So...Bush's FDA sprang into action and is allowing the Pentagon to use American citizens in their clinical trials without their permission. No, I'm not crazy you are reading this correctly. I'm not the only one who is outraged. Republican Senator Charles Grassley (Iowa) sent the following to the acting FDA commissioner, Dr. Andrew C. von Eschenbach, a Bush appointee.
"It is outrageous that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes every citizen in the United States a potential 'guinea pig,' without providing a practical, informative warning to the public."
An FDA regulation, enacted in 1996 and rarely used, "allows for waiver of the consent required in clinical trials, if some type of community outreach program is put into practice was used to make informed consent irrelevant."
"I am skeptical," Grassley wrote the FDA, "that any participating medical centers managed to conduct effective, practical outreach to the community and to provide a meaningful, informative warning to the public about the PolyHeme study."
So all you citizens in Hampton Roads, Falls Church and Richmond listen up. Do you remember hearing anything about these community forums to inform the public of these proposed clinical trials being allowed in your community sans informed consent? Better yet, were you able to attend one?
It sounds like the few people who did attend one of these forums in NC were not told that the first part of this three part trial ended abruptly due to 10 heart attacks among the first 81 patients. (Two of these 10 patients died.) The Wall Street Journal (2/22/06) reported that Northfield Laboratories Inc., which makes PolyHeme, quietly shut down that part of the trial and has refused to publicly disclose the results. The hospitals failed to mention the 10 heart attacks at their community meetings and presented PolyHeme as being considered safe due to these trials.
Northfield pushed to have its product testing started again without publishing any results from previous trials held through 2001. In December 2003, the FDA allowed Northfield to start signing up trauma centers. Now, at least 600 people have taken part, the study needs 120 more patients in the third part of it's trial.
The "typical" patient can't offer the informed consent that normally is required for clinical trials. The 1996 FDA rule, that is being used by Bush's FDA commissioner, says it is acceptable to give trauma patients experimental treatments without their knowledge. The hospitals (not the patient who is taking the risk) are typically paid around $10,000 from Northfield Laboratories for each patient they treat with PolyHeme.
Sentara Norfolk General Hospital, Virginia Commonwealth University Hospital and Innova Fairfax Hospital are some of the hospitals participating in this study. At this time, Sentara's status is "no longer recruiting", Innova is no longer participating, and VCU remains an active study participant.
Some of the suspected side-effects of Polyheme are: heart attack,various "serious" cardiovascular adverse experiences, and pneumonia.
The Pentagon has other studies in the pipeline that they want tested.
At least one other blood substitute, Hemopure, manufactured by a company called Biopure, appears likely to be tested using the same opt-out consent system. Asked whether the study protocol will use an opt-out or opt-in consent, Biopure's spokesman said the opt-out design is how they are currently done. A spokesperson for the Navy, which is running tthe Hemopure study, said it would be premature to comment on consent waivers because there could be potential changes in protocol.
This trial is currently being conducted in 18 states that include California, Colorado, Delaware, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, and Virginia
So if you travel, or live, in these states and suffer a traumatic injury or need emergency treatment at a participating trauma center, you could become an unknowing research subject without your consent. Unless you happen to be wearing a light blue wristband imprinted with the statement: "I decline the Northfield PolyHeme Study."
Warning: This bracelet won't protect you from any future studies in the Pentagon/FDA pipeline.
I agree with Senator Grassley, "The idea that the FDA would put the burden on the public to opt out of this mass experiment is outrageous."
Congress needs to pass a law and close this looloophole ASAP. Contact your Senators and Representative, Ask them to support Senator Grassley on this issue and get legislation enacted now. Request that they stop supporting the pharmaceutical firms and start representing your interests!
In the meantime, you can obtain that light blue "hospital" wristband by emailing Investor_Relations@northfieldlabs.com It took about two weeks for my light blue bracelets to arrive.