The EPA's Unethical PM2.5 Air Pollution Experiments

Environmental Protection Agency Seal
Environmental Protection Agency Seal (Photo credit: DonkeyHotey)

By John Dale Dunn MD JD (via email)

United States Environmental Protection Agency (EPA) Administrator Lisa Jackson testified before Congress in September of 2011 that small-particle (2.5 microns or less) air pollution is lethal. “Particulate matter causes premature death. It’s directly causal to dying sooner than you should.”

At the hearing, Representative Edward J. Markey (D-MA) asked, “How would you compare [the benefits of reducing airborne PM2.5] to the fight against cancer?” Ms. Jackson replied, “Yeah, I was briefed not long ago. If we could reduce particulate matter to healthy levels, it would have the same impact as finding a cure for cancer in our country.” Cancer kills a half-million Americans a year — 25 percent of all deaths in the U.S. annually.

That same month, September 2011, Environmental Health Perspectives (EHP), a journal sponsored by the National Institutes of Health, reported an experiment that exposed a 58-year-old lady to high levels of small particles in a chamber. After 49 minutes in the chamber, the lady, who was obese with hypertension and a family history of heart disease, who also had premature atrial heartbeats on her pre-experiment electrocardiogram, developed a rapid heart beat irregularity called atrial fibrillation/flutter, which can be life threatening. She was taken out of the chamber, and she recovered, but she was hospitalized for a day. Weeks later, an abnormal electrical heart circuit was fixed by cardiologists, as reported in EHP.

It is illegal, unethical, and immoral to expose experimental subjects to harmful or lethal toxins. The Reference Manual on Scientific Evidence, 3rd Ed. (2011), published by the Federal Judicial Center, on page 555 declares that exposing human subjects to toxic substances is “proscribed” by law and cites case law. The editor of EHP refused a request to withdraw the paper and conduct an investigation.

The EPA’s internal policy guidance on experimental protocols prohibits, under what is called the “Common Rule,” experiments that expose human subjects to lethal or toxic substances. Milloy referenced the “Common Rule” that governs EPA policy on research conduct in human experimentation in his letter to the inspector general of the EPA requesting an investigation of the matter.

A full report on the research study shows that 41 other people were exposed to what the EPA says are harmful or lethal levels of small particles, with some enduring up to 10 times the EPA’s declared safe level of 35 micrograms per cubic meter of air. The EPA human experiments described were conducted from January 2010 to June 2011, according to the information obtained by JunkScience.com on a Freedom of Information Act request, and ended three months before Ms. Jackson’s congressional testimony, but she still asserted dramatic claims of PM2.5’s lethality — thousands of deaths at stake and hundreds of billions in economic consequences from the deaths and disabilities caused by small particles.

According to the congressional testimony of Lisa Jackson, these experiments risked the lives of these 42 people. So what could have possessed these EPA researchers to do the experiments? The authors reveal the reason in their case report on the lady:

Although epidemiologic data strongly support a relationship between exposure to air pollutants and cardiovascular disease, this methodology does not permit a description of the clinical presentation in an individual case. To our knowledge, this is the first case report of cardiovascular disease after exposure to elevated concentrations of any air pollutant.

The people at the EPA claim that they must control air pollution to prevent the deaths of thousands. Then they expose human subjects to high levels of air pollution. Is it possible that they are lying, or unethical, or both?

In the experimental protocol, seven subjects were exposed to levels 10 times greater than the 24-hour safe limit for small particles, and all of the other 40 subjects were exposed to more than the 35 micrograms per cubic meter that the EPA says is the 24-hour safety limit. The researchers failed to report that none of the other subjects had any adverse effects, which is unscientific, since researchers are obligated to report results both for and against their hypothesis.

The only way out for the EPA in this episode is to acknowledge the reality that ambient levels or even higher levels of PM2.5 are not toxic or lethal, based on their own research, and to admit that their claims of thousands of lives lost from small particles is nonsense. Or they can stay with their assertions about small particle toxicity and face charges of criminal and civil neglect.

The individuals who were the subjects of this experiment certainly might be concerned if the EPA claim of small particle toxicity and lethality is true. There is good reason to believe that the EPA itself doesn’t believe the claims. However, based on congressional testimony by EPA officials, any death now or later of the subjects of this experiment from heart and lung disease or cancer would be under the cloud of concern about the EPA claims that small particles kill. What were the EPA officials and researchers thinking?

John Dale Dunn MD JD

Consultant Emergency Services/Peer Review

Civilian Faculty, Emergency Medicine Residency

Carl R. Darnall Army Med Center

Fort Hood, Texas

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June 4, 2012 7:49 am

That Lisa Jackson, she’s such a tool, literally. I’d love to be a fly on the wall in the room where she is given her marching orders. I wonder who is present. Who’s giving the orders and who’s making sure?

Chris H
June 4, 2012 7:51 am

All of the experimental subjects should have been given an information sheet approved by a Research Ethics Committee. It would set out, in layman’s language, what the trial involved and it’s benefits and risks. The application to the REC should have set out the same information and be fully referenced. All of this should be in the public domain and discoverable by FoI.
No REC in its right mind would approve a study with the risks, which leads me to the conclusion that the EPA evidence was a gross exaggeration of the risks.

ferd berple
June 4, 2012 7:52 am

eyesonu says:
June 4, 2012 at 6:27 am
Laws and policies need to be enacted to force leaders of those organizations to confirm any so-called research presented to Congress to be independently confirmed as correct.
===========
The problem is that you can always find a scientist willing to independently confirm any result. You will find them the next year, working for the office of the results they confirmed.
The problem is that government has both money and power in large supply with which to corrupt those individuals so motivated. Which is why the founding fathers of America recognized the dangers of government and the harm that it can do if left to grow unchecked.
Unfortunately over the years these controls have been largely eroded as government has taken control of increasingly large portions of people’s lives, in the name of “helping” people. This process has greatly accelerated in recent years as the government has taken to declaring “war” on problems. Fear has driven an associated reduction in personal freedoms resulting in extremely high incarceration rates.
http://en.wikipedia.org/wiki/File:Incarceration_rates_worldwide.gif
Small governments help the people. Large governments help themselves. Too much of a good thing is not a good thing.

June 4, 2012 7:54 am

That Rotund, wheezing, unfortunate individual was their “Ringer”. She was bound to keel over from something…. I wish her well.

David, UK
June 4, 2012 7:57 am

“Is it possible that they are lying, or unethical, or both?”
You missed out “stupid”.

June 4, 2012 7:58 am

I understand the outrage against this. But why the surprise??
The same people did this:
http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment
After all, you can’t make an omelet without breaking eggs.
Regards,
Steamboat Jack (Jon Jewett’s evil twin)

ferd berple
June 4, 2012 8:04 am

What about the fine particle pollution thrown up by the wind? Moving vehicles, bicycles, even people leave a cloud of fine particles in their wake.
Anyone with any training in science can spot the obvious flaws in the EPA study. 42 people, one study. It is nowhere near the size required to establish significance.
Who can say that the one obviously ill person would not have developed the same symptoms if the air had 0.0 ppm? Was a control done to ensure the stress of the test environment didn’t induce her symptoms?
How do you know you are measuring air pollution? Testing itself introduces stress which affects individuals. Which is why you need a double blind study, with a control grow that is tested identically in clean air, with neither party aware of which group has the dirty air.
Only after the statistics are compiled do you reveal the group exposed to pollution, and thereby establish if there is a correlation between pollution and disease, or testing and disease. This methodology has apparently gone out the window of late in government run science. Yet they require just this sort of testing by private industry.
What is good for the goose is apparently not good for the gander.

Dr. Bob
June 4, 2012 8:05 am

I have followed the research of Drs. Jacob McDonald and Joe Mauderly of the Lovelace Respiratory Institute. They conduct experiments to measure effects of engine emissions at ambient exposure levels, not multiple times expected exposure levels. This gives a better indication of how the respiratory system responds to “pollutants” and heals itself before permanent damage occurs. In most cases, exposure to ambient levels of engine exhaust do not cause lung damage as expressed by histological responses.
The link below is to a Healt Effects Institute discussion of some of this work.
http://www.healtheffects.org/Pubs/RR166-Press_Release.pdf

Dodgy Geezer
June 4, 2012 8:05 am

“…conceded a couple of years ago that the three units of alcohol daily recommendation for safe drinking, (small glaas of wine per unit), was plucked out of thin (possibly warming or cooling) air, & were based on no actual evidence whatsoever, just somebody’s opinion at the BMA that that was the safe Politically Correct amount to consume!…”
What is it that gives me the feeling that three ‘units’ of alcohol a day was what the members of that BMA committee consumed….?
“…And after all, WE’RE all right, aren’t we…?”

David, UK
June 4, 2012 8:11 am

Steamboat Jack, June 4, 2012 at 7:58 am:
You miss the point, Jack. Syphilis is real.

ferd berple
June 4, 2012 8:11 am

Steamboat Jack says:
June 4, 2012 at 7:58 am
http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment
================
quote:
“Now studies require informed consent (with exceptions possible for U.S. Federal agencies which can be kept secret by Executive Order),[2] communication of diagnosis, and accurate reporting of test results.[3]”
or this government funded study
http://www.whale.to/b/Project%20MKULTRA.pdf

wobble
June 4, 2012 8:18 am

That same month, September 2011, Environmental Health Perspectives (EHP), a journal sponsored by the National Institutes of Health, reported an experiment that exposed a 58-year-old lady to high levels of small particles in a chamber. After 49 minutes in the chamber, the lady, who was obese with hypertension and a family history of heart disease, who also had premature atrial heartbeats on her pre-experiment electrocardiogram, developed a rapid heart beat irregularity called atrial fibrillation/flutter, which can be life threatening.

Wow! Just wow! There is so much wrong with this that’s it’s difficult to know where to start.
The is absolute junk science.
1. EPA is attempting to use an anecdote as evidence that particulate matter (or anything) is harmful. FDA and CDC would absolutely cringe at this.
2. There is absolutely NO mechanism for particulate matter to cause immediate atrial fibrillation – making this further cringe worthy. How on earth hasn’t EPA been widely attacked by the cardiology community for suggesting otherwise???
3. People with premature atrial contractions are more likely to experience atrial fibrillation. Even if there was a statistically significant correlation between the chamber experiment and atrial fibrillation, the use of a control group being put into the chamber without any particulate matter exposure could reveal that atrial fibrillation is caused by the stress of the chamber experience rather than exposure to particulate matter.

woodNfish
June 4, 2012 8:33 am

The US government has a long history of illegal human experimentation and human rights abuses. The government has performed radiation experiments on orphaned retarded children, LSD experiments on unsuspecting victims some who later committed LSD- caused suicide, and others who were driven insane and committed. Those are only two examples of many and none of the perpetrators or enablers of these atrocities have ever been tried or convicted, or even arrested for their crimes. The US government is nothing more than a super-large criminal organization and has been for many years.

wobble
June 4, 2012 8:36 am

BFL says:
June 4, 2012 at 5:35 am
Below find an example of just how far these people will go to protect the industry

BFL, learn something about the prudent use of statistics and the problem with touting anecdotes. Burzynski hasn’t been statistically successful curing cancer. If he offered a “good” treatment, then he would be able to cure more patients than standard methods.
Don’t be so easily fooled by these type of “snake oil salesmen” videos.

June 4, 2012 8:47 am

Wobble,
Craziness abounds.There’s no mechanism for CO2 to make it cold either, yet, we’ve seen the warmists scramble to show it’s true.
“2. There is absolutely NO mechanism for particulate matter to cause immediate atrial fibrillation – making this further cringe worthy. How on earth hasn’t EPA been widely attacked by the cardiology community for suggesting otherwise???”

kakatoa
June 4, 2012 9:09 am

Next time they want to run an experiment how about using a natural event such as a sandstorm- http://www.nytimes.com/2011/07/07/us/07dust.html
and checking out a large group of folks. Alternatively, they could head over to Beijing for a few weeks and do a few studies there…. on say a sub group of folks that have just arrived from the countryside……………………

Gail Combs
June 4, 2012 9:19 am

Steamboat Jack says:
June 4, 2012 at 7:58 am
I understand the outrage against this. But why the surprise??
The same people did this:
http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment
After all, you can’t make an omelet without breaking eggs.
Regards,
Steamboat Jack (Jon Jewett’s evil twin)
___________________________________________
My Mom was a guinea pig in the following experiment and she was never even told. The (self-snip) doctors killed her with their darned experiments and Dad had to PAY THEM for their “treatment” TOO!
THE HUMAN RADIATION EXPERIMENTS

Gail Combs
June 4, 2012 9:23 am

The Wine study was another case of fabricated “evidence”

Researcher Who Studied Benefits Of Red Wine Falsified Data Says University
An extensive misconduct investigation that took three years to complete and produced a 60,000-page report, concludes that a researcher who has come to prominence in recent years for his investigations into the beneficial properties of resveratrol, a compound found in red wine, “is guilty of 145 counts of fabrication and falsification of data”.
In a statement published on the university’s news website on Wednesday, the University of Connecticut (UConn) Health Center said the investigation has led them to inform 11 scientific journals that had published studies conducted by Dr Dipak K. Das, a professor in the unversity’s Department of Surgery and director of its Cardiovascular Research Center.
The internal investigation, which covered seven years of work in Das’s lab, was triggered by an anonyomous allegation of “research irregularities” in 2008…..

June 4, 2012 9:30 am

Lisa Jackson is a charlatan. She says that about PM 2.5 but closes here eyes to the fact that the US and most other countries are spraying 40,000 tons US of bauxite and 100,000 tons US of High Carbon Ferromanganese in very fine particulate (10 micron and less) into the atmosphere each year. Using people as her guinea pigs is unconscionable. These people should sue Lisa Jackson directly.

pat
June 4, 2012 9:32 am

The EPA is made of of fools. Many uncredentialed in real science, but educated in collateral fields such as environmental studies, climatology, environmental justice, etc. The ‘sciences; that require no science. Lisa Jackson, I am sure, would have made a very competent chemical engineer. However she was never employed as such.her entire career has been an association with often loony environmentalists that are far more concerned with destroying the chemical industry than developing the same.

kadaka (KD Knoebel)
June 4, 2012 9:32 am

The assumption is made that laws and ethics need apply to the EPA.
Depart this path, lest one assume the EPA has good intentions and perhaps a conscience.

John West
June 4, 2012 9:51 am

Ian W says:
“Is there any conclusion other than Environmental Protection Agency Administrator Lisa Jackson lied in her testimony to Congress?”
Yes, that they exposed people to what they believed to be harmful doses of particulate matter.
Personally, I’m in the “she lied” camp, but there’s no escaping that either she lied to Congress or committed unethical research. Either way, she should be sent packing along with all the other EPA leaches that pander to every alarmist conjecture with increasingly asinine regulations direct from the bureaucratic class.

June 4, 2012 9:56 am

eyesonu says:
June 4, 2012 at 6:27 am
Lying to Congress or misleading Congress should be a crime.

It *is* — but only if you are testifying under oath. That’s one reason John Kerry has never been charged with self-admitted war crimes.
False testimony leads to bad policy decisions that can have enormous consequences.
That’s the reason people do it — the potential for advancing their agenda vastly outweighs the consequence of getting caught. And the consequence of getting caught telling lies before Congress in unsworn testimony is, for all practical purposes, *nothing*…

Neo
June 4, 2012 10:07 am

the lady, who was obese with hypertension and a family history of heart disease, who also had premature atrial heartbeats on her pre-experiment electrocardiogram, developed a rapid heart beat irregularity called atrial fibrillation/flutter, which can be life threatening
SO they put this lady with a known heart problem in danger.
Frankly, from the description of the experiment, we have no idea if the high levels of small particles in a chamber, her being obese, she may have had a craving to eat, or perhaps she was claustrophobic, that triggered her already known cardiac problem.
Next, I suppose, the Department of Education will conduct experiments, using subjects with know peripheral vascular disease, to see if corporal punishment is truly life threatening.

geography lady
June 4, 2012 11:10 am

EPA in Washington DC (headquarters) has not changed in how they handle dusts (the different sizes and types-referring to asbestos, silica and coal) and human safety exposures. The levels are suppose to be based on health studies of working environments or actual living/environment conditions. They may be based on animal or cellular studies if the former do not exist. I can’t imagine placing people in experiments that are suspected to be hazardous. But often times the levels of “safety” are based on suposition of animal studies or working conditions, not on actual factual data.
I have over 35 years working on asbestos issues and exposures. EPA-Washington DC. is junk science. They use in their literature that “as little as one fiber will cause cancer and death”. This statement is not based on anything other than a quick, off the cuff remark made by Dr. Selikoff at a meeting at NIH when he was pushed into saying what was a “safe exposure”. So a remark by L. Jackson that micro dust will cause death and therefore not exposure is safe, doesn’t surprise me. But life can be hazardous, for eventually if we are borne, we will eventually die.
I seperate out EPA headquarter from the real scientists at RTP that I have worked with in the past. They didn’t believe 1/2 the stuff put out by Washington.