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Lyme
disease vaccines prove effective
Clinical trials conducted at Yale over the past two years
have proven the effectiveness of two Lyme disease vaccines—one
developed by Yale faculty—the first such drugs of their
kind. Advisory panels have now endorsed both vaccines and the
pharmaceutical companies that own the drugs are awaiting FDA
approval to begin marketing them.
In studies at Yale and other centers involving more than 20,000
people over two Lyme disease seasons, the vaccines were found
to prevent the disease in a majority of cases. The Yale vaccine,
LYMErix, was found to prevent 76 percent after three injections.
SmithKline Beecham has obtained exclusive licensing to the Yale
vaccine.
ImuLyme, a vaccine developed by Pasteur Merieux Connaught
of Swiftwater, Pa., was found to prevent Lyme disease in 68 percent
of cases after two injections and 92 percent of cases after a
third dose. Differences in efficacy between the two vaccines
could be due to varying methods of surveillance. ImuLyme excluded
people over 65, while LYMErix included all adult age groups.
The results of the studies were published in the July 23 issue
of The New England Journal of Medicine.
“These two studies demonstrate that vaccination can be
an important new approach to preventing Lyme disease, which is
the most common tick-borne disease in the United States,”
said Robert T. Schoen, M.D., clinical professor of internal medicine
and a member of the team that studied the Yale vaccine.
Lyme disease was first identified by Yale researchers Stephen
E. Malawista, M.D., and Allen C. Steere, M.D., in 1975. The vaccine
was derived from basic research performed at the School of Medicine
by a team including Richard A. Flavell, Ph.D., professor and
chair, section of immunobiology, Fred S. Kantor, M.D., the Paul
B. Beeson Professor of Medicine, Erol Fikrig, M.D., associate
professor of medicine, and Stephen W. Barthold, D.V.M., Ph.D.
This work was supported by grants from the National Institute
of Health and the Centers for Disease Control, as well as a generous
grant from the Mathers Foundation.
Both vaccines stimulate immune responses to produce antibodies
against Lyme disease. The vaccines not only provide immunity,
but also may kill the spirochete, the bacterium in the mid gut
of the tick that causes Lyme disease. |
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Physician
associates gain their master’s
Starting next
year, graduates of the physician associate program will receive
master’s degrees instead of the graduate professional degree
now awarded. The Yale Corporation approved the change in June
in recognition of the program’s curriculum, long considered
to be of master’s level. The Class of 1999 will be the first
since the program started in 1971 to receive master’s degrees.
The change comes,
says Elaine E. Grant, PA-C, M.P.H. ’92, assistant dean and
director of the physician associate program, as the profession
debates whether a degree or a title is more appropriate. Students
themselves have made their preference clear. “We started
seeing more and more students choosing other schools to get a
master’s,” Ms. Grant says.
Four years ago,
in response to new standards for accreditation, the curriculum
was amended to include research methodology, biostatistics and
epidemiology. The 25-month course includes 10 months of classroom
studies and 15 months of clinical training. For graduation, students
must successfully complete 12 four-week rotations, which expose
them to primary and emergency care. To ensure that students understand
the profession they are entering, Ms. Grant said applicants must
have worked as emergency medical technicians, nurses, hospital
volunteers, research assistants or medical technicians or had
other health care experience.
Physician associates,
generally known as physician assistants, are licensed health
care professionals who work with physicians. In most states they
are licensed to prescribe medications and most work in primary
care. The Yale program’s first class of five students graduated
in 1973; in August, 36 students in the Class of 2000 began their
studies. Students learn to take medical histories, perform physical
examinations, order and interpret lab tests, diagnose and treat
illnesses, assist in surgery and counsel patients. “The
profession has been successful because the generalist educational
component has allowed the profession to be flexible in fulfilling
the health care needs of the country,” Ms. Grant said. “Physician
associates have been able to shift as needs have shifted.” |
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11
grants awarded to advance research in women’s health
The Ethel F.
Donaghue Women’s Health Investigator Program at Yale announced
its first round of grants in August for studies of women’s
health. These are the first awards made since the program received
a $6.5 million grant in February from The Patrick and Catherine
Weldon Donaghue Medical Research Foundation. The new program
was created to advance women’s health research and develop
new cutting edge areas of investigation that will result in direct
practical benefit for women.
“These
projects represent a wide variety of research interests in women’s
health, and provide an exciting cornerstone for our program,”
said Carolyn Mazure, Ph.D., professor of psychiatry and director
of the research program. “The funded areas of study address
unanswered questions in women’s health and begin the process
of changing both the health and health care of women.”
1998 Donaghue Women’s
Health
Investigator Award Recipients
Aydin Arici, M.D., associate professor
of obstetrics and gynecology, will study how estrogen protects
the blood vessel walls from degeneration in women with cardiovascular
disease. The goal is to develop a better understanding of the
molecular mechanisms of estrogen action, which may lead to development
of improved estrogenic substances providing more targeted cardiovascular
interventions for women.
Linda M.
Bartoshuk,
Ph.D., professor of surgery, will study burning mouth syndrome,
an intense oral pain that afflicts about one in six postmenopausal
women. The study will identify and characterize those at risk,
and test a drug therapy which may provide effective treatment
to ease the pain of this syndrome.
Priscilla
S. Dannies,
Ph.D., professor of pharmacology, is seeking ways to improve
the survival rate of women suffering from ovarian cancer. Specifically,
she will study whether certain estrogen antagonists combined
with chemotherapeutic agents can induce ovarian cancer cell death.
This knowledge will enhance the use of these agents in clinical
settings, and hopefully improve the outcome of patients suffering
from ovarian cancer.
Marc Galloway, M.D., associate professor
of orthopaedics and rehabilitation, is investigating how to improve
the surgical recovery of women athletes who undergo knee surgery.
Laboratory studies suggest that pain threshold and immune responses
vary according to the menstrual cycle. This study will determine
if surgical outcomes can be improved by correlating surgical
procedures with the time of the menstrual cycle. The study will
also examine differences in social support and adherence to exercise
regimens for men and women, both of which have been shown to
influence the rate of recovery.
Bruce G.
Haffty,
M.D., associate professor of therapeutic radiology, is trying
to determine whether women who carry the genetic mutations BRCA1
and BRCA2 have a higher risk of local recurrences in conservatively-treated
breast cancer. The results will provide information to women
diagnosed with early stage breast cancer who carry the genetic
mutations, so they can make more informed decisions about options
for treatment.
Harvey Kliman, M.D., Ph.D., a research
scientist in obstetrics and gynecology, is seeking predictors
of successful embryo implantation in infertile couples. More
than 10 percent of reproductive age couples suffer from infertility,
and in 20 to 25 percent of such couples there is no proven cause.
Implantation success predictors are likely to lead to a better
understanding of the causes of infertility in women and to improved
efficacy and reliability of embryo transfer.
John M. Leventhal, M.D., professor of
pediatrics, is studying whether a volunteer-based, home-visit
program can improve the health, social functioning, and parenting
of young inner-city mothers. Trained volunteers, who will be
matched with pregnant women between the ages 15 to 25 who are
receiving care at Yale-New Haven Hospital, will provide practical
advice about parenting and meeting the mother’s social and
economic needs. The study will determine if this type of intervention
can improve the success of these young mothers.
Mark J. Mamula, Ph.D., associate professor
of medicine (rheumatology), is investigating systemic lupus erythematosus
(SLE), an immunologic disease of unknown causes that afflicts
primarily women. The study will examine how specific cellular
proteins or antigens become targeted for attack by the immune
system. Dr. Mamula hopes to identify autoantigenic candidates
that may initiate this autoimmune cascade and provide a first
step for intervention in this disease.
Nina S. Stachenfeld, Ph.D., research scientist
in the John B. Pierce Laboratory, is examining the actions of
estrogen and progesterone on the systems that regulate body fluid
balance. Researchers suspect that female sex hormones increase
disease susceptibility and progression in post-menopausal women.
Understanding of body fluid regulation could lead to the eventual
prevention or treatment of a variety of chronic diseases that
specifically affect women.
Suzanne Swan, Ph.D., associate research
scientist in the department of psychiatry, plans to study the
conditions under which women use violence in domestic relationships.
Evidence suggests women become violent in self-defense, out of
fear, and as a response to violence perpetrated against them;
however, such action often results in more violent retaliation.
Dr. Swan hopes to understand these patterns in order to develop
and implement domestic violence intervention and prevention programs
for women.
Viola Vaccarino, M.D., Ph.D., assistant
professor of epidemiology and public health, will study whether
women benefit from coronary bypass surgery to the same extent
as men in terms of symptom relief and functional and psychosocial
recovery. This study will improve the ability of healthcare professionals
to counsel female patients, enhance decision-making for women
considering bypass surgery, and develop interventions to improve
women’s recovery after bypass surgery.
These projects
are led by Yale investigators with collaborators across departments
and disciplines, in conjunction with researchers from other major
institutions, and with the help of community clinicians. The
program will publish its second request for applications this
fall. |
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A
high school link to the Human Genome Project
With the help
of a Yale geneticist, some New Haven-area high school students
have been advancing the frontiers of molecular biology. For the
past year and a half Yale geneticist Wesley Bonds Jr., Ph.D.,
has worked with the students from the Sacred Heart Academy in
Hamden and their teacher to teach DNA sequencing. Since then
the students themselves have gone on to teach sequencing workshops
to teachers and other students, attended the International Conference
on Gene Mapping and Sequencing and established what may be the
country’s first high school gene bank.
“The students
are getting a unique, hands-on introduction to modern molecular
biology,” says Dr. Bonds, an associate research scientist
in genetics. “DNA sequencing is the perfect way to introduce
students to scientific experiments because it is repetitive work
and can be easily evaluated.”
Sister Mary
Jane Paolella, a biology teacher at the school, first became
interested in teaching DNA sequencing to her students in March
of 1997. She had read about a researcher at the University of
Washington in Seattle who taught high school students to sequence
chromosome fragments. That researcher put her in touch with Dr.
Bonds here in New Haven. The efforts of Dr. Bonds and Sister
Paolella have been incorporated into a course on biotechnology,
with 11 students this academic year. Those 11 students have learned
to mentor students and teachers from urban and suburban high
schools at the marathon sequencing days they offer twice a year.
They are also part of the High School Human Genome Project, a
miniature of the National Human Genome Project, which is working
to map all of the 3.2 billion pairs of DNA molecules that comprise
the human genome.
“The same
sequencing theories and problems in finding a gene are identical
to the national project,” says Dr. Bonds. “The students
are doing the same things, but on a smaller scale with less equipment.”
DNA sequencing
is a unique teaching tool, Dr. Bonds believes, in that it allows
students to use current research techniques to understand biological
systems usually approached in other ways. Because DNA sequences
are now readily available over the Internet, Sister Paolella
and Dr. Bonds believe that many other high schools should be
able to involve themselves in genomics, even if they don’t
have access to sequencing equipment themselves.
“Our hope
is to get other high schools and universities working together
to change the focus of high school biology,” says Sister
Paolella. |
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Estrogen
studies yield hope of breast cancer treatment
Yale University
researchers have visualized in atomic detail how two important
female sex hormones, progesterone and estrogen, bind to their
receptors—an accomplishment that could help scientists design
better medications to treat breast cancer, ease the symptoms
of menopause and prevent unwanted pregnancies.
The Yale scientists’
data are available to the worldwide research community through
the Protein Data Bank at Brookhaven National Laboratories on
Long Island. Paul B. Sigler, M.D., Ph.D., professor of molecular
biophysics and biochemistry, and his colleagues are the first
to make the structure of the estrogen-receptor complex available
to scientists through the data bank.
Dr. Sigler’s
detailed atomic comparison of the estrogen and progesterone receptors
binding—prepared in collaboration with Yale graduate student
David M. Tanenbaum and postdoctoral associates Shawn P. Williams,
Ph.D., and Yong Wang, Ph.D.—was published in the May 26
issue of the Proceedings of the National Academy of Sciences.
A separate report by Dr. Sigler and Dr. Williams on the progesterone
receptor alone was published May 28 in the journal Nature.
Drugs such as
tamoxifin and raloxifene that bind to the estrogen receptor and
block the uptake of estrogen have been shown in recent studies
to be effective in treating and even preventing breast cancer.
However, even more effective estrogen blockers could be created
using the three-dimensional, computerized “snapshot”
of the estrogen receptor captured at Yale, said Dr. Sigler, a
Howard Hughes Medical Institute investigator at Yale. Tailor-made
medications that improve the uptake of estrogen instead of blocking
it could help relieve menopausal symptoms.
“Our work
with the progesterone receptor has given us by far the highest
resolution, that is, the clearest look we have ever had, of the
chemistry that underlies a steroid binding to its receptor,”
said Dr. Sigler. Using a technique called X-ray crystallography,
the researchers generated an image of progesterone bound snugly
in its receptor’s specific binding pocket at a resolution
of 1.8 angstroms, which is roughly the distance between two atoms. |
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Seeing
the whole person
instead of the disease
Tracing the
rise of medical technology from ancient examples of trepanation
to the advent of the X-ray, John H. Lienhard, Ph.D., host of
a popular National Public Radio science program, urged physicians
to look at the whole human rather than individual ailments. The
keynote speaker at the 50th annual meeting of Associates of the
Cushing/Whitney Medical Library at Yale University on May 6,
Dr. Lienhard spoke on the dangers of reducing the person to an
illness during treatment. He is the M.D. Anderson Professor of
Mechanical Engineering and History at the University of Houston.
“Medicine
has to find its way back to the tough problem of curing the whole
body instead of just pieces of it,” Dr. Lienhard said during
his talk, The Lesion Within: What Happened to Medicine When
19th Century Ingenuity Seized Upon an 18th Century Perception?
His radio program, Engines of Our Ingenuity, describes
the way art, technology and ideas have shaped mankind.
According to
Dr. Lienhard, 18th century physicians discovered how “specific
disorders caused suffering and death” and in the 19th century
physicians invented stethoscopes and X-rays to peer inside the
body without violating it. But, he argued, technology shifted
emphasis from the patient to the disease. “Handling a bedpan
is no less essential to the healing process than transplanting
a human heart,” he said.
The following
morning Dr. Lienhard returned to the relationship between technology
and medicine at Grand Rounds in the Fitkin Amphitheater. He praised
computers and their use in medicine, but cautioned that they
affect human thought by creating on a two-dimensional screen
what “the mind’s eye” once had to imagine. Medieval
architects, he said, designed Gothic cathedrals, not with advanced
mathematics or detailed drawings, but from a vision in their
minds. “See to it that your children in public schools aren’t
allowed to avoid thought by pushing buttons,” he said. “Believe
me, the eye of the mind is under attack.” |
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Weighing
privacy and progress, Congress considers limits on
patient data
Advances in
genetic screening abilities have put the medical world on alert
about threats to patient privacy. In August, Sen. Christopher
Dodd, D-Conn., came to the medical school to ask faculty about
ways to ensure the privacy of genetic records.
Sen. Dodd, who
is sponsoring legislation that would bar insurers and employers
from discriminating based on genetic predisposition to disease,
told reporters, “The last thing I would want is any suggestion
that we are trying to limit the importance of moving forward
with genetic technology.”
Several faculty
members who met with Sen. Dodd agreed. Maurice J. Mahoney, M.D.,
J.D., professor of
genetics, pediatrics and obstetrics and gynecology, pointed to
the importance of the flow of information to physicians and family
members. “One has to reach a balance,” he said. “We
don’t want to inhibit that kind of flow. If we develop a
culture in which we are fearful of the consequences of sharing
information within the profession, that is to the detriment of
health care. On the other hand, I have fears about allowing medical
information to flow freely in the economic structures of our
society and government.”
Sen. Dodd told
the gathering, “It seems to me we ought to be able to strike
a balance here in pursuing that, while, at the same time, offering
people some sense of security that this information is not going
to be used to deprive them of insurance or employment.”
According to Sen. Dodd, discussions with constituents showed
strong concerns about privacy. “The public response to that
issue dwarfed every other issue.”
Also present
at the press conference were patients and families concerned
about the potential economic and professional consequences of
the genetic diseases they carry. Peter Przybylski said his 11-year-old
daughter Ashley has carbamoyl phosphate synthase deficiency,
in which blood ammonia levels can become lethal without proper
management. “I would hate to see her have to take a position
based on her medical coverage, as opposed to what she wanted
to do,” he said. |
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Building
a town-gown partnership, from high school to medical school
A five-year
collaboration between Yale University and New Haven’s Career
High School entered a new phase in September, as students and
teachers moved to a new building a few blocks away from the medical
center. The proximity, as well as a new shuttle bus, will bring
students closer to the anatomy classes they take and their internships
at the medical school and Yale-New Haven Hospital.
Career High—or
Hill Regional Allied Health and Business Career High School,
as the school will be known in its new building—was created
in 1983 to introduce students to careers in health, business
and computer technology. Until this year the magnet school and
its 450 students occupied a former elementary school on Wooster
Square that was originally built to handle only 300 students.
The new 165,000-square-foot building at 140 Legion Ave. opened
this year with 600 students. It will admit a full complement
of 750 next year.
The school’s
relationship with Yale began in 1993 when Career students came
to the medical school for anatomy lessons given by medical students
and William B. Stewart, Ph.D., associate professor of surgery
and section chief for anatomy and experimental surgery. Since
then it has grown into a multifaceted program that two years
ago became a formal partnership. The School of Nursing has provided
mentors and internships, and medical library staff have trained
teachers in the use of the Internet. This past summer 15 Career
students participated in a two-week program on the campus of
the medical school, living in Harkness Hall and studying biology
and chemistry with faculty from the medical school, Yale College
and the New Haven public schools. Medical faculty and staff have
advised Career staff on computer networks and laboratory equipment.
The new school will have 650 networked computers with links to
the Yale computer network.
“What’s
exciting about the partnership is that it goes beyond simply
trying to inspire kids to become a physician or a nurse or researcher,”
says Claudia Merson, Ed.M., Coordinator of Career High School
Partnership at the medical school. ”We work with the faculty
to provide opportunities for students to acquire the skills and
discipline they are going to need to get there.”
“Another
facet of the collaboration has been the opportunity for every
student to take advantage of at least one of a series of internships
offered at the hospital and medical school. Students spend two
days a week working in a clinical or laboratory setting while
gaining academic credit for their work. These internships give
our students the chance to apply and expand upon skills learned
in the classrooms at a first-rate medical center,” says
school principal Charles Williams. “The kids love it.” |
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A
new tool to combat
cocaine addiction
Yale researchers
have found that a combination of medication and counseling can
be effective in treating cocaine addiction, a significant finding
given the lack to date of any generally effective medication
to treat cocaine dependence. The research also suggests a promising
strategy involving treatment of those who abuse a combination
of drugs, such as alcohol and cocaine.
The study, led
by Kathleen M. Carroll, Ph.D., associate professor of psychiatry,
and researchers at the Substance Abuse Treatment Unit at the
Department of Psychiatry, compared different treatments for alcohol
and cocaine abusing patients. Some patients received a combination
of disulfiram and one of three types of counseling while others
received counseling but no medication. Because most cocaine-dependent
people also abuse alcohol, the application of disulfiram, also
known as antabuse, could have broad implications in the treatment
of cocaine abuse. The researchers’ findings were published
this year in Addiction. The National Institute on Drug
Abuse sponsored the study.
The best outcomes
in the 12-week study of 122 people who abused both cocaine and
alcohol occurred among those who received both disulfiram and
psychotherapies which encouraged them to get involved in self-help
groups or taught them skills for coping with situations in which
they were likely to use illicit drugs.
Alcohol dependence
is often a problem among cocaine users, according to the authors.
A 1990 study found that 85 percent of those considered cocaine-dependent
also met standards for alcohol abuse. Also, once use of both
substances becomes a pattern, it is hard to abstain from one
without renouncing both. Researchers have begun new studies to
determine the best combination of antabuse and counseling to
reduce cocaine use and craving. |
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A
new strategy for stroke and Alzheimer’s?
Researchers
at the School of Medicine have found that blocking an enzyme
known to be involved in cell death could help treat Alzheimer’s
disease, Parkinson’s disease, strokes and other age-related
neurological diseases.
The findings,
published in the Aug. 7 issue of Cell, were the result
of observations of mice bred with defective copies of the Caspase-9
gene. The Caspase family of genes plays a role in programmed
cell death, called apoptosis, a necessary element of normal biological
processes. “The balance between cell production and cell
death is important for normal brain development,” said Pasko
Rakic, M.D., SC.D., the Dorys McConnell Duberg Professor of Neurobiology.
“Too much or too little cell death can cause severe malformations
leading to disorders such as mental retardation and childhood
epilepsy. This study shows that Caspase-9 is essential for cell
death and therefore gives new insight into how the brain develops
in normal and pathological conditions.”
In experiments
with mice lacking Caspase-9, the investigators found that the
absence of the gene blocked neuronal apoptosis. Abnormal activation
of cell death is implicated in many human diseases and specific
caspases have been linked to a handful of diseases. The research
suggests that a therapy could be designed to stop Caspase-9 from
triggering apoptosis, thereby blocking cell death linked to certain
neurological diseases.
“When mitochondria,
the energy factories of cells, are damaged, Caspase-9 is activated,
leading to cell death,” said Richard A. Flavell, M.D., professor
of immunobiology and biology, and one of the researchers. “In
cells lacking Caspase-9 this damage did not give rise to cell
death.” |
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Personal
warmth, hostile slogans for medical delegation to Iran
On their arrival
at a hotel in the Iranian desert city of Shiraz, members of a
medical delegation from the West, including three Yale physicians,
were greeted by a banner declaring, in English, “Down with
USA.” Inside the hotel, however, a friendlier reception
awaited. “You’re from the United States?” the
clerk asked the physicians. “It’s nice to have you
here.”
The physicians
were members of a delegation sent by the International Society
of Nephrology in March. It was the first exchange involving nephrologists
since the society sponsored an exploratory trip three years ago.
Other scientific exchanges are planned over the next two years.
“There
had been a lot of concern in Iran about scientific isolation,”
said Asghar Rastegar, M.D., associate chair for academic affairs
in the department of medicine, who three years ago made the exploratory
trip on behalf of the society. “The society then decided
to support scientific exchanges with Iran.” The March trip
was at the invitation of the Iranian Society of Nephrology and
was timed to coincide with their annual scientific conference
in Tehran.
The delegation
included Dr. Rastegar, Fredric O. Finkelstein, M.D., clinical
professor of medicine; Michael Kashgarian, M.D., ’58, professor
of pathology and biology; Saeed Fatenejad, M.D., assistant professor
of medicine; Bernd Sterzel, M.D., chair of nephrology at the
University of Erlangen in Germany. Also on the trip were Dr.
Finkelstein’s wife, Susan H. Finkelstein, M.S.W., an assistant
clinical professor of social work and psychiatry, and Dr. Sterzel’s
daughter, Hannah. During their two weeks in Iran, the physicians
traveled about the country, met with fellow nephrologists and
gave lectures at nephrology and pathology conferences in Tehran
and Shiraz.
Although a U.S.-imposed
economic embargo never barred scientific exchanges, American
academics have been reluctant to travel to Iran over fears about
conditions there and a perceived hostility towards Americans.
The embargo has also denied the country the economic wherewithal
to import modern medical equipment.
“Medicine
in Iran has always been very sophisticated,” said Dr. Finkelstein.
“There is an artistic tradition and education is really
revered in Iran. The problem is the rigidity of the Islamic government
and the limits placed on Iranian access to knowledge from the
outside world.”
Dr. Finkelstein
and Dr. Rastegar first met in Iran in 1978, when Dr. Finkelstein
was visiting on a three-month exchange. Five years later, Dr.
Rastegar left when religious fundamentalists dismissed him from
a university post. Over the past nine years, however, he has
made regular visits to Iran to maintain contact with Iranian
physicians and to see his family.
“Iranian
scientists look to the United States and many of them have trained
here,” he said.
Dr. Kashgarian
offered a mixed assessment of Iranian medicine. “The quality
of care is probably equivalent to care anywhere in the West,”
he said. “Some of the facilities are not quite up to date.
Their access to the latest drugs is more restricted.”
The physicians
said the Islamic regime’s dictates have changed the teaching
of medicine. The student body is of mixed caliber, Dr. Kashgarian
said, because it is divided into students who compete for admission
and those who are admitted, under lower standards, because of
links to religious or revolutionary organizations. Also, because
the Islamic government rapidly expanded the number of medical
schools from seven to 34 and the number of graduates from 800
to 5,000 each year, the quality of education has fallen, Dr.
Rastegarsaid.
The role of
women in medicine has also changed because of religious dictates.
Only women should examine women, according to religious leaders.
As a result, more than half the medical students are female.
They are expected to enter certain specialties such as obstetrics
and gynecology, but Dr. Rastegar noted that women also study
neurosurgery. “It has opened certain doors and closed certain
doors,” he said.
Medicine is
not the only area where women’s status has changed. Ms.
Finkelstein contrasted the oppression she felt as a woman with
the vibrant, intelligent Iranian women she met there. On the
plane to Iran, she said, women wore fashionable Western clothing—until
they entered Iranian air space. “Out came the scarves and
the coats,” she said, referring to the clothing women, including
foreign visitors, must wear in Iran. Even in a Tehran hotel she
was expected to cover all but her face every time she ventured
outside her room. Some Iranian women, she said, turn their clothing
into a political statement by including brighter colors than
religious law permits or wearing scarves looser than allowed.
“Things are loosening up a little bit,” she said. “There
really is a kind of cohesive society, wonderful family life,
wonderful food, a rich culture that people really enjoy and appreciate.
There is a lot there that is truly very positive.”
According to
Dr. Rastegar, to understand the attitudes of Iranians one must
place the events of the past 20 years in the context of the revolutionary
changes that have occurred. Although he is quick to acknowledge
that Iran is not a democracy, he finds that debate about the
nature of politics and society is more open than it was under
the repressive regime of theShah Mohamad Reza Pahlavi. Television
images of mobs storming the U.S. Embassy, however, have created
a “scar” that taints American perceptions of Iran and
defines relations. “For the American people to deal with
that scar they had to demonize the people behind it,” says
Dr. Rastegar. “This can only be broken if there is face
to face contact between individuals. This trip was a step in
that direction.” |
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Yale
ethicist defends
safeguards in human investigations
Is the pace
of medical advances moving beyond existing safeguards regarding
the use of human subjects in experimentation? A series of recent
federal reports to the U.S. Congress asserted just that. Responding
to the reports, Yale faculty member Robert J. Levine, M.D., told
Congress in June that the present methods and guidelines employed
by medical schools to assure the safe and ethical use of humans
in investigations are “working very well.”
According to
four reports recently issued by the inspector general’s
office of the Department of Health and Human Services, the system
designed to protect human subjects in clinical trials has failed
to keep pace with advances in medicine such as gene therapy.
“Our total effort reveals a brittle system and even a few
cracks,” George Grob, deputy inspector general for evaluations
and inspections, testified in June on his office’s year-long
inquiry before the House Government Reform and Oversight Subcommittee
on Human Resources.
Not so, said
Dr. Levine, a professor of medicine and lecturer in pharmacology,
who testified in rebuttal on behalf of the Association of American
Medical Colleges. Dr. Levine, who chairs the Human Investigation
Committee at the School of Medicine, said, the reports “created
the impression that the IRB [Institutional Review Board] system
is a disaster just looking for a place to happen.
“It would
be easy to infer there is a systemic threat to patients,”
Dr. Levine testified. “Yet, quite to the contrary, the report
acknowledges the study yielded no evidence of harm or abuse to
patients.”
For the past
two decades, medical schools have been required to follow federal
regulations for in-house institutional review boards. Any federally
funded research involving human subjects must pass through several
layers of review by the school’s board.
While Dr. Levine
disagreed with many of the reports’ findings, he did agree
with some recommendations for improving the existing system.
He concurred that IRBs, in which participation is voluntary,
face tremendous workloads and would benefit from greater resources.
Requiring IRB review after funding has been approved would reduce
the workload, he said, and ensure that research involving humans
has been reviewed. He also agreed that training for investigators
and IRB members is essential.
Although he
described IRBs as overworked and short of resources, he said,
“By any standards of realistic performance the IRB system
works very well.” |
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Children
thrive when fathers
stay at home
Fathers can
play the traditional child-rearing role of mothers with no detriment
to the children, according to a 12-year Yale study. The study,
led by Kyle D. Pruett, M.D., who presented his findings last
December at the American Psychoanalytic Society’s annual
meeting in New York City, found that stay-at-home fathers raise
“vital and vigorous” children while enhancing their
own capacities for intimacy and self-regard. The study followed
18 Hispanic, white and African-American children from two-parent
households of various income levels.
According to
Dr. Pruett, clinical professor in the Child Study Center and
psychiatry, the fathers initially feared they would become intellectually
bored and overweight, lose physical prowess and become more isolated
socially. They confronted problems such as a baby’s persistent
crying by wondering what their wives would do. Then, according
to the report, within 10 days to a few months later the fathers
developed their own care-giving styles. The children thrived
and, on average, exceeded norms on standard development tests,
especially those measuring problem-solving skills. Researchers,
who conducted biennial evaluations over 12 years, reported no
signs of intellectual or emotional trouble among the children.
“They felt a zest for life, were both assertive and comfortably
dependent, showed a vigorous drive for mastery and expressed
the usual childhood worries for boys and girls,” the report
said. The fathers’ involvement stimulated the emotional
attachment that is vital to development of personality in the
early years, according to the report.
The findings
have been published in a variety of journals and lay publications,
including The Psychoanalytic Study of the Child. |
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HIV
drug resistance an increasing threat
Despite the
clinical gains a new generation of AIDS medications have yielded,
drug-resistant strains of HIV and the frequency of their transmission
increasingly threaten public health efforts to thwart the spread
of AIDS, according to an analysis co-authored by the director
of the Yale AIDS Program.
“Prevention
of both development of HIV drug resistance as well as transmission
of drug-resistant variants is a central issue of public health
importance,” wrote Gerald H. Friedland, M.D., professor
of medicine and epidemiology and director of the Yale AIDS Program,
and Mark A.Wainberg, Ph.D., of the McGill University AIDS Center
in Montreal. In their report, published in the June 24 issue
of The Journal of the American Medical Association, the
two sounded a warning about antiretroviral therapy.
Researchers
have identified viruses resistant to the antiviral agents longest
in use, according to the report. Current methods for detecting
HIV resistance may be inadequate and resistance may be more widespread
than previously thought. They also found that failure to adhere
to just one of three medications in a regimen can lead to a resistance
to all three.
The authors
call for increased emphasis on adherence to medications and population-based
studies of the prevalence, mechanisms and transmission rates
of drug-resistant strains of HIV. “In the meantime,”
they wrote, “prevention of both occurrence and transmission
of drug-resistant HIV is important in the public health arena.
These subjects must be addressed if antiviral therapy is to play
its optimal role in blunting and altering the course of the HIV
pandemic.” |
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“Ticked
off” about Lyme disease treatment
While physicians discussed
therapies, vaccines and research at a Yale symposium on Lyme disease in
early June, several dozen people took to Cedar Street to protest what
they called improper diagnosis and treatment of the tick-borne illness
by Yale clinicians and researchers. According to the protesters, who carried
placards and distributed flyers saying they were “ticked off”
at Yale, medical school physicians minimize the severity and frequency
of the illness. “Many of us have gone undiagnosed and untreated because
of the Yale protocol,” said Maureen Albertson of Bridgeport.
Physicians at Yale have
maintained that many cases of Lyme disease cannot be verified. “Lyme
disease has become a magnet for people who do not feel well,” said
Stephen E. Malawista, M.D., a professor of medicine and one of two researchers
who identified Lyme disease in 1975. “No one doubts that they are
suffering. The question is whether they are suffering from Lyme disease.
There is a difference between hope or belief and hard clinical evidence.
A danger is that some other condition will be ignored while the possibility
of Lyme disease, however remote, is being endlessly pursued.”
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