The EPA says categorically that its new rule will not permit testing on children. However, the EPA will permit “observational studies” of children who are already being exposed to pesticides in their daily lives. This is not just farm workers. “Off” is a pesticide for EPA regulatory purposes. And children who play soccer on nicely kept fields or who use dishwashing soap are exposed to pesticides. Any product that “kills germs on contact” contains a pesticide.
Recently the EPA sponsored a study of children who come in contact with pressure-treated wood (which contains a pesticide). This wood is widely used in playground equipment.
EPA will permit such studies (which may require monitoring of behavior, testing urine, drawing blood, etc.) under strictly controlled conditions if there is parental consent, or in the case of children where parental consent is impossible if an independent “Institutional Review Board” finds that the proposed research meets a very stringent set of requirements.
Do you think we would all be better off if such studies were prohibited?

Posted by: JR | Sep 20 2005 19:02 utc | 3

I am still bothered and angered that the EPA would even discuss the possibility of a different and lower standard of care in testing to be applied to abused and neglected children.
My problem is that neither from the Sun’s article nor from Billmon’s post I do get ANY information that EPA is really lowering the standards. Is there any mentioning of “before” and “after”?
Looking at the “request for comment” from EPA, I do not find the evidence the Sun article makes me assume that it is there.
I am sick of getting manipulated from the right. I don´t need the same shit from the left.
There are reasonable points pro and con and I would like a discussion about the pros and cons not just simple bullshitting.

Posted by: b | Sep 20 2005 22:47 utc | 5

What’s the Context for this?
EPA acceptance of overseas industry studies, which are often performed in countries that have minimal or no ethical standards for testing, as long as the tests are not done directly for the EPA.
Isn’t this the EPA’s equivalent of Nike’s beat ’em & starve ’em, but do it overseas & subcontract. Goddamnit, No Fingerprints!

Posted by: jj | Sep 21 2005 3:12 utc | 7

Check out Democracy Now! past December and May :
Guinea Pig Kids: How New York City is Using Children to Test Experimental AIDS Drugs
Hundreds of HIV+ Foster Children in NYC Subjected to Experimental Drug Trials

Posted by: John Francis Lee | Sep 21 2005 4:05 utc | 9

In a way the links that JFL has posted tell us how impossible this problem is to solve simply by regulation.
There were controls on testing kids that had people to look out for them so the drug companies skirted the issue by finding kids with no such protection and (presumably) bribed their ‘guardians’ by offering resources to organisations badly in need of money and staff.
If the regulations are tightened up sufficiently in the US then the companies will move their experiments offshore to somewhere without such stringent rules or where enforcement can be ‘persuaded’ to look the other way.
I do have to agree with liberterians when they argue that in many cases regulation makes the regulators content because they feel they have done something but doesn’t do much for those that the regs are meant to be addressing.
This is particularly true when the rules become complex and arcane the way these rules seem to be heading.
There has to be a better way to skin this cat because dealing with problems this way doesn’t really help anyone bar lawyers and experts.
As long as researchers’ benefits are dependant far more on outcomes than the amount of work they have put in we can expect corrupt research practises such as uninformed consent and plagiarism.
And yes I am aware that paying no mind to the quality and relevance of the research output would create a system redolent of the excesses of the soviet system, but it is critical that we find a medium between the two.
Scientist are humans first which means in general that they have the ethics they can afford to have.
Now it’s not possible to go back in time to the era when scientists’ remuneration and status wasn’t so dependant on satisfying the needs of large corporations and show that only ethical and humane research was done then.
However many of the worst cases that we now know about were probably not considered to be that ethically suspect at the time. The difference is a change in social mores.
Research committees were aggressive in ensuring that research was ethically sound and they did consider themselves to have professional standards of conduct. The narrow range of people that had the opportunity to be researchers meant that many issues were comepletely outside the committee members’ range of experience and therefore consideration.
This is no longer the case but research committees themselves tend to be comprised of members heavily dependant on corporations for their careers and their funding.
The EPA can make as many rules as they like but until there is a better seperation between resources, status and corporate outcomes, these rules will be honored in their avoidance rather than their application.

Posted by: Debs is dead | Sep 21 2005 6:59 utc | 11

Mary, Ferrie & the Monkey Virus:
The Story of an Underground Medical Laboratory
by Edward T. Haslam
1995, Wordsworth Communications
ISBN 0964398125
Illustrated, 258 pages.
Review by Kelleigh Nelson:
Ed Haslam’s book is a major dot connector. Think about it. We already know thanks to A&E’s Investigative Reports that Oswald did NOT kill Kennedy, but that’s not the big jist of this book. What needs to be understood is that the polio virus vaccine all the baby boomers received via shots and sugar cubes in the 50s and 60s was contaminated with SV-40 Simian Monkey Virus…the results…an epidemic of soft tissue cancer. And SV-40 shows up in autopsies of cancer victims. However, even more horrific is that the SV-40 contamination does not end with those of us that received the polio vaccine. It is passed to our children and grandchilren even though they have not received the vaccine. Who is responsible? Ed Haslam’s fabulous research was given to us in this book in 1995, and five years later, in the February, 2000 issue of Atlantic Monthly, it is finally discussed by the “regular” media.
THIS BOOK IS IN PRINT
Available commercially.

Posted by: Uncle $cam | Sep 21 2005 12:12 utc | 13

hm
Yet, despite the absence of a medical justification for mass screening, “It’s going like a house on fire.” Indiscriminate screening is an ill-advised irresponsible policy. Acceding to researchers’ demand for access to the DNA of newborns exposes infants to unnecessary, even harmful treatments – babies who would otherwise have led normal lives may become prisoners of medical providers. The Times reports that “in most states today, parents are not asked if they want their babies tested, though they have the right to decline it; it is simply done, with the cost, about $70 to $120, built into their hospital bills.”
Another ill-advised, government sponsored screening initiative was recommended by the President’s New Freedom Commission on Mental Health– the entire population is to be screened for undetected mental health disorders – even though no valid, objectively verifiable screening tools exist.
story also includes 60 minutes report
But some of the patients in the Sonoma State study were put through painful procedures like the pneumoencelphalogram, in which air is injected into the brain before a series of X-rays. “Imagine puncturing someone’s spinal cord, drawing fluid out and putting a foreign substance in there. Gas,” says Karen. “When they trap air in your body, you’re in pain, excruciating pain, for days.”
“They were the raw material of medical research,” says Susan Lederer, who teaches medical history at Yale University. She was a member of the presidential committee that investigated the radiation experiments, and she says she wasn’t shocked by the findings because researchers have been using disabled children in experiments for over a century. “Children in orphanages, children in homes of the mentally retarded, these are all good populations from the sense of medical research, because you have an easily accessible group of people living in controlled circumstances, and you can monitor them,” says Lederer.

Posted by: annie | Sep 21 2005 14:17 utc | 15

Let’s look again at EPA language quoted above:
“Much research of relevance to EPA decision-making is conducted by people who are not regulated by the Agency and can be presumed to have no intention to submit it to the agency. This may include research done in academic institutions, much research done outside the U.S., and a substantial portion of published research. As a practical matter, EPA is unable to identify in advance what research (conducted without the intention to submit it to EPA) might someday be relevant to an EPA decision.” (emphasis mine)
It is my understanding that most US academic institutions, even when conducting studies sponsored by corporations or other private entities, assume compliance with Good Clinical Practice; and these guidelines actually exceed the federal regulations protecting human subjects.
Most European countries also comply with Good Clinical Practice. So rather than comparing US standards with Swedish standards (which at the very least meet US standards), compare with standards in countries that do not have meaningful human subject protections — say, in Africa.
But what the EPA language suggests to me is not that they propose to fund studies without adequate protection (let alone intentionally harm anyone), but rather:

1. In some cases not commission certain studies at all, conveniently declining to fund studies that might prove problematic — be it because of budget, or an attempt to sidestep regulations — and instead rely on private and/or overseas studies
2. They are therefore able to avoid applying important human subject protections to these studies, and instead apply a different ethical standard — the “ethical standards prevailing at the time the research was conducted,” which means that country’s presumed standard
3. Therefore they let themselves and/or the corporations who conduct the study off the hook unless it meets a lower ethical threshold — they can shrug their shoulders and say “Hey, it was out of our hands, but let’s use the data, anyway”

Remember that prior to 1962 the ethical guidlines for human testing was generally low, and prior to the Nuremburg Code of 1948 there were essentially NO guidelines. The EPA is literally saying they could use Dr. Mengele’s research given the standards of the time. Not that they’re stupid enough to do so, or that they would even consider it; but rather that other, less-horrifying but still pernicious studies could be used. And that is an issue.
Finally, remember from whence this proposal comes: the Bush administration. They are fundamentally anti-science and anti-regulation. EPA veterans have quit in droves given the hostility to anything other than corporate concerns. We can assume that if the Bushies create a loophole, they intend to drive a Mack truck through it.

Posted by: Sakitume! | Sep 21 2005 17:08 utc | 17

In a different issue Laura Rozen sees the same problem with some arguments/reports against the right I see with my post on the EPA stuff.

Granted, the temptation to use neoconservative standards of evidence to make a case against the neoconservatives is tempting, but doesn’t that defy the liberal argument against the whole Iraq-did-9/11, Niger docs, Atta-in-Prague paradigm in the first place?

Posted by: b | Sep 21 2005 20:05 utc | 19