Medical HR Scandals at the University of Rochester (CAQ essay)

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Ali Shehzad Zaidi

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Nov 27, 1999, 3:00:00 AM11/27/99
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From: Ali Shehzad Zaidi <az001g>
Subject: Medical Scandals at the University of Rochester (CAQ essay)
Date: Fri, 26 Nov 1999 03:11:56 -0500 (EST)

Sentimentality and Responsibility in the University

by A. S. Zaidi

The hidden history of the University of Rochester (UR) includes
plutonium and uranium injection experiments during the late forties,
CIA-sponsored mind-control experiments during the fifties, and lead
injection experiments during the sixties. UR's problems with human medical
experimentation continue well into the nineties.

Since their perceptions are conditioned to a great extent by the
upbeat pronouncements in university publications, UR alumni and students
remain largely unaware of their university's moral crisis.

Rochester Review is such a publication, containing features that
enhance the appeal and reputation of the University of Rochester. The
Spring-Summer 1996 Review, for instance, noted that U. S. News & World
Report ranked Strong Memorial Hospital, UR's teaching hospital, among the
100 best hospitals in the country. The Spring-Summer 1998 Review, to take
another example, celebrated UR School of Medicine and Dentistry's third
place ranking among the nation's top primary-care schools in the 1998 U. S.
News & World Report.

In The Moral and Spiritual Crisis in Education, David Purpel
distinguishes between sentimentality, which does not acknowledge how one's
actions contribute to a moral crisis, and responsibility, which acknowledges
how those actions shape that crisis. Recent events at the University of
Rochester serve to illustrate Purpel's thesis and raise questions about the
ethics of human experimentation and the adequacy of regulatory oversight at
university teaching hospitals.

On March 29, 1996, a symposium on the ethics of medical
experimentation on human subjects was held at the University. That same day,
a sophomore, Nicole Wan, took part in a UR-sponsored medical experiment that
cost her life.

Wan had been paid $150 for participating in an experiment at Strong
Memorial Hospital, UR's teaching hospital, which involved having cells
extracted from her lungs in order to study the effects of smoking and
pollution. Wan left the bronchoscopy unit trembling from an overdose of
lidocaine, an anesthetic. A couple of hours later, Wan had a seizure and was
rushed to Strong, where she was placed on life support. She died a couple of
days later.

Calling Wan's death an "isolated, very unfortunate incident," UR
President Thomas Jackson offered what he called "an imperfect analogy." "If
a student or somebody was hit by a car, would that lead people to think the
campus was not safe? I hope not."

Was Wan's death comparable, however imperfectly, to a car accident?
The facts speak for themselves. The autopsy by the Monroe County medical
examiner revealed lesions in Wan's lungs. The doctors failed to record the
amount of lidocaine administered to Wan, who was given four times the
maximum allowable dosage that UR had established in 1981. This maximum
dosage was inexplicably absent from the research protocol of the experiment
in which Wan participated. Finally, the hospital staff failed to assess
Wan's condition before she left the bronchoscopy unit.

Just seven months prior to Wan's death, an inspector from the Food
and Drug Administration (FDA) warned UR that its failure to follow proper
procedures for human experimentation placed subjects at risk. UR officials
denied that there was a link between Wan's death and the deficiencies cited
by the FDA inspector.

In October 1996, evaluators from the National Institutes of Health
(NIH) visited UR and found that many research projects lacked the files that
would enable their proper review. The NIH ordered UR to provide more staff
and resources for UR's Human Subjects Review Board, and to write quarterly
reports regarding progress in safeguarding research subjects.

In his condolence letter, published in the April 4, 1996 Campus
Times, UR's student newspaper, UR President Thomas Jackson wrote that Wan's
death "occurred following her willing participation in support of one of the
basic missions of the university -- research that will enable individuals to
live better."

Jackson claimed in his letter that UR would "immediately and
rigorously explore the circumstances" of Wan's death, and would "continue to
press for all relevant facts." (The administration has never released the
findings of its internal investigation into Wan's death.) In April 1996,
Wan's family filed a $100 million lawsuit against UR, which later settled
the case for an undisclosed sum.

Around the time of Wan's death, Strong underwent a major
restructuring. In the Winter 1996-97 Review, readers learned of changes in
store for UR's hospital. Jay Stein, UR vice provost for health affairs,
wrote: "The challenge to hospitals is clear: Cut your costs or you will be
out of business... The University of Rochester Medical Center and the rest
of the nation's academic medical centers must adapt if we are to continue to
fulfill our role as the keystone of the health care system that is the envy
of the world." Lost on the Review's readers were the implications of the UR
administration's sentimental view of a corporatized health care system in
which profit takes precedence over human well-being.

The UR administration cut $40 million from Strong's $360 million
budget in just two years, eliminating 412 hospital jobs, including 114 nurse
positions. It also eliminated the nurses' contractual weekend pay, and,
according to many nurses, was forcing them to do "mandatory voluntary
overtime." Nurses complained that lower-paid aides were being hired to do
bedside care formerly undertaken by themselves, that patient units were
dangerously understaffed, and that they were being assigned to new units
without adequate training or sufficient advance notice of unit closings.
The staff cuts left many nurses feeling isolated and unable to ask for help
in the event of an emergency. The solution of the administration was to give
the nurses walkie-talkies.

In spring 1996, contract negotiations stalled between UR and Local
1199, the Hospital and Health Care Employees Union, which represents
clerical and cleaning crew workers at Strong. The UR administration sought
to reduce vacation pay, compensation for overtime, and tuition assistance
for its union health care workers, most of whom earn between $17,000 and
$19,000 a year. The UR administration wanted workers to contribute $150 a
month for their health benefits package, and intended to cut health benefits
for its future retirees who were 50 or older. UR, meanwhile, was doubling
its contribution to the retirement fund of its managers.

The following year, 1997, saw a unionization drive for Strong nurses
fail because of a barrage of UR administration anti-union propaganda and
because of the lack of a student-labor coalition at UR to support the
nurses. The nurses' concerns about patient safety at Strong did, however,
become a public issue.

In the spring of that year, two health care workers and three
patients in Strong's maternity unit were infected with a strain of invasive
Group A streptococcus. One patient, Susan Doughtery, died after developing
necrotizing fascitis, the flesh-eating form of the disease. In the ensuing
panic, some patients canceled operations at Strong, which was deluged with
phone calls from individuals seeking information about the disease. A
Rochester Democrat and Chronicle editorial criticized Strong for
contributing to the panic by not releasing enough information about the
outbreak:

"It's not the first time the University of Rochester's teaching hospital has
opted for the silent treatment. A year after a student died in a medical
research study, the hospital has yet to disclose exactly what went wrong and
what precautions have been put in place to prevent it happening again."

New York Health Commissioner Barbara DeBuono hastened to reassure
the public that Strong was "perfectly safe." "I would have no hesitation,"
she said, " in recommending any member of my family [to] go there."
Nonetheless, the New York State Health Department cited several deficiencies
in the care given to Doughtery and another patient. There had been a delay
in recognizing Doughtery's condition and in aggressively treating it.
Doughtery's attending physician had failed to see her for almost 60 hours.
Even though they knew that Doughtery was allergic to latex, hospital staff
twice used the substance in treating her. When Doughtery's heart stopped
beating, it took ten minutes for personnel to locate emergency equipment.
No cardiac monitor or defibrillator was on hand in the maternity unit.
Strong's Chief Medical Officer, Raymond Mayewski, later explained that the
equipment had been moved a few days earlier when a unit closed.

At a press conference, Mayewski refused UR's responsibility for
Doughtery's death even while confirming the state health department's
findings:

"Today, I would like to tell you and the public what I've already told
Susan's family: We let you down. And we are deeply, deeply sorry. And we are
going to do whatever is necessary to make sure that these problems never
happen again in this institution. Could we have prevented Susan's death? We
believe the answer is no. We believe that there was nothing we could have
done because of the horrible nature of this infection. But we're not asking
anyone to accept that. The fact is she died, the fact is we made mistakes."

In July 1997, the Accreditation Council for Graduate Medical
Education issued a warning letter to UR for its deficiencies in seven
residency programs, for its inadequate supervision of residents, and for
failing to conduct internal reviews of its programs until 1995, thirteen
years after the reviews were first required. Interviewed by the Campus
Times, UR Provost Charles Phelps denied that the deficiencies cited in the
report jeopardized patient care.

In March 1998, state health department inspectors visited Strong in
response to patient complaints concerning the lack of resident supervision.
Residents told inspectors that they often worked 10 to 30 hours beyond the
80 hour a week limit mandated by state regulations.

Thanks to a 1976 National Labor Relations Board decision, the status
of medical residents in private hospitals is that of students rather than
employees. That decision is up for review soon. As matters stand, many UR
medical residents are reluctant to bring institutional shortcomings to the
attention of superiors whose letters of recommendation and evaluations will
determine their suitability for the profession.

UR's moral crisis in medicine has a long history. During the late
1940s, UR physicians injected uranium, plutonium and polonium in unwitting
human subjects. Eileen Welsome's 1993 Pulitzer Prize-winning series on the
plutonium experiments drew attention to Atomic Energy Project activities at
UR, which, in 1943, was chosen to host the medical division of the Manhattan
Project and to monitor workers at nuclear plants around the country.

Eleven of the nation's eighteen plutonium injection experiments took
place at UR's Strong Memorial Hospital. UR research teams prepared an
experimental plan for injecting human subjects with radioisotopes and
following up the injections with the collection of tissue, urine, and stool
samples. Researchers used the codeword "product" for "plutonium" in all
communications and documents. The human subjects had code numbers preceded
by the letters "HP" -- for "Human Product."

Henry Slack, a 69-year-old alcoholic suffering from liver disease
and pneumonia, was admitted to Strong on December 12, 1945. In a report, a
UR physician described Slack as a "poorly nourished, weak, thin male who is
slightly confused." After spending two months in the metabolism ward, Slack
was injected with 6.5 micrograms of plutonium, subjecting him to about 56
times the radiation the average person could expect in a lifetime. Slack, a
veteran of the Spanish-American War, died six days later, having served his
country for the last time. The cause of death given was cirrhosis of the
liver.

After doctors had taken tissue samples from Slack's corpse to trace
plutonium, Wright Langham, group leader in radiobiology at the Los Alamos
National Laboratory, who coordinated the plutonium injection experiments
nationally, wrote to Samuel Bassett, head of UR's metabolism ward. He
recommended that terminal cases be injected with 10 times more plutonium
than healthier patients. "In case you should decide to do another terminal
case, I suggest you do 50 micrograms instead of 5. This would permit the
analysis of much smaller samples and would make my work considerably
easier... I feel reasonably certain there would be no harm in using larger
amounts of material if you are sure the case is a terminal one..."

In his March 27, 1946 reply to Langham, Bassett wrote: "This case
did turn out to be terminal but at the time I started the experimental
period, there was sufficient uncertainty regarding the outcome to make me
feel that the dose would be within the range of tolerance... The larger doses
that you mention, particularly 50 micrograms, might be given if a suitable
opportunity occurred and if you are anxious that I should carry it through.
I will see what can be done."

Janice Stadt, a hairdresser, was another unwitting guinea pig at
Strong. UR physicians injected Stadt with plutonium-239 dissolved in a
citrate complex so that the isotope would be effectively deposited in her
muscles and bones. Milton Stadt, her son, commented at a 1995 public
hearing on the radiation experiments:

"My mother, Janice Stadt, had a number, HP-8. She was injected with
plutonium on March 9th, 1946. She was forty-one years old, and I was eleven
years old at the time. My mother and father were never told or asked for any
kind of consent to have this done to them. My mother went in [to the
hospital] for scleroderma... and a duodenal ulcer, and somehow she got
pushed into this lab where these monsters were."

In 1974, three survivors of the plutonium experiments came to Strong
to provide blood, urine, and stool samples, not knowing that the purpose of
the follow-up tests was to trace the plutonium remaining in their bodies.
The patient-subjects were provided with first-class hotels, limousines, and
fresh flowers -- sentimental touches indeed. Two UR research scientists even
gave their autographs to a patient-subject.

UR researchers also injected or fed radium, polonium, uranium and
lead to human subjects. The uranium experiments at Strong were explicitly
designed to harm the subjects. The researchers stated in a 1948 report that
the experiments were "designed to find the dose of a soluble uranium salt
that when introduced intravenously would produce a just detectable renal
injury..."

Mary Jean Connell is the only living survivor of the uranium
experiments. Connell, a farmer's daughter who weighed only 81 pounds at the
time of the experiment, went to Strong at the request of a physician who
believed that she needed to gain weight. Upon her arrival at Strong in
September 1946, Connell immediately gained 584 micrograms -- the amount of
uranium that a Strong doctor injected into her vein. In later years, Connell
suffered from urinary tract infections and kidney pain. After she got an
apology and a $400,000 settlement from the federal government in 1996,
Connell commented, "I'm afraid it's going to happen again you know."

The federal Advisory Committee on Human Radiation Experiments, which
was established early in Clinton's presidency, concluded in its 1995 final
report that there was "no expectation that the patient-subjects would
benefit medically from the plutonium injections" and that the recollections
of those involved in the plutonium experiments "all suggest that the
patients did not know they had been injected with radioactive material or
even that they were subjects of an experiment." While guidelines for human
medical experimentation during the 40s and 50s were lax by today's
standards, the need for informed consent was understood even then. In 1942,
the chair of the federal Committee on Medical Research advised a UR
researcher who sought to "work out a human experiment on the chemical
prophylaxis of gonorrhea," as follows: "When any risks are involved,
volunteers only should be utilized as subjects, and these only after the
risks have been fully explained and after signed statements have been
obtained which shall prove that the volunteer offered his services with full
knowledge and that claims for damage will be waived. An accurate record
should be kept of the terms in which the risks involved were described."

The Advisory Committee summed up the ethics of the radioisotope
injection experiments in this way:

"The egregiousness of the disrespectful way in which the subjects of
the injection experiments and their families were treated is heightened by
the fact that the subjects were hospitalized patients. Their being ill and
institutionalized left them vulnerable to exploitation. As patients, it
would have been reasonable for them to assume that their physicians were
acting in their best interests, even if they were being given 'experimental'
interventions. Instead, the physicians violated their fiduciary
responsibilities by giving the patients substances from which there was no
expectation they would benefit and whose effects were uncertain. This is
clearest at Rochester where at least the uranium subjects, and perhaps the
plutonium subjects, were apparently the personal patients of the principal
investigator."

A legacy of the radiation experiments is the contamination of the
UR campus. In 1945 or 1946, UR researchers buried rat carcasses and waste
contaminated with plutonium, radium and polonium, at a remote point on UR
grounds, 50 to 100 yards from a barge canal. A UR spokesman recently
described the incident as a "historical footnote." UR officials foresee no
health hazards.

In another historical footnote, UR Manhattan Project researchers
deliberately contaminated a field next to the UR medical school with
radiosodium in order to ascertain the shielding requirements for
radiation-measuring equipment. In a 1980 interview, UR researcher Harold
Hodge recalled what happened after the researchers mixed sodium-24 with
water and poured it into sprinklers:

We walked along and sprinkled the driveway. This was after dark... The next
thing, we went out and sprayed a considerable part of the field... It was
sprayed and then after a while sprayed again, so there was a second and
third application. We were all in rubber, so we didn't get wet with the
stuff... then Staff [Stafford Warren, head of the medical division of the
Manhattan Project] said that one of the things we needed was to see what
would be the effect on the inside of a wooden building. So we took the end
of the parking garage, and we sprinkled that up about as high as our
shoulders, and somebody went inside and made measurements, and we sprinkled
it again. Then we wanted to know about the inside of a brick building, and
so we sprinkled the side of the animal house... I had no idea what the
readings were... I hadn't the foggiest idea of what we were doing, except
that obviously it was something radioactive.

During the 1950s and 1960s, UR participated in CIA-sponsored mind-control
experiments, for which it has yet to accept responsibility. The experiments,
codenamed MK ULTRA, were intended to develop surreptitious means to cause
amnesia, shock, confusion or impulsive behavior in individuals, to program
people to carry out instructions, to incapacitate individuals with a
knockout pill, and to publicly discredit individuals through the use of
chemical substances. CIA director Richard Helms destroyed the MK ULTRA
records in 1973, shortly before congressional committees began investigating
the CIA.

UR psychology chairman Richard Wendt, who served on 25 national
defense committees, participated in Operation Chatter, an MK ULTRA program
designed to find methods of eliminating free will in others. The CIA was
particularly interested in finding a "truth serum" that would make subjects
dependent on their interrogators.

Using the Office of Naval Research as a front, the CIA funded
Wendt's research under the guise of continuing his grant to study motion
sickness. Wendt and his colleagues experimented on UR students in a testing
facility in the university library attic. They observed the test subjects
through a two-way mirror and took notes on their reactions.

John Marks recounts Wendt's 1952 trip to West Germany on behalf of
the CIA in his book on the MK ULTRA experiments, The Search for the
"Manchurian Candidate." Wendt had developed a concoction consisting of
seconal, a depressant; dexedrine, a stimulant; and tetrahydrocannabinol, the
active ingredient in marijuana. Tested on involuntary subjects who were
defectors and double agents, the drug combination proved useless for
interrogatory purposes of the CIA.

A Department of Defense document on Wendt's CIA project concluded
that while he "is producing certain results, he has lost sight of the
original requirement and has become enthralled by research on human
behavior." Consequently, Wendt's CIA grant was terminated. His private
assistant destroyed the heroin, morphine and mescaline that were found in
Wendt's private safe after his death in 1977.

Besides the MK ULTRA experiments, there were dangerous experiments
at Strong that involved children. In 1963, a UR researcher under an Atomic
Energy contract studied the intake of iodine-131 in children, including a
six-year-old, who were given milk from a cow that had been fed the element.
While iodine concentrates in the human thyroid gland and is essential to
human health, its unstable form, known as I-131, has four extra neutrons, is
radioactive, and can alter the DNA gene code or cause cancer. One of the
children involved in the UR I-131 experiment subsequently developed thyroid
cancer.

The tragedies at Strong underscore the need for better regulation of
human subject experimentation and patient care at teaching hospitals.
Institutions that violate research guidelines or federal and state laws
ought to suffer consequences, whether in the form of hefty fines, loss of
institutional research grants, suspension of the professional licenses of
researchers, or public embarrassment. There is little indication that
federal or state regulatory agencies are up to the task. The state health
department failed to fine UR for the deficiencies that led to Wan's death,
and waived the $8,000 fine it imposed on UR in the Doughtery case.

UR recently announced it would construct a state-of-the-art research
facility estimated to cost $73 million and would spend $40 million in
renovations to existing laboratories and offices. The project will be funded
by donations, grants, loans and medical center operating funds. The
extravagance underscores UR's phenomenal growth in corporate-sponsored
research.

Until UR comes to terms with its past, it may never come to terms
with its present. For now, questions remain. What is the human toll of
cost-cutting? What has UR sacrificed on the altar of science and profit?
When will public relations sniffles give way to acceptance of
responsibility?


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