No Safe Level of Exposure: EPAs Human Experiments With Par=culate - - PowerPoint PPT Presentation

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No Safe Level of Exposure: EPAs Human Experiments With Par=culate Ma@er Presenta(on to the Na(onal Academy of Sciences Commi7ee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental

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‘No Safe Level of Exposure’: EPA’s Human Experiments With Par=culate Ma@er

Presenta(on to the Na(onal Academy of Sciences Commi7ee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants By Steve Milloy, MHS, JD, LLM Publisher JunkScience.com, milloy@me.com Senior Legal Fellow, Energy & Environment Legal Ins(tute August 24, 2016

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Steve Milloy

  • Publisher, award-winning JunkScience.com
  • Senior Legal Fellow, Energy & Environment Legal Ins(tute

– Public interest, 501(c)(3), www.eelegal.org

  • Educa(on

– BA, Natural Sciences, Johns Hopkins University – MHS, Biosta(s(cs, Johns Hopkins Univ. School of Public Health – JD, University of Bal(more, – LLM, Securi(es Regula(on, Georgetown University

  • Consultant (environment/public health), author, former

mutual fund manager & coal company execu(ve

  • Bio at h7p://www.junkscience.com/about

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3

Dedicated to

Haiyan ‘Nicole’ Wan 1977-1996

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EPA’s Human Experiments

  • Substances experimented with:

– Par=culate ma@er (PM, PM2.5) – Diesel exhaust (95% PM2.5) – Ozone (smog) – Combina(ons of above – Chlorine gas and other substances

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Imagining PM

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Sources of PM – Natural

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Sources of PM - Manmade

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PM Lethality:

Any Exposure Can Kill, Within Hours

  • From EPA’s 2009 PM2.5 “Integrated Scien(fic

Assessment”:

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PM Lethality (cont’d):

No Safe Exposure

  • Former EPA CASAC Chair Jonathan Samet in

New England J. Med. (July 11, 2011).

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PM Lethality (cont’d):

Death from Any Exposure

  • Le7er from then-EPA air chief Gina McCarthy

to House Energy Commi7ee (Feb. 3, 2012)

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PM Lethality (cont’d):

Death Within Hours of Exposure

  • From EPA 2004 Integrated Scien(fic

Assessment for PM2.5:

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PM Lethality (cont’d):

Just Death. No Sickness.

  • During a September 22, 2011 hearing of the

Oversight and Inves(ga(ons Subcommi7ee of the House Energy and Commerce Commi7ee, Administrator Jackson tes(fied:

– “Par%culate ma-er causes premature death. It doesn’t make you sick. It’s directly causal to dying sooner than you should.”

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PM Lethality (cont’d):

1 Out of 5 Deaths Caused by PM

  • From September 22, 2011 House hearing (transcript):

– REP. MARKEY: How would you compare it to the fight against cancer, reducing parDculate maEer? – MS. JACKSON: Yeah, I was briefed not long ago. If we could reduce parDculate maEer to healthy levels it would have the same impact as finding a cure for cancer in our country. – REP. MARKEY: Could you say that sentence one more Dme? – MS. JACKSON: Yes, sir. If we could reduce par%culate ma-er to levels that are healthy we would have an iden%cal impact to finding a cure for cancer.

  • Annual US cancer mortality

– ~570,000 – ~ 20+% of all US deaths annually

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PM Lethality (cont’d):

Air in LA, NY & EPA Experiments May Kill

  • Declara(on of clinical studies coordinator for

EPA’s CAPTAIN study:

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PM Lethality (cont’d):

Deadly Within Hours, No Safe Exposure

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PM Lethality (Cont’d):

EPA-Funded Researcher Renounces PM Experiments

  • Ajer Brook’s EPA-funded human experiments

with PM were reported in the Detroit News (July 23, 2013):

– “I’m not going to do (these tests) because I don’t believe in exposing people. I’ve shown PM2.5 is bad for you.”

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EPA Regulates on the Basis that PM Kills

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PM Is Most Toxic Substance?

As Lethal As A Bullet to the Brain?

  • EPA says any exposure to PM can kill in as

li7le as hours – no safe exposure.

  • Even radia(on and chemical carcinogens

regulated on the basis of the linear no- threshold model (LNT) ‘only’ have cancer as the health endpoint.

  • No known poison kills on an ‘any exposure’

basis.

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No Disclosure of the Nature of PM’s Lethality to IRBs

  • EPA staff researchers and EPA-funded

university researchers did NOT provide any

  • f this toxicity informa=on or equivalent to

any Ins=tu=onal Review Board (IRB).

– At most, occasional, vague, soj-pedaled and/or glancing men(on of PM’s correla(on with ‘mortality’ – IRBs only given impression of ‘minimal risk.’

  • From Common Rule:

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EPA’s Human Experiments

Exhaust from Idling Diesel Truck…

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EPA Human Experiments (cont’d):

… Pumped Into Chamber Containing Study Subject

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Who Does EPA Say Are Most Vulnerable to The Effect of PM?

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Who Are EPA’s Human Subjects?

The Elderly

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Who Are EPA’s Subjects? (cont’d):

Even More Elderly

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Who Are EPA’s Subjects? (cont’d):

Even More Elderly

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Who Are EPA’s Subjects? (cont’d):

Children

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Who Are EPA’s Subjects? (cont’d)

  • Diesel exhaust par(cles sprayed up noses of

children.

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Who Are EPA’s Subjects? (cont’d)

  • How old were the children?

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Who Are EPA’s Subjects? (cont’d)

  • EPA-funded researchers described risk to

Ins(tu(onal Review Board as ‘minimal.’

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Who Are EPA’s Subjects? (cont’d)

  • State of California determined in 1998 that

diesel exhaust causes cancer and that there is no safe exposure.

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Who Are EPA’s Subjects? (cont’d)

  • EPA commenced the process to ban

experimen(ng on children in 2003 and finalized the ban in 2006.

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Who Are EPA’s Subjects? (cont’d)

  • EPA-funded USC experiments on children
  • ccurred during 2004-2005.

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EPA fails to explain dele=on of kids diesel experiment on from data base

  • As reported on JunkScience.com (April 25,

2013):

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Who Are EPA’s Subjects? (cont’d):

Unhealthy People –Metabolic Syndrome

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Who Are EPA’s Subjects? (cont’d):

Unhealthy - Older Asthma=cs

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Who Are EPA’s Subjects? (cont’d):

Unhealthy People - Diabe=cs

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Who Are EPA’s Subjects? (cont’d):

Unhealthy People: Heart A@ack Wai=ng to Happen

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Who Are EPA’s Subjects? (cont’d):

Unhealthy People: Heart A@ack Wai=ng to Happen

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Who Are EPA’s Subjects? (cont’d):

Unhealthy People: Heart A@ack Wai=ng to Happen

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Who Does EPA Say Are Most Vulnerable to Effects of PM?

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How Much PM Did EPA Expose Study Subjects to?

  • Recall: There is no safe exposure to PM,

according to EPA.

  • Average U.S. outdoor air has ~ 10 micrograms

per cubic meter of PM2.5, according to EPA.

– ‘Minimal risk’ level for Common Rule purposes

  • EPA acute exposure standard to PM2.5 is 35

micrograms per cubic meter.

– Exceeding standard violates the law

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How Much PM Did EPA Expose Study Subjects to?

  • 58 year-old woman spotlighted in the Case

Report

  • 112 micrograms/m3 is:

– 3.2 (mes greater than EPA acute PM standard – 11 (mes greater than ‘minimal risk’

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How Much PM Did EPA Expose Study Subjects to?

  • Diesel exhaust experiments
  • 300 micrograms/m3 is:

– 8.5 (mes greater than EPA acute PM standard – 30 (mes greater than ‘minimal risk’

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How Much PM Did EPA Expose Study Subjects to?

  • Concentrated PM par(cles
  • 600 micrograms/m3 is:

– 17 (mes greater than EPA acute PM standard – 60 (mes greater than ‘minimal risk’

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How Much PM Did EPA Expose Study Subjects to?

  • ‘Oops!’ exposure
  • 750 micrograms/m3 is:

– 21 (mes greater than EPA acute standard – 75 (mes greater than ‘minimal risk’

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Are EPA’s PM human experiments fundamentally unethical/illegal?

  • Nuremberg Code

– 5. [An experiment] should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury.

  • Principles adopted by California
  • Applied by Maryland Court to Appeals to EPA-funded experiments in Grimes v.

Kennedy Krieger InsDtute (2001).

  • Common Rule – as adopted by EPA

– No more than ‘minimal risk’ allowed (i.e., risk of harm no more than in

  • rdinary life)
  • EPA Rule 1000.17

– ‘Presump(on’ against studies with risk of ‘substan(al injury’ or ‘irreversible health effects.’

  • The EPA IG report never addressed whether the experiments are

‘fundamentally unethical/illegal.’

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Informed Consent

  • Instead of the ‘fundamentally unethical/

illegal’ issue, EPA IG opted to focus on informed consent deficiency.

  • Informed consent required by

– Nuremberg Code – Common Rule – State Law (applies EPA researchers who are state- licensed physicians)

  • Felony

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Recall what EPA tells the public and Congress about PM

  • Any exposure to PM can be lethal.
  • Lethality can occur within hours.
  • PM kills hundreds of thousands of people

annually at current outdoor levels.

  • Old/sick are especially vulnerable.

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What did EPA tell study subjects?

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Some EPA Guineas Pigs Received This Sort of ‘Disclosure’

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Alleged CAPTAIN Experiment Disclosure

  • EPA clinical studies coordinator claimed to
  • rally state to study subjects, ‘you may die

from this.’

  • But Common Rule would require wri@en

disclosure for risk of death – if such an experiment were even permissible in the first place.

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Why Is EPA Experimen=ng With PM

  • n Human Beings?
  • EPA claims ‘thousands’ for studies support its

regula(on of PM (Source: EPA ‘Fact Sheet’)

– Epidemiology – Animal toxicology – Human ‘clinical studies’ -- i.e., human experiments

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EPA Admits PM Epidemiology Inadequate

  • From 2012 li(ga(on with EPA about EPA’s

CAPTAIN human experiment:

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Animal Toxicology Not Helpful to EPA

  • No laboratory animal has ever died from

mere PM exposure, despite extremely high

  • exposures. [Source: EPA’s 2009 ISA for PM]

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EPA’s Last Resort: Human Guinea Pigs

  • EPA explana(on for human experiments from

2012 li(ga(on over EPA’s CAPTAIN study:

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SO…

Is EPA doing these experiments to see… …if incredibly high exposures to PM… can actually kill or… seriously harm someone… who is supposed to be especially vulnerable… all while claiming… there is only ‘minimal risk’ to study subjects?

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‘Fundamentally Unethical’

  • Le7er from EPA Human Studies Review Board

to EPA Science Advisor (October 26, 2009):

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EPA’s Claimed Defense

  • Risks only occur in the popula(on not study

subjects.

  • From our human tes(ng lawsuit, EPA writes:

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Breaking Down EPA’s Claimed Defense

  • EPA admits PM kills people
  • EPA claims risk is large in the popula(on, but small to individuals

– Popula(ons are made up of people

  • EPA says hundreds of thousands killed by PM annually
  • ‘Only’ 31,000 killed in auto accidents annually – don’t apply EPA ra(onale on

your way home today

– PM can kill hours ajer inhala(on

  • Popula(on doesn’t collec(vely breathe

– EPA researcher Dr. Robert Brook – stopped doing experiments because PM not safe

  • EPA claims risk small is unless you are old/sick

– But old/sick are precisely who the study subjects are

  • EPA has already determined there is no safe exposure to PM and

has regulated PM on the basis of lethality since 1997

– What is the purpose of the experiments?

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Beyond PM Toxicity: Danger to Study Subjects from Experimental Protocol

  • 19-year-old college student Haiyan ‘Nicole’ Wan

killed during PM research (overdose of lidocaine administered for bronchoscopy).

  • Many EPA experiments involve bronchoscopy

– UNC college student told me she had 6 or 7

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Are EPA’s Experiments Scien=fic?

  • Examine spreadsheet of published human experiments

in docket submi7ed by EPA (Summary Human Challenge Studies PM).

  • Experiments not systema(cally designed/conducted

– Study sizes small (as few a n=4) – Myriad PM tested (diesel, wood smoke, concentrated PM) – Various exposure levels, (mes – All results for all study subjects published? – Misrepresenta(on of study results

  • Ghio et al. (EHP, Sep 2011), “Case Report:…”

– No men(on of other human study subjects, i.e., contrary results – Disregard actual cause of reported health effect

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Are EPA’s Experiments Scien=fic? (cont’d)

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Are EPA’s Experiments Scien=fic? (cont’d)

  • U(lity of EPA’s human experiments in doubt,

admit EPA funded PM researchers:

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Are EPA’s Experiments Scien=fic? (cont’d)

  • Report from EPA’s Science Advisory Board:

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Are EPA’s Experiments Scien=fic? (cont’d)

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Are EPA’s Experiments Scien=fic? (cont’d)

  • Common Rule prohibits bad science:
  • EPA human experiments are

– Not systema(c – Not generalizable

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‘History of Regulatory Viola(ons’

  • From internal EPA memo:

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Conclusion

  • Based on EPA-determined lethality of PM, the
  • ld/sick nature of study subjects, disclosure/

consent problems, and their non-scien(fic nature, EPA’s PM human experiments are:

– Fundamentally unethical, if not – Illegal.

  • EPA has withheld key informa(on from IRBs,

study subjects, and the NAS Commi7ee.

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Implica=ons of Conclusion

  • If PM is as deadly as EPA claims, then its

experiments violated every law/regula(on established for the protec(on of human study subjects since the Nuremberg Code.

  • The only way EPA does not have this legal

culpability, is if PM is not as dangerous as EPA has told the public and Congress.

  • No third op(on.

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Thank you!

  • Contact me for more informa(on:

– E-mail: milloy@me.com – JunkScience.com/contact – Twi7er: @JunkScience

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