Soda, Diabetes Linked by Scientific Misconduct?

By Steven Milloy
August 27, 2004,

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

Chesapeake Bay Needs Science, Not Slogans

By Steven Milloy
July 23, 2004,

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,

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

Fishy Mercury Warning

By Steven Milloy
December 25, 2003,

The Food and Drug Administration just issued a new warning to pregnant women about mercury in seafood (search). You can “protect your baby” from developmental harm by following three rules, claims the FDA. Continue reading Fishy Mercury Warning

McJunk Science: Over Five Billion Fooled

By Steven Milloy
June 27, 2003,

McDonald’s just ordered its meat suppliers to phase out antibiotics for promoting animal growth. It’s the second time in the past year that McDonald’s has fed the public McNothing-burgers smothered in the pseudo-sauce of activist-defined corporate social responsibility. Continue reading McJunk Science: Over Five Billion Fooled

Cancer Miracle or Mirage?

By Steven Milloy
June 06, 2003,

The media and stock market are again atwitter with news of another supposed cancer breakthrough. Avastin (search), a drug developed by biotech giant Genentech (search), reportedly extended the median survival time of terminally ill colon cancer patients in a clinical trial by 4.7 months.

The news was formally released at last weekend’s meeting of the American Society of Clinical Oncology (search) (ASCO). The price of Genentech stock has risen by about 65 percent since mid-May when the news began leaking.

One biotech analyst said annual sales of Avastin could reach $2 billion as almost 150,000 Americans are diagnosed with colon cancer and 57,000 die from it every year.

And based on headlines such as the Los Angeles Times’ “New Drug Combinations Effective on Colon Cancer,” the Avastin claims sound exciting.

But since cancer breakthrough news is usually more smoke than fire, a closer look is warranted — especially since Avastin wasn’t effective in an earlier breast cancer trial.

It’s too bad a closer look isn’t possible.

Detailed information in standard study form about the Avastin trial isn’t available — not from the Duke University Medical Center, whose news release claimed Avastin’s efficacy was “proved,” and not from Genentech, whose market value increased by $15 billion on the news.

Both were happy to be contacted about the study, no doubt expecting more giddy and gullible reporting. But no detailed write-up was available. The Genentech spokesperson couldn’t even say when a study might be published.

Only a brief study summary or abstract was available, one omitting or glossing over key information and basic questions about the trial.

The trial involved 925 patients. About 800 patients were either given Avastin plus a standard chemotherapy or the chemotherapy alone. Another 100 patients were given Avastin in combination with another standard chemotherapy.

The abstract only contains results for the 800-patient treatment group. What happened in the 100-patient treatment group? Was Avastin effective there, too? If so, why not report it?

Avastin reportedly increased survival time by almost five months. But that claim relies on the major assumption that at the beginning of the trial, patients in the Avastin group, on average, had a similar expected survival time as patients in the chemotherapy-alone group.

Individual study subjects, though, likely had different types of colon cancer and were at different stages in the progression of their colon cancers. If the Avastin treatment group was, on average, at an earlier stage of colon cancer or had less aggressive colon cancers and metastases, it wouldn’t be surprising that their survival time is longer.

The researchers apparently hoped that random assignment of subjects to the Avastin and non-Avastin treatment groups would equalize the expected survival times of the treatment groups at the trial’s beginning.

This may have worked, but we just don’t know. Without some information about, and validation of the assumption, the touted results are based on a huge leap of faith.

The trial was multicenter in nature, meaning that patients were treated at several locations around the country. Such decentralization may give rise to a phenomenon known as “multicenter bias,” where the results from one study center may be skewed because of some systematic difference in the conduct of its part of the trial.

We can’t tell whether multicenter bias occurred in the Avastin trial because the data weren’t reported by a study center.

I asked lead researcher Herbert Hurwitz whether the study was peer-reviewed. He said it was reviewed by a committee of ASCO — the group putting on the medical conference where the results were announced.

But how could the committee perform a credible review with only the superficial abstract? No reputable journal would publish results without more. We must also wonder if the committee was truly objective since ASCO may have been eager to have such headline-grabbing claims announced at its annual meeting.

One final reason for requiring something more than “science by press conference” is that the biological mechanism by which Avastin is supposed to work, the blocking of blood vessels in tumors (anti-angiogenesis), hasn’t really panned out yet.

Based on studies in laboratory animals, anti-angiogenesis drugs were first touted several years ago in a front-page New York Times article that caused dramatic speculation in biotech stocks. But subsequent studies in humans have disappointed and biotech stock prices collapsed.

Given the huckster-ish history of anti-angiogenesis drug claims, Genentech and Hurwitz should realize more than a vague abstract is needed to show Avastin works. A detailed study would be a start, followed by more clinical trials.

Proven effective or not, terminally-ill cancer patients shouldn’t be denied Avastin or any other potentially helpful drug they are willing to try on their own dime. But cancer treatments shouldn’t be hailed until they are actually proven to work.

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

Consumer Watchdog: Vinyl Toys Are Just Ducky

By Steven Milloy
February 28, 2003,

The Consumer Product Safety Commission did the right thing last week in ruling rubber duckies and other vinyl toys pose “no demonstrated health risk” to children. This should end a long-running controversy contrived by environmental extremists.

“Consumers may have a high level of assurance that soft plastic products pose no risk to children,” said Commissioner Mary Sheila Gall following a unanimous vote by CPSC commissioners.

Vinyl toys are made from polyvinyl chloride (PVC), softened by the chemical diisononyl phthalate (DINP). DINP has been used for more than 50 years in applications such as flooring, wall coverings, carpet backing, cable sheathing and toys. There are no reports of harm caused by DINP in commercial products.

Despite this track record of safety, the National Environmental Trust, Greenpeace, Physicians for Social Responsibility and other activist groups petitioned the CPSC in November 1998 to “ban polyvinyl chloride from all toys and products intended for children five years of age and under and to issue a national advisory on the health risks that have been associated with PVC toys and products.”

The ostensible reason for the requested ban — we’ll get to the real reason later — was the alleged risk of liver and kidney damage to children exposed to DINP by mouthing PVC toys.

In December 1998, the CPSC released the results of a preliminary study of DINP concluding, “few, if any, children are at risk of liver or other organ toxicity from mouthing teethers, rattles, and other PVC toys that contain DINP.”

Still, the CPSC said further study was desirable, and convened a special panel to study DINP in toys.

The special panel’s three-year review concluded, “there may be a DINP risk for any young children who routinely mouth DINP-plasticized toys for 75 minutes per day or more. For the majority of children, the exposure to DINP from DINP-containing toys would be expected to pose a minimal to non-existent risk of injury.” The panel also concluded DINP posed no risk of cancer or reproductive and developmental harm.

CPSC staff then conducted a behavioral observation study to better quantify DINP exposure to children.

One hundred sixty-nine children between the ages of 3-36 months were studied by trained observers for two hours on each of two days. The average daily mouthing time of soft plastic toys for children 12-24 months of age (the age group with the highest mouthing time) was 1.9 minutes per day — well below the 75 minutes per day that the special panel indicated might be of concern.

CPSC staff also conducted a hypothetical “worst-case” analysis involving pacifiers, which have the highest mouthing times of any toys. The staff assumed pacifiers contained DINP — they currently do not — and that the pretend-DINP migrated out of the pacifiers at the same extremely low rate as observed in soft plastic toys.

In this worst case analysis, even at the 99th percentile of exposure, the acceptable daily intake of DINP for a child would not be exceeded.

The staff concluded, “Since children mouth other products even less than they mouth toys and dermal penetration is expected to be minimal, [we] do not believe they would pose a risk to children five years of age and under.”

The irony of the controversy is that the Greens aren’t really concerned about DINP or children’s health at all. The attack on DINP is simply a tactical ploy to advance the Greens’ broader war against the element chlorine — a key ingredient in the production of innumerable consumer products, including PVC.

The Greens previously have tried unsuccessfully to scare the public about other PVC ingredients. They try these roundabout attacks because the direct assault on chlorine has failed.

The Greens have wanted to ban the industrial use of chlorine since at least 1994. They nearly convinced the Clinton administration to support a legislative proposal to that effect.

But even the activist-friendly Clintonites realized the foolhardiness of banning chlorine.

About 12 million tons of chlorine are produced in North America annually for use in manufacturing other important chemicals, pharmaceuticals and plastics; pulp and paper bleaching; and drinking water purification and wastewater disinfection.

Chlorinated drinking water is generally acclaimed as one of the greatest advances in public health of the 20th century.

A chlorine ban would risk public health and cost consumers more than $90 billion per year for alternative products and process — with no guarantee of equivalent performance or quality, according to the Chlorine Chemistry Council.

When the Greens filed their November 1998 petition to ban PVC in toys, Newsweek headlined its story, “Vinyl Ducky, Out of Lucky.” An updated headline based on 5 years of review might read, “Vinyl’s ducky, Greenies yucky.”

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

Hormone Hysteria or Hype?

By Steven Milloy
August 2, 2002,

Women have been scared during the last several weeks with new studies about alleged health risks from hormone replacement therapy (HRT). This scare contrasts starkly with the preceding decades of HRT being touted as the fountain of youth.

What should women and their physicians believe? Past hype? Recent hysteria?


HRT, originally estrogen alone and later estrogen in combination with progestin, was approved in 1942 by the Food and Drug Administration to relieve the short-term symptoms of menopause such as night sweats and hot flashes.

Two decades later, though, HRT began being touted as a wonder drug for many long-term health concerns of women, not just menopausal symptoms. HRT mania was kicked off by Dr. Robert Wilson’s 1966 book Feminine Forever. Unknown at the time, the book was financed by Wyeth-Ayerst, the leading manufacturer of HRT.

Studies appeared in the scientific literature touting HRT as reducing bone loss, the risk of heart disease and the risk of some cancers.

But anyone who paid attention to the data rather than the hype would have known that these studies didn’t at all demonstrate HRT to be a panacea.

The studies invariably reported weak statistical correlations between HRT use and long-term health benefits — and that’s with the study populations biased in favor of the reported results.

The study populations taking HRT tended to be comprised of thinner, wealthier and better-educated women under physician care. It is not surprising that these women were healthier than the women in the “control” groups.

Myths about the long-term benefits of HRT nevertheless took hold. Premarin, the most popular HRT made by Wyeth-Ayerst, was recently used by about 12 million women in the U.S. at a cost of about $180 per year.

Or it used to be so widely used.

Early July saw a rash of epidemiologic (human population) studies allegedly linking HRT with a variety of health risks. “NIH says type of hormone therapy hurts instead of helping women’s hearts and causes breast cancer,” headlined The Associated Press.

The New York Times quoted a female physician stating, “I may have taken my last pill this morning.”

But the most notable of the recent studies reported that, among 8,506 estrogen-plus-progestin HRT users, there was only a 29 percent increase in heart disease occurrence. The result was barely statistically significant, meaning there’s a worrisome possibility it was a fluke.

The study reported only a 26 percent increase in breast cancer occurrence. That result wasn’t statistically significant.

The study’s reported results for other health concerns were of similar magnitude and statistical significance — that is to say, weak.

But you don’t have to accept my characterization of such results.

As the National Cancer Institute points out: “In epidemiologic research, [risks of less than 100 percent] are considered small and usually difficult to interpret. Such increases may be due to chance, statistical bias or effects of confounding factors that are sometimes not evident.”

In other words, these results should be treated as preliminary — particularly until they are replicated many times by independent researchers. That’s just Scientific Method 101.

Moreover, these women were only studied for five years and previous studies report contradictory results. It seems the panic is premature.

David Sturdee, former chairman of the British Menopause Society, once said: “A lot of nonsense is talked by those who say HRT is the best thing since sliced bread. Equally, I am incensed by the idea that all HRT is unsafe. Some women feel undue pressure either to take HRT or not to.”

What kind of pressure? Wyeth-Ayerst pressed women to take HRT. Now others are trying to scare women about HRT.

Pharmaceutical manufacturer Eli Lilly promoted HRT fears in the fall of 1997 as it awaited approval of it rival drug, raloxifene (Evista).

Lilly placed full-page advertisements in women’s magazines that ominously read, “Many women have serious worries about a possible link between estrogen replacements and cancer.” The implication was that Evista didn’t increase cancer risk.

Lilly even touted preliminary studies reporting a slight decrease in cancer risk among Evista users.

This marketing-by-scaremongering was eventually brought to a halt by a federal judge who issued an injunction against Lilly touting research that did not prove Evista prevented breast cancer.

No one disputes the short-term benefits of HRT for menopausal symptoms. Moreover, there is no substitute for it. But HRT’s supposed long-term benefits and risks so far seem to have more to do with unscrupulous marketing than science.