FDA grants guinea pig status to US citizens
By Evelyn Pringle
Journal Contributing Writer
Mar 1, 2006, 00:31
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
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.
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.
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.�
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.
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 study."
�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," 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
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."
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.
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.
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.
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 years.
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
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 real
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
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.
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 own patients.
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 do
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."
year," according to the WSJ, "the FDA required Northfield to mention
on its Web site "serious cardiovascular adverse experiences" with
"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
oversight, if any, has FDA conducted related to the PolyHeme Study?
consultation with representatives of the community was conducted?
public disclosure to communities was conducted prior to initiation of the
"4. Were known
adverse events, including but not limited to those reported in the WSJ,
disclosed with the risks and expected benefits information?
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
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