The statement of outrage above was included in a letter to acting FDA Commissioner, Dr von Eschenbach, from Senator Charles Grassley (R-Iowa) on February 24, 2006. Senator Grassley has been keeping a close eye on the performance of the FDA in recent years.
As a Senator representing the State of Iowa and Chairman of the Committee on Finance, which has jurisdiction over the Medicare and Medicaid programs, the Senator wrote, "I am responsible for oversight of matters that affect my constituents and the beneficiaries of these federal health care programs."
In the letter, he advised Dr von Eschenbach that he found a recent Wall Street Journal article titled, "Amid Alarm Bells, A Blood Substitute Keeps Pumping," alarming.
"I understand the value of a viable blood substitute," Senator Grassley told Dr von Eschenbach in the letter, "but I'm really disturbed by what I'm hearing about the FDA's role here and I want to find out what's going on."
PolyHeme contains hemoglobin processed from expired blood donations and is designed to be given to trauma victims in place of blood or saline solution. The product is supposed to be used as a temporary measure when there is a large blood loss and no readily available blood supply, according to Northfield.
Under guidelines for emergency teams participating in the study, at trauma sites, they administer PolyHeme to half of the patients, and standard saline solution to the other half. At the emergency room, patients who get PolyHeme at the trauma site continue to receive PolyHeme.
The 1996 federal regulation in question allows trials of possible life-saving treatments without patient consent if participating facilities inform members of the community about the trial and gauge public sentiment.
"I am skeptical," Sen Grassley told 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."
"If you're in a car accident, of course you want emergency doctors to save your life," Sen Grassley said in a press release. "But no reasonable person would expect to be treated as an experimental subject without consent," he added.
The 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 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.
That is, unless you happen to be wearing a lightblue wristband imprinted with the statement: "I decline the Northfield PolyHeme Study."
This silly provision has further angered the Senator. "The idea that the FDA would put the burden on the public to opt out of this mass experiment is outrageous," he said.
An unknown number of community meetings were reportedly held in participating states and anyone who took time to attend a meeting could opt out by wearing continuously for an undetermined period of time one of these light-blue wristbands.
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