Posted: Tuesday, August 23, 2005

PRESS RELEASE
Publication Date: August 23, 2005

New York, NY -- August 23, 2005 (also: see Updates at bottom).  The American Council on Science and Health (ACSH) today petitioned the Environmental Protection Agency (EPA) to eliminate "junk science" from the process by which it determines whether a substance is likely to cause cancer in humans. 

The petition, filed on behalf of ACSH by the Washington Legal Foundation (WLF), a public interest law firm, argues that current EPA guidelines violate the Information Quality Act (IQA) -- the law that requires the federal government to ensure the "equality, objectivity, utility, and integrity" of information it dispenses to the public. 

Specifically, EPA routinely declares chemicals "carcinogens" -- implying a likelihood of a health threat to humans -- based solely on the creation of tumors in lab rodents by the administration of superhigh doses irrelevant to ordinary human exposure levels.  Furthermore, effects in a single species may not be applicable to another species (rat tests do not even reliably predict effects in mice, which are closely related to rats, let alone effects in humans), though similar effects in multiple species might be an indicator of a genuine problem. 

As ACSH has explained in its report America's War on "Carcinogens", declaring substances "carcinogens" (when they would more properly be called high-dose rodent carcinogens) is a chief source of health panics, public outcry, activist crusades against chemicals, and waste of resources from unnecessary abatement, cleanup, and product recall/reformulation/replacement. 

EPA recently adopted Guidelines for Carcinogen Risk Assessment that provide guidance to agency personnel in making determinations that a substance is either a human carcinogen or is "likely" to be carcinogenic to humans.  The ACSH/WLF petition requests that EPA comply with the IQA by eliminating "junk science" from those Guidelines.  In particular, ACSH and WLF request that EPA eliminate statements that indicate that a substance may properly be labeled a "likely" human carcinogen based solely or primarily on the results of animal studies.  Such statements are scientifically unsound, argues the petition, which notes that the great majority of toxicologists share that assessment. 

The law permits EPA, if it so chooses, to adopt policies that err on the side of caution when faced with genuinely equivocal evidence regarding a substance's carcinogenicity, but the IQA does not permit EPA to distort the scientific evidence in furtherance of such policies.  The petition argues that EPA distorts scientific evidence through its Guidelines' use of "default options," its purported right -- based not on scientific evidence but its regulatory mission to protect human health -- to assume that tumors in lab rodents indicate that much smaller doses can cause cancer in humans.  Erring on the "safe side" in regulatory decisions does not, argues the petition, permit EPA to falsely claim that such regulated substances truly are "likely to be carcinogenic to humans." 

To do so, argues ACSH, is a distortion of both science and law. 

For further information, contact ACSH Associate Director Jeff Stier, Esq., at 212-362-7044 (or Stier[at]acsh.org) or contact WLF Chief Counsel Richard Samp at 202-588-0302.

A copy of the petition can be found on WLF's website at: http://wlf.org/Litigating/casedetail.asp?detail=368

UPDATE: EPA responded after ninety days with a request for sixty more days to formulate their response.

UPDATE #2: EPA responded after the additional sixty days with a request for sixty more days -- now its new self-declared deadline for responding to ACSH's petition is March 21.   

UPDATE #3: EPA eventually decided that the Information Quality Act doesn't apply to its policy statements.

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Peliculas Online

By Elizabeth M. Whelan, Sc.D., M.P.H.
Posted: Friday, May 14, 2010
Publication Date: May 14, 2010

The President’s Cancer Panel has released a report on the causes of cancer and how we might best avoid them. Among its recommendations: Take off your shoes before entering your home.

The panel’s 200-plus-page report is a scientific travesty that claims environmental chemicals have been routinely understated as a cause of cancer. Made up of just two members — Dr. LaSalle Leffall of Howard University and Dr. Margaret Kripke, professor emeritus at the M.D. Anderson Cancer Center in Houston —the panel concluded that there is “grievous harm” being done by chemicals and there is “a growing body of evidence linking environmental exposures [to chemicals] to cancer.”

If Dr. Leffall and Dr. Kripke had simply consulted a standard textbook on cancer epidemiology, they would have learned that lifestyle factors such as smoking, obesity, excessive alcohol consumption, and overexposure to sunlight are the underlying preventable causes of human cancer — not “chemicals” in air, water, and food.

The panel’s report, which was roundly criticized by the American Cancer Society and other experts on cancer causation, was constructed on a number of false premises:

1. It assumed that “chemicals” are dangerous by definition and our exposure to them should be limited. Well, that would indeed be a problem, since all things, natural and synthetic, are comprised of “chemicals.” When you have a cold, refreshing glass of water, you are drinking dihydrogen monoxide.

2. It assumes that our goal in cancer prevention should be to eliminate all exposure to “toxic” and “carcinogenic” agents. Sorry, that is impossible. Safe, natural foods come replete with toxins (such as the traces of naturally occurring arsenic in every potato) and “carcinogens,” defined as chemicals that cause cancer at high dose in laboratory animals (like the safrole in black pepper or the eatechol in a cup of coffee).

3. The panel appears to be oblivious to the concept of “dose” — as expressed in the classic toxicological premise “only the dose makes the poison.” Exposure to chemicals like vinyl chloride at high levels for long periods of time has indeed, decades ago, caused cancer in the workplace. Such true human carcinogens are always detected via careful collection of epidemiological data. But that level of occupational exposure has no relationship to environmental exposure to trace levels of chemicals.

4. The panel relies upon and endorses the so-called “precautionary principle,” which demands that every chemical be proven safe before it is used. How can you prove anything to be safe? You can’t. It’s like trying to prove a negative.

For example, the panel’s report repeatedly targets the chemical BPA as posing numerous health risks, including cancer. BPA is a ubiquitous industrial chemical — essential in the manufacture of many hard plastic products — and used in the lining of cans to prevent the development of foodborne illnesses, such as botulism. BPA has been used for over 50 years and subjected to thousands of safety evaluations. Expert panels from around the world (including our own Food and Drug Administration and Environmental Protection Agency) have concluded that BPA is safe as used. Yet the panel still raises anxieties about adverse health effects from this chemical. In other words, despite all the studies, under the panel’s “precautionary principle,” BPA still does not make the cut to be labeled “safe.” Under that standard, what chemical would ever get the government’s seal of approval?

The President’s Cancer Panel is an assault on the science of cancer epidemiology. Its findings — such as avoiding environmental cancer-causing agents by taking off your shoes and leaving the “carcinogens” you picked up on the way home at the doorstep — are ludicrous and, by distracting Americans from the proven cancer risk factors, are more likely to increase than decrease our nation’s cancer burden. This prestigious-sounding panel (which New York Times columnist Nicholas Kristof dubbed “the Mount Everest of the medical mainstream” — it isn’t) urges us to eat organic foods, filter our water, and microwave only using ceramic or glass, rather than plastic — instead of confronting us with the truth: At least 35 percent of cancer deaths this year can be causally linked to cigarette smoking, and another significant percentage can be traced to other lifestyle factors such as obesity. The exact contribution of environmental chemicals to our nation’s cancer toll has not been calculated — but today the best estimate of that contribution is close to zero.

– Dr. Elizabeth M. Whelan is president of the American Council on Science and Health.

Originally published on National Review Online's Critical Condition blog , May 14, 2010. 

View the original article here

Peliculas Online

By Elizabeth M. Whelan, Sc.D., M.P.H., and Dr. Henry I. Miller
Posted: Wednesday, June 2, 2010
Publication Date: June 2, 2010

Originally published on Forbes.com, June 2, 2010 .

President Barack Obama's cancer panel has recently released a report on the supposed causes of cancer and how to avoid them. The subject is important--cancer is the second leading cause of death in the United States--and the report could have been useful. Instead it is a travesty, a paragon of political correctness and unscientific, naive speculation and misinterpretation.

The 200-page document produced by the "panel"--which consists entirely of two scientists lacking expertise in cancer epidemiology--is a rehash of myths and misapprehensions about the causes of cancer. The report concluded that "grievous harm" results from exposure to chemicals and that there is "a growing body of evidence linking environmental exposures [to chemicals] to cancer."

If the authors had only bothered to consult a standard textbook on cancer epidemiology, they would have learned that lifestyle factors such as smoking, obesity, excessive alcohol consumption and overexposure to sunlight--not chemicals in air, water and food--are the underlying causes of most preventable human cancers.

They could also have referred to the summary statement from one of their own previous meetings, "Strategies for Maximizing the Nation's Investment in Cancer," held in San Diego in 2007, which concluded: "Similar to the previous meeting in this series, participants stressed that the greatest reduction in cancer mortality could be achieved by eliminating tobacco use; they vocalized disappointment in the lack of political will to eradicate this killer. Smoking remains the single largest preventable cause of cancer. ... Significant impact on morbidity and mortality could also be achieved by 'following the evidence' and applying what we know--screening and early detection of cancer; better preventive interventions and treatments for those cancers with the highest morbidity and mortality (e.g., breast, colon, lung, prostate); and expanded access to cancer care."

But instead of following the available evidence, the current panel relied on several specious premises.

First, it assumed that chemicals, by definition, are dangerous, and that our exposure to them should be limited, even at huge cost. That is puzzling because all things, natural and synthetic, including our own bodies, are composed of chemicals.

Second, it assumed that the goal of cancer prevention should be to eliminate all exposure to toxic and carcinogenic agents. The very idea is puerile, not to mention impossible. Safe, natural foods are replete with toxins. Nutmeg contains myristicin, which in high doses can induce convulsions, palpitations and generalized body pain; licorice has glycyrrhizic acid, which if consumed in large amounts can give rise to dangerously high blood pressure; soy-based products such as tofu contain high levels of plant-based estrogens that could affect hormonal balance.

Many foods also contain carcinogens--chemicals that cause cancer at high dose in laboratory animals--such as safrole in cinnamon. The American Council on Science and Health has actually constructed a "holiday dinner menu" of common foods that are replete with toxins and carcinogens .

Third, the panel appeared to be oblivious to the critical relationship of dose--as expressed in the classic toxicological principle "the dose makes the poison"--to risk. Exposure to chemicals like vinyl chloride at high levels for long periods of time did indeed, decades ago, cause cancer in the workplace, as did chimney sweeps' exposure to soot. The existence of such true human carcinogens is detected via careful collection of epidemiological data, but those high levels of occupational exposure are quite different from environmental exposure to trace levels of chemicals.

Fourth, the panel relied on and endorsed the so-called precautionary principle, which puts the burden of proving what amounts to absolute safety on the makers and purveyors of almost any product. It is not a principle at all but merely a highly risk-averse, unrealistic philosophical premise demanding that every activity and product be proven safe before it is undertaken or used. But how can you prove anything is completely safe? It amounts to trying to prove a negative. Critics can always say you didn't test in enough species, or for long enough, or at a high enough dose.

A perfect example of the shortcomings of the precautionary principle is the concern raised in the report about the chemical BPA. BPA is a ubiquitous industrial chemical that is essential in the manufacture of many hard plastic products, and it has been used in the lining of cans to prevent the development of foodborne illnesses like botulism. BPA has been used for more than half a century and has been subject to thousands of safety evaluations, with expert panels from around the world (including our own Food and Drug Administration and Environmental Protection Agency) concluding it is safe as used. Yet the panel still raises anxieties about supposed risks. In other words, in spite of all the studies, under the panel's "precautionary principle," BPA still does not qualify as "safe." According to that standard, what chemical could?

The president's cancer panel's report is an assault on the science that underlies cancer epidemiology. Some of its recommendations--such as avoiding environmental cancer-causing agents by taking off your shoes and leaving at the doorstep the "carcinogens" you picked up on the way home--are ludicrous. By distracting Americans from proven cancer risks, they will more likely increase rather than decrease our nation's cancer burden, to say nothing of the public's anxiety.

This prestigious-sounding panel offers advice that owes more to celebrity-babble on Oprah than to sound science: Eat organic foods, filter your water, use only ceramic or glass, rather than plastic, in the microwave. However, according to the National Cancer Institute's statistics, smoking accounts for 29% to 31% of cancer deaths, diet for 20% to 50%, infectious disease for 10% to 20%, ionizing and ultraviolet light for 5% to 7%, occupational exposure (from high dose exposures to vinyl chloride, benzene, etc.) for 2% to 4% and pollution (such as radon gas) for 1% to 5%.

The truth is that few chemicals are as toxic as the report of the president's cancer panel, which will only fuel the Obama administration's and activists' ill-advised, unscientific vendetta toward chemicals.

Henry I. Miller, a physician and molecular biologist, is a fellow at Stanford University's Hoover Institution. He writes a bi-weekly column for Forbes.

Elizabeth Whelan is president of the American Council on Science and Health.

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