FDA May Make Breathing Difficult for Asthmatics

By Steven Milloy
January 26, 2006, FoxNews.com

The government may tell asthmatics to “take a hit” for the environment. But that “hit” won’t be from their inhalers, which might be taken away.

A Food and Drug Administration advisory panel voted this week to recommend removing the “essential use” status that permits inexpensive, nonprescription asthma inhalers, like Primatene Mist, to remain on sale.

Powered by chlorofluorcarbon (CFC) propellants, the inhalers shoot epinephrine into the lungs of asthmatics, allowing them to breathe during potentially life-threatening asthma attacks. But environmentalists labeled CFCs a threat to the ozone layer in the 1980s, leading to an international phase-out of CFCs under the 1987 Montreal Protocol.

Nonprescription inhalers – and millions of asthmatics – have so far survived the Montreal Protocol because CFC use in inhalers is deemed to be “essential” and, therefore, exempt from the ban. Wyeth Consumer Healthcare estimates that 3 million Americans use its Primatene for mild or intermittent asthma and about 700,000 use Primatene alone because they can’t get prescriptions or lack health insurance, according to the Seattle Times (Jan. 25). Wyeth says that substitute non-CFC inhalers won’t be ready until 2009 or 2010 – and probably at a much higher cost.

But the FDA panel was apparently swayed by arguments that CFC-inhaler use threatens the ozone layer and public health. The hypothesis-of-hysteria is that CFCs thin the stratospheric ozone layer which, in turn, allows more solar ultraviolet (UV) radiation to reach the Earth’s surface which, in turn, increases the risk of skin cancer, cataracts and other health problems.
But asthmatics should not have to gasp for air because of this guesswork.

First, accepting for argument’s sake that ozone depletion alarmism is justified, only a trivial amount of CFCs would be released into the atmosphere due to inhaler use. No detectable damage to the ozone layer would likely result.

Global CFC production peaked pre-ban at over 1 million metric tons. But in 1999, for example, the U.S. requested an “essential use” exemption of only about 4,000 metric tons for inhalers – hardly a return to the old days when CFCs were used in a wide range of consumer and industrial products.

Back to the real world, however, the ozone depletion hypothesis has a great big hole of its own.

No one disputes the basic chemistry of ozone depletion – chlorine atoms from CFCs released into the environment can find their way into the stratosphere where they can chemically react with and “destroy” ozone.

It should be noted, however, that CFCs aren’t the only source of chlorine atoms in the stratosphere – Mother Nature, in fact, may supply most of them. Also, ozone is also continually being created so we won’t ever run out of ozone.

In any event, none of the alleged environmental and public health horrors of CFC-induced ozone “destruction” have ever been observed despite extensive study – one of the best kept secrets of environmentalism.

While overexposure to UV is a risk factor for some types of skin cancer and cataracts, no scientific study has ever demonstrated a link between ozone depletion and such overexposure or any health effects.

A December 2003 article in the journal Photochemical & Photobiological Sciences, for example, would only go so far as to say that “The potential health effects of elevated levels of ambient UV-B radiation are diverse, and it is difficult to quantify the risks.”

The absence of evidence linking ozone layer thinning with health effects isn’t surprising because the phenomenon was never thought (by experts, anyway) to lead to more than a trivial (10 percent) increase in UV radiation reaching the Earth’s surface.

As there is about a 5000 percent increase in UV radiation moving from the poles to the equator, a 10 percent increase in the mid-latitudes equates to a move 60 miles to the south – “hardly a source for health concerns,” says physicist Dr. S. Fred Singer of the Science and Environmental Policy Project.

It’s not even clear that ozone depletion, in its pre-phaseout heyday, ever increased the amount of UV radiation hitting the Earth’s surface. “There has been, of course, a determined search for a secular increase in [UV radiation] to match the presumed depletion of ozone. But no such trends had been observed,” says Dr. Singer.

And a little common sense about UV radiation goes a long way. Life flourishes in the tropics where UV radiation levels are far higher than in the quite inhospitable polar regions.

Yes, there is an “ozone hole,” but that label is more appropriately applied to the Montreal Protocol than the ever-changing thickness of the ozone layer over the Antarctic polar region.

Former Vice President “Ozone Al” Gore acknowledged in a recent presentation I attended that the real value of the Montreal Protocol was that it demonstrated the global political power of the environmental movement.

But while getting a junk science-fueled international treaty signed may have been a valuable political exercise for environmentalists, the Montreal Protocol can hardly be considered a success if it winds up needlessly depriving asthmatics of available, affordable and effective medication.

Steven Milloy publishes JunkScience.com and CSRwatch.com, and is an adjunct scholar at the Competitive Enterprise Institute.

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).

Kyoto Count-Up

By Steve Milloy
February 22, 2005, FoxNews.com

Feb. 16, 2005, is a day that may well live in scientific and economic infamy. That’s the day that the international global warming treaty known as the Kyoto Protocol (search) went into effect around the world — but, fortunately, not in the U.S. and Australia. Continue reading Kyoto Count-Up

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.

Chesapeake Bay Needs Science, Not Slogans

By Steven Milloy
July 23, 2004, FoxNews.com

Progress on reducing the pollution flowing into the Chesapeake Bay, North America’s largest estuary, has been “significantly overstated,” The Washington Post hyperventilated in a front-page story this week. It seems that the allegedly erroneous estimates of pollution reduction were based on faulty computer modeling, not actual sampling of bay water. Continue reading Chesapeake Bay Needs Science, Not Slogans

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).