February 17,1998
David Frankel
Editor
The Lancet
N.Y., N.Y.,10011
Fax: 212-633-3850Dear Mr. Frankel,
Attached is our letter to the editor in response to the Davis et al article, Vol, 350, Number 9088,, Nov. 1997, which I discussed with you. Although this submission is offered beyond the eight week window since publication, we believe that the article is so politicized that our response is of importance to the Lancet and to your readership. We request a prompt publication of our response.
We declare that we have no conflicts of interest in this matter. We have all participated fully in the research behind our comments and the preparation of this submission.
Sincerely,
/s/
Kay Jones Ph.D.
Michael Gough, Ph.D.
Joel BucherP.S. Please fax receipt confirmation to (206) 720-4992
Letter to the Editor
The Lancet
245 West 17th St.
N.Y., N.Y. 10011
We are writing to you in reference to the article, "Short-term Improvements in Public Health from Global-Climate Policies on Fossil-fuel Combustion: an Interim Report," by Davis et al, 19971. In addition to numerous technical deficiencies there are two glaring issues which undermine the credibility and scientific approach used in the article. There is also no clarifying information as to what organization assembled the 'Working Group on Public Health and Fossil Fuel Combustion" or when further reports will be forthcoming. In addition to our critique of the article itself, it appears that the article fails to meet your publication guidelines and goals.
Davis et al. conclude that eight million people will die prematurely between the years 2000 and 2020 unless air pollution is curbed. Their analyses rely upon two papers that report relationships between particulate air pollution and (1) premature mortality from respiratory diseases (the "Pope study"(2)) and (2) sudden infant death syndrome (SIDS) or cot death (the "Woodruff study"(3)). Davis et al. ignore serious problems that we have identified in the underlying studies. A widely circulated paper Uones et al., May 1994 (4)) seriously questioned the use of the Pope study in setting the new U.S. PM 2.5 ambient standard. This report was presented at a Capitol Hill press conference which was covered on the AP wire services(5) and is a part of the Congressional record(6).
The Health Effects Institute (HEI) sponsored a workshop(7) to begin review of the methodology and conclusions from the Pope study (and the other major study that identifies a link between air particulate pollution and premature mortality, the "Harvard Six City Study"(8)). Our paper, presented at that conference, showed that Pope's findings were suspect because available data for several cities were excluded from the analysis. We performed our own analysis with some additional and some common cities and found no statistical association between PM 2.5 and mortality. We also showed that EPA's mortality estimates were inflated because EPA did not note that Pope mistakenly used 'median" rather than "mean" particulate data. EPA acknowledged our finding and reduced its annual mortality estimate by 25@o, from 20,000 annual deaths to 15,000. Moreover, EPA's estimate of 15,000 deaths includes 14,000 that are estimated to occur among people exposed to less than what EPA set as the standard which the EPA presumed to have as a 3 reasonable margin of safety, i.e., a median of 15 ug/m3 or a mean of 18 ug/m . When we assume that there is no discernable premature mortality below the assumed threshold level, the number of premature deaths dropped to less than 1,000 annually. This number will be zero if the HEI review confirms our findings about the Pope study i.e., no statistical association between PM 2.5 and mortality. Several authors and reviewers of the Davis et al. article are employees of EPA, and they were fully aware of our and other's criticisms of the Pope study.
The most severe criticism of the reliance of Davis et al. on the Pope study comes from Pope himself. Interviewed by a reporter from Science News after the publication of Davis et al., Pope said that he "hopes that people will not place too much weight on the [Davis et al.] estimates of lives that can be saved by climate policies. Those numbers are still preliminary and rest on substantial uncertainties."(9)
The Woodruff study is a product of EPA and the U.S. Centers for Disease Control. Even so, based on our inquiries to EPA(10, the study protocol was neither developed nor approved by EPA or the CDC, and the study results were not formally reviewed or endorsed by EPA's Office of Health Effects Research. It is impossible for us or anyone else to replicate the Woodruff study analysis because the specific bimonthly air pollution data upon which the analysis was based are unavailable from EPA. We have been unable to find out why the air pollution data used in that study are missing.
Let's turn to the study design itself. The authors have chosen the zero exposure as the effects threshold for their health impact model. Simply stated, the authors contend that burning one lump of coal produces pa rticulate matter which kills N people, burn two lumps of coal and greater than 2N people are killed. The referenced Regulatory Impact Analysis (RIA) (11) and even the article's EPA advisors do not ascribe to the concept of a zero threshold.
It is abundantly clear that the authors failed to acknowledge these major barriers to a"iving at their conclusion that "In the U.S., by the year 2020, at least 33,000 deaths a year could be avoided from implementation of the climactic - policy scenario." Given the fact that PM 2.5 levels are declining and will continue to decline to levels below 18ug/M3 in all U.S. urban areas, the projection would be zero deaths with or without the Pope et al results.
The conclusion, "Regardless of how or when greenhouse gases alter climate, reducing them now will save. lives by lessening particulate air pollution" is scientifically baseless.
It is readily apparent that both the Woodruff et al and Davis et al. studies were publicized at opportune fimes in public policy debates. The Woodruff study results were announced before publication and just prior to the President's announcement that he endorsed EPA's 1997 tightening of air pollution regulations. Lancet published the Davis et al. paper on the eve of the December 1997 Kyoto Summit on Global Warming. We are not convinced that these papers, which have immediate policy implications, were subjected to the wide and rigorous scrutiny they warranted before publication, especially in Lancet.
Kay H. Jones, Ph.D.
Michael Gough, Ph.D.
Joel BucherREFERENCES,
1. Davis DL, Short-term Improvements in Public Health from Global-climate Policies on Fossil-fuel Combustion: an Interim Report; Lancet, Vol 350, No 9088, Nov. 1997.
2. Pope CA et al, Particulate Air Pollution as a Predictor of Mortality in a Prospective Study of US Adults, Am J Resp Crit Care Medicine, 1996 151: 669-74.
3. Woodruff Tj et al, The Relationship Between Selected Causes of Post Neonatal Infant Mortality and Particulate Air Pollution in the United States, Environ HeathPerspect, 1997,105:608-12.
4. Jones KH et al, Is EPA Misleading the Public About the Health Risks from PM2.5, Citizens for a Sound Economy Foundation, Wash DC, May 1997.
5. Associated Press, May 13, C)pponents Question Science Used for EPA's Air Quality Rules.
6. House Commerce Committee Joint Hearing of the Health and Environment Subcommittee, May 15,1997.
7. Health Effects Institute Workshop on the reanalysis of the Six Cities and American Cancer Society Studies of premature mortality., Boston MA, June 19, 1997.
8. Dockery DW et al, An Association Between Air Pollution and Mortality in Six US Cities, N Engl J. Med., 329:1753-1759,11993.
9. Science News, Nov. 8, 1997.
10. Freedom of Information Act request responses from EPA, Sept. 1997.
11. The Environmental Protection Agency, Regulatory Impact Analyses for the Particulate Matter and Ozone National Ambient Air Quality Standards and Proposed Regional Haze Rule, Research Triangle Park, USEPA, Office of Air Quality Planning and Standards, 1997.
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