EPA's ETS Risk Assessment

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The 1990 threat posed by the Environmental Protection Agency's (EPA's) assessment of the risk posed by second-hand smoke (ETS) to non-smokers, was a landmark event in the battle over cigarettes and public health. The EPA planned to list second-hand smoke as a Group A (known) carcinogen -- and they followed the process of putting out a DRAFT determination and inviting comment from biomedical scientists and statisticians. The battle went on for three years during the Bush 1 Administration, and the DRAFT was only released as a full-determination after Bill Clinton became President in early 1993 as the report "Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders," (EPA/600/6-90/006F).

In the 1970's and 1980's the cigarette companies were winning the battle over active smoking and health by:

  • making some real and some pretend modifications to their cigarettes, to marginally reduce the biological threat.
  • engaged in an unprecedented level of political corruption, media manipulation, and mis-characterisation and distortion of science and research findings
  • strongly maintaining that smoking was a human rights issue, since people chose to smoke.
THE TOBACCO INDUSTRY'S COUNTERS
The tobacco industry mounted a major counter-attack on the EPA itself; the techniques used in the Risk Assessment; and the scientific research which lay behind the determination. Specifically, they attacked:
  • 90% confidence intervals (actually, in sum, these were 99.9%).
  • meta-analysis (the combination of multiple studies)
  • later studies they claimed were ignored.
  • smoke exposure measurements.
See the EPA's explanations.

This argument collapsed when the attention turned to the rights of non-smoker to breathe smoke-free air in their homes, work environments and public venues -- passive smoking. The industry's major threat then became a matter of workshop/office safety, and general public-health regulations on where people could smoke, which could easily cut sales in half.

The EPA justified their interest (made later):

The EPA report classified secondhand smoke as a Group A carcinogen, a designation which means that there is sufficient evidence that the substance causes cancer in humans. The Group A designation has been used by EPA for only 15 other pollutants, including asbestos, radon, and benzene. Only secondhand smoke has actually been shown in studies to cause cancer at typical environmental levels. EPA estimates that approximately 3,000 American nonsmokers die each year from lung cancer caused by secondhand smoke. Every year, an estimated 150,000 to 300,000 children under 18 months of age get pneumonia or bronchitis from breathing secondhand tobacco smoke. Secondhand smoke is a risk factor for the development of asthma in children and worsens the condition of up to one million asthmatic children.[2]

The Occupational Safety & Health Administration (OSHA) was the obvious regulator, but it was captured largely by big corporations and big unions who were not inclined to take action. The Food & Drug Administration (FDA) already had enough battles on their hands with pesticides, herbicides, and dioxins. Health and Human Services (HHS) dealt with emergency-type problems, rather than chronic.

In the washout it was left to the Environmental Protection Agency (EPA) to do a thorough study of workplace and general household air quality, and so create an ETS Risk Assessment with some supporting figures (which must of necessity be estimates) as to how many US citizens were being killed or injured each year by second-hand smoke.

The tobacco industry had inside information from most of these regulatory agencies, and so they became well aware in 1988 that the EPA was planning to release a DRAFT document for public comment.

Industry Counteractions - The Main Philip Morris Players

The tobacco industry was an old hand at fighting these political battles, and it had had many years of preparation before the EPA began this project. They had already spent a fortune in the secret recruitment of hundreds of compliant research scientists and academics to support their case. Specifically for the EPA, they had a few main techniques in their arsenal ready to deflect the attack:

  1. Countering the research findings of the dangers of second-hand smoke, with other research which found nothing. The main study they came to depend on was the Varela Study (see outline below)
  2. Claiming that no single study showed adverse health effects from passive smoking -- and that studies showing no effect were suppressed by the universities or ignored by the media.
  3. Maintain that all the scientists who had found health problems with second-hand smoke were biased against smoking, and had distorted their findings unfairly. The paid George L Carlo a substantial amount of money to create a loaded questionnaire which was circulated as a study and formed the basis of Carlo's claim that the other scientists were biased.
  4. That the EPA's combination of dozens of small studies into one overall result (using a statistical technique called 'Meta-analysis') was invalid and should be ignored.

Varela Study

A 1987 doctoral thesis by Luis R Varela' at Yale, 'Assessment of the association between passive smoking and lung cancer' had been discovered by the tobacco industry. Varela had died in February 1990 and this large study (begun by Varela's teacher, Janerich, in 1980) had never been finalised or peer-reviewed. The numbers Varela himself investigated were relatively low statistically (439 case-controlled families only -- with only 191 cases of primary lung-cancer). However he had not demonstrated any strong linkage between passive smoking and lung cancer among either the wives of smokers or their co-workers. However his dissertation on this subsection of the larger study earned him his PhD just before his death.

Philip Morris's 'Science Issues' manager Thomas Borelli, realised the value of Varela's paper as a counter to Japanese scientist Hirayama who had investigated non-smoking wives of smokers, and found that they had much higher rates of lung-cancer than normal. Borelli decided to maintain the line that the Varela study had been deliberately suppressed by health activists and the medical establishment.

Janerich's refutation

Varela's academic supervisor at Yale, Dr Dwight T Janerich had begun the overall study before Varela came to Yale. He re-examined Varela's thesis and published a rebuttal of tobacco industry claims, releasing an extension of study with another 191 patients who had been diagnosed with lung cancer from 1982 through 1984. This confirmed the EPA figures for passive-smoking illnesses among non-smokers-- and particularly, the problems with children.

The estimate from the study suggests that 1,700 cases of lung cancer each year result from childhood exposure to secondhand smoke, according to figures from the EPA. The agency said that of the 150,000 new cases of lung cancer diagnosed each year, about 25,000 involve people who are not currently smokers and about 10,000 who never smoked. (New York Times)

See published final study [3]

Documents & Timeline

1989 Sept 13 The Newman Partnership Ltd had been selected by Philip Morris as its science public relations counsel for the ETS projects. This document is a semi-contract. They have a charging limit of $3 million dollars for 16 months. The anticipated average professional fee will be $117,000 per month (with three months up front). This was signed by Lloyd N Newman, and sent to Nelson Beane at PM. The charge-rate sheet lists NPL as now having staffers:

[4]


1989 OctThe minutes of Philip Morris's ETS (second-hand smoke) worldwide executive meeting notes that "the Newman partnership has been idenfied as a PR firm that will support PM ETS initiatives (Borelli/Osdene) This has been sent to executive Nelson Beane."

Science Issues Manager, Tom Borelli and VP Research & Development, Thomas S Osdene are the two senior PM executives concerned with science corruption activities. [5]


1989 Nov Philip Morris mounted the McGill University ETS Symposium with about 200 participants at this time. This introduced a number of new corporate science corrupters into the attack on the EPA (See for further details).

Subsequently they also set up the ETS Group of mercenary scientists who were willing to attack the EPA's risk assessment for a fee.


1989 Dec 6 Tom Borelli and his assistant Amy Millman are still working on ways to counter the Environmental Protection Agency (EPA's) DRAFT determination that second-hand smoke is injurious to health. They circulate a memo within Philip Morris: the release of the EPA's DRAFT Risk Assessment has been delayed and they have time for a new day-by-day strategy.

  • Dec 11 - Lobbyists Mannett Phelps will have an EPA action plan ready.
  • Dec 15 - The McGill University ETS Symposium proceedings will be available for review.(The McGill Conference report must be distributed to scientists and policy makers.)
    [ Paul Dietrich who ran the Institute for International Health & Development (IIHD) for the tobacco industry has the job of publishing and distributing the proceedings.]
  • Jan 10 - is their first opportunity to leak the EPA document to the press.
    [They already have a confidential copy, but they need to have some cover for the leak. Lisa Barrera has an inside contact at the EPA.]
  • Feb 15 - The EPA's Scientific Advisory Board (SAB) will begin its review of the EPA's Risk Assessment.
    [The SAB was reasonably independent -- although the industry managed to get a couple of their tame scientists on it.]
  • Feb 19 - 21 The Toxicology Forum (can be used). Another strategy we should pursue is to try and get a sympathetic scientist appointed to the health effects panel. New scientists are chosen each time an SAB panel is convened.
    [The Toxicology Forum was run by Coca-Cola executive Alex Malspina who also ran the ILSI. They believe that he is subject to PM/Kraft 'influence' if it comes in cash in a brown paper bag. This forum gives them an opportunity to release scientific denial documents which Amy has prepared.]
    "We can use the McGill findings, and the information we have received that the group preparing the risk assessment was unable to establish a synergistic relationship between radon and ETS, nor were they able to prove a significant dose response. The Tobacco Institute will undoubtedly respond to media inquiries, but we should consider using the Newman Partnership creatively.
    We need evidence that the scientists conducting research into, or reviewing the science of ETS, are less objective than they would be if they were dealing with another substance.
    [Note: radon research provided the tobacco industry with an alternative 'possible cause' of lung cancer. This scare about radon was generated by tobacco industry funding and the fear at this time about radio-active fallout.
    [The last paragraph was a clear reference to a number of "Bias studies" they had had done. See the main one by George L Carlo.] [6]

1990 March 19 Tom Borelli gets a memo from the Newman Partners Ltd. public relations company. They are promoting the Varela study as an example of scientific bias -- a study which was ignored because it didn't suit the EPA to recognise it.

RE: Varela news conference -- Purpose:

  1. Announce existence and results of largest study ever done on potential health risks of environmental tobacco smoke (ETS).
  2. Pre-empt or counteract EPA Risk Assessment (which does not include Varela study)
When:     10 am March 29 (One week before the tentative release date of the DRAFT EPA Risk Assessment)
Where     National Press Club, Washington DV (with sateilite hook-ups to New York, Chicaco, Los Angeles, Boston, Atlanta, San Francisco).
Audience  Individual invitations to selected journalists. [7]

1990 Mar 29 Comments on the Varela dissertation; The paper is being circulated through the Scientific Issues division of Philip Morris, and checked by its lawyers Shook Hardy & Bacon. They list a couple of ways the study can be challenged. [8] The communications strategy is already being organised: [9]


1990 Apr 4 NPL are working on developing a 'tracking system for ETS research'. This is in the very early days of on-line searching using Printer-terminals, and a pre-Internet communications protocol called X-25 which requires 300 bit/sec modems. There are a half-dozen database consolidators around the world that can be accessed on-line using these terminals, and the most popular one is DIALOG run by Lockheed and ORBIT run by SBC. [10]


1990 Apr 4 Note from Newman Partners Ltd to Tom Borreli on how to used the Varela Study.

RE: Variations on Varela
SITUATION: It is still desireable to bring the Varela Study to the attention of the scientific world and the general public because * Varela shows that the ETS-Lung Cancer issue is not resolved.

  • Varela offers comfort to smokers and PM employees who have been the target of the anti-ETS campaign.
  • Varela's advisor (Janerich) is about to publish "reworked data" alleging that ETS is linked to lung cancer. (They had plans to limit his criticism, since Yale had given Varela his PhD) Janerich had actually collected the basic data himself before handing it to Varela. See their counter-plan to defeat Janerich: [11]
  • The EPA Risk Assessment is about to say that the ETS-Lung Cancer issue is resolved and ETS is killing 3000+ people a year.

They want to bypass the normal media processes and give their version of the story to only Lawrence Altman of the New York Times. If they get a negative reaction they will dump the Varela Study story; it i is positive, they will run the Times story as an advertisement claiming that the story was being suppressed by the health zealots and the media. There is already a plan for the Tobacco Institute to utilize the Varela story. It should be linked to George L Carlo's 'bias study' which will 'prove' that the media is biased against tobacco good news (although it wasn't then finished)

[12]


1990 Apr 23 Amy Millman is distributing a Philip Morris memo on EPA Strategy re Risk Assessment.

  • The EPA was about to release its draft Risk Assessment "Lung Cancer and Other Respiratory Effects of ETS" which will include an estimated death toll from lung-cancer of 3-5000. The heart disease estimate is 10 times that of lung cancer. This is a multi-point plan to handle the release.
  • Philip Morris has submitted names of scientists as candidates for a Science Advisory Board (SAB) to review the EPA document (before the final document is released).
  • The final date for full release is 'late summer'
* The fake 'Varela Study' has not been included. (They will circulate it via Newman Partnership. [13]
* Tom Borelli, Jim W Dyer, and Amy Millman will produce a one page synopsis and objections for members of Congress. [14]

1990 June The imminent release of the DRAFT EPA's ETS Risk Assessment (release date June 25): "Health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children.". This lead to a strategy document by Philip Morris "Discussion of Activities Related to the ETS Issue" with a 90 day time-table.

They decided that the EPA's Scientific Advisory Board (SAB) is potentially a way to influence the EPA's final risk assessment,

At this time, there are several general activities which will need the attention of and action by the ETS team.

  • Monitor the ongoing work on ETS and related risks such as Janerich, Moskowitz, Garfinkel, Whitten, Garland etc.
  • Monitor publication date of Janerich (the correction to the Varela Study) material and try to find out his results in reworking the [Varela] data.
  • Identify others who will be submitting material to the [EPA's] SAB.
  • Identify the composition of the SAB Committee that will review he ETS Draft Risk Assessment [get profiles of SAB members - research background] (Prof Bill Davis)
  • Prepare letter to Dr Robert Flaak formally requestion time on the SAB agenda.
  • Identify individuals to submit the McGill study and the proceedings of the Toxicology Forum to the SAB. Have them entered into the record.
    [The McGill study documents was being handled by Alvan Feinstein, a tobacco-lackey, and Walter O Spitzer, from McGill Uni in Canada. Later by Paul Dietrich at the fake Institute for International Health & Development
    The Toxicology Forum was a subsidiary of the ILSI with considerable tobacco industry influence. It was run by Coca Cola PR executive Alex Malaspina ]
  • Obtain a copy of scientific questions to which the SAB will be responding (with the help of Gary Flamm and Gio Gori)
  • Promote radon as the primary risk.
  • Monitor proposal to ban smoking at EPA offices nationwide. (monitor release of survey of EPA employees)
  • Monitor Congress and research past debates for five years
  • Maintain an appropriate level of public debate on the ETS
- Determine ways to utilize the Hippocrates article/editorial on the education of a smoker basher?
- Monitor publication date of Janerich material and prepare appropriate response.
- Continue to use the press kit/media blitz vis a vis the science issues.
- Determine means to counter adverse studies referenced in EPA risk assessment and publicize their faults. [15]

1992 A study of Florida women by Heather Stockwell et al. found a 60% overall increased risk of lung cancer from exposure to their husband's smoke, with significant results for both the highest exposure group and the exposure-response trend.

1992 A study of Missouri women by Ross C Brownson et al. found no overall increased risk, but it did demonstrate a significant increase in risk in the highest spousal smoking exposure group and a positive exposure-response trend. Since this study was published after the EPA' cut-off date, the tobacco industry charged the EPA with deliberate bias in "excluding" studies not supporting their conclusions. In fact, four new lung cancer epidemiology studies, including the Brownson study, have been published since the literature review cutoff date for the 1993 EPA report and all support EPA's conclusions.


The battle over the EPA's assessment of risk continued until 1993


1994 A study by Elizabeth Fontham et al. of women in two California and three Southern cities is the largest case-control study on the subject ever conducted and is considered by EPA to be the best designed study on secondhand smoke and lung cancer conducted to date. This study found significantly increased risks for overall exposure and in the highest exposure group and a strong positive exposure-response relationship. These findings were significant not only for exposure from spouses, but also for exposure in the workplace and in social situations.

Conclusions

1993 Feb /E In early 1993, EPA released a report (Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders; EPA/600/6-90/006 F) that evaluated the respiratory health effects from breathing secondhand smoke (also called environmental tobacco smoke (ETS)). In that report, EPA concluded that secondhand smoke causes lung cancer in adult nonsmokers and impairs the respiratory health of children. These findings are very similar to ones made previously by the National Academy of Sciences and the U.S. Surgeon General.[16]

Classification of Secondhand Smoke as a Known Human (Group A) Carcinogen

The finding that secondhand smoke causes lung cancer in nonsmoking adults is based on the total weight of the available evidence and is not dependent on any single analysis. This evidence includes several important facts.

  1. First, it is indisputable that smoking tobacco causes lung cancer in humans, and there is no evidence that there is a threshold below which smoking will not cause cancer.
  2. Second, although secondhand smoke is a dilute mixture of mainstream" smoke exhaled by smokers and sidestream" smoke from the burning end of a cigarette or other tobacco product, it is chemically similar to the smoke inhaled by smokers, and contains a number of carcinogenic compounds.
  3. Third, there is considerable evidence that large numbers of people who do not smoke are exposed to, absorb, and metabolize significant amounts of secondhand smoke.
  4. Fourth, there is supporting evidence from laboratory studies of the ability of secondhand smoke both to cause cancer in animals and to damage DNA, which is recognized by scientists as being an instrumental mechanism in cancer development.
  5. Finally, EPA conducted multiple analyses on the then-available 30 epidemiology studies from eight different countries which examined the association between secondhand smoke and lung cancer in women who never smoked themselves but were exposed to their husband's smoke.

The most important aspect of the epidemiology studies is the remarkable consistency of results across the many studies. This supports a causal association between secondhand smoke and lung cancer. When looking only at whether the husband ever smoked, 24 of 30 studies reported an increase in risk of lung cancer for nonsmoking women with smoking husbands. The EPA did not take into consideration the other great adult disease associated with smoking -- cardiovascular disease. This may be equally as dangerous and even more disabling over a lifetime.

The EPA never claimed that minor exposure to secondhand smoke posed a major individual cancer risk. The lung cancer risk from secondhand smoke is relatively small compared to the risk from direct smoking. However unlike a smoker who chooses to smoke, the nonsmoker's risk is often involuntary. In addition, exposure to secondhand smoke varies tremendously among exposed individuals. The EPA estimated that secondhand smoke was responsible for about 3,000 lung cancer deaths each year among nonsmokers in the U.S.; of these, they estimated 800 from exposure at home and 2,200 from exposure in work or social situations.

They also estimated that every year, between 150,000 and 300,000 children under 1.5 years of age get bronchitis or pneumonia from breathing secondhand tobacco smoke, resulting in thousands of hospitalizations.

Ongoing Battle

The tobacco industry did not stop attacking the EPA after publication of its Risk Assessment in early 1993.

1994 This is Philip Morris overview of the problem with getting high-enough exchange rates (indoor with outdoor air) through PM's own Filtered Air Control Technology (FACT) displacement ventilation system. FACT was very expensive to run. This note also contains details of:
Various ongoing studies on ETS

  • Signifiant Studies being Monitored (Genuine studies)
  • Ross C Brownson - one of the largest on ETS and lung-cancer reported no significant risk.
  • Heather Stockwell - large US study in 1992. No overall increase in lung cancer. Gio Gori was trying to get access to this raw data (but obviously finding resistance).
  • Elizabeth Fontham - large ETS/lung cancer (60% completed in 1991). Marginal positive finding seen by Fontham as evidence of causal relationships.
  • Anna H Wu-Williams - large case-control study. Not found anything of significance.
  • Trade Organizations
  • Consultants
  • Barrer Associates: EPA consultants who keep us informed on all EPA activities.
  • Shook Hardy & Bacon (lawyers)
  • Jim Tozzi. He is organising an ILSI Seminar which the EPA will join unless they "back out as a result of the Tox Forum events". Also crypticaly mentioned was IRIS, which was SH&B's "Integrated Risk Information System."
  • Thorne Auchter was discussing costs of increased regulation with Mayoral groups.
  • Patrick R Tyson, reports from a lawyer-lobbyist (Constagny, Brooks & Smith, Atlanta) He was the ex director of the OSHA who became a PM consultant on workplace health matters.
  • CIAR Personal monitoring study and confounder study.

[17]

References