"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."
The above statement of outrage was included in a February 24 letter to acting
FDA Commissioner Dr. Andrew C. von Eschenbach, from Senator Charles Grassley
(R-Iowa). 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,”
According to Grassley, the WSJ says the FDA is allowing Illinois-based Northfield
Laboratories to test a blood substitute called PolyHeme, in a clinical trial
without the consent of patients, who may be unconscious or otherwise incapable
of providing informed consent, pursuant to a rarely used FDA regulation, which
allows for waiver of the consent required in clinical trials, if some type of
community outreach program is put into practice.
"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," 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
“If you’re in a car accident, of course you want emergency doctors
to save your life,” Grassley said in a press release. “But no reasonable
person would expect to be treated as an experimental subject without consent,"
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,
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 light blue 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.
"Why should Americans have to wear a bracelet at all times to protect
themselves from a government-sanctioned medical experiment if they happen to
get into a car accident?" he asked the FDA.
"I suspect many people, if they knew this," Senator Grassley noted,
"might reasonably ask, "Where do I get my wristband?'”
This question is not readily answerable, according to the senator. "It’s
not apparent from any information on the FDA’s website," he said.
Researchers at Legacy Health System and Oregon Health & Science University
in Portland, Oregon, suspended their plans to test the blood substitute after
attempts to get local approval for the experiment were unsuccessful for two
The WSJ reported that, in an earlier clinical trial of PolyHeme, 10 out of
81 patients suffered heart attacks within a week of receiving the substitute
and that two of those people died.
Besides the heart attacks and deaths, the trial suggested the PolyHeme was
linked with other adverse events such as heart rhythm aberrations and pneumonia.
These events occurred in 54 percent of the PolyHeme patients versus 28 percent
in the control group, according to Northfield's internal documents.
The previous study differs from the current study in that patients in the first
study were not trauma patients, they were undergoing surgery to repair aneurysms
in their aortas and consented to participating in the study. In the first study,
patients in one group received PolyHeme and patients in the control group received
In the second half of 2001, "Northfield abruptly shut down the study,
explaining in a Securities and Exchange Commission filing that it was taking
too long to complete," the WSJ reports. The paper says Northfield failed
to make the results of the study public.
Northfield's chief executive, Steven Gould, says it has not been proven that
the adverse events in the trial were caused by PolyHeme and claims the heart
attacks may have been caused by doctors who pumped too much fluid into patients,
when adding PolyHeme and real blood.
William Hoffman, chief of the cardiac-surgery intensive-care unit at Massachusetts
General Hospital in Boston, told the WSJ that substitutes in a class that includes
PolyHeme are associated with heart attacks and strokes. "It is self-serving
and potentially misleading to associate harmful effects with something other
than the test drug," he said.
Doctors who took part in the first study have questions but said Northfield
restricted access to the full data so they only knew what happened to their
At the University of Pennsylvania, Dr. Fairman told the WSJ that he and a colleague,
Albert Cheung, repeatedly called Dr Gould at Northfield. "We said, 'Let's
sit down and write up the data,' " Dr. Fairman recalls. "He wouldn't
Dr. Cheung proposed a meeting of doctors at the 21 hospitals that had taken
part in the study and says Dr Gould agreed to the meeting, but then cancelled
it at the last minute.
T.J. Gan, a Duke University anesthesiologist involved in the study, told the
WSJ he called Northfield three years ago to ask if results had been published
and Dr. Gould told him, "Someone's working on it."
Northfield issued a statement saying company officials do not recall the specifics
of any discussion about a meeting with Dr Cheung or the conversation with Dr
Gan. It denies that it "resisted publication" but says, "We did
not allocate resources to publication. In retrospect, reporting the full study
results earlier would have been better."
"Last year," according to the WSJ, "the FDA required Northfield
to mention on its Web site "serious cardiovascular adverse experiences"
"Five of the 31 hospitals in the trauma study followed suit, but well
after many trauma patients had been treated," the paper noted.
In his letter, Senator Grassley told the FDA to address the issue "by
providing the public with meaningful information related to what it should already
have known about the PolyHeme study."
In addition, he instructed the agency to provide his committee with a detailed
briefing regarding the study by March 8.
"Over the next few days," Senator Grassley wrote, "my committee
staff will contact your staff with more specific requests for information, but
at the minimum your staff should be prepared to address the following issues
related to the PolyHeme Study:
"1. What oversight, if any, has FDA conducted related to the PolyHeme
"2. What consultation with representatives of the community was conducted?
"3. What public disclosure to communities was conducted prior to initiation
of the PolyHeme Study?
"4. Were known adverse events, including but not limited to those reported
in the WSJ, disclosed with the risks and expected benefits information?
"5. Has Northfield Laboratories, Inc., met all regulatory reporting
requirements related to its PolyHeme product, including but not limited to
timely reporting of all adverse events?"
He also asked the FDA to provide a detailed list and summary of all clinical
trials conducted since January 1, 1996, under the FDA regulation governing exception
from informed consent requirements.
In regard to the current study, Northfield says an independent committee monitoring
the study reviewed reports of death and other serious problems four times, and
each time recommended the trial continue unchanged, according to Reuters News
on February 24.
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