Dr. Broun, now the chair of the pertinent subcommittee, was almost right in his response to the pathetic report of the US EPA Inspector general on the Human Exposure Experiments scandal.
The problem is that Dr. Broun didn’t get good legal advice on the ethical rules for EXPERIMENTAL USE OF HUMAN SUBJECTS, which is different from medical consents that he is familiar with.
quote from Nazi doctor Josef Mengele:
“The more we do to you, the less you seem to believe we are doing it.”
I just received the response from Dr. Broun. Provided By SST.
His effort is to condemn the IG report that white washes the EPA misconduct on human experiments.
Here is the link to the IG’s pathetic report that says no problem, EPA just needs to be more careful of consents.
Here’s Dr. Broun’s letter from the committee.
For Immediate Release
April 2, 2014
Media Contact: Zachary Kurz
EPA Conducted Experiments on Humans with Cancer-Causing and Lethal Pollutants
Washington, D.C. – In response to a request from Oversight Subcommittee Chairman Paul Broun M.D. (R-Ga.), the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) today released a report that examined whether the agency followed applicable laws and procedures when it exposed human subjects to diesel exhaust, particulate matter and ozone.
The EPA conducted five research studies in 2010 and 2011 involving 81 human subjects during which the OIG determined that “exposure risks were not always consistently represented,” and the agency “did not include information on long-term cancer risks in its diesel exhaust studies’ consent forms.”
In his letter that requested the OIG report Chairman Broun noted that numerous EPA sources, including the agency’s own science, indicate that even at low levels these pollutants can cause death, cancer and other negative health effects. Despite EPA regulations establishing a presumption against human experiments “involving risk of substantial injury to a human subject” or “irreversible health effects,” the OIG reports that the agency tested extremely high levels of pollutants. According to the report:
“Diesel exhaust is a complex mixture of more than 40 toxic air contaminants. These include 19 known or suspected carcinogens, such as benzene, formaldehyde, and 1,3-butadiene.” (Page 6)
“A 2006 EPA assessment document further reports associations between short-term [particulate matter] exposures and mortality and morbidity.” (Page 22)
“The EPA classifies diesel exhaust as ‘likely to be carcinogenic to humans by inhalation’” (Page 23)
Chairman Broun: “It is abhorrent for EPA to be conducting these human experiments without providing robust information and notification to the patients about the risks of death and following the strictest protocols. While the EPA champions protecting human health, in one case, EPA doubled the amount of particulate matter it was exposing individuals to without fully informing the participants or all the proper ethical review boards. This blatant disregard for the safety and well-being of others is despicable, and the proper steps must be taken to ensure that such carelessness does not occur again.”
The OIG’s report revealed troubling details:
· “[E]vidence suggests that at least some human study subjects would like to know if a study involves risk of death, even if the risk is very small. In the future, the EPA should include the long-term risk of cancer to potential subjects in its consent forms so study subjects can make the most informed decisions about whether to participate in a study.” (Page 25)
· “[W]e found that the five studies’ consent forms inconsistently addressed the risks of being exposed to [Concentrated Airborne Particles] and diesel exhaust.” (Page 19)
· “[O]nly one of five studies’ consent forms provided the subject with information on the upper range of the pollutant he or she would be exposed to and only two of five alerted study subjects to the risk of death for older individuals with cardiovascular disease.” (Page 21)
· “Only two of the five studies’ consent forms included the risk of death from exposure to high levels of selected air pollutants such as [Particulate Matter] and diesel exhaust, and only one study’s consent form included the upper limits of exposure levels.” (Page 24)
· “The EPA did not report two of the six adverse events it identified in a timely manner…” (Page 29)
· EPA “defines an adverse event as undesirable and unintended, though not necessarily unanticipated, injury or physical or emotional consequence to a human subject. These events can be serious and/or unanticipated.” (Page 5)
· “An August 2013 article in the Journal of Clinical Best Practices states that ‘most people would want to know whether a medical procedure involves a risk of death, even if the chance of dying is very small.’” (Page 24)
The full report can be found HERE.
The full report by the IG can be found HERE.
So you read the Broun response above.
Read my hot objection to his response.
Dr. Broun, a well-intentioned physician who should know better, got terrible advice. This is the reason he screwed this up. He thinks in terms of a practicing physician who get’s consent for treatment.
That is not what consent for experiments is about. If I propose a treatment it may have some downside risks that must be revealed to the patient. If I propose to do an experiment on a person, a subject, I am not offering them a treatment with some side effects or negative effects that require informed consent.
HOW COULD BROUN NOT BE AWARE OF THE DIFFERENCE? EASY, NO ONE TOLD HIM. HE DOESN’T NECESSARILY UNDERSTAND. And the IG set up a straw man.
Broun is a practicing physician who understands consent to treatment issues. He does not understand ethics issues as they relate to human subjects in experiments.
SOOOOOO, Broun is just plain wrong and he has been suckered by the IG, into the IG game of ruminating on the consent issues and the small risk of exposure to small particles. Small? I thought Lisa Jackson said it was the equivalent in impact to cancer in testimony before Congress. See my essay above.
In fact the IG is recognizing that the EPA probably exaggerated the small particle toxicity and now wants to provide cover for them, even though the EPA claimed small particles kill hundreds of thousands of Americans every year. Consent is not the issue and Broun got suckered into taking up the IG arguments and assertions, which were mendacious.
Sure he properly condemned the conduct of the EPA but in an ignorant way. If he would have called me I could have got him up to speed in 5 minutes without notes. His staff is incompetent.
These Congressmen travel around with satchel and briefcase carriers who think they know stuff–sometimes yes, sometimes no.
The Common Rule and all the other ethics guidelines and legal precedents, AND COMMON SENSE, DAMN IT, PROSCRIBE EXPERIMENTS THAT EXPOSE SUBJECTS TO HARM—PERIOD.
Risk of harm stops the experiment. NOT NECESSARILY LETHAL, JUST HARMFUL but in the case at hand the experiment was exposing subjects to what the EPA stated killed 300,000 plus Americans annually. No experiment is justified or legal or ethical.
That’s a risk of harm—the gall of the IG to say the risk was slight, given he EPA position and publications, their claims of how they are going to save hundreds of thousands by reducing small particles.
I say the IG is mendaciously running cover for the EPA project.
We know, don’t we, that EPA says small particle pollution kills, so that’s it—THAT’S IT. NO EXPERIMENTS.
Don’t adults supervise and review statements from congressional Committees after reviewing the appropriate materials. Look at the Common Rule, the Nuremberg Code, the Helsinki and Belmont guidance on ethics in human experiments.
The IG lied, Broun accepted their lies and tried to condemn the EPA for failure to get proper consent when he should have pointed out—game over, IG, you are mendacious or ignorant in your report—this is not about consent, it’s about immoral/unethical/illegal human experiments that create a risk of harm, even death.
IF THE EPA BELIEVES THEIR STATEMENTS ABOUT THE HARM FROM TOXICITY, CARCINOGENICITY, AND LETHALITY OF SMALL PARTICLES THEY ARE PROSCRIBED BY LAW AND CUSTOM AND ETHICS FROM DOING ANY EXPERIMENT. CONSENT IS NOT A CONSIDERATION. SUBJECTS ARE NOT ALLOWED TO CONSENT TO HARM OR DEATH RISKS.
Broun should have said, we need to have another hearing so we can find out who is responsible for this IG report and review the law and ethics on human experiments.
John Dale Dunn MD JD signing off—America is plagued by mendacious and perfidious miscreants.
Broun just got suckered and got no help from the committee’s staff or lawyers who should have read the Common Rule, the Nuremberg Code and other ethics guidance. Easily done in 15 minutes. Use Google, Idiots. I am just an emergency physician in the country and I know more about the ethics of such a thing than a US Congressman with a retinue of sycophants?
Here’s my essay from yesterday that explains the ethical issues and gives the text info.
Here’s my essay today that shows that everybody is covering for the EPA and the sponsored medical schools and faculty.
Dr. Broun got dragged into the perfidious IG set up about well, gee maybe a better consent would have done it, after all it’s not that toxic.
I never said the EPA told the truth, I said that the EPA is PROHIBITED from doing experiments with substances it claims are toxic—even if they weren’t toxic. What would an innocent subject know?
Since the US EPA claims that small particles are lethal, every subject was battered or subject to mental distress—get that, civil and criminal Battery adn infliction of mental distress.
I am just sick—Dr. Broun wants to be a Senator, and he gets pulled into a stupid morass by a mendacious and duplicitous IG report that didn’t properly state the ethical prohibition against experiments that harm—much less kill?
There are some extreme situations where subjects might be allowed to consent to harm—but the benefits must be compelling and the circumstances unique. For example some ethicists allow for a situation where the researchers expose themselves for compelling reason and accept a risk of harm.
I am not really mad at Dr. Broun for his report—it gives me a chance to emphasize how the IG created a straw man to deal with when the rule is no, not only no but hell no—you can’t expose human subjects to harm anytime anywhere, and subjects cannot consent away the prohibition. End of lecture. I teach ethics to Emergency Medicine Residents, I be an expert, and not just because i stayed at a Holiday Inn Express.
Do I make myself clear???