EPA admits to Court: Human subjects ‘may die’ from air pollution experiments

EPA has admitted to a federal court that it asks human guinea pigs to sacrifice their lives for regulatory purposes — and $12 per hour.

EPA has responded to our emergency motion for a temporary restraining order (TRO) against its ongoing human experiment (called “CAPTAIN”) involving the air pollutant known as PM2.5.

In the declaration of Martin W. Case, the EPA clinical research studies coordinator for CAPTAIN, Case claims he verbally warns study subjects before the experiment as follows:

… My first approach after being introduced to the subject by the medical station staff is to ask the subject if they have read the consent form. The subjects for CAPTAIN have been given the informed study consent form on a previous visit, and, they are also given the same consent to read again if they have not read the consent the day of the training…

I provide participants with information about fine particles (PM2.s). I say that PM2.s are particles so small that they are able past through your airways and go deep into your lungs, these particles are so small that your usual lining and cilia of your airways are not able to prevent these particles from passing into your lungs, Therefore, if you are a person that for example lives in a large city like Los Angeles or New York, and it’s been a very hot day, and you can see the haze in the air, and you happen to be someone that works outside, and if you have an underlying unknown health condition, or, you may be older in age; the chances are that you could end up in the emergency room later on that night, wondering what’s wrong, possibly having cardiac changes that could lead to a heart attack; there is the possibility you may die from this

Here’s the analysis of Case’s remarkable admission — that is, if we can even rely on Case’s declaration:

  1. Prohibition on human sacrifice. Every law, regulation and code developed since World War II strictly prohibits human sacrifice (i.e.,significant injury or death) for no health benefit to the patient (the wage of $12 per hour does not count as a “benefit”). EPA employee Case explicitly admits in this declaration that short-term exposure to PM2.5can be lethal.And though Case attempts to distance this warning from the experiment by explaining the risk in terms of a person living “in a large city like Los Angeles or New York”, EPA states in its IRB application for approval of CAPTAIN, “The particle burden, on a mass basis presented to the volunteer will not exceed an exposure an individual receives over a 24 hour period while visiting a typical urban center in America on a smoggy day.” Moreover, EPA has repeatedly stated in numerous regulatory documents and public statements that there is no safe level of exposure to PM2.5 and that any exposure to PM2.5 can kill within hours or days.
  2. Failure to obtain substantive informed consent. Despite Case’s admission that experimental exposure to PM2.5 may cause death, according to the EPA-provided consent form given to study subjects, the risks of experimental exposure to PM2.5 are only as follows:

    PM exposure: During the exposure to the concentrated air pollution particles, you may experience some minor degree of airway irritation, cough, and shortness of breath or wheezing. These symptoms typically disappear 2 to 4 hours after exposure, but may last longer for particularly sensitive people. You will be monitored continuously during the exposure session through a window in the chamber or by closed-circuit television, and can communicate with a staff member via an intercom. Your heart rate and rhythm will also be constantly monitored for any adverse changes brought about by the exposure. In the unlikely event that you develop medically significant symptoms, the exposure will be terminated and the appropriate medical intervention will be provided if required. A physician is always available on the premises to respond to an emergency and full resuscitation equipment is available for use in the event of a cardiac or pulmonary emergency.

    Air pollution particles may induce an inflammatory reaction that can last for 24 hours after exposure and may increase the chance of you catching a cold. You should not engage in heavy levels of exercise for 24 hours before and after the exposure period. If you have any tendency to become uncomfortable in small closed spaces, it is possible that you may become uncomfortable during the chamber exposure. Although the chamber is somewhat small, it has multiple windows and you will be in constant visual contact with the investigator who will be monitoring you during the exposure. You also will be able to verbally communicate with the investigator via a microphone headset.

    So in the place in the consent form where EPA is legally required to disclose to study subjects all the risks the experiment entails, EPA omits death, as well as all the dangers it mentioned to the institutional review board in the IRB application, including:

    Numerous epidemiological studies have demonstrated an association between acute and chronic exposure to ambient levels of particulate matter (PM) and various adverse cardiopulmonary effects including mortality, respiratory tract infection, exacerbation of asthma, chronic bronchitis, ischemic heart disease, and stroke (see review, (1)). A recent national scale epidemiological study has shown that short-term exposure to particulate matter (PM) is associated with increased rates of hospital admission for cardiovascular and respiratory symptoms. The cardiovascular risk tended to be higher in the Eastern United States. This study also indicated a disproportionate risk among the elderly who are exposed to PM (2). Dietary factors such as intake of omega-3 fatty acids have been linked to human susceptibility to the adverse effects of ambient PM (14).Although air pollution exposure has long been known to be a risk factor for respiratory disease, over the last decade, a growing body of epidemiological studies has heightened concern over elevated rates of cardiovascular events related to both short-term and long-term exposure to PM (3). The risk of death from cardiovascular disease (myocardial infarction, heart failure, and fatal arrhythmias) in response to chronically high levels of air pollution was much greater than that from lung disease (4-6). Short-term elevations in ambient PM levels are capable of evoking cardiac arrhythmias, worsening heart failure, and triggering acute atherosclerotic/ischemic cardiovascular complications, particularly in certain at-risk subsets of population (3). PM exposure can result in increases in heart rate, and decreases in heart rate variability (HRV; defined as changes in mean heart rate during 24 hrs, which is a reflection of autonomic tone on the heart (7). PM has been associated with transient increases in plasma viscosity (8), endothelial dysfunction (9) and acute-phase reactants (10, 11) such as C-reactive protein (12). Animal studies have suggested that long-term exposure to low concentration of PM altered vasomotor tone, induces vascular inflammation and potentiates atherosclerosis (13). Despite a decade of intensive studies, much about the PM health effects problem, especially the cardiovascular effect, is still not well understood. The present study is designed to test the hypothesis that genetic expression of the Phase II metabolizing enzyme GSTM1 alters the outcome of adverse responses
    to PM exposure.

  3. Failure to provide/obtain written consent. The Common Rule, as codified in federal regulation 40 CFR 26.117, specifically requires that written informed consent be obtained when risk of serious injury or death is involved in an experiment. As the consent form provided by EPA makes no mention of the risk of death, written consent acknowledging that they are willing sacrifice themselves for EPA regulatory purposes is not obtained.
About these ads

29 responses to “EPA admits to Court: Human subjects ‘may die’ from air pollution experiments

  1. Sounds to me like the EPA just doesn’t get it.

    • Sure it does. You forget that for liberals/regressives the end justifies the means. Wouldn’t it be wonderful to have real, quantified, scientific data that could be used to shut down every diesel engine in America? Certainly that would be worth a few random deaths or cases of asthma.

  2. Caught between a rock hard lie and a political agenda. Glad this unravels. Steve Milloy really did something extraordinary here.

  3. It would be great if the moderator of the next Pres. debate asked Obama why he supports illegal human experimentation. That is the only way this story will be covered by the national media.

  4. Great work Steve Milloy. Has anybody forwarded this to the Romney/Ryan camp? It would make a great campain ad. Your government killing you trying to prove a political agenda. I suppose this proves their computer models are programmed by the same people doing AWG work.

  5. Yikes! Linking at priscillaking.blogspot.com.

  6. What was the chemical nature of the particulate? Some substances are far more harmful than others. Healthy lungs are coated with mucus which is constantly being moved out of the lungs by the cilia. If the cilia are healthy there is nothing magically toxic about 2.5 micron particles. Now, if they were crystalline silica particles, there we have the cause of silicosis. No mention has been made of the substance itself, just the particle diameter.

    • MM, it was diesel exhaust diluted with fresh incoming air.

      However, given the admission by their own people that it was potentially deadly and the statemetns before congress about it being lethal based on particle size alone, that knowledge isn’t even necessary.

  7. The EPA is desperate to “prove” their hypothesis by connecting one or more of these subjects deaths to particulate inhalation as proof positive that their economy busting regulations are worth the price of destroying all energy consuming industries, a fact that bothers them not at all. What is the loss of a few hundred thousand jobs and a percent or two of GDP weighed against their zealous quest to “save the planet.” Accolades from their fellow idealists, royalties from books and autobiographies and visions of a Nobel Prize are far more important than any mundane economic considerations. Some must suffer, sacrifices must be made to “save the planet” but not by them. Their glorification, position of unwarranted authority and power and financial gain trumps all else. A bureaucrats orgasmic fantasy.

  8. I find the EPA’s response to the restraining order, that it is solely to delay regulations, to be extraordinarily and almost laughably weak. They really shot themselves in the foot here. Either (1) they have to admit Lisa Jackson lied to Congress, or (2) they have to admit to illegal and unethical human experiments. Sounds like Hobson’s Choice.

  9. If the EPA can’t follow the regulations it is subject to, how can they expect us to follow the regulations they subject us to?

    • Huh? Who’s going to put the EPA in jail?

      • Captain, any honest person that we can find in the Department of Justice. Definitely not under this president, and maybe not ever (after all, the Tuskegee syphilis trials were much worse and no one was ever held responsible). However, I would love to see Jackson herself behind bars over this.

        The most we can hope for is to throw them out of office and cast a shadow of doubt over any actions in the future, forcing them to bring up good science before they decide to make up the law off of the seat of their pants.

  10. Could this be another example of the strategy, – Push and expand the boundaries of power, influence, control etc. as far as possible until some push back is experienced. Then pull back a little. Yield a fraction of the gain to demonstrate ‘willingness to compromise !?’, Hold the rest and wait until the heat dies down and memories blur. Then repeat the process.
    This is well known and self acknowledged tactic of the Marxist/Socialist /Communist international movement. It goes all the way back to their beginings. It has been used frequently in all sorts of situations during the 20th. Century and is still very much in use today.

  11. Better water boarding by Bush than lethal gas by 0bama.

  12. I’m an education prof, and I am so fed up with all of the useless, irrelevant IRB training modules and paperwork I have to complete to simply ask students to fill out an anonymous checklist survey that asks them about the teaching they experience. Nothing personal. Nothing sensitive. Yet these “researchers” get away with this? I can’t wait for the next training module I am going to have to complete before I can have a similar research project approved.

  13. Nos Lapre from Sydney, Australia

    What can you expect from the U.S. EPA, when they refuse to admit, that the ban on D.D.T. in 1972 was a total disaster and has sofar cost some 60 million lives lost due to typhus and malaria?. When I questioned Ms. Lisa Jackson last year about her persistence in this genocide and that there has never been proof of one case of cancer caused by D.T.T. in humans, while the ban was based on the false claims made by Rachel Carson in her book: “Silent Spring”, written in 1962, I received a very weak explanation from one of her managers. She wrote to me, that the W.H.O. still deems D.D.T. a probable cause of cancer in humans, eventhough they do not have factual proof of their claims! It is very worrying, when institutions like the EPA, the W.H.O. and so many others, like the W.W.F., the Audubon Society, Greenpeace, The Sierra Club etc. have become so immoraly corrupt and powerful enough to sway so many governments. And Obama is totally enslaved by their harebrained ideas and has become a danger to the U.S. economy. Enviromentalists have become rabid zealots since the 1960′s and that is why Patrick Moore, the co-founder of Greenpeace has distanced himself from that group. Prince Philip of Britain himself, has once publicly announced, that he hated humankind so much, that his wish was to return in his second life in the form of a very deadly virus that could wipe out all of man-kind, so that only nature and wild-life would remain. Thus, the main aim of “green” zealots is to sacrifice humans (but not themselves, of course) sothat nature would reign supreme. What a nut-heads and hypocrites!

  14. There’s the barrel, bending over now.

  15. The US government has a long history of Nazi-like human experiments on unknowing and ignorant citizens. The government did radiation experiments on soldiers, but also retarded orphans. The CIA carried out experiments using LSD and other hallucinogens an unsuspecting members of their own services, at least one victim of those experiments committed suicide that the family maintained was the fault of the CIA.

    The fact that the fascist democrats like and encourage human experimentation doesn’t surprise me a bit. After all, the Nazis were socialists too. All communist derivatives are misanthropic at many levels.

  16. thelastdemocrat

    I don’t get it. The full story is not here. The investigators tell the potential subjects some things verbally, but the potential subject does not receive this in writing? The norm is to give you a copy of the consent form you sign, and to provide you with a phone number in case you have a question or problem later.

    These particles are suspected of being harmful based on observational data. They are likely harmful to people with compromised health. If this study is investigating what a sub-threshold level of exposure does physiologyically, such as what physiological reactions get activated, and a doc is right by, I don’t see the big problem in the study idea of exposing people to this pollutant in an sub-dangerous dose.

    The consent process has not been decently presented to us readers, or maybe I missed something.

    • The full story has been dealt out here in bits and pieces, but it’s available on the EPAHumanTesting Site and dealt with pretty fully in the court finding. The forms given to the subjects (which Milloy has) did not mention the possibility of long term side effects. This statement is a “but we really did tell them” cop-out.

      As for the problem, there are rigorous requirements about testing on humans. The quick list is: the data cannot be gotten any other way, they must be fully informed, there cannot be any undue or unavoidable risk, and there must be a real and tangible benefit.

      They hooked up a diesel generator’s exhaust to an air blower and sent the mix of exhaust and air into a test chamber. This isn’t considered safe by any definition (even if we assume these levels of particulate are not dangerous, we are still one failed blower away from Carbon monoxide poisoning). The subjects were not fully informed in writing, and we have only this unverifiable claim to say that they were informed at all that this was potentially deadly according to Lisa Jackson’s sworn testimony before congress. Finally, not only could this easily have been done with animal studies, but there is no apparent benefit to this testing. What benefit could possibly be served by it? It fails every single requirement for human testing.

      What really ticks me off, though, is the hypocrisy. The EPA is constantly framing themselves as the good guys against the evil oil companies, yet they would violate every medical protocol in existence to expose people to what they claim is instantly deadly?

    • “Moreover, EPA has repeatedly stated in numerous regulatory documents and public statements that there is no safe level of exposure to PM2.5 and that any exposure to PM2.5 can kill within hours or days.”

      According to EPA, there is no “sub-threshold” that is safe.

      EPA has no valid objective justification for its seemingly hyper-inflated health benefits from rules that, if promulgated, might mitigate PM2.5.

      The Utility MATS rule has a very small health benefit for Hg reduction, according to EPA. EPA further admits it will cost ratepayers an additional $10 billion/yr to implement this rule. The cost for this rule, in EPA’s own assessment, far exceeds direct benefits. All this information can be found in the preamble to the rule.

      EPA was forced to utilize indirect health benefits to economically justify this rule. Nearly all of the health benefits EPA purports for this rule are due to the indirect impact of PM2.5 reduction when the rule is implemented.

      EPA has used this tact double-counting purported PM2.5 related indirect benefits for well over a dozen rules that do not directly regulate PM2.5 emissions (e.g, Boiler MACT, Portland Cement MACT, etc.)

      This is because the economic analyses for direct health benefits for all these rules cannot possibly stand on their own merit.

      In order to justify these rules on indirect PM2.5 mitigation, EPA must produce a smoking gun (Mr. Milloy refers to this as “the bodies”). Making the claim that tens of thousands of lives will be saved each year is pure hyperbole unless and until it can be backed up by objective data.

      Hence the human experiments.

  17. Uhh. Am I missing something here? You claim the consent form makes no mention of the risk of death, yet the italicized text directly below, which I am led to assume is the actual consent form, mentions the risk of death in the first sentence. It’s the first adverse effect mentioned. Am I crazy, or really just the only one who knows what “mortality” means in a medical context…?

    • What you read was the IRB application… not the consent form. The consent form makes no mention of mortality risk.

      So EPA sort of informs the IRB about some mortality risk, but not the study subjects.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s