was a dire need <strong>for</strong> studies assessing coarse particle effects directly. Now that findings fromseveral are available, at <strong>the</strong> very least <strong>the</strong>y show little consistency in supporting a dominant role<strong>for</strong> fine PM.The CD attempts to undermine <strong>the</strong> validity <strong>of</strong> <strong>the</strong> observations in <strong>the</strong> studies in whichcoarse PM effects were detected, although <strong>the</strong> syn<strong>the</strong>sis (p.6-229 (line 22)-230 & 235) providesa more balanced assessment. For example, <strong>the</strong> statement that “several [studies] do showstatistical[ly] distinctly larger and significant mortality associations with PM 2.5 than <strong>for</strong> nonsignificantPM 10-2.5 effects” (p.6-54, line5-6) ignores <strong>the</strong> fact that several do not. And, while itmay be true that no study has <strong>the</strong> power to adequately compare effect estimates sizes between<strong>the</strong> fine and coarse range, this has previously not prevented comparisons <strong>of</strong> effect sizes <strong>of</strong> manyparticle metrics that are highly correlated. In response to <strong>the</strong> Lippmann findings in Detroit it isargued that <strong>the</strong> coarse fraction findings are present because <strong>the</strong> coarse fraction is correlated with<strong>the</strong> fine fraction [6-55, line 10-11; 6-127, line 13-16]. In response to <strong>the</strong> findings in Phoenix it isargued that <strong>the</strong> apparent coarse effects may be due to biogenic particles in that fraction (6-55,line 27 & 6-77, line 22-26). This argument is speculative and should be framed as such. I als<strong>of</strong>ind it unlikely. None <strong>of</strong> <strong>the</strong> above arguments supporting a more toxic role <strong>for</strong> fine PM iscompelling. Given <strong>the</strong> new data on coarse PM which were not available at <strong>the</strong> time <strong>of</strong> <strong>the</strong> lastCD, it is difficult to argue strongly that fine PM effects are dominant, regardless <strong>of</strong> setting.It is also my opinion that <strong>the</strong> conclusions regarding crustal effects (p.6-78, line 2-4 and 6-267, line 10-11) are too strong. Although <strong>the</strong> studies making use <strong>of</strong> factor analyses to attempt toattribute effects to various sources generally do not find much to support adverse effects <strong>of</strong>crustal sources (Laden 2000, <strong>for</strong> example), and some studies incorporating wind patterns inattempting to identify periods <strong>of</strong> large crustal contribution to PM (Spokane and Salt Lake Citystudies) argue against a crustal PM effect, it is difficult to ignore <strong>the</strong> findings from studies wherePM is almost entirely crustal in nature (Anchorage, Phoenix (<strong>for</strong> coarse mode PM), CoachellaValley, etc.).If <strong>the</strong> authors <strong>of</strong> <strong>the</strong> CD disagree with <strong>the</strong>se assessments <strong>of</strong> coarse fraction effects andeffects <strong>of</strong> crustal particles, at <strong>the</strong> least a better attempt at making <strong>the</strong> case should be made,preferably in <strong>the</strong> summarizing sections.A small point: it is not appropriate to compare PM 2.5 and PM 10 on a mcg per mcg basis(6-231, line 19-22).2. Balance in review <strong>of</strong> relevant studiesThere is still an un<strong>for</strong>tunate, and unnecessary, tendency in <strong>the</strong> body <strong>of</strong> this chapter to usea different (more stringent) yardstick in evaluating studies that report findings at odds with <strong>the</strong>favored hypo<strong>the</strong>ses (PM effects are more consistent than gaseous effects; fine PM effects arestronger than coarse fraction effects). Some examples follow:6-45 Most <strong>of</strong> <strong>the</strong> cities included in NMMAPS II only had every 6-day PM measurements, yetthis is never brought up as a criticism, whereas this is identified as a weakness in <strong>the</strong>Moolgavkar study (2000) that stressed <strong>the</strong> importance <strong>of</strong> gaseous pollutant effects overPM effects.6-101 Criticisms <strong>of</strong> <strong>the</strong> EPRI study are based on <strong>the</strong> argument that factors that are in <strong>the</strong> “causalchain” cannot confound an association, and that <strong>the</strong> population sample isunrepresentative. However, equally severe criticisms regarding lack <strong>of</strong>representativeness could have been leveled at <strong>the</strong> ACS study, but were not. Thediscussion regarding high blood pressure as a potential step in <strong>the</strong> development <strong>of</strong> PMinducedmortality is very much speculative and has no place in <strong>the</strong> description <strong>of</strong> thisstudy. Why is it noted that <strong>the</strong> study has “no matched control or placebo” (6-100, line14) when <strong>the</strong>se are not relevant given <strong>the</strong> study design, and are not considerations <strong>for</strong> <strong>the</strong>o<strong>the</strong>r cohort studies?6-127 The paradoxical findings from <strong>the</strong> first 5 years <strong>of</strong> <strong>the</strong> Atlanta hospitalization study aredownplayed since <strong>the</strong> AIRS database is used <strong>for</strong> PM, whereas <strong>the</strong> more expected findings<strong>for</strong> one year using Supersite data are emphasized. Recall that NMMAPS made use <strong>of</strong> <strong>the</strong>AIRS database.6-129 In reviewing <strong>the</strong> Burnett hospitalization studies in which effects <strong>of</strong> gaseous pollutants areA - 11
dominant, one criticism is that “best lags” were reported, yet this use <strong>of</strong> best lags isjustified later (6-238). Almost all studies explore “data driven” lag structures.6-131 It is bizarre that <strong>the</strong> mortality data are brought up in this section dealing withhospitalizations to “shore up” <strong>the</strong> argument <strong>for</strong> PM & cardiovascular effects.6-134 Why does this summary only include <strong>the</strong> US studies, which incidentally are all “positive”studies, when important international studies, many <strong>of</strong> which are “negative” studies, arenot included?To summarize, ra<strong>the</strong>r than attempting to shore up favored hypo<strong>the</strong>ses, and through doing so,revealing a bias, it would be preferable to do less editorializing during presentation <strong>of</strong> studies,and stand back <strong>for</strong> a more objective look at <strong>the</strong> studies as a whole. This is what we expect froma CD.3. ConfoundingConfounding remains an issue <strong>of</strong> concern. In <strong>the</strong> time-series studies, concerns regardingmeteorology, in <strong>the</strong> absence <strong>of</strong> more innovative approaches to specifying <strong>the</strong> <strong>for</strong>m <strong>of</strong>meteorology in <strong>the</strong> time series regression models, can probably be put to rest given <strong>the</strong> manyattempts to incorporate alternative specifications without significant impacts on <strong>the</strong> PMestimates <strong>of</strong> effect. The CD is probably correct in this regard.Confounding by co-pollutants, a perennial concern, has also been addressed in <strong>the</strong> CD.Several points should be noted. First, it is correctly noted that effects based on attempts tocontrol <strong>for</strong> confounding in two-pollutant or multi-pollutant models are <strong>of</strong>ten difficult to interpretbecause <strong>of</strong> <strong>the</strong> typically strong between-pollutant correlations that are present in <strong>the</strong> time-seriesstudies. However, this does not imply that effects from single-pollutant models <strong>of</strong> PM areunconfounded estimates. The findings regarding PM effects, as well as estimates <strong>of</strong> PM effect in<strong>the</strong> CD, are largely reported only from single-pollutant models (as one example, p.6-142, line17). Second, results from various alternatives to <strong>the</strong> use <strong>of</strong> multi-pollutant models inestimating PM effects unconfounded by co-pollutants are presented. These approaches aremotivated by frustration at interpreting PM effects from multi-pollutant models. In NMMAPS IIgaseous pollutant effects were controlled in a second stage (multiple city) analysis after <strong>the</strong>individual-city single-pollutant PM effects were estimated. This is probably justified in thissetting given <strong>the</strong> relatively large number <strong>of</strong> cities included, although it seems difficult to imaginethat adequate control <strong>for</strong> co-pollutants could be adequately accomplished without attending to<strong>the</strong> seasonal variation in co-pollutant concentrations, variation that itself differs from region toregion across <strong>the</strong> country. A different approach to addressing potential confounding by gaseouspollutants is exemplified by <strong>the</strong> multi-city hospitalization studies, including NMMAPS II(Schwartz 2000, Zanobetti 2000). Firstly, <strong>the</strong> description <strong>of</strong> <strong>the</strong>se methods is difficult to followin <strong>the</strong> CD narrative (6.223-225). Descriptions <strong>of</strong> <strong>the</strong>se alternative approaches to accounting <strong>for</strong>co-pollutant effects are difficult to follow. I still cannot figure out <strong>the</strong> rationale behind some <strong>of</strong><strong>the</strong>se approaches from reading this section, which may mean that o<strong>the</strong>rs cannot ei<strong>the</strong>r. Clearerrationale <strong>for</strong> <strong>the</strong> specific approaches taken is needed. Paren<strong>the</strong>tically, I wonder whe<strong>the</strong>r <strong>the</strong>correct correlation (r) between PM and <strong>the</strong> co-pollutants should be <strong>the</strong> correlation after adjusting<strong>for</strong> long-term trends and meteorology (that is, correlations between <strong>the</strong> effect estimates ra<strong>the</strong>rthan raw correlations). Secondly, we have much less confidence in <strong>the</strong> success <strong>of</strong> this approachgiven <strong>the</strong> much smaller number <strong>of</strong> cities ( and <strong>of</strong>ten smaller size <strong>of</strong> cities [e.g., Boulder,Youngstown) used <strong>for</strong> <strong>the</strong>se analyses. The CD seems to uncritically accept this approach tocontrolling confounding by <strong>the</strong> gaseous pollutants (6-126, line 4, <strong>for</strong> example).There has been discussion <strong>of</strong> <strong>the</strong> potential <strong>for</strong> <strong>the</strong> gaseous pollutants to confound <strong>the</strong>association between PM and health effects from <strong>the</strong> perspective <strong>of</strong> <strong>the</strong> definition <strong>of</strong> confounding.It is argued that some <strong>of</strong> <strong>the</strong> co-pollutants cannot be viewed as confounders since, based onbiomedical knowledge, <strong>the</strong>y should not affect <strong>the</strong> outcomes <strong>of</strong> interest. Nei<strong>the</strong>r SO 2 , sulfate norCO can reasonably be argued to cause many <strong>of</strong> <strong>the</strong> effects with which <strong>the</strong>y are <strong>of</strong>ten associated.It would be true that <strong>the</strong>se pollutants could not confound if in fact <strong>the</strong> ambient co-pollutantconcentrations were truly measuring exposure to <strong>the</strong>se specific pollutants. Realistically,however, <strong>the</strong>y do not. The co-pollutants are likely measuring various aspects <strong>of</strong> <strong>the</strong> pollutionmeteorologymix and acting as surrogate measures <strong>of</strong> important exposures that we do not nowA - 12
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