Comments on: Company Responds to Human Guinea Pig Story

By: Mark Thompson

Mark Thompson — Tue, 11 Jul 2006 20:26:41 +0000

There are problems–the results from the first phases of tests -read entire results-the company has not released, full release of ALL results from these trials should be mandatory. If being in the test if you are without a wristband is mandatory, the release of all data should be also as threre is alot riding on the outcome of them [read safety and cash].
The makers sent out a presser:
“Lead ANH trial investigator Edward Norris, MD of Johns Hopkins University Hospital, will present the full study results at the Network for the Advancement of Transfusion Alternatives (NATA) meeting in April 2006. We believe his presentation will substantiate our conclusions as does our extensive experience with PolyHeme in trauma settings.”
They had to retact the above after they failed to give the good doctor all the data and Johs Hopkins forced them to write a retraction.

By: Jeremy Z

Jeremy Z — Tue, 11 Jul 2006 00:27:31 +0000

To answer the last person’s questions “were these patients compensated for their cooperation” the answer would be yes, they’re still alive today because of receiving this product vs. normal saline which doesn’t carry oxygen to their traumatized organs! As a Firefighter/Paramedic I’m looking forward to this drug passing the trails so we can carry it on our ambulances. Its life saving abilities will help severely injured people survive a potentially fatal crash because it took 30 plus minutes to cut them from the wreckage that once was their mini-van or the hospital was just to far away from the crash site even by chopper.

By: Fred

Fred — Mon, 10 Jul 2006 20:03:09 +0000

The question central to the Brian Ross investigation is not the right to conduct medical experiments. God bless the experimenters. No, it’s the right of people to know when they are being experimented upon. No one has the right to use your body to test it’s new products. And, since it’s a potentially-lucrative product–fake blood–I wonder if the patients were compensated for their unsolicited cooperation. I’ll guess they were not–in fact, I’ll bet the and their insurance companies had to pay for that artificial blood.

By: jim

jim — Mon, 10 Jul 2006 19:05:36 +0000

It is interesting that Ross (and the Wall Street Journal) conveniently ignored important facts that would have ruined the “investigative” aspect of the story. For one, a previous, smaller in-hospital consent trauma trial showed Polyheme to be not only perfectly safe, but offered strong indications that it is a life-saver. As matters stand, if someone you love is in a major car accident and bleeding, they get only salt water in the ambulance to keep up blood pressure, and more salt water for 45 minutes of more in hospital as you blood is being typed. Many people die for lack of oxygen from hemoglobin loss. Another big reason trauma doctors want this trial to succeed is that even when you get properly typed blood, some patients die of “multiple organ failure” (or MOF) as a reacton to massive transfusion. There are indications that Polyheme does not cause MOF. If this stuff works, it will be one of the largest medical breakthroughs of the past several decades. It appears that a few months ago it saved the life of a daughter of Hank Williams junior — at least the RNs on the copter that rescued her from an otherwise fatal car accident were quoted in USA Today as saying they were certain from their experience that she would be dead with only saltwater and without the transfusion of Polyheme (given while she was unconscious and therefore without her consent). Hillary Williams and her parents think she wouldn’t be here without this “experiment” on her.

By: Greg Hampton

Greg Hampton — Mon, 10 Jul 2006 18:37:05 +0000

The real question here is why did ABC and Brian Ross wait until the trial was almost over to do the story ??? and they got scooped by the WSJ by 2 whole months… You lame asses…the trial will end this week …and why not talk about Biopure which is doing the same thing, but using COW BLOOD !!!!

By: Chris

Chris — Mon, 10 Jul 2006 18:35:12 +0000

Is there some critial space shortage that keeps ABC from publishing the whole statement from Northfield :ABC’s 20/20 report on Northfield’s pivotal Phase III study with PolyHeme® lacked balance. It failed to note the following key points:
• It is critical to conduct rigorous scientific research to improve patient care and outcomes in emergencies. The PolyHeme study is designed to address the critical, unmet need for an alternative to blood when blood may not be immediately available. In the case of a man-made or natural disaster, PolyHeme represents a potential life-saving resource to sustain lives that otherwise might be lost.
• This study is being conducted under a federal regulation passed in 1996. The regulation allows a waiver of informed consent when patients are in a life-threatening situation, when obtaining individual informed consent is impossible, and when current therapy is unproven or unsatisfactory. The most critical stipulation is that there is the potential for direct benefit to the patients enrolled: a survival benefit. Northfield’s trauma study meets these criteria.
• The study protocol was approved by FDA and by 32 institutional review boards at
Level I trauma centers across the country.
• Extensive community consultation was conducted by participating centers, using print and electronic media, as well as community meetings. Over 60 million media impressions were created by these efforts.
• An Independent Data Monitoring Committee is charged with overseeing patient safety in this study. After reviewing the data on the first 60, 120, 250, and 500 of the planned 720 patients to be enrolled in the study, the IDMC four times recommended that the study continue without modification. Following the 500 patient review, the IDMC recommended that the study go to completion.
• Northfield recently announced that the study has passed the 700 patient mark.

By: B. Davis

B. Davis — Mon, 10 Jul 2006 17:12:32 +0000

I’m curious… are there any other medical companies that also require us to wear a wristband in order to avoid becoming a part of their “experiments?” If this is permitted to continue, soon you’ll see people with 50 wristbands on their arms trying to avoid becoming unwilling participants a bevy of medical companies’ field tests. The concept behind this is proposterous and unconstitutional.

By: B. Reinking

B. Reinking — Mon, 10 Jul 2006 16:35:11 +0000

I am interested in the names of the cities where the experimental test for artificial blood is being used. Thank You!