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Thomas Bodenheimer
Elaine Batchlor and Marianne Laouri
Jerry
Avorn
John
E. Calfee
Martin
T. Gahart et al.
D A T A W A T C H : D R U G A D S W E B E X C L U S I V E
26 February 2003
Consumers Reports On The Health Effects Of Direct-To-Consumer Drug Advertising
This study found no widespread
adverse health affects resulting from drug ads aimed at consumers, but society
still needs to weigh in on the consequences of this advertising.
Joel S. Weissman, David Blumenthal,
Alvin J. Silk, Kinga Zapert, Michael Newman, and Robert Leitman
ABSTRACT:
We conducted a national telephone survey about health care experiences associated
with direct-to-consumer advertising (DTCA) of prescription drugs. Among the
35 percent of our sample who had a physician visit during which DTCA was discussed,
25 percent received a new diagnosis, of which 43 percent were considered high
priority according to authoritative sources. More than half also reported actions
taken by their physician other than prescribing the advertised drug. Despite
concerns about DTCAs negative consequences, we found no differences in
health effects between patients who took advertised drugs and those who took
other prescription drugs.
Until just a few years ago advertising of prescription drugs was aimed almost
exclusively at physicians and other health professionals. Although physician
drug detailing (in-person visits by drug company representatives) has been criticized
for exerting undue influence on prescribing habits, physicians training
and experience equip them, at least in theory, to process and evaluate advertisers
claims and make informed prescribing decisions for their patients.1
The near-exclusive focus on physicians changed in the late 1990s, when the pharmaceutical
industry increased its use of direct-to-consumer advertising (DTCA). Although
modest at first, spending on DTCA more than doubled to approximately $2.5 billion
in 2000 following the relaxation of regulations from the U.S. Food and Drug
Administration (FDA) in 1997.2
The practice of DTCA is controversial because it operates at the nexus of health
care and for-profit enterprise. Views on DTCA center on three effects: cost,
communication, and health of the public. Critics claim that DTCA raises health
care costs by stimulating consumers to demand newer, more expensive drugs, often
with high profit margins.3 Some members of Congress
are so concerned about this possibility that they have suggested limiting Medicare
beneficiaries access to heavily advertised drugs.4
The pharmaceutical industry rejects arguments that DTCA is inflationary, and
while not denying the profit motive, it points out that DTCA serves a patient
education function.5 The industrys argument
is that patients are highly motivated to seek the best available treatment for
their condition, and they need and deserve more and better information on which
to base their judgments. Some patients may be even more informed than their
physicians are regarding particular treatments. DTCA critics take a skeptical
view of this claim, fearing that pressure from patients erodes physicians
authority and may lead to inappropriate prescribing.6
Others worry that patients are confused by deceptive advertising and that precious
time is wasted during physician office visits to discuss minor conditions or
cosmetic issues brought to patients awareness by ads.7
Jane Henney, former FDA commissioner, summarized the debate by asking, Do
these advertisements provide consumers with information that empowers them to
care for their health, or are they misleading in a way that presents a public
health hazard?8
There is scant research on the health effects of DTCA. Prior surveys by the
FDA and Prevention magazine consider mainly indirect effects of DTCA
on health by examining consumers understanding of advertisements and patient-doctor
interactions.9 Most Americans are aware of DTCA,
and huge numbers are having discussions about advertised drugs with their physicians.
However, past investigations have not explored the types of conditions that
are discussed with physicians during these conversations, the actions that result
from discussions about DTCA between doctors and patients, and the effect, if
any, on health outcomes.
This paper reports results of a survey of a national sample of consumers who
have discussed advertised drugs with their physicians. Our goal was to describe
actual health care experiences and outcomes, rather than opinions and attitudes.
The underlying assumption was that DTCA stimulates patients to discuss advertised
drugs during physician visits and leads to actions taken that result in health-related
outcomes. Using patients reports, our research sought to determine the
health-related value (or harm) resulting from these visits. It addressed three
questions: (1) What sorts of conditions or problems are discussed during physician
visits that include a discussion about an advertised drug? (2) What actions
are taken by physiciansincluding additional tests and treatmentsas
a result of these visits? (3) Do outcomes of care differ by whether the patient
takes the advertised drug that was discussed during the visit or some other
drug?
Data And Methods
The data are from a telephone survey designed by a team of researchers from
Harvard University/Massachusetts General Hospital and Harris Interactive. The
team had full control over the content of the survey, access to the data, and
control over interpretation of the results. Telephone interviews with a national
probability sample of 3,000 adults were conducted by Harris Interactive between
9 July 2001 and 16 January 2002 using random-digit dialing and random household
member selection procedures. Response rates were enhanced in a number of ways.
A $10 incentive was offered for completion of the interview (including $2 up
front for difficult-to-reach respondents). Where telephone numbers of nonrespondents
could be matched with an address (58 percent), letters were mailed explaining
the purpose of the survey and encouraging response. A toll-free number was offered
so that respondents could complete the survey at a convenient time. Attempts
also were made to contact nonrespondents at various times of the day and days
of the week. The response rate was 53 percent. Although lower than optimal,
this compares favorably with other published data from national consumer surveys.10
Questionnaire development.
The survey was designed to gather data on health care experiences resulting
from ambulatory visits with physicians. To develop the survey questions, we
performed an extensive literature review and then held a focus group run by
a professional facilitator in Boston in January 2001. The instrument underwent
cognitive testing, was revised based upon our findings, and was pretested on
twenty respondents.11
Our initial concept was to compare the health care experiences of patients who
were aware of DTCA with those of patients who were not. However, research from
the FDA as well as our own pretesting showed that exposure to DTCA in the United
States is nearly universal. An alternative design was tested that would compare
patients who were prompted solely by DTCA to schedule a physician visit with
those who had a physician visit that was not prompted by DTCA. This also was
rejected, because pretesting suggested that patients schedule appointments with
physicians for a variety of reasons, based on multiple sources of information.
Very rarely would consumers identify DTCA as the sole reason for scheduling
a visit. As a result, we took the perspective that there exists a continuum
of visit types ranging from those for which DTCA had no influence on seeing
the doctor to those for which DTCA was the principal influence. We focused,
therefore, on visits during which DTCA prompted patients to discuss their health,
regardless of why the visit was scheduled. Other survey questions elicited the
level of DTCA influence on the visit. This study focuses for the most part on
the health care experiences that transpired following those visits.
Variables and relevant subpopulations.
The survey was designed to ask questions tailored to subgroups of patients defined
by their familiarity with DTCA and by relevant medical events. All respondents,
regardless of medical history, were asked about health status, presence of chronic
illnesses, and sociodemographic characteristics (sex, race/ethnicity, education,
insurance status, and drug coverage).
The major subgroup consisted of respondents who had ever been prompted by a
DTC ad to talk to a doctor about an advertised drug or other health issue or
concern (35 percent). We refer to these as DTCA discussions or DTCA visits,
to distinguish them from visits during which a DTC ad is not discussed. DTCA
visits were categorized by whether the patient primarily discussed a drug, a
new health concern, or a possible change in treatment for an ongoing concern.
Subsequent questions focused on the content of a single DTCA visit, so if patients
had more than one, we asked them to choose the one that was most important to
their health. Because pretesting suggested that patients motivation to
speak with their physician is multifactorial, respondents also were asked to
identify other sources of information that influenced their decision to have
the discussion with their doctor and to note which were the most important.
Respondents were then asked to report the condition or problem discussed during
the visit, and whether the condition had ever been confirmed (Did a doctor
or other medical professional ever tell you that you had [the marker condition]?).
This is similar to the approach used by the Agency for Healthcare Research and
Quality (AHRQ) in its Medical Expenditure Panel Survey (MEPS).12
These conditions were reviewed by a physician and coded into a reason
for visit using the classification system employed by the National Ambulatory
Medical Care Survey (NAMCS).13 A few conditions
either were too general (for example, infections) or merely mentioned
a particular drug (for example, Viagra) and so were not forced into
a NAMCS category. Furthermore, to address whether DTCA resulted in the diagnosis
of or treatment for conditions of public health interest, we identified the
fifteen high priority conditions listed by AHRQ and adopted by the
Institute of Medicine (IOM) in its report Crossing the Quality Chasm.14
A series of questions addressed actions taken as a result of the DTCA visit.
We asked whether the physician wrote a prescription for the advertised drug
or another prescription drug, or recommended an over-the-counter (OTC) drug.
We inquired whether the physician made a referral to a specialist, suggested
a change in diet or exercise, ordered a laboratory test, or suggested limitations
in smoking or drinking.
A second subgroup included all respondents who had a DTCA visit, were prescribed
a drug, and took the drug as prescribed (21 percent). They were asked a series
of health-related quality-of-life questions, including reported presence of
side effects, and improvement/worsening of overall health, symptoms, and laboratory
results. Finally, among respondents who reported switching medications to treat
their conditions (5 percent), we asked which drug had worse side effects (comparing
the old drug to the new drug) and which drug was easier
or more difficult to remember to take (compliance). If one drug had no side
effects and the other did, we assumed that the drug with side effects was worse.
Analysis.
The primary
purpose of the analysis was to describe the experiences of patients who reported
having a DTCA visit. However, because patients are subject to multiple influences
in making health care decisions, we attempted to isolate further the influence
of DTCA. We did this in two ways: (1) We compared patients for whom DTCA was
one of the two most important sources of information that influenced them to
have the health discussion with their doctor versus all other patients (high
versus low DTCA influence); and (2) among patients who were prescribed drugs
and took them, we compared patients who received the DTCA drug versus all other
patients.
Because they may be at higher risk for poor outcomes, we compared patients in
fair or poor health with all other patients. We also compared patients with
and without high-priority diagnoses. Bivariate differences were tested using
the chi-square statistic. We then adjusted the responses by direct standardization,
employing logistic regression models. The predicted logits were retransformed
to percentages. This approach assigns each person the attribute of interestfor
example, fair/poor health statusbut all other characteristics are assumed
to be at the sample mean. Statistical inferences were based on the results of
the underlying logistic regressions. Initial runs included all of the variables
in Exhibit 1, but since health status
and insurance coverage for drugs were the only variables that were consistently
significant (p < .05), the percentages are adjusted only for those
variables. However, because none of the results changed by more than a percentage
point or two, we present only the unadjusted results.
Analyses were performed with SPSS. To account for nonresponse, all responses
were weighted so as to represent a national sample.15
To account for possible recall bias, we repeated the analyses for just those
respondents who had a DTCA discussion in the three months before the interview.
Study Results
Our sample included 76 percent white, non-Hispanics; 39 percent college graduates;
and 88 percent adults with health insurance (Exhibit
1). The study procedures resulted in a sample that closely resembled national
data in terms of regional representation, health status, and recent ambulatory
visits. There was a slight underrepresentation of younger, minority, less educated,
and uninsured adults.
Effects of DTC ads.
Approximately 86 percent of all consumers saw or heard a DTC ad in the last
year. About 35 percent of all respondents were prompted by an ad to have a discussion
about an advertised drug or other health concern during a visit with a physician
(DTCA visit). Nearly two-fifths of patients having a DTCA visit talked about
a prescription drug, about one in five discussed a new concern, and about one-third
talked about a possible change in treatment for an ongoing condition (Exhibit
2). DTCA was one of many health information sources influencing patients
decision to discuss a health issue with their physician. Other than DTCA, 51
percent of patients were influenced by friends/family, 40 percent by broadcast
media, 34 percent by print media, 33 percent by pamphlets in doctors offices,
33 percent by another doctor, 16 percent by the Internet, and 17 percent by
a pharmacist. Of persons with a DTCA visit, about 45 percent (n = 474) were
(by our definition) highly influenced by DTCA to have the discussion with their
physician, and 19 percent (n = 198) were in fair/poor health. People in good
health or who were highly influenced by DTCA were more likely than others to
have a DTCA discussion about a particular prescription drug rather than about
new or ongoing health concerns (p < .01).
About half of patients with DTCA visits had previously been diagnosed with the
condition discussed during the visit, and nearly one in four were given new
diagnoses. New and existing conditions are listed in the exhibit only if they
were confirmed by a health professional (according to the respondent). The five
most common existing conditions were allergies (13 percent), arthritis (10 percent),
high cholesterol (7 percent), diabetes (7 percent), and asthma (5 percent).
The most common new diagnoses were allergies (9 percent); diseases of the esophagus,
duodenum, and stomach (including gastro esophageal reflux disease, or GERD)
(8 percent); high cholesterol (6 percent); arthritis (6 percent); hypertension
(6 percent); diabetes (5 percent); and depression (5 percent). Approximately
43 percent of new diagnoses and 51 percent of existing diagnoses were high
priority conditions according to AHRQ/ IOM criteria (data not shown).
Notably, 8.8 percent of patients did not specify a condition discussed during
the visit, and an additional 20.1 percent of conditions were not confirmedthat
is, the patient did not recall being told by a doctor or other health professional
that he or she had the condition reported in the survey.16
Physicians actions.
Exhibits
3 and 4
refer to actions taken by physicians as a result of the DTCA visit. Nearly three-quarters
of respondents with a DTCA visit received a drug prescription; 43 percent of
DTCA visits resulted in a prescription for the advertised drug. Other actions
taken included referrals to specialists, lifestyle changes, recommendations
for OTC drugs, lab tests, and reductions in smoking/ drinking.
Nearly all respondents (95
percent) with a DTCA visit reported at least one action taken. Even after we
excluded prescriptions for the DTCA drug, 53 percent still resulted in at least
one action taken by the physician. People in fair/poor health and with high-priority
conditions generally had more actions taken on their behalf, but they did not
differ significantly from their healthier counterparts in terms of the likelihood
of receiving a DTCA drug. Patients with unconfirmed conditions were less likely
to have actions taken, and patients with new conditions were slightly more likely
than others were to receive a lifestyle recommendation. People who were highly
influenced by DTCA were no more likely than others were to be prescribed the
advertised drug but were less likely than others were to be referred to a specialist,
have a lab test ordered, or have a lifestyle change suggested (p <
.001).
Health-related outcomes.
About four out of five patients who received a prescription drug and took it
as prescribed reported that they felt much better or somewhat better overall
after taking the drug, and similar numbers reported that their symptoms improved.
Among persons who underwent lab tests, 84 percent reported that their test results
improved. These health-related quality-of-life outcomes generally did not vary
by type of drug prescribed (DTCA versus other) (p < .05). Among patients
who switched prescription drugs for the same condition (5 percent of all consumers),
28 percent said that the new drug was easier to take or remember to take, 8
percent said that it was more difficult, and 64 percent said that it was about
the same. None of these effects varied significantly by whether the patient
switched to a DTCA or to another drug (all p < .05), and no clinically
notable differences occurred between patients with new or existing diagnoses.
However, those who switched to a DTCA drug were less likely than others who
switched were to report that side effects of the new drug were worse (8 percent
versus 22 percent) (overall p = .041).17
Because patient reports are subject to recall bias, we repeated the analyses
for people who had a DTCA visit in the three months before the interview (n
= 257, or 25 percent of all DTCA visits). Virtually all of the figures were
within a few percentage points of the results for the full sample, although
fewer differences were statistically significant because of the smaller sample
sizes.
Discussion
Effects on consumers.
This study provides a new perspective on the health consequences of DTCA visits,
as perceived by patients. As a marketing tool, DTCA is clearly effective when
one considers the large number of people who are aware of the ads, and the number
who discuss the ads with their physicians and who eventually receive the advertised
drug. But marketing theory also suggests that consumers can gain extra benefits
not limited to the advertised drug, by obtaining supplementary information about
their health.18 Prior consumer surveys suggest
some of these spillover effects, including raised awareness of new conditions,
attentiveness to side effects, increased information seeking, and education
about nondrug treatments.19 These benefits may
be countered by the potential for harm resulting from possibly deceptive advertising,
or overuse that may result from targeting relatively healthy people or by medicalizing
nonmedical problems.20
Reassuring findings.
Our data add to the literature on health effects by addressing the study questions
raised earlier and are reassuring on several counts. First, we found that a
sizable portion of patients with DTCA visits reported seeing physicians for
clinically important conditions and that many visits resulted in new diagnoses.
Some of the most common new diagnoses that were discovered as a result of these
visitshigh cholesterol, hypertension, diabetes, and depressionare
often underdiagnosed and undertreated in the general population.21
Very few visits were for cosmetic or lifestyle problems.
Second, we found that DTCA visits resulted in health care actions taken on behalf
of patients that went beyond the expected prescribing of drugs, both advertised
and not. Third, given concerns over the possible adverse health consequences
of DTCA, our study is notable for what it does not show. We failed to find large
negative health consequences for patients on a number of health-related aspects,
including symptom relief, improved laboratory results, and ease of taking the
drug, and for the most part found no difference by whether the patient took
the drug that was advertised or some other drug. There seemed, in fact, to be
a small advantage in relief of side effects among patients who switched their
medications to the advertised drug after their visit, although the number of
respondents was small. At a minimum, therefore, we did not detect widespread
adverse effects of DTCA based on self-reported health status.
Methodological issues.
The data from our study and the focus groups that preceded the survey raise
at least two methodological questions about researchers ability to attribute
specific motives to patients behavior. First, consumers rely on a multitude
of information sources, and the process leading from an ad to a prescription
is complex. Many intervening steps often must occur, including scheduling a
physician visit, taking and interpreting laboratory tests (for example, for
allergies or high blood cholesterol), and perhaps trying lifestyle changes first.22
Second, people who are interested in making informed decisions about their health
may be more likely to exhibit better health habits than others are, thus confounding
the effect of public education. Research on mass communications and advertising
has long recognized that even when exposure is widespread, perception and retention
are usually motivatedthat is, selective. For example, Republicans are
more likely than Democrats are to pay attention to advertisements for Republican
candidates.23 Thus, we expect prior interest in
ones health to be correlated with attention to and recall of DTC advertising.
Study limitations.
This investigation has certain other limitations that may affect its interpretation
and generalizability. The basic study design provides descriptive, cross-sectional
data. We did not collect information on outcomes for patients who had physician
encounters without a DTCA-prompted discussion. However, as noted above, DTCA
awareness is widespread, and so it is unlikely that any cross-sectional study
in this country would be able to isolate its effects so completely. Second,
even though we had a large national sample, it was still too small to allow
for rigorous control of underlying clinical conditions other than overall health
status. Future studies restricted to specific conditions might obtain different
results.
Third, the generally positive health outcomes we found may be subject to placebo
effects or recall bias, although on the latter issue our reanalysis using three-month
data suggests otherwise. Furthermore, the duration of experience with new drugs
may not have been long enough to identify side effects, and retrospective assessments
of outcomes can be biased, although they also can be valid reflections of patients
beliefs.24 Fourth, future studies should include
some measure of appropriateness of treatments.
Fifth, it is difficult to assess the magnitude of our findings without additional
context. For example, we found that 8 percent of all adults received a new diagnosis
from a health care professional as a result of a visit during which a DTCA-prompted
discussion took place. This represents approximately sixteen million peoplea
very large number. But given the multitude of health care influences, it would
be difficult to ascribe all of that benefit to DTCA. Sixth, we did not measure
health outcomes for people not receiving a prescription drug, although in our
study this represented only 27 percent of people with DTCA visits.
Seventh, documented positive effects in our study may be attributable to either
the physician-patient interaction, to the dispensing of pharmaceuticals, or
both. Eighth, the response rate was less than optimal. Although prior research
on survey methods has demonstrated that response rates even lower than 50 percent
can provide valid estimates of consumer opinion, these results may not apply
to reports of health care experiences.25
Areas not addressed.
Finally, some of the criticisms of DTCA are economic or ethical and were not
addressed by this study. We cannot comment on whether patients were receiving
drugs that were more expensive than necessary, or whether consumers were misled
by DTC ads. Surveys of consumers also cannot address whether DTCA adds costs
to the health care system, and if it does, whether its benefits are worthwhile.
Despite these limitations,
our study reports on data heretofore unavailable on patients experiences
with DTCA. Our results suggest that DTCA is a potentially powerful source of
consumer health information with effects that include, but also transcend, promoting
the use of advertised drugs. DTCA appears to affect patients behavior,
resulting in more physician visits that detect treatable disease but also precipitating
a variety of other health actions whose consequences remain to be understood.
The advent of DTCA coincides with a general trend toward consumerism, with expectations
on the part of patients that their physicians will interpret health information
for them and help them judge its value.26 It is
telling, perhaps, that physicians belonging to the National Medical Association,
whose members tend to treat more disadvantaged patients, perceive that DTCA
benefits their patients by increasing awareness and improving doctor-patient
communication.27
In conclusion, there seem to be no widespread adverse health effects from these
visits, on balance. From a societal standpoint, a definitive judgment on the
consequences of DTCA awaits further study and reflection. One important question
is whether other sources of health information could achieve DTCAs educational
benefits at less cost and with fewer undesirable consequences. To answer this
question would require that public and nonprofit agencies launch comparable
efforts to educate the public about their health and that those efforts be systematically
studied. For now, however, DTCA constitutes an influential purveyor of health
information for the general public, one whose power and prominence on our health
care scene may be unmatched by any other factor.
This work was supported by a grant from the American Medical Association
(AMA)Industry Roundtable Steering Committee and selected members of the
Ad Hoc Working Group on the Economics of the Pharmaceutical Industry (AstraZeneca,
Aventis, Bristol-Myers Squibb, Johnson and Johnson, Merck, Pharmacia, Pfizer,
Wyeth, and the National Pharmaceutical Council). The authors are grateful to
Kimberly Dietrich for valuable comments on the study design and manuscript;
to Kathryn Aiken for technical advice on the questionnaire; to Eran Bendavid
for advice on grouping conditions; to Stephen Soumerai for comments on an earlier
draft; to Petra Symister for data management; and to Sandra Feibelmann for research
assistance.
NOTES
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S.M. Wolfe, Direct-to-Consumer AdvertisingEducation or Emotion Promotion?
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M.F. Hollon, Direct-to-Consumer Marketing of Prescription Drugs: Creating
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4. R. Pear, Medicare Proposal Urges Incentives for Generic
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7. Wolfe, Direct-to-Consumer Advertising; S.G. Stolberg,
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and Evaluation, vol. 38, Applied Social Research Methods Series (Thousand
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12. Agency for Healthcare Research and Quality, Survey
Instruments and Associated Documentation, www.meps.ahrq.gov/survey.htm
(13 January 2003).
13. National Center for Health Statistics, 1997 Reason
for Visit Classification, www.cdc.gov/nchs/data/ahcd/rvc97.pdf
(13 January 2003).
14. Institute of Medicine, Crossing the Quality Chasm: A
New Health System for the Twenty-first Century (Washington: National Academies
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(13 January 2003).
15. Using estimates from the March 2001 Current Population
Survey, US Census Bureau.
16. Complete lists of diagnoses and conditions are available
on request from the authors; contact Joel Weissman by e-mail, jweissman@partners.org.
17. For further details, see J.S. Weissman et al., The Public
Health Impact of Direct-to-Consumer Advertisements of Prescription Drugs: Report
to Funders (New York: Harris Interactive, 2002).
18. J.E. Calfee, Public Policy Issues in Direct-to-Consumer
Advertising of Prescription Drugs, Journal of Public Policy and Marketing
21, no. 4 (2002): 174193.
19. Ibid.
20. B. Mintzes, For and Against: Direct to Consumer Advertising
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26. Institute for the Future, Twenty-first Century Health
Care Consumers (San Francisco: Jossey-Bass, 1998); and IOM, Crossing
the Quality Chasm.
27. S.D. Allison-Ottey, K. Ruffin, and K.B. Allison, To
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Joel Weissman is an associate
professor in the Department of Medicine, Harvard Medical School, where David
Blumenthal is a professor. Weissman and Blumenthal are also members of the Department
of Health Care Policy, Harvard Medical School, and the Institute for Health
Policy, Massachusetts General Hospital, all in Boston. Alvin Silk is the Lincoln
Filene Professor Emeritus, Graduate School of Business Administration, Harvard
University. Kinga Zapert is vice-president, Health Policy Research, at Harris
Interactive in New York City. Michael Newman is a senior research manager there,
and Robert Leitman is division president, Health Care.
Related
papers on this topic are available by clicking the author's name below:
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