December 18

EPA Diesel Gas & Pollutant Inhalation Experiments

The EPA website states:

Particulate matter, also known as particle pollution or PM, is a complex mixture of extremely small particles and liquid droplets. Particle pollution is made up of a number of components, including acids (such as nitrates and sulfates), organic chemicals, metals, and soil or dust particles.The size of particles is directly linked to their potential for causing health problems. EPA is concerned about particles that are 10 micrometers in diameter or smaller because those are the particles that generally pass through the throat and nose and enter the lungs. Once inhaled, these particles can affect the heart and lungs and cause serious health effects.”

According to EPA’s own scientific assessment reports (2004, 2009), Particulate Matter 2.5 can kill people shortly after exposure–death can occur within hours: “there is strong epidemiological evidence linking short-term (hours, days) exposure to PM2.5 with cardiovascular and respiratory mortality and morbidity.”  

The American Lung Association agreers: "Overwhelming evidence shows that particle pollution—like that coming from exhaust smoke—can kill. Particle pollution can increase the risk of heart disease, lung cancer and asthma attacks and can interfere with the growth and work of the lungs." 

On September 21, 2012, the American Tradition Institute Environmental Law Center filed a lawsuit in federal court charging EPA scientists with exposing human subjects in these experiments to PM2.5 from diesel truck exhausts to levels 90 times the average environmental exposure of the general population levels, and 135 times the mean diesel truck emissions exposure in the United States, thereby increasing the risk of their immediate death by 10 percent.

The human subjects of these immoral and illegal experiments are vulnerable elderly human beings—some of who are healthy, some suffer from chronic diseases, and some have genetic predispositions to such diseases. These human subjects were / are exposed to risk of death with absolutely no potential therapeutic benefit.

They were paid $12 an hour for pollutant exposure sessions lasting 2 hours.. During the sessions, subjects are cordoned off in a sealed chamber inhaling fine particle pollutants, including diesel exhaust that is piped in from an idling diesel truck. (EPA photos below)

EPA human pollutant inhalation experiments demonstrably violate universal ethical, medical and legal standards of civilized medical research, including The Nuremberg Code, The Declaration of Helsinki, and "The Common Rule" of the US Code of Federal Regulations. epa_busted.jpg

According to EPA, there is no safe level of PM2.5: 

The Alliance for Human Research Protection believes that it is not an overstatement to compare these wholly non-therapeutic   poison inhalation experiments, conducted by EPA scientists and  EPA-funded academics, to the experiments conducted by the Nazi doctors who were tried and convicted at Nuremberg. These government sponsored experiments are in violation of the US Common Rule.

Indeed, according to EPA officials, there is no safe level of PM2.5

“The best scientific evidence, confirmed by independent, Congressionally-mandated expert panels, is that there is no threshold level of fine particle pollution below which health risk reductions are not achieved by reduced exposure.”  See, letter by EPA Assistant Administrator Gina McCarthy to the Chairman of the Committee on Energy and Commerce ((Feb. 2012).

  "For ozone and particulate-matter pollution, no thresholds have been identified below which there is no risk."  See, Jonathan Samet, MD, an international authority on effects of smoking and air pollution on health, in the NEJM  (2011)

epa_chief_lisa_jackson.jpg

"Particulate matter causes premature death. It doesn’t make you sick. It’s directly causal to dying sooner than you would."
See,  Congressional testimony, EPA Administrator, Lisa Jackson  (Sept. 2011)

Even as EPA’s chief acknowledged the lethality of PM2.5, EPA scientists have / are conducting at least four separate projects in which healthy elderly people as well as adults with chronic diseases–such as asthma, metabolic syndrome, diabetes–were / are knowingly and deliberately exposed to high-levels of diesel exhaust and toxic air pollution particles. 

XCON Study. Starting in 2004, the EPA exposed adults with metabolic syndrome (including the elderly) to high levels of toxic PM2.5.

  • OMEGACON Study. Starting in 2007, the EPA exposed older adults to high levels of diesel exhaust (which contains PM2.5 and other “toxic” substances) and then “treated” them with omega-3 fatty acids to see if whatever harm caused by PM2.5 was mitigated. In 2008, the diesel exhaust was replaced by plain PM2.5.
  • KINGCON Study. Starting in 2008, the EPA exposed older adults with moderate asthma to PM2.5.

  • CAPTAIN Study. The EPA is now recruiting elderly adults (including 75 year olds) to “… find out if a component of ambient air pollution to which we are all exposed, particulate matter (PM), produced by car and coal-fired power plants, increases the risks of changes in the heart and whether genotype will lessen the risks caused by PM.

Several academic centers from coast to coast are also engaged in EPA-funded pollution inhalation experiments

For example, the  Rochester PM Center (University of Rochester, NY) received a $8 million grant (# R832415)  to conduct  Source-Specific Health Effects of Ultrafine / Fine Particles human experiments. The University of Rochester investigators:  Oberdörster, Günter , Finkelstein, Jacob N. , Frampton, Mark W. , Hopke, Philip K. , Peters, Annette , Utell, Mark J. The EPA Project Officers: Stacey Katz / Gail Robarge

The EPA website states:epa-u_rochester_check_8_mill.jpg

 Studies are proposed to identify health hazards of source-specific physicochemical components of fine PM (e.g., UFP; organics) in epidemiological, controlled clinical, animal, and in vitro studies; a main focus will be on characterizing fine PM and determining pathophysiological mechanisms of effects to test the hypothesis that ambient ultrafine (UF)/fine PM cause oxidative stress and trigger cardiovascular adverse health effects, with specific emphasis on events leading to endothelial dysfunction.”

 The Expected Results: 

“We anticipate to uncover mechanisms of adverse vascular and cardiac events, directly or indirectly induced by PM. These involve activation of endothelial cells and blood platelets, resulting in thrombus formation with potential fatal consequences in susceptible subjects with predisposing cardiovascular disease. We also expect to see oxidative stress responses in the CNS at sensitive target sites. Our multidisciplinary team approach will result in novel findings to be used in regulatory decision-making for protecting public health. “

Below are three abstracts from reports published in 2012 in Swiss Medical Weekly and Current Opinion Pulmonary Medicine. The findings:

"Controlled human exposure studies of cardiovascular effects show that, comparable to other particle-associated exposures, diesel exhaust has a capacity to precipitate coronary artery disease. In addition, there is a relationship between diesel exhaust and DEP exposure and vascular endpoints; these effects in diesel exhaust may be diminished with removal of DEP."

"Using bronchoalveolar lavage, bronchial biopsies, and sputum collection, studies have demonstrated inflammation in the airways of healthy individuals after exposure to diesel exhaust and DEPs. This inflammation has included neutrophils, eosinophils, mast cells, and lymphocytes."

A sample consent form for a Diesel Exhaust Pilot Study conducted at the University of North Carolina-Chapel Hill: EPA—IRB Study 07-0190–GCRC #2579–involving elderly adults, aged 59-75 states:      "Your participation in this pilot study will include one training session for about 3 hours, 3 exposure sessionseach of which will last approximately 8 hours, and another 3 sessions which will occur 18 hours after each exposure and last approximately 3 hours."

  epa_diesel_truck_piping_exahust_fumes_into_sealed_chamber.jpgepa_diesel_exhaust_piped_into_sealed_steel_chamber.jpg

epa_particulate_inhalation_test_chamber.jpg

"You will be paid approximately $12 per hour…total compensation for completion ….approximately $1953."

"If you are injured by this research: …the researchers will help you get medical care, but any costs for the medical care will be billed to you and /or your insurance company"

"Neither the University of North Carolina-Chapel Hill nor the US EPA has set aside funds to pay for any [ ] reactions or injuries, or for the related medical care."  [bold in original]

EPA exploited human beings  who were used as a means to an end. They were deliberately exposed to poisonous substances–against their best interest–in order to determine the degree of harm the mixture of pollutants and diesel gas produce in human beings.

These unconscionable experiments were conducted by medical doctors and academic scientists–they violate all ethical, medical and legal codified standards of civilized medical research. 
1. The Nuremberg Code;  2. The Declaration of Helsinki ; 3. The Common Rule

It is not an overstatement to compare these wholly non-therapeutic, high risk experiments to those conducted by Nazi doctors who were tried and convicted at Nuremberg.

That such experiments passed the regulatory Institutional Review Board (IRB) process demonstrates the utter failure of the US regulatory system.

Abstracts from 2012 EPA reports are posted at:

Read extensive EPA documents at: http://epahumantesting.files.wordpress.com/2012/09/2012-09-21-complaint-as-filed.pdf

Vera Sharav 

 


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