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Shofar FTP Archive File: miscellany/medical-experimentation/fda-permits-experimentation


FDA changes policy to allow experimentation on some patients without consent

     The U.S. Food and Drug Administration (FDA) has amended its informed
consent regulations to allow certain patients who are in life-threatening or
emergency situations to be enrolled in medical research studies and
experimentation programs without the knowledge or consent of the patient, the
family members, or the patient's appointed representative. The new policy,
which took effect on 11/1/96, is a clear departure from the post-WWII
Nuremberg Code, the ethical code developed 50 years ago as the result of
medical crimes against humanity during the Nazi regime. The first principle of
the Nuremberg Code
states that in all medical experimentation involving humans, "The voluntary
consent of the human subject is absolutely essential." 

According to the FDA, the policy change was needed "in response to growing
concerns that current rules are making high quality acute care research
activities difficult or impossible to carry out at a time when the need for
such research is increasingly recognized." [FDA, "Protection of Human Subject;
Informed Consent," Summary, Docket No. 95N-0158, 10/2/96] 

The new policy allows for an informed consent waiver for emergency research
under certain conditions, which include: 

     the "human subject" is in a "life-threatening situation" and cannot give
informed consent because of his or her medical      condition; 

     "available treatments are unproven or unsatisfactory"; 

     the research (which can include "randomized placebo-controlled
investigations") is necessary to "determine the safety and effectiveness of
particular interventions"; 

     the research "holds out the prospect of direct benefit" to the subject,
and the risks involved are "reasonable"; 

     the research "could not practicably be carried out without the waiver";

     the research investigator "has committed to attempting to contact a
legally authorized representative" of the incompetent patient. [FDA, 21 CFR
Sec. 50.24(a)] 

More than a year before the new policy took effect, the FDA issued an
announcement laying the groundwork for the intended change. The release

"Emergency-use products often have to be used in situations when the patient
is unconscious and there is no time to locate a legal representative
authorized to give consent for the use of an unapproved device or medicine. As
a result, these patients are being denied the benefits of a promising new
therapy, and some studies involving emergency-use products are encountering
problems in enrolling patients in clinical trials." [FDA Announcement,

The FDA claims that the new policy carves out only a very "narrow exception"
to its previous informed consent regulations regarding experimentation on
human subjects and that the policy change actually provides stronger
protections for patients who end up in emergency situations, rendered
incompetent by their medical conditions. "It's essential to protect patients,
and it's also important to give them a chance to use new therapies," said
Health and Human Services Secretary Donna Shalala. "The [FDA] proposals
accomplish both. They also have broad support from industry, medical and
consumer groups," she added. [FDA Announcement, 9/21/95] 

But Boston University ethicist George Annas is concerned that researchers and
investigators are "just trying to make research more efficient at the expense
of human rights." "Most people would not want a doctor to flip a coin when
they come into an emergency room." According to Annas, the FDA's claim that
patients would otherwise not receive new promising therapies in emergency
situations is "silly." Experimental drugs or devices are experimental
precisely because no one really knows if the treatment would be beneficial or
too risky. "If we knew it would work, it would be a treatment," he added. [New
York Times, 11/5/96] 
The fact that the FDA policy allows for "randomized placebo-controlled
investigations" is an indication that patients' best interests may not always
be the paramount concern. The patients who receive the placebo can hardly be
expected to benefit from the experimental treatment. 

Critics of the new policy also point out that drug companies and medical
device manufacturers have a vested interest in research and experimentation
programs which would use human subjects. In the "Supplementary Information"
section of the new regulations, the FDA even listed the Pharmaceutical 
Research and Manufacturers of America and the Health Industry 
Manufactures Association as two organizations which supported the 
policy change. But policy advocates
argue that strong oversight safeguards are contained in the regulations which
would protect patients from unscrupulous researchers and doctors and that the
hospital's institutional review board as well as an independent physician must
agree before a patient could be enlisted without consent into an experimental
program. [FDA, 21 CFR, Sec. 50.24(a)] 

The British medical journal The Lancet recently ran an editorial critical of
the FDA's policy change, stating, "The needs of research have triumphed over
the need for consent." The editorial addressed, in part, the conflict of
interest associated with drug and medical device research: 

"We have seen enough difficulties with conflicts of interest to know that they
can be subtle and are not always resolved on the side of good behaviour. Might
an overly optimistic researcher, pharmaceutical company, or medical device
manufacturer try to convince a community to begin, prematurely, a trial of a
potentially profitable new product?" ["Voluntary consent goes down,"
The Lancet, 11/16/96:1323] 

The editorial then pointed to a 1994 Lancet article which reported that, in
the U.S., there were already cases in which unconscious or mentally
incapacitated patients were being treated with experimental drugs and devices
without consent. In one
New York hospital, the "do not resuscitate" orders of terminally-ill, end-
stage cancer and heart patients were ignored, and instead these patients were
treated with an experimental cardiac resuscitation device. In another
instance, a Minnesota
hospital's institutional review board, responsible for overseeing experimental
research projects, approved the testing of an experimental resuscitation
device designed for adults on children as young as 8 years-old. [The Lancet,

Another editorial critical of the new FDA regulations appeared in The Oakland
Tribune (CA) and opined, "Under the new FDA rules, consent comes not from the
patient, but from a hospital board with the power to decide who will become
guinea pigs, and who will die in peace." The editorial continued: 

"In fact, the FDA is essentially condoning assisted suicides by allowing
doctors to experiment with drugs they know full well will kill the test
subject. The FDA has declared that those tested will be patients with
absolutely no chance of recovery. But who is to judge? How many times has the
patient miraculously recovered after all hope had been lost?" ["New FDA rules
may strip dignity from dying," The Oakland Tribune, 1/3/97] 

Adding fuel to the "slippery slope" argument -- that once the informed consent
requirement is waived for one group of patients, other groups will also be
targeted -- one professional organization has already called for the expansion
of the new regulations. In a letter to the FDA, Gregory L. Henry, M.D.,
president of the American College of Emergency Physicians (ACEP), wrote that
his organization (representing over 18,000 members) "strongly" supports the
"FDA's intent in issuing these proposed regulations." However, Henry added the
following recommendation: "The regulations should be expanded to apply not
only to conditions which are life-threatening, but also to conditions that involve the
strong potential for serious and permanent disability." [ACEP letter to FDA,
11/6/95; emphasis added] 

But the ACEP does not represent the views of all emergency room physicians.
Commenting on the new FDA policy on the condition of anonymity, two emergency
room doctors told the IAETF: 

"In light of the unsavory behavior I have witnessed among my peers in response
to the current ethical dilemmas inherent in capitated medical systems, I can
say with complete certainty that many physicians are not up to the moral
challenge of the
recent loosening of FDA requirements for informed consent prior to human

"The new FDA rules reintroduce the dark veil of human experimentation without
the right of informed consent into the practice of medicine. Patients need to
know their doctor will respect their right to participate in medical care
choices. Removing the
requirement of informed consent strikes to the heart of the physician-patient
relationship and undermines patient trust." 

Given the emphasis on patient autonomy in the U.S. and the fact that the new
policy could be perceived as a possible threat to that autonomy, the FDA
offered the suggestion that special medical bracelets indicating the patient's
objection to participation in experimental research should be made available.
The agency also suggested that health care advance directives could be worded
to reflect the signer's desire not to be a subject used for medical
experimentation. [FDA, "Protection of Human Subject; Informed Consent,"
Supplementary Information, 10/2/96] 

Comment: In the "Ethical Objections" section of the new policy, the FDA makes
the following statement: 

"The agency does not believe that this rule creates a situation that differs
significantly from other emergency decisions warranting intervention in that
individuals in life-threatening situations are often unable to direct
decisions concerning their health care and are, therefore, unable to consent
or object to a particular treatment. Yet they are routinely treated by State-
licensed medical practitioners. This inability to exercise autonomy is not
unique to the subjects who will be eligible for this research -- it is common
to the majority of individuals who may be in these life-threatening
situations." [FDA, "Supplementary Information:
Ethical Objections to the Rule, 10/2/96] 

Apparently the FDA has lost sight of a very basic but important distinction
between medical experimentation and medical treatment. Experimentation is
something that is done to a subject. Medical treatment, on the other hand, is
something that is
done for a patient. Ethically speaking, there is a world of difference between
the action taken by emergency room doctors in providing recognized,
therapeutic treatment for patients without their consent in order to try to
save those patients' lives and the action of researchers using human subjects
without their consent primarily to obtain test data for a pharmaceutical
company or medical device manufacturer seeking FDA approval for their product.
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