Minority Health Archive

Davitt, Joan K.

Racial/Ethnic Disparities in Home Health Care: Charting a Course for Future Research

: The discipline of an LHD's lead executive as a clinician appears to have a significant relationship with the impact of LHD practice on reducing black-white mortality disparities. This study suggests that the discipline of an LHD's leadership may be an important factor to consider in relation to local public health capacity to impact health disparities. Further research related to the mechanisms at play in these relationships is warranted

Bekemeier, Betty

Grembowski, David

Yang, Youngran

Herting, Jerald R

Leadership matters:  local health department clinician leaders and their relationship to decreasing health disparities.

Abstract available at publisher's website

Smith, Katherine Clegg

Kromm, Elizabeth Edsall

Brown, Natasha Ann

Klassen, Ann Carroll

“I Come from a Black-Eyed Pea Background”: The Incorporation of History into Women's Discussions of Diet and Health

Whitney, S. N.

The Python’s Embrace: Clinical Research Regulation by
Institutional Review Boards
Subject consent and its waiver are critical topics in contemporary
research. Institutional review boards (IRBs), acting under the wary
eye of the Ofﬁce for Human Research Protections (OHRP), typically
may waive consent when research involves no more than minimal
risk, waiver would not harm the subjects, and the research would be
impracticable without the waiver.1 IRBs constrict research when they
cautiously interpret “impracticable” to mean “impossible” and insist
on consent. And, in an ironic twist, IRBs can thus injure the vulner-
able groups they imagine they are protecting.
A disturbing pair of articles by Rich and his colleagues, one from 20102
and the second in this issue of Pediatrics,3 demonstrate how this
works. SUPPORT, the parent study, investigated the impact of different
respiratory care regimens on lung disease, retinopathy, and survival
in premature infants born between 24 and 27 weeks’ gestational
age.4,5 Eighteen IRBs reviewed the protocol; all required that consent
be obtained, even though these interventions are routinely provided
without speciﬁc consent in everyday practice. This study reveals 3 of
the resultant costs.
The ﬁrst cost is time and money. Obtaining consent drained $200 000
from the project, and if 75% of the eligible but not enrolled infants
had been included, recruitment would have been completed in 18
instead of 48 months. The requirement for informed consent also led
to the second, predictable6 cost of biased trial entry. Compared with
mothers of infants enrolled in the trial, mothers of infants not en-
rolled were less likely to be white, insured, have a high school ed-
ucation, and have received prenatal care. As the article in this issue
demonstrates,3 their infants were also more likely to die.
African American infant mortality in the United States is double that of
white infants.7 The IRB system’s stated goals include the pursuit of justice
and the protection of vulnerable groups; yet the SUPPORT ﬁndings—
fruits of the hard work of physicians and nurses at 18 major medical
centers over 4 years—are, as a result of IRB action, more applicable to
white infants than to black infants.
The IRB system’s third cost, and its greatest error, is hidden in plain
sight: patients die while better treatments are still in development.
During the years SUPPORT was delayed, neonatologists, awaiting the
trial ﬁndings, knew less about how to save infants in their care from
respiratory failure, blindness, and death. Collins et al8 ﬁrst articulated
the fundamental issue at work here—that when regulation delays
lifesaving research, lives are lost. Schneider and I have conﬁrmed the
estimate of Collins et al that consent-related delays in research in heart
attack treatment in the 1980s cost thousands of lives.9 Beauchamp10
recently made a similar point, noting that OHRP’s delay of the Keystone
initiative to reduce ICU infections, if continued, might have caused
AUTHOR: Simon N. Whitney, MD, JD
Department of Family and Community Medicine, Baylor College of
Medicine, Houston, Texas
The author is entirely responsible for this submission. Dr
Whitney received suggestions from the individuals identiﬁed in
the acknowledgments, but none meet the criteria for
authorship.
Opinions expressed in these commentaries are those of the
author and not necessarily those of the American Academy of
Pediatrics or its Committees.
www.pediatrics.org/cgi/doi/10.1542/peds.2011-3455
doi:10.1542/peds.2011-3455
Accepted for publication Nov 21, 2011
Address correspondence to Simon N. Whitney, MD, JD,
Department of Family and Community Medicine, Baylor College of
Medicine, 3701 Kirby Dr, Suite 600, Houston, TX 77098. E-mail:
swhitney@bcm.edu
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2012 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The author has indicated he has no
ﬁnancial relationships relevant to this article to disclose.
FUNDING: Dr Whitney is supported in part by the William W.
O’Donnell, MD, & Regina O’Donnell Chair in Family Medicine at
Baylor College of Medicine and by the Center for Clinical
Research and Evidence-Based Medicine at the University of Texas
Health Science Center at Houston Medical School, Houston,
Texas.
COMPANION PAPER: A companion to this article can be found on
page 480 and online at www.pediatrics.org/cgi/doi/10.1542/
peds.2011-2121.
576 WHITNEY
unnecessary patient deaths. To Ding-
wall,11 a British sociologist, 1 cost of
ethics constriction of his study of why
physicians and nurses reuse single-
use medical devices is “the lives that
will not be saved.” And, Heimer has
said, “The biggest ethical lapse in
American regulation of human sub-
jects research is the death and suf-
fering that has resulted from slowing
the pace and altering the focus of re-
search and squandering research
funds.”12 These are serious charges,
but no defender of the system has
argued that Collins, Beauchamp,
Dingwall, Heimer, or Schneider and I
are mistaken. Just as a python’s victim
shows no outward signs of trauma,
biomedical protocols appear little
changed by regulatory constriction. But
IRB regulation of clinical research costs
lives as surely as the python’s embrace.
We can intelligently discuss a system of
social control only if we understand its
nature. This system, comprising OHRP
and the IRBs it regulates, functions as
a federal regulatory agency. Its work-
ers are employed by a variety of fed-
eral, state, and private institutions,
but federal regulations created IRBs,
a federal ofﬁce oversees them, and
IRBs refer to federal law to justify their
actions. Like any governmental inven-
tion, this system’s merits and defects
should be scrutinized and its value
vigorously debated. Although its de-
fenders invoke ethics to justify its ex-
istence and impeach its critics,13–15
this system is not intrinsically moral,
nor is its existence mandated by past
abuses. No special shield protects it
from folly or error.
Thirty years ago, Levine16 estimated
that IRBs cost $130 000 000 per year,
and asked the right question: “What do
we think we are buying with all this
money?” The answer requires the
same analysis we would make of any
other agency. A legitimate regulatory
system produces societal beneﬁts that
exceed its costs. Ethicists have left the
costs and beneﬁts of the IRB system
untouched, but this vacuum has begun
to be ﬁlled by experts in law and public
policy. At a symposium at Northwest-
ern University School of Law in 2007,
Hyman17 stated that “there is no em-
pirical evidence that IRBs have any
beneﬁt whatsoever,” and Zywicki18
concluded that the system’s costs
“substantially exceed” its beneﬁts.
No proponent of this regulatory regi-
menhassteppedforwardtorebut these
charges. Instead, there are calls for
reform,19,20 including proposals by
the federal government itself.21 But if
Hyman17 and Zywicki18 are correct, the
logical response to the system’s fail-
ings is not reform. The logical response
is abolition.
ACKNOWLEDGMENTS
The authoracknowledges the insight-
ful comments of Karen Brisch, Mats
Hansson, Kathleen Kennedy, Paula
Knudson, Patricia Serventi Naughton,
HeidiRussell,CarlE.Schneider, JonTyson,
and Susan Wootton.
REFERENCES
1. 45 CFR 46.116(d)
2. Rich WD, Auten KJ, Gantz MG, et al; National
Institute of Child Health and Human De-
velopment Neonatal Research Network. Ante-
natal consent in the SUPPORT trial: challenges,
costs, and representative enrollment. Pediat-
rics. 2010;126(1). Available at: www.pediatrics.
org/cgi/content/full/126/1/e215
3. Rich W, Finer NN, Gantz MG, et al; SUPPORT
and Generic Database Subcommittees of the
Eunice Kennedy Shriver National Institute of
Child Health and Human Development Neo-
natal Research Network. Enrollment of ex-
tremely low birth weight infants in a clinical
research study may not be representative.
Pediatrics. 2012;129(3):480–484
4. Finer NN, Carlo WA, Walsh MC, et al; SUP-
PORT Study Group of the Eunice Kennedy
Shriver NICHD Neonatal Research Network.
Early CPAP versus surfactant in extremely
preterm infants. N Engl J Med. 2010;362
(21):1970–1979
5. Carlo WA, Finer NN, Walsh MC, et al; SUP-
PORT Study Group of the Eunice Kennedy
Shriver NICHD Neonatal Research Network.
Target ranges of oxygen saturation in ex-
tremely preterm infants. N Engl J Med.
2010;362(21):1959–1969
6. Tyson J. Dubious distinctions between re-
search and clinical practice using experi-
mental therapies: have patients been well
served? In: Goldworth A, ed. Ethics and
Perinatology. New York, NY: Oxford Univer-
sity Press; 1995:214–230
7. Mathews TJ, MacDorman MF. Infant mor-
tality statistics from the 2007 period linked
birth/infant death data set. Natl Vital Stat
Rep. 2011;59(6):1–30
8. Collins R, Doll R, Peto R. Ethics of clinical
trials. In: Williams CJ, ed. Introducing New
Treatments for Cancer: Practical, Ethical
and Legal Problems. Chichester, UK: John
Wiley & Sons Ltd; 1992:49–65
9. Whitney SN, Schneider CE. Viewpoint:
a method to estimate the cost in lives of
ethics board review of biomedical re-
search. J Intern Med. 2011;269(4):396–
402
10. Beauchamp TL. Viewpoint: why our con-
ceptions of research and practice may not
serve the best interest of patients and
subjects. J Intern Med. 2011;269(4):383–
387
11. Dingwall R. The ethical case against ethi-
cal regulation in humanities and social
science research. 21st Century Society.
2008;3(1):1–12
12. Heimer CA. The unstable alliance of law and
morality. In: Hitlin S, Vaisey S, eds. Hand-
book of the Sociology of Morality. New York,
NY: Springer Science1Business Media;
2010:179–202
13. Feeley MM. Response to comments. Law
Soc Rev. 2007;41(4):811–818
14. Burris S. Regulatory innovation in the gov-
ernance of human subjects research: a cau-
tionary tale and some modest proposals.
Regulation & Governance. 2008;2(1):65–84
15. van den Hoonaard WC. The Seduction of
Ethics: Transforming the Social Sciences.
Toronto, Canada: University of Toronto
Press; 2011:103–110
16. Levine RJ. Ethics and Regulation of Clin-
ical Research. Baltimore, MD: Urban &
Schwarzenberg; 1981:241
COMMENTARY
PEDIATRICS Volume 129, Number 3, March 2012 577
17. Hyman D. Institutional review boards: is
this the least worst we can do? North-
western University Law Review. 2007;101
(2):749–774
18. Zywicki TJ. Institutional review boards as
academic bureaucracies: an economic and
experiential analysis. Northwestern Uni-
versity Law Review. 2007;101(2):861–896
19. Fost N, Levine RJ. The dysregulation of hu-
man subjects research. JAMA. 2007;298
(18):2196–2198
20. Emanuel EJ, Menikoff J. Reforming the regu-
lations governing research with human sub-
jects. N Engl J Med. 2011;365(12):1145–1150
21. Department of Health and Human Services,
Ofﬁce of the Secretary, and Food and Drug
Administration. Advanced Notice of Pro-
posed Rulemaking. Human Subjects Re-
search Protections: enhancing protections
for research subjects and reducing bur-
den, delay, and ambiguity for investigators
(proposed amending 45 CFR Parts 46, 160,
and 164 and 21 CFR Parts 50 and 56). Fed
Regist. 2011;76(143):44512–44531
DOES ICE DESERVE THE COLD SHOULDER?: Last week, my son pulled a muscle
while playing soccer. He immediately applied ice to the skin over the muscle.
When he got home he noted that his muscle did not hurt much but that the entire
area around the pulled muscle was completely numb and walking felt odd. Within
a week, he was playing soccer again but his actions made me wonder whether
there is any data to support the use of ice for the treatment of athletic muscu-
loskeletal injuries. According to an article in The New York Times (Blogs: January
4, 2012), despite the widespread belief that ice is beneﬁcial, little data exists to
support it. A review of the topic in 2004 concluded that icing decreased pain but
could not ﬁnd strong evidence for any other beneﬁt. Since then, a small ran-
domized trial did not ﬁnd any beneﬁt to icing muscle injuries. Injured muscles
that were iced did not heal faster and weren’t less painful than injured muscles
with no ice applied. More recently, a review of more than 30 studies concluded
that icing helped decrease the pain associated withmuscle injury by numbing the
area. However, icing was also associated with reduced muscular strength and
power, impaired ﬁne motor coordination, and even occasionally impaired pro-
prioception. Most of these effects were short lived, e.g. 15 minutes or so after the
ice was removed. Interestingly, athleteswho immediately returned to competition
after icing, found it detrimental to their athletic performance. Athletes who iced
for 20 minutes could not run as fast, jump as high, or throw a ball as well.
Whether icing actually leads to an increased risk of injury in athletes who rapidly
return to competition was not examined. Why athletes have impaired perfor-
mance after icing is unknown. Possible explanations include reduced nerve
conduction velocity or altered muscle-tendon mechanics. So what are the
implications for the average weekend warrior? For those who exercise and ex-
perience muscular skeletal pain afterwards, ice is an inexpensive and effective
way to decrease pain. For those highly competitive athletes who are seeking to
return to play, waiting several minutes after the ice has been removed may be
prudent.
Noted by WVR, MD
578 WHITNEY


The Python's Embrace: Clinical Research Regulation by Institutional Review Boards

Fu, P.

Panneerselvam, A.

Clifford, B.

Dowlati, A.

Ma, P.

Zeng, G.

Halmos, B.

Leidner, R.

Simpson's paradox - aggregating and partitioning populations in health disparities of lung cancer patients

Freeh,

Sporkin,

Sullivan,

Report of the Special Investigative Counsel Regarding the Actions of The Pennsylvania State University Related to the Child Sexual Abuse Committed by Gerald A. Sandusky

Smith, Mark

Saunders, Robert

Stuckhardt, Leigh

McGinnis, J. Michael

Best Care at Lower Cost: The Path to Continuously Learning
Health Care in America

VIRGINIA MOYER, A PEDIATRICIAN WITH A 
keen interest in health screening, remem-
bers what it was like to be on the U.S. Pre-
ventive Services Task Force (USPSTF) 
before it became notorious—back when 
“we felt like we were toiling in obscurity.” 
Created by the Department of Health and 
Human Services (HHS) 3 decades ago, the 
panel examines clinical data and decides 
whether methods of preventing disease—
many of them already in use—are backed 
by evidence that they’re worth using. 
Moyer’s USPSTF term began in 2003 and 
except for a 2-year break, she has served 
ever since, becoming its chair in 2011. It 
was in 2009 that she and the rest of the task 
force shed their relative anonymity when 
they addressed a question many had thought 
settled: Should healthy women in their 40s 
get an annual mammogram?
The panel’s explosive answer: No, 
because giving such advice would do more 
harm than good. It would lead to a huge 
number of false alarms and biopsies, the 
16-member task force found, but would do 
little to reduce cancer deaths. 
That’s not how the panel worded its con-
clusion, however. Using carefully honed 
metrics, it gave a “C” grade (meaning weak) 
to evidence for beneﬁ ts of mammography 
in this age group, a topic the task force had 
studied in various ways for years. After fail-
ing to agree on a ﬁ rst vote, USPSTF had 
commissioned new modeling studies to 
clarify risks and beneﬁ ts. Then the majority 
voted “against” a proposed recommendation 
that 40-year-olds get annual mammograms.
Turmoil ensued. Congressional com-
mittees grilled USPSTF members—nearly 
all of whom were physicians or nurses, and 
many of whom had Ph.D.s. Critics hastened 
to point out that none were cancer special-
ists. Advocates of mammography com-
plained that a nerdy committee was trying to 
cut medical beneﬁ ts. Radiologists claimed 
that, maybe because panel members didn’t 
work directly with cancer patients, they 
under valued the lifesaving power of mam-
mography. Kathleen Sebelius, the HHS 
secretary, went on television to urge calm, 
arguably undercutting the panel by asking 
women to “do what you’ve always done: … 
Talk to your doctor” (Science, 19 February 
2010, p. 936). 
The noisy response was partly the result 
of bad timing, says Moyer, a professor at 
Baylor College of Medicine in Houston, 
Texas. The task force issued its f inding 
in the fall of 2009 when debate over the 
Administration’s health care reform was 
raging and congressional election cam-
paigns were heating up. It was a “perfect 
storm,” agrees epidemiologist J. Michael 
McGinnis, an advocate of preventive health 
care and senior scholar at the Institute of 
Medicine in Washington, D.C.
USPSTF touched off another furor in 
May 2012 when it voted to reject a widely 
used method of screening for prostate can-
cer: the blood test based on prostate-speciﬁ c 
antigen (PSA). In this case, USPSTF found 
strong negative evidence and concluded that 
routine screening of healthy men should 
stop. Urologists were outraged; since then, 
their professional associations have urged 
Congress to overhaul USPSTF. They want 
medical specialists like themselves seated 
on future USPSTF panels.
McGinnis says he expected some storms 
both within and outside government when, 
as a top HHS ofﬁ cial, he created USPSTF 
in 1984. That’s why HHS set it up as an 
independent body: “We wanted them to be 
totally unfettered by anything but the evi-
dence in the way they went about their busi-
ness.” But the nature of controversy has 
Task Force’s Prevention Advice
Proves Hard to Swallow
The current chair of the U.S. Preventive Services Task Force defends the panel’s 
controversial decisions on issues such as cancer screening
DISEASE PREVENTION
 www.sciencemag.org/special/prevention
Public Health Measures in Disease Prevention
21 SEPTEMBER 2012    VOL 337    SCIENCE    www.sciencemag.org 
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IC
IN
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; 
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.C
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M
The mineral 
iodine plays a crucial role in the 
development of the body and the 
brain; a deﬁ ciency can lead to 
mental retardation, cretinism, and 
thyroid problems. Switzerland was 
the ﬁ rst to introduce iodized salt, 
in 1922, as a way to help prevent 
these conditions, and the United 
States and many other countries 
would soon adopt the practice.
PASS THE SALT:
Scurvy, which was recognized as far back as Hippocrates, 
results from a deﬁ ciency of vitamin C and prevents the formation of collagen. Scurvy 
was once a common problem for those on long marine voyages, killing more than a 
million sailors according to some estimates, but evidence slowly built that eating 
citrus fruits and other foods rich in vitamin C could prevent it. Ultimately, Britain’s 
1867 Merchant Shipping Act would mandate that sailors in the country’s Royal 
Navy or Merchant Navy receive a daily ration of lime or lemon juice to prevent the condition.
Vaccines for infectious pathogens, often mandatory, are a widespread method of preventing diseases 
in a population, but organizations and countries have also tackled noncommunicable diseases with a 
variety of public health measures. Here are some notable examples.
C-ING OFF SCURVY:
1468
Questioner. Pediatrician Virginia Moyer likes to 
ask, “Why are we doing this?”
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SPECIALSECTION
Rates of 
obesity, heart disease, 
and diabetes are all 
increasing worldwide, and 
many nutritionists lay the blame 
on eating too much food laden with sugar and fats. Last year, 
Denmark sought to curb poor nutrition by making certain prod-
ucts more expensive, introducing a tax adjusted to the saturated 
fat content on products such as butter, milk, cheese, pizza, meat, 
oil, and processed foods.
A TAXING 
EFFORT:
Cavities, or caries, 
result when an infection—usually bacterial—
demineralizes teeth, but more than a century ago 
researchers began to explore whether ﬂ uoride 
in water could stymie that process. After a 
study in a Michigan city showed that ﬂ uori-
dating the water supply reduced tooth decay 
among residents, U.S. ofﬁ cials backed the 
prevention strategy in 1951. Water ﬂ uorida-
tion would soon become widespread in the 
United States and many other countries, 
though some worry about its other health 
implications or argue it infringes their rights.
THWARTING DECAY:
www.sciencemag.org    SCIENCE    VOL 337    21 SEPTEMBER 2012 
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1469
changed since the 1980s. When USPSTF 
began, McGinnis says, he imagined that it 
would highlight the beneﬁ ts of preventive 
services, “to show that the evidence base for 
prevention was even stronger than for many 
treatment interventions.” At the time, clini-
cal medicine “was overwhelmingly focused 
on the treatment side,” McGinnis says.
McGinnis, who started in the Carter 
Administration and also served 
under presidents Ronald Reagan 
and Bill Clinton, agrees with Moyer 
that the 2009 storm over mammog-
raphy was partly about politics. But 
he says that experts were at odds, 
and that unlucky timing and “poor 
communication” of ﬁ ndings con-
tributed to USPSTF’s woes. 
Ned Calonge, the physician-epidemiologist 
who was chair of USPSTF when it made its 
mammography recommendations in 2009, 
says that what really surprised him was being 
shut out of the subsequent public debate. “It 
was frustrating to me not being able to coun-
teract the very carefully crafted misinforma-
tion from the advocates” of mammography 
screening, says Calonge, now CEO of The 
Colorado Trust in Denver, a philanthropy. 
“We could not get control of the message.”
In its early days, USPSTF undertook 
two reviews of more than 150 preventive 
measures—trying to cover the universe, 
McGinnis says. But medicine was changing 
too rapidly to keep up this pace; in the late 
1990s the panel switched to doing analyses of 
single topics, which it now selects with input 
from researchers and the public. This year, 
for example, more than 20 topics are under 
review, from screening for abdominal aortic 
aneurysms to the use of vitamin D supple-
ments to prevent cancer and osteoporosis.
Calonge, Moyer, and McGinnis all say 
that USPSTF needs to learn to communi-
cate ﬁ ndings more clearly. And they agree 
on another point: A bill proposed in Con-
gress this year to revamp USPSTF would 
not be a great way to improve scientific 
reviews. Introduced by Representative 
Marsha Blackburn (R–TN) and others, the 
USPSTF Transparency and Accountabil-
ity Act of 2012 (H.R. 5998) would require 
the task force to include “stakeholders” 
and “specialty care providers” 
on decision-making panels. This 
is the plan backed by urological 
associations.
Moyer acknowledges that the 
task force can use advice from 
medical specialists, but only if 
they are experienced in clinical 
epidemiology and primary care—and are 
thoroughly impartial. Recruiting advocates 
as reviewers would defeat the purpose of the 
task force, she says.
Time is running out for the Blackburn 
bill in this Congress. But if it fails this year, 
the appeal to shake up USPSTF by includ-
ing advocates may come back in 2013. 
Science recently spoke with Moyer about 
her role, her task force’s recent fame, and 
its future. Her answers have been edited for 
brevity and clarity. 
–ELIOT MARSHALL
Q: How did you get into this ﬁ eld?
V.M.: I think I got into evidence-based medi-
cine because I tend to say, why are we doing 
this? (I have a journalist father and a scien-
tist mother.) I was extremely fortunate to go 
to an early workshop sponsored by McMas-
ter University, one of the birthplaces of 
evidence-based medicine. I got very 
involved. … I had written a paper about 
whether there was any evidence for what we 
do in pediatric checkups. I looked at pro-
cedures that were recommended by at least 
two august bodies for these checkups and 
dug up the evidence for them, and it turns 
out there’s not a lot of it. That doesn’t mean 
they don’t work.
Q: On the task force, was there concern 
about potential harms from preventive 
measures from the beginning?
V.M.: Yes, this was a new way of looking at 
things. We don’t just say, “Oh, prevention is 
wonderful.” As in all of medicine, you have 
to look at the upsides and the downsides, 
the beneﬁ ts and the harms. … If you have 
someone who feels ﬁ ne when they come 
into the ofﬁ ce, and you give them a screen-
ing test, you can’t make them feel better. 
The only thing you can do is make them feel 
worse. So we balance both the beneﬁ ts and 
the harms of any preventive service. 
Q: Did a concern over cost drive this 
balancing act?
V.M.: That was not a big concern. It was 
more general. … You don’t want to do some-
thing that doesn’t work—that is just a waste 
of money. More important, it is a waste of 
time. In a clinical encounter, you don’t want 
to waste any of the limited time you have.
Q: Why was the recommendation against 
routine mammography controversial?
V.M.: The timing of the release coincided 
with health reform and the election. People 
were looking for a reason to be upset. … 
The health care reform bill said that if the 
USPSTF makes a recommendation with a 
grade of A or B, that service would be ﬁ rst-
dollar covered [by health care providers]. 
Well, the task force didn’t give mammogra-
phy for women aged 40 to 49 an A or B, so 
people interpreted it to mean they wouldn’t 
be able to get [insurance] coverage. But that 
isn’t what the recommendation says at all.
Online
sciencemag.org
Podcast interview 
with author Eliot 
Marshall (http://scim.ag/
pod_6101a).
Published by AAAS
 
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1470
DISEASE PREVENTION
 www.sciencemag.org/special/prevention
Q: What did you take away from 
that experience?
V.M.: We learned that we were suddenly 
in the public eye, which has dramatically 
changed how we communicate. We have 
expanded the transparency of what we do 
and opportunities for input from the public 
and from other stakeholders.
Q: Did you have public 
comment before?
V.M.: We did not. … 
Everything went out for 
review to all kinds of 
people who we thought 
would be interested. 
Now it is put out on our 
Web site for anyone who 
wants to respond. We 
now invite public com-
ment at the point when 
we are starting to think 
about a topic, so the 
public can say, “Well, 
you are not asking the 
right questions.” … It 
really helps us to under-
stand what people are 
interested in, what they 
are concerned about. 
And other experts may look at an issue and 
say, “I think you should frame it differently.” 
Q: Did the PSA recommendation turn out to 
be as controversial as mammography?
V.M.: In some ways it is probably more 
controversial. The mammography recom-
mendation itself is not all that exciting. … 
It says: Think carefully because there are 
some downsides. … Don’t just leap into it. 
The PSA recommendation says: Don’t do 
it. That has been very controversial with the 
urologists and with some but not all advo-
cacy organizations. … We all have great 
hope [that preventive screening will work], 
and it is pretty painful to have that hope 
taken away.
Q: Have task force recommendations 
caused a change in behavior?
V.M.: There has been a change in mammog-
raphy frequency—that has been pretty well 
studied now over the last couple of years. 
And there have been a 
couple of studies look-
ing at the frequency of 
PSA [tests]. And [both] 
have gone down a little 
bit.
Q: Does it take a long 
time for recommenda-
tions to be acknow-
ledged?
V.M.: Absolutely. We 
shouldn’t be surprised 
by this. There are tons 
and tons of data out there 
on how long it takes for 
changes in health care to 
really take hold in prac-
tice. There was a study 
decades ago that’s always 
quoted that says it takes 
18 years to get anything new into practice—
that may not be exactly accurate, but it is true 
that change is hard and it takes a long time. 
Q: There’s a bill in Congress mandating 
that medical specialists be included on 
USPSTF panels. What do you think of it?
V.M.: It is important to recognize that … we 
[at USPSTF] already do have the appropri-
ate specialists on the panel: specialists in 
primary care and in evaluating science. Our 
recommendations are addressed to primary 
care clinicians about people who visit their 
generalists without speciﬁ c concerns; these 
are not people who are going to specialists 
with a concern. If you put advocates on the 
panel, all you’re doing is asking for advo-
cacy, not science. 
Q: How much should task force 
work be linked to policy, such as 
spending decisions?
V.M.: In many countries—England is a 
good example—the body that does the type 
of work we do is directly linked to policy 
decisions. In this country, that doesn’t go 
as well. … We do not do cost-effectiveness 
analysis. That is a scientiﬁ c ﬁ eld in and of 
itself, and it’s very resource-intensive. We 
don’t do that. 
Q: Some say it would be a mistake to link 
the scientiﬁ c review and policy decisions 
because the science would suffer.
V.M.: That tends to be right. … We don’t 
ignore the fact that there are [financial] 
costs associated with things, and we partic-
ularly consider cost to the individual to be a 
potential harm, but not in an explicit quan-
titative way. We do consider the fact that a 
false-positive test not only ends up requir-
ing in many instances invasive and unpleas-
ant procedures to determine that it was a 
false positive, but it can also be costly to 
the individual in time and money. My most 
recent false-positive mammogram cost me 
$2000 out of pocket, because insurance 
only covers the mammogram; it doesn’t 
cover the biopsy. Two thousand dollars is 
real money. Our purpose is not to save the 
system money. Our purpose is to improve 
the health of all Americans.
Q: Will the task force always be in the 
middle of controversy?
V.M.: Probably. And that’s OK. Somebody 
needs to be looking at the things that we 
[physicians] always do with a critical eye. 
Screening shocker. The task force’s deci-
sion on mammography upset many groups.
In response 
to a 1964 report on smoking by the Sur-
geon General, the United States became 
the ﬁ rst country to mandate health-haz-
ard warnings for cigarettes and other 
tobacco products. Other countries have 
followed suit, and 
the warnings 
have recently 
become even 
more graphic 
and aggressive.
21 SEPTEMBER 2012    VOL 337    SCIENCE    www.sciencemag.org 
There’s frequently 
debate about whether a screening method saves 
lives, but few doubt the effectiveness of one 
widely used method: the phenylketonuria (PKU) 
test now given to newborns in many industrial-
ized countries. Often part of an arsenal of other 
newborn assays, the PKU test checks whether 
an infant has a toxic buildup of the amino acid 
phenylalanine, which can lead to mental retar-
dation and other medical problems. If PKU is 
detected in a newborn, the infant can be given a 
specialized diet and avoid most health effects.
BABY SAFEGUARD: TOBACCO WARNING: The addition of folic acid to 
breads, grains, ﬂ our, and other food products in 
many industrialized countries has been credited 
with reducing the number of babies born with 
neural tube defects. The U.S. Food and Drug 
Administration announced in 1996 that it would 
begin requiring folic acid fortiﬁ cation in certain 
foods, and a few other countries have taken the 
same action. Similarly, niacin has been volun-
tarily added to enriched ﬂ our in some countries 
to help ward off pellagra, the sometimes fatal 
disease caused by a B vitamin deﬁ ciency.
FLOUR POWER:
C
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T
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):
 I
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P
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; 
C
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B
IS
Published by AAAS
 
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Public Health Measures in Disease Prevention

Kaiser, J.

21 SEPTEMBER 2012    VOL 337    SCIENCE    www.sciencemag.org 1472
DISEASE PREVENTION
 www.sciencemag.org/special/prevention
C
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“black box” warning label. 
The pendulum began to swing back in 
favor of aspirin, however, when Rothwell, a 
neurologist, noticed that fewer overall can-
cers had occurred among patients in the 
treatment arm of randomized trials launched 
in the 1980s to test aspirin as a way to pre-
vent stroke. Amassing details on the can-
cers from patients’ paper health records and 
U.K. health databases, his team initially con-
ﬁ rmed aspirin’s ability to ward off colorec-
tal cancers, reporting in 2007 that there were 
24% fewer cases and 35% fewer deaths in 
the aspirin group after several years. Then 
in late 2010, they reported that patients 
taking aspirin at any dose daily for at least 
5 years cut by 21% the long-term risk of 
dying from colorectal, gastrointestinal, 
esophageal, stomach, pancreatic, brain, 
lung, and prostate cancers.
Rothwell’s group expanded on these 
results in three papers published in The 
Lancet and The Lancet Oncology this 
spring. One, a meta-analysis of 51 random-
ized trials in which aspirin was taken daily, 
found 37% fewer deaths from cancers after 
5 years. (The study came 
with a large caveat: It 
excluded WHS and an ear-
lier trial that found no ben-
eﬁ t, the Physicians’ Health 
Study, because participants 
in each took aspirin only every other day.) 
This meta-analysis also found that while 
the aspirin group had more stomach bleeds, 
these incidents were not fatal—people 
recovered—and the bleeding risk went down 
after several years on aspirin. Another paper 
found that people on aspirin who developed 
cancer were 36% less likely to have tumors 
that had spread. A third paper found a 
“remarkable consistency” in the drop in can-
cers among aspirin users in epidemiologic 
studies and clinical trials, Rothwell says.
While these studies weren’t designed spe-
ciﬁ cally to test aspirin against cancer, some 
researchers say that because so many people 
now take aspirin off-label it would be difﬁ -
cult to conduct better tri-
als. The Rothwell studies 
are “probably the best evi-
dence we’ll ever have on this 
topic,” Chan says.
Weighing risks
Chan is part of an interna-
tional panel on cancer pre-
vention that, in response 
to the Rothwell studies, plans to update its 
stance on aspirin published 3 years ago. 
The group’s leader, epidemiologist Jack 
Cuzick of Queen Mary, University of Lon-
don expects the panel may suggest that 
people take low doses of aspirin daily start-
ing around age 50 and stopping by age 70, 
when the risk of internal bleeding rises. The 
group may also discuss whether doctors 
should screen patients for the ulcer-causing 
Helicobacter pylori bacterium, treating 
those who test positive with antibiotics 
before putting them on aspirin, to reduce 
the risk of bleeds. 
Some U.S. researchers also suggest that 
it’s time for the U.S. Preventive Services 
Wondering How the Wonder Drug Works
Believer. Peter Rothwell’s can-
cer studies convinced him to 
take a daily aspirin.
HOW DOES TAKING ASPIRIN WARD OFF CANCER? RESEARCHERS 
still don’t understand the mechanism, a lack of knowledge that threat-
ens to frustrate development of better cancer prevention agents. 
But some say the latest clinical studies linking low-dose aspirin use 
with less cancer (see main story, p. 1471) suggest there’s no need to 
improve upon this 113-year-old workhorse drug.
Among its many known effects, aspirin, or acetylsalicylic acid, 
inhibits two forms of enzymes known as cyclooxygenases (COX) that 
convert arachidonic acid into lipids called prostaglandins. Prosta-
glandins made by COX-1 protect the stomach lining, while those made 
by COX-2 are involved in inﬂ ammation. Aspirin’s inhibitor effects 
on COX-1 seem to explain why the medicine can upset stom-
achs and trigger internal bleeding. Many researchers have 
concluded that aspirin prevents cancer mainly by blocking 
the activity of COX-2. That’s because the same inﬂ amma-
tion-driven responses that help tissue recovery from wound 
injury—cell division, blood vessel formation, and suppression 
of programmed cell death, for example—may also help tumors grow.
Several lines of evidence implicate COX-2 in cancer induction. 
The enzyme is overproduced in many cancer types; mice lacking 
its gene are less prone to colon cancer; and trials of nonsteroidal 
anti-inﬂ ammatory drugs (NSAIDs) that target only COX-2 protected 
against precancerous colon polyps in people at high risk. 
Reducing inﬂ ammation via COX-2 probably isn’t the only way aspi-
rin prevents cancer, however. “We are as a ﬁ eld getting down to some 
of the mechanisms, but it’s very complicated,” says Raymond Dubois 
of the MD Anderson Cancer Center in Houston, Texas. A decade ago, 
researchers found that aspirin can block production of a protein called 
NF-κB that protects cells from early death. Although the studies were 
done in the test tube at aspirin doses much higher than those in the 
bloodstream, the NF-κB hypothesis remains on the table—along with 
more than a dozen possible mechanisms—from inhibiting various cell 
growth pathways to targeting cancer stem cells. “There are a number 
of very different, divergent ideas,” says Asad Umar of the National Can-
cer Institute’s Division of Cancer Prevention in Bethesda, Maryland.
Some experts say new clinical studies of low-dose aspirin and can-
cer suggest that COX-2 isn’t directly involved at all. That’s because at 
low doses, the drug doesn’t block COX-2 but still impairs platelets, the 
small cell fragments in blood that help form clots, via the COX-1 path-
way. Studies suggest that platelets blunt the immune attack on cancer 
cells traveling in blood and produce growth factors that help them take 
root in a new place, notes University of Pennsylvania pharmacologist 
Garrett FitzGerald. Some experiments suggest that activated platelets 
can also stimulate the COX-2 pathway in adjacent cells, which would 
explain how aspirin, by damping COX-2 at the site of an injury, could 
block the early stages of colorectal cancer, says Carlo Patrono, a phar-
macologist at the Catholic University in Rome, Italy. 
Efforts to make an alternative to standard aspirin haven’t yet panned 
out. Several drugs that target only COX-2, notably Vioxx and Celebrex, 
unacceptably raised heart attack risk, for example. And a version of 
acetylsalicylic acid containing a chemical group called nitric oxide that 
was supposed to reduce side effects failed to gain regulatory approval. 
Some researchers are combining aspirin with other compounds such 
as a lipid to reduce stomach upset. But these are years from the clinic. 
For now, “I don’t think a better aspirin is the issue,” but rather ﬁ guring 
out which individuals stand to beneﬁ t from it most, FitzGerald says. –J.K. 
Published by AAAS
 
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Wondering How the Wonder Drug Works

Trivedi, B.

Chronic Disease Vaccines Need Shot in the Arm

University of Pittsburgh

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