcohol consumption, physical activity, history of hypertension or high blood cholesterol, family history of myocardial infarction before age 60, profession, and fibre intake — the weak relative risk is substantially reduced (by more than 50 percent) and becomes statistically insignificant.

  • The relative risk of coronary heart disease associated with an absolute increase of 2 percent in the intake of trans fatty acids was … 1.14 (95 percent confidence interval, 0.96 to 1.35) in the Alpha-Tocopherol Beta-Carotene Cancer Prevention Study

    The spotlighted result is a weak association that is not statistically significant. This study consisted of 21,930 male smokers. Can you really study dietary factors for heart disease in a population where the basic lifestyle (i.e., smoking and its attendant unhealthy tendencies) is a risk factor for heart disease?

  • The relative risk of coronary heart disease associated with an absolute increase of 2 percent in the intake of trans fatty acids was… 1.93 (95 percent confidence interval, 1.43 to 2.61) in the Nurses’ Health Study.

    This is my favorite study of the bunch. Check out its results.

    • It reports no statistically significant association between total fat intake and risk of cornary heart disease.
    • It reports no statistically significant association between animal fat intake and risk of cornary heart disease.
    • It reports no statistically significant association between saturated fat intake and risk of cornary heart disease.
    • It reports no statistically significant association between cholesterol intake and risk of cornary heart disease.
    • The reported association between trans fat and coronary heart disease is only statistically significant for the highest consumption of trans fats — but it’s still a very weak statistical association (relative risk = 1.53).

    This study basically reports that all we’ve been told about the association between fat consumption and heart disease is not supported by data collected from 90,000 nurses over a period of 20 years. So either the study data is wrong or the public health establishment has been wrong about fat consumption being associated with heart disease risk. If the study data is wrong, then I doubt the trans fat result. If the public health establishment is wrong then why should we believe it about trans fat when it has been generally wrong about fat consumption for the last two or three decades?

That’s the epidemiology supposedly supporting the proposition that trans fats are so much of a risk for heart disease they need to be labelled. Are you convinced yet?

But there’s more. Check out the authors of the studies discussed above. See if you notice anything unusual (like the underlined names).

  • Ascherio A, Hennekens CH, Buring JE, Master C, Stampfer MJ, Willett WC. Trans-fatty acids intake and risk of myocardial infarction. Circulation 1994;89:94-101.
  • Bolton-Smith C, Woodward M, Fenton S, Brown CA. Does dietary trans fatty acid intake relate to the prevalence of coronary heart disease in Scotland? Eur Heart J 1996;17:837-45.
  • Aro A, Kardinaal AF, Salminen I, et al. Adipose tissue isomeric trans fatty acids and risk of myocardial infarction in nine countries: the EURAMIC study. Lancet 1995;345:273-8.
  • Ascherio A, Rimm EB, Giovannucci EL, Spiegelman D, Stampfer M, Willett WC. Dietary fat and risk of coronary heart disease in men: cohort follow up study in the United States. BMJ 1996;313:84-90.
  • Pietinen P, Ascherio A, Korhonen P, Hartman AM, Willett WC, Albanes D, Virtamo J. Intake of fatty acids and risk of coronary heart disease in a cohort of Finnish men: the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. Am J Epidemiol 1997;145:876-87.
  • Hu FB, Stampfer MJ, Manson JE, Rimm E, Colditz GA, Rosner BA, Hennekens CH, Willett WC. Dietary fat intake and the risk of coronary heart disease in women. N Engl J Med 1997;337:1491-9.

ALL THE STUDIES supposedly showing trans fats are associated with heart disease risk involved Alberto Ascherio and Walter Willett.

You may also be interested in knowing who authored the editorial: Alberto Ascherio, Martijn B. Katan, Peter L. Zock, Meir J. Stampfer,and Walter C. Willett.

Should the FDA be taking action because of a duet of scientists whose results are so thin? Has the FDA ever heard of the scientific method and its requirement for independent replication of scientific results?