Pharmacology and Therapeutics

Does Prior Authorization of Sibutramine

Improve Medication Compliance or Weight
Loss?
Joseph A. Risser,* Peter D. Vash,* and Lurline Nieto*

Abstract
RISSER, JOSEPH A., PETER D. VASH, AND LURLINE
NIETO. Does prior authorization of sibutramine improve
medication compliance or weight loss? Obes Res. 2005;13:
86 92.
Objective: This study was designed to examine whether
prior authorization for insurer reimbursement of weight loss
medication affects compliance with taking sibutramine or
adherence to a medical weight control program. The underlying hypothesis is that physician advocacy through prior
authorization increases patient compliance and treatment
outcomes.
Research Methods and Procedures: A retrospective review
was conducted of 22 subjects who had received a prescription for sibutramine that was reimbursed through their
health insurer by prior authorization (PAR) and compared
them with 47 randomly selected subjects who were also
prescribed sibutramine but did not receive reimbursement
(non-PAR). Outcome measures included the percentage
weight lost, visits to the clinic, and number of prescriptions
received at 3, 6, 9, and 12 months.
Results: The proportion of subjects remaining in the clinic
program, the number of clinic visits made, the number of
prescriptions received, and the amount of weight lost were
all significantly greater among PAR subjects than among
non-PAR subjects. PAR subjects used the medication 37%
longer by month 6 (2.43 vs. 1.52 prescriptions; p 0.02),
visited the clinic 44% more often (72.5 vs. 40.5 visits in 12
months; p 0.0006), and achieved 38% better maximal
weight loss (16% vs. 9.9% at 6 months; p 0.49) than
non-PAR subjects.

Received for review February 17, 2004.

Accepted in final form October 28, 2004.
*Lindora Medical Clinics, Costa Mesa, California and UCLA School of Medicine, Department of Endocrinology, Los Angeles, California.
Address correspondence to Joseph A. Risser, Lindora Medical Clinics, 3505 Cadillac
Avenue, Suite N-2, Costa Mesa, CA 92626.
E-mail: jrisser@attglobal.net
Copyright 2005 NAASO

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OBESITY RESEARCH Vol. 13 No. 1 January 2005

Discussion: This study suggests that, when those medications are not included on a health insurers formulary, the
use of the prior authorization process may improve both
medication and behavioral compliance.
Key words: pharmacotherapy, compliance, prior authorization, sibutramine, weight loss

Introduction
Medication compliance is notoriously poor in all conditions, with reported rates as low as 5% over 5 years among
women taking hormone replacement (in 1991) (1), 38% for
a 10-day course of antibiotics for community-acquired
pneumonia (2), and 47% for life-saving chemotherapy
among black children in South Africa diagnosed with leukemia (3). The long-term management of obesity is particularly beset by medication noncompliance. The risk for
weight regain is even greater than the risk for those with
major organ cancer to succumb to the cancer (4). Long-term
medication use could become an increasingly necessary
proposition. Understanding medication compliance in the
treatment of obesity is, thus, a fundamental concern.
The cost of medication is one of a long list of variables
that affect compliance. In the United States, there are varying degrees of insurer medication coverage and costs to the
patient:

free medication (e.g., samples, 100% third party coverage)

minimal cost medication without third party payer reimbursement (e.g., very low cost medication offered by
community clinics; typically $5 to $10 per month or
course of treatment)
multi-tier formulary medication (e.g., low copay for generics, medium copay for preferred brand name products,
and the highest copay for nonpreferred brand name drugs;
typically covering a range of $15 to $40)

Does Prior Authorization Improve Compliance/Weight Loss? Risser et al.

non-formulary medication reimbursed through a prior

authorization process (PAR)1 (also in the $15 to $40
range)
expensive non-formulary medication not reimbursed ($40
to $200 or more)

One might speculate that cost drives medication compliance where the prior authorization process is concerned. As
indicated above, a PAR-approved medication can save a
patient hundreds of dollars per month. However, when the
effect of cost on compliance was actually measured, a
modest 10% increase in compliance was derived from a
50% decrease in copayment (5).
Prior authorization typically requires that a letter or form
be submitted to an insurer by the prescribing provider. Prior
authorization is a requirement imposed by the payer that a
provider must justify specific need before the drug will be
covered. In terms of a particular prescription drug, the
provider must justify why that drug is needed for a particular patient. PAR has traditionally been a broad-based system for cost control of non-formulary medications. Many
payers place new (i.e., more expensive) medications on the
prior authorization requirement list for the companys drug
formulary. In a three-tiered system, pharmaceuticals not
previously covered by the plan are then allowed, although
with greater consumer cost sharing through copayments (6).
With medication costs rapidly outpacing inflation (7), the
prior authorization process is assuming an increasingly important role to subjects and payees alike. Recently, the
threat of requiring prior authorization before medication
could be prescribed for public assistance recipients was
used as leverage in getting discounts on prescription drugs
for non-public assistance recipients (8).
In our review of the literature, no published study has
evaluated the relative effect on compliance or outcomes by
comparing subjects with prior authorization approval to
those taking the same medication without reimbursement.
The working hypothesis of this retrospective analysis is that
the prior authorization process denotes a level of physician
commitment not required of the other levels of cost/reimbursement. This may be perceived by the patient as supportive endorsement by the physician and, therefore, effect
a greater commitment on the patients part to adhere to the
medication regimen.
A February 2002 study survey of 78 physicians and 1431
subjects found that subjects requested a specific prescription
from their provider at 12% of physician office visits (9). The
prior authorization request process is often the inverseit is
a physicians statement that, I believe my patient will

1
Nonstandard abbreviations: PAR, prescription partially reimbursed by prior authorization;
non-PAR, prescription not reimbursed by prior authorization.

significantly benefit from the use of this medication, and I

will actively negotiate for reimbursement by taking additional steps. The patient may or may not be an active
participant in requesting authorization.

Research Methods and Procedures

A retrospective chart review was conducted in three
Lindora Medical Clinics (commercial medically-based
weight loss clinics in southern California). All 22 subjects
who had received a prescription for sibutramine between
January 1, 2002 and April 30, 2003, in response to prior
authorization through their health care insurer (PAR), were
compared with 47 randomly selected subjects who did not
receive reimbursement of, although they were prescribed,
sibutramine (non-PAR) during the same time period.
The variables of compliance measured were medication
compliance and frequency of visits to nursing and allied
staff. A chart review was completed using the following
criteria:

ability to track a patients progress and treatment through

electronic and paper chart documentation
patient met the standard of care for treatment: BMI 30
kg/m2, appropriate follow-up visits, regularly recorded
vital signs, laboratory results, and appropriate documentation of treatment
age, 18 to 70 years
no weight loss medications other than sibutramine were
prescribed (e.g., orlistat or phentermine)
no contraindications for use of sibutramine (e.g., controlled hypertension with a blood pressure 160/95 mm
Hg and heart rate 100 beats/min).

Diet
Throughout the study, all subjects were instructed to
follow an initial weight loss phase consisting of 800 to 1200
kcal/d. They were instructed to record 24-hour food diaries
that were usually provided. Food diaries were reviewed at
each visit, and appropriate counseling was provided. After 8
weeks of weight loss, emphasis was placed on strategies to
maintain or lose at a more gradual rate.

Visits
In the first 10 weeks, subjects were seen 2 to 5 days per
week by a registered nurse with specific training in nutrition
and exercise counseling. Patients also saw a physician initially and on an as-needed basis (typically, once or twice in
a 3-month period). Every visit included a patient weigh-in,
exercise assessment, review of diet diary, and medication
tolerability. Blood pressure, heart rate, and anthropometric
measurements were also recorded weekly. During the subOBESITY RESEARCH Vol. 13 No. 1 January 2005

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Does Prior Authorization Improve Compliance/Weight Loss? Risser et al.

sequent 40 weeks, emphasis was placed on weight maintenance through well-balanced meals and regular exercise.
Medication
Every subject in the study was initially prescribed 15 mg
daily of sibutramine, with 30 capsules per month. Only 1
month of medication was prescribed at a time. Follow-up
visits with a physician were made after 1 week of medication use and then on an as-needed basis to assess medication
efficacy or adverse affects. Dosing was flexible and was
increased or decreased as required by individual patient
circumstances. If a higher dose of medication was indicated,
the number of pills required to last 30 days was prescribed.
Given the long list of variables that may influence compliance with medication or a weight loss regimen, five
covariates were defined in this population (age, sex, starting
BMI, geographic area, and comorbidities of obesity). PAR
and non-PAR subjects were matched on all five.
Program compliance was studied by recording the number of clinic sessions attended compared with the number
available (as a percentage of the total). Relative compliance
was defined by the total number of visits in a given time
period compared with the other 68 study subjects. Visits
consisted of sessions with a registered nurse or licensed
vocational nurse skilled in dietary and exercise counseling.
Program continuation was defined by the number of months
during which the patient visited the clinic at least once every
60 consecutive days.
Medication compliance was defined by the number of
months in which a prescription was written at 3, 6, 9, and 12
months. No confirmation that a written prescription was
actually filled, or if filled, that the medication was taken,
was made. Medication continuation was defined by the
number of continuous months that a prescription was written, with 60 days between prescriptions. Analysis was
conducted by intention to treat in both groups. No inclusion
criteria were dependent on medication or program compliance.
Statistical Analysis
The Students t test statistic was used to detect differences between groups in terms of weight loss and visit and
medication compliance. All p values are two-tailed; p
0.05 was considered statistically significant. To evaluate
relative proportion of visits (Table 2, visits months 1 to 12
by rank), statistical comparison of upper quartile visits
with lower quartile visits was done using Wilcoxon ranksum tests for counts of visits, with stratification by proportion of visits made (i.e., 25% of available visits, 25% to
50% of available visits, 50% to 75% of available visits, and
75% to 100% of available visits). To detect dropout (Table
3), we used the Fisher exact test comparison of dichotomous
variables, assuming unequal variances. Data are expressed
as means SD.
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OBESITY RESEARCH Vol. 13 No. 1 January 2005

Table 1. Demographics
Variables*

PAR

Non-PAR

Subjects (no.)
Mean age (years)
Percent men
Mean starting BMI
New/continuing subjects (no.)

22
49.4 12
9.1
39.3 7
11/11

47
47.1 10
21.3
37.1 6.12
28/19

* Values given as mean SD, except where otherwise noted, with

no significant differences among baseline parameters.

Results
Twenty-two subjects were eligible as PAR subjects. An
additional 47 subjects who were prescribed sibutramine
without PAR were randomly selected for comparison.
The baseline characteristics of the subjects are shown in
Table 1. There were no significant differences between the
groups in age, starting BMI, race, weight, or comorbidities.
More than twice as many men were in the non-PAR than the
PAR group. Fifty percent (11 of 22) of the subjects were
new to the program in the PAR group vs. 40% (28 of 47) in
the non-PAR group. To evaluate how these differences
could impact outcomes, weight loss by sex in both PAR and
non-PAR groups was analyzed and found to be insignificantly different.
Weight Loss
Weight loss by percentage of initial body weight at
months 3, 6, 9, and 12 is shown in Table 2 and Figure 1.
Mean weight loss among PAR subjects was 8.6 0% of
initial body weight by month 3 compared with 5.8 0.4%
among non-PAR subjects (p 0.02). The relative difference between groups was maximal by month 6, when PAR
subjects had lost 16 3.6% of their initial body weight,
which was 40% more than non-PAR subjects, who averaged
a loss of 9.9 3.8% (p 0.49). By month 9, the percentage
weight loss between groups was nearly identical in the PAR
and non-PAR groups (15.0 3.0% and 15.4 6.6%,
respectively; p 0.95). The trend continued through month
12. In absolute terms, average weight loss was 9.3 kg among
PAR vs. 6.1 kg among non-PAR subjects by month 3, 17.3
vs. 10.4 kg by month 6, 16.2 vs. 16.2 kg by month 9, and
11.2 vs. 10.6 kg by month 12.
Visit Compliance
The frequency of clinic visits stands out as the most
significantly different variable between PAR and nonPAR groups. PAR subjects made an average of 36.9 7.5
visits in the first 3 months compared with 24.6 4.6 in
the non-PAR group (p 0.006). Visit frequency re-

Does Prior Authorization Improve Compliance/Weight Loss? Risser et al.

Table 2. Weight loss and compliance outcomes

PAR
Variables
Weight loss
Percent weight loss by month
Percent weight loss by month
Percent weight loss by month
Percent weight loss by month
Visit compliance
No. of visits months 1 to 3
No. of visits months 4 to 6
No. of visits months 7 to 9
No. of visits months 10 to 12

Non-PAR

Mean (95% CI)

3
6
9
12

No. of visits months 1 to 12 by rank

Medication compliance
No. of prescriptions in 3 months
No. of prescriptions in 6 months
No. of prescriptions in 9 months
No. of prescriptions in 12 months

SE

8.6 (8.57 to 8.63)

16.0 (12.4 to 19.6)
15.0 (12.0 to 18.0)
11.0 (1.8 to 23.8)

Mean (95% CI)

SE

p
0.02*
0.49
0.95
0.46

0.83
0.61
0.39
1.71

5.8 (5.4 to 6.2)

9.9 (6.1 to 13.7)
15.4 (8.8 to 22.0)
10.0 (4.4 to 24.4)

0.95
1.59
3.33
1.92

36.9 (29.4 to 44.4)

23.2 (5.6 to 40.8)
22.2 (3.2 to 41.2)
14.9 (7.3 to 22.5)

3.43
3.05
2.38
2.79

24.6 (20.0 to 29.2)

13.2 (7.2 to 19.2)
19.4 (9.5 to 29.3)
21.7 (10.9 to 32.5)

2.38
2.96
4.78
6.64

72.5 (54.3 to 90.7)

8.74

40.5 (34.5 to 46.5)

1.67 (1.34 to 2.0)

2.43 (0.17 to 4.69)
2.76 (0.40 to 5.12)
2.76 (1.23 to 4.29)

0.17
0.32
0.44
0.60

1.46 (1.19 to 1.73)

1.52 (1.19 to 1.85)
1.76 (1.31 to 2.21)
1.85 (1.36 to 2.34)

0.006*
0.01*
0.09
0.12
(relative ranking)
5.97
0.0006*
0.13
0.17
0.23
0.25

0.34
0.02*
0.05*
0.11

Values given as mean [Confidence Interval (CI)], with no significant differences among baseline parameters.
* Significant difference at p 0.05.

mained significantly higher during the subsequent 3 months

at 23.2 17.6 vs. 13.2 6.0 (p 0.01). By month 9, visit
frequency no longer differed significantly between groups
with 22.2 19.0 vs. 19.4 9.9 (p 0.09) and 14.9 7.6
vs. 21.7 10.8 visits (p 0.12) in the 3-month periods
ending at 9 and 12 months, respectively. When all visits in
the 12-month period were ranked by quartile, PAR subjects
made 72.5 18.2 vs. 40.5 6.0 visits for non-PAR
subjects (p 0.0006).

Medication Compliance
PAR group subjects received significantly more prescriptions than non-PAR subjects in most of the 3-month intervals (Figure 2). Mirroring the trend in weight loss, the
difference between groups was significant by month 3, by
which time PAR subjects had received an average of 1.67
0.33 vs. 1.46 0.27 prescriptions (p 0.34), and was most
significant by month 6, when PAR subjects had received
2.43 2.26 vs. 1.52 0.33 prescriptions (p 0.02). PAR

Figure 1: Weight loss with 95% confidence intervals at 3, 6, 9, and 12 months in PAR and non-PAR groups.

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Does Prior Authorization Improve Compliance/Weight Loss? Risser et al.

Figure 2: Number of prescriptions with 95% confidence intervals at 3, 6, 9, and 12 months in PAR and non-PAR groups.

subjects continued to receive more prescriptions than their

non-PAR counterparts, although not as significantly as in
earlier months [2.76 2.36 vs. 1.76 0.45 (p 0.05) and
2.76 2.53 vs. 1.85 0.49 (p 0.11) at 9 and 12 months,
respectively].
When visit and program compliance were assessed by
dropout rate (Table 3), the difference between groups was
striking. None of the PAR subjects had dropped out by
month 3 compared with 47% of non-PAR subjects (p
0.00004). The trend continued through all 12 months, with
cumulative dropout rates of 18% vs. 68% at 6 months (p
0.0002), 45% vs. 79% at 9 months (p 0.01), and 55% vs.
85% at 12 months (p 0.01).

Discussion
In this study, subjects who received prior authorization
for sibutramine were more compliant with taking their medication, and they used the recommended dietary counseling
visits more frequently.
Three key findings of this study were 1) the proportion of
subjects dropping out of the clinic program was much

Table 3. Ranking of proportion dropping out of

clinic program at 3, 6, 9, and 12 months

No. (%) dropping

by month 3
No. (%) dropping
by month 6
No. (%) dropping
by month 9
No. (%) dropping
by month 12

PAR

Non-PAR

0 (0)

22 (47)

0.00004*

4 (18)

32 (68)

0.0002*

10 (45)

37 (79)

0.01*

12 (55)

40 (85)

0.01*

out
out
out
out

* Significant difference at p 0.05.

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OBESITY RESEARCH Vol. 13 No. 1 January 2005

higher among non-PAR subjects from the very start of the

program. As expected, the relative difference in attrition between groups decreased over time, although it remained highly
statistically significant throughout the 12 months (Table 3); 2)
a related variable, the number of clinic visits, was 40% higher
among PAR subjects throughout the 12 months (Table 2; No.
of visits months 1 to 12 by rank); and 3) weight loss was 40%
greater among PAR subjects than non-PAR subjects by month
6 (Figure 1).
Interestingly, two of the three trends (dropout and clinic
visits) were associated with desirable behaviors unrelated to
taking medication. Reasons for the trends are not entirely
clear. Given that prior authorization preceded these nonmedication outcomes, there may have been an unexpected
benefit of participating in the prior authorization process
that actually boosts adherence to visits and non-medication
therapies.
It may be that the patientphysician interaction required
to complete prior authorization elevates the patients perception of their condition from one of a behavioral orientation based on willpower, fortitude, or vanity to a more
bona-fide, disease-based medical orientation. The prescription of specific medications may validate the medical
basis of the patients disease and their weight loss efforts
and thereby mitigate some of the cultural shame subjects are
forced to carry in our body-conscious society. This, in turn,
may lead to a stronger doctorpatient therapeutic bond,
which is reflected in a lower dropout rate and better results.
Restoring hope in a patient can be seen as one of the
physicians most important charges. This is no more evident
than in the treatment of obesitya condition that is notoriously difficult to treat, for patient and physician, and that
is dependent on maintaining patient motivation. Advocating
on a patients behalf for a medical solution elevates the
physicians role of restoring hope.
Weight loss was significantly greater among PAR subjects as long as they continued to take the medication.
Surprisingly, even those subjects qualifying for prior authorization approval (and, thus, provided sibutramine at a sig-

Does Prior Authorization Improve Compliance/Weight Loss? Risser et al.

nificant discount) were non-compliant. There may be a

particular unwillingness among obese subjects to take medication as part of their treatment. Just as subjects embarking
on weight loss have expectations that far exceed the norm
(10), they may also be inappropriately confident in their
ability to lose and maintain weight without the assistance of
medication. In a survey of subjects in these same clinics,
only 12% indicated that they would definitely or probably (on a five-point Likert scale) use medication to assist
in weight loss. It should also be noted that no medication is
universally effective in producing weight loss. In this study,
18% in the PAR group and 40% in the non-PAR group were
non-responders to medication.
How medication is prescribed may also predict compliance. No studies were identified in which compliance was
associated with the amount of medication prescribed at a
time or the number of refills given. Adherence to clinic
visits and compliance with medication are certainly relatedmedication cannot be continued without regular visits
to a physicians office. However, some prescriptions are
written for 6 months or longer and, thus, require very
infrequent visits. In this study, only 30 capsules of sibutramine were prescribed at a time, and no refills were given,
with the intention that it would require more frequent visits.
An unpublished study of our clinics showed a strong association between the frequency of clinic visits and weight
loss outcomes. This is consistent with earlier studies, including a 1967 study in which subjects instructed to weigh
themselves four times a day lost and maintained more
weight loss than subjects in nearly every study published
since (11).
This was a retrospective study, and as such, groups could
not be carefully controlled. However, this may present real
world conditions in which participants do not receive incentives to comply with medication or program expectations. Nursing and counseling staff were unaware of which
subjects had PAR assistance, reducing the likelihood of a
Hawthorne effect (whereby the process of repeatedly measuring or inquiring about a behavior will affect the frequency of that behavior). Other confounding variables included the cost of both medication and a for-profit weight
loss program. Given a cost differential as much as 5-fold
between groups, we submit that cost had the most powerful
effect on compliance of any of the variables. However, the
clinics where the study was conducted are located in a
very-high-income region of southern California, and the
cost of medication may not be a limiting factor for some
participants. It should also be noted that, although the PAR
group received nearly twice as many prescriptions as nonPAR subjects, both were very non-compliant (PAR subjects
received just 23% of the prescriptions recommended for 1
year). However, that rate is comparable with subjects taking
medication for the treatment of type II diabetes, who have
been shown to be, on average, just 36% compliant at the end

of 1 year (12). These rates are dismal when considering

abundant evidence, on the one hand, that weight loss can
substantially reduce both costs and risks associated with
diabetes, hypertension, and hyperlipidemia (13,14) and, on
the other hand, that medication can prevent the comorbidities of diabetes. Also, there is no societal or media reinforcement for compliance associated with taking weight
control medication as occurs with every public service
announcement or pharmaceutical advertisement for the comorbidities of obesity. The study is also limited in scope by
not evaluating the amount of medication actually taken
(only the number of prescriptions dispensed) or the process
of prior authorization, which would better delineate patient
and physician roles in initiating a request. A follow-up study
may better show whether physician- or patient-initiated
prior authorization is more likely to improve compliance.
One of the primary criteria for requiring prior authorization should be a shown efficacy for the specific prescribed
medication that is greater than that provided by the standard formulary medication. In the treatment of obesity,
weight regain is usually the rule, so efficacy is defined by
long-term outcomes. To date, only sibutramine and orlistat
have shown long-term efficacy. With only 23% of potentially available prescriptions filled, this study suggests that,
perhaps, insurers should pay more attention on how to foster
compliance rather than on limiting access to these medications.
This study also intimates a link between physician commitment through the prior authorization process and compliance with medication. Continued medication use enhances long-term behavior change, which maintains weight
loss as long as it is used (15). Multi-tiered prescription drug
benefits do lower health plan prescription drug costs (16).
However, medication included on a formulary or approved
by the prior authorization process can prove essential in
preventing a relapse, hospitalization, or more serious exacerbations of an underlying disease (16). Whether such severe consequences are acute, as in asthma, or are long
delayed, as in obesity, subjects deserve to have a fair assessment of medication options from their physician and,
when appropriate, reimbursement from their insurer.

Acknowledgments
This was an investigator-initiated study by Dr. Risser,
which was not supported by any entity or company. Drs.
Risser and Vash have served as consultants for Abbott
Pharmaceuticals, the manufacturer of the study medication,
sibutramine. Dr. Vash is a member of the Speakers Bureau
of Abbott Pharmaceuticals. We thank Jerry Holderman
(Lindora Medical Clinics) and Dr. John Foreyt for critical
review of the manuscript and Cynthia Stamper-Graff (President and CEO of Lindora Medical Clinics) for ongoing
support, encouragement, and vision.
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