McJunk Science: Over Five Billion Fooled

By Steven Milloy
June 27, 2003, FoxNews.com

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, FoxNews.com

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 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).

Consumer Watchdog: Vinyl Toys Are Just Ducky

By Steven Milloy
February 28, 2003, FoxNews.com

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 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).

Hormone Hysteria or Hype?

By Steven Milloy
August 2, 2002, FoxNews.com

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?

Neither.

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.

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

The CDC's Public Health Turkeys

by Steven Milloy
November 21, 2001, FoxNews.com

The Centers for Disease Control and Prevention performed admirably in managing the recent anthrax attacks. But that performance is a lone highlight for an agency in desperate need of something useful to do.

The CDC’s public health crisis of the moment is traveling by car during the Thanksgiving holiday. The CDC issued an advisory reminding motorists to wear seat belts, restrain children appropriately and to not drink and drive.

While this is sensible advice, the CDC offers it because “in 2000 during the Thanksgiving holiday, motor-vehicle crashes killed approximately 500 persons and resulted in more than 43,000 hospital emergency department visits.” CDC portrays Thanksgiving as a particularly risky time for motorists.

In fact, though, the Thanksgiving holiday is no more dangerous to motorists than any other five-day period.

About 40,000 persons are killed and 3.2 million are injured in automobile accidents every year. This averages out to about 110 killed and about 8,800 injured every day. So for any five-day period, we might expect 550 deaths and 44,000 injuries resulting from automobile accidents. There doesn’t seem to be extra motorist carnage during the Thanksgiving holiday.

The CDC pulls a similar stunt every Halloween, alarming parents about increased child pedestrian deaths. During 1975 to 1996, from 4 p.m. through 10 p.m. on October 31, a total of 89 deaths occurred among pedestrians aged 5 to 14 years, compared with 8,846 on all other evenings.

This works out to about 4 deaths each Halloween, compared to 1 death on all other evenings. It apparently never occurred to the CDC that there is a many-fold increase in child pedestrians on Halloween night.

If the CDC more appropriately compared death rates, instead of just numbers of deaths, it most likely would have found the child pedestrian death rate actually decreases on Halloween. But what kind of scare would that make?

Holidays aren’t our only public health “problem,” according to CDC researchers. Suburban living is another.

Early November saw the release of “Creating a Healthy Environment: The Impact of the Built Environment on Public Health” — a report authored by two senior CDC researchers.

The reasons why suburban living is a public health problem, according to the report, include:

  • Increased commuting means more air pollution and respiratory disease (Never mind that the air is cleaner today than 30 years ago, according to the U.S. Environmental Protection Agency, even though there are many more vehicles on the road.)
  • Because suburbanites drive more, they engage in less physical activity, which makes them obese and unhealthier. (This point was not supported by any data comparing urbanites and suburbanites. Also, whether you walk or drive to the neighborhood convenience store isn’t a reliable indicator of physical activity, body weight and overall health.)
  • Residential development next to farmland creates a “zone of conflict” from the “spillover effects of agriculture, such as excess noise, blowing dust and pesticide overspray.” (The citation for this claim is a “report” by the anti-growth activists at the American Farmland Trust.)

The CDC’s sprawl alert is only the latest of the agency’s efforts to medicalize behavior into a public health problem. Past efforts have targeted such familiar politically incorrect activities as firearms ownership, smoking and alcohol consumption.

The CDC also has extended its alarmism to pets (4.7 million dog bites per year), youth sports (“injuries are common and can be severe”), swimming pools (“try your best to avoid even having water in your mouth”) and dating (“courtship violence ranges up to 65%”).

Virtually every human activity may have personal health and injury consequences. That, however, should not make every human activity a public health problem subject to CDC nanny-ing.

The CDC was originally called the “Communicable Disease Center” when formed in 1946. Its mission was to control infectious disease. In 1970 when that mission was largely accomplished, the CDC’s name was changed to the “Centers for Disease Control” to reflect a broader mission in preventative health — i.e., bureaucratic sprawl.

The only successful effort beating back the CDC’s interference in every aspect of our lives was achieved in 1996 when Congress banned the CDC from engaging in gun control advocacy.

In the wake of the recent anthrax attacks, the Bush Administration wants to increase CDC’s funding. The CDC, however, could probably accomplish its new bio-terrorism mission within current budget limits if its activities were restricted to actual public health problems.

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).