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 One previous industry-supported, unpublished study showed no link.”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?