YJML6.1layoutFall2010 2

Editor-in-Chief
Abraar Karan
from the editor
Managing Editors
I
Yifan Chen
Jaymin Patel
Swati Yanamadala n this special collaborative issue, we explore the ever entangled themes of the future
Senior Editors
of medicine and the ethical quandaries that accompany this future. The rate of medi-
Rachel Chen cal advancement is truly astounding with innovations crowding the market every day.
Rebecca Linfield
From synthetic red blood cells that can be used as drug delivery tools to artificial limbs that
Content Editors
Lara Fourman may soon function directly via brain signals, the technological future of medicine appears
Tobias Kuehne promising. The first of our two cover interviews is with Dr. Stephen Oesterle, Senior Vice
Ben Liu
Alison Pease President for Medicine and Technology at Medtronic, in which he further elucidates the
Layout Directors developments in medical technology and their multiform implications. Furthermore, we
Aubrey Alleman
Cynthia Jin delve into the future of healthcare systems and the associated actors such as pharmaceutical
Graphics Director
companies. We fly you across the seas with medical tourism and back to America where the
Lucia Tang idea of consumer directed health plans is in discussion.
Research Director However, in our excitement for the future, we also recognize the dangers of advance-
Varoon Bashyakarla
ment. The advent of electronic medical records brings with it concerns for patient privacy;
Business Directors the power of genetic screening could lead to a market for human traits; and the debate over
Byron Edwards
Yuning Liu stem cells continues with the notions of life and when it begins. We are honored to have
Distribution Director our second cover interview with Dr. Paul Root Wolpe, Director of the Center for Ethics at
Parker Collins
Emory University. Dr. Wolpe speaks with the YJML on several of the article topics covered
Development Directors including organ donations and healthcare reform, and also shares his experience as the only
Christopher Lee
Courtney Rubin bioethicist working for NASA. In our first collaborative issue, I am proud to present the
Online Media Director future of medicine and bioethics as topics that must go hand in hand; they are as essential
Julia Goldberg
to each other as law is to medicine.
Staff Writers
Connie Cho As always, the Journal dedicates itself to accurate, compelling, and informative journal-
Paulo Coelho Filho
Jenny Mei
ism that will facilitate and encourage a dialect of health politics and policy within the larger
Ben VanGelder Yale community. The writing, editorial, research, layout/design, and business staffs have
Annie Wang
Vincent Yu put in many hours to make this issue possible and I would like to thank them for their work.
Board of Advisors
Robert A. Burt, JD, MA
Alexander M. Bickel Professor of Law
Yale Law School
Thomas Pogge, PhD.
Professor of Philosophy and
International Affairs
Yale University
Carl Zimmer, Abraar Karan, ‘11
Author, Journalist
Editor-in-Chief
Howard P. Forman, MD, MBA
Professor of Diagnostic Radiology and
Healthcare Economics
Sharon Terry, MA Writing • Editing • Business • Research • Layout & Design
President, CEO of Genetic Alliance
This journal is published by Yale University

students. Yale University is not responsible
for its contents. The opinions expressed
by the contributers to the Yale Journal
of Medicine and Law do not necessarily
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reflect those of its staff or its advertisers.
The design and content of this publication
are copyright of YJML and may not be re-
If you are interested in joining the Yale Journal of Medicine and Law,
printed without express written consent please contact us at info@yalemedlaw.com.
from the Editor-in-Chief.
2 Fall 2010 Vol. VII Issue I Yale Journal of Medicine and Law http://www.yalemedlaw.com
Volume VII
Issue I
Fall 2010
Table of Contents
Articles P
Sorting Out Fact from Fiction 4 Consumer-Directed Advertising 20 Advances in Genetics: 46
Aubrey Alleman Rachel Chen What are the Risks?
So Yeon Choe
Use of Embryonic Stem Cells in 6 Compassionate Drug Use 22
the United States Parker Collins
Veronica Wallace
Synthetic Red Blood Cells: 30
Interviews
The Ethics of 8 A Macro Leap in Dr. Stephen Oesterle, MD 24
Electronic Health Records Microbiological Medicine Senior Vice President
David M. Carel Eduard B. Vangelder for Medicine and Technology-
Medtronic
Computers and the 10 The Social Disease of 36 Jaymin Patel
Future of Healing Fat Discrimination
Parker Collins Paulo Coelho Filho Paul Root Wolpe, Ph.D. 32
Director of Center for Ethics
Male Circumcision 12 The Risk of a Market 38 Emory University
for Organ Donations
Lara Fourman
Rachel Chen
Rachel Chen I
The Future of Surgery: 14
Regulating Assisted 40
The Development of Robot-
Assisted Surgery Reproductive Technology Commentary
David M. Carel Connie Cho
Gonzales v. Carhart: When the 28
Consumer-Directed Healthcare 16 Pharmaceutical Companies 42 Court Practices Medicine
Rachel Chen and the Future of Medicine Connie Cho
Alison Pease
Bypass Surgery as a Souvenir 18
The Nature of Medical Tourism Advances in Prosthetic Limbs 44
Nicole Negbenebor Katherine Zhou
http://www.yalemedlaw.com Yale Journal of Medicine and Law Fall 2010 Vol. VII Issue I 3
Sorting Out
Fact From Fiction
Written By Aubrey Alleman
W
hether it be AIDS, cancer, We are still awaiting the verdict on the
the War on Terror, or global answers to most of these questions. As
warming, paranoia seems to for cell phones, a study conducted by By lowering the maximum volume and the duration of listening, one can virt
be everywhere in our society. As tech- Joseph L. RotiRoti, Ph.D. at Washing-
nology continues to progress and scien- ton University School of Medicine in St.
tists get closer and closer to decoding the Louis revealed “no statistically signifi- day medical investigation, 480 male and
human genome, intricacies of the hu- cant increases in any tumor type, includ- female rats were exposed to analog and
man body are being unearthed and the ing brain, liver, lung or kidney compared digital cell phone frequencies in order to
potential of human discovery is being to the control group.” During this 505- evaluate whether common cell phone
recognized. However, with this knowl- signals were possible cancer-causing
edge comes fear—a fear that at times is agents. The exposed tissues were found
There’s really no biological to have no signs of genetic damage.
grounded in fact but is often inflated by
the media’s exaggerated claims. basis for you to be con- Thus, while some issues such as life-
We are constantly forced to question long exposure to cell phone radiation and
the technology that has seemingly made
cerned about radio waves. infant vulnerability to radio frequency
our lives so much easier. Do cell phones Nevertheless, people are. signals have yet to be fully explored, the
truly cause brain tumors? Do microwave current consensus, according to WebMD
ovens lead to cancer? And what about John Boyce, Scientific Director Health News, concludes that cell phones
the headphones on our iPods…do they International Epidemiology Institute are non-carcinogenic. As John Boice, the
really induce hearing loss? scientific director of the International
However, health authorities claim
that microwave ovens can alter the food
they are designed to heat, transforming
vegetables and meats into carcinogenic
hazards. Jim Felton, the Associate Direc-
tor for Cancer Control at the University
of California, Davis, shoots down such
claims, commenting, “I can honestly tell
you that I have never seen a valid scien-
tific study—and I pay attention to most
of the cooking research out there—that
has given us reason to test whether mi-
crowaving food could cause cancer.”
Headphones, on the other hand, are
a slightly different story. According to
a study published in the Archives of
International Medicine, a significant de-
gree of hearing loss can result from a
two hour per day, five day per week, 90%
maximum volume iPod-listening routine.
However, listening to an iPod for a to-
tal of 90 minutes per day at 80% maxi-
mum volume results in almost no risk of
noise-induced hearing loss.
Brian Fligor, the director of Diagnos-
tic Audiology at Children’s Hospital Bos-
ton, suggests that the shorter the dura-
tion and the lower the maximum volume
of sound your ears are exposed to, the
lower the risk of hearing damage. Thus,
simply changing one of these factors
can virtually eliminate the possibility of
headphone-induced hearing loss.
FE LIYA/FLICKR The moral of the story? It may be
tually eliminate the probability of headphone-induced hearing loss. beneficial to question media-based myths
about the evils of technology. This is
not to say that there are no risks associ-
Epidemiology Institute, said, “There’s the low-frequency radiation that they ated with new technologies or that one
really no biological basis for you to be emit causes cancer in human beings. should ignore health warnings that seem
concerned about radio waves. Nonethe-
to dominate the news. However, perhaps
less, people are.”
I can honestly tell you that a greater focus on investigating “health
The microwave oven is another tech-
hazards” that seem overstated could re-
nological appliance that has gained un- I have never seen a valid duce the anxiety that media certainly can
necessary publicity over its possible link
scientific study... that has cause. As the ancient Greek poet Aesop
to cancer. Like cell phones, however,
once wrote, “Don’t believe everything
microwave ovens simply do not emit given us reason to test you hear.” Separate the meat from the
enough radiation to damage our DNA
whether microwaving food fufu and filter out the pure music of fact
and interfere with cellular reproduction.
from the misleading background noise
Thus, while microwave ovens are capa- can cause cancer. of media mayhem.
ble of heating food to a temperature hot
enough to burn inattentive users, there James Felton, Assc. Dir. for Cancer Control
Aubrey Alleman is a senior in Ezra Stiles College and
University of California, Davis
is insufficient evidence to conclude that a layout director for YJML.
Use of Embryonic
is effectively the destruction of human
life. Opponents also argue that using
embryonic stem cells for research is a
“slippery slope” of experimentation.
Stem Cells in the

ESC research may open the doors for
commodification of human life or even
creation of preferentially engineered hu-
man beings. The biggest risk in arguing
United States
the opposition, however, is to allow the
debate on ESC research to slip into a
dispute on fundamentally and ethically
distinct material: the debate on abortion,
for instance, is a highly controversial but
disparate debate.
As more knowledge about the biol-
ogy of human development emerges,
debaters on both sides must struggle
with the challenge of answering what
we know and what we need to know to
guide our future course of action. The
inherent paradox of the embryonic stem
cell debate is that we will never be able
to possess an in-depth knowledge of the
Written By Veronica Wallace nature and potential of embryonic stem
cells until they are rigorously researched.
Researchers have made some prog-
O
ver one year ago, many scien- sphere consisting of a fluid-filled cavity ress to find alternative sources of stem
tists hailed President Obama’s (the blastocoel) and a mass of cells (the cells that possess characteristics identi-
reversal on the restriction of inner cell mass). ESCs used in laboratory cal to ESCs. In February of 2010, the
federal funding for embryonic stem cell research are derived from the inner cell research team headed by Dr. Joseph Wu
research as a great step forward in realiz- mass. In the typical developmental pro- and Dr. Michael Longaker from Stan-
ing the potential of embryonic stem cells cess occurring in vivo, the 4-5 day old ford University reported in their Nature
(“ESC”) for therapeutics and regenera- blastocyst is observed prior to implan- Methods online publication that they
tive medicine. The Bush administration tation in the female’s uterus. ESCs have were able to simply and safely induce
had banned federal funding for ESC re- unique regenerative capabilities which stem cells derived from human fat tissue
search in 2001 and had made available are of particular interest to research sci- into pluripotent stem cells. ESCs are also
only a few lines of ESCs. Many research- entists for therapeutic research purposes. pluripotent, meaning they have the capa-
ers argued that these restrictions under Those in favor of ESC research as- bility to give rise to any cell type in the
the Bush administration impeded the sert that science and society will benefit body. Wu and Longaker’s research may
progress to uncover the capacity of stem tremendously, particularly because re- be promising in providing an alternative
cells for both research and therapeutics. searchers will gain more comprehensive source for some stem cells. However, in-
The central issue with stem cell usage understanding of both disease mecha- duced pluripotent stem cells still do not
has been the ethical considerations ac- nisms and the opportunities to treat and biologically equate to natural pluripotent
companying a somewhat nebulous defi- cure illness. Scientists claim that ESCs stem cells. Scientists have already estab-
nition of when life actually begins. will illuminate the path to treatment for lished many similarities between induced
Embryonic stem cells that are cur- cancers, diabetes, spinal cord injuries, Al- pluripotent stem cells and natural plurip-
rently utilized in scientific research are zheimer’s, and Parkinson’s disease. otent stem cells but are still working to
obtained, upon consent of the donor, The critics of ESC research aver establish a comprehensive understand-
from eggs that have been fertilized for that the research is unethical on moral ing of their differences.
the purpose of in vitro fertilization in grounds. For those who believe that hu- Scientists must continue to push for
clinical settings. Developmentally, the man life begins at the moment when a further legislation to allow for embry-
ESC is 4-5 days old and is a hollow sperm and an egg fuse, the use of ESCs onic stem cell usage and funding. The
GE HEALTHCARE/FLICKR
Human neural stem cells from the fetal cortex.
full potential of ESCs has not yet been stem cell research and abortion. How- for the common good for society.
realized, and indeed, ESCs may hold the ever fantastic the opposition to ESC re- But we also need up-to-date informa-
key to discovering treatments and thera- search may be, the popular media must tion to keep the general public and legis-
peutics for many terminal and debilitat- make an honest effort to convey infor- lators knowledgeable about biology and
ing diseases. The public, however, must mation from the scientific community in medicine. For example, researchers need
also grant the scientific community the an accurate and thorough manner. to interface more efficiently with the
time and flexibility to work through the The most logical step forward is not media. With a greater public presence,
inherently time-intensive and multi-step to oppose research but to generate wide- research scientists may also help dispel
research process. Our sound-bite media ly applicable ethical guidelines that target much of the skepticism directed at their
culture demands quick and easy answers the shared core values of science and endeavors. For the skeptics and the stal-
to pointed specific questions. By its very society: a value and respect for human wart critics, however, this means grant-
nature, scientific discovery is slow and life and a commitment to do no harm. ing that the scientific community as a
complex; it is a long road requiring great The most compelling reasons to oppose whole is seeking the best for society and
investment in time and resources, and stem cell research may not have even yet the betterment of all individuals. Trust
the outcome of research hypotheses may become apparent. We need legislation to is a requisite: that as a team, physicians
vastly differ from anticipated results. regulate emerging technology and inter- and researchers aim to provide the best
The opposition to embryonic stem disciplinary teams of research scientists, care for the most people and protect the
cell research is often made graphic and medical doctors, ethicists, and lawmak- sanctity of life.
sensational by mainstream media, as ers to share their knowledge and works
evidenced by the erroneous collation of towards the common goal of providing Veronia Wallace is a recent Yale alumna.
The Ethics of
Electronic Health
Records
Written By David M. Carel
I
n early 2009, as part of the massive they offer the opportunity for epidemio-
effort to revive the economy, Presi- logical research on a scale never before
dent Obama called for the mod- seen; and with the right protections, they
ernization of health care by digitizing all can even provide a tool for law enforce- The digitization of health records has raised a number of ethical concerns, su
health records. Following former Presi- ment to track suspicious drug-activity,
dent Bush’s call for ubiquitous electronic such as the abuse of painkillers.
health records (EHRs) by 2014, Obama However, there remain numerous also that viruses threaten the irrecover-
unveiled his plan for computerization of technical impediments to mass digitiza- able deletion of medical records.
health records to provide a much needed tion of health record. First, cost levels Additionally, several ethical con-
boost for America’s healthcare system. pose serious concerns. Independent cerns shroud the proposal in skepti-
Proponents of EHRs cite scores of pos- studies from Harvard, RAND and the cism, most notably privacy. At the
sible benefits. If orchestrated correctly, Commonwealth Fund have concluded most fundamental level, issues arise
that the expenses over the next ten years about the sheer number of people who
EHRs have the potential to provide
will total $75 billion to $100 billion. will have ready access to the health in-
complete, accurate and searchable medi-
Moreover, the transition from paper to formation of a vast patient population,
cal information to allow for more in-
digital medical records will require tech- as well as about unauthorized access via
formed medical decision making on the
nological innovation that many believe hacking. The EHRs of the Veterans Af-
part of the healthcare provider; they will
is lacking in America and comprehen- fairs Department, a model often looked
allow for more efficient healthcare deliv-
sive training for health care providers at when discussing digitized medical
ery by eliminating the tedious exchange
who cannot afford hours upon hours records, has notably suffered from sev-
of paperwork; they can help reduce the
of learning a new system. Concerns eral security breaches over the past few
number of adverse events due to illeg-
about hackers and system failures also years, including the theft of a laptop in
ibility, disorganization and other sources
plague Obama’s proposal. It is feared 2006 containing the medical records of
of human error in reading medical files; 26.5 million veterans. It only takes a
not only that files may be breached but
its impression to the employer. Patients
may resort to paying out of pocket to
hide the record or certain medical tests.
Some even avoid medical help alto-
gether in order to circumvent receiving
diagnoses which have stigmas associ-
ated with them, such as an addiction or
sexually transmitted disease. This phe-
nomenon has two major implications.
First, electronic records could therefore
potentially harm the quality of medi-
cal care rather than improve it. Second,
EHRs could provide skewed data which
might muddle research.
Steps have been taken, however,
to help alleviate these concerns. One
of the main methods of precaution is
through an audit trail of precisely who
accesses the electronic records. This
not only allows the patient to see who
has been viewing the record but also
helps alert the hospital to improper ac-
cess. The implications of this were seen
at Yale this past fall following the tragic
murder of Annie Le. Revealing its ef-
ficacy, an electronic audit revealed the
names of several employees who had il-
legally accessed Le’s private medical re-
cords, allowing Yale University Health
Services to punish the perpetrators. To
further disincentivize breaches of pri-
ANDREW*/FLICKR
vacy, legislators in several states are call-
uch as privacy and the quality of patient-doctor-interactions. ing for the closure of loopholes which
permit marketing of health informa-
tion, as well as for harsh legal repercus-
single breach for a patient’s files to be sell them to markets and pharmaceuti-
sions for improperly using EHRs.
endlessly replicated, rendering it virtu- cal companies to help them target their
As Obama has explained, digitizing
ally impossible to restore confidentiality advertising.
health information is of the utmost im-
after a security lapse. However, the dilemma grows in-
portance for the future of our nation’s
Compounding the problem, com- creasingly complex. Not only is there
healthcare. It holds the prospects of
puter scientists have proven that anony- the potential for breaches of privacy,
reduced medical errors, more efficient
mous data can be re-identified fairly but even the very fear of such breaches
medical care, and expanded research
easily since eighty-seven percent of has been shown to negatively impact
opportunitiesprovided that steps of
Americans can be uniquely identified patient-doctor interactions. According
precaution are taken to avoid abuse.
using only their date of birth, gender to the New Jersey Law Journal, when
With the proper safeguards, such as
and ZIP code. For instance, several people feel that their medical records
regular auditing, the criminalization of
years ago, AOL released thousands of will not be kept private, they take steps
security breaches, and the creation of
anonymous health records. The New to protect themselves. For example, out
a secure, nationally trusted database,
York Times shortly thereafter published of fear that a potential employer may
EHRs will be able to live up to their im-
a story including personal information see their health records and reject them
mense potential.
about the patients. Additionally, many as a candidate, patients may ask doctors
fear that data brokers may purchase to alter diagnoses, for instance from
David M. Carel is a sophomore in Pierson College.
medical and pharmaceutical records to “depression” to “dysthymia” to blunt
Computers and the
Future of Healing
Written By Parker Collins
T
here is an episode of Dr. Who, a mention eerie—pleas for their mothers:
famous British television series, “Mummy? Are you my mummy?” That
that scares me half to death. seems to be all they could utter and all
The Doctor and his sassy companion, I could hear in my dreams for the next
Rose Tyler, travel back in time to World few nights.
War II and the Blitzkrieg in London After much drama and peril, the
where they find odd humanoid creatures Doctor discovers that these monsters
lurking around the war-torn city. Com- were once human and were changed by
mon among all of them are the gas mask Nanogenes (small robots that resemble a rather the kidney. In a study published
that seems to be biologically adhered to flighty firefly) that function to restore liv- in Nature Biotechnology by Bradt et
their face and their incessant—not to ing beings back to their original, healthy al., biological computers comprised of
form. It turns out that these Nanogenes nothing more than RNA, DNA, and as-
had never encountered the human form sorted proteins were able to read cellular
This new technology may and therefore confused the state of a signals within cultures of human kidney
herald the end of such frightened little boy for that of a grown cells —an ability previously unheard of.
man. After the Doctor fixed them and By breaking the molecular language bar-
excessive treatments as flew away in his time machine, I won- rier, they can label specific cells for treat-
chemotherapy, where dered how far off science and technol- ment, allowing for a very local target re-
ogy must be from actually achieving this gion that can even trigger self-treatment
diseased and healthy cells sort of progress. I was surprised by the in sick cells. This new technology may
alike are subjected to harsh answer. herald the end of such excessive treat-
Researchers at Harvard and Princeton ments as chemotherapy, where diseased
chemicals. University are quite close to emulating and healthy cells alike are subjected to
the technology of our beloved Doc- harsh chemicals.
tor. The proof is in the pudding… or Unlike the Nanogenes in Dr. Who,
quite simply, the “leech-ulator” is a glo-
rified calculator comprised of neurons
taken from leeches. However, the team
of scientists has high hopes for the
potential of this machinery in the near
future. Unlike the computers of today,
these biological computers will have
the capability to solve problems inde-
pendently, with limited external input.
The leader of the project, Professor Bill
Ditto, says he is amazed by the stupidity
of today’s computers and that his team’s
device will eventually be able to “think
for itself.” This would grant computers
a range of flexibility not heard of until
now. “With the neurons, we only have to
direct them towards the answer and they
get it themselves,” said Professor Ditto
in an interview with the BBC. Professor
Ditto summarizes his team’s goal as the
integration of “robotics, electronics, and
these types of computers” for the pur-
pose of creating more sentient robots.
Regardless of the aim, the idea of
a biocomputer has swept the nation as
well as the globe. A Google search of
“biological computer” returned nearly
eight million hits as of October 18 of
this year. While the means may be some-
what unified, the purported ends run the
gamut: everything from monitoring the
diagnosis of a drug to killing off cancer-
LUCIA TANG ous cells. Nevertheless, research is still
in the preliminary stages, meaning that
the new biological computers would be the actual mechanism by which these the ability to buy pill-sized biocomputers
implanted in humans to monitor cells for biocomputers operate is surprisingly for a dollar a pound at Wal-Mart is still a
the long term, instead of simply flitting simple. Once inside a cell, they examine while away.
around “fixing” whatever happens to be the chemicals present in the cytoplasm During the final moments of the two-
in the way. While this may be somewhat for certain red flags. Soon after the depart Dr. Who saga, when the Nanogenes
more invasive, the implantation will tai- tection of a problem, such as a mutated swarm around affected humans to heal
lor biological computers to each indi- gene or a precursor signal of disease, the them in an enveloping magical glow, I
vidual. “Each human cell already has all computers are programmed to release couldn’t help but think how fascinating
of the tools required to build these bio- a molecule that is easily observed with it would be to do that in real life. At the
computers on its own,” said Harvard’s ordinary laboratory equipment, thus time it seemed so far-fetched. Yet, these
Yaakov Benenson, a Bauer Fellow in the alerting medical professionals before it biocomputers could have implications in
Center for Systems Biology. Benenson spreads and becomes a real problem. pharmacology, immunology, and several
and his team are simply providing the A little further south, collaborating other fields. The process itself may not
“genetic blueprint” for the infinitesimal researchers at the Georgia Institute of appear magical, but the results definitely
machinery. Technology and Emory University are will.
Even though evaluating Boolean working on something along the same
Parker Collins is a sophomore in Trumbull College
equations sounds remarkably difficult, lines they call the “leech-ulator.” Put
and the Distributional Director for YJML.
Male Circumscision
Mill Says the “Individual is Sovereign”
Take Control of Your Body! (and All of Its Parts)
Written By Lara Fourman
T
he media takes it upon itself to Australian study reasons that the in- Trials in African countries where HIV
convey to the public its defi- ner foreskin of the penis has the larg- is endemic, including Uganda, South Af-
nition of “healthy behavior.” est concentration of Langerhans’ cells, rica, and Kenya, have found that male
Protect your skin from the sun. Wash the initial cellular targets in the sexual circumcision reduced HIV infection by
your hands. Maintain a well-rounded transmission of HIV. If these cells that 50 percent in heterosexual men. The
diet. Get regular doctor’s check-ups. are most susceptible to the virus are re- sample population was comprised of
Have protected sex. moved, the chances of contracting the men who were at high risk of infection
However, over the past few years, US virus will be reduced. Peter Kilmarx, from women with HIV. However, indi-
health officials have considered requir- the CDC HIV/AIDS Division’s chief viduals at the highest risk of contracting
ing routine circumcision for all baby epidemiologist, finds that mandatory cir- HIV in the United States are men who
boys born in the United States. Detract- cumcision would be another “tool in the have sex with men. Without scientific
ing somewhat from previous policy, they toolbox” to contain the HIV epidemic in support that mimics transmission con-
have abandoned the Millian philosophy the United States. ditions in the United States, the CDC
that the “individual is sovereign.” The Of course, refusal of circumcision should more closely examine whether
Center for Disease Control dangerously may have cultural and religious grounds, circumcision prevents the spread of
threatens to infringe upon this philoso- such as the belief that circumcision is HIV among homosexuals. The United
phy of individual autonomy when it a form of genital mutilation. Besides States government should not be con-
comes to our health, a right that Ameri- raising issues concerning an individual’s sidering a policy in which the means of
cans cherish very dearly. right to control his body, contempla- disease transmission has not been tested.
This deliberation stems from new tion of mandated circumcision requires Perhaps our sovereignty over our
studies that suggest that male circum- a close examination of the studies that bodies would be worth sacrificing if
cision reduces the spread of HIV. An propose such a procedure. mandated circumcision would guarantee
the prevention of HIV transmission. It suggests that individuals engaging in nearly 30 percent since 1985. This statis-
would be selfish to endanger the lives casual sex use condoms to prevent the tic explains the decline in teenage birth
of others if we knew that the spread of transmission of sexually transmitted rates, but also sends a larger message:
disease could definitely be prevented. diseases. If men are under the impres- safe sex can be taught. That being said,
However, at best, circumcision could sion that circumcision will reduce the the health benefits of circumcision can
potentially reduce the risk of infection. spread of HIV, people can more easily be taught as well.
It does not eliminate it. Furthermore, rationalize that circumcision can replace The media checklist for “healthy be-
it is possible that the reduction plan can condoms as a protection against STDs. havior” is already quite long and most
backfire: men decide not to use condoms The global health consequences of such people are largely aware of its contents—
because they have been circumcised, a scenario can be catastrophic. adding circumcision to the end would
causing HIV transmission to increase With all of these potential repercus- not be difficult. Just like any healthy
in the long run. Along the same logic, sions, the CDC should not conclude practice, the benefits of male circum-
an attempt to reduce HIV transmission that circumcision should be compulsory. cision should be reintegrated into the
could reduce a woman’s ability to negoti- However, that should not thwart the minds of new parents, not forced upon
ate condom use. CDC and the media from heavily push- the bodies of baby boys. Ultimately, the
The largest nationally representative ing for education concerning circumci- government should not mandate a medi-
survey about American sexual habits in sion. Sex ed works—the percentage of cal procedure, especially one founded on
nearly twenty years was published in The people, especially teenagers, having safe circumstantial scientific evidence.
Journal of Sexual Medicine in October sex has increased in the last decades.
2010. Research found that condom use A May 2010 publication by the CDC Lara Fourman is a sophomore in Saybrook College
was twice as likely with casual sex than showed that contraceptive use during a and a Content Editor for YJML.
with sex in a relationship. This finding woman’s first sexual encounter rose by
The Future of Surgery
The Development of Robot-Assisted Surgery
Written By David M. Carel
W
hen the FDA first approved North America, Europe, Asia and Aus-
robot-assisted surgery, FDA tralia. The technology has become so
commissioner Jane E. Hen- pervasive that it has been the feature
ney exclaimed, “This system is the first of reports by CNN’s Dr. Sanjay Gupta
step in the development of new robotic and ABC’s Good Morning, America.
technology that eventually could change Robot-assisted surgery has even made a
the practice of surgery.” Almost ten cameo appearance on the popular televi-
years later, Dr. Henney’s words have sion show Grey’s Anatomy. It has burst
proved to be an understatement. through the seams of its initial confine-
In December of 2009, Craig Har- ment to only bladder and reflux disease
rison of North Texas became the first surgery, spreading into every field of
patient to undergo robot-assisted re- medicine from urology to cardiology to
moval of a lung tumor, marking the lat- oncology – and its rate of growth does
est leap forward in the nascent field of not appear to be stopping anytime soon.
robotic surgery. Instead of performing The field of robot-assisted surgery
conventional “open surgery,” Harrison’s has its origins in the 1985 production Many of the limitations of traditional surgery can be overcome by robotic tec
surgeon removed the tumor by using a of the PUMA560 robotic surgical arm.
complex joystick to control automated This was used in a delicate brain biopsy. 2000 with the FDA’s approval of Intui-
tools strategically inserted into the pa- Just two years later, it was used in a gall tive Surgical’s da Vinci surgical system.
tient. As documented by Intuitive Surgi- bladder removal. By 1990, the FDA had Far surpassing its predecessors of the
cal, the manufacture of the most widely approved Computer Motion’s AESOP 1980s and 1990s, the da Vinci console
sold robotic surgery console, robot-as- surgical system, the first such approval in was the first robotic system approved
sisted surgery has found its way into hun- the field of endoscopic surgery. How- for laparoscopic surgeries in American
dreds of locations worldwide, including ever, the most considerable advance in operating rooms.
nearly twenty major centers throughout the field of robotic surgery came in July
make three or four small incisions in the to purchase and incurs yearly expenses
patient’s abdomen through which endo- in excess of $100,000 due to the limited
scopic cameras and surgical instruments lifespan of several parts, a price prohibi-
are placed. These devices, held in place tively expensive for many hospitals and
by the robotic arms, can be monitored countries. Furthermore, in order to be-
and controlled remotely by the surgeon come qualified to operate using robot-as-
sitting at the console on the other side of sisted systems, surgeons must complete
the operating room. supplementary training after a minimum
The advantages of robot-assisted of five years of surgical residency, an ad-
surgery using the da Vinci system have ditional expense which many are unwill-
surfaced time and again. First and fore- ing or unable to meet.
most, it greatly reduces the amount of However, the future of this technol-
trauma to the patient and cuts the post- ogy is promising as it begins only its
operative recovery time. For instance, second decade of use. Both the cost
conventional open-heart surgery entails and the learning curve will most likely
about a one foot long incision to expose contract significantly as robot-assisted
the patient’s chest cavity while the da surgery continues to become more com-
Vinci system requires only three or four monplace and better accommodated
incisions of one centimeter each. Addi- by medical school training. Addition-
tionally, several built-in features help im- ally, perhaps as the financial savings and
prove the precision of the surgeon. One health benefits to patients increase and
of the features most lauded by surgeons are recognized by insurance companies,
who have used the system is the three- insurance reimbursement policies may
dimensional video feed. In contrast to make robotic surgical machines more
traditional laparoscopic surgery, which fiscally appealing. From a technological
relies on an ordinary monitor for visu- perspective, as the machines themselves
al data, the da Vinci system’s advanced continue to develop, not only will the
video console provides the doctor with surgical robots become increasingly in-
a vibrant life-like image that can be mag- dependent of the surgeons controlling
nified and analyzed at far greater detail them but also they will be able to func-
than even open surgery provides. Fur- tion at progressively further distances
thermore, the robotic arms have become from the operating room, creating the
increasingly advanced over the last sev- possibility of so-called “telesurgery.” As
eral years and now provide several fea- lag time between the patient and control
tures that enhance a surgeon’s capability. console decreases with improved tech-
Not only do the “wrists” of the surgical nology, surgeries conceivably could be
instruments have greater flexibility and performed in different buildings, cities
range of motion than the human hand, or even different countries, effectively
but the system also detects and auto- providing the services of capable sur-
matically eliminates any hand tremors, geons to understaffed and under-skilled
allowing for more precise and delicate regions of the world.
ANDY G/FLICKR procedures which may previously have Robotic surgery has already proven it-
chnology. been prohibitively precarious. Addition- self as a viable option in cardiothoracic,
ally, robot assisted surgery greatly cuts neurological, urological and gynecologi-
Running a price upwards of $1.5 down the number of personnel needed cal procedures. As last December’s inno-
million, the da Vinci surgical system in the operating room, helping to mini- vation proved, its momentum still goes
consists of two primary components: a mize health care costs. strong. With the promises of this devel-
console for viewing and control and a Yet for all its acclaim, many impedi- oping technology, traditional surgery in
surgical arm unit which includes a num- ments still confront the growing field, its entirety may soon be a thing of the
ber of robotic arms. In a typical robot- the most conspicuous of which is the past.
assisted surgery, a human surgeon must cost of the machinery itself. Each da
Vinci system costs well over $1,000,000 David M. Carel is a sophomore in Pierson College.
Consumer-Directed
Healthcare
Written By Rachel Chen
I
n their efforts to curtail healthcare the relatively high deductible amount in
expenditures and to broaden con- their health plan. But, despite the poten-
sumer choice, policymakers, em- tial for high out-of-pocket expense, the
ployers, and insurers have developed a plan’s high deductible means monthly
growing interest in a novel insurance ap- premiums are often lower than for tra-
proach called “consumer-directed health ditional health insurance. Also, consum-
care.” Combining a high-deductible ers may keep any unspent dollars in their
health insurance plan with a tax-pre- account, creating an additional incentive
ferred savings account such as Health to be cost-conscious when purchasing
Savings Accounts (HSAs) or Health Re- their health services.
imbursement Accounts (HRAs) to pay Proponents of consumer-directed
for routine health care expenses, these healthcare argue that in the current
consumer-directed plans seek to give pa- health care system, insured individuals
tients an incentive to be their own cost have little perception of the true cost of
watchdogs and to minimize the moral services because out-of-pocket costs are
hazard dilemma. While HSAs and HRAs primarily limited to a share of insurance sured, because the lower premium costs
are both tax-preferred health accounts, premium costs, co-payments and other associated with high deductible health
they offer different legal requirements cost sharing. These proponents claim plans will be more affordable for the un-
and incentives. that if consumers pay for services di- insured to purchase. Furthermore, some
In summary, individuals with con- rectly with funds from an HSA, they will posit that the expansion of CDHAs will
sumer-directed health plans bundled be more cost-conscious of services, and be an incentive for providers, insurers,
with HSAs typically pay for routine will take initiative to research and make and employers to improve health care
health care expenses out of their tax-ex- more informed and prudent choices quality, promote competition, improve
empt savings accounts, which generally when they purchase services. This consumer knowledge, and make the
are funded by the employer or the indi- would reduce unnecessary health care health system more transparent. To help
viduals themselves. After these accounts spending and thus reduce costs. Propo- equip consumers in making purchasing
are depleted, individuals pay directly nents also argue that consumer-directed decisions, many insurers have developed
out-of-pocket until they have reached plans will reduce the number of unin- web-based tools that provide informa-
ple from obtaining health services that
they need. Furthermore, it is well-doc-
umented that a relatively small, dispro-
portionately ill segment of the popula-
tion accounts for a large share of health
care spending and there is little evidence
suggesting that this population could re-
duce expenditures, given their substan-
tial health needs. Since individuals with
expensive health needs often spend be-
yond the deductible and out-of-pocket
maximum levels, the incentives in HSA/
high deductible health plans may not af-
fect a large share of health care spend-
ing.
Another area of concern involves
how well people can shop for health
care services given their health literacy
and the current state of information
technology. Consumer-directed plans
presume that people can obtain suffi-
cient information about the price and
quality of their health care to make
good decisions. However, it is not clear
whether the proposed web tools and
technologies would be sufficient to help
consumers make such complicated de-
cisions. Furthermore, there is little in
the way of good information about the
costs of different health care services
and provider charges.
These concerns leave many question-
ing if and how HSAs will affect rising
health care costs and the growing num-
ber of the uninsured. So far, enrollment
is low and research is limited. How-
ever, that may change, as enrollment
A.DRIAN/FLICKR has been growing in both the individual
and employer-sponsored health insur-
ance markets. According to the Kai-
tion about common medical treatments versely affect risk selection and increase ser Family Foundation, then-President
as well as basic information about the out-of-pocket costs for people who are Bush proposed committing $25 billion
relative quality and cost of different currently insured through traditional in- to expanding HSAs in the Fiscal Year
treatment options and providers. In- surance. For example, the plans may at- 2007 Federal Budget, and many states
creased use of consumer-directed plans tract a disproportionate share of healthy have already revised their tax laws to ac-
would also encourage health care pro- enrollees with low health spending. This commodate HSA utilization. Given the
fessionals to release reports on quality in turn, would leave traditional, compre- implications for the health care system
of care and to make quality improve- hensive health plans with a relatively less of expanding consumer-directed plans,
ments to attract consumers. healthy clientele who, as a result, will there will be much at stake in their im-
Some are concerned about whether need to pay higher premiums. The po- plementation and expansion.
consumer-directed plans guide health tentially high out-of-pocket liability in
care financing in the proper direction. consumer-directed plans also could de- Rachel Chen is a senior in Berkeley College and a se-
They warn that these plans may ad- ter low-income and chronically ill peo- nior editor for YJML.
Bypass Surgery as a
Souvenir?
The Nature of Medical Tourism
Written By Nicole Negbenebor
R
ight now, look at the tag of your tions that patients can “travel to around
t-shirt. Does it say that it was the world for medical and dental care”.
made in [some country other Some of the more popular packages are
than the U.S.]? Now, imagine being able total knee replacement in Costa Rica, in-
to say the same thing for your hip re- guinal hernia surgery in Mexico, and face
placement or your new nose job. Medi- lift plus top and bottom blepharoplasty
cal tourism, medical travel, health tour- (eyelid surgery) in Thailand. Often, the
ism, global healthcare—all are names for package expense includes both the prices
the ever growing popularity of traveling for surgery and several days in a hotel,
internationally for health care services. sometimes with meals included.
I had heard of this phenomenon in Although the popularity of medi-
cal tourism is recent, the practice has dures such as dental work in places like
the past, but it was not until I Google
been around since Greek pilgrims would Indonesia as opposed the US? Some
searched “medical tourism” that the
travel from the Mediterranean region to scholars attribute it to the high cost of
world of global healthcare opened up to
the area of Epidauria in the Aegean Sea. health care, long waiting periods for
me. The first result was medicaltourism. surgical procedures, affordability of in-
com, a free resource for any patient and It was said to be the “sanctuary of the
healing god Asklepios” and had become ternational travel, and technological im-
industry provider who ever wanted to provements and regulations for care in
know the ins and outs of medical tour- the leading travel destination for medi-
cal and health tourism. What has led to other countries. Sites for medical tour-
ism. ism compare prices for specific medical
The medical procedures listed span this recent popularity of getting proce-
procedures for a patient; in most cases
anywhere from tummy tucks to gyne- the US prices for the medical procedure
cology to liver transplantation. Further- were significantly more expensive. Heart
more, non-medical procedures such as The quality of post-oper-
bypass surgery in the U.S. can cost up to
psychiatry, convalescent care, and alter- ative care can differ signifi- $144,000, while in Mexico and India it
native treatments are also offered. As will cost only $21,100 and $10,000, re-
impressive as their list of medical pro- cantly, depending on either spectively. An estimated 750,000 Ameri-
cedures was, I was more surprised by
the hospital or the country... cans went abroad for health care in 2007,
the number of destinations where the and the report estimated that a million
medical procedure could be performed. and a half would seek health care outside
Places such as Turkey, Hong Kong, and the US in 2008. It is predicted that the
Barbados are just some of the destina-
legal trade in the black market. Finally,
in places like the US, which has high
standards of quality, medical tourism
is viewed as risky. The quality of post-
operative care can differ significantly,
depending on either the hospital or the
country and prove to be different from
US standards. These differences in glob-
al healthcare provider standards have
been recognized by the World Health
Organization, which in 2004 launched
the World Alliance for Patient Safety.
This organization assists hospitals and
governments around the world in estab-
lishing patient safety policy and practices
that become especially relevant when
providing services for medical tourism.
So, what exactly do you have to do
if you want to get your knee replaced in
New Zealand?
1. Contact your local medical tourism

provider.
2. Provide a medical report and any oth-
er additional info the provider may re-
quest from you.
3. Certified doctors advise which medi-
cal treatment will be performed.
4. Discuss the expenses, hospital selec-
tion, tourist destination, and duration of
stay.
5. Sign consent agreements.
growth in medical tourism will cost US suggest long periods of rest after having 6. Get recommendation letters for medi-
health care providers billions of dollars major surgery and there is a high pos- cal visa from embassy.
in lost revenue since they cannot keep sibility that the aggravation of travel will 7. Travel to your chosen destination.
up with the prices the consumers are de- slow the process of recovery. Secondly, 8. A case executive who is assigned to
manding. receiving medical care abroad may lead you takes care of your accommodations
Rachel, a customer on the medical- to medical tourists experiencing legal is- and treatment.
tourism website’s testimonial page, trav- sues they are not familiar with. Litigation 9. After medical treatment, you remain
eled to Bangkok, Thailand for breast in many countries is limited and is the in tourist destination for however many
augmentation and returned to the US basis for the lower cost of care overseas. days have been discussed.
to report that her experience was excel- If problems were to arise, healthcare
lent. Her surgeon had “trained in the specialists claim that patients might not If this sounds like the process you
US and spoke perfect English.” In the be “covered by adequate personal insur- would like to go through to receive
same way that Rachel has, many patients ance or might be unable to seek compen- healthcare, then medical tourism might
report positive experiences associated sation via malpractice lawsuits.” Thirdly, be for you. Who knows? As the stan-
with medical tourism. However, there is the illegal purchase of organs and tissues dards for international medical care im-
a darkness looming in the midst of the for transplantation in the years prior to prove and health care costs continue to
six star hotels, cheap medical costs, and 2007 has been alleged in countries such rise in the US…in the future, medical
“medical safaris”. Traveling long dis- as India and China and raises many ethi- tourism might be for all of us.
tances soon after surgery can increase cal issues. Medical tourism is a business
the risk of complications. Most doctors that has also become notorious for its il- Nicole Negbenebor is a junior in Saybrook College.
Consumer-Directed
vertisements, the Food and Drug Ad-
ministration (FDA) has the authority
to directly regulate only product-claim
ads. The regulations require that thera-
Advertising
peutic claims not be false or mislead-
ing. The agency regulations differenti-
ate between print and broadcast DTC
product-claim ads. Print ads must con-
tain all the risk information described
in the drug’s FDA-approved label, in-
cluding major side effects, contrain-
dications, and precautions. Broadcast
advertisements, however, must directly
state only major risk information and
must direct viewers and listeners to
other sources from which they can ac-
cess the complete risk information.
Help-seeking ads also are directed
toward consumers but make no health
claims. Reminder ads also make no
health claims but are primarily directed
toward doctors and health care profes-
sionals, who are more likely than con-
sumers to know about the advertised
product and its use. They also serve to
acquaint consumers with brand names
of products. Although the agency
monitors these two types of ads, to en-
sure there is no implication of a prod-
uct claim, it has issued only draft guid-
ance on them because it does not have
Written By Rachel Chen the authority to regulate these ads.
This report focuses on the impact
O
of product claim ads and the regula-
ver the past quarter-century, dio today has likely seen or heard some tory requirements for these ads. This
prescription drug manufac- sort of DTCA for prescription drugs. report also discusses FDA’s funding,
turers in the United States The ads usually fall into one of three enforcement authority and initiatives,
have increasingly invested in direct- categories: “commercial speech” court rulings,
to-consumer advertising (DTCA) de- previous legislation, and other relevant
signed to build brand recognition and 1. “Product-claim” ads that include agency activities.
to foster patients’ belief in the quality a product’s name and a therapeutic
of their products. claim about the product.
Direct-to-Consumer advertising is 2. “Help-seeking” ads that discuss ...critics say this type of
usually described as any promotional a particular disease or health con- advertising contributes to
effort by pharmaceutical companies to dition and advise the consumer to
rising drug costs and leads
present prescription drug information “see your doctor” but do not men-
to the general public through the lay tion the product’s name. people to demand unnec-
media. DTCA shows up in magazines, 3. “Reminder” ads that call atten- essary or inappropriate
newspapers, non-medical journals, tion to the product’s name but make
no reference to the health condition medications.
pharmacy brochures, and direct-mail
letters and on television, radio, videos, the drug is used to treat.
and Internet websites. Anyone who More than ten years after the FDA
watches television or listens to the ra- Of these three categories of ad- issued new rules governing broadcast
and others have begun to look at the
factors contributing to these rapid in-
creases, including the potential role of
DTCA.
Furthermore, a study conducted by
the Harvard School of Public Health
examined changes in DTCA and phy-
sician promotion activities from 2000
to 2007 and their effects on drug sales
within five therapeutic drug classes,
chosen based on prevalence of DTCA
within the classes and variation in ad-
vertising patterns and product life-
cycles of drugs within the classes.
Impacts of the changes in DTCA and
physician promotion on the market
share of individual drugs within each
class and on sales for the entire class
Source: IMS Health, Integrated Promotional Services TM and CMR, 6/2004 were calculated. After accounting for
the fact that drugs with higher sales
are more likely to be advertised to con-
DTCA -- which allow television and ra- pharmaceutical representatives that sumers and have higher levels of pro-
dio ads to promote specific drugs with are directed to office-based physi- motion to physicians, the study found
less detailed information in the ad it- cians (often referred to as “detail- that increases in DTCA were associ-
self about side effects and precautions ing”). ated with significant growth in sales
than is required of print ads -- the mar- c. Hospital promotion captures the for the classes of drugs studied: for
keting of prescription medications di- costs associated with sales activities every ten percent increase in DTCA,
rectly to consumers remains the focus of pharmaceutical drug sales within the classes studied
of considerable debate. Proponents representatives that are directed to increased on average by two percent.
argue that DTCA informs consumers hospital-based physicians and direc- No evidence was found that changes
about important, treatable health con- tors of pharmacies. in DTCA affected the market share of
ditions and encourage doctor- patient d. Journal advertising reflects adver- individual drugs within the classes.
communication, while critics say that tising expenditures for prescription DTCA is an important, but not the
this type of advertising contributes to products appearing in medical jour- primary, driver of growth in prescrip-
rising drug costs and leads people to nals. tion drug spending. For pharmaceuti-
demand unnecessary or inappropriate e. The retail value of the product cal manufacturers, the return gener-
medications. sampling activities of pharmaceu- ated by increasing spending on DTCA
Promotion and prescription drug tical representatives are those di- appears to be significant. Although
DTC spending has reached significant rected to office-based physicians, as prescription drug spending growth
levels in recent years. Table 1 shows reported by members of their front has moderated somewhat in the last
annual spending since 1996 on DTC office staff. couple years, annual increases in the
advertising, along with spending on nine to twelve percent range are still
other types of promotional activities According to the Kaiser Family expected for most of the next decade.
by pharmaceutical companies. Foundation, actuaries at the Depart- Given this continuing rapid growth,
ment of Health and Human Services the debate over the costs and benefits
a. DTC promotion represents the project that prescription drug spend- of DTCA are likely to continue. It is
expenditures for direct-to-consum- ing will continue to grow at between extremely important that policymakers
er pharmaceutical advertising for 9% and 12% annually through most of evaluate both the benefits and costs of
prescription products on television, the next decade. Concerned about the DTCA.
magazines, newspapers, radio, and impact that this cost growth is having
outdoors. on the availability and affordability of Rachel Chen is a senior in Berkeley College and a se-
b. Office promotion includes costs prescription drugs, policymakers, pub- nior editor for YJML.
associated with sales activities of lic and private health plan managers,
Compassionate
Drug Use
Written By Parker Collins
A
t first glance, he’s nothing more going the necessary clinical trials and the
than some crusty old man with completion of FDA approval. Approved
a cane and a Vicodin addiction. in 1987, the FDA’s Compassionate Drug
He’s bossy, crude, and has a perpetual program offers two options for eligible
five o’clock shadow. At the end of every patients. First, a company that has made
episode, some seemingly incurable pa- it to Phase III of the drug approval
tient walks out of his ward with nothing process, the stage at which a company
more than an IV scar and a welt from must run clinical human trials, is given
a seizure to remind them of their stay. permission to create an Expanded Ac-
Dr. Gregory House, the protagonist/ cess Program (EAP) for patients who
antagonist of the FOX medical mystery are not able to participate in the clinical
show “House,” employs an assortment I take risks. Sometimes trial. However, if an EAP isn’t available
of questionable practices to get results, patients die, but not taking for a certain patient, the patient’s doctor
but he does get results. Does the cure can work with the drug company to ask
justify the course? This question has risks causes more patients the FDA for single patient access. These
guided medicine for years and is current- individual requests are usually processed
to die—so I guess my big-
ly delaying the implementation of what within 24 hours.
has come to be called “compassionate gest problem is I’ve been According to Dr. Timothy Moyni-
drug use”. han, an oncologist at the Mayo Clinic,
cursed with the ability to
Compassionate drug use, formally there are several essential criteria to be
known as “investigational drug use,” al- do the math. considered for compassionate drug use.
lows the administration of experimental The disease in question must be fatal,
Dr. House rare, and have no known cure. Approved
drugs to terminally ill patients while for-
associated costs of the treatment.
The greatest risk and argument
against compassionate drug use lies in
the inability to predict the efficacy and
side effects of treatment. There is no
way to know how an individual patient
will react to the experimental drug, much
less whether the drug will cure or kill the
patient.
In the episode “Detox,” Dr. House is
called in for a diagnosis after a patient’s
girlfriend wrecks her father’s Porsche be-
cause the sight of the patient’s blood in
the passenger seat distracts her. At some
point before the patient’s belabored di-
agnosis of Napthalene poisoning, Dr.
House responds to one Dr. Lisa Cuddy
saying “I take risks, sometimes patients
die, but not taking risks causes more
patients to die—so I guess my biggest
problem is I’ve been cursed with the
ability to do the math.” Is it really a curse
to pursue whatever means necessary for
the wellbeing of a patient?
In a case where compassionate drug
use is a possibility, the patient has the
right to do with his body as he pleases.
The primary doctor and other medical
professionals can give their educated
recommendations, but ultimately it is
up to the patient to choose. If there is
even the slightest chance that an experi-
mental medicine could prevent a futilely
prolonged hospital stay and eventual
death, then it is the patient’s prerogative
AYENA to choose to pursue a risky treatment in
spite of whatever unforeseeable hazards
may exist.
treatments for the disease must have capacity to remove the red tape and con-
Upon graduating from medical
failed to yield satisfactory results and the duct a possibly life saving experiment.
school, nearly every prospective medical
patient is not eligible for the clinical tri- However, even this process has its hur-
professional takes the Hippocratic Oath,
als currently studying the experimental dles. In most cases, the FDA requires
a promise made unto all future patients
drug that might prove curative. From the submission of an investigational
to foster proper practices. In the mod-
an institutional standpoint, the oversee- new drug application in order to obtain
ern translation of the ancient Greek text,
ing physician agrees that the patient has a drug during its preclinical develop-
those taking the oath swear to “…apply,
no other options and may benefit from ment. Even after the application process,
for the benefit of the sick, all measures
an experimental treatment and the com- the drug company has no obligation to
[that] are required.” Maybe Dr. House
pany that makes the experimental drug comply with the request for their drug.
isn’t all that great at sticking to the rules,
must agree to provide a sufficient dosage Moreover, if the pharmaceutical com-
but at least he got one thing right.
to the patient. pany accepts the request, there may be a
Essentially, in the most severe cases, charge for the drug and it is unlikely that
Parker Collins is a sophomore in Trumbull College
doctors and drug companies have the an insurance company will pay for any
and the Distributional Director for YJML.
Interview
Dr. Stephen Oesterle

Senior Vice President for Medicine and Technology
Medtronic
Interviewed by Jamin Patel
Stephen N. Oesterle, M.D., joined Medtronic

in 2002 as its Senior Vice President for Medi-
cine and Technology, overseeing the company’s
scientific research, formation of technological
strategies and continued development of strong
cooperative relationships with the world’s medi-
cal communities, such as technical universities,
financial institutions, and emerging medical de-
vice companies.
Previously, Dr. Oesterle served as an Associate

Professor of Medicine at the Harvard University Medical School and
as the Director of Invasive Cardiology Services at Massachusetts Gen-
eral Hospital, Boston. He has also developed and directed interven-
tional cardiology programs at Good Samaritan Hospital, Los Angeles;
at Georgetown University; and at Stanford University. Dr. Oesterle re-
ceived his medical doctorate from Yale University in 1977
Medtronic recently released the re-
sults of its deep brain stimulation
therapy for epilepsy, in which a de- We’re just trying to use technology, whether it’s information
vice was surgically implanted into the
brain to electrically stimulate certain
technology, communications technology, biotechnology,
targets. Will such treatments become genomics, you name it, to ultimately take money out of the
commonplace?
system and provide better healthcare.
Well, first of all, this technology isn’t
Dr. Stephen Oesterle
specific to just epilepsy. For instance,
we’ve already developed a Deep Brain
Stimulation process for treating a neu- you get enough into the area of interest recognize that there are many interest-
ropsychiatric disorder called obsessive so that something good will happen. On ing drugs that could be given locally and
compulsive disorder in which we target the other hand, most devices, either me- would be much more effective in smaller
certain structures in the brain to amelio- chanical or electrical, are targeted, con- doses and with less side effects.
rate if not abolish the symptoms, which trolled local delivery systems. As a result
can be crippling for some people. We’re of this local treatment, they generally As more of these devices and prod-
also in the middle of doing a study in have very few side effects as opposed to ucts are developed, do you think
which we will try to stimulate patients drugs – take Vioxx for example. We also costs, in terms of the devices them-
into a mood altering situation in order to treat with biologics, including protein selves and the procedures to implant
erase profound symptoms of drug-resis- and siRNA. However, you cannot ingest them, will become excessive and thus
tant depression. We also have similar tar- these the way you ingest pills; if you in- prohibitive for most patients?
gets for drug addiction and Deep Brain gest biologics, you will digest them. Most
Stimulation is an approved approach and often, they need to be delivered through We’re not in the business of adding
a standard of care for advanced Parkin- a device acting as an infusion system. costs. If we can’t prove that our prod-
son’s disease. So the epilepsy story is just Thus, we see devices catalyzing the re- ucts are cost effective, we’ll never get
a continuing application for a technol- alization of such biotechnology, which reimbursements for them, so we don’t
ogy that we’ve been developing over 20 ultimately will replace pills. think we’re actually going to add costs to
years. the system. For example, right now, the
Medtronic generally works with the single greatest consumption of health-
You mention obsessive compulsion device side of medication. Will it ex- care dollars in the United States is tied
and depression. Some would argue pand into developing the biogenics up in hospitalized patients with heart
that this is going beyond treating that you’ve just mentioned? failure - we spend about $35-$40 billion
more traditional illnesses and is in- a year on these patients. We think we
stead altering mood and personality We’re not a discovery operation. We can keep 20-30% of these people out of
- how people think and feel. Do you generally don’t discover new proteins as the hospital using an implanted pressure
receive any resistance from bioethics a rule, but we have all sorts of collabo- sensor that we’re working on that moni-
groups for this? rations with biotechnology companies. tors their pulmonary pressure. These
For example, the leading company in the sensors would speak to a handheld de-
I think your premise here is wrong. world in siRNA is in Cambridge, MA - a vice such as a Blackberry, which would
Depression is a profound illness; it’s no company called Alnylam. We have a very then use broadband networks to com-
different than hypothyroidism or diabe- active collaboration with them to try to municate with distant data storage facili-
tes. These are chemical imbalances caus- silence the abnormal proteins that are ties that would keep track of patients. So
ing abnormalities in neurotransmitter associated with Huntington’s chorea. We that’s 20-30% of $40 billion saved. We’re
release that we are trying to fix. In terms also have all sorts of collaborations with just trying to use technology, whether
of treatment for these types of illness- pharmaceutical companies to package it’s information technology, communi-
es, this is one of the major differences their drugs into our pumps and devices. cations technology, biotechnology, ge-
between devices and pharmaceuticals. We have these collaborations because, nomics, you name it, to ultimately take
Most pharmaceuticals are small mol- as you say, Medtronic is largely an engi- money out of the system and provide
ecules that are taken by mouth and sys- neering company and we generally don’t better healthcare.
temically distributed and you hope that do biology or drug discovery, but we (Cont’d on next page)
Interview
(Cont’d from prev. page) all are interested in handheld devices

and we’ve talked to broadband networks
Another example would be patients ranging from Verizon in the US to Do-
with high blood pressure. Generally, you como in Japan. We also have Microsoft in
would go to the doctor every 2 weeks or our lives all the time; we’re trying to figure
every month and have you blood pres- out how we can use interactive databases
sure checked to have your medications so that, for instance, patients who are
adjusted. There’s no reason we couldn’t being operated on in India can have their
remotely manage hypertension in a much pacemakers remotely programmed from
more efficient way through a combina- Minneapolis. If you think about it – if
tion of wearable sensor technology and you were Apple and you had a choice be-
broadband communication. This would tween sending iTunes over the internet
mean more efficient care and better care and sending vital physiologic data, which
which translates to less money wasted. one do you think could be more valu-
In addition, in the last 10 years, we’ve able to them ultimately? Accordingly,
seen the unraveling of the human ge- the Apple iPhone is perfectly set up for
nome. As sequencing gets faster, we healthcare management. In fact there are
think genomics is going to play a major already applications if you go the Apple
role in so called “personalized medicine”. Store. Nike, for example, has over a mil-
We’ll be able to decide, for example, who lion people running around with sensor
should and who shouldn’t take Lipitor, in their shoes speaking to their iPods;
or who should get an implantable de- that gives you a little glimpse of where
fibrillator, or who would benefit from companies like Apple are going. I think
cardiac resynchronization. I think we’re everybody’s going to part of this trend in
going to be able to sort all that stuff out. healthcare management.
You say devices are part of the key to

We support the healthcare reducing costs in the system. None-
theless, the Healthcare bill that just
bill, but do we want to be passed incorporates a multi-billion
taxed for it-- no. It will hurt dollar tax on medical device manu-
facturers. Why do you think your in-
innovation and it becomes dustry has been targeted and what
another challenge for us. will be the implications of this tax?
A medical professional holds up a Medtronic ventricular pacing device.
Dr. Stephen Oesterle Well, Congress has been gotten mon-
ey from many areas in healthcare. The
less money we have available to put back
logic behind it is that if more people are
in the company in terms of R&D. We
insured, those are more customers for
support the healthcare bill, but do we
How are you working with compa- companies like us. But that isn’t neces-
want to be taxed for it – no. It will hurt
nies like Google, Research in Motion, sarily true since most of the patients
innovation and it becomes another chal-
or Microsoft to develop these remote we treat are elderly Medicare patients
lenge for us.
monitoring systems? already, so the uninsured have not been
that big of an issue for us. The real wind-
Another exciting area in Medtronic
We talk to all of these companies. We fall in this is going to be for pharmaceu-
research is diabetes management –
talked to IBM, for example, because if tical companies and in hospitals where
you mentioned wearable pumps and
we want to remotely manage millions of patients will have access to medications
such. What challenges are there in
people, we need supercomputer capabil- and hospitalizations in a way they haven’t
developing these sorts of devices?
ity. It also takes a new web architecture before. What you’re saying is basically
to handle the data. In terms of telecom- right. The tax is basically a tax on inno-
For years the Juvenile Diabetes Re-
munication, Qualcomm, Apple, they are vation because the more tax we pay the
search Foundation had a basic goal of
organ damage.
As you develop into the international

market, do you find that there are dif-
ferent demands there than in the US?
We are a global company - we operate

in 120 countries. Some of our biggest
growth markets are in places like China,
India, Russia, and Brazil. But there are
many things different in these emerg-
ing markets. In China, though there is
health insurance, most people pay out
of pocket and the average person there
makes $300 a year. It changes the mar-
ketplace dramatically. Of the 1.3 billion
people in China, there are probably only
200-300 million who can easily afford
healthcare. We must therefore adapt dif-
ferent distribution models everywhere
we go. Right now the US spends 16-17%
of its GDP on healthcare whereas the
UK spends half of that, and it’s even less
in other places. Thus, we face issues of
reimbursement and affordability that are
different in every country.
Our other major issue in places like
China is really around training. Unlike
pharmaceuticals, which are not very
hard to administer, you can’t just hand
over a neurostimulator to a physician. If
a trained technician isn’t available on the
spot, you need remote communication
STEV.IE/FLICKR capability to allow someone to remotely
program the devices and such.
Historically, Medtronic has been

curing diabetes, but in the last few years pump reacts. The goal is to get more strong on health-related technolo-
there’s been a sort of cultural change; accurate and timelier. We’ve already re- gies. Will that be the trend in the fu-
they’ve realized that maybe what they leased a product that has the pump ac- ture?
want instead is to perfect a closed-loop celerate as blood sugar goes up. But the
artificial pancreas. And that’s where challenge is to do that safely because if We think the most interesting chal-
we’ve positioned our business. We have you accelerate the pump and the blood lenge in the next 20 years is in the neuro
a pump that pumps insulin into the body sugar goes too low, it quickly becomes a field. There’s going to be a dramatic
and communicates with a wearable sen- problem. The other challenge is in prov- increase in neuro-degeneration inci-
sor, essentially mimicking what your pan- ing to people that pumping insulin is bet- dence with the baby boomers – things
creas does - sensing ambient blood glu- ter than injections. A lot of people just like Alzheimer’s disease and Parkinson’s.
cose and responding with the release of prefer to take their one or two injections So it’s the one area where we see the
insulin. The challenge is that it’s never as per day. Thus, we’re doing clinical trials greatest need for work.
good as nature makes it. There’s a certain now to prove that a continuous flow of
lag time between what the sensor senses insulin is a more efficient and better way Jaymin Patel is a junior in Timothy Dwight College
in the subcutaneous tissue and how the to deliver insulin in terms of minimizing and a Managing Editor for YJML.
Commentary
Gonzales v. Carhart findings of fact and politicians should

never have the power to create specific
medical standards, as it is outside their
line of expertise. The misplacement of
medical authority undermines the integ-
When the Court Practices Medicine rity of the medical profession and poses
danger to general public health.
The Court asserts that in the face of
“medical uncertainty,” legislators have
wide discretion on the subject. How-
ever, the loss of the procedure from the
medical arsenal results either in the sta-
tus quo or heightened maternal health
risks and endangerment.
After Griswold v. Connecticut (1965)
established the fundamental constitu-
tional right to privacy, Roe v. Wade and
Planned Parenthood of Southeastern
Pennsylvania v. Casey (1992) established
that the substantive due process right
to privacy included the abortion deci-
Written By Connie Cho sion. In these cases, the core dilemma
lay in weighing the state’s interest in the
health and safety of the woman as well
T
he term “partial birth abortion” judicial power, disregarded the impor- as her individual privacy rights against
is a politically-generated misno- tance of a maternal health exception, the state’s interest in the protection of
mer. This abortion procedure, thereby infringing upon the right of a fetal rights.
medically known as “intact dilation and patient to make safe medical decisions. The Court established that fetal per-
extraction” (D&E), involves removing a The Court’s decision lets an affected no- sonhood and state’s interests began at
fetus from a uterus in one fell swoop, as tion of a “respect for life,” a subjective the point of viability, when the fetus
opposed to the alternative standard pro- and weak interpretation of the state’s would be able to live outside of the
cedure, which removes a fetus in pieces. interest, override the privacy rights and womb with medical assistance. The de-
Intact D&E is a “late term” procedure, bodily integrity of a pregnant woman. velopment of a fetus is measured not in
performed mostly on pre-viable fetuses inches out of the womb, as the Act and
in the second trimester but can even oc- the Gonzales decision now suggests.
cur in the first trimester. Politicians should never Justice Kennedy, author of the majority
In 2003, Congress passed the Par- opinion, has either redefined fetal per-
tial Birth Abortion Act, categorically have the power to create sonhood or is giving “dignity” to a fetal
banning the intact D&E procedure for body that cannot survive independently
specific medical standards.
all pregnant women without a mater- from its mother. “Respect for the dig-
nal health exemption provision. Some nity of life” does not mitigate the ques-
variations of D&E were still allowed. tion of fetal personhood.
In 2007, the Supreme Court upheld this Congressional evidence from the The Gonzales decision cites Con-
ban as constitutional in the case Gon- Act claims that intact D&E was “never gress’s assertion that “partial-birth
zales v. Carhart, directly contradicting medically necessary.” This claim was abortion…confuses the medical, legal,
a previous ruling in an almost identical countered by the American Congress and ethical duties of physicians to pre-
case, Stenberg v. Carhart (2000). of Obstetricians and Gynecologists serve and promote life, as the physician
Although Gonzales did not overturn in an amicus brief advising that intact acts directly against the physical life of
the right to an abortion established in D&E can be safer than standard D&E a child.” Here Congress makes two im-
Roe v. Wade (1973), the ban is unduly for some women. The reality is that the portant inflammatory characterization
burdensome. The Supreme Court, in a medical information that the Court re- errors, in titling intact D&E abortion
narrow and overextending exercise of lied upon in Gonzales are Congressional “partial-birth abortion”, and in calling
LUCIA TANG
the pre-viable fetus a “child.” Both er- be grotesque and inhumane if consid- of rare diseases and unique individu-
rors stem from the same problems of ered out of context. als requires personalized diagnoses and
redefining where life begins and they Critics may then argue that a neither personalized care.
disregard the viability distinction that intact nor standard D&E should be per- The Courts have steadily sought to
Justice Kennedy faces in invoking a “re- formed because both are equally unsa- finesse the right to autonomy and bodi-
spect for human life.” vory procedures. However, the banning ly integrity under the substantive due
of all D&E procedures would effec- process right to privacy. But Gonzales
tively eliminate late term abortions. This v. Carhart’s narrow, unduly burdening
“Respect for the dignity of would certainly be a substantial obstacle condemnation of a safe medical proce-
for a woman seeking an abortion and is dure has halted such progress as it inter-
life” does not mitigate the thus an undue burden, prohibited un- feres with patient autonomy rights and
question of fetal person- der the Casey decision. The varying and the physician-patient relationship. The
vague notion of “human dignity” across arbitrariness of the Court’s repulsion
hood. individuals in relation to their comfort towards intact D&E over other abortion
with medical practices is not substantial procedures and the short life of the pre-
Kennedy is obviously repulsed by the enough to overrule a woman’s right to vious Stenberg v. Carhart holding reflect
intact D&E procedure. This repulsion is an abortion. poorly upon the integrity of judgment
subjective and inconsistent but plays a The Court states that banning intact on abortion law from the Court to the
large role in justifying the offensive na- D&E is not an undue burden “because great detriment of women seeking an
ture of intact D&E. Some would assert standard D&E is the most common sec- abortion.
that taking the fetus out of a uterus limb ond-trimester abortion method… the
by limb, as in standard D&E, is more Act would impose an undue burden if it Connie Cho is a sophomore in Silliman College and a
grotesque. All medical procedures can covered standard D&E.” But the world staff writer for the YJML.
Synthetic Red Blood
mental building block of natural RBCs,
to form the structure of the sRBC itself.
These layers were cross-linked to provide
additional stability, and then the PGLA
Cells
template-core was removed using a mix-
ture of 2-propanol and tetrahydrofuran
(THF). This left in its wake synthetic
particles that closely resembled the struc-
ture of natural RBCs.
A Macro Leap in Microbiological Medicine
It is not the similarities,
however, but the differ-
ences that grant promise
in the future of medicine to
synthetic particles such as
the sRBC.
Apart from physical resemblance,

the recently developed sRBCs also share
many functional similarities with natural
red blood cells. Trials to test the ability
of the sRBCs to hold oxygen, a critical
Written By Eduard B Vangelder function of the natural RBC, showed
that, when coated with additional hemo-
globin, sRBCs are able to hold levels of
oxygen that are comparable to normal
RBCs. Furthermore, additional test-
A
ing showed that the sRBCs are capable
s the frontier of medical dis- According to Dr. Mitragoti’s results, of retaining up to 90% of this oxygen-
covery expands every day, our published in the Proceedings of the Na- carrying capacity after one week. More
focus on understanding and tional Academy of the Sciences (PNAS), importantly in terms of treatment ap-
controlling our own biological systems the sRBCs were designed and created plication, the sRBCs, like their organic
is growing, especially at the microscopic based on the natural process by which counterparts, are able to change their
level. In fact, many advances in the past real red blood cells (RBCs) are made. In shape in response to flow, allowing them
few years have allowed us to issue novel the human body, the red blood cell’s fa- to move through channels and capillar-
treatments at the cellular and molecu- miliar donut-like shape is created when a ies that are smaller than they are. This,
lar levels. For example, this past year, a spherical reticulocyte undergoes a com- in turn, could allow the sRBCs to have
team of chemical and macromolecular plex fold reduction. Dr. Mitragoti and a large degree of accessibility in the hu-
engineers from the University of Califor- company modeled RBC genesis first by man body.
nia, Santa Barbara, and the University of designing a hollow, spherical polymer It is not the similarities, however, but
Michigan, led by Dr. Samir Mitragoti, has template using a biocompatible and bio- the differences that grant promise in the
developed synthetic carriers that directly degradable polymer known as polylactic future of medicine to synthetic particles
mimic the structure and function of red acid-co-glycolide (PGLA). By exposing such as the sRBC. Due to the nature of
blood cells. Further application of these this template to 2-propanol, they caused its structure, the sRBC structure can be
synthetic red blood cells (sRBCs) could the PGLA polymer to collapse into the either externally or internally loaded with
have profound implications in the areas familiar shape of a natural RBC. Onto drugs and chemicals useful in the fields
of drug delivery, medical imaging, and this template, they added up to nine lay- of drug delivery and medical imaging.
understanding blood related disorders, ers of cationic and anionic polymers, The flexibility and accessibility of the
such as sickle-cell anemia. including hemoglobin, which is a funda- sRBC allow it to carry these substances
to their destination elegantly and effec- It is possible that these side effects could treatment, the techniques employed by
tively. be avoided through the more easily regu- Mitragoti and his companions to create
In the area of drug delivery, tests lated use of sRBCs to administer the the sRBC may also prove pivotal in the
have been done confirming the effective- drug. future of cellular modeling. The engi-
ness of sRBC, “especially in the vascular Other tests indicate the potential of neers of the sRBC themselves have said
department,” according to the findings sRBCs in medical imaging. Studies con- in their report that their techniques can
of Mitragotri et al. A test involving the ducted by the researchers that developed be used to model not only healthy RBCs
drug heparin, which is used as an anti- the sRBC demonstrate the ability of but also “the shapes and properties of
coagulant to prevent clotting, yielded the the carrier to uniformly and thoroughly diseased cells.” In the near future, this
most promising results. Results showed incorporate iron oxide nanoparticles, may allow us to gain a better understand-
that the sRBCs demonstrated not only which serve as a contrast agent in mag- ing of blood disorders such as sphero-
the ability to contain large amounts of netic resonance imaging (MRI). This cytosis and sickle-cell anemia. Ultimately,
heparin but also the ability to release it could allow for greater accuracy, for ex- as techniques in cellular and microbio-
slowly and continuously over the course ample, in techniques of therapeutic de- logical modeling continue to advance
of several days. This would prove ben- livery and the treatment of cancerous and conform to the natural processes of
eficial considering the potential risks tumors. Still, other contrast agents can the human body, the understanding and
of administering heparin parenterally be attached to the surfaces of the sRBC treatment of many disorders will con-
(through an injection or IV), which in- molecules, allowing for more discoveries tinue to improve.
clude hyperkalemia (elevated levels of in the application of this realm.
potassium in blood), alopecia (hair loss), In addition to the potential contri- Eduard B. Vangelder is a sophomore in Jonathan
and osteoporosis (bone degeneration). bution to the advancement of medical Edwards College.
The Risk of a Market
for Organ Donations
Written By Rachel Chen
T
he 2009 arrest of Levy Izhak states that human organs cannot be ex-
Rosenbaum, a businessman changed “for valuable consideration,”
accused of buying and selling meaning something of monetary value. come from a living donor because, while
kidneys in the United States, has drawn But for years, members of the trans- people are born with two kidneys, they
attention once again to the ever-grow- plant community have debated the idea only need one to function normally.
ing organ shortage in this country. The of providing incentives to organ do- Since donations from the deceased alone
number of people waiting for an organ nors, such as tax credits or even direct are not likely to meet the demand for kid-
in the U.S. has soared upward, increas- payments. However, skeptics fear that
ing from 31,000 people in 1993 to over these types of incentives could lead to
101,000 today, according to the United an unregulated market for organs and The problem with markets
Network for Organ Sharing (UNOS), are therefore not worth the risk. While
the non-profit organization that keeps implementation of incentives is likely is that rich people would
track of all organ transplants in the U.S. to be far off, the issue has divided the descend upon poor people
As the shortage grows, the dilemma re- transplant community, and no clear con-
mains: how can the number of dona- sensus exists. to buy their organs, and the
tions rise to meet the need? Some think Perhaps the greatest amount of dis- poor don’t have any choice
this supply-and-demand problem could cussion concerning financial incentives
have a financial solution through mon- surrounds kidney donation. Not only about it.
etary incentives to donors. is the need for this organ the greatest
Dr. Francis L. Delmonico
Currently, the sale of organs in the (about 80,000 people on the UNOS list
Transplant Surgeon & Medical Director
U.S. is illegal as a result of the 1984 are candidates to receive a kidney), but New England Organ Bank
National Organ Transplant Act, which it is also one of the few organs that can
it would alleviate some concerns that
potential living donors might have.” Ini-
tiatives to remove financial disincentives
“may increase living donation,” says Dr.
Francis L. Delmonico, a transplant sur-
geon and medical director of the New
England Organ Bank in Newton, Mas-
sachusetts.
There are 49 million people in the
U.S. without health insurance, according
to Arthur Matas, a surgeon and director
of the University of Minnesota’s Renal
Transplant Program. Providing them
with reimbursements for medical care or
providing them with full-fledged health
insurance should they be unable to get
coverage due to a preexisting condition
may ease their worries about being a
donor. The American Society of Trans-
plant Surgeons also supports these initia-
tives and has a program that provides aid
to living donors who have lost money
as a result of their donation. Donors,
however, must apply for the funds, and
Delmonico reports that the program has
only reimbursed about 500 donors in the
U.S.
Money for Kidneys?
Imagine if people were not just reim-

bursed but actually paid for their kidneys.
Some people think that a regulated sys-
neys (last year there were about 16,000 complications from the procedure, they tem could be put in place in which true
kidneys donated by the deceased, cover- may have to pay for lifelong medical financial incentives — ones that result in
ing only 20 percent of the number of treatment. Other donors may have to financial gain — are provided to donors.
people on the waitlist for kidneys), some pay for their travel to and from the hos- This incentive could be a cash payment or
have focused their attention on ways to pital, or they may lose money when they something less direct, like lifetime health
increase the number of living donors. take time off work after the procedure. insurance. One of the biggest fears with
The National Kidney Foundation introducing financial incentives is that it
Take Away “Disincentives” (NKF) is in favor of covering these might lead to an “organ market” and cre-
types of donation-related expenses, says ate a situation in which the rich could ex-
Since some people actually end up Dolph Chianchiano, the vice president ploit the poor for organs. “Once you in-
losing money when they give an organ, for health policy and research at the sert monetary gain into the equation of
one idea is to take away any financial ob- foundation. For instance, NKF supports organ donation, now you have a market.
stacles that might hinder someone from state and federal legislation to create tax Once you have a market, markets are not
making a living donation. While some credits for living donors that would re- controllable, markets are not something
people who favor these types of incen- imburse their out-of-pocket donation you can regulate,” says Delmonico. “The
tives will not go as far as to say donors costs, he says, even if it does not increase problem with markets is that rich people
should benefit financially, they do agree donations. “The main reason [we sup- would descend upon poor people to buy
that donors should not be put at a mone- port reimbursement] is that it’s the right their organs, and the poor don’t have any
tary loss for their altruism. For example, thing to do for the living donors,” says choice about it.” (Cont’d on p. 37)
in the rare case that donors experience Chianchiano. “But one would hope that
Interview
Paul Root Wolpe, Ph. D.

Director of the Center for Ethics
Emory University
Interviewed by Rachel Chen
Paul Root Wolpe, Ph.D. is the Asa Griggs

Candler Professor of Bioethics, the Raymond F.
Schinazi Distinguished Research Chair in Jew-
ish Bioethics, a Professor in the Departments
of Medicine, Pediatrics, and Sociology, and the
Director of the Center for Ethics at Emory
University. Dr. Wolpe also serves as the first
bioethicist for the National Aeronautics and
Space Administration (NASA), where he is re-
sponsible for formulating policy on bioethical
issues and safeguarding research subjects. He
is Co-Editor of the American Journal of Bio-
ethics (AJOB), the premier scholarly journal in
bioethics, and Editor of AJOB Neuroscience, and sits on the editorial
boards of over a dozen professional journals in medicine and ethics.
Dr. Wolpe is a past President of the American Society for Bioethics
and Humanities; a Fellow of the College of Physicians of Philadelphia,
the country’s oldest medical society; a Fellow of the Hastings Center,
the oldest bioethics institute in America; and is the first National Bio-
ethics Advisor to Planned Parenthood Association of America.
As the director of the Ethics Center
at Emory, what are your missions?
What would you like to accomplish? People are so bad at statistics to begin with, and what people
The Emory Center is a general ethics
center. We do business ethics, legal eth-
are supposed to do with this information is problematic. Even
ics, life science ethics and bioethics. So knowing susceptibility doesn’t solve the problem. I really
that regard, one of my goals there is to
develop a general model of what an eth- think that in terms of medicine, our ability to genetically prog-
ics center looks like. In bioethics, we’re nosticate will not solve as many problems as people predict,
trying to do a number of things. We are
working in creating a comprehensive but instead raise more questions.
medical ethics educational program, not
Paul Root Wolpe, Ph.D.
just for students in the medical school,
Director of the Center for Ethics, Emory University
but for people in the life sciences. We are
also expanding the ethics program for all It has been a lot of fun. I am the only medicine is delivered in space, it is im-
graduate students at Emory, including bioethicist for NASA, focusing on re- portant to clarify the underlying value
English and history students that focus search ethics. There have been very inter- on which we make decisions. I had origi-
on issues such as conflict of interest, esting and unique issues that have come nally made an assumption that turned
responsible conduct, mentorship, and up. Under President Bush, NASA began out to be completely wrong. In a White
peer review. On the research side, I am to develop long duration programs to Paper that I wrote, I began the paper by
very interested in the field of emerging the moon and Mars. That would have saying that the first and most important
technologies and am in the process of required, for the first time ever, a sig- principle underlying biomedical ethics
planning a conference to bring together nificant change in the way which medical in space is the health and safety of the
people to discuss the guidelines for fu- care is delivered in space. Up until then, crew. I thought that was an uncontrover-
ture scientific development. the philosophy of space medicine was if sial statement. Well, it turned out to be a
it was minor, treat them in space; if it very controversial statement. Do you al-
How did you get into the field of bio- was something major, get them back to ways turn around and go back, no ques-
ethics? Was there anything or anyone earth. You can’t really do that if you’re on tions asked? Not always, it’s a balancing
specifically that sparked your inter- a lunar spaceship or if you’re on the way act.
est? to Mars. This therefore requires a fully-
My generation and older almost all stocked medical spaceship, which raises What is your opinion of Obama’s
got into bioethics in some quirky way. so many questions. We need to balance stem cell policy?
I learned about bioethics as an under- three things: likelihood of occurrence, First, I’m very disappointed with
graduate at Penn. When I graduated, I severity, and effectiveness of the treat- Obama’s stem cell policy. With that said,
wanted to be a sociologist of medicine. ment. So we want to be able to provide what I think is so interesting with the
After graduate school at Yale, I took my the best care and cover the largest array stem cell debate is that it is time-limited.
first job at Jefferson Medical College in of treatment with limited resources. All In other words, it is going to go away. It
Philadelphia, and was asked to review the of these balancing acts require an ethical is going to go away when we master cel-
grant proposals that were coming out of sensibility about them. lular dynamics well enough that we can
the department before they went to the What if someone dies in space? What start to create stem cells from somatic
IRB in order to catch anything ahead of if someone has a traumatic head injury cells- which we can do now, but we’re
time. After that, I moved to Penn and and become psychotic or violent? Do not good at it yet. Once that happens, I
I was the first faculty member that was we equip the craft with a straight-jacket? don’t think we’ll need to use embryonic
hired for the Center for Bioethics there. There are also issues of communication. stem cells anymore. I think it is impor-
That was my move over to the field of If someone’s son gets hit by a car, do tant to get as much public buy-in in these
bioethics. Unlike some of my colleagues, you tell them? If 9/11 happens, do you controversial issues as you can. By elect-
I never really had a conversion moment. tell them? There are many kinds of is- ing Obama, I think the public made a
For me, it was really a process. sues that require multiple disciplines to statement about what they wanted. But
think about, but the ethics of them be- Obama is dragging his feet, in all practi-
What has been your experience as come very important. cal senses, on this policy.
the bioethicist for NASA? In order to completely change how (Cont’d on next page.)
What are the implications of in-
creased technological development
in the field of genetics (e.g. preventa-
tive screening)?
First, we are going to find that genet-
ics is less determinative than we original-
ly thought. That being said, it is probably
likely that in the near future that we will
be able to create a list of susceptibility
to all types of diseases for each of us.
Think about what that implies. Medi-
cine is going to turn into a personal risk
susceptibility system, and you’re sup-
posed to behave accordingly. I actually
think that is a potentially extraordinarily
confusing development. People are so
bad at statistics to begin with, and what
people are supposed to do with this in-
formation is problematic. Even knowing
susceptibility doesn’t solve the problem.
I really think that in terms of medicine,
our ability to genetically prognosticate
will not solve as many problems as peo-
ple predict, but instead raise more ques-
tions.
In your opinion, what is the most im-

SEIUHEALTHCARE775NW/FLICKR
portant issue in ethics today?
Protesters at the May 2009 Healthcare Reform Rally in Seattle, Washington I think the most important issue in
ethics today is no different than the most
(Cont’d from prev. page) a more robust opt-in system and create important issue in ethics 3,000 years ago.
a generational change if we made a con- People think of ethics too simplistically.
Why do you think the United States certed effort. People think of ethics as simply a choice
pales in comparison to other coun- between right and wrong, and choosing
tries when it comes to organ dona- What is your take on the healthcare correctly. I actually think that some form
tions? reform? Are there any implications of ethical sensibility underlies much
The reason that our organ donation for the bioethics field? more basically the way we live our lives
pales in comparison to many European To me, the broader issue is a bio- everyday and are part of decisions we
countries is because we are an opt-in ethical issue. It is astounding to me that made that doesn’t seem like ethical deci-
policy. An opt-out policy is not practical not everyone in the U.S. sees the ethi- sions. The biggest challenge we have to
in our system because there is too much cal implication of having people in this trying to instill in people a strong ethical
suspicion of the government and too country not have insurance. At least that sensibility in whatever career. The good
much paranoia based on the idea that has changed. In other words, it is no news about that, I think, is the increased
doctors want to harvest your organs as longer tenable for people on the other awareness of ethics today. Modern med-
soon as possible. Unfortunately, for rea- side of the issue to argue that everyone icine started to raise such fundamental
sons that are understandable, especially shouldn’t have insurance. In some sense, ethical questions that everyone cared
for minority groups who have had abso- at least that issue has been won. The about that people became interested. I
lutely horrible experiences with the U.S. bottom line of the health care bill is that think that the public has recently come
medical system, many are not willing to it is far more important to have passed to recognize the role of ethics in all
give medicine the benefit of the doubt. something, anything. I see this as the first fields.
We could certainly do a better job of step, and now that we have a base line,
properly educating the public and teach- we have to work even harder to develop, Rachel Chen is a senior in Berkeley College and a se-
ing them what it really means to be an amend, and sculpt this bill over time to nior editor for YJML.
organ donor. We probably could create something more helpful.
Market for Organ Donations
(Cont’d from p. 33)
Others, however, feel that such a sys-
tem could be overseen by transplant pro-
fessionals who would screen donors and
decide if they are healthy enough to do-
nate, according to Dr. Benjamin Hippen,
a nephrologist. This system would be
drastically different from the organ traf-
ficking schemes that have arisen in other
countries such as India and Pakistan. In
these unregulated systems, the middle-
man who purchases the organ for a re-
cipient has no interest in the health of
the donor. “The sort of thing that I’m
thinking about changes the incentives so Kidneys would be allocated in the is a concern that certain religious groups
that there’s a focus on the propriety of same way as are those from deceased would be turned off by the idea of fi-
safety [and] on the transparency about donors — through UNOS. UNOS has a nancial incentives, according to Caplan.
the risks to the person exchanging their contract with the government to manage If individuals in these groups stopped
kidney,” Hippen says. organ procurement and transplantation, donating organs, the organ supply could
Extremely poor people could also be and people who need organs are matched actually decrease. Moreover, even if in-
excluded from the system, according to through the UNOS system. “That’s a centives are put in place, they may not
Hippen, because poverty is associated fairly efficient and medically sound way persuade many people to provide their
with a high risk of kidney disease, so an to allocate kidneys,” says Hippen, who organs for transplant. “There’s not a lot
exchange involving a very poor donor thinks such a system would also work for of evidence that what is stopping people
would not benefit either party. Removing live donations. This set-up would mean from giving kidneys when they’re alive or
poor people from the system would also that the rich and poor would have equal when they die is money,” says Caplan.
prevent this group from being exploited access to kidneys. Hippen says, “There “While almost everyone is in agree-
by those with more money. However, wouldn’t be any discrimination [regard- ment that the disincentives need to be
Hippen does not consider fear of exploi- ing] the recipients’ socioeconomic sta- removed, there is great debate about
tation as a reason to omit the poor from tus; kidneys would really be allocated whether or not to provide financial in-
this system. “I don’t think the mere fact according to medical criteria and not by centives, with people passionate on both
of being poor renders poor people inca- how much money the recipient has.” De- sides,” says Arthur Matas of the Univer-
pable of making decisions that material- creasing the organ shortage in the U.S. sity of Minnesota. If financial incentives
ly affect their lives,” he says. In this pro- would also reduce the market for organ were ever put in place, they would most
spective system, the government would trafficking in other countries, according likely first need to go through pilot tri-
pay for the incentive, regardless of its to Hippen. “The reason that organ traf- als to test out different systems. They
form. The cost of keeping a patient who ficking flourishes is because it’s econom- could be carried out in a few regions in
needs a kidney on dialysis is so expensive ically supported by wealthy countries the country and conducted like research
— around $65,000 to $75,000 per year where there’s a disparity between the de- studies, with a trial and follow-up peri-
— that it would be in the government’s mand for and supply of organs,” he says. od. Before any studies could take place,
interest to pay for a transplant as well as Those opposed to financial incen- however, the National Organ Transplant
an incentive, according to Hippen. “The tives, however, argue that the risk of Act would need to be lifted for that area.
transplant pays for itself versus dialysis slipping from incentives into a market is “Right now we’re not even close to there
after about 18 months,” he says. too big to take. “We’ve just been through yet,” says Hippen. Meanwhile, the wait-
two years of complete economic col- list problem remains. “As we have these
I don’t think the mere fact lapse at the inability to regulate markets debates about what to do, the waiting
because people cut corners, cheat [and] list gets longer and the waiting times get
of being poor renders poor are not forthcoming,” says Arthur Ca- longer,” says Matas. “We need a radical
people incapable of making plan, a professor of bioethics at the Uni- change to our approach.”
versity of Pennsylvania. “And there’s no
decisions. reason to think a market in organs would Rachel Chen is a senior in Berkeley College and a se-
work any differently.” Additionally, there nior editor for YJML.
Dr. Benjamin Hippen, Nephrologist
The Social Disease of
Fat Discrimination
Written By Paulo Coelho Filho
O
besity is stigmatized in our me- it certainly exists at school when a fat
dia-driven society that places child is the victim of bullying or in the
great value on wafer-thin bod- workplace when employees hear sup-
ies. Although research points to genetic posedly funny comments about their
origins of obesity, many people think bodies. Today, it is not uncommon to
that obese individuals are weak-willed read about overweight people who
people who should simply “close their might not be hired by a company, get
mouths” and not eat that piece of choc- into their dream college, or participate
olate cake thin individuals would pain- in a public event because of their body
size. This is not to mention the resulting The motto of the National Association to Advance Fat Acceptance (NAAFA) is
fully avoid. Worse, these misconceptions
lead to rampant discrimination. Accord- lack of confidence that may lead to de-
ing to Yale University’s Rudd Center for pression or even suicide attempts. ers, adults, and the elderly to engage in
Food Policy and Obesity, which inter- healthier habits such as practicing sports
viewed 1,100 adults between 1995 and and having balanced nutrition with less
1996 and again between 2004 and 2006, The social repulsion associ- fat and more vegetables. Fat discrimi-
weight discrimination is as common as ated with being overweight nation may indeed discourage some
other discriminatory practices, such as people from eating very unhealthy fast
racial discrimination. has been used as a stimulus food, but it can cause serious harm to
Obesity is a disease. It increases the for children, teenagers, many more people. According to re-
chances of hypertension, heart attacks, search conducted by the U.S. Center
and diabetes. Nevertheless, the conse- adults, and the elderly to for Disease Control, more than 72 mil-
quences of the obesity stigma can be as engage in healthier habits. lion U.S. adults and 16 million U.S. chil-
or even more harmful than the disease dren are obese (body mass index of 30
itself. Obesity may not only lead to psy- or greater). Thus, if fat discrimination
chological problems but can also affect Yet, despite its negative effects on is encouraged, more than one third of
academic, professional, and personal obese people, the social repulsion asso- the population in the U.S. might have to
opportunities. This type of discrimina- ciated with being overweight has been suffer the negative consequences of this
tion may be subtle or imperceptible, but used as a stimulus for children, teenag- social stigma.
though the “off label” prescription of
medications approved by the Food and
Drug Administration is not illegal, the
decisions by these doctors are ethically
– and medically – questionable. Thus,
the HAES recommends that doctors fo-
cus on a patient’s health rather than a
patient’s weight loss. If allied with “ap-
propriate-sized medical equipment” and
better communication between doctors
and patients, HAES can help obese pa-
tients be treated with more dignity and
compassion.
Fat discrimination is a harmful atti-
tude, and it is now illegal in some areas.
Through the Elliot-Larsen Civil Rights
Act, Michigan became the first U.S. state
to include “weight” into the categories
of discrimination. Washington, D.C.
prohibits discrimination on the basis of
“personal appearance,” while the cities
of San Francisco and Santa Cruz have
legislation similar to that of Michigan.
Weight discrimination can be injurious
not only for discriminated individuals
but also for entire communities. In Ar-
ticle 33 of the Code of the City of San
Francisco, the Board of Supervisors as-
serts that “discrimination foments strife
and unrest, and it deprives the City and
County of the fullest utilization of its
capacities for development and ad-
ANNA TANCZOS/BEHANCE
vancement.”
“We come in all sizes”.
On the federal level, there are no
laws about weight discrimination, but
Created in 1969, the non-profit Na- Size” (HAES) philosophy, an approach NAAFA strongly advocates amend-
tional Association to Advance Fat Ac- that encourages healthy diets and activi- ing Title VII of the Civil Rights Act of
ceptance (NAAFA) strives to eradicate ties not solely for obese people, but for 1964, which currently prohibits any sort
size discrimination. With the motto everyone, given the shift in focus from of discrimination on the basis of race,
“We come in all sizes,” the organiza- “weight loss” to “health.” color, religion, national origin, or sex. If
tion actively combats fat discrimination The HAES philosophy, however, an action of such legal magnitude hap-
at school, in the workplace, and in the does not simply revolve around the pens, U.S. courts will be able to punish
healthcare system. Recently, after First political sector. HAES also encourages those who practice obesity discrimina-
Lady Michelle Obama announced the medical professionals to discuss healthy tion. This measure will guarantee that
launch of “Let’s Move,” a campaign habits with their patients instead of obese people can report discriminatory
to reduce childhood obesity, NAAFA prescribing drugs, especially question- acts to authorities and expect institu-
urged the First Lady to fully examine able ones. A CNN report, for example, tionalized sanctions for offenders. By
existent research over child obesity in showed that pediatricians prescribe am- doing so, another right will be awarded
order to avoid methods that end up do- phetamines used to treat attention defi- to every American: to be of any size.
ing “more harm than good.” Among cit and hyperactivity disorder to over-
the alternatives advocated by NAAFA, weight patients because of the drug’s Paulo Coelho Filho is a sophomore in Ezra Stiles Col-
for instance, is the “Health At Every capacity to suppress appetite. Even lege and a staff writer for YJML.
Regulating Assisted
tions such as endometriosis or fallopian
tube damage in a female or poor semen
quality in a male. According to the CDC
National Survey of Family Growth, ap-
Reproductive
proximately twelve percent of the female
population of reproductive age is con-
sidered infertile. The market for ART
procedures has expanded to same sex
Technology
couples and women who want children
but do not wish to experience pregnancy.
Dorothy Greenfeld, clinical professor
of Obstetrics, Gynecology, and Repro-
ductive Sciences at the Yale School of
Medicine, adds, “The law is way behind
the technology. The guidelines come
much more rapidly, so people have re-
ally come to rely on these very clear
standards.” The fast-paced, constantly
changing world of medical knowledge
Written By Connie Cho
makes comprehensive legislation diffi-
cult. Other nations such as the United
I
n January 2009, news of octuplets which increase risk of complications like Kingdom have found their solution in
born to Nadya Suleman, dubbed preterm delivery and preeclampsia. creating ART governmental agencies
“Octomom,” led to fierce debate After the birth of the octuplets, the that set standards.
about the role of regulation in assisted U.S. faced international criticism for In 2005, the UK ended sperm donor
reproductive technology (ART). The use lack of ART industry regulation. Pro- anonymity citing the rights of the child,
of ART has grown exponentially in the fessional standards, legally unenforce- a concern in ART development. The act
United States, reflecting both high de- able, are set by private agencies like the caused a short term shortage in sperm
mand and minimal legislative regulation. ASRM and the Society for Assisted Re- donations and once again, criticism of
In 2006, the CDC reported 41,343 live productive Technology (SART), a self- governmental over-regulation. But the
birth deliveries using assisted reproduc- proclaimed “governmental watchdog.” rights of children born through ART are
tive technologies, more than double the However, quality metrics established by increasing and rightfully “moving in the
number of deliveries in 1996. The ques- these agencies are often easily abused. direction of more transparency” because
tion remains of how best to regulate as- For instance, fertility clinic success rate of a “grassroots movement” to identify
sisted reproduction. data can be manipulated by implanting egg donors, sperm donors, and gesta-
ART includes fertility treatments that more embryos in women, which increas- tional mothers, says Greenfeld.
manipulate both egg and sperm, with es the risk of multiple births, or by turn- The issues surrounding IVF are fur-
in-vitro fertilization (IVF) being the ing away difficult, unpromising cases. ther complicated by pre-implantation
most popular. In IVF, egg and sperm On the other hand, supporters of the genetic diagnosis (PGD), which allows
are joined outside of the womb to create free-market approach to reproductive people to select for or against traits such
an embryo which is then implanted into technology cite fears of an overbear- as gender, birth defects and disabilities,
the uterus. The Suleman octuplets were ing government in the deeply personal or tissue matches for other individuals in
conceived through IVF, as were their six experience of having a child. The field the fertilized embryos. Opponents say it
older siblings. Suleman’s fertility doctor, of ART developed out of the need to facilitates eugenics and discrimination.
Dr. Michael Kamrava, implanted six em- address infertility due to medical condi- PGD in its worst form can lead to dis-
bryos into Suleman – a number far high- criminatory social selection and “design-
er than the two embryos recommended er babies” available to the wealthy who
Commercial surrogacy in
by the American Society for Reproduc- can pay for expensive PGD testing and
tive Medicine (ASRM). CDC studies India alone is worth $500 IVF treatment. Countries like France
have shown that IVF is riskier than nor- and the UK extensively regulate PGD.
million a year.
mal pregnancies, mostly due to the high- However, the British government faced
er rate of multiple-birth pregnancies, criticism in 2008 of disability discrimi-
LINUSEKENSTAM/FLICKR
nation when a deaf couple wanted to tionally, IVF procedures are commonly medical necessity of the ART treatments
select for a deaf child. This request was accompanied by the cost of donor eggs as well as the right to procreate and raise
deemed impermissible under current or sperm and surrogacy contracts. The a child.
laws since PGD testing in IVF embryos still sky-high costs of ART create a sys- Assisted reproductive technology
compels the potential parents to select tem of class inequality in access, making originates from well-intentioned scien-
against deafness. ART a luxury. Commercial surrogacy in tific means to ameliorate the particu-
Many anti-abortionists oppose PGD India alone is worth approximately $500 larly emotional medical condition of
and IVF because of the destruction of million a year since it was legalized in infertility and the biologically ingrained
unused embryos. A stronghold of anti- 2002. These surrogates, desperate for desire to reproduce. However, the lack
abortion sentiment, the official doctrine money, are often exploited and become of regulation has the propensity to lead
Roman Catholic Church firmly opposes sources of cheap wombs for western to medical irresponsibility, even jeopar-
ART as a whole. The Church believes couples, straining women’s rights. dizing maternal health, as in the case of
ART violates the natural process of con- Although there is some state level the Suleman octuplets. To date, Kamrava
ception and parentage. regulation of surrogacy in the United has been expelled from the ASRM for
Despite opposition to ART, the fer- States, there has not been any unifying repeated offenses and is being sued by
tility industry has become a multi-billion federal regulation to date. An American the California Medical Board for multi-
dollar business. Harvard Business School Congress of Obstetricians and Gynecol- ple counts of gross negligence. Though
political economist and author of The ogists (ACOG) study reports that “sur- detailed standards may be left to medi-
Baby Business, Debora Spar calls it the rogacy arrangements often take place cal experts, the negligent absence of
“fertility-industry complex.” At risk in between parties with unequal power, legal regulation and enforcement in the
the fertility industry is the commoditiza- education, and economic status.” In ad- United States leaves too many women,
tion of babies as products and women dition, this socioeconomic disparity can children, and families at risk.
as surrogate mother incubators. Accord- serve as an inequitable obstacle to access.
ing to the ASRM, on average, one IVF Insurance coverage of ART treatments Connie Cho is a sophomore in Silliman College and a
cycle costs upwards of $12,000. Addi- varies from state to state, questioning the staff writer for the YJML.
Pharmaceutical
Companies and the
Future of Medicine
Written By Alison Pease
R
ecent pharmaceutical industry in prescription spending. Underlying
statistics are staggering. Ac- factors can be traced as far back as 1978
cording to the Kaiser Family when President Carter initiated a large-
Foundation’s (KFF) report, Prescription scale review of industrial innovation.
Drug Trends, Americans spent $286.5 This led to the 1984 passage of what is Prozac, an antidepressant drug, has been one of the most well-advertised pr
billion on prescription drugs in 2007, up commonly known as the Hatch-Waxman
from a relatively modest $40.3 billion in Act. In effect, Hatch-Waxman allowed a particular drug was approved by the
1990. Though prescription drug spend- generic drugs to be brought to market in Food and Drug Administration. In this
ing currently accounts for only ten per- a much easier fashion. In addition, the way, pharmaceutical companies could
cent of national healthcare expenditure, act amended patent laws in order to aid better recoup their research and devel-
it is a fast-growing segment. The U.S. companies that had exhausted many of opment expenses and thus continue to
Department of Health and Human Ser- their years of patent protection before create new drugs.
vices predicts that the national market The increased availability of gener-
will continue to increase, reaching $515.7 ic medications coupled with an aging
billion in 2017. ...When Merck & Co. put
“baby boomer” generation and recent
What factors are driving these eco- $145 million into advertis- changes in Medicare Part D is creating
nomic changes, and what kind of impact a healthcare industry increasingly based
will they inevitably have on the future of ing the drug Vioxx, sales of on prescription drugs. In fact, accord-
medicine? The KFF’s report identified the drug rose by an as- ing to the KFF’s report, the change in
“changes in the number of prescriptions Medicare prescription coverage which
dispensed, price changes, and changes tounding $1.5 billion. has been in effect since January 2006
in the types of drugs used” as the three caused the Medicare program to jump
main reasons behind the transformation from two percent to eighteen percent of
and its impact on prescription drug sales
noted that when Merck & Co. put $145
million into advertising the drug Vioxx,
sales of the drug rose by an astounding
$1.5 billion.
The same study went on to survey
doctors at a Midwestern clinic, finding
that 87.2 percent believed that too much
money was being spent on direct-to-
consumer advertising. In the competi-
tion for business, the study posits, doc-
tors can feel pressured to prescribe the
drug a patient requests out of concern
that otherwise the patient will leave to
receive treatment at another clinic or
practice. However, it is not simply the
relationship between doctor and pa-
tient that is at risk of being influenced
by pharmaceutical companies. In 2001,
for instance, the pharmaceutical industry
collectively spent $13 billion on physi-
cian-focused drug promotions, which
can include everything from “pens, cof-
fee mugs and umbrellas” to free samples
of a new prescription drug. In Parker
and Pettijohn’s study, only 52.2 percent
of doctors reported they agreed that the
free samples distributed by pharmaceu-
tical companies did not influence pre-
scriptions.
It remains to be seen how profoundly
the future of medicine will be affected by
the current changes in the pharmaceuti-
roducts of the pharmaceutical industry.
cal industry through increased spending
on prescription drugs, direct-to-consum-
overall U.S. prescription spending. This advertising by the pharmaceutical indus- er advertising, and drug promotions for
upward trend is poised to continue as try has shifted the way in which many physicians. The U.S. medical system will
more of the U.S. population becomes people navigate the healthcare system. always be influenced to some degree by
eligible for Medicare. While fifty-nine A study in 2003 found that consum- pharmaceutical companies, simply be-
percent of those under sixty-five years ers’ positive reception of this type of cause of the nation’s heavy reliance on
of age have prescription drug expenses, pharmaceutical marketing caused about prescription drugs. Consequently, it
that figure rises to ninety-one percent of ten million people to ask their doctors is likely that the future will bring some
the population when considering those to prescribe a drug they had seen adver- amount of debate about changes in
at least sixty-five years of age. tised. Perhaps even more telling is the government regulations of this indus-
Beyond the trends of growing usage fact that at least eighty percent of people try. The challenge at that time will be
and spending on prescription drugs, the who requested an advertised drug were in maintaining a sufficiently profitable
changing relationship between pharma- prescribed it. As these statistics suggest, and innovative pharmaceutical industry
ceutical companies, doctors, and patients the pharmaceutical industry’s market- while ensuring that drug companies do
is also placing the pharmaceutical indus- ing strategy has proven highly success- not have an excessive influence on either
try in a more powerful position to affect ful. For example, a study by R. Stephen doctors or patients.
medicine than it has in the past. To be Parker and Charles E. Pettijohn on the
sure, the increase in direct-to-consumer ethics of direct-to-consumer advertising Alison Pease is a sophomore in Calhoun College.
Advances in
surgery. Moreover, the rewired neurons
take months to grow after the operation,
and often the electrodes must be further
adjusted as the nerves shift position.
Prosthetic Limbs
This method of developing a bionic
arm also does not apply to people with
extensive damage to their nerves, such
as patients with cervical spine injuries.
In an effort to make bionic arms
more versatile and broadly applicable,
scientists would like to design robotic
arms controlled directly by the neurons
in the brain through a brain-machine in-
terface (BMI). In the 1960s, a noninva-
sive device called the electroencephalo-
gram (EEG) was developed to measure
electrical activity in different regions of
Written By Katherine Zhou the brain. In the 1970s, scientists found
ways to measure electrical activity at the
resolution of a single neuron using a de-
vice that must be inserted into the brain.
I
n Peter Pan, Captain Hook uses a that stimulate some of Sullivan’s chest Since then, researchers have been devel-
hook as an artificial hand; in Star muscles. As a result, whenever he would oping ways of using primates’ neuronal
Wars, Luke Skywalker uses a re- think about moving his amputated arm, activity to control external devices.
markably lifelike prosthetic arm that his brain sent signals that would cause Today, about a hundred electrodes
gives him complete control and sensa- his chest muscles to contract. Elec- can be used to measure the firing of neu-
tion, equipped with an outer layer of trodes that could detect these chest rons in the motor cortex of the mon-
synthetic flesh that has the appearance muscle contractions enabled Sullivan to key’s brain, and the signals detected by
and texture of organic tissue. Today, move his prosthetic arm in particular di- the electrodes can then be used to con-
prosthetic technology lies somewhere rections using thought alone. trol a robotic arm. Using this method,
between these two extremes: amputees Although other physicians have per- scientists have successfully implemented
are already using bionic limbs con- formed similar procedures on about 30 robotic arms that monkeys can use to
trolled by their own rerouted nerves and different people in the United States, feed themselves. This past summer,
mind-controlled artificial limbs have Canada, and Europe, there are still ma- researchers prepared to test a similar
just recently entered Phase III testing jor limitations to the procedure. Pa- technology on humans, as the Modular
on human subjects. Nearly 1.7 million tients’ range of motion with these bion- Prosthetic Limb (MPL), an artificial arm
Americans and countless other people ic arms is still restricted by the technical designed to be controlled by thought,
living with limb loss now have reasons challenge of rewiring nerves through entered Phase III trials. Researchers
to believe that new and better prosthetic are developing implantable micro-arrays
limbs will soon be available. that would both record neural signals
One of these people is Jesse Sullivan, and stimulate the brain. Such a micro-
an electrical technician who lost both his The development of a good array would “read” the mind and use
arms after he was electrocuted by a live prosthetic limb involves that information to control the pros-
wire. In 2003, he became the first per- thesis, and the MPL in turn would send
son to receive a bionic limb controlled many different issues, in- signals back to make the micro-array
by a nerve-muscle graft, through a tech- volving both the mechani- stimulate the brain as a form of sensory
nology called targeted muscle reinner- feedback from the prosthesis.
vation (TMR). Due to the amputation, cal aspect and the electron- Perhaps due to the fine control nec-
the nerve cells that were once used to ics... essary for natural arm movement, the
drive Sullivan’s arm motions now ended greatest developments in mind-con-
in the stump of his arm. Physicians trolled artificial limbs have been made
reconnected these neurons to nerves with arm prostheses. The development
of leg prostheses faces a whole differ- has been put forth is to screw the arti- will likely need to use more electrodes
ent set of challenges. For instance, leg ficial leg into the patient’s bone. In this to allow for a wider range of movement,
prostheses need to be strong enough method, a titanium-coated bolt is insert- and to devise electrodes that last longer,
to support the amputee, but also suffi- ed into the cavity of the bone, and the read from multiple neurons, and com-
ciently light and flexible to allow supple bone is then allowed to grow around the municate with the robotic device wire-
movements. One very popular leg pros- bolt. Next, the bolt is extended using lessly, all of which would make it more
theses is the C-Leg, which uses hydraulic another titanium component that con- feasible to use a bionic limb controlled
controls to move the knee. In the past nects to the artificial limb. The direct at- directly by the brain. Scientists are also
years, the C-Leg has been developed tachment of the prostheses to the skel- working to refine the spatial and tempo-
into a microchip-controlled prostheses eton gives the amputee greater control ral resolution of the electrode readings.
that automatically adapts to changes in over the artificial limb and eliminates Once these challenges have been solved,
speed and direction, and that can be some of the problems associated with a bionic limb controlled directly by the
programmed to different modes such as the socket method, such as skin irrita- brain could become available, allowing
walking, biking, and driving. tion or the need to readjust the socket for people with amputated or paralyzed
Another major challenge for lower due to changes in stump size. limbs to achieve near-normal mechani-
extremity prostheses is the site of at- The development of a good prosthet- cal function. The future of medicine
tachment between the stump and the ic limb involves many different issues, and its integration with mechanical ad-
prosthesis. The traditional method, involving both the mechanical aspect vancements shows great promise for the
developed in the 1980’s, is the Sabol- and the electronics involved in the com- many who use artificial limbs.
ich Socket, which is designed to wrap munication between the artificial limb
snugly around the stump of the ampu- and the patient’s brain. To create a truly Katherine Zhou is a junior in Saybrook College.
tee’s limb. And alternative option that mind-reading artificial limb, scientists
Advances in Genetics:
What are the Risks?
Written By So Yeon Choe
O
ur knowledge about genetic Genetic information is a broad term,
disorders as well as genetic sus- but it is defined as genetic test results
ceptibility to certain illnesses of an individual, an individual’s fam-
like breast cancer has rapidly expanded ily members (up to and including 4th The digitization of health records has raised a number of ethical concerns, suc
during the last 30 years. Although there degree relatives), or a fetus, as well as
is still much to be understood about the family medical history. A genetic test in
turn is referred to as an analysis of hu- Two questions that arise are: “Do
influence of genes compared to environ-
mental factors, uncovering genes associ- man DNA, RNA, chromosomes, pro- you want to know your entire genetic
ated with diseases is full of potential as teins, or metabolites performed in order code?” and “Should others have access
effective treatments such as gene therapy to determine genotypes, mutations, or to your genetic information?” Open ac-
chromosomal changes. cess to one’s genetic information may
can be readily developed. While there are
aid health professionals in providing
still many more genes to be discovered,
early interventions, but also allows for
those that already have been discovered
genetic discrimination. Some fear that
are not yet completely understood in Even though GINA is an employers and heath insurance com-
the larger context of human biological panies may use genetic information as
pathways. However, genetics has come a important step towards
a basis for hiring or granting coverage.
long way and several diseases that were safeguarding privacy, it is Furthermore, an individual’s genetic in-
once considered untreatable can now be formation could be used for research in
treated. According to the Technology limited in its reach.
a pharmaceutical company in order to
Review by MIT, it is now possible to se- generate profit from developing phar-
quence your genome for as little as one macological treatments. It is crucial that
hundred dollars. public policy regulates the risks of such
prohibit health insurance companies
from using genetic test results in de-
termining life insurance, disability in-
surance, and long-term care insurance.
Individuals who are in need of genetic
tests are those who are more likely to
have a genetic disorder and thus make
up the higher proportion of Americans
who need disability insurance or long-
term care insurance. Most alarmingly,
GINA does not protect individuals who
already have preexisting medical condi-
tions from general discrimination, with
or without knowledge of their genetic
testing results.
Lastly, GINA also does not regulate
personal genetic testing. Recently, there
has been a surge in personal genetic
testing for genetic disorders including
Huntington’s disease, Phenylketonuria
(PKU), and Down’s syndrome, along
with various cancers. Private companies
who use genetic testing can sell genetic
information to outside parties, as long
as the right to sell and use genetic in-
formation is in the contractual clauses.
Oftentimes, it is up to the person get-
ting tested to ask for a confidentiality
statement and to request that the ge-
netic information be omitted from his
or her medical record. Yet, the demand
for genetic tests is unlikely to dimin-
ANNA TANCZOS/BEHANCE ish because early intervention in treat-
ch as privacy and the quality of patient-doctor-interactions.
ing diseases increases the success rate.
GINA seems far-reaching during the
biomedical age of our time, but in fact,
biomedical advancements. viding a baseline level of protection it is limited in protecting personal pri-
GINA, or the Genetic Information against genetic discrimination. vacy in medicine.
Nondiscrimination Act of 2008 (P.L. What exactly does GINA do? In the At the moment, the genetic code of
110-233, 112 Stat. 881) provides this realm of health insurance, GINA gen- an individual is just simply that: a genet-
regulation as reported by the Depart- erally prohibits health insurers or health ic code. There is still much to be learned
ment of Health and Human Services plan administrators from requesting ge- about genes and their association to
(HHS). Supported overwhelmingly by netic information from an individual or various diseases. GINA is an important
Democrats and Republicans alike, the his or her family members. Health in- first step in safeguarding the civil rights
bill was signed into law by President surance companies cannot use genetic of Americans. However, as biomedicine
George W. Bush on May 21, 2008. Sena- information to determine coverage, advances, more supervision will be nec-
tor Edward M. “Ted” Kennedy lauded rates, or preexisting conditions. GINA essary. As we discover more ways to ac-
GINA as “the first civil rights bill of also prohibits most employers from hir- quire genetic information, we will need
the new century of the life sciences.” ing, firing, or promoting employees on to continuously reassess its risk and
This federal law prohibits discrimina- the basis of genetic information. benefits carefully.
tion based on genetic information with Even though GINA is an important
regard to health coverage and employ- step towards safeguarding privacy, it is So Yeon Choe is a senior in Jonathan Edwards Col-
ment. GINA affects state laws by pro- limited in its scope. GINA does not lege.
yalemedlaw.com

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