quote:In a rare exception to the way clinical trials are conducted, Loyola University Health System plans to test an experimental blood substitute on patients without their permission.
quote:The PolyHeme trial will be at least the second major blood-substitute study on trauma patients. In 1998, Baxter Healthcare abandoned its HemAssist blood substitute after a study found that patients who received HemAssist died at a higher rate than those who received standard care.
In case the article doesn't make it clear, the "subjects" in the older study didn't get to say "no" either.
Not only that, but when the story of the discontinuation of the 1998 story broke, no mention was made that the study was conducted under the exemption for "informed consent" - or consent of any kind, for that matter.
(there's an article on a website that consists mostly of quotes from me. I didn't exactly write it. The editor cut and pasted some email rants I did on the subject - especially about the media's amnesia. The NY Times reporter who wrote about the change in FDA regs that created the exemption also wrote about the discontinuation of the Baxter artificial blood study.)
I connected the dots for a reporter at the Chicago Trib who did a story that still ended up slanted in favor of the practice of doing this kind of research without permission of the people being used as guinea pigs. (And, no, I got no credit for connecting the dots for the reporter, either.)
I put in a call today to the ACLU, which claims to fight for fundamental human rights. I haven't gotten a call back yet. For reasons I have yet to fathom, they don't see a connection between a "right to privacy" - which they claim to support and a "right to get to say no" to being an experimental subject.
Hard to figure out who I'm not angry at today.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
posted
No lawsuits. The FDA authorized the waiving of consent, so it's legal. No grounds for a lawsuit.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
posted
Well, I know one thing. We need to be sure that whatever hotel gets picked for Jatraquon/KamaCon is more than 10 miles from Loyola.
In all seriousness, though, it should be noted that these are NOT patients who would otherwise receive blood -- they would receive SALINE. While I am not sanguine about this, I am not nearly as troubled by this specific case as y'all seem to be.
I am very concerned about the broader implications.
Posts: 32919 | Registered: Mar 2003
| IP: Logged |
Those in the "control" group who need blood when they get to the hospital will get blood.
Those in the "experimental" group will continue receiving the blood substitute for up to twelve hours or 6 units (whichever comes first, I guess.)
Yep - it is actually a formal reversal of the Nuremburg Code. Not that we ever formally adopted it as something that applies to ourselves.
This is just the tip of the iceberg - in recent years, restrictions on "enlistment" in medical research of those unable to give consent have been loosened considerably as well.
Edit to add: Remember also, rivka, that the earlier study had similary high expectations and assurances of low risk. Turned out not to be true.
posted
My office is in the town right next to Maywood (the Chicago suburb where Loyola is located) - less than 2 miles.
The whole idea of informed consent is that human beings have a right to weigh the potential risks and benefits of any given study, and decide for themselves whether or not to participate.
I don't want to villanize the researchers, either. I'm sure they're convinced the risk is low (the researchers in the other study were convinced of the same thing). But, researchers are human, and subject to being motivated by multiple concerns.
The first is the potential for saving lives. I think that's real - they do care about that.
But...
There's the prestige factor in being a prominent part of an important study;
and the economic incentives - for the researchers (they don't do research for free).
and also for the company (which is in the Chicago community)which will stand to profit enormously if their product is the first to win FDA approval. More profits, jobs, construction of new facilities, etc.
Human rights consideratios aside (not that I want to), one very good reason for requiring informed consent is that it forces researchers to be more accountable (although there have been some rather spectacular failures with this as well.).
This is not a good development at all.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
Loyola is not the first to do this, by far. Not surprisingly, much of the blood substitute research is funded by the military, since blood banks are a limited commodity in a war zone. Ben Taub Hospital in Texas already did at least one study on Polyheme (which is basically free hemoglobin), which by the way has been approved for use by the South African equivalent of the FDA and is on schedule for approval in several other countries (did you know it takes our FDA an average of ten years longer to approve stuff? We won't accept nonAmerican data.) There is already a ton of animal data on it's use, and artificial blood using bovine hemoglobin is also in the works. Completely artificial blood has so far been a complete flop.
Similarly, performing research on patients without their consent is not new, either (and I'm not talking about the Tuskeegee syphilis study, which was actually ethical by the standards of its time, at least for the FIRST twenty years or so....) The FDA has for decades had a policy that exceptions to the informed consent rule can be made for emergency/trauma situations where consent is not possible, as have Institutional Review Boards for non-FDA approved uses of approved drugs or equipment. The exceptions are usually made for field (i.e. prehospital) therapies, often for comparing two known therapies. Examples include trying out different types of antiarrhythmia therapies for heart attacks, new types of airway equipment, or different types of IV solution for resuscitation in trauma. This is no different, and the article is sensationalist. I personally have run four IRB-approved studies that waive informed consent in trauma patients, since I got to New Orleans.
There is nothing paternalistic about this, either. If you have something that works better than the standard therapy in the lab and in animals, sooner or later you have to try it in people. You just can't get informed consent in an emergency (some people argue that you can't really get "informed consent," ever.) The Polyheme study is basically like trying two different IV fluid resuscitation protocols (which has been done MANY times for trauma). It's a big deal because it's "blood," only it's not. It IS a blood product, like plasma, cryoprecipitate, Factor VII, thrombin, and a whole bunch of other things that no one ever seems to have been up in arms about over the last 70 years since transfusions were invented.
I can e-mail you a review article on blood substitutes, if you are interested.
posted
Bob, Correct me if I'm wrong, but your doctor friend reply seems to not really be addressing the issue.... His stance seems to be that it's legal, has been done in the past, therefore it's o.k. to continue to do it.
Posts: 13123 | Registered: Feb 2002
| IP: Logged |
I don't have time to hunt for links right now - got some real work to do.
But a couple of points.
I thought I made it clear in my message that this wasn't new - it's the first time this has visited Chicago since I got here.
While your friend is right about waivers existing for quite some time, they were considered too restrictive for research. As a result, a bunch of bioethicists lobbied the FDA for a change in the regulations. This change was enacted in 1996.
As for nonvoluntary research going back decades, that's true. But a discussion of what some of that entailed doesn't exactly fill one with confidence that researchers should be entrusted with more power in enlisting people without their permission. (example: A lot of the hepatitis vaccine research was done at Willowbrook institution - on kids and adults incarcerated there. Their parents were pursuaded to give consent in ways considered coercive now. This was during the 1960s.)
At the time of the passage of the rules making it much easier to engage in the emergency research, the FDA had finished a review finding systemic problems with the research process in the United States. Slightly over 50% of researchers were failing to meet existing standards of documentation, ensuring informed consent, etc.
Arrrgghhh. More later.
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
posted
We had a similar situation here in our city/county for several years involving the use of M.A.S.T. pants on severe trauma victims. I was working for the ambulance department (volunteer) at the time.
MAST pants are inflatable pants you would apply to a trauma patient and inflate on their lower extremities in order to keep up their blood pressure and reduce shock until you got them to the hospital. They were used on-ambulance only, usually removed in ER.
Only we were a test site for them. So they came up with a plan that we would use them on qualifying trauma patients on "even" days, and not use them on calls on "odd" days. The study went on over 5 years, I believe.
In the end, it was decided that the use of MAST pants did nothing to help survival (there was a much higher rate of patients making it TO the hospital before expiring, but overall, the long-term survival rate for the patients showed that MAST made no longer-term difference in survival rates -- it just basically kept them alive while en route.)
I can see Bob's doctor friend's point about HOW do you test these things any other way? You have no informed consent because usually the patient is unconscious.
In fact, it was quite a joke in town for awhile, that if you were to get in a car accident, you better hope it would be on an "even" day (when people thought they were saving more lives).
I am in agreement with Steven about the need for informed consent on many things, yet I also see a need to reconcile this with research -- otherwise many life-saving devices would never get developed at all.
posted
I just put in a call to WGN "medical watch" - their coverage of this study reads like a press release from the University and the manufacturer.
For one thing, they imply if you don't get the substitute blood product, you won't get blood at all. That's true at the site of the emergency.
BUT as soon as you get to the hospital, if you haven't gotten the experimental product, you'll be given blood, if needed. If you started on the experimental product, that's what you'll get for up to twelve hours.
And, of course, no mention of the previous product trials (a different manufacturer) that had to be discontinued...
How are people supposed to be "informed" if the only side they're getting is the side of the people promoting the "need" for this study and its alleged safety?
Posts: 4344 | Registered: Mar 2003
| IP: Logged |
Printer-friendly view of this topic
![[Mad]](mad.gif)
![[Frown]](frown.gif)
![[Smile]](smile.gif)
