Healthcare fraud

Sunday, March 26, 2006

Heresy in the ETS debate?

For evaluation and analysis, anyone like to comment?

The spin-doctors will have to work overtime to clean up the latest mess.

Is there any wonder the EPA is ignoring them?

The American Lung association has provided new evidence, which would suggest previous research concluding ETS to be a deadly carcinogen and a major health risk were largely flawed. When taken into consideration the low and inconclusive results of many major epidemiology papers the new information should prove those associations to be overstated or unfounded. Recent submissions should prove consistently the existence of ETS likely inconsequential other than an irritant in indoor air, as common sense would dictate.

Recent submissions stating another highly significant co-founder is likely three times as high as previously believed. This allows in a re-examination of previous research, if indeed the research were believed to be credible, allowances would have to have been made for a constant exposure in ambient air. A co-founder in previous research, which should indicate constant exposure as opposed to incidental exposure when in contact with ETS, could not possibly be inconsequentially in the results of the calculations. Inhalation exposures to outdoor air as a major component of indoor air cannot be simply dismissed if no analysis was done to differentiate the two. A description of the health effects largely identical to those described consistently in the effects of ETS leave cause for major concern.

As we know from previous research, the value of ventilation is inconsequential in respect to indoor air RSP or the PPAH produced known to be .08% of the former. In short the common belief would be designated smoking rooms, do not offer protection from a hazard ETS is believed to have a safe level of 16.3 picograms per cubic meter of air. Supporting statements, no safe level exists. Are we all doomed or is there cause for hope in reassessing the known facts? These facts as confirmed in research widely accepted in court and Government submissions globally, as shown by one of the more popular lobbyists here. et al Repace 1999 Brook v. Burswood Casino. In a submission August 7 2005 Critical Evaluation of Lincoln Scott’s Burswood Casino Air Quality.

If as the American Lung Association contends Outdoor air is three times as consequential in health risk. The expectation would have to be other risks were largely overstated. With the overwhelming agreement as demonstrated by a ratio of 8 to 1 As explained on the ALA website a ratio of those speaking in favor of lowering the limits of particulate matter substantially. Perhaps the global panic largely created by similar proposals promoting smoking bans can be seen as crying wolf, in the absence of other explanations to the contrary. Additionally the 8 to 1 ratio as described could be observed as a proof, in quality as opposed to quantity as a more reliable guide. HIA Health Interventions as abdicated by the Industry financed Lobby group also known, as The World health Organization, may be highly effective in control of decision-making processes. The process is impressive on the surface until you realize what they failed to disclose. The increased embarrassment potential when a theory is found to be wrong or in conflict with another is greatly increased. Theoretic calculations presented as fact have limits, as there are only so many deaths to go around. Public knowledge created in advocacy is much more wide spread because of HIA and a huge danger is present to credibility of process and all those involved Stakeholders. As in gold rush mentality in get rich quick schemes, they rarely pan out.

The many potential components and many products described by the EPA and others in epidemiology research simplistically as cigarette smoke or tobacco smoke. An ethical malaise exists in the fraudulent representation in the research of the smoke defined as a single dimensional disease vector. This would explain the vast diversity of outcomes as a result of these studies and in perspective how much value they truly represent. In an overall inspection of the outcomes, the larger studies have consistently shown inconclusive results in ETS research.

The WHO study although the conclusions were largely ignored, the findings should have shown; when taken into perspective a margin of error the study was marginal or in respect to curative indications in children’s studies, to be a pretty good indication of the limitations of this research method. Elimination of physical science from the evaluation was deceptive. Research based in environmental controls and ingredients regulations based in product safety are well known to be much more suitable for the task at hand. Widespread victim bashing was financially beneficial to all parties or stakeholders involved, including the product manufacturers, however a strategy based in deceit is destined to fail.

Further in evaluating the credibility of the presentation included it needs to be understood; deaths formerly attributed to other sources are now possibly associated to and more likely to be caused by PM2.5 the former associations would understandably decrease significantly. In some cases, the RR factor of these disease categories would require re-evaluation in deciding significance if any, in human population and reduced ETS advocacy relevance.

Information from the ALA website the latest research indicates the following;

Daily exposures to Particulate matter result in premature death three times greater than previously reported.

Some of the highlights of the more than 50 new studies summarized include:

A long-term study showing risk of premature death attributable to PM is three times greater than previously reported;

• Studies linking daily exposures in PM with increased hospital admissions for strokes, congestive heart failure, heart attacks, COPD and other respiratory problems;

• A toxicology study showing links between exposure to PM2.5 at levels near or below the current standards and development of atherosclerotic plaques;

• Many studies elucidating the biological mechanisms and pathways for cardiovascular effects;

• Studies linking prenatal exposure to air pollution with increased risk of low birth weight, preterm birth, infant mortality, and cancer;

• Research showing that coarse particles exacerbate respiratory disease;

• Three meta-analyses linking ozone air pollution with premature mortality and a multi-city study showing that effects are not due to temperature;

• Intervention studies showing that reductions in air pollution yield measurable improvement in children’s respiratory health and reduction in premature deaths; and

• Policy analyses showing the need for strong annual and daily fine particle standards to protect susceptible populations and provide equivalent levels of protection to different regions of the country.

Links to the full articles or abstracts are provided. A copy of the bibliography is attached.


Attached files

2005 Research Highlights: Air Pollution and Health

( 1-32-2005 2005 Health studies final.pdf 357.56 KB )

Highlights of 2005 Health Studies on PM and Ozone

ALA Testimony at Chicago Public Hearing

( ALA testimony Chicago Public Hearing PM NAAQS 3082006.doc 55.00 KB )

Testimony of Janice Nolen 3-8-06

Testimony of George Thurston

( EPA_GDT_testimony061.doc 106.00 KB )

4-6-05 testimony at Philadelphia public hearing





STATEMENT OF DR. GEORGE D. THURSTON, Sc. D.

TO THE

U.S. ENVIRONMENTAL PROTECTION AGENCY

PUBLIC HEARINGS REGARDING THE PROPOSED REVISIONS TO THE PM2.5 AMBIENT AIR QUALITY STANDARDS

Holiday Inn Historic District

400 Arch St.

Philadelphia, Pennsylvania

RE: THE NEED TO MORE STRINGENTLY CONTROL PM2.5 AIR POLLUTION THAN PROPOSED BY THE EPA ON JANUARY 17, 2006

MARCH 8, 2006


I am George D. Thurston, a tenured Associate Professor of Environmental Medicine at the New York University (NYU) School of Medicine. My scientific research involves investigations of the human health effects of air pollution.

The adverse health consequences of particulate matter are serious and well documented. This documentation includes impacts demonstrated by controlled chamber exposures and by observational epidemiology showing consistent associations between this pollutant and adverse impacts across a wide range of human health outcomes. Unfortunately, the implementation of the NAAQS standards proposed by the U.S. EPA on January 17, 2006 will fail to provide sufficient public health protection to the American people, as is called for by the Clean Air Act, and as indicated is necessary by the latest air pollution health effects science.

Particulate Matter (PM) air pollution is composed of two major components: primary particles, or "soot", emitted directly into the atmosphere by pollution sources such as industry, electric power plants, diesel buses, and automobiles, and; "secondary particles" formed in the atmosphere from sulfur dioxide (SO2) and nitrogen oxide (NOx) gases, emitted by many combustion sources, including coal-burning electric power plants.

Observational epidemiology studies have shown compelling and consistent evidence of adverse effects by PM. These studies statistically evaluate changes in the incidence of adverse health effects in a single population as it undergoes varying real-life exposures to pollution over time, or across multiple populations experiencing different exposures from one place to another. They are of two types: 1) population-based studies, in which aggregated counts of effects (e.g., hospital admissions counts) from an entire city might be considered in the analysis; and, 2) cohort studies, in which selected individuals, such as a group of asthmatics, are considered. Both of these types of epidemiologic studies have confirmed the associations of ozone and PM air pollution exposures with increased adverse health impacts, including:

- decreased lung function (a measure of our ability to breathe freely);

- more frequent respiratory symptoms;

- increased numbers of asthma attacks;

- more frequent emergency department visits;

- additional hospital admissions, and;

- increased numbers of daily deaths.

Among those people known to be most affected by the adverse health implications of air pollution are: infants, children, those with pre-existing respiratory diseases (such as asthma and emphysema), older adults, and healthy individuals exercising or working outdoors.

The state of the science on particulate matter and health has undergone thorough review, as reflected in the in the recently released U.S. EPA Criteria Document for Particulate Matter—of which I am a contributing author. Since the fine particle (PM2.5) standard was set in 1997, the hundreds of new published studies, taken together, robustly confirm the relationship between PM2.5 pollution and severe adverse human health effects. In addition, the new research has eliminated many of the concerns that were raised in the past regarding the causality of the PM-health effects relationship, and has provided plausible biological mechanisms for the serious impacts associated with PM exposure.

In my own research, I have found that both ozone and particulate matter air pollution are associated with increased numbers of respiratory hospital admissions in New York City, Buffalo, NY, and Toronto, Ontario, even a Furthermore, I was Principal Investigator of an NIH funded research grant that showed, in an article published in the Journal of the American Medical Association (JAMA), that long-term exposure to particulate matter air pollution is associated with an increased risk of death from cardio-pulmonary disease and lung cancer, as displayed in Figure 1 (Pope et al, 2002). In fact, the increased risk of lung cancer from air pollution in polluted U.S. cities was found in this study to be comparable to the lung cancer risk to a non-smoker from living with a smoker. Thus, the health benefits to the U.S. public of reducing long-term exposures to particulate matter can be substantial. But the January, 2006 EPA proposal ignores this new science, and the ignores the sound scientific advice of its own CASAC panel of scientists. The EPA NAAQS proposal therefore also fails to sufficiently protect the U.S. public from this serious health risk.t levels below the current standards. These results have been confirmed by other researchers considering locales elsewhere in the nation and the world, as documented in the most recent PM Criteria document, which was prepared by the EPA staff and reviewed by the EPA’s independent Clean Air Scientific Advisory Committee.

Figure 1. Lower PM2.5 Levels Are Associated with Lower Mortality

Source: Pope, Burnett, Thun, Calle, Krewski, Ito , and Thurston. (Journal of the American Medical Association, JAMA, 2002)

Especially a problem is the fact that the EPA Administrator has ignored the new information regarding the increased risk of lung cancer and cardio-pulmonary mortality now known to be associated with long-term exposure to PM2.5. For example, new scientific documentation from both epidemiological studies, such as the JAMA paper I co-authored (Pope et al., 2002), and toxicological studies, such as the recent JAMA article showing increased accumulation of plaque in the hearts of mice as a result of long-term PM exposure (Sun et al., 2006), are effectively ignored by the Administrator

The Administrator has instead chosen to raise and over-emphasize certain scientific issues in order to support his inaction on the issue of protecting the public from the dangers of long-term PM air pollution exposure. For example, the preamble to this decision (Federal Register, January 17, 2006, Vol. 71, No. 10, pp. 2652) raises education and sulfur dioxide (SO2) as issues. These comments in the preamble do not represent a full and balanced consideration of all the facts. Indeed, when the HEI Reanalysis of the ACS data reported these associations, they also noted that “The Reanalysis Team concludes that this modifying effect is not necessarily attributable to education per se, but could indicate that education is a marker for a more complex set of socioeconomic variables that impact upon the level of risk.” The Pope et al. (2002) study does correct for these issues through the inclusion of education indices. Similarly, the HEI report also notes that the SO2 association with mortality was unlikely to be causal, but was more likely a marker of another component of the air pollution, stating: “ The absence of a plausible toxicological mechanism by which sulfur dioxide could lead to increased mortality further suggests that it might be acting as a marker for other mortality-associated pollutants.” Based upon my own recent analysis, it is apparent that SO2 is acting as a marker for coal combustion fine particle pollution in this PM2.5 dataset. However, the HEI Reanalysis report’s clarifying statements are ignored by the Administrator. In no way do these factors, fully considered, take away from the scientific evidence, both from the ACS and other studies, that long-term exposure to PM2.5 is causing needless deaths every year. They also do not justify the Administrator’s ignoring of the ACS JAMA manuscript and the other recent studies providing confirmation of PM’s long-term adverse health effects, and additionally indicating mortality impacts even larger than that reported by the ACS study (e.g., from the Veterans Cohort by Lipfert et al, 2003; and from the 6-Cites Study cohort follow-up by Laden et al., 2006).

Instead of a balanced and full view of this issue, the Administrator apparently decided to selectively choose the “scientific intelligence” that fit the decision he wanted to make, as has ignored the overwhelming evidence that ran opposite to the proposed decision to do nothing to further protect the American people from the health dangers of long-term exposure to PM pollution. EPA’s own analyses (U.S.EPA Staff Paper, 2005) indicate that the Administrator’s inaction on this standard will result in thousands of avoidable deaths each year. I hope that the Administrator will reconsider this decision, listen to the advice of the health experts on CASAC, and instead act to lower the annual PM2.5 standard, thereby avoiding thousands of needless deaths in the U.S. each year. I recommend an annual standard of 12 ug/m3.

As to the short-term (24-hour average) standard proposed by the Administrator, the level chosen is insufficiently stringent to adequately protect the public health. It is so lax that it provides little public health benefits when compared with the present standard. Indeed, the study of older adults in more than 200 counties across the nation that was released today in the prestigious journal, the Journal of the American Medical Association (JAMA), further documents that short-term excursions of fine particle air pollution are associated with a significant increase in the daily risk of hospital admissions from cardiac and respiratory causes. (I have attached a copy of that new paper to my testimony for your examination.) Even eliminating all days above 35 ug/m3 from consideration from the study (as per the U.S. EPA’s proposed standard) failed to change the conclusions of this study, with significant associations still being found between PM2.5 exposure and excess cardiac and respiratory admissions at levels of PM2.5 below 35 ug/m3 (Personal Communication, Francesca Dominici, March 8, 2006). In my view, the available science supports a short-term PM2.5 standard of 25 ug/m3, in order to most appropriately protect the health of the U.S. public.

Thank you for the opportunity to testify on this important issue.


References

Dominici F, Peng RD, Bell M, Pham L, McDermott D, Zeger J, Samet J. (2006). Fine Particulate Air Pollution and Hospital Admission for Cardiovascular and Respiratory Diseases. J. Am. Med. Assoc. (JAMA). March 8, 2006 Vol. 295, No. 10, pp 1127-1134.

Krewski, D. et al. Reanalysis of the Harvard Six Cities Study and the American Cancer Society Study of Particulate Air Pollution and Mortality: Investigators' Report Part I: Replication and Validation. 2000. Health Effects Institute, Cambridge, MA.

Lipfert FW, Perry HM Jr, Miller JP, Baty JD, Wyzga RE, Carmody SE. (2003). Air pollution, blood pressure, and their long-term associations with mortality. Inhal Toxicol. 2003 Apr 25;15(5):493-512.

Laden F, Schwartz J, Speizer FE, Dockery DW. Reduction in Fine Particulate Air Pollution and Mortality: Extended follow-up of the Harvard Six Cities Study.

Am J Respir Crit Care Med. 2006 Jan 19.

Pope, C.A. III, Burnett, R.T., Thun, M.J., Calle, E.E., Krewski, D., Ito, K., and Thurston, G.D. Lung cancer, cardiopulmonary mortality and long-term exposure to fine particulate air pollution. J. Am. Med. Assoc. (JAMA) 287(9):1132-1141 (2002).

Sun Q, Wang A, Jin X, Natanzon A, Duquaine D, Brook RD, Aguinaldo JG, Fayad ZA, Fuster V, Lippmann M, Chen LC, Rajagopalan S. (2006). Long-term air pollution exposure and acceleration of atherosclerosis and vascular inflammation in an animal model. JAMA. 2005 Dec 21;294(23):3003-10.

U.S. EPA (2004). Air Quality Criteria for Particulate Matter (October, 2004). EPA/600/P-99/002aF. National Center for Environmental Assessment, Office of Research and Development. Washington, DC.

U.S. EPA, (2005). Review of the National Ambient Air Quality Standards for Particulate Matter: Policy Assessment of Scientific and Technical Information OAQPS Staff Paper. EPA-452/R-05-005. Office of Research and Development, Washington, DC.

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