A Scoop of Debunkey Monkey, Please

By Steven Milloy
July 8, 2000, FoxNews.com

The Environmental Protection Agency says the much-ballyhooed environmental contaminant dioxin is 10 times more dangerous than previously thought. Environmental activists already have begun a food scare campaign centered on dioxin. But amidst this eco-terrorism, the long-running and costly health scare over the dreaded dioxin is finally debunked — courtesy of ice cream maker, Ben & Jerry’s. Continue reading A Scoop of Debunkey Monkey, Please

Vinyl IV Bags: Media lose message

By Steven J. Milloy
March 27, 2000, Chicago Sun-Times

Deerfield-based Baxter Healthcare has been vindicated on a major health scare. But don’t expect to read about it in the media. It’s more fun to scare readers about vinyl IV bags causing cancer than it is to set the record straight. Continue reading Vinyl IV Bags: Media lose message

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(Note: The many links in this article are no longer active but have been left in for historical purposes.)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?

PSA test: Promoting Stress and Anxiety?

by Steve Milloy
October 6, 1999, JunkScience.com

I hate to admit it. But I’m at that age where prostate cancer enters the mind – especially since my father just completed a course of radiation treatment for his prostate cancer.

Prostate cancer is the most commonly diagnosed cancer among U.S. men. And at about 40,000 annual deaths, it is the second deadliest behind lung cancer. Prostate cancer is the male version of breast cancer. It’s not preventable and early detection is the key to survival. But – and it’s a big “but” – controversy has arisen over early detection.

The prostate is a chestnut-sized gland in the make pelvic area. It plays a role in generating seminal fluid that helps transport sperm. For unknown reasons, the gland can enlarge and cancer can develop. Some cancers are fatal. Some aren’t. While most prostate cancer occurs in older men, it can strike younger men as well. Half of prostate cancer deaths occur in men over the age of 75. Fewer than 5 percent of deaths occur in men who were under 60 at diagnosis.

Until about 10 years ago, prostate cancer was detected by a technique euphemistically named the “digital rectal exam.” But rectal exams often don’t catch cancers until after they have spread – at which point it may be too late to cure. Then came the PSA test, a blood test that measures the level of prostate specific antigen. PSA is usually elevated in men with prostate cancer, but can also be elevated, usually to a lesser degree, in men with benign prostate growth.

The PSA test did wonders for diagnosing prostate cancer. The number of men diagnosed with prostate cancer in 1985 was about 85,000. By 1996, the number diagnosed had jumped to almost 320,000. Sounds great right? It was early detection we needed and early detection we got. But maybe not.

Though more prostate cancer is being detected now than 10 years ago, it’s not that more men are getting prostate cancer. It’s just that more prostate cancer is being detected by the PSA test. Not all prostate cancer is fatal. In older men, prostate cancer can be slow-growing so that they will die with it, not of it.

An elevated PSA test does not automatically mean that cancer is present. Like the digital rectal exam, a PSA a test can erroneously indicate prostate cancer and erroneously fail to detect a prostate cancer. So while the screening may lead to life-extending diagnosis and treatment, it can also lead to treatment of cancers that don’t need to be treated – or even cancer that a man may choose not to treat. Treatment may cause urinary incontinence or impotence.

Several years ago, controversy arose over whether routine screening for prostate cancer.

The American College of Physicians says that routine prostate-cancer screening “is not for everyone” and that it is “a complex decision that patients should make after talking to their physician, understanding the risks and benefits, and coming to an informed, individualized decision. A urologist said in the British Medical Journal that [PSA testing] “merely Promotes Stress and Anxiety.”

But the American Urology Association and the American Cancer Society recommend that, annual PSA testing be done annually beginning at age 50, and earlier for men at high risk. The developer of the PSA test, Dr. William J. Catalona, professor and chief of urology and the Washington University School of Medicine says “PSA testing has exhibited all the features of an effective cancer-screening tool.” But note that he didn’t say it saves lives. Why? Because there’s no proof it has.

The National Cancer Institute criticized the American Cancer Society in 1992 for acting hastily in recommending routine screening without waiting for proof that mass screening reduces mortality. The ACS’ chief medial officer offered the weak defense that “Physicians and the public are demanding to be told what to do.”

Until recently, there have been no controlled studies on whether PSA testing reduces the prostate cancer death rate. The first clinical trial to examine the value of PSA screening, released in May 1998, reported that PSA screening led to a 69 percent reduction in prostate cancer death rates. While sounding impressive, researchers immediately raised questions about potential bias in the study data. Men who agreed to be screened may have been healther than those who did not agree.

Now, a new study in the Oct. 6 Journal of the National Cancer Institute reports that PSA levels may mean something entirely different than originally thought.

So what do you do? How do you choose between the American College of Physicians and the American Urological Association? Does it help to know that the ACP recommendation is “evidenced-based”? The ACP examined and reviewed more than 40 studies to determine the potential benefits of screening, the complication rate of treatment, and the balance of benefits harms and costs. In contrast, the AUA recommendation represents a consensus of expert opinion. Evidence vs. expert opinion? Wouldn’t you think expert opinion would be based on evidence? Confused? As my father-in-law, a prominent south Florida urologist said, “Urologists have the most experience, but they also have the most to gain from routine screening.”

What do urologists have to gain? You decide. PSA testing costs about $100. An elevated PSA could lead to more testing or a biopsy costing around $1,500. The prostate testing market is worth about $200 million to $300 million annually. Until recently, the developer of – and the leading cheerleader for – the PSA test, William Catalona, was receiving $1 million per year “to study the effectiveness of the PSA test,” largely from Hybritech, a pharmaceutical firm that manufactures the PSA test.

Recently, Catalona criticized the American College of Physicians for recommending against routine screening in favor of physicians and patients discussing the potential benefits and known harms of screening diagnosis and treatment and making individual decisions. Catalona wrote “This sounds reasonable but is impractical because busy doctors lack time for long discussions.”

Prostate cancer can be life-threatening. If your physician doesn’t have the time to discuss your options, get a new doctor. And whatever you do, don’t fall for the unproven and undeciphered PSA test.

Steve Milloy is the publisher of JunkScience.com.

Saving Secret Science

By Steven Milloy and Michael Gough
May 24, 1999, New York Post

Rep. James Walsh, an upstate Republican, apparently wants New Yorkers to spend billions of dollars annually based on the Environmental Protection Agency’s “secret science.”

In 1996, the EPA proposed new, more stringent national air-quality standards, estimated to cost New Yorkers as much as $3.3 billion annually and a loss of 10,000 jobs.

The EPA’s justification? It claimed the rules would save 15,000 American lives per year.

But that claim was based on a single scientific study (the “Pope study”). And that study wasn’t published in (and therefore peer-reviewed via) a top-line journal such as the New England Journal of Medicine, but a journal of the American Lung Association – a group that gets millions in EPA grants and lobbied actively for the new air-quality regulations.

Only the EPA has ever seen the Pope study data – and when Congress requested the data for independent examination, the EPA refused. Under political pressure, it relented – and the researchers took up the stonewall.

They claimed proprietary right to the data – event though the study was paid for with taxpayer dollars, was being used to impose huge costs and was requested by a Congress hardly interested in going into the scientific research business.

The EPA then cavalierly disregarded all objections – from its own science advisers, Congress and a bipartisan group of governors and mayors – and imposed the new regulations.

Industry sued. Congress legislated.

A new law extends the Freedom of Information Act to cover taxpayer-funded studies which are used to justify federal regulations. This would prevent agencies from regulating on the basis of “secret science.”

Now Rep. Walsh is leading a charge to have this “sunshine in the government” law repealed: He’s set to present an amendment today to block the law.

The EPA is confident the “data access” law is doomed: It’s now using the Pope study to justify new rules covering gasoline’s sulfur content and sport-utility-vehicle tailpipe emissions.

The EPA claims the rules will cost $3.5 billion a year – to save up to 2,400 lives per year. Is that claim accurate? Who knows? The EPA continues to refuse access to the Pope study.

Fortunately for now, a federal court this month found the EPA’s air-quality standards to be unconstitutional. But the EPA is unlikely to give up. Assuming the agency can figure out a constitutional way of regulating, Rep. Walsh is helping ensure that the science won’t face public scrutiny.

Steven Milloy is an adjunct scholar with the Cato Institute. Michael Gough is a senior scientist with the Competitive Enterprise Institute.

Fear and ignorance followed Three Mile Island

By Michael Fox and Steven Milloy
March 28, 1999, News Tribune (Tacoma, WA)

It was the event that changed the future of electrical power – and not for the better. Continue reading Fear and ignorance followed Three Mile Island

Save plastic IV-bags so they can save you

By Steven J. Milloy
March 1, 1999, Washington Times

Chemical companies have helped Americans attain the highest standard of living in history. But one would never know it from the industry. The least credible accusation against its products can send manufacturers into panicked retreat. That’s a fact that anti-chemical activists have learned all too well and exploit unmercifully, to the great detriment of consumers who might otherwise have benefited from these products. Continue reading Save plastic IV-bags so they can save you

Did You Hear? Good News from Cancer Alley

By Michael Gough
October 15, 1997, Cato Daily

Everyone knows that cancer rates are sky-high along the Mississippi River between Baton Rouge and New Orleans. How could it be otherwise? Louisiana is one of the three states with the most “industrial toxic emissions.” Chemical refineries line the banks of the river that, loaded with the effluent of the farms and factories of the Midwest in addition to whatever it picks up in Louisiana, is the source of New Orleans’s drinking water. No wonder the area’s called “cancer alley.” Continue reading Did You Hear? Good News from Cancer Alley

Junk Science: It's The Law

by Steven Milloy and Michael Gough
August 25, 1997, Investor’s Business Daily

Bad science comes. Bad science goes. That’s the great thing about science. It’s only as permanent as it is sound. But what happens when bad science becomes law? Continue reading Junk Science: It's The Law