September 20, 2005
WB: Paging Dr. Mengele
Paging Dr. Mengele
Hmm - not quite so. That Baltimore Sun report Billmon cites avoids a lot of context. It is mostly pure manipulation.
We usually blame the right-wing for avoiding context and bending the facts to their liking. We probably should not fall into the same hole (though I admit, sometimes it just happens and sometimes is even fun to do so.)
Please see for yourself:
The EPA briefing is "inviting public comment on a rulemaking", it is not rules set forth. A fair but critical article about the proposed rules would be welcome. But like in any text you can take bits and put them into a bullet point "Ethically deficient" like the Sun or manipulative cite them like this:
Unless there is clear evidence that the conduct of that research was fundamentally unethical (e.g., the research was intended to seriously harm participants or failed to obtain informed consent), or was significantly deficient relative to the ethical standards .., EPA will generally accept and rely on relevant, scientifically valid data from research
Nasty, isn´t it? They really allow unethical studies - these assholes.
But here is the full text (emph. mine):
Sec. 26.601 Human research conducted prior to [effective date of the final rule].
Unless there is clear evidence that the conduct of that research was fundamentally unethical (e.g., the research was intended to seriously harm participants or failed to obtain informed consent), or was significantly deficient relative to the ethical standards prevailing at the time the research was conducted, EPA will generally accept and rely on relevant, scientifically valid data from research that:
(a) Was initiated prior to [effective date of the final rule],
(b) Involved intentional exposure of a human subject,
(c) Did not involve intentional exposure of a pregnant woman, fetus, newborn, or child, and
(d) Is being considered under the Federal Insecticide, Fungicide, and Rodenticide Act or the Federal Food, Drug, and Cosmetic Act.
Can we use data today from studies about pesticitey influence on human health done in the 1960s? We better do so in my view, even if we would probably never allow such studies again.
Another example for a bit of redacted citing are the "neglected or abused children". Read the paragraph:
.. if the IRB [an independent oversight group] determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, State or local law.
Not quite Dr. Mengele's empty pages rulebook.
The "direct benefit" bullet point the Baltimore Sun cites as a negativ is not only not bad, it is good and standard procedure. The EPA paper says:
EPA will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds and documents that:
(a) The risk is justified by the anticipated benefit to the subjects.
(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches.
(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in Sec. 26.408.
The EPA paper also asks specifically for public comment on the above rule.
Imagine having children with some kind of very nasty, painful skin condition and no current medicine is helping. Would you allow the use of something that "might well" help but "maybe might" harm? Well, I probably would. Essentially it is the question some parents have to answer when allowing chemotherapy on children with cancer. Usually they go for it.
The last point the Baltimore Sun makes is on the use of foreign studies. Yes, there are countries with bad testing ethics, but there are also countries with good testing ethics and EPA has been accused before for NOT allowing test results from Sweden and elsewhere to influence its ruling. So this point, like the others, depends on the frame you choose to use.
I would love to blast on EPA for several issues. There are even good points to make against the proposed ruleset. But the Baltimore Sun here is not doing a reporting job. It is manipulating the reader with fear by taking issues totally out of context.
That is a typical right wing tactic and I see no reason why the left should go down that path.
Posted by b on September 20, 2005 at 10:32 AM | Permalink
Paging Dr Occam.
Posted by: pb | Sep 20, 2005 12:51:02 PM | 1
Or, "Bush to Public: Drop Dead".
After the infamous Thalidomide study (deformed babies, etc) and the infamous Tuskegee Syphillis Study, so much has been done in this country to regulate and guide the ethical treatment of human subjects, which includes procuring informed consent. Under the Common Rule, persons with diminished capacity -- and surely abused children count among this group -- are entitled to additional protections, NOT fewer protections!
Certainly this decision follows neither Good Clinical Practice nor the International Ethical Guidelines for Biomedical Research Involving Human Subjects. Though commonly adhered to in the US, maybe the Bush administration thinks these guidelines are just for Eurofags.
Sue 'em and fuck 'em. I cannot believe the EPA's decision is legal, say nothing of unethical. Paging Dr. Mengele, indeed.
Posted by: Sakitume! | Sep 20, 2005 2:22:10 PM | 2
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 3:02:45 PM | 3
Despite reading everything here that tries to put the Baltimore Sun report in context, and assure us that the EPA is not really as bad as Dr. Mengele, 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.
I don't know what other conclusion you could possibly draw from knowing that such a discussion is taking place within our government other than the one that Billmon's headline does.
Posted by: bcf | Sep 20, 2005 6:31:26 PM | 4
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 6:47:36 PM | 5
I used this story on the radio Sunday, but I am chastened, I think B makes a good case. At least further reference is required here; no single sourcing for an article like this.
Posted by: Malooga | Sep 20, 2005 7:04:54 PM | 6
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 20, 2005 11:12:00 PM | 7
(CYA - Nike & the rest of the apparel industry. Don't mean to imply they're the worst or only culprits here.)
Posted by: jj | Sep 20, 2005 11:14:33 PM | 8
jj, the context is this: the EPA rule is not merely about restricting testing. It also imposes complex rules for establishing independent Institutional Review Boards, obtaining informed consent, and documenting everything that is done. (This stuff is expensive and time-consuming and compliance is highly technical.)
Now, suppose a study is done at a Swedish university in accordance with Swedish regulations. The study fails the technicalities of the new EPA rule -- the researchers have never even read the rule, much less tried to meet its requirements. They have their own onerous Swedish regulations to comply with. The study shows that a certain pesticide is unsafe to children. They publish the results in a reputable journal. May the EPA consider the study? You think it may not. In fact, you think that the EPA may not read articles in scientific journals at all unless the research was pre-cleared with the EPA. The EPA disagrees with you.
Here's how they put it:
"EPA considered extending its codification of the Common Rule to all
human research which the Agency obtains and uses in its decision-
making, without regard to the intent of the investigators or sponsors to submit it to the Agency. This approach would extend Common Rule protections to the subjects of a wider range of research, but it would entail serious problems in implementation. 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. Thus, a researcher could not readily tell before conducting the research whether it would fall within the scope of an extension of EPA's Common Rule. The researcher would only know with certainty whether EPA had decided to use the results of his or her research after it was completed, when it would be
impossible to comply with the Common Rule. The commitment to comply
with the Common Rule must be made before conducting the research, since it imposes procedural and other requirements on the conduct of the research. Thus, the requirement to comply with the Common Rule must also be known before the research begins. While EPA has not put this forward as its preferred approach, the Agency encourages comment and suggestions that may modify its proposed position."
Posted by: | Sep 21, 2005 2:19:13 AM | 10
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 2:59:01 AM | 11
i really can't believe that this is even a discussion. testing on kids is just not an option. period. would you let your kid or pregnant wife be the guinea pig? i bet not. billmon's post is right on the money. it is not the semantics but it is the fact that it is even brought up! in order for the public to join the discussion the public needs to be informed. unfortunately only a few news outlets report and the "public" is not shut off from the discussion but is basically unaware of such a discussion even happening. assuming that the epa has been politicized by cronies of this administration as other gov't agencies have, would you trust them?
Posted by: | Sep 21, 2005 3:41:33 AM | 12
Mary, Ferrie & the Monkey Virus:
The Story of an Underground Medical Laboratory
by Edward T. Haslam
1995, Wordsworth Communications
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
Posted by: Uncle $cam | Sep 21, 2005 8:12:54 AM | 13
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 10:17:59 AM | 15
The Democracy Now report John FL linked and the WaPo story dk links to are exactly the reason why such regulation is needed.
The argument you should never test in children is wrong in my view. If there is a possible new anti moscitos spray available you do want to test that before allowing widespread use.
If it works better than DDT and other nasty stuff, several million childrens per year living in malaria areas could survive. But you want to make sure they are not harmed by that stuff. Thereby you test before use.
Posted by: b | Sep 21, 2005 12:48:35 PM | 16
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:
- 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
- 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
- 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 1:08:06 PM | 17
has anyone else here seen the flick THE CONSTANT GARDNER
the main culprit that emerges is the heavy hand of greed as the pharmaceutical companies exploit helpless victims of tuberculosis for the purpose of testing and marketing an experimental drug
i recommend it
Posted by: annie | Sep 21, 2005 2:10:45 PM | 18
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 4:05:55 PM | 19
There is nothing conservative or liberal about this issue. EPA is not permitting testing of unapproved pesticides on any children regardless of where they live or what their status is.
The issue is, how do you study exposures that kids already are subject to?
The studies do not expose children to any more pesticide than they are already, legally, exposed to. So these studies will either not change the status quo or will lead to the banning or restriction of use of pesticides.
They can't possibly increase the hazards that children face. They can only limit those hazards.
Posted by: JR | Sep 21, 2005 5:42:59 PM | 20