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Thanks to Post Human Blues and Sentient Developments for this:
And while I pondering technology and our future, IEET published a piece by Randall Mayes that gets to something about blood substitutes that I didn’t know:
The FDA has placed a number of blood substitutes in clinical trials at selected hospitals for accident victims in the United States which are trauma victims in life threatening situations. Although blood substitutes do not have white blood cells found in whole blood, they have hemoglobin from expired human blood to carry oxygen.
Biopure’s Hemopure failed in the United States, but was approved for use in South Africa. Unfortunately, in the United States the other candidates have either failed or were withdrawn due to side effects including liver and kidney failure, irritated blood vessels, and heart attacks.
The most promising candidate, PolyHeme, was developed by Northfield Laboratories to overcome the drawbacks of working with whole blood. It has a shelf life of over twelve months while stored at room temperature, is purified it to minimize risk of viral disease transmission, and is compatible with all blood types.
In circumstances where a patient at least eighteen years old is in critical condition at the scene of the injury, random patients either received saline solution or PolyHeme for up to twelve hours as needed after transported to selected trauma centers. It was one of the few candidates to complete phase III clinical trials, but it also failed to win approval with an unfavorable risk-benefit assessment.
In 2008, the Journal of American Medical Association released the paper, Cell-Free Hemoglobin Based Blood Substitutes and Risk of Myocardial Infarction and Death, which is a meta-analysis study of 16 clinical trials of blood substitutes, including 5 products, and 3711 patients. The paper was the bearer of bad news as it revealed patients in clinical trials had a 30 percent greater chance of death when compared to a control group.
The Informed Consent Dilemma
Humans are involuntarily used as guinea pigs for blood substitute clinical trials? In 2006, those living in 32 communities in 18 states and anyone traveling through these communities were potential guinea pigs without consent in Polyheme’s Phase III clinical trials. PolyHeme is the fifteenth experiment allowed by the FDA for emergency medical trials exempted from informed consent.
This is disconcerting since one of the distinguishing factors between eugenics and transhumanism is that the H+ movement is based on voluntary use of medical treatments and artificial human enhancements. But, what if someone is incapable of giving informed consent and a blood substitute is the only hope for survival to an accident victim or a soldier?
In order to avoid participating in the clinical trials, citizens had to inform their local testing site and wear a medical bracelet. Although I live several blocks away form the Duke University Medical Center which is one of the trauma centers across the United States which is sanctioned by the FDA, I was not aware of the clinical trials or the exemption procedures.
Even more disturbing, bioethicists Dickert and Sugarman disclosed in the Kennedy Institute of Ethics Journal that Northfield Laboratories was able to withhold proprietary data relating to the trials which remained unpublished because they had no government requirement to report problems . It wasn’t until Public Citizen filed a law suit that FDA released the data.
I have restored my interest in skeptical blogging on education and humanities. I just needed a good little while to get enough stuff done to have something to write about.
“It will sometimes strike a scientific man that the philosophers have been less intent on finding out what the facts are, than on inquiring what belief is most in harmony with their system.” -Charles Sanders Peirce
Which brings me to today’s post. Living In Dialogue has blogged about how the National Governor’s Association has set-up a council for new national standards that literally only includes one teacher and will be kept completely confidential until it is complete.
Now the other shoe has dropped. On Wednesday, the NGA and the Council of Chief State School Officers (CCSSO) released their plan for developing national standards for Mathematics and English.
They propose a process that will result in new national K-12 standards by next December, and launched a new website where we can watch the magic unfold. They also released the names of those on the Mathematics and English “Work Groups” that will draft the standards, and the “Feedback Groups” who will advise them once drafts have been offered. We are informed that “The Work Group’s deliberations will be confidential throughout the process.” As far as public input, “States and national education organizations will have an opportunity to review and provide evidence-based feedback on the draft documents throughout the process.” There does not appear to be any avenue for the public at large, students, parents or teachers to provide direct input.
So who makes up the two Work Groups? Of the 25 individuals on the two teams, (four people are on both) six are associated with the test-makers from the College Board, five are with fellow test-publishers ACT, and four are with Achieve. Zero teachers are on either Work Group. The Feedback Groups have 35 participants, almost all of whom are university professors. There appears to be exactly one classroom teacher involved in the entire process, on one of the Feedback Groups.
Now if that isn’t bad enough, look who the people are ACT and the College Board who make standardized tests are setting the standards. While I understand wanting to keep interests out of the situation and stop a lobbying fiasco, there is a clear conflict of interest in turning the various private testing boards into such power blocks. Furthermore the push to send everyone into some sort of credentialing has increased. Georgia’s Work Ready program is already using a test designed by the ACT to certify people for work.
We can’t be fairly skeptical or positively evaluate these standards, because they are matters of trade-secret.
I actually think national standards are a necessity, but I do not think literally teaching to the test by having the private test-makers set the standards is a smart way to do this NOR is something the most successful educating nations do like Finland or Canada. I also don’t think everyone who goes through a secondary school needs to be college bound.
And besides teachers, parents, and children, why aren’t more NOT partial cognitive sciences and education researchers who aren’t tied to a test-making body included? In fact, I think the later are more important than the former.
Another thing that bothers me is that this continues to ignore science education and the boarder humanities, BOTH are suffering severely under the current focus. Science literacy is key for many areas of life and its omission is truly tragic.
Why do politicians and testing-organizations get all the power? I think the obvious answer is that they already have it and don’t want to give it up. For those who thought that perhaps most sensible or a more inclusive view of education may come out of the Obama era or the state governors, I think we still have every reason to be skeptical.
