U.S. Adults Ambivalent about the Risks and Benefits of
Off-label Prescription Drug Use
ROCHESTER, N.Y. – December 7, 2006 – According to the latest
Wall Street Journal Online/Harris Interactive Health-Care Poll, U.S. adults are
either divided or ambivalent when it comes to the issue of off-label
prescription drug use. While it is legal for doctors to prescribe prescription
drugs for diseases other than those for which they have been approved by the
U.S. Food and Drug Administration (FDA), there are strict rules governing the
marketing of a drug for treatment of a disease for which it hasn't been
approved. About one-third (27%)of adults say that prescribing drugs off-label
should be allowed, while one-third say in most cases, the risks of doing so
outweigh the benefits.
These are some of the results of an online survey of 3,018 U.S. adults, ages
18 and older, conducted by Harris Interactive® between November 15
and 17, 2006 for The Wall Street Journal Online’s Health Industry Edition (www.wsj.com/health).
Interestingly, half (50%) of all adults incorrectly believe that once a drug
is approved, a doctor can prescribe it only for the diseases for which it has
been approved by the FDA, and another quarter (25%) are unsure. Nearly half
(48%) think that doctors should not be allowed to prescribe drugs for off-label
uses and even more (69%) think drug companies should not be allowed to encourage
off-label use. However, a plurality (55%) agrees that if doctors aren’t
allowed to prescribe freely, it will be much more difficult to find new and
innovative ways to treat diseases.
Approximately one in three (31%) adults believes that in most cases, the
benefits of off-label prescription drug use outweigh the risks, but an equal
proportion (34%) believes the opposite is true. The greatest level of agreement
amongst adults in this poll is on the potential prohibition of off-label
prescription drug use, except as part of a clinical trial, with nearly
two-thirds (62%) agreeing with such restrictions.
What do these findings suggest for payers and regulators who continue to look
for ways to contain the rising costs of healthcare; and for drug companies whose
products often garner significant revenue from off-label usage? According to
Katherine Binns, Division President of Healthcare Research for Harris
Interactive, "Precedent has been set for prohibiting payment for certain
types of surgical procedures except to patients who are enrolled in a clinical
trial. These findings suggest that U.S. adults do not want to hamper innovation,
but would also be supportive of increased oversight and limitations being
applied to the off-label use of prescription drugs."
TABLE 1
PRESCRIBING FDA APPROVED DRUGS
"The Food and Drug Administration (FDA) approves new
prescription drugs for use only after medical research has found that they are
safe and effective for treating specific diseases. Which of the following do you
think is true?"
Base: All Adults
| |
2004 |
2006 |
|
% |
% |
|
Once a drug is approved, a doctor can prescribe it only for the
diseases for which it has been approved by the FDA. |
51 |
50 |
|
Once a drug is approved, a doctor can prescribe it for any disease,
including those for which it has not approved. |
31 |
26 |
|
Not sure |
17 |
25 |
Note: Percentages may not add up exactly to 100% due to rounding.
TABLE 2
PRESCRIBING DRUGS OFF-LABEL
"Do you think doctors should or should not be allowed to
prescribe a drug for diseases for which that drug has not been approved by the
FDA?"
Base: All Adults
| |
2004 |
2006 |
|
% |
% |
|
Should be allowed |
31 |
27 |
|
Should not be allowed |
48 |
48 |
|
Not sure |
22 |
24 |
Note: Percentages may not add up exactly to 100% due to rounding.
TABLE 3
PHARMACEUTICAL COMPANIES ENCOURAGING DOCTORS TO PRESCRIBE
DRUGS OFF-LABEL
"Do you think that pharmaceutical companies should
or should not be allowed to encourage doctors to prescribe a drug for diseases
for which that drug has not been approved by the FDA?"
Base: All Adults
| |
2004 |
2006 |
|
% |
% |
|
Should be allowed |
12 |
12 |
|
Should not be allowed |
73 |
69 |
|
Not sure |
15 |
20 |
Note: Percentages may not add up exactly to 100% due to rounding.
TABLE 4
PERCEPTIONS OF THE PROS AND CONS OF OFF-LABEL PRESCRIBING
"To what extent do you agree or disagree with the
following statements?"
Base: All Adults
| |
Agree Strongly/ Somewhat (NET) |
Agree Strongly |
Agree Somewhat |
Disagree Strongly/ Somewhat
(NET) |
Disagree Somewhat |
Disagree Strongly |
Not Sure |
|
% |
% |
% |
% |
% |
% |
% |
|
Doctors should be allowed to decide which prescription drug treatments
to use with their patients regardless of what diseases they have or have
not been approved for by the FDA. |
45 |
16 |
29 |
46 |
23 |
23 |
10 |
|
Prescription drug use for unapproved medical conditions should be
prohibited except as part of the clinical research trial. |
62 |
30 |
32 |
28 |
18 |
10 |
10 |
|
If doctors aren’t allowed to prescribe freely it will be much more
difficult to find new and innovative ways to treat diseases. |
55 |
20 |
35 |
35 |
21 |
14 |
10 |
Note: Percentages may not add up exactly to 100% due to rounding.
TABLE 5
PRESCRIBING DRUGS FOR UNAPPROVED DISEASES
"When it comes to using prescription drugs for unapproved
diseases, which of these statements would you tend to agree with more?"
Base: All Adults
| |
Total |
|
% |
|
In most cases the risks outweigh the benefits. |
34 |
|
In most cases the benefits outweigh the risks. |
31 |
|
Not sure |
36 |
Note: Percentages may not add up exactly to 100% due to rounding.
Methodology
Harris Interactive® conducted this online survey within the
United States between November 15 and 17, 2006 among a national cross section of
3,018 adults, ages 18 years and over. Figures for age, gender, race/ethnicity,
education, income and region were weighted where necessary to align with
population proportions. Propensity score weighting was also used to adjust for
respondents' propensity to be online.
All surveys are subject to several sources of error. These include: sampling
error (because only a sample of a population is interviewed); measurement error
due to question wording and/or question order, deliberately or unintentionally
inaccurate responses, nonresponse (including refusals), interviewer effects
(when live interviewers are used) and weighting.
With one exception (sampling error) the magnitude of the errors that result
cannot be estimated. There is, therefore, no way to calculate a finite
"margin of error" for any survey and the use of these words should be
avoided.
With pure probability samples, with 100 percent response rates, it is
possible to calculate the probability that the sampling error (but not other
sources of error) is not greater than some number. With pure probability samples
of 3,018 adults, one could say with a ninety-five percent probability that the
results would have a sampling error of +/- 3 percentage points. However that
does not take other sources of error into account. This online survey is not
based on a probability sample and therefore no theoretical sampling error can be
calculated.
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About Harris Interactive
Harris Interactive is the 12th largest and fastest-growing market
research firm in the world. The company provides research-driven insights and
strategic advice to help its clients make more confident decisions which lead to
measurable and enduring improvements in performance. Harris Interactive is
widely known for The Harris Poll, one of the longest running, independent
opinion polls and for pioneering online market research methods. The company has
built what it believes to be the world’s largest panel of survey respondents,
the Harris Poll Online. Harris Interactive serves clients worldwide through its
United States, Europe and Asia offices, its wholly-owned subsidiary Novatris in
France and through a global network of independent market research firms. The
service bureau, HISB, provides its market research industry clients with
mixed-mode data collection, panel development services as well as syndicated and
tracking research consultation. More information about Harris Interactive may be
obtained at www.harrisinteractive.com.
Press Contacts:
Michelle Soto
Harris Interactive
585-214-7665
Christine Mohan
Dow Jones & Company
212-416-2114
|
